1,968 New and Expanded Secretarial Powers Under the Health Reform Law, P.L.
111-148, Signed into Law March 23, 2010
1001
1 HHS/Labor/Treasury
COVERAGE OF PREVENT VE HEALTH SERV CES The Sec e a y sha es ab sh a
m n mum n e va be ween he da e on wh ch a ecommenda on … s ssued
and he p an yea … s e ec ve
1001 HHS
EXTENS ON OF DEPENDENT COVERAGE b REGULAT ONS —The
Sec e a y sha p omu ga e egu a ons o define he dependen s o wh ch cove -
age sha be made ava ab e …
1001 HHS
DEVELOPMENT AND UT L ZAT ON OF UN FORM EXPLANAT ON OF COVERAGE
DOCUMENTS AND STANDARD ZED DEF N T ONS a No a e han 12 mon hs
a e he da e o enac men o he PPACA he Sec e a y sha deve op s anda ds
o use by a g oup hea h p an and a hea h nsu ance ssue o e ng g oup o
nd v dua hea h nsu ance cove age …
1001 HHS
DEVELOPMENT AND UT L ZAT ON OF UN FORM EXPLANAT ON OF COVERAGE
DOCUMENTS AND STANDARD ZED DEF N T ONS g DEVELOPMENT OF STAN-
DARD DEF N T ONS — 1 The Sec e a y sha … p ov de o he deve opmen o
s anda ds o he defin ons o e ms used n hea h nsu ance cove age …
1001 HHS
ENSUR NG THE QUAL TY OF CARE a QUAL TY REPORT NG — 1 No a e han
2 yea s a e he da e o enac men o he PPACA he Sec e a y … sha deve op
epo ng equ emen s o use by a g oup hea h p an and a hea h nsu ance
ssue o e ng g oup o nd v dua hea h nsu ance cove age …
1001 HHS
ENSUR NG THE QUAL TY OF CARE 2 REPORT NG REQU REMENTS — A A g oup
hea h p an and a hea h nsu ance ssue o e ng g oup o nd v dua hea h
nsu ance cove age sha annua y subm o he Sec e a y and o en o ees unde
he p an o cove age a epo on whe he he benefi s unde he p an o cove age
sa s y he e emen s …
1001 HHS
ENSUR NG THE QUAL TY OF CARE C REGULAT ONS —No a e han 2 yea s
a e he da e o enac men o he PPACA he Sec e a y sha p omu ga e egu a-
ons ha p ov de c e a o de e m n ng whe he a e mbu semen s uc u e s
desc bed
1001 HHS
STANDARD HOSP TAL CHARGES —Each hosp a ope a ng w h n he U S
sha o each yea es ab sh and upda e and make pub c n acco dance w h
gu de nes deve oped by he Sec e a y a s o he hosp a s s anda d cha ges
o ems and se v ces p ov ded by he hosp a …
1001 HHS
DEF N T ONS —The Sec e a y n consu a on w h he Na ona Assoc a on o
nsu ance Comm ss ons sha es ab sh un o m defin ons o he ac v es
epo ed …
1001 HHS
The Sec e a y sha awa d g an s o S a es o enab e such S a es … o es ab sh
expand o p ov de suppo …
1001 HHS
CR TER A —A S a e ha ece ves a g an unde h s sec on sha comp y w h
c e a es ab shed by he Sec e a y o ca y ng ou ac v es unde such g an
1001 HHS/Treasury/Labor
DATA COLLECT ON — … an o fice o hea h nsu ance consume ass s ance o
ombudsman p og am sha be equ ed o co ec and epo da a o he Sec e a y
… The Sec e a y sha u ze such da a o den y a eas whe e mo e en o ce-
men ac on s necessa y and sha sha e such n o ma on
1001 HHS
N T AL PREM UM REV EW PROCESS —The Sec e a y … sha es ab sh a
p ocess o he annua ev ew beg nn ng w h he 2010 p an yea … o
un easonab e nc eases n p em ums o hea h nsu ance cove age
1001 HHS
JUST F CAT ON AND D SCLOSURE — … equ e hea h nsu ance ssue s o
subm o he Sec e a y and he e evan S a e a us fica on o an un easonab e
p em um nc ease p o o he mp emen a on o he nc ease … The Sec e a y
sha ensu e he pub c d sc osu e o n o ma on on such nc eases and us fica-
ons o a hea h nsu ance ssue s
1001 HHS
MON TOR NG BY SECRETARY OF PREM UM NCREASES — A Beg nn ng w h
p an yea s beg nn ng n 2014 he Sec e a y n con unc on w h he S a es …
sha mon o p em um nc eases o hea h nsu ance cove age o e ed h ough
an Exchange and ou s de o an Exchange
1001 HHS
GRANTS N SUPPORT OF PROCESS — 1 PREM UM REV EW GRANTS DUR NG
2010 THROUGH 2014 —The Sec e a y sha ca y ou a p og am o awa d g an s
o S a es … A n ev ew ng and app op a e unde S a e aw app ov ng p e-
m um nc eases o hea h nsu ance cove age and B n p ov d ng n o ma on
and ecommenda ons o he Sec e a y …
1001 HHS
ALLOCAT ON —The Sec e a y sha es ab sh a o mu a o de e m n ng he
amoun o any g an o a S a e
1101 HHS
No a e han 90 days a e he da e o enac men o h s Ac he Sec e a y sha
es ab sh a empo a y h gh sk hea h nsu ance poo p og am …
1101 HHS
ADM N STRAT ON — 1 The Sec e a y may ca y ou he p og am unde h s
sec on d ec y o h ough con ac s o e g b e en es
1101 HHS
EL G BLE ENT T ES —To be e g b e o a con ac … an en y sha … B subm
o he Sec e a y an app ca on a such me n such manne and con a n ng such
n o ma on as he Sec e a y may equ e …
1101 Treasury
REQU REMENTS — A qua fied h gh sk poo mee s he equ emen s o h s
pa ag aph such poo — B p ov des hea h nsu ance cove age — … he Sec-
e a y may mod y such m necessa y o ensu e he poo mee s he ac ua a
va ue m unde c ause
1101 HHS
REQU REMENTS — A qua fied h gh sk poo mee s he equ emen s o h s
pa ag aph such poo — D mee s any o he equ emen s de e m ned app op -
a e by he Sec e a y
1101 HHS
REQU REMENTS —A qua fied h gh sk poo mee s he equ emen s o h s
pa ag aph such poo — … such nd v dua — 3 has a p e-ex s ng cond on
as de e m ned n a manne cons s en w h gu dance ssued by he Sec e a y
1101 HHS
PROTECT ON AGA NST DUMP NG R SK BY NSURERS — 1 The Sec e a y
sha es ab sh c e a o de e m n ng whe he hea h nsu ance ssue s and
emp oymen -based hea h p ans have d scou aged an nd v dua om ema n ng
en o ed n p o cove age based on ha nd v dua s hea h s a us
1101 HHS
PROTECT ON AGA NST DUMP NG R SK BY NSURERS — 2 SANCT ONS —An
ssue o emp oymen -based hea h p an sha be espons b e o e mbu s ng he
p og am … o he med ca expenses ncu ed by he p og am o an nd v dua
who based on c e a es ab shed by he Sec e a y he Sec e a y finds was
encou aged by he ssue o d sen o om hea h benefi s cove age p o o
en o ng n cove age h ough he p og am
1101 HHS
n he case o an nd v dua whose p em um o he p o cove age exceeded
he p em um equ ed by he p og am … — he p o cove age s a po cy ha
s no onge be ng ac ve y ma ke ed as defined by he Sec e a y by he ssue
1101 HHS
OVERS GHT —The Sec e a y sha es ab sh— 1 an appea s p ocess o enab e
nd v dua s o appea a de e m na on unde h s sec on and 2 p ocedu es o
p o ec aga ns was e aud and abuse
1101 HHS
FUND NG TERM NAT ON OF AUTHOR TY — 2 NSUFF C ENT FUNDS — he Sec-
e a y es ma es o any fisca yea ha he agg ega e amoun s ava ab e o he
paymen o he expenses o he h gh sk poo w be ess han he ac ua amoun
o such expenses he Sec e a y sha make such ad us men s as a e necessa y
o e m na e such defic
1101 HHS
TERM NAT ON OF AUTHOR TY — B TRANS T ON TO EXCHANGE —The Sec e a y
sha deve op p ocedu es o p ov de o he ans on o e g b e nd v dua s en-
o ed n hea h nsu ance cove age o e ed h ough a h gh sk poo es ab shed
unde h s sec on n o qua fied hea h p ans o e ed h ough an Exchange Such
p ocedu es sha ensu e ha he e s no apse n cove age … he Sec e a y
de e m nes necessa y o avo d such a apse
1101 HHS
L M TAT ONS —The Sec e a y has he au ho y o s op ak ng app ca ons o pa -
c pa on n he p og am unde h s sec on o comp y w h he und ng m a on …
1102 HHS
RE NSURANCE FOR EARLY RET REES a ADM N STRAT ON — 1 No a e han
90 days a e he da e o enac men o h s Ac he Sec e a y sha es ab sh
a empo a y e nsu ance p og am o p ov de e mbu semen o pa c pa ng
emp oymen -based p ans o a po on o he cos o p ov d ng hea h nsu ance
cove age o ea y e ees …
1102 HHS
2 REFERENCE — A HEALTH BENEF TS —The e m “hea h benefi s means
med ca su g ca hosp a p esc p on d ug and such o he benefi s as sha be
de e m ned by he Sec e a y …
1102 HHS
b PART C PAT ON — 1 EMPLOYMENT-BASED PLAN EL G B L TY —A pa c pa -
ng emp oymen -based p an s an emp oymen -based p an ha — B subm s
o he Sec e a y an app ca on o pa c pa on n he p og am a such me n
such manne and con a n ng such n o ma on as he Sec e a y sha equ e
1102 HHS
b PART C PAT ON — 1 EMPLOYMENT-BASED PLAN EL G B L TY —A pa c pa -
ng emp oymen -based p an s an emp oymen -based p an ha C s ce fied by
he Sec e a y
1102 HHS
c PAYMENTS — 1 SUBM SS ON OF CLA MS — A A pa c pa ng emp oymen -
based p an sha subm c a ms o e mbu semen o he Sec e a y wh ch sha
con a n documen a on o he ac ua cos s o he ems and se v ces o wh ch
each c a m s be ng subm ed
2
2001 HHS
MED CA D COVERAGE FOR THE LOWEST NCOME POPULAT ONS y NCREASED
FMAP FOR MED CAL ASS STANCE FOR NEWLY EL G BLE MANDATORY ND V DU-
ALS — B FULL BENEF TS —The e m u benefi s means … o s de e m ned
by he Sec e a y o be subs an a y equ va en o he med ca ass s ance ava -
ab e o an nd v dua …
2001 HHS
e he S a e has e ec ed he op on o p ov de a p esump ve e g b y pe od
… he S a e may e ec o p ov de a p esump ve e g b y pe od … o nd v du-
a s who a e e g b e o med ca ass s ance … n he same manne as he S a e
p ov des o such a pe od … sub ec o such gu dance as he Sec e a y sha
es ab sh
2001 HHS
gg MA NTENANCE OF EFFORT — 1 GENERAL REQU REMENT TO MA NTA N EL -
G B L TY STANDARDS UNT L STATE EXCHANGE S FULLY OPERAT ONAL —Sub ec
o he succeed ng pa ag aphs o h s subsec on du ng he pe od ha beg ns on
he da e o enac men o he PPACA and ends on he da e on wh ch he Sec e a y
de e m nes ha an Exchange es ab shed by he S a e …
2001 HHS
3 NONAPPL CAT ON —Du ng he pe od ha beg ns on Janua y 1 2011 and
ends on Decembe 31 2013 … he S a e ce fies o he Sec e a y ha w h
espec o he S a e fisca yea du ng wh ch he ce fica on s made he S a e
has a budge defic o w h espec o he succeed ng S a e fisca yea he S a e
s p o ec ed o have a budge defic …
2001 HHS
d ANNUAL REPORTS ON MED CA D ENROLLMENT — 1 STATE REPORTS … be-
g nn ng Janua y 2015 and annua y he ea e he S a e sha subm a epo o
he Sec e a y ha con a ns— A he o a numbe o en o ed and new y en o ed
nd v dua s n he S a e p an o unde a wa ve o he p an … o unde a wa ve o
he p an as he Sec e a y may equ e C any o he da a epo ng de e m ned
necessa y by he Sec e a y o mon o en o men and e en on o nd v dua s
e g b e o med ca ass s ance …
2001 HHS
2 REPORTS TO CONGRESS —Beg nn ng Ap 2015 and annua y he ea e
he Sec e a y o HHS sha subm a epo o he app op a e comm ees o
Cong ess on he o a en o men and new en o men n Med ca d … and sha
nc ude n each such epo such ecommenda ons o adm n s a ve o eg s a-
ve changes o mp ove en o men n he Med ca d p og am as he Sec e a y
de e m nes app op a e
2002 HHS
NCOME EL G B L TY FOR NONELDERLY DETERM NED US NG MOD F ED GROSS
NCOME a … Fo pu poses o comp y ng w h he ma n enance o e o e-
qu emen s … a S a e sha wo k ng w h he Sec e a y es ab sh an equ va en
ncome es ha ensu es nd v dua s e g b e o med ca ass s ance unde he
S a e p an o unde a wa ve o he p an on he da e o enac men o he PPACA
do no ose cove age unde he S a e p an o unde a wa ve o he p an The
Sec e a y may wa ve such p ov s ons as a e necessa y o ensu e ha S a es
es ab sh ncome and e g b y de e m na on sys ems ha p o ec benefic a es
2002 HHS
E TRANS T ON PLANN NG AND OVERS GHT —Each S a e sha subm o he
Sec e a y o he Sec e a y s app ova he ncome e g b y h esho ds p oposed
o be es ab shed us ng mod fied g oss ncome and househo d ncome … The
Sec e a y sha ensu e ha he ncome e g b y h esho ds p oposed o be
es ab shed us ng mod fied g oss ncome and househo d ncome … w no
esu n ch d en who wou d have been e g b e o med ca ass s ance unde he
S a e p an o unde a wa ve o he p an on he da e o enac men o he PPACA
no onge be ng e g b e o such ass s ance
2202 HHS
PERM TT NG HOSP TALS TO MAKE PRESUMPT VE EL G B L TY DETERM NAT ONS
FOR ALL MED CA D EL G BLE POPULAT ONS a … B … any hosp a ha s
a pa c pa ng p ov de unde he S a e p an may e ec o be a qua fied en y
o pu poses o de e m n ng … whe he any nd v dua s e g b e o med ca
ass s ance unde he S a e p an o unde a wa ve o he p an … sub ec o such
gu dance as he Sec e a y sha es ab sh
2202 HHS
c EFFECT VE DATE — 2 EXCEPT ON F STATE LEG SLAT ON REQU RED — n
he case o a S a e p an o med ca ass s ance … wh ch he Sec e a y o HHS
de e m nes equ es S a e eg s a on … he S a e p an sha no be ega ded
as a ng o comp y w h he equ emen s o such e so e y on he bas s o s
a u e o mee h s add ona equ emen …
2401 HHS
COMMUN TY F RST CHO CE OPT ON A AVA LAB L TY —The S a e sha make
ava ab e home and commun y-based a endan se v ces and suppo s o e g b e
nd v dua s … p ov ded by an nd v dua who s qua fied o p ov de such
se v ces nc ud ng am y membe s as defined by he Sec e a y
2401 HHS
E co ec and epo n o ma on as de e m ned necessa y by he Sec e a y o
he pu poses o app ov ng he S a e p an amendmen …
1102 HHS
c PAYMENTS 2 PROGRAM PAYMENTS — he Sec e a y de e m nes ha a
Title I: Health Insurance Coverage
pa c pa ng emp oymen -based p an has subm ed a va d c a m unde pa a-
g aph 1 he Sec e a y sha e mbu se such p an o 80 pe cen o ha po on
o he cos s a bu ab e o such c a m ha exceed $15 000 …
1102 HHS
c PAYMENTS 4 USE OF PAYMENTS —Amoun s pa d o a pa c pa ng
emp oymen -based p an sha be used o owe cos s o he p an … Such pay-
men s sha no be used as gene a evenues … The Sec e a y sha deve op a
mechan sm o mon o he app op a e use o such paymen s by such en es
1102 HHS
c PAYMENTS 6 APPEALS —The Sec e a y sha es ab sh— A an appea s
p ocess o pe m pa c pa ng emp oymen -based p ans o appea a de e m na-
on o he Sec e a y w h espec o c a ms subm ed unde h s sec on and B
p ocedu es o p o ec aga ns aud was e and abuse unde he p og am
1102 HHS
d AUD TS —The Sec e a y sha conduc annua aud s o c a ms da a subm ed
by pa c pa ng emp oymen based p ans …
1102 HHS
e FUND NG —The e s app op a ed o he Sec e a y ou o any moneys n he
T easu y no o he w se app op a ed $5 000 000 000 o ca y ou he p og am
unde h s sec on …
1102 HHS
L M TAT ON — The Sec e a y has he au ho y o s op ak ng app ca ons o
pa c pa on n he p og am based on he ava ab y o und ng …
1103 HHS
a NTERNET PORTAL TO AFFORDABLE COVERAGE OPT ONS — 1 MMED ATE
ESTABL SHMENT —No a e han Ju y 1 2010 he Sec e a y n consu a on
w h he S a es sha es ab sh a mechan sm nc ud ng an n e ne webs e
h ough wh ch a es den o any S a e may den y a o dab e hea h nsu ance
cove age op ons n ha S a e
1103 HHS
b ENHANC NG COMPARAT VE PURCHAS NG OPT ONS — 1 No a e han
60 days a e he da e o enac men o h s Ac he Sec e a y sha deve op a
s anda d zed o ma o be used o he p esen a on o n o ma on e a ng o he
cove age op ons …
1103 HHS
b ENHANC NG COMPARAT VE PURCHAS NG OPT ONS 2 USE OF FORMAT —The
Sec e a y sha u ze he o ma deve oped unde pa ag aph 1 n comp ng
n o ma on conce n ng cove age op ons on he n e ne webs e …
1103 HHS
c AUTHOR TY TO CONTRACT —The Sec e a y may ca y ou h s sec on h ough
con ac s en e ed n o w h qua fied en es
1104 HHS
ADM N STRAT VE S MPL F CAT ON 4 REQU REMENTS FOR F NANC AL AND
ADM N STRAT VE TRANSACT ONS — A The s anda ds and assoc a ed ope a -
ng u es adop ed by he Sec e a y sha — … enab e de e m na on o an
nd v dua s e g b y and financ a espons b y … be comp ehens ve …
p ov de o me y acknow edgmen esponse and s a us epo ng … and
v desc be a da a e emen s … n unamb guous e ms equ e ha such da a
e emen s be equ ed o cond oned upon se va ues n o he fie ds and p oh b
add ona cond ons …
1104 HHS
B REDUCT ON OF CLER CAL BURDEN — n adop ng s anda ds and ope a ng
u es o he ansac ons e e ed o unde pa ag aph 1 he Sec e a y sha
seek o educe he numbe and comp ex y o o ms … and da a en y equ ed
by pa en s and p ov de s
1104 HHS
g OPERAT NG RULES — 1 The Sec e a y sha adop a s ng e se o ope a ng
u es o each ansac on e e ed o unde subsec on a 1 w h he goa o
c ea ng as much un o m y n he mp emen a on o he e ec on c s anda ds as
poss b e …
1104 HHS
4 MPLEMENTAT ON — A The Sec e a y sha adop ope a ng u es … o -
ow ng cons de a on o he ope a ng u es deve oped by he non-p ofi en y
desc bed n pa ag aph 2 and he ecommenda on subm ed by he Na ona
Comm ee on V a and Hea h S a s cs … and hav ng ensu ed consu a on w h
p ov de s
1104 HHS
C EXPED TED RULEMAK NG —The Sec e a y sha p omu ga e an n e m fina
u e app y ng any s anda d o ope a ng u e ecommended by he Na ona Com-
m ee on V a and Hea h S a s cs … The Sec e a y sha accep and cons de
pub c commen s on any n e m fina u e …
1104 HHS
h COMPL ANCE — 1 HEALTH PLAN CERT F CAT ON — A EL G B L TY FOR A
HEALTH PLAN HEALTH CLA M STATUS ELECTRON C FUNDS TRANSFERS HEALTH
CARE PAYMENT AND REM TTANCE ADV CE —No a e han Decembe 31 2013 a
hea h p an sha fi e a s a emen w h he Sec e a y n such o m as he Sec e a y
may equ e ce y ng ha he da a and n o ma on sys ems o such p an a e n
comp ance w h any app cab e s anda ds … and assoc a ed ope a ng u es …
o e ec on c unds ans e s e g b y o a hea h p an hea h c a m s a us and
hea h ca e paymen and em ance adv ce espec ve y
1104 HHS
2 DOCUMENTAT ON OF COMPL ANCE —A hea h p an sha p ov de he Sec e-
a y n such o m as he Sec e a y may equ e w h adequa e documen a on o
comp ance w h he s anda ds and ope a ng u es … A hea h p an sha no be
cons de ed o have p ov ded adequa e documen a on and sha no be ce -
fied as be ng n comp ance w h such s anda ds un ess he hea h p an— A
demons a es o he Sec e a y ha he p an conduc s he e ec on c ansac ons
spec fied n pa ag aph 1 n a manne ha u y comp es w h he egu a ons
o he Sec e a y and B p ov des documen a on show ng ha he p an has
comp e ed end- o-end es ng o such ansac ons w h he pa ne s such as
hosp a s and phys c ans
1104 HHS
4 CERT F CAT ON BY OUTS DE ENT TY —The Sec e a y may des gna e ndepen-
den ou s de en es o ce y ha a hea h p an has comp ed w h he equ e-
men s unde h s subsec on p ov ded ha he ce fica on s anda ds emp oyed
by such en es a e n acco dance w h any s anda ds o ope a ng u es ssued
by he Sec e a y
1104 HHS
5 COMPL ANCE W TH REV SED STANDARDS AND OPERAT NG RULES — A
A hea h p an … sha fi e a s a emen w h he Sec e a y n such o m as he
Sec e a y may equ e ce y ng ha he da a and n o ma on sys ems o such
p an a e n comp ance w h any app cab e ev sed s anda ds and assoc a ed
ope a ng u es unde h s subsec on o any n e m fina u e p omu ga ed by
he Sec e a y …
1104 HHS
6 AUD TS OF HEALTH PLANS —The Sec e a y sha conduc pe od c aud s o
ensu e ha hea h p ans … a e n comp ance w h any s anda ds and ope a ng
u es …
1104 HHS
REV EW AND AMENDMENT OF STANDARDS AND OPERAT NG RULES — 1
ESTABL SHMENT —No a e han Janua y 1 2014 he Sec e a y sha es ab sh
a ev ew comm ee …
1104 HHS
3 NTER M F NAL RULEMAK NG — A Any ecommenda ons o amend adop ed
s anda ds and ope a ng u es ha have been app oved by he ev ew comm -
ee and epo ed o he Sec e a y … sha be adop ed by he Sec e a y h ough
p omu ga on o an n e m fina u e no a e han 90 days a e ece p o he
comm ee s epo
1104 HHS
4 REV EW COMM TTEE — A DEF N T ON —Fo he pu poses o h s subsec-
on he e m ev ew comm ee means a comm ee cha e ed by o w h n
he Depa men o Hea h and Human se v ces ha has been des gna ed by he
Sec e a y o ca y ou h s subsec on nc ud ng … any app op a e comm ee as
de e m ned by he Sec e a y
1104 HHS
5 OPERAT NG RULES FOR OTHER STANDARDS ADOPTED BY THE SECRETARY —
The Sec e a y sha adop a s ng e se o ope a ng u es … o any ansac on
o wh ch a s anda d had been adop ed pu suan o subsec on a 1 B
1104 HHS
PENALT ES — 1 PENALTY FEE — A No a e han Ap 1 2014 and annua y
he ea e he Sec e a y sha assess a pena y ee … aga ns a hea h p an
ha has a ed o mee he equ emen s unde subsec on h w h espec o ce -
fica on and documen a on o comp ance w h … a s anda d … o any o he
financ a and adm n s a ve ansac ons
1104 HHS
B FEE AMOUNT —Sub ec o subpa ag aphs C D and E he Sec e a y sha
assess a pena y ee aga ns a hea h p an n he amoun o $1 pe cove ed e
un ce fica on s comp e e …
1104 HHS
F DETERM NAT ON OF COVERED ND V DUALS —The Sec e a y sha de e m ne
he numbe o cove ed ves unde a hea h p an based upon he mos ecen
s a emen s and fi ngs ha have been subm ed by such p an o he Secu es
and Exchange Comm ss on
1104 HHS/Treasury
2 NOT CE AND D SPUTE PROCEDURE —The Sec e a y sha es ab sh a p oce-
du e o assessmen o pena y ees unde h s subsec on ha p ov des a hea h
p an w h easonab e no ce and a d spu e eso u on p ocedu e p o o p ov s on
o a no ce o assessmen by he Sec e a y o he T easu y …
1104 HHS/Treasury
3 PENALTY FEE REPORT —No a e han May 1 2014 and annua y he ea e
he Sec e a y sha p ov de he Sec e a y o he T easu y w h a epo den y ng
hose hea h p ans ha have been assessed a pena y ee
1104 HHS
c PROMULGAT ON OF RULES — 1 UN QUE HEALTH PLAN DENT F ER —The
Sec e a y sha p omu ga e a fina u e o es ab sh a un que hea h p an den fie
… based on he npu o he Na ona Comm ee on V a and Hea h S a s cs …
1104 HHS
2 ELECTRON C FUNDS TRANSFER —The Sec e a y sha p omu ga e a fina u e
o es ab sh a s anda d o e ec on c unds ans e s …
1104 HHS
3 HEALTH CLA MS ATTACHMENTS —The Sec e a y sha p omu ga e a fina u e
o es ab sh a ansac on s anda d and a s ng e se o assoc a ed ope a ng u es
o hea h c a ms a achmen s … ha s cons s en w h he X12 Ve s on 5010
ansac on s anda ds …
Title II: Government Programs (52 Delegations)
2401 HHS
5 EVALUAT ON DATA COLLECT ON AND REPORT TO CONGRESS — A EVALU-
AT ON —The Sec e a y sha conduc an eva ua on o he p ov s on o home and
commun y-based a endan se v ces and suppo s unde h s subsec on n o de
o de e m ne he e ec veness o he p ov s on o such se v ces and suppo s …
2401 HHS
B DATA COLLECT ON —The S a e sha p ov de he Sec e a y w h he o ow ng
n o ma on ega d ng he p ov s on o home and commun y-based a endan
se v ces and suppo s …
2402 HHS
REMOVAL OF BARR ERS TO PROV D NG HOME AND COMMUN TY-BASED SER-
V CES a OVERS GHT AND ASSESSMENT OF THE ADM N STRAT ON OF HOME
AND COMMUN TY-BASED SERV CES — The Sec e a y o HHS sha p omu ga e
egu a ons o ensu e ha a S a es deve op se v ce sys ems …
2402 HHS
6 STATE OPT ON TO PROV DE HOME AND COMMUN TY-BASED SERV CES TO
ND V DUALS EL G BLE FOR SERV CES UNDER A WA VER — C AUTHOR TY
TO OFFER D FFERENT TYPE AMOUNT DURAT ON OR SCOPE OF HOME AND
COMMUN TY-BASED SERV CES —A S a e may o e home and commun y-based
se v ces o nd v dua s … 1 A so ong as such se v ces a e w h n he scope o
se v ces … o wh ch he Sec e a y has he au ho y o app ove a wa ve and do
no nc ude oom o boa d
2402 HHS
7 STATE OPT ON TO OFFER HOME AND COMMUN TY-BASED SERV CES TO
SPEC F C TARGETED POPULAT ONS — C RENEWAL — An e ec on by a S a e
may be enewed o add ona 5-yea e ms he Sec e a y de e m nes p o
o beg nn ng o each such enewa pe od ha he S a e has— adhe ed o
he equ emen s … and me he S a e s ob ec ves w h espec o qua y
mp ovemen and benefic a y ou comes
2402 HHS
e EL M NAT ON OF OPT ON TO L M T NUMBER OF EL G BLE ND V DUALS OR
LENGTH OF PER OD FOR GRANDFATHERED ND V DUALS F EL G B L TY CR TER A
S MOD F ED — … The S a e subm s o he Sec e a y n such o m and manne
and upon such equency as he Sec e a y sha spec y he p o ec ed numbe o
nd v dua s o be p ov ded home and commun y-based se v ces …
2405 HHS
FUND NG TO EXPAND STATE AG NG AND D SAB L TY RESOURCE CENTERS Ou o
any unds n he T easu y no o he w se app op a ed he e s app op a ed o he
Sec e a y o HHS ac ng h ough he Ass s an Sec e a y o Ag ng $10 000 000
o each o fisca yea s 2010 h ough 2014 …
2501 HHS
PRESCR PT ON DRUG REBATES a NCREASE N M N MUM REBATE PERCENTAGE
FOR S NGLE SOURCE DRUGS AND NNOVATOR MULT PLE SOURCE DRUGS — 2
… C SPEC AL RULE FOR NCREASED M N MUM REBATE PERCENTAGE —The
Sec e a y sha ad us such paymen educ on o a ca enda qua e o he
ex en he Sec e a y de e m nes based upon subsequen u za on and o he
da a …
2501 HHS
c EXTENS ON OF PRESCR PT ON DRUG D SCOUNTS TO ENROLLEES OF MED-
CA D MANAGED CARE ORGAN ZAT ONS — 1 … cove ed ou pa en d ugs
d spensed o nd v dua s e g b e o med ca ass s ance who a e en o ed w h
he en y sha be sub ec o he same eba e … cap a on a es pa d o he
en y sha be based on ac ua cos expe ence … and he en y sha epo
o he S a e on such me y and pe od c bas s as spec fied by he Sec e a y n
o de o nc ude n he n o ma on subm ed by he S a e o a manu ac u e and
he Sec e a y … n o ma on on he o a numbe o un s o each dosage o m
and s eng h and package s ze by Na ona D ug Code o each cove ed ou pa en
d ug d spensed o nd v dua s … and such o he da a as he Sec e a y de e -
m nes necessa y o ca y ou h s subsec on
2503 HHS
PROV D NG ADEQUATE PHARMACY RE MBURSEMENT a PHARMACY RE M-
BURSEMENT L M TS — 5 USE OF AMP N UPPER PAYMENT L M TS — The Sec-
e a y sha ca cu a e he Fede a uppe e mbu semen m … The Sec e a y
sha mp emen a smoo h ng p ocess o ave age manu ac u e p ces …
2503 HHS
7 REDUCT ON OF STATE DSH ALLOTMENTS ONCE REDUCT ON N UN NSURED
THRESHOLD REACHED — A … n he case o any fisca yea a e he fi s fisca
yea … w h espec o a S a e he Sec e a y de e m nes … ha he pe cen -
age o uncove ed nd v dua s es d ng n he S a e s ess han he pe cen age o
such nd v dua s de e m ned o he S a e o he p eced ng fisca yea …
2503 HHS
C F SCAL YEAR DESCR BED — … he fisca yea desc bed n h s subpa a-
g aph w h espec o a S a e s he fi s fisca yea ha occu s a e fisca yea
2012 o wh ch he Sec e a y de e m nes … ha he pe cen age o uncove ed
nd v dua s es d ng n he S a e s …
2503 HHS
D EXCLUS ON OF PORT ONS D VERTED FOR COVERAGE EXPANS ONS — … he
DSH a o men o a S a e ha wou d be de e m ned … sha no nc ude any po -
on o he a o men o wh ch he Sec e a y has app oved he S a e s d ve s on
o he cos s o p ov d ng med ca ass s ance o o he hea h benefi s cove age …
Special thanks to the Health Policy Source for their help in organizing the content of this chart.
2701 HHS
FA R HEALTH NSURANCE PREM UMS a PROH B T NG D SCR M NATORY
PREM UM RATES — B SECRETAR AL REV EW —The Sec e a y sha ev ew he
a ng a eas es ab shed by each S a e … he Sec e a y de e m nes a S a e s
a ng a eas a e no adequa e o ha a S a e does no es ab sh such a eas he
Sec e a y may es ab sh a ng a eas o ha S a e
2701 HHS
FA R HEALTH NSURANCE PREM UMS a PROH B T NG D SCR M NATORY
PREM UM RATES — 3 PERM SS BLE AGE BANDS —The Sec e a y n consu a-
on w h he Na ona Assoc a on o nsu ance Comm ss one s sha define he
pe m ss b e age bands o a ng pu poses
2702 HHS
GUARANTEED AVA LAB L TY OF COVERAGE b ENROLLMENT — 3 REGULA-
T ONS —The Sec e a y sha p omu ga e egu a ons w h espec o en o men
pe ods …
2705 HHS
PROH B T NG D SCR M NAT ON AGA NST ND V DUAL PART C PANTS AND BEN-
EF C AR ES BASED ON HEALTH STATUS a A g oup hea h p an and a hea h
nsu ance ssue o e ng g oup o nd v dua hea h nsu ance cove age may no
es ab sh u es o e g b y … o any nd v dua o en o … 9 Any o he hea h
s a us- e a ed ac o de e m ned app op a e by he Sec e a y
2705 HHS/Treasury/Labor
PROH B T NG D SCR M NAT ON AGA NST ND V DUAL PART C PANTS AND BEN-
EF C AR ES BASED ON HEALTH STATUS WELLNESS PROGRAM DEMONSTRA-
T ON PROJECT — 1 No a e han Ju y 1 2014 he Sec e a y n consu a on
w h he Sec e a y o he T easu y and he Sec e a y o Labo sha es ab sh a
10-S a e demons a on p o ec … o p og ams o hea h p omo on o e ed by
a hea h nsu ance ssue ha o e s hea h nsu ance cove age n he nd v dua
ma ke …
2705 HHS/Treasury/Labor
PROH B T NG D SCR M NAT ON AGA NST ND V DUAL PART C PANTS AND BENEF -
C AR ES BASED ON HEALTH STATUS WELLNESS PROGRAM DEMONSTRAT ON
PROJECT 2 EXPANS ON OF DEMONSTRAT ON PROJECT — he Sec e a y …
n consu a on w h he Sec e a y o he T easu y and he Sec e a y o Labo
de e m nes ha he demons a on p o ec … s e ec ve such Sec e a es may
beg nn ng on Ju y 1 2017 expand such demons a on p o ec o nc ude ad-
d ona pa c pa ng S a es
2705 HHS/Treasury/Labor
PROH B T NG D SCR M NAT ON AGA NST ND V DUAL PART C PANTS AND BENEF -
C AR ES BASED ON HEALTH STATUS WELLNESS PROGRAM DEMONSTRAT ON
PROJECT 3 REQU REMENTS — A MA NTENANCE OF COVERAGE —The Sec e-
a y n consu a on w h he Sec e a y o he T easu y and he Sec e a y o Labo
sha no app ove he pa c pa on o a S a e n he demons a on p o ec unde
h s sec on un ess he Sec e a es de e m ne ha he S a e s p o ec s des gned
n a manne ha — w no esu n any dec ease n cove age and w no
nc ease he cos o he Fede a Gove nmen …
2705 HHS
PROH B T NG D SCR M NAT ON AGA NST ND V DUAL PART C PANTS AND BEN-
EF C AR ES BASED ON HEALTH STATUS WELLNESS PROGRAM DEMONSTRA-
T ON PROJECT 3 REQU REMENTS — B OTHER REQU REMENTS —S a es ha
pa c pa e n he demons a on p o ec unde h s subsec on — v sha ensu e
and demons a e o he sa s ac on o he Sec e a y ha he d scoun s o o he
ewa ds p ov ded unde he p o ec eflec he expec ed eve o pa c pa on n
he we ness p og am nvo ved and he an c pa ed e ec he p og am w have
on u za on o med ca c a m cos s
2706 HHS
NON-D SCR M NAT ON N HEALTH CARE a PROV DERS — … No h ng n h s
sec on sha be cons ued as p even ng a g oup hea h p an a hea h nsu ance
ssue o he Sec e a y om es ab sh ng va y ng e mbu semen a es based on
qua y o pe o mance measu es
1301 HHS
QUAL F ED HEALTH PLAN DEF NED a QUAL F ED HEALTH PLAN — 1 The e m
qua fied hea h p an means a hea h p an ha — C s o e ed by a hea h
nsu ance ssue ha — v comp es w h he egu a ons deve oped by he
Sec e a y …
1302 HHS
ESSENT AL HEALTH BENEF TS REQU REMENTS a ESSENT AL HEALTH BENEF TS
PACKAGE — he e m essen a hea h benefi s package means w h espec
o any hea h p an cove age ha — 1 p ov des o he essen a hea h benefi s
defined by he Sec e a y …
1302 HHS/Labor
ESSENT AL HEALTH BENEF TS REQU REMENTS b ESSENT AL HEALTH BEN-
EF TS — 2 L M TAT ON — A The Sec e a y sha ensu e ha he scope o he
essen a hea h benefi s s equa o he scope o benefi s p ov ded unde a yp ca
emp oye p an as de e m ned by he Sec e a y …
1302 HHS
ESSENT AL HEALTH BENEF TS REQU REMENTS b ESSENT AL HEALTH BENEF TS
3 NOT CE AND HEAR NG — n defin ng he essen a hea h benefi s … he
Sec e a y sha p ov de no ce and an oppo un y o pub c commen
1302 HHS
ESSENT AL HEALTH BENEF TS REQU REMENTS b ESSENT AL HEALTH BENEF TS
4 REQU RED ELEMENTS FOR CONS DERAT ON — n defin ng he essen a hea h
benefi s he Sec e a y sha — A ensu e ha such essen a hea h benefi s
eflec an app op a e ba ance among he ca ego es desc bed … B no
make cove age dec s ons de e m ne e mbu semen a es es ab sh ncen ve
p og ams o des gn benefi s … C ake n o accoun he hea h ca e needs o
d ve se segmen s o he popu a on … D ensu e ha hea h benefi s es ab shed
as essen a no be sub ec o den a o nd v dua s aga ns he w shes … E
p ov de ha a qua fied hea h p an sha no be ea ed as p ov d ng cove age o
he essen a hea h benefi s
1302 HHS
ESSENT AL HEALTH BENEF TS REQU REMENTS b ESSENT AL HEALTH BENEF TS
4 REQU RED ELEMENTS FOR CONS DERAT ON H pe od ca y upda e he es-
sen a hea h benefi s o add ess any gaps n access o cove age o changes n
he ev dence base he Sec e a y den fies n he ev ew
1302 HHS
ESSENT AL HEALTH BENEF TS REQU REMENTS c REQU REMENTS RELAT NG TO
COST-SHAR NG — 4 PREM UM ADJUSTMENT PERCENTAGE — … he p em um
ad us men pe cen age o any ca enda yea s he pe cen age any by wh ch
he ave age pe cap a p em um o hea h nsu ance cove age n he U S o he
p eced ng ca enda yea as es ma ed by he Sec e a y no a e han Oc obe 1
o such p eced ng ca enda yea exceeds such ave age pe cap a p em um o
2013 as de e m ned by he Sec e a y
1302 HHS
ESSENT AL HEALTH BENEF TS REQU REMENTS d LEVELS OF COVERAGE — 2
ACTUAR AL VALUE — A Unde egu a ons ssued by he Sec e a y he eve o
cove age o a p an sha be de e m ned on he bas s …
1302 HHS
ESSENT AL HEALTH BENEF TS REQU REMENTS d LEVELS OF COVERAGE — 3
ALLOWABLE VAR ANCE —The Sec e a y sha deve op gu de nes o p ov de o a
de m n m s va a on n he ac ua a va ua ons used n de e m n ng he eve o
cove age o a p an o accoun o d e ences n ac ua a es ma es
1303 HHS
DETERM NAT ON BY SECRETARY — The Sec e a y may no de e m ne … ha
he commun y hea h nsu ance op on … sha p ov de cove age o se v ces …
as pa o benefi s o he p an yea un ess he Sec e a y— assu es comp -
ance w h he equ emen s o pa ag aph 2 assu es n acco dance w h
app cab e p ov s ons o gene a y accep ed accoun ng equ emen s c cu a s on
unds managemen o he OMB and gu dance on accoun ng o he GAO ha no
Fede a unds a e used o such cove age and … akes a necessa y s eps
o assu e ha he U S does no bea he nsu ance sk o a commun y hea h
nsu ance op on s cove age o se v ces …
1303 HHS
D ASSURED AVA LAB L TY OF VAR ED COVERAGE THROUGH EXCHANGES —
The Sec e a y sha assu e ha w h espec o qua fied hea h p ans o e ed
n any Exchange es ab shed— he e s a eas one such p an ha p ov des
cove age o se v ces desc bed e sewhe e and he e s a eas one such p an
ha does no p ov de cove age o se v ces
1303 HHS
a S a e has one Exchange cove ng mo e han 1 nsu ance ma ke he
Sec e a y sha mee he equ emen s o c ause sepa a e y w h espec o
each such ma ke
1303 HHS
C ACTUAR AL VALUE OF OPT ONAL SERV CE COVERAGE — The Sec e a y
sha es ma e he bas c pe en o ee pe mon h cos de e m ned on an ave age
ac ua a bas s o nc ud ng cove age unde a qua fied hea h p an …
1302 HHS
CONS DERAT ONS — n mak ng such es ma e he Sec e a y— may ake
n o accoun he mpac on ove a cos s o he nc us on o such cove age …
sha es ma e such cos s as such cove age we e nc uded o he en e
popu a on cove ed
1311 HHS
AFFORDABLE CHO CES OF HEALTH BENEF T PLANS a ASS STANCE TO STATES
TO ESTABL SH AMER CAN HEALTH BENEF T EXCHANGES — 2 AMOUNT SPEC -
F ED — Fo each fisca yea he Sec e a y sha de e m ne he o a amoun ha
he Sec e a y w make ava ab e o each S a e o g an s …
1311 HHS
A … he Sec e a y may enew a g an awa ded he S a e ec p en — s
mak ng p og ess as de e m ned by he Sec e a y owa d— es ab sh ng an
Exchange and mp emen ng he e o ms … and s mee ng such o he
benchma ks as he Sec e a y may es ab sh
1311 HHS
5 TECHN CAL ASS STANCE TO FAC L TATE PART C PAT ON N SHOP EXCHANG-
ES —The Sec e a y sha p ov de echn ca ass s ance o S a es o ac a e he
pa c pa on o qua fied sma bus nesses n such S a es n SHOP Exchanges
1311 HHS
c RESPONS B L T ES OF THE SECRETARY — 1 The Sec e a y sha by egu a on
es ab sh c e a o he ce fica on o hea h p ans as qua fied hea h p ans …
1311 HHS
… D be acc ed ed w h espec o oca pe o mance on c n ca qua y mea-
su es such as he Hea hca e E ec veness Da a and n o ma on Se pa en ex-
pe ence a ngs on a s anda d zed Consume Assessmen o Hea hca e P ov de s
and Sys ems su vey as we as consume access u za on managemen qua y
assu ance p ov de c eden a ng comp a n s and appea s ne wo k adequacy and
access and pa en n o ma on p og ams by any en y ecogn zed by he Sec e a y
o he acc ed a on o hea h nsu ance ssue s o …
1311 HHS
F u ze a un o m en o men o m ha qua fied nd v dua s and qua fied
emp oye s may use … and ha akes n o accoun c e a ha he Na ona As-
soc a on o nsu ance Comm ss one s deve ops and subm s o he Sec e a y …
2503 HHS
F UNCOVERED ND V DUALS — n h s pa ag aph he e m “uncove ed nd v du-
a s” means nd v dua s w h no hea h nsu ance cove age a any me du ng a
yea as de e m ned by he Sec e a y based on he mos ecen da a ava ab e
2602 HHS
PROV D NG FEDERAL COVERAGE AND PAYMENT COORD NAT ON FOR DUAL
EL G BLE BENEF C AR ES a ESTABL SHMENT OF FEDERAL COORD NATED
HEALTH CARE OFF CE — 1 … he Sec e a y o HHS … sha es ab sh a Fede a
Coo d na ed Hea h Ca e O fice
2701 HHS
ADULT HEALTH QUAL TY MEASURES a DEVELOPMENT OF CORE SET OF
HEALTH CARE QUAL TY MEASURES FOR ADULTS EL G BLE FOR BENEF TS UNDER
MED CA D —The Sec e a y sha den y and pub sh a ecommended co e se o
adu hea h qua y measu es o Med ca d e g b e adu s …
2701 HHS
b DEADL NES — 1 RECOMMENDED MEASURES — … he Sec e a y sha
den y and pub sh o commen a ecommended co e se o adu hea h qua y
measu es o Med ca d e g b e adu s 2 D SSEM NAT ON — … he Sec e a y
sha pub sh an n a co e se o adu hea h qua y measu es ha a e app cab e
o Med ca d e g b e adu s 3 STANDARD ZED REPORT NG — … he Sec e a y n
consu a on w h S a es sha deve op a s anda d zed o ma o epo ng n o ma-
on based on he n a co e se o adu hea h qua y measu es and c ea e p oce-
du es o encou age S a es o use such measu es o vo un a y epo n o ma on
ega d ng he qua y o hea h ca e o Med ca d e g b e adu s
2701 HHS
5 ESTABL SHMENT OF MED CA D QUAL TY MEASUREMENT PROGRAM — A …
he Sec e a y sha es ab sh a Med ca d Qua y Measu emen P og am …
2701 HHS
B REV S NG STRENGTHEN NG AND MPROV NG N T AL CORE MEASURES — …
he Sec e a y sha pub sh ecommended changes o he n a co e se o adu
hea h qua y measu es ha sha eflec he esu s o he es ng va da on and
consensus p ocess o he deve opmen o adu hea h qua y measu es
2701 HHS
d ANNUAL STATE REPORTS REGARD NG STATE SPEC F C QUAL TY OF CARE
MEASURES APPL ED UNDER MED CA D — 2 PUBL CAT ON — … he Sec e a y
sha co ec ana yze and make pub c y ava ab e he n o ma on epo ed by
S a es …
2702 HHS
PAYMENT ADJUSTMENT FOR HEALTH CARE-ACQU RED COND T ONS a The
Sec e a y o HHS … sha den y cu en S a e p ac ces ha p oh b paymen
o hea h ca e-acqu ed cond ons and sha nco po a e he p ac ces den fied
o e emen s o such p ac ces wh ch he Sec e a y de e m nes app op a e o
app ca on o he Med ca d p og am n egu a ons …
2702 HHS
c MED CARE PROV S ONS — n ca y ng ou h s sec on he Sec e a y sha ap-
p y o S a e p ans o wa ve s … he egu a ons p omu ga ed … e a ng o he
p oh b on o paymen s based on he p esence o a seconda y d agnos s code
spec fied by he Sec e a y n such egu a ons as app op a e o he Med ca d
p og am The Sec e a y may exc ude ce a n cond ons …
2703 HHS
STATE OPT ON TO PROV DE HEALTH HOMES FOR ENROLLEES W TH CHRON C
COND T ONS a STATE PLAN AMENDMENT — … and any o he p ov s on o h s
e o wh ch he Sec e a y de e m nes s necessa y o wa ve … a S a e …
may p ov de o med ca ass s ance unde h s e o e g b e nd v dua s w h
ch on c cond ons …
2703 HHS
b HEALTH HOME QUAL F CAT ON STANDARDS — The Sec e a y sha es ab sh
s anda ds o qua fica on as a des gna ed p ov de o he pu pose o be ng
e g b e o be a hea h home o pu poses o h s sec on
2703 HHS
3 PLANN NG GRANTS — A Beg nn ng Janua y 1 25 2011 he Sec e a y may
awa d p ann ng g an s o S a es o pu poses o deve op ng a S a e p an amend-
men unde h s sec on …
2703 HHS
g REPORT ON QUAL TY MEASURES — … a des gna ed p ov de sha epo o
he S a e n acco dance w h such equ emen s as he Sec e a y sha spec y
on a app cab e measu es o de e m n ng he qua y o such Se v ces …
2703 HHS
h DEF N T ONS — n h s sec on 1 EL G BLE ND V DUAL W TH CHRON C CON2
D T ONS — B RULE OF CONSTRUCT ON —No h ng n h s pa ag aph sha
p even he Sec e a y om es ab sh ng h ghe eve s as o he numbe o seve y
o ch on c o men a hea h cond ons o pu poses o de e m n ng e g b y o
ece p o hea h home se v ces …
2703 HHS
5 DES GNATED PROV DER —The e m des gna ed p ov de means … ha s
de e m ned by he S a e and app oved by he Sec e a y o be qua fied o be a
hea h home o e g b e nd v dua s w h ch on c cond ons … B sa sfies he
qua fica on s anda ds es ab shed by he Sec e a y unde …
1311 HHS
3 RAT NG SYSTEM —The Sec e a y sha deve op a a ng sys em ha wou d
a e qua fied hea h p ans o e ed h ough an Exchange n each benefi s eve on
he bas s o he e a ve qua y and p ce …
1311 HHS
5 NTERNET PORTALS —The Sec e a y sha — A con nue o ope a e
ma n a n and upda e he n e ne po a and o ass s S a es n deve op ng and
ma n a n ng he own such po a and B make ava ab e o use by Exchanges a
mode emp a e o an n e ne po a ha may be used …
1311 HHS
6 ENROLLMENT PER ODS —The Sec e a y sha equ e an Exchange o
p ov de o — A an n a open en o men as de e m ned by he Sec e a y such
de e m na on o be made no a e han Ju y 1 2012 B annua open en o -
men pe ods as de e m ned by he Sec e a y o ca enda yea s a e he n a
en o men pe od C spec a en o men pe ods …
1311 HHS
4 FUNCT ONS —An Exchange sha a a m n mum— D ass gn a a ng o
each qua fied hea h p an o e ed h ough such Exchange n acco dance w h he
c e a deve oped by he Sec e a y …
1311 HHS 1
e CERT F CAT ON —An Exchange may ce y a hea h p an as a qua fied hea h
p an — A such hea h p an mee s he equ emen s o ce fica on as p omu -
ga ed by he Sec e a y …
1311 HHS
FLEX B L TY — 1 REG ONAL OR OTHER NTERSTATE EXCHANGES —An Ex-
change may ope a e n mo e han one S a e — B he Sec e a y app oves such
eg ona o n e s a e Exchange
1311 HHS
2 GU DEL NES —The Sec e a y n consu a on w h expe s n hea h ca e qua -
y and s akeho de s sha deve op gu de nes conce n ng he ma e s …
1311 HHS
h QUAL TY MPROVEMENT — 1 ENHANC NG PAT ENT SAFETY —Beg nn ng on
Janua y 1 2015 a qua fied hea h p an may con ac w h— B a hea h ca e
p ov de on y such p ov de mp emen s such mechan sms o mp ove hea h
ca e qua y as he Sec e a y may by egu a on equ e
1311 HHS
h QUAL TY MPROVEMENT 2 EXCEPT ONS —The Sec e a y may es ab sh
easonab e excep ons …
1311 HHS
h QUAL TY MPROVEMENT 3 ADJUSTMENT —The Sec e a y may by egu a on
ad us he numbe o beds …
1311 HHS
h QUAL TY MPROVEMENT 4 STANDARDS — A The Sec e a y sha es ab sh
s anda ds o nav ga o s nc ud ng p ov s ons o ensu e ha any p va e o pub c
en y ha s se ec ed as a nav ga o s qua fied and censed app op a e o
engage n he nav ga o and o avo d confl c s o n e es …
1311 HHS
5 FA R AND MPART AL NFORMAT ON AND SERV CES —The Sec e a y n co -
abo a on w h S a es sha deve op s anda ds o ensu e ha n o ma on made
ava ab e by nav ga o s s a accu a e and mpa a
1311 HHS
k CONFL CT —An Exchange may no es ab sh u es ha confl c w h o p even
he app ca on o egu a ons p omu ga ed by he Sec e a y …
1312 (e) HHS
CONSUMER CHO CE e ENROLLMENT THROUGH AGENTS OR BROKERS — The
Sec e a y sha es ab sh p ocedu es unde wh ch a S a e may a ow agen s o
b oke s— 1 o en o nd v dua s n any qua fied hea h p ans … and 2 o
ass s nd v dua s n app y ng o p em um ax c ed s and cos -sha ng educ ons
o p ans so d h ough an Exchange …
1313 HHS
F NANC AL NTEGR TY a ACCOUNT NG FOR EXPEND TURES — 2 NVEST -
GAT ONS —The Sec e a y n coo d na on w h he nspec o Gene a o he
Depa men o HHS may nves ga e he a a s o an Exchange may exam ne
he p ope es and eco ds o an Exchange and may equ e pe od c epo s n
e a on o ac v es unde aken by an Exchange …
1313 HHS
F NANC AL NTEGR TY a ACCOUNT NG FOR EXPEND TURES 3 AUD TS —An
Exchange sha be sub ec o annua aud s by he Sec e a y
1313 HHS
F NANC AL NTEGR TY a ACCOUNT NG FOR EXPEND TURES 4 PATTERN OF
ABUSE — he Sec e a y de e m nes ha an Exchange o a S a e has engaged n
se ous m sconduc … he Sec e a y may esc nd om paymen s o he w se due
o such S a e nvo ved unde h s o any o he Ac adm n s e ed by he Sec e a y
an amoun …
1313 HHS
F NANC AL NTEGR TY a ACCOUNT NG FOR EXPEND TURES 5 PROTECT ONS
AGA NST FRAUD AND ABUSE — … he Sec e a y sha p ov de o he e fic en
and non-d sc m na o y adm n s a on o Exchange ac v es and mp emen
any measu e o p ocedu e ha — A he Sec e a y de e m nes s app op a e
o educe aud and abuse … and B he Sec e a y has au ho y o mp emen
unde h s e o any o he Ac
1321 HHS
STATE FLEX B L TY N OPERAT ON AND ENFORCEMENT OF EXCHANGES AND RE-
LATEDREQU REMENTS a ESTABL SHMENT OF STANDARDS — 1 The Sec e a y
sha … ssue egu a ons se ng s anda ds … o— A he es ab shmen and
ope a on o Exchanges nc ud ng SHOP Exchanges B he o e ng o qua fied
hea h p ans h ough such Exchanges C he es ab shmen o he e nsu ance
and sk ad us men p og ams unde pa V and D such o he equ emen s as
he Sec e a y de e m nes app op a e …
1321 HHS
STATE FLEX B L TY N OPERAT ON AND ENFORCEMENT OF EXCHANGES AND RE-
LATEDREQU REMENTS b STATE ACT ON —Each S a e ha e ec s a such me
and n such manne as he Sec e a y may p esc be o app y he equ emen s
… 1 he es ab shed ede a s anda ds o 2 a S a e aw o egu a on ha he
Sec e a y de e m nes mp emen s he s anda ds w h n he S a e
1321 HHS
c FA LURE TO ESTABL SH EXCHANGE OR MPLEMENT REQU REMENTS — 1
— A a S a e s no an e ec ng S a e b o B he Sec e a y de e m nes … ha
an e ec ng S a e— w no have any equ ed Exchange ope a ona by Janu-
a y 1 2014 o has no aken he ac ons he Sec e a y de e m nes necessa y
o mp emen — he o he equ emen s se o h n he s anda ds o he
equ emen s and amendmen s made e sewhe e he Sec e a y sha … es ab sh
and ope a e such Exchange w h n he S a e and he Sec e a y sha ake such
ac ons as a e necessa y o mp emen such o he equ emen s
1321 HHS
e PRESUMPT ON FOR CERTA N STATE-OPERATED EXCHANGES — … he Sec e-
a y sha p esume ha such Exchange mee s he s anda ds … un ess he Sec e-
a y de e m nes … ha he Exchange does no comp y w h such s anda ds
1321 HHS/the States
e PRESUMPT ON FOR CERTA N STATE-OPERATED EXCHANGES — 2 PRO-
CESS —The Sec e a y sha es ab sh a p ocess o wo k w h a S a e o p ov de
ass s ance necessa y o ass s he S a e s Exchange n com ng n o comp ance
w h he s anda ds …
1322 HHS/CO-OP
FEDERAL PROGRAM TO ASS ST ESTABL SHMENT AND OPERAT ON OF NON-
PROF T MEMBER RUN HEALTH NSURANCE SSUERS a ESTABL SHMENT OF
PROGRAM — 1 —The Sec e a y sha es ab sh a p og am o be known as he
Consume Ope a ed and O en ed P an CO–OP p og am
1322 HHS/CO-OP
b LOANS AND GRANTS UNDER THE CO–OP PROGRAM — 1 —The Sec e a y
sha p ov de h ough he CO–OP p og am o he awa d ng o pe sons app y ng
o become qua fied nonp ofi hea h nsu ance ssue s o …
1322 HHS
2 REQU REMENTS FOR AWARD NG LOANS AND GRANTS — A n awa d ng
oans and g an s unde he CO–OP p og am he Sec e a y sha — ensu e
ha he e s su fic en und ng o es ab sh a eas 1 qua fied nonp ofi hea h
nsu ance ssue n each S a e …
1322 HHS
B STATES W THOUT SSUERS N PROGRAM — no hea h nsu ance ssue
app es o be a qua fied nonp ofi hea h nsu ance ssue w h n a S a e he
Sec e a y may use amoun s … o he awa d ng o g an s o encou age he
es ab shmen …
1322 HHS
C AGREEMENT — The Sec e a y sha equ e any pe son ece v ng a oan o
g an unde he CO–OP p og am o en e n o an ag eemen w h he Sec e a y …
1322 HHS/Treasury
FA LURE TO MEET REQU REMENTS — he Sec e a y de e m nes ha a
pe son has a ed o mee any equ emen … such pe son sha epay o he
Sec e a y …
1322 HHS
c QUAL F ED NONPROF T HEALTH NSURANCE SSUER — 3 GOVERNANCE
REQU REMENTS —An o gan za on sha no be ea ed as a qua fied nonp ofi
hea h nsu ance ssue un ess— C as p ov ded n egu a ons p omu ga ed by
he Sec e a y …
1322 HHS
29 CO–OP HEALTH NSURANCE SSUERS — B COND T ONS FOR EXEMP-
T ON —Subpa ag aph A sha app y o an o gan za on on y — he o gan -
za on has g ven no ce o he Sec e a y n such manne as he Sec e a y may by
egu a ons p esc be …
1323 HHS
SEC 1323 COMMUN TY HEALTH NSURANCE OPT ON b ESTABL SHMENT OF
COMMUN TY HEALTH NSURANCE OPT ON — 1 ESTABL SHMENT —The Sec e-
a y sha es ab sh a commun y hea h nsu ance op on …
1323 HHS
5 PREM UMS — A PREM UMS SUFF C ENT TO COVER COSTS —The Sec e a y
sha es ab sh geog aph ca y ad us ed p em um a es n an amoun su fic en o
cove expec ed cos s …
1323 HHS
C COLLECT ON OF DATA —The Sec e a y sha co ec da a as necessa y o se
p em um a es …
1323 HHS
D NAT ONAL POOL NG — … he Sec e a y may ea a en o ees n commun y
hea h nsu ance op ons as membe s o a s ng e poo
2703 HHS
6 TEAM OF HEALTH CARE PROFESS ONALS — The e m eam o hea h ca e
p o ess ona s means … o any en y deemed app op a e by he S a e and ap-
p oved by he Sec e a y
2703 HHS
2 SURVEY AND NTER M REPORT — A … he Sec e a y o HHS sha su vey
S a es ha have e ec ed he op on unde … and epo o Cong ess …
2703 HHS
B MPLEMENTAT ON REPORT NG —A S a e … sha epo o he Sec e a y as
necessa y on p ocesses ha have been deve oped and essons ea ned ega d-
ng p ov s on o coo d na ed ca e h ough a hea h home o Med ca d benefic a-
es w h ch on c cond ons …
2704 HHS
DEMONSTRAT ON PROJECT TO EVALUATE NTEGRATED CARE AROUND A HOSP -
TAL ZAT ON a AUTHOR TY TO CONDUCT PROJECT — 1 The Sec e a y o HHS
… sha es ab sh a demons a on p o ec … o eva ua e he use o bund ed
paymen s o he p ov s on o n eg a ed ca e o a Med ca d benefic a y …
2704 HHS
b REQU REMENTS — … 1 The demons a on p o ec sha be conduc ed n up
o 8 S a es de e m ned by he Sec e a y based on cons de a on o he po en a
o owe cos s unde he Med ca d p og am wh e mp ov ng ca e o Med ca d
benefic a es … bu he Sec e a y sha nsu e ha as a who e he demons a on
p o ec s … ep esen a ve o he demog aph c and geog aph c compos on o
Med ca d benefic a es na ona y
2704 HHS
2 The demons a on p o ec sha ocus on cond ons … as de e m ned by he
Sec e a y
2704 HHS
3 … The Sec e a y may mod y he ep sodes o ca e as we as he se v ces o
be nc uded … The Sec e a y may a so va y such ac o s among he d e en
S a es pa c pa ng n he demons a on p o ec
2704 HHS
4 The Sec e a y sha ensu e ha paymen s made unde he demons a on
p o ec a e ad us ed o seve y o ness and o he cha ac e s cs o Med ca d
benefic a es …
2704 HHS
6 The Sec e a y and each S a e se ec ed o pa c pa e n he demons a on
p o ec sha ensu e ha he demons a on p o ec does no esu n he Med-
ca d benefic a es whose ca e s sub ec o paymen unde he demons a on
p o ec be ng p ov ded w h ess ems and se v ces …
2704 HHS
d EVALUAT ON AND REPORT — 1 DATA —Each S a e se ec ed o pa c pa e n
he demons a on p o ec unde h s sec on sha p ov de o he Sec e a y n such
o m and manne as he Sec e a y sha spec y e evan da a necessa y o …
2705 HHS
MED CA D GLOBAL PAYMENT SYSTEM DEMONSTRAT ON PROJECT a The
Sec e a y o HHS … sha … es ab sh he Med ca d G oba Paymen Sys em
Demons a on P o ec …
2705 HHS
b DURAT ON AND SCOPE — … The Sec e a y sha se ec no mo e han 5
S a es o pa c pa e n he demons a on p o ec
2705 HHS
c EL G BLE SAFETY NET HOSP TAL SYSTEM OR NETWORK — … he e m e -
g b e sa e y ne hosp a sys em o ne wo k means a a ge sa e y ne hosp a
sys em o ne wo k as defined by he Sec e a y ha ope a es w h n a S a e
se ec ed by he Sec e a y …
2705 HHS
3 MOD F CAT ON — … he Sec e a y may n he Sec e a y s d sc e on mod y
o e m na e he demons a on p o ec conduc ed unde h s sec on
2705 HHS
e REPORT — … he Sec e a y sha subm o Cong ess a epo … d
oge he w h ecommenda ons o such eg s a on and adm n s a ve ac on as
he Sec e a y de e m nes app op a e
2706 HHS
PED ATR C ACCOUNTABLE CARE ORGAN ZAT ON DEMONSTRAT ON PROJECT a
AUTHOR TY TO CONDUCT DEMONSTRAT ON — 1 The Sec e a y o HHS … sha
es ab sh he Ped a c Accoun ab e Ca e O gan za on Demons a on P o ec …
2706 HHS
b APPL CAT ON —A S a e ha des es o pa c pa e n he demons a on p o -
ec unde h s sec on sha subm o he Sec e a y an app ca on a such me
n such manne and con a n ng such n o ma on as he Sec e a y may equ e
1323 HHS
(304 Delegations)
6 RE MBURSEMENT RATES — A NEGOT ATED RATES —The Sec e a y sha ne-
go a e a es o he e mbu semen o hea h ca e p ov de s o benefi s cove ed
unde a commun y hea h nsu ance op on
1323 HHS
7 SOLVENCY AND CONSUMER PROTECT ON — A SOLVENCY —The Sec e a y
sha es ab sh a Fede a so vency s anda d o be app ed w h espec o a com-
mun y hea h nsu ance op on …
1323 HHS
B M N MUM REQU RED — he Sec e a y sha equ e a ese ve und ha sha
be equa o a eas he do a va ue o he ncu ed bu no epo ed c a ms o a
commun y hea h nsu ance op on
1323 HHS
8 REQU REMENTS ESTABL SHED N PARTNERSH P W TH NSURANCE COM-
M SS ONERS — A The Sec e a y … may p omu ga e egu a ons o es ab sh
add ona equ emen s o a commun y hea h nsu ance op on
1323 HHS
c START-UP FUND — 1 ESTABL SHMENT OF FUND — B FUND NG —The e
s he eby app op a ed o he S a -Up Fund ou o any moneys n he T easu y
no o he w se app op a ed an amoun eques ed by he Sec e a y o HHS as
necessa y o— pay he s a -up cos s assoc a ed w h he n a ope a ons o
a commun y hea h nsu ance op on and pay he cos s o mak ng paymen s
on c a ms …
1323 HHS
4 REPAYMENT — B SANCT ONS N CASE OF FOR-PROF T CONVERS ON —
n any case n wh ch he Sec e a y en e s n o a con ac w h a qua fied en y
o he o e ng o a commun y hea h nsu ance op on and such en y s
de e m ned o be a o -p ofi en y by he Sec e a y such en y sha be—
mmed a e y ab e o he Sec e a y o any paymen s ece ved by such en y
om he S a -Up Fund …
1323 HHS
e AUTHOR TY TO CONTRACT TERMS OF CONTRACT — 1 AUTHOR TY A —The
Sec e a y may en e n o a con ac o con ac s w h one o mo e qua fied en -
es o he pu pose o pe o m ng adm n s a ve unc ons … The Sec e a y sha
have he same au ho y w h espec o a commun y hea h nsu ance op on …
1323 HHS
2 QUAL F ED ENT TY —To be qua fied o be se ec ed by he Sec e a y o o e
a commun y hea h nsu ance op on an en y sha … and G mee such o he
equ emen s as he Sec e a y may mpose
1323 HHS
3 TERM —A con ac p ov ded o … sha be o a e m o a eas 5 yea s bu
no mo e han 10 yea s as de e m ned by he Sec e a y A he end o each such
e m he Sec e a y sha conduc a compe ve b dd ng p ocess o he pu poses
o enew ng ex s ng con ac s o se ec ng new qua fied en es …
1323 HHS
4 L M TAT ON —A con ac may no be enewed un ess he Sec e a y de e -
m nes ha he con ac ng adm n s a o has me pe o mance equ emen s
es ab shed by he Sec e a y …
1323 HHS
6 REVOCAT ON —A con ac awa ded sha be evoked by he Sec e a y … The
Sec e a y may evoke such con ac he Sec e a y de e m nes ha such ad-
m n s a o has engaged n aud decep on was e abuse o powe neg gence
m smanagemen o axpaye do a s o g oss m smanagemen …
1323 HHS
7 FEE FOR ADM N STRAT ON A —The Sec e a y sha pay he con ac ng ad-
m n s a o a ee o he managemen adm n s a on and de ve y o he benefi s
unde h s sec on
1323 HHS
B REQU REMENT FOR H GH QUAL TY ADM N STRAT ON —The Sec e a y may
nc ease he ee … based on he ex en o wh ch he con ac ng adm n s a o n
he de e m na on o he Sec e a y mee s pe o mance equ emen s es ab shed
by he Sec e a y …
1323 HHS
8 L M TAT ON — … he Sec e a y sha nego a e he e mbu semen a es …
1331 HHS
STATE FLEX B L TY TO ESTABL SH BAS C HEALTH PROGRAMS FOR LOW- NCOME
ND V DUALS NOT EL G BLE FOR MED CA D a ESTABL SHMENT OF PROGRAM —
1 The Sec e a y sha es ab sh a bas c hea h p og am mee ng he equ emen s
o h s sec on unde wh ch a S a e may en e n o con ac s o o e 1 o mo e
s anda d hea h p ans p ov d ng a eas he essen a hea h benefi s … o e g b e
nd v dua s n eu o o e ng such nd v dua s cove age h ough an Exchange
1331 HHS
2 CERT F CAT ONS AS TO BENEF T COVERAGE AND COSTS —Such p og am
sha p ov de ha a S a e may no es ab sh a bas c hea h p og am unde h s
sec on un ess he S a e es ab shes o he sa s ac on o he Sec e a y and he
Sec e a y ce fies ha — A n he case o an e g b e nd v dua en o ed n a
s anda d hea h p an o e ed h ough he p og am he S a e p ov des …
1331 HHS
d TRANSFER OF FUNDS TO STATES 1 — he Sec e a y de e m nes ha a
S a e e ec ng he app ca on o h s sec on mee s he equ emen s o he p o-
g am he Sec e a y sha ans e o he S a e o each fisca yea …
1331 HHS
3 AMOUNT OF PAYMENT — A SECRETAR AL DETERM NAT ON — The amoun
de e m ned o any fisca yea s he amoun he Sec e a y de e m nes s equa o
85 pe cen o he p em um ax c ed s … ha wou d have been p ov ded o he
fisca yea o e g b e nd v dua s en o ed n s anda d hea h p ans …
1331 HHS
SPEC F C REQU REMENTS —The Sec e a y sha make he de e m na on on
a pe en o ee bas s and sha ake n o accoun a e evan ac o s necessa y o
de e m ne he va ue o he p em um ax c ed s and cos -sha ng educ ons …
1331 HHS
B CORRECT ONS —The Sec e a y sha ad us he paymen o any fisca yea o
eflec any e o …
1331 HHS
SECRETAR AL OVERS GHT —The Sec e a y sha each yea conduc a ev ew
o each S a e p og am o ensu e comp ance nc ud ng ensu ng ha he S a e
p og am mee s …
1332 HHS
WA VER FOR STATE NNOVAT ON a APPL CAT ON — 1 A S a e may app y o he
Sec e a y o he wa ve o a o any equ emen s … Such app ca on sha —
A be fi ed a such me and n such manne as he Sec e a y may equ e
1332 HHS
3 PASS THROUGH OF FUND NG — … he Sec e a y sha p ov de o an a e -
na ve means by wh ch he agg ega e amoun o such c ed s o educ ons …
sha be pa d o he S a e o pu poses o mp emen ng he S a e p an unde he
wa ve Such amoun sha be de e m ned annua y by he Sec e a y …
1332 HHS
4 WA VER CONS DERAT ON AND TRANSPARENCY — A An app ca on o a
wa ve unde h s sec on sha be cons de ed by he Sec e a y …
1332 HHS
B REGULAT ONS —No a e han 180 days a e he da e o enac men o h s
Ac he Sec e a y sha p omu ga e egu a ons e a ng o wa ve s unde h s
sec on ha p ov de— v a p ocess o he pe od c eva ua on by he Sec e a y
o he p og am unde he wa ve
1332 HHS
5 COORD NATED WA VER PROCESS —The Sec e a y sha deve op a p ocess o
coo d na ng and conso da ng he S a e wa ve p ocesses …
1332 HHS
b GRANT NG OF WA VERS — 1 The Sec e a y may g an a wa ve eques on y
may g an a eques o a wa ve on y he Sec e a y de e m nes ha he S a e
p an— A w p ov de cove age ha s a eas as comp ehens ve as he cove -
age defined e sewhe e and o e ed h ough Exchanges …
1332 HHS
c SCOPE OF WA VER — 1 The Sec e a y sha de e m ne he scope o a wa ve
o a equ emen …
1332 HHS
d DETERM NAT ONS BY SECRETARY — 1 T ME FOR DETERM NAT ON —The
Sec e a y sha make a de e m na on … no a e han 180 days a e he ece p
o an app ca on om a S a e …
1332 HHS
e TERM OF WA VER —No wa ve may ex end ove a pe od o onge han 5
yea s un ess he S a e eques s con nua on o such wa ve and such eques
sha be deemed g an ed un ess he Sec e a y … e he den es such eques n
w ng o n o ms he S a e n w ng w h espec o any add ona n o ma on
wh ch s needed …
1333 HHS
PROV S ONS RELAT NG TO OFFER NG OF PLANS N MORE THAN ONE STATE a
HEALTH CARE CHO CE COMPACTS — 1 No a e han Ju y 1 2013 he Sec e a y
sha n consu a on w h he Na ona Assoc a on o nsu ance Comm ss one s
ssue egu a ons o he c ea on o hea h ca e cho ce compac s unde wh ch 2 o
mo e S a es may en e n o an ag eemen …
1333 HHS
3 APPROVAL OF COMPACTS —The Sec e a y may app ove n e s a e hea h
ca e cho ce compac s on y he Sec e a y de e m nes ha such hea h ca e
cho ce compac — A w p ov de cove age … B w p ov de cove age and
cos sha ng p o ec ons … C w p ov de cove age o a eas a compa ab e
numbe o s es den s … D w no nc ease he Fede a defic and E w
no weaken en o cemen o aws and egu a ons …
1333 HHS
b AUTHOR TY FOR NAT ONW DE PLANS — 3 PLAN REQU REMENTS —An
ssue mee s he equ emen s o h s subsec on w h espec o a na onw de
qua fied hea h p an n he de e m na on o he Sec e a y— A he p an o e s
a benefi s package ha s un o m n each S a e … B he ssue s censed
… C he ssue mee s a equ emen s o h s e w h espec o a qua fied
hea h p an … D he ssue de e m nes … E he ssue o e s he na onw de
qua fied hea h p an n a eas 60 pe cen o he pa c pa ng S a es … F
he ssue sha o e he p an n pa c pa ng S a es ac oss he coun y … and
G he ssue c ea y no fies consume s ha he po cy may no con a n some
benefi s o he w se manda ed o p ans n he S a e … n acco dance w h u es
p omu ga ed by he Sec e a y
1333 HHS
4 FORM REV EW FOR NAT ONW DE PLANS — … An ssue may appea he
d sapp ova o a na onw de qua fied hea h p an o m o he Sec e a y
2706 HHS
c REQU REMENTS — 1 PERFORMANCE GU DEL NES —The Sec e a y … sha
es ab sh gu de nes o ensu e ha he qua y o ca e de ve ed o nd v dua s by
a p ov de ecogn zed as an ACO unde h s sec on s no ess han he qua y o
ca e ha wou d have o he w se been p ov ded o such nd v dua s
2706 HHS
2 SAV NGS REQU REMENT —A pa c pa ng S a e n consu a on w h he Sec-
e a y sha es ab sh an annua m n ma eve o sav ngs n expend u es o ems
and se v ces cove ed unde he Med ca d p og am …
2706 HHS
d NCENT VE PAYMENT —An ACO ha mee s he pe o mance gu de nes …
sha ece ve an ncen ve paymen o such yea equa o a po on as de e -
m ned app op a e by he Sec e a y o he amoun o such excess sav ngs The
Sec e a y may es ab sh an annua cap on ncen ve paymen s o an ACO
2707 HHS
MED CA D EMERGENCY PSYCH ATR C DEMONSTRAT ON PROJECT a AUTHOR-
TY TO CONDUCT DEMONSTRAT ON PROJECT —The Sec e a y o HHS … sha
es ab sh a demons a on p o ec unde wh ch an e g b e S a e … sha p ov de
paymen unde he S a e Med ca d p an … o an ns u on o men a d seases …
2707 HHS
c EL G BLE STATE DEF NED — 2 APPL CAT ON —A S a e seek ng o pa c pa e
n he demons a on p o ec … sha subm o he Sec e a y a such me and n
such o ma as he Sec e a y equ es an app ca on ha nc udes such n o ma-
on p ov s ons and assu ances as he Sec e a y may equ e
2707 HHS
3 SELECT ON —A S a e sha be de e m ned e g b e o he demons a on by
he Sec e a y on a compe ve bas s among S a es … he Sec e a y sha seek
o ach eve an app op a e na ona ba ance n he geog aph c d s bu on o such
p o ec s
2707 HHS
4 FUNDS ALLOCATED TO STATES —Funds sha be a oca ed o e g b e S a es
on he bas s o c e a … as de e m ned by he Sec e a y
2705 HHS
5 PAYMENTS TO STATES —The Sec e a y sha pay o each e g b e S a e …
an amoun … o med ca ass s ance … As a cond on o ece v ng paymen
a S a e sha co ec and epo n o ma on as de e m ned necessa y by he
Sec e a y o he pu poses o p ov d ng Fede a ove s gh and conduc ng an
eva ua on …
2705 HHS
EVALUAT ON AND REPORT TO CONGRESS — 1 EVALUAT ON —The Sec e a y
sha conduc an eva ua on o he demons a on p o ec n o de o de e m ne
he mpac on he unc on ng o he hea h and men a hea h se v ce sys em and
on nd v dua s en o ed n he Med ca d p og am …
2705 HHS
g WA VER AUTHOR TY — 1 The Sec e a y sha wa ve he m a on o … o
pu poses o ca y ng ou he demons a on p o ec unde h s sec on
2801 HHS
MACPAC ASSESSMENT OF POL C ES AFFECT NG ALL MED CA D BENEF C AR ES
3 RECOMMENDAT ONS AND REPORTS OF STATE-SPEC F C DATA —MACPAC
sha — B subm epo s and ecommenda ons o Cong ess he Sec e a y and
S a es based on such ev ews
2801 HHS
14 PROGRAMMAT C OVERS GHT VESTED N THE SECRETARY —MACPAC s
au ho y o make ecommenda ons n acco dance w h h s sec on sha no a -
ec o be cons de ed o dup ca e he Sec e a y s au ho y o ca y ou Fede a
espons b es w h espec o Med ca d and CH P
2951 HHS
MATERNAL NFANT AND EARLY CH LDHOOD HOME V S T NG PROGRAMS b
REQU REMENT FOR ALL STATES TO ASSESS STATEW DE NEEDS AND DENT FY AT
R SK COMMUN T ES — 2 COORD NAT ON W TH OTHER ASSESSMENTS — …
he S a e sha coo d na e w h and ake n o accoun o he app op a e needs
assessmen s conduc ed by he S a e as de e m ned by he Sec e a y …
2951 HHS
3 SUBM SS ON TO THE SECRETARY —Each S a e sha subm o he Sec e a y
n such o m and manne as he Sec e a y sha equ e— A he esu s o he
s a ew de needs assessmen … and B a desc p on o how he S a e n ends o
add ess needs den fied by he assessmen …
2951 HHS
c GRANTS FOR EARLY CH LDHOOD HOME V S TAT ON PROGRAMS — 1
AUTHOR TY TO MAKE GRANTS — … he Sec e a y sha make g an s o e g b e
en es o enab e he en es o de ve se v ces unde ea y ch dhood home
v s a on p og ams …
2951 HHS
3 GRANT DURAT ON —The Sec e a y sha de e m ne he pe od o yea s o
wh ch a g an s made o an e g b e en y …
1333 HHS
5 APPL CABLE RULES —The Sec e a y sha n consu a on w h he Na ona
Assoc a on o nsu ance Comm ss one s ssue u es o he o e ng o na on-
w de qua fied hea h p ans …
1333 HHS
6 COVERAGE —The Sec e a y sha p ov de ha he hea h benefi s cove age
p ov ded o an nd v dua h ough a na onw de qua fied hea h p an …
1341 HHS
TRANS T ONAL RE NSURANCE PROGRAM FOR ND V DUAL AND SMALL GROUP
MARKETS N EACH STATE b MODEL REGULAT ON — 1 … he Sec e a y n
consu a on w h he Na ona Assoc a on o nsu ance Comm ss one s he
NA C sha nc ude p ov s ons ha enab e S a es o es ab sh and ma n a n a
p og am unde wh ch— A hea h nsu ance ssue s and h d pa y adm n s a-
o s on beha o g oup hea h p ans a e equ ed o make paymen s o an ap-
p cab e e nsu ance en y … and B he app cab e e nsu ance en y co ec s
paymen s …
1341 HHS
2 H GH-R SK ND V DUAL PAYMENT AMOUNTS —The Sec e a y sha nc ude
he o ow ng … A DETERM NAT ON OF H GH-R SK ND V DUALS —The me hod
by wh ch nd v dua s w be den fied as h gh sk nd v dua s o pu poses o he
e nsu ance p og am …
1341 HHS
3 DETERM NAT ON OF REQU RED CONTR BU8T ONS — A —The Sec e a y sha
nc ude … he me hod o de e m n ng he amoun each hea h nsu ance ssue
and g oup hea h p an … s equ ed o con bu e …
1342 (a) HHS
ESTABL SHMENT OF R SK CORR DORS FOR PLANS N ND V DUAL AND SMALL
GROUP MARKETS a The Sec e a y sha es ab sh and adm n s e a p og am o
sk co do s o ca enda yea s 2014 2015 and 2016 …
1343 HHS
R SK ADJUSTMENT b CR TER A AND METHODS —The Sec e a y n consu a on
w h S a es sha es ab sh c e a and me hods o be used n ca y ng ou he
sk ad us men ac v es …
1401 Treasury
REFUNDABLE TAX CRED T PROV D NG PREM UM ASS STANCE FOR COVERAGE
UNDER A QUAL F ED HEALTH PLAN SEC 36B REFUNDABLE CRED T FOR COVER-
AGE UNDER A QUAL F ED HEALTH PLAN NDEX NG — n he case o axab e
yea s beg nn ng n any ca enda yea a e 2014 he Sec e a y sha ad us he
n a and fina app cab e pe cen ages …
1401 Treasury/HHS
a S a e equ es a qua fied hea h p an … o cove benefi s n add on o he
essen a hea h benefi s equ ed o be p ov ded by he p an he po on o he
p em um o he p an p ope y a ocab e unde u es p esc bed by he Sec e a y
o HHS …
1401 HHS
E SPEC AL RULE FOR PED ATR C DENTAL COVERAGE — … he po on o he
p em um o he p an desc bed n such sec on ha unde egu a ons p e-
sc bed by he Sec e a y s p ope y a ocab e o ped a c den a benefi s …
sha be ea ed as a p em um payab e o a qua fied hea h p an
1401 HHS/Treasury
3 SECRETAR AL AUTHOR TY —The Sec e a y o HHS n consu a on w h he
Sec e a y sha p esc be u es se ng o h he me hods by wh ch ca cu a ons o
am y s ze and househo d ncome a e made …
1401 HHS
g REGULAT ONS —The Sec e a y sha p esc be such egu a ons as may be
necessa y … wh ch p ov de o — 1 he coo d na on o he c ed a owed …
and 2 he app ca on … whe e he fi ng s a us o he axpaye o a axab e
yea s d e en om such s a us used o de e m n ng he advance paymen o
he c ed
1402 HHS
REDUCED COST-SHAR NG FOR ND V DUALS ENROLL NG N QUAL F ED HEALTH
PLANS B COORD NAT ON W TH ACTUAR AL VALUE L M TS — The Sec e a y
sha ensu e he educ on unde h s pa ag aph sha no esu n an nc ease
n he p an s sha e o he o a a owed cos s o benefi s p ov ded unde he p an
above …
1402 HHS
2 ADD T ONAL REDUCT ON FOR LOWER NCOME NSUREDS —The Sec e a y
sha es ab sh p ocedu es unde wh ch he ssue o a qua fied hea h p an o
wh ch h s sec on app es sha u he educe cos sha ng unde he p an …
1402 HHS
3 METHODS FOR REDUC NG COST-SHAR NG — B CAP TATED PAYMENTS —
The Sec e a y may es ab sh a cap a ed paymen sys em o ca y ou he pay-
men o cos -sha ng educ ons unde h s sec on …
1402 HHS
5 SPEC AL RULE FOR PED ATR C DENTAL PLANS — an nd v dua en o s n
bo h a qua fied hea h p an and a p an desc bed n sec on 1311 d 2 B
o any p an yea subsec on a sha no app y o ha po on o any educ on
n cos -sha ng unde subsec on c ha unde egu a ons p esc bed by he
Sec e a y s p ope y a ocab e o ped a c den a benefi s …
1402 HHS/Treasury
e RULES FOR ND V DUALS NOT LAWFULLY PRESENT — 3 SECRETAR AL AU-
THOR TY —The Sec e a y n consu a on w h he Sec e a y o he T easu y sha
p esc be u es se ng o h he me hods by wh ch ca cu a ons o am y s ze and
househo d ncome …
1411 HHS/Treasury
PROCEDURES FOR DETERM N NG EL G B L TY FOR EXCHANGE PART C PAT ON
PREM UM TAX CRED TS AND REDUCED COST-SHAR NG AND ND V DUAL RE-
SPONS B L TY EXEMPT ONS a ESTABL SHMENT OF PROGRAM —The Sec e a y
sha es ab sh a p og am o de e m n ng— 1 whe he an nd v dua … who s
o be cove ed n he nd v dua ma ke by a qua fied hea h p an o e ed h ough
an Exchange o who s c a m ng a p em um ax c ed o educed cos -sha ng
mee s he equ emen s …
1411 HHS
b NFORMAT ON REQU RED TO BE PROV DED BY APPL CANTS — 2 C T ZEN-
SH P OR MM GRAT ON STATUS —The o ow ng n o ma on sha be p ov ded
w h espec o eve y en o ee B … he en o ee s soc a secu y numbe
app cab e and such den y ng n o ma on w h espec o he en o ee s mm -
g a on s a us as he Sec e a y a e consu a on w h he Sec e a y o Home and
Secu y de e m nes app op a e
1411 HHS/Treasury/DHS/SSA
4 METHODS — A The Sec e a y n consu a on w h he Sec e a y o he
T easu y he Sec e a y o Home and Secu y and he Comm ss one o Soc a
Secu y sha p ov de ha ve fica ons and de e m na ons unde h s subsec-
on sha be done— h ough use o an on ne sys em o o he w se … o by
de e m n ng he cons s ency o he n o ma on subm ed w h he n o ma on …
h ough such o he me hod as s app oved by he Sec e a y
1411 HHS/Treasury
B FLEX B L TY —The Sec e a y may mod y he me hods used unde he p o-
g am es ab shed by h s sec on o he Exchange and ve fica on o n o ma on
he Sec e a y de e m nes such mod fica ons wou d educe he adm n s a ve
cos s and bu dens on he app can …
1411 HHS
d VER F CAT ON BY SECRETARY — n he case o n o ma on p ov ded … he
Sec e a y sha ve y he accu acy o such n o ma on n such manne as he
Sec e a y de e m nes app op a e …
1411 HHS
e ACT ONS RELAT NG TO VER F CAT ON — 1 Each pe son o whom he Sec-
e a y p ov ded n o ma on sha epo o he Sec e a y unde he es ab shed
me hod he esu s o s ve fica on and he Sec e a y sha no y he Exchange
o such esu s Each pe son o whom he Sec e a y p ov ded n o ma on unde
subsec on d sha epo o he Sec e a y n such manne as he Sec e a y
de e m nes app op a e
1411 HHS
B EXEMPT ON FROM ND V DUAL RESPONS B L TY — n o ma on p ov ded …
he Sec e a y sha ssue he ce fica on o exemp on …
1411 HHS
REASONABLE EFFORT —The Exchange sha make a easonab e e o o
den y and add ess he causes o such ncons s ency … as he Sec e a y …
may den y
1411 HHS
NOT CE AND OPPORTUN TY TO CORRECT — … The Sec e a y may ex end he
90-day pe od … o en o men s occu ng du ng 2014
1411 HHS/Treasury
APPEALS AND REDETERM NAT ONS — 1 The Sec e a y n consu a on w h
he Sec e a y o he T easu y he Sec e a y o Home and Secu y and he Com-
m ss one o Soc a Secu y sha es ab sh p ocedu es by wh ch he Sec e a y o
one o such o he Fede a o fice s— A hea s and makes dec s ons w h espec
o appea s o any de e m na on … and B ede e m nes e g b y on a pe od c
bas s n app op a e c cums ances
1411 HHS
2 EMPLOYER L AB L TY — A The Sec e a y sha es ab sh a sepa a e appea s
p ocess o emp oye s who a e no fied … ha he emp oye may be ab e o a
ax mposed … w h espec o an emp oyee …
1411 HHS
REASONABLE CAUSE EXCEPT ON — No pena y sha be mposed … he
Sec e a y de e m nes ha he e was a easonab e cause o he a u e and ha
he pe son ac ed n good a h
1411 HHS/Treasury
STUDY OF ADM N STRAT ON OF EMPLOYER RESPONS B L TY — 1 The Sec-
e a y o HHS sha n consu a on w h he Sec e a y o he T easu y conduc a
s udy o he p ocedu es … ha he o ow ng gh s a e p o ec ed A The gh s
o emp oyees o p ese ve he gh o confiden a y o he axpaye e u n n-
o ma on and he gh o en o n a qua fied hea h p an h ough an Exchange
an emp oye does no p ov de a o dab e cove age B The gh s o emp oy-
e s o adequa e due p ocess and access o n o ma on necessa y o accu a e y
de e m ne any paymen assessed on emp oye s
1412 HHS/Treasury
ADVANCE DETERM NAT ON AND PAYMENT OF PREM UM TAX CRED TS AND COST-
SHAR NG REDUCT ONS a The Sec e a y n consu a on w h he Sec e a y o
he T easu y sha es ab sh a p og am unde wh ch— 1 upon eques o an
Exchange advance de e m na ons a e made … w h espec o he ncome
e g b y o nd v dua s en o ng n a qua fied hea h p an …
1412 HHS/Treasury
b ADVANCE DETERM NAT ONS — 1 The Sec e a y sha p ov de … ha ad-
vance de e m na on o e g b y w h espec o any nd v dua sha be made—
A du ng he annua open en o men pe od app cab e o he nd v dua o
such o he en o men pe od as may be spec fied by he Sec e a y and B on
he bas s o he nd v dua s househo d ncome o he mos ecen axab e yea
o wh ch he Sec e a y a e consu a on w h he Sec e a y o he T easu y
de e m nes n o ma on s ava ab e
2951 HHS
d REQU REMENTS — … The e g b e en y es ab shes sub ec o he ap-
p ova o he Sec e a y quan fiab e measu ab e 3- and 5-yea bench ma ks o
demons a ng ha he p og am esu s n mp ovemen s o he e g b e am es
pa c pa ng n he p og am …
2951 HHS
B DEMONSTRAT ON OF MPROVEMENTS AFTER 3 YEARS — REPORT TO THE
SECRETARY — … he en y subm s o he Sec e a y a epo demons a ng
mp ovemen n a eas 4 o he a eas …
2951 HHS
CORRECT VE ACT ON PLAN — he epo subm ed … a s o demons a e
mp ovemen n a eas 4 o he a eas spec fied … he en y sha deve op and
mp emen a p an o mp ove ou comes n each o he a eas spec fied … sub ec
o app ova by he Sec e a y The p an sha nc ude p ov s ons o he Sec e a y
o mon o mp emen a on o he p an and conduc con nued ove s gh o he
p og am …
2951 HHS
ADV SORY PANEL —The Sec e a y sha es ab sh an adv so y pane o pu -
poses o ob a n ng ecommenda ons ega d ng he echn ca ass s ance p ov ded
o en es …
2951 HHS
v NO MPROVEMENT OR FA LURE TO SUBM T REPORT — he Sec e a y de e -
m nes … ha an e g b e en y … has a ed o demons a e any mp ovemen n
he spec fied a eas o he Sec e a y de e m nes ha an e g b e en y has a ed
o subm he epo … he Sec e a y sha e m na e he en y s g an and may
nc ude any unexpended g an unds n g an s made o nonp ofi o gan za ons …
2951 HHS
C F NAL REPORT — … he e g b e en y sha subm a epo o he Sec e a y
demons a ng mp ovemen s …
2951 HHS
3 CORE COMPONENTS — … The Sec e a y sha es ab sh c e a o ev dence
o e ec veness o he se v ce de ve y mode s and sha ensu e ha he p ocess
o es ab sh ng he c e a s anspa en and p ov des he oppo un y o pub c
commen
2951 HHS
e APPL CAT ON REQU REMENTS —An e g b e en y des ng a g an unde h s
sec on sha subm an app ca on o he Sec e a y o app ova …
2951 HHS
… he en y w … subm annua epo s o he Sec e a y ega d ng he p o-
g am and ac v es ca ed ou unde he p og am …
2951 HHS
g EVALUAT ON — 1 NDEPENDENT EXPERT ADV SORY PANEL —The Sec e a y
… sha appo n an ndependen adv so y pane cons s ng o expe s n p og am
eva ua on and esea ch educa on and ea y ch dhood deve opmen —
2951 HHS
B NONPROF T ORGAN ZAT ONS — … a S a e has no app ed o been ap-
p oved o a g an … he Sec e a y may use amoun s app op a ed … o make
a g an o an e g b e en y ha s a nonp ofi o gan za on … The Sec e a y sha
spec y he equ emen s o such an o gan za on o app y o and conduc he
p og am …
2951 HHS
3 RESEARCH AND OTHER EVALUAT ON ACT V T ES —The Sec e a y sha
ca y ou a con nuous p og am o esea ch and eva ua on ac v es n o de o
nc ease know edge abou he mp emen a on and e ec veness o home v s ng
p og ams … The Sec e a y may ca y ou such ac v es d ec y o h ough
g an s coope a ve ag eemen s o con ac s
2951 HHS
B REQU REMENTS —The Sec e a y sha ensu e ha — eva ua on o a
spec fic p og am o p o ec s conduc ed by pe sons o nd v dua s no d ec y
nvo ved n he ope a on o such p og am o p o ec and he conduc o e-
sea ch and eva ua on ac v es nc udes consu a on w h ndependen esea ch-
e s S a e o fic a s and deve ope s and p ov de s o home v s ng p og ams …
2951 HHS
4 REPORT AND RECOMMENDAT ON — … he Sec e a y sha subm a epo o
Cong ess ega d ng he p og ams conduc ed w h g an s unde h s sec on The
epo … sha nc ude— C ecommenda ons o such eg s a ve o adm n s a ve
ac on as he Sec e a y de e m nes app op a e
2952 HHS
SUPPORT EDUCAT ON AND RESEARCH FOR POSTPARTUM DEPRESS ON a RE-
SEARCH ON POSTPARTUM COND T ONS — 1 EXPANS ON AND NTENS F CAT ON
OF ACT V T ES —The Sec e a y o HHS … s encou aged o con nue ac v es on
pos pa um dep ess on o pos pa um psychos s …
1413 HHS
STREAML N NG OF PROCEDURES FOR ENROLLMENT THROUGH AN EXCHANGE
AND STATE MED CA D CH P AND HEALTH SUBS DY PROGRAMS a The Sec e a y
sha es ab sh a sys em mee ng he equ emen s o h s sec on unde wh ch
es den s o each S a e may app y o en o men n ece ve a de e m na on o
e g b y o pa c pa on n and con nue pa c pa on n app cab e S a e hea h
subs dy p og ams …
1413 HHS
b REQU REMENTS RELAT NG TO FORMS AND NOT CE — 1 REQU REMENTS
RELAT NG TO FORMS — A The Sec e a y sha deve op and p ov de o each S a e
a s ng e s eam ned o m ha — may be used o app y o a app cab e S a e
hea h subs dy p og ams w h n he S a e may be fi ed on ne n pe son by ma
o by e ephone may be fi ed w h an Exchange o w h S a e o fic a s ope a ng
one o he o he app cab e S a e hea h subs dy p og ams and v s s uc u ed o
max m ze an app can s ab y o comp e e he o m sa s ac o y …
1413 HHS
C SUPPLEMENTAL EL G B L TY FORMS — The Sec e a y may a ow a S a e o
use a supp emen a o a e na ve o m n he case o nd v dua s who app y o
e g b y ha s no de e m ned on he bas s o he househo d ncome …
1413 HHS
4 SECRETAR AL STANDARDS —The Sec e a y sha … p omu ga e s anda ds
gove n ng he m ng con en s and p ocedu es o da a ma ch ng …
1413 HHS
d ADM N STRAT VE AUTHOR TY — 1 AGREEMENTS — … he Sec e a y may
es ab sh mode ag eemen s and en e n o ag eemen s o he sha ng o da a
1414 HHS
D SCLOSURES TO CARRY OUT EL G B L TY REQU REMENTS FOR CERTA N PRO-
GRAMS a D SCLOSURE OF TAXPAYER RETURN NFORMAT ON AND SOC AL SECU-
R TY NUMBERS — 1 TAXPAYER RETURN NFORMAT ON — … 21 D SCLOSURE
OF RETURN NFORMAT ON TO CARRY OUT EL G B L TY REQU REMENTS FOR CER-
TA N PROGRAMS — A The Sec e a y upon w en eques om he Sec e a y o
HHS sha d sc ose … e u n n o ma on o any axpaye whose ncome s e evan
n de e m n ng any p em um ax c ed … o any cos -sha ng educ on …
1414 HHS
… such o he n o ma on as s p esc bed by he Sec e a y by egu a on as
m gh nd ca e whe he he axpaye s e g b e o such c ed o educ on …
1414 HHS
B NFORMAT ON TO EXCHANGE AND STATE AGENC ES —The Sec e a y o HHS
may d sc ose … any ncons s ency be ween he n o ma on p ov ded by he
Exchange o S a e agency o he Sec e a y and he n o ma on p ov ded o he
Sec e a y …
1414 HHS
x The Sec e a y o HHS and he Exchanges … a e au ho zed o co ec and
use he names and soc a secu y accoun numbe s o nd v dua s as equ ed o
adm n s e he p ov s ons o and he amendmen s made by …
1414 HHS
b HEALTH NSURANCE CRED T AMOUNT 2 he agg ega e amoun o none ec-
ve con bu ons wh ch he emp oye wou d have made du ng he axab e yea
unde he a angemen each emp oyee aken n o accoun unde pa ag aph 1
had en o ed n a qua fied hea h p an wh ch had a p em um equa o he ave age
p em um as de e m ned by he Sec e a y o HHS …
1414 HHS/Labor
C HOURS OF SERV CE —The Sec e a y n consu a on w h he Sec e a y o
Labo sha p esc be such egu a ons u es and gu dance as may be necessa y
o de e m ne he hou s o se v ce o an emp oyee …
1414 HHS
g APPL CAT ON OF SECT ON FOR CALENDAR YEARS 2011 2012 AND 2013 2
AMOUNT OF CRED T —The amoun o he c ed de e m ned unde subsec on b
sha be de e m ned— C by subs u ng o he ave age p em um … he amoun
he Sec e a y o HHS de e m nes s he ave age p em um o he sma g oup
ma ke n he S a e n wh ch he emp oye s o e ng hea h nsu ance cove age
o o such a ea w h n he S a e as s spec fied by he Sec e a y
1414 HHS
REGULAT ONS —The Sec e a y sha p esc be such egu a ons as may be
necessa y o ca y ou he p ov s ons o h s sec on …
5001 HHS
REQU REMENT TO MA NTA N M N MUM ESSENT AL COVERAGE e EXEMP-
T ONS — … ND V DUALS WHO CANNOT AFFORD COVERAGE — D NDEX-
NG — n he case o p an yea s beg nn ng n any ca enda yea a e 2014 h s
sha be app ed by subs u ng o 8 pe cen he pe cen age he Sec e a y o
HHS de e m nes eflec s he excess o he a e o p em um g ow h be ween
he p eced ng ca enda yea and 2013 ove he a e o ncome g ow h o such
pe od
5001 HHS
B SPEC AL RULES — … The Sec e a y sha p esc be u es o he co ec on
o he pena y mposed by h s sec on n cases whe e con nuous pe ods nc ude
mon hs n mo e han 1 axab e yea
5001 HHS
5 HARDSH PS —Any app cab e nd v dua who o any mon h s de e m ned
by he Sec e a y o HHS unde sec on 1311 d 4 H o have su e ed a ha dsh p
w h espec o he capab y o ob a n cove age unde a qua fied hea h p an
5001 HHS
M N MUM ESSENT AL COVERAGE — … E OTHER COVERAGE —Such o he
hea h benefi s cove age such as a S a e hea h benefi s sk poo as he Sec-
e a y o HHS n coo d na on w h he Sec e a y ecogn zes o pu poses o h s
subsec on
1502 HHS
REPORT NG OF HEALTH NSURANCE COVERAGE a Eve y pe son who p ov des
m n mum essen a cove age o an nd v dua du ng a ca enda yea sha a such
me as he Sec e a y may p esc be make a e u n …
1502 HHS
b FORM AND MANNER OF RETURN — 1 A e u n s desc bed n h s subsec-
on such e u n— A s n such o m as he Sec e a y may p esc be …
1502 HHS
2 NFORMAT ON RELAT NG TO EMPLOYER-PROV DED COVERAGE — … C he
hea h nsu ance cove age s a qua fied hea h p an n he sma g oup ma ke o -
e ed h ough an Exchange such o he n o ma on as he Sec e a y may equ e
o adm n s a on o he c ed …
1512 HHS
EMPLOYER REQU REMENT TO NFORM EMPLOYEES OF COVERAGE OPT ONS …
a— n acco dance w h egu a ons p omu ga ed by he Sec e a y an emp oye
o wh ch h s Ac app es sha p ov de o each emp oyee a he me o h ng …
w en no ce …
1512 HHS/Labor
d DEF N T ONS AND SPEC AL RULES — 4 FULL-T ME EMPLOYEE — B HOURS
OF SERV CE —The Sec e a y n consu a on w h he Sec e a y o Labo sha
p esc be such egu a ons u es and gu dance as may be necessa y o de e -
m ne he hou s o se v ce o an emp oyee …
1512 HHS
e ADM N STRAT ON AND PROCEDURE — 1 Any assessab e paymen p ov ded
by h s sec on sha be pa d upon no ce and demand by he Sec e a y …
1512 HHS
2 T ME FOR PAYMENT —The Sec e a y may p ov de o he paymen o any
assessab e paymen p ov ded by h s sec on on an annua mon h y o o he
pe od c bas s as he Sec e a y may p esc be
1514 HHS
LARGE EMPLOYERS REQU RED TO REPORT ON HEALTH NSURANCE COVERAGE
a Eve y app cab e a ge emp oye … sha a such me as he Sec e a y may
p esc be make a e u n …
1514 HHS
b FORM AND MANNER OF RETURN —A e u n s desc bed n h s subsec on
such e u n— 1 s n such o m as he Sec e a y may p esc be
1514 HHS
d COORD NAT ON W TH OTHER REQU REMENTS — … he Sec e a y may
p ov de ha — 1 any e u n o s a emen equ ed … may be p ov ded as pa
o any e u n o s a emen … and 2 n he case o an app cab e a ge emp oye
o e ng hea h nsu ance cove age o a hea h nsu ance ssue he emp oye
may en e n o an ag eemen w h he ssue …
1552 HHS
TRANSPARENCY N GOVERNMENT No a e han 30 days a e enac men he
Sec e a y o HHS sha pub sh on he n e ne webs e o he Depa men o HHS
a s o a o he au ho es p ov ded o he Sec e a y unde h s Ac and he
amendmen s made by h s Ac
1557 HHS
NOND SCR M NAT ON c REGULAT ONS —The Sec e a y may p omu ga e egu-
a ons o mp emen h s sec on
3021 HHS
HEALTH NFORMAT ON TECHNOLOGY ENROLLMENT STANDARDS AND PROTOCOL
a 1 STANDARDS AND PROTOCOLS —No a e han 180 days a e he da e
o enac men o h s e he Sec e a y n consu a on w h he H T Po cy Com-
m ee and he H T S anda ds Comm ee sha deve op n e ope ab e and secu e
s anda ds and p o oco s … as de e m ned by he Sec e a y
3021 HHS
2 METHODS —The Sec e a y sha ac a e en o men n such p og ams
h ough me hods de e m ned app op a e by he Sec e a y wh ch sha nc ude
p ov d ng nd v dua s and h d pa es au ho zed by such nd v dua s and he
des gnees no fica on o e g b y and ve fica on o e g b y …
302 HHS
b CONTENT —The s anda ds and p o oco s o e ec on c en o men n he Fed-
e a and S a e p og ams desc bed n subsec on a sha a ow o he o ow ng
1 E ec on c ma ch ng aga ns ex s ng Fede a and S a e da a nc ud ng v a
eco ds emp oymen h s o y en o men sys ems ax eco ds and o he da a
de e m ned app op a e by he Sec e a y o se ve as ev dence o e g b y and n
eu o pape based documen a on
3021 HHS
d GRANTS FOR MPLEMENTAT ON OF APPROPR ATE ENROLLMENT H T — 1
The Sec e a y sha awa d g an s o e g b e en es o deve op new and adap
ex s ng echno ogy sys ems o mp emen he H T en o men s anda ds and
p o oco s …
3021 HHS
3 SHAR NG — A The Sec e a y sha ensu e ha app op a e en o men H T
adop ed unde g an s unde h s subsec on s made ava ab e …
3021 HHS
B QUAL F ED ENT T ES —The Sec e a y sha de e m ne wha en es a e qua -
fied o ece ve en o men H T …
2952 HHS
SERV CES TO ND V DUALS W TH A POSTPARTUM COND T ON AND THE R FAM -
L ES … he Sec e a y may make g an s o e g b e en es o p o ec s o he
es ab shmen ope a on and coo d na on o e ec ve and cos -e fic en sys ems
o he de ve y o essen a se v ces o nd v dua s w h o a sk o pos pa um
cond ons and he am es
2952 HHS
b CERTA N ACT V T ES — … he Sec e a y sha ensu e ha p o ec s … p ov de
educa on and se v ces w h espec o he d agnos s and managemen o pos -
pa um cond ons o nd v dua s w h o a sk o pos pa um cond ons and
he am es The Sec e a y may a ow such p o ec s o nc ude …
2952 HHS
c NTEGRAT ON W TH OTHER PROGRAMS — … he Sec e a y may n eg a e he
g an p og am unde h s sec on w h o he g an p og ams ca ed ou by he
Sec e a y …
2952 HHS
d REQU REMENTS —The Sec e a y sha es ab sh equ emen s o g an s made
unde h s sec on … and a equ emen o each e g b e en y ha ece ves a
g an o subm o each g an pe od a epo o he Sec e a y ha desc bes how
g an unds we e used du ng such pe od
2952 HHS
e TECHN CAL ASS STANCE —The Sec e a y may p ov de echn ca ass s ance o
en es seek ng a g an unde h s sec on n o de o ass s …
2952 HHS
2 REPORT BY THE SECRETARY — A STUDY —The Sec e a y sha conduc a
s udy on he benefi s o sc een ng o pos pa um cond ons … he Sec e a y
sha comp e e he s udy …
2953 HHS
PERSONAL RESPONS B L TY EDUCAT ON a ALLOTMENTS TO STATES — 1
AMOUNT — … o each o fisca yea s 2010 h ough 2014 he Sec e a y sha
a o o each S a e an amoun equa o he p oduc …
2953 HHS
C APPL CAT ON REQU RED TO ACCESS ALLOTMENTS — A S a e sha no be
pa d om s a o men o a fisca yea un ess he S a e subm s an app ca on
o he Sec e a y o he fisca yea and he Sec e a y app oves he app ca on …
and mee s such add ona equ emen s as he Sec e a y may spec y
2953 HHS
REQU REMENTS —The S a e app ca on sha con a n an assu ance ha he
S a e has comp ed w h he equ emen s o h s sec on n p epa ng and sub-
m ng he app ca on and sha nc ude he o ow ng as we as such add ona
n o ma on as he Sec e a y may equ e
2953 HHS
4 … A GRANTS FROM UNEXPENDED ALLOTMENTS — … he S a e sha no
onge be e g b e o subm an app ca on o ece ve unds om he amoun s a -
o ed o he S a e o each o fisca yea s 2010 h ough 2014 and such amoun s
sha be used by he Sec e a y o awa d g an s … The Sec e a y a so sha use
any amoun s om he a o men s o S a es ha subm app ca ons unde h s
sec on o a fisca yea …
2953 HHS
B 3-YEAR GRANTS — The Sec e a y sha so c app ca ons o awa d 3-yea
g an s n each o fisca yea s 2012 2013 and 2014 o oca o gan za ons and
en es … FA TH-BASED ORGAN ZAT ONS OR CONSORT A —The Sec e a y
may so c and awa d g an s unde h s pa ag aph o a h-based o gan za ons
o conso a
2953 HHS
6 DATA COLLECT ON AND REPORT NG —A S a e o oca o gan za on o en y
ece v ng unds unde h s sec on sha coope a e w h such equ emen s … as
he Sec e a y sha spec y
2953 HHS
B SECRETAR AL RESPONS B L T ES — RESERVAT ON OF FUNDS —The
Sec e a y sha ese ve 10 pe cen o such ema nde o expend u es by he
Sec e a y o he ac v es desc bed … PROGRAM SUPPORT —The Sec e a y
sha p ov de … esea ch a n ng and echn ca ass s ance … o suppo he
ac v es o ec p en s o g an s and o he S a e ba and commun y o gan za-
ons wo k ng o educe een p egnancy … EVALUAT ON —The Sec e a y
sha eva ua e he p og ams and ac v es ca ed ou w h unds made ava ab e
h ough a o men s o g an s unde h s sec on
3
3001 l HHS
HOSPITAL VALUE-BASED PURCHASING PROGRAM … the Secretary shall
establish a hospital value-based purchasing program … under which value-
based incentive payments are made in a fiscal year to hospitals that meet
the performance standards …
3001 l HHS 3005 l HHS shall take steps to (A) seek to avoid duplication of measures used; and (B)
(III) … for which there are not a minimum number (as determined by the
Secretary) of measures that apply to the hospital for the performance
period …
3001 l HHS …, the Secretary may specify a measure that is not so endorsed as long as
(IV)… for which there are not a minimum number (as determined by the
Secretary) of cases for the measures that apply to the hospital for the perfor-
mance period …
3001 l HHS (4) PUBLIC AVAILABILITY OF DATA SUBMITTED.—The Secretary shall estab-
(IV) EXEMPTION.— … the Secretary may exempt such hospital from the
application of this subsection if the State which is paid under such section
submits an annual report to the Secretary …
3001 l HHS & Medicaid Services.
The Secretary shall select measures, other than measures of readmissions,
for purposes of the Program …
3001 l HHS a plan to implement a value-based purchasing program for payments
… the Secretary shall ensure that selected measures include efficiency
measures, including measures of ‘Medicare spending per beneficiary’. Such
measures shall be adjusted for factors such as age, sex, race, severity of
illness, and other factors that the Secretary determines appropriate.
3001 l HHS bundling across the spectrum of care given practice patterns ….
(A) ESTABLISHMENT.—The Secretary shall establish performance standards
with respect to measures …
3001 l HHS the Medicare program … for home health agencies …
(C) TIMING.—The Secretary shall establish and announce the performance
standards not later than 60 days prior to the beginning of the performance
period for the fiscal year involved.
3001 l HHS 3006 l HHS and resource use to the public in accordance with the public reporting
(D) CONSIDERATIONS IN ESTABLISHING STANDARDS.— In establishing
performance standards with respect to measures under this paragraph, the
Secretary shall take into account appropriate factors …
3001 l HHS
(5) HOSPITAL PERFORMANCE SCORE.— … the Secretary shall develop a
methodology for assessing the total performance of each hospital based
on performance standards … Using such methodology, the Secretary shall
provide for an assessment … for each hospital for each performance period.
3001 l HHS 3006 l HHS to an entity unless the entity agrees that it will make available … non-
(B) APPLICATION.— ‘‘(i) APPROPRIATE DISTRIBUTION.—The Secretary shall
ensure that the application of the methodology … results in an appropriate
distribution of value-based incentive payments …
3001 l HHS affected parties; and (B) consider experience with such demonstrations
… The methodology developed shall provide for the assignment of weights
for categories of measures as the Secretary determines appropriate.
3001 l HHS MENT PROCEDURES. The Secretary shall ensure that the development of
(6) CALCULATION OF VALUE-BASED INCENTIVE PAYMENTS.— In the case of
a hospital that the Secretary determines meets (or exceeds) the performance
standards … the Secretary shall increase the base operating DRG payment
amount …
3001 l HHS (B) MEASURES.— (i) The Secretary shall establish appropriate measures
(C) VALUE-BASED INCENTIVE PAYMENT PERCENTAGE.—The Secretary shall
specify a value-based incentive payment percentage for a hospital for a
fiscal year.
3001 l HHS (B) AUTHORIZATION OF ADJUSTMENT. Insofar as the Secretary determines
(7) FUNDING FOR VALUE-BASED INCENTIVE PAYMENTS.— ‘‘(A) AMOUNT.—
The total amount available for value based incentive payments … shall be
equal to the total amount of reduced payments for all hospitals for such fiscal
year, as estimated by the Secretary.
3001 l HHS 3023 l HHS practice expense geographic adjustments …and evaluate data that fairly
(B) ADJUSTMENT TO PAYMENTS.— The Secretary shall reduce the base op-
erating DRG payment amount … for a hospital for each discharge in a fiscal
year (beginning with fiscal year 2013) by an amount … The Secretary shall
make such reductions for all hospitals in the fiscal year involved, regardless
of whether or not the hospital has been determined by the Secretary to have
earned a value-based incentive payment …
3001 l HHS (ii) NO ADDITIONAL PROGRAM EXPENDITURES. Payments … for appli-
(10) PUBLIC REPORTING.— ‘‘(A) HOSPITAL SPECIFIC INFORMATION.— The
Secretary shall make information available to the public regarding the perfor-
mance of individual hospitals under the Program …
3001 l HHS the Secretary determines appropriate …
(11) IMPLEMENTATION.— ‘‘(A) APPEALS.—The Secretary shall establish
a process by which hospitals may appeal the calculation of a hospital’s
performance assessment with respect to the performance standards …
The Secretary shall ensure that such process provides for resolution of such
appeals in a timely manner.
3001 l HHS (5) SYSTEMS-BASED CARE.—The Secretary shall … apply the payment
(12) PROMULGATION OF REGULATIONS.—The Secretary shall promulgate
regulations to carry out the Program … used to determine the amount of
value-based incentive payments …
3001 l HHS 3021 l HHS disease prevention.
(2) AMENDMENTS FOR REPORTING OF HOSPITAL QUALITY INFORMATION.—
… The Secretary may require hospitals to submit data on measures that are
not used for the determination of value-based incentive payments …
3001 l HHS (7) APPLICATION.— … On or after January 1, 2017, the Secretary may
(VIII) … the Secretary shall provide for such risk adjustment as the Secretary
determines to be appropriate to maintain incentives for hospitals to treat
patients with severe illnesses or conditions.
3001 l HHS (C) ADDITIONAL FACTORS FOR CONSIDERATION. In selecting models for test-
(IX)(aa) … each measure specified by the Secretary under this clause shall
be endorsed by the entity with a contract …
3001 l HHS … shall include … the following: (ix) ...Other measures, including measures
(bb) In the case of a specified area or medical topic determined appropriate
by the Secretary for which a feasible and practical measure has not been
endorsed by the entity … the Secretary may specify a measure that is not
so endorsed … or adopted by a consensus organization identified by the
Secretary.
3001 l HHS (and the Chief Actuary of CMS … certifies), after testing has begun, that the
(X) … the Secretary shall …take steps to ensure that the measures speci-
fied by the Secretary under this clause are coordinated and aligned with
quality measures …
3001 l HHS model tested.
(XI) The Secretary shall establish a process to validate measures …
3001 l HHS 3023 l HHS cian specialties, the Secretary shall provide funding to States to enable such
(x)(I) The Secretary shall develop standard Internet website reports tailored to
meet the needs of various stakeholders such as hospitals, patients, research-
ers, and policymakers.
3001 l HHS applicable hospital, as determined by the Secretary.
(5) HHS STUDY AND REPORT.—(A) STUDY.—The Secretary of HHS shall
conduct a study on the performance of the hospital value-based purchasing
program …
3001 l HHS 3023 l HHS priate payment rates for such tests.
(b)(1) VALUE-BASED PURCHASING DEMONSTRATION PROGRAM FOR INPA-
TIENT CRITICAL ACCESS HOSPITALS. (A) The Secretary shall establish … the
Secretary of HHS shall establish a demonstration program under which the
Secretary establishes a value based purchasing program under the Medicare
program … with respect to inpatient critical access hospital services … in
order to test innovative methods of measuring and rewarding quality and
efficient health care furnished by such hospitals.
3001 l HHS 3011 l HHS certifies that such expansion would reduce (or would not result in any
(iii) SITES.—The Secretary shall conduct the demonstration program under
this paragraph at an appropriate number (as determined by the Secretary)
of critical access hospitals. The Secretary shall ensure that such hospitals
are representative of the spectrum of such hospitals that participate in the
Medicare program.
3001 l HHS (2) IDENTIFICATION OF PRIORITIES.— The Secretary shall identify national
(b)(1)(B) WAIVER AUTHORITY—The Secretary may waive such requirements
of titles XI and XVIII of the Social Security Act as may be necessary …
3001 l HHS 3021 l HHS 3024 l HHS (iii) IMPROVEMENTS TO RISK ADJUSTMENT FOR SPECIAL NEEDS INDIVIDU-
(b)(1)(C) BUDGET NEUTRALITY REQUIREMENT.—In conducting the demon-
stration program, the Secretary shall ensure that the aggregate payments
made by the Secretary do not exceed the amount which the Secretary would
have paid if the demonstration program was not implemented.
3001 l HHS (83) ... provide for implementation of the payment models specified by the
(2) VALUE-BASED PURCHASING DEMONSTRATION PROGRAM FOR HOSPI-
TALS EXCLUDED FROM HOSPITAL VALUE-BASED PURCHASING PROGRAM
AS A RESULT OF INSUFFICIENT NUMBERS OF MEASURES AND CASES.— (A)
ESTABLISHMENT… the Secretary shall establish a demonstration program
under which the Secretary establishes a value-based purchasing program
under the Medicare program … for applicable hospitals …
3001 l HHS quality measures shall be measures identified by the Secretary …
(iv) SITES.—The Secretary shall conduct the demonstration program under
this paragraph at an appropriate number (as determined by the Secretary) of
applicable hospitals.
3001 l HHS Secretary may work together to manage and coordinate care for Medicare
(b)(2)(B) WAIVER AUTHORITY.—The Secretary may waive such requirements
of titles XI and XVIII of the Social Security Act as may be necessary …
3001 l HHS the end.
(b)(2)(C) BUDGET NEUTRALITY REQUIREMENT.— … the Secretary shall en-
sure that the aggregate payments made by the Secretary do not exceed the
amount which the Secretary would have paid if the demonstration program
was not implemented.
3002 l HHS information— … (3) other information, as the Secretary determines to be
(3) AUTHORITY.—For years after 2014, if the Secretary of HHS determines it
to be appropriate, the Secretary may incorporate participation in a Main-
tenance of Certification Program and successful completion of a qualified
Maintenance of Certification Program practice assessment into the compos-
ite of measures of quality of care …
3002 l HHS updating, or expansion … In identifying such gaps and existing quality mea-
(7) INTEGRATION OF PHYSICIAN QUALITY REPORTING AND EHR REPORT-
ING.—Not later than January 1, 2012, the Secretary shall develop a plan to
integrate reporting on quality measures … Such integration shall consist of
the following: … (B) Such other activities as specified by the Secretary.
3002 l HHS identification.
(I) INFORMAL APPEALS PROCESS.—The Secretary shall … establish and
have in place an informal process for eligible professionals to seek a review
of the determination that an eligible professional did not satisfactorily submit
data on quality measures under this subsection.
3003 l HHS (B) REPORTING REQUIREMENTS. An ACO shall submit data in a form and
(ii) REPORTS ON RESOURCES.—The Secretary shall use claims data … to
provide confidential reports to physicians (and, as determined appropriate by
the Secretary, to groups of physicians) that measure the resources involved
in furnishing care to individuals under this title. ‘‘(iii) INCLUSION OF CERTAIN
INFORMATION.—If determined appropriate by the Secretary, the Secretary
may include information on the quality of care furnished to individuals …
3003 l HHS (3) ELIGIBLE ENTITIES.—To be eligible for a grant or contract, an entity shall
(4)(9)(A) DEVELOPMENT OF EPISODE GROUPER.— The Secretary shall de-
velop an episode grouper that combines separate but clinically related items
and services into an episode of care for an individual, as appropriate … (iii)
PUBLIC AVAILABILITY.—The Secretary shall make the details of the episode
grouper … available to the public. (iv) ENDORSEMENT.—The Secretary shall
seek endorsement of the episode grouper … (B) REPORTS ON UTILIZA-
TION.—Effective beginning with 2012, the Secretary shall provide reports
to physicians that compare, as determined appropriate by the Secretary,
patterns of resource use of the individual physician to such patterns of
other physicians. (C) ANALYSIS OF DATA.—The Secretary shall …establish
methodologies …
3003 l HHS 3024 l HHS nfla on
(D) DATA ADJUSTMENT.—In preparing reports under this paragraph, the
Secretary shall make appropriate adjustments …
3003 l HHS (2) CATEGORIES OF MEASURES.—The measures developed under this
(ii) TREATMENT OF GROUPS.—Such term includes, as the Secretary deter-
mines appropriate, a group of physicians.
3003 l HHS 3013 l HHS (d) PAYMENTS AND TREATMENT OF SAVINGS. (1) PAYMENTS. (A) … pay-
(10) COORDINATION WITH OTHER VALUE-BASED PURCHASING REFORMS.—
The Secretary shall coordinate the Program with the value-based payment
modifier … and, as the Secretary determines appropriate, other similar
provisions of this title.
3003 l HHS the Secretary … and (ii) the ACO meets the requirement ….
(6) REVIEW AND ENDORSEMENT OF EPISODE GROUPER UNDER THE PHYSI-
CIAN FEEDBACK PROGRAM.—The entity shall provide for the review and,
as appropriate, the endorsement of the episode grouper developed by the
Secretary …
3004 l HHS 3013 l HHS care expenditures … is at least the percent specified by the Secretary below
(C) SUBMISSION OF QUALITY DATA.— … each long-term care hospital shall
submit to the Secretary data on quality measures … Such data shall be
submitted in a form and manner, and at a time, specified by the Secretary …
3004 l HHS 3022 l HHS ditions or procedures that are high volume or high expenditures … (or other
(D) QUALITY MEASURES.— … any measure specified by the Secretary
must have been endorsed by the entity with a contract … (ii) EXCEPTION.—
… the Secretary may specify a measure that is not so endorsed as long as
due consideration is given to measures that have been endorsed or adopted
by a consensus organization identified by the Secretary.
3004 l HHS Secretary shall, to the extent practicable, expand the applicable conditions
(E) PUBLIC AVAILABILITY OF DATA SUBMITTED.—The Secretary shall estab-
lish procedures for making data … available to the public. … The Secretary
shall report quality measures that relate to services furnished in inpatient
settings in long-term care hospitals on the Internet website of the Centers for
Medicare & Medicaid Services.
3004 l HHS (a) MULTI-STAKEHOLDER GROUP INPUT INTO SELECTION OF QUALITY
(C) SUBMISSION OF QUALITY DATA.— … each rehabilitation facility shall
submit to the Secretary data on quality measures … Such data shall be
submitted in a form and manner, and at a time, specified by the Secretary for
purposes of this subparagraph.
3004 l HHS considering.
(D) QUALITY MEASURES.— … any measure specified by the Secretary must
have been endorsed by the entity … (ii) EXCEPTION.— … the Secretary
may specify a measure that is not so endorsed as long as due consideration
is given to measures that have been endorsed or adopted by a consensus
organization identified by the Secretary.
3004 l HHS (4) TERMINATION. The Secretary may terminate an agreement with an ACO
(E) PUBLIC AVAILABILITY OF DATA SUBMITTED.—The Secretary shall estab-
lish procedures for making data … available to the public … The Secretary
shall report quality measures that relate to services furnished in inpatient
settings in rehabilitation facilities on the Internet website of the Centers for
Medicare & Medicaid Services.’’
3004 l HHS (6) ASSESSMENT OF IMPACT.—Not later than March 1, 2012, and at least
(C) SUBMISSION OF QUALITY DATA.— … each hospice program shall
submit to the Secretary data on quality measures … Such data shall be
submitted in a form and manner, and at a time, specified by the Secretary for
purposes of this subparagraph.
3004 l HHS efficiency measures used by the Secretary. Such process shall include …
(D) QUALITY MEASURES.— … any measure specified by the Secretary
… must have been endorsed by the entity … ‘‘(ii) EXCEPTION.— … the
Secretary may specify a measure that is not so endorsed as long as due
consideration is given to measures that have been endorsed or adopted by a
consensus organization identified by the Secretary.
3004 l HHS and expand existing dissemination methods in disseminating quality and
(E) PUBLIC AVAILABILITY OF DATA SUBMITTED.—The Secretary shall estab-
lish procedures for making data submitted … available to the public … The
Secretary shall report quality measures that relate to hospice care provided
by hospice programs on the Internet website of the Centers for Medicare &
Medicaid Services.
3005 l HHS
(2) SUBMISSION OF QUALITY DATA.— … each hospital described in such
section shall submit to the Secretary data on quality measures …Such data
shall be submitted in a form and manner, and at a time, specified by the
Secretary.
(3) QUALITY MEASURES.— … any measure specified by the Secretary …
must have been endorsed by the entity … ‘‘(B) EXCEPTION.—In the case of
a specified area or medical topic determined appropriate by the Secretary for
which a feasible and practical measure has not been endorsed by the entity
due consideration is given to measures that have been endorsed or adopted
by a consensus organization identified by the Secretary.
3005 l HHS Insurance Trust Fund … in such proportion as the Secretary determines
lish procedures for making data … available to the public …The Secretary
shall report quality measures of process, structure, outcome, patients’
perspective on care, efficiency, and costs of care that relate to services fur-
nished in such hospitals on the Internet website of the Centers for Medicare
3006 l HHS out the public reporting of performance information … (2) COLLECTION AND
(a) SKILLED NURSING FACILITIES.— The Secretary of HHS … shall develop
under the Medicare program … for skilled nursing facilities …
3006 l HHS (3) SCOPE. The Secretary shall ensure that the data collection, data aggrega-
(a)(2)(E) Any other issues ... Any other issues determined appropriate by the
Secretary
3006 l HHS 3015 l HHS 3307 l HHS seminate to the public and to the appropriate Committees of the Congress,
(b) HOME HEALTH AGENCIES.—The Secretary of HHS … shall develop a
plan to implement a value-based purchasing program for payments under
3006 l HHS (ii) ESTABLISHMENT OF PERIOD BY THE SECRETARY. The Secretary, as
(b)(2)(E) Any other issues determined appropriate by the Secretary.
(b)(3) CONSULTATION.—In developing the plan, the Secretary shall— (A)
consult with relevant affected parties; and (B) consider experience with such
demonstrations that the Secretary determines are relevant to the value-
based purchasing program …
3006 l HHS grated and compared across multiple sources. The Secretary shall provide
(f) AMBULATORY SURGICAL CENTERS.—The Secretary shall develop a plan
to implement a value-based purchasing program for payments under the
Medicare program …
(f)(2)(E) Any other issues determined appropriate by the Secretary.
3006 l HHS AND FOR POST-ACUTE CARE. (A) The Secretary … shall develop quality
(f)(3) CONSULTATION.— … (1) the Secretary shall— (A) consult with relevant
that the Secretary determines are relevant to the value-based purchasing
program …
3007 l HHS
(p) ESTABLISHMENT OF VALUE-BASED PAYMENT MODIFIER.— The Secretary
shall establish a payment modifier that provides for differential payment to a
physician or a group of physicians under the fee schedule …
3007 l HHS use of the reports and of performance reporting Internet websites.
of the quality of care furnished by a physician or group of physicians to
individuals enrolled, such as measures that reflect health outcomes. Such
measures shall be risk adjusted as determined appropriate by the Secretary.
(ii) The Secretary shall seek endorsement of the measures established by the
entity …
3007 l HHS may be necessary to carry out the program.
(3) COSTS.— … costs shall be evaluated, to the extent practicable, based on
a composite of appropriate measures of costs established by the Secretary
… and other factors determined appropriate by the Secretary.
3007 l HHS furnished … In selecting such models, the Secretary shall give preference
(4) IMPLEMENTATION.— (A) PUBLICATION OF MEASURES, DATES OF IMPLE-
MENTATION, PERFORMANCE PERIOD.—Not later than January 1, 2012, the
Secretary shall publish the following: … (i) INITIAL IMPLEMENTATION.— …
the Secretary shall begin implementing the payment modifier … for the physi-
cian fee schedule … (ii) INITIAL PERFORMANCE PERIOD.— (I) The Secretary
shall specify an initial performance period for application of the payment modi-
fier … with respect to 2015. (II) PROVISION OF INFORMATION DURING INITIAL
PERFORMANCE PERIOD.—During the initial performance period, the Secretary
shall … provide information to physicians and groups of physicians about
the quality of care (iii) APPLICATION.—The Secretary shall apply the payment
modifier … (I) … with respect to specific physicians and groups of physicians
3007 l HHS (B) INCLUSION OF CERTAIN SERVICES. A payment methodology tested under
(C) BUDGET NEUTRALITY.—The payment modifier established under this
subsection shall be implemented in a budget neutral manner.
3007 l HHS testing of a model to certain geographic areas.
modifier … in a manner that promotes systems-based care.
3007 l HHS shall (I) be comprehensive, covering the costs of applicable services and
(6) CONSIDERATION OF SPECIAL CIRCUMSTANCES OF CERTAIN PROVID-
ERS.— … the Secretary shall … take into account the special circum-
stances of physicians or groups of physicians in rural areas and other
underserved communities.
3007 l HHS is evidence that the model addresses a defined population for which there
apply this subsection to eligible professionals as the Secretary determines
appropriate.
3007 l HHS 3021 l HHS 3401 l HHS 6005
(8) DEFINITIONS.—For purposes of this subsection: (A) COSTS.—The term
‘costs’ means expenditures per individual as determined appropriate by the
Secretary. … (B) PERFORMANCE PERIOD.—The term “performance period”
means a period specified by the Secretary.
3007 l HHS (3) BUDGET NEUTRALITY. (A) INITIAL PERIOD. The Secretary shall not require,
(9) COORDINATION WITH OTHER VALUE-BASED PURCHASING REFORMS.—
The Secretary shall coordinate the value-based payment modifier … with
the Physician Feedback Program and, as the Secretary determines appropri-
ate, other similar provisions of this title.
3008 l HHS the design and implementation of a model unless the Secretary determines
(B) CRITERIA DESCRIBED.— The criteria described in this subparagraph …
as determined by the Secretary. (ii) RISK ADJUSTMENT.— … the Secretary
shall establish and apply an appropriate risk adjustment methodology.
3008 l HHS (4) EVALUATION. (A) The Secretary shall conduct an evaluation of each
(C) EXEMPTION.— … the Secretary may exempt such hospital from the
application of this subsection …
3008 l HHS (B) INFORMATION. The Secretary shall make the results of each evaluation
(3) HOSPITAL ACQUIRED CONDITIONS.— … the term ‘hospital acquired con-
dition’ means a condition identified … and any other condition determined
appropriate by the Secretary that an individual acquires during a stay in an
3008 l HHS 3021 l HHS consideration of innovative methods of implementing bundled payments
(4) APPLICABLE PERIOD.— … the term “applicable period” means, with
respect to a fiscal year, a period specified by the Secretary.
3008 l HHS 3021 l HHS form and manner, and at a time, specified by the Secretary …
(6) REPORTING HOSPITAL SPECIFIC INFORMATION.— The Secretary shall
make information available to the public regarding hospital acquired
conditions of each applicable hospital. (B) OPPORTUNITY TO REVIEW AND
SUBMIT CORRECTIONS.— The Secretary shall ensure that an applicable
hospital has the opportunity to review, and submit corrections for, the
information to be made public with respect to the hospital …
(a) ESTABLISHMENT OF NATIONAL STRATEGY AND PRIORITIES.— (1)
NATIONAL STRATEGY.—The Secretary …shall establish a national strategy
to improve the delivery of health care services, patient health outcomes, and
population health.
3011 l HHS ate to participate in the demonstration program. The entity shall report on
priorities for improvement …
3011 l HHS inpatient settings in psychiatric hospitals and psychiatric units on the Internet
(C) CONSIDERATIONS.—… the Secretary shall take into consideration the
recommendations submitted by the entity … and other stakeholders.
3011 l HHS the program under the applicable titles.
(D) COORDINATION WITH STATE AGENCIES.—The Secretary shall collaborate,
coordinate, and consult with State agencies responsible for administering
the Medicaid program … and the Children’s Health Insurance Program …
with respect to developing and disseminating strategies, goals, models, and
timetables …
3011 l HHS participating in the demonstration program.
(b) STRATEGIC PLAN.— … (A) Coordination among agencies within the
Department, which shall include steps to minimize duplication of efforts and
utilization of common quality measures, where available. Such common
3011 l HHS and encourages investment in infrastructure and redesigned care processes
(c) PERIODIC UPDATE OF NATIONAL STRATEGY.—The Secretary shall update
the national strategy not less than annually …
3011 l HHS fee-for service beneficiaries through an ACO; and (B) ACOs that meet quality
(d) SUBMISSION AND AVAILABILITY OF NATIONAL STRATEGY AND UP-
DATES.— (1) DEADLINE FOR INITIAL SUBMISSION OF NATIONAL STRAT-
EGY.— Not later than January 1, 2011, the Secretary shall submit to the
relevant committees of Congress the national strategy …
3011 l HHS the following groups of providers of services and suppliers which have
(e) HEALTH CARE QUALITY INTERNET WEBSITE.—Not later than January
1, 2011, the Secretary shall create an Internet website to make public
appropriate.
3013 l HHS professionals participating in the ACO as the Secretary determines necessary
(b) IDENTIFICATION OF QUALITY MEASURES.— (1) IDENTIFICATION.—The
Secretary …shall identify, not less often than triennially, gaps where no qual-
ity measures exist and existing quality measures that need improvement,
sures that need improvement, the Secretary shall take into consideration …
3013 l HHS teredness criteria specified by the Secretary, such as the use of patient and
(2) PUBLICATION.—The Secretary shall make available to the public on an
Internet website a report on any gaps … and the process used to make such
3013 l HHS shall determine appropriate measures to assess the quality of care furnished
(1) The Secretary shall award grants, contracts, or intergovernmental agree-
ments to eligible entities for purposes of developing, improving, updating, or
expanding quality measures …
3013 l HHS manner specified by the Secretary on measures the Secretary determines
(2) PRIORITIZATION IN THE DEVELOPMENT OF QUALITY MEASURES.—In
awarding grants, contracts, or agreements, the Secretary shall give priority
to the development of quality measures that allow the assessment of …(J)
other areas determined appropriate by the Secretary.
3013 l HHS 3022 l HHS 3301 l HHS consumers, experts in health literacy, representatives of racial and ethnic
… (E) submit an application to the Secretary at such time and in such man-
ner, as the Secretary may require.
3013 l HHS determined appropriate, provide for a demonstration project to test whether
(d) OTHER ACTIVITIES BY THE SECRETARY.—The Secretary may use
amounts available … to update and test, where applicable, quality measures
endorsed by the entity with a contract under section 1890(a) of the Social
Security Act or adopted by the Secretary.
3013 l HHS ing, electronic health records, and other similar initiatives … and may use
(f) DEVELOPMENT OF OUTCOME MEASURES.— (1) The Secretary shall
develop, and periodically update … provider-level outcome measures for
hospitals and physicians, as well as other providers as determined appropri-
ate by the Secretary.
3013 l HHS The Secretary shall determine an appropriate method to assign Medicare
subsection shall include, to the extent determined appropriate by the
Secretary …
(4) TIMEFRAME.— (A) ACUTE AND CHRONIC DISEASES.—Not later than 24
months after the date of enactment of this Act, the Secretary shall develop
not less than 10 measures described … (B) PRIMARY AND PREVENTIVE
CARE.—Not later than 36 months after the date of enactment of this Act, the
Secretary shall develop not less than 10 measures described …
3013 l HHS 3025 l HHS other purposes as determined appropriate by the Secretary. The Secretary
(e) DEVELOPMENT OF QUALITY [AND EFFICIENCY] MEASURES.— The
Administrator of CMS shall through contracts develop quality and efficiency
measures …
(f) HOSPITAL ACQUIRED CONDITIONS.—The Secretary shall, to the extent
practicable, publicly report on measures for hospital-acquired conditions that
are currently utilized by CMS for the adjustment of the amount of payment to
hospitals based on rates of hospital-acquired infections.’’
3014 l HHS sufficient time for such effective date to be repealed if the Secretary deter-
(7) CONVENING MULTI-STAKEHOLDER GROUPS.— (A) The entity shall con-
vene multistakeholder groups to provide input on— … (II) such measures
that have not been considered for endorsement by such entity but are used
or proposed to be used by the Secretary for the collection or reporting of
quality and efficiency measures
3014 l HHS (4) in collaboration with local health care providers, develop and implement
… (iv) gaps in endorsed quality measures, which shall include measures
that are within priority areas identified by the Secretary under the national
strategy …
3014 l HHS (2) PAYMENTS FOR SHARED SAVINGS. Subject to … quality performance
MEASURES.—The Secretary shall establish a pre-rulemaking process under
which the following steps occur with respect to the selection of quality and
efficiency measures described … (2) PUBLIC AVAILABILITY OF MEASURES
CONSIDERED FOR SELECTION.— … the Secretary shall make available to
the public a list of quality and efficiency measures … that the Secretary is
3014 l HHS The limitation … shall not apply to the Secretary with respect to drugs
(4) CONSIDERATION OF MULTI-STAKEHOLDER INPUT.—The Secretary
shall take into consideration the input from multistakeholder groups … in
selecting quality and efficiency measures … that have been endorsed by
the entity …
3014 l HHS (3) CONTRACT WITH THIRD PARTIES. The Secretary shall enter into a contract
(5) RATIONALE FOR USE OF QUALITY MEASURES.—The Secretary shall
publish in the Federal Register the rationale for the use of any quality and
efficiency measure that has not been endorsed by the entity with a contract.
3014 l HHS and certified),
once every three years thereafter, the Secretary shall...
3014 l HHS (i) OPTION TO USE OTHER PAYMENT MODELS. (1) If the Secretary deter-
(b) PROCESS FOR DISSEMINATION OF MEASURES USED BY THE SECRETARY.
(1) The Secretary shall establish a process for disseminating quality and
(A) The incorporation of such measures, where applicable, in workforce pro-
grams, training curricula, and any other means of dissemination determined
appropriate by the Secretary.
3014 l HHS Secretary.
(2) EXISTING METHODS. To the extent practicable, the Secretary shall utilize
efficiency measures …
3014 l HHS
Title III: Health Care Delivery (588 Delegations)
(c) REVIEW OF QUALITY [AND EFFICIENCY] MEASURES USED BY THE
SECRETARY. (1) The Secretary shall (A) periodically (but in no case less
often than once every 3 years) review quality and efficiency measures …
and (B) … determine whether to (i) maintain the use of such measure;
or (ii) phase out such measure. (2) CONSIDERATIONS. … The Secretary
take into consideration current innovative methodologies and strategies
for quality and efficiency improvement practices in the delivery of health
care services that represent best practices for such quality and efficiency
improvement and measures ….
3014 l HHS beginning … on the date of the enactment of this section and ending on the
(c) FUNDING. … the Secretary shall provide for the transfer, from the Federal
Hospital Insurance Trust Fund … and the Federal Supplementary Medical
appropriate, of $20,000,000, to the CMS Program Management Account for
each FYs 2010 through 2014.…
3015 l HHS (1) The Secretary shall establish a pilot program for integrated care during
COLLECTION AND ANALYSIS OF DATA FOR QUALITY AND RESOURCE USE
MEASURES. (a) (1) ESTABLISHMENT OF STRATEGIC FRAMEWORK. The Sec-
retary shall establish and implement an overall strategic framework to carry
AGGREGATION OF DATA. The Secretary shall collect and aggregate consistent
data on quality and resource use measures from information systems used
to support health care delivery, and may award grants or contracts for this
purpose. The Secretary shall align such collection and aggregation efforts…
tion, and analysis systems …involve an increasingly broad range of patient
populations, providers, and geographic areas over time.
(b) GRANTS OR CONTRACTS FOR DATA COLLECTION. (1) The Secretary
may award grants or contracts to eligible entities to support new, or
improve existing, efforts to collect and aggregate quality and resource use
measures ….
3015 l HHS 3135 l HHS D drug in a category or class that is otherwise required to be included in the
(D) agree to report, as determined by the Secretary, measures on quality
process ….
3015 l HHS 3026 l HHS the technical component for imaging …from 25 percent to 50 percent …
(c) CONSISTENT DATA AGGREGATION. The Secretary may award grants or
contracts … only to entities that enable summary data that can be inte-
standards for the protection of the security and privacy of patient data.
3015 l HHS condition of an applicable beneficiary for purposes of determining the most
(d) MATCHING FUNDS. The Secretary may not award a grant or contract …
Federal contributions toward the activities to be carried out under the grant
or contract in an amount equal to $1 for each $5 of Federal funds provided
under the grant or contract.
3015 l HHS (IV) Any other information the Commissioner of Social Security determines
PUBLIC REPORTING OF PERFORMANCE INFORMATION. (a) DEVELOPMENT OF
PERFORMANCE WEBSITES. The Secretary shall make available to the public,
through standardized Internet websites, performance information summariz-
ing data on quality measures.
3015 l HHS (3) CONSULTATION. In developing the plan … the Secretary shall consult with
(c) CONSULTATION. (1) … the Secretary shall consult with the entity with
a contract … and other entities, as appropriate, to determine the type of
information that is useful to stakeholders and the format that best facilitates
3015 l HHS (d) IMPLEMENTATION. Notwithstanding any other provision of law, the Secre-
(d) COORDINATION. Where appropriate, the Secretary shall coordinate the
manner in which data are presented through Internet websites … and for
public reporting of other quality measures by the Secretary ….
3021 l HHS (B) REQUIREMENTS. The Secretary shall develop requirements for entities to
(a) CENTER FOR MEDICARE AND MEDICAID INNOVATION ESTABLISHED. (1)
There is created within the CMS a Center for Medicare and Medicaid Innova-
tion (“CMI”) to carry out the duties described in this section. The purpose of
the CMI is to test innovative payment and service delivery models to reduce
program expenditures … while preserving or enhancing the quality of care
to models that also improve the coordination, quality, and efficiency of health
care services ….
3021 l HHS Secretary shall make payments … for services ….
(2) DEADLINE. The Secretary shall ensure that the CMI is carrying out the
duties … by not later than January 1, 2011.
3021 l HHS cable items and services … for applicable beneficiaries for a year shall
(3) CONSULTATION. …the CMI shall consult representatives of relevant Fed-
eral agencies, and clinical and analytical experts with expertise in medicine
and health care management. The CMI shall use open door forums or other
mechanisms to seek input from interested parties.
3021 l HHS 3140 l HHS 4102 l HHS n AUTHOR TY TO MOD FY OR EL M NATE COVERAGE OF CERTA N PREVENT VE
(5) TESTING WITHIN CERTAIN GEOGRAPHIC AREAS. For purposes of testing
payment and service delivery models … the Secretary may elect to limit
3021 l HHS 3023 l HHS implemented.
(b) TESTING OF MODELS (PHASE I). (1) The CMI shall test payment and
service delivery models … to determine the effect … program expenditures
…and the quality of care ….
(2) SELECTION OF MODELS TO BE TESTED. (A) The Secretary shall select
models to be tested from models where the Secretary determines that there
are deficits in care leading to poor clinical outcomes or potentially avoid-
able expenditures. The Secretary shall focus on models expected to reduce
program costs … while preserving or enhancing the quality of care received
by individuals receiving benefits …
ing…, the CMI may consider the following additional factors...
3021 l HHS
as a condition for testing a model …, that the designof such model ensure
that such model is budget neutral initially with respect expenditures ….
3021 l HHS the Secretary on quality measures … during each year of the pilot program
(B) TERMINATION OR MODIFICATION. The Secretary shall terminate or modify
model is expected to ...
3021 l HHS 3023 l HHS 3112 l HHS 1 o mo e g an s o ac y-based se ngs o he deve opmen o bes p ac ces
3021 l HHS plan …
… available to the public in a timely fashion and may establish requirements
for States and other entities participating in the testing of models … to
collect and report information that the Secretary determines is necessary to
monitor and evaluate such models.
(C) MEASURE SELECTION. To the extent feasible, the Secretary shall select
measures … that reflect national priorities for quality improvement and
patient-centered care ….
(c) EXPANSION OF MODELS (PHASE II). Taking into account the evaluation …
the Secretary may, through rulemaking, expand (including implementation on
a nationwide basis) the duration and the scope of a model … or a demon-
stration project … to the extent determined appropriate by the Secretary, if
(1) the Secretary determines that such expansion is expected to (A) reduce
spending … without reducing the quality of care; or (B) improve the quality
of patient care without increasing spending; (2) the Chief Actuary of CMS
increase in) net program spending … and (3) the Secretary determines that
such expansion would not deny or limit the coverage or provision of benefits
… In determining which models or demonstration projects to expand … ,
the Secretary shall focus on models and demonstration projects that improve
the quality of patient care and reduce spending.
3021 l HHS cedures shall ensure that a psychiatric hospital and a psychiatric unit has the
(1) WAIVER AUTHORITY. The Secretary may waive such requirements … as
may be necessary solely for purposes ... testing models ….
(e) APPLICATION TO CHIP. The Center may carry out activities … with respect
to title XXI in the same manner as provided under this section with respect to
3021 l HHS
Secretary for implementation on a nationwide basis unless the State demon-
strates to the satisfaction of the Secretary that implementation would not be
administratively feasible or appropriate to the health care delivery system of
the State.
3022 l HHS 3024 l HHS lish … a description of any evaluation conducted … during the preceding
(a) ESTABLISHMENT. (1) Not later than January 1, 2012, the Secretary
shall establish a shared savings program that promotes accountability for a
patient population and coordinates items and services under parts A and B,
for high quality and efficient service delivery. Under such program (A) groups
of providers of services and suppliers meeting criteria specified by the
performance standards established by the Secretary are eligible to receive
payments for shared savings ….
3022 l HHS a commun y-based gove n ng o adv so y boa d
(b) ELIGIBLE ACOS. (1) … As determined appropriate by the Secretary,
established a mechanism for shared governance are eligible to participate as
ACOs …
3022 l HHS in an episode, the average cost of providing care per episode, and other
(E) The ACO shall provide the Secretary with such information regarding ACO
to support the assignment of Medicare fee-for-service beneficiaries … the
implementation of quality and other reporting requirements … and the
determination of payments for shared savings …
3022 l HHS (II) TRANSITION. The Secretary shall provide for a 4-year phase-in … with
(H) The ACO shall demonstrate to the Secretary that it meets patient-cen-
caregiver assessments or the use of individualized care plans.
3022 l HHS (i) Nothing in this section shall be construed as requiring the Secretary to
(3) QUALITY AND OTHER REPORTING REQUIREMENTS. (A) The Secretary
by the ACO …
3022 l HHS increases in cost sharing or decreases in benefits offered under the plan.
necessary … in order to evaluate the quality of care … Such data may
include care transitions across health care settings, including hospital dis-
charge planning and post-hospital discharge follow-up by ACO professionals,
as the Secretary determines appropriate.
(C) QUALITY PERFORMANCE STANDARDS. The Secretary shall establish
quality performance standards to assess the quality of care furnished by
ACOs. The Secretary shall seek to improve the quality of care … over time
by specifying higher standards new measures …
3022 l HHS 3024 l HHS making payment adjustments for home health services under the Medicare
(D) OTHER REPORTING REQUIREMENTS. The Secretary may, as the Secretary
determines appropriate, incorporate reporting requirements and incentive
payments related to the physician quality reporting initiative (PQRI) … includ-
ing such requirements and such payments related to electronic prescrib-
alternative criteria than would otherwise apply … for determining whether to
make such payments …
3022 l HHS (2) MONITORING APPLICABLE BENEFICIARIES. The Secretary may monitor
(c) ASSIGNMENT OF MEDICARE FEE-FOR-SERVICE BENEFICIARIES TO ACOS.
fee-for-service beneficiaries to an ACO based on their utilization of primary
care services provided … by an ACO professional ….
3022 l HHS (F) EVALUATION AND REPORT. If the Secretary determines it appropriate to
ments shall continue to be made to providers of services and suppliers
participating in an ACO under the original Medicare fee-for-service program
under parts A and B in the same manner as they would otherwise be made
except that a participating ACO is eligible to receive payment for shared
savings … if (i) the ACO meets quality performance standards established by
3022 l HHS shall begin to collect such data by not later than January 1, 2011.
(B) SAVINGS REQUIREMENT AND BENCHMARK. (i) DETERMINING SAVINGS. In
each year of the agreement period, an ACO shall be eligible to receive pay-
ment for shared savings … only if the estimated average per capita Medi-
the applicable benchmark … The Secretary shall determine the appropriate
percent … to account for normal variation in expenditures… based upon the
number of Medicare fee-for-service beneficiaries assigned to an ACO.
(ii) ESTABLISH AND UPDATE BENCHMARK. The Secretary shall estimate
a benchmark for each agreement period for each ACO using the most
recent available 3 years of per-beneficiary expenditures for parts A and B
services for Medicare fee-for-service beneficiaries assigned to the ACO.
Such benchmark shall be adjusted for beneficiary characteristics and such
other factors as the Secretary determines appropriate and updated by the
projected absolute amount of growth in national per capita expenditures for
parts A and B services under the original Medicare fee-for service program,
as estimated by the Secretary. Such benchmark shall be reset at the start of
each agreement period.
3022 l HHS the Secretary shall seek the endorsement … but may apply such measures
standards established by the Secretary … if an ACO meets the requirements,
a percent (as determined appropriate by the Secretary) of the difference
between such estimated average per capita Medicare expenditures … The
Secretary shall establish limits on the total amount of shared savings… paid
to an ACO ….
3022 l HHS (D) APPLICABLE PERIOD. The term “applicable period” means, with respect to
(3) MONITORING AVOIDANCE OF AT-RISK PATIENTS. If the Secretary deter-
mines that an ACO has taken steps to avoid patients at risk in order to re-
duce the likelihood of increasing costs to the ACO the Secretary may impose
an appropriate sanction on the ACO, including termination ….
3022 l HHS specified by the Secretary …
if it does not meet the quality performance standards established by the
Secretary ….
3022 l HHS each … hospital under the program. (B) OPPORTUNITY TO REVIEW AND
(f) WAIVER AUTHORITY. The Secretary may waive such requirements of
sections 1128A and 1128B and title XVIII of this Act as may be necessary to
carry out the provisions of this section.
3022 l HHS 3133 l HHS 3301 l HHS by the Secretary, that are likely to create a high risk of medication-related
mines appropriate, the Secretary may use any of the payment models … for
making payments under the program ….
3022 l HHS determines that alternative data is available which is a better proxy for the
(2) PARTIAL CAPITATION MODEL. (A) … AThe Secretary may limit a partial
capitation model to ACOs that are highly integrated systems of care and
to ACOs capable of bearing risk, as determined to be appropriate by the
3022 l HHS The Secretary shall make information on all patient readmission rates …
(B) NO ADDITIONAL PROGRAM EXPENDITURES. Payments to an ACO for
items and services … shall be established in a manner that does not result
in spending more for such ACO for such beneficiaries than would otherwise
be expended …if the model were not implemented, as estimated by the
Secretary.
3022 l HHS
(3) OTHER PAYMENT MODELS. (A) … a model … is any payment model that
the Secretary determines will improve the quality and efficiency of items and
services….
3022 l HHS of a specified hospital submitting to the Secretary … data and information
(j) INVOLVEMENT IN PRIVATE PAYER AND OTHER THIRD PARTY ARRANGE-
MENTS. The Secretary may give preference to ACOs who are participating in
similar arrangements with other payers.
3022 l HHS (ii) The term “specified hospital” means … hospitals described … and, as
(k) TREATMENT OF PHYSICIAN GROUP PRACTICE DEMONSTRATION. …
date the program is established, the Secretary may enter into an agreement
with an ACO under the demonstration … subject to rebasing and other
modifications deemed appropriate by the Secretary.
3023 l HHS years after …enactment … the Secretary shall make available a program
NATIONAL PILOT PROGRAM ON PAYMENT BUNDLING (a) IMPLEMENTATION.
an episode of care provided to an applicable beneficiary around a hospital-
ization in order to improve the coordination, quality, and efficiency of health
care services ….
3023 l HHS beds … exceed ng 200 pe cen o he base ne numbe
(B) APPLICABLE CONDITION. The term ‘applicable condition’ means 1 or
more of 10 conditions selected by the Secretary. In selecting conditions …,
the Secretary shall take into consideration the following factors...
3023 l HHS 3134 l HHS o ow ng ob ec ves …
(vi) ...Which conditions the Secretary determines are most amenable to
3023 l HHS 3026 l HHS 3135 l HHS (i) FORMULARY REQUIREMENTS. (I) … a PDP sponsor offering a prescrip-
(v) ...Other services the Secretary determines appropriate.
3023 l HHS Secretary provides funding to … furnish improved care transition services to
appropriate, may establish a period … for an episode of care under the pilot
program.
3023 l HHS hospital … identified by the Secretary as having a high readmission rate ….
(3) DEADLINE FOR IMPLEMENTATION. The Secretary shall establish the pilot
program not later than January 1, 2013.
3023 l HHS ciary’’ means a Medicare beneficiary who has attained a minimum hierarchi-
(b) DEVELOPMENTAL PHASE. (1) DETERMINATION OF PATIENT ASSESSMENT
INSTRUMENT. The Secretary shall determine which patient assessment in-
strument … shall be used under the pilot program to evaluate the applicable
clinically appropriate site for the provision of post-acute care …
3023 l HHS (B) EXPANSION. The Secretary may expand the duration and the scope of
(2) DEVELOPMENT OF QUALITY MEASURES FOR AN EPISODE OF CARE
measures for use in the pilot program (i) for episodes of care; and (ii) for
post-acute care.
3023 l HHS (2) APPLICATION; PARTICIPATION. (A) (i) APPLICATION. An eligible entity
(C) COORDINATION WITH QUALITY MEASURE DEVELOPMENT AND ENDORSE-
quality measures … is … consistent with the measures ….
3023 l HHS 3026 l HHS relevant affected parties.
(c)(1)(B) EXPANSION. The Secretary may, at any point after January 1, 2016,
expand the duration and scope of the pilot program, to the extent determined
appropriate by the Secretary, if (i) the Secretary determines that such expan-
sion is expected to (I) reduce spending … (iii) the Secretary determines that
such expansion would not deny or limit the coverage or provision of benefits
under this title for individuals.
3023 l HHS 3026 l HHS Secretary shall take into consideration the cost of drugs and biological ….
participate in the pilot program … Such requirements shall ensure that ap-
plicable beneficiaries have an adequate choice of providers of services and
suppliers under the pilot program.
(3) PAYMENT METHODOLOGY. (A) (i) ESTABLISHMENT OF PAYMENT METH-
ODS. The Secretary shall develop payment methods for the pilot program
for entities participating in the pilot program. Such payment methods may
include bundled payments and bids from entities for episodes of care. The
3023 l HHS accurate geographic adjustments across fee schedule areas …
be established in a manner that does not result in spending more for such
entity for such beneficiaries than would otherwise be expended … were not
implemented, as estimated by the Secretary.
3023 l HHS 3109 l HHS tion of the demonstration program …
the pilot program shall include payment for the furnishing of applicable
services and other appropriate services, such as care coordination, medica-
tion reconciliation, discharge planning, transitional care services, and other
patient-centered activities as determined appropriate by the Secretary.
(C) BUNDLED PAYMENTS. (i) A bundled payment under the pilot program
other appropriate services furnished to an individual during an episode of
care (as determined by the Secretary); and (II) be made to the entity which is
participating in the pilot program.
3023 l HHS to submit materials as requested by the Secretary, or during the course of
(D) PAYMENT FOR POST-ACUTE CARE SERVICES AFTER THE EPISODE OF
CARE. The Secretary shall establish procedures, in the case where an ap-
plicable beneficiary requires continued post-acute care services after the last
day of the episode of care, under which payment for such services shall be
made.
3023 l HHS (b) ADMINISTRATION. Notwithstanding any other provision of law, the Sec-
(4) QUALITY MEASURES. (A) The Secretary shall establish quality measures
(including quality measures of process, outcome, and structure) related to
care provided by entities participating in the pilot program. Quality measures
of patient outcomes, determined appropriate by the Secretary.
3023 l HHS information concerning the impact of not enrolling … (6) The Secretary of
(B) REPORTING ON QUALITY MEASURES. (i) A entity shall submit data to
(in a form and manner … specified by the Secretary). (ii) SUBMISSION OF
DATA THROUGH ELECTRONIC HEALTH RECORD. To the extent practicable, the
Secretary shall specify that data on measures be submitted … through the
use of a qualified EHR … in a manner specified by the Secretary.
(d) WAIVER. The Secretary may waive such provisions of this title and title XI
as may be necessary to carry out the pilot program.
(1) INDEPENDENT EVALUATION. The Secretary shall conduct an independent
evaluation of the pilot program.
3023 l HHS on the ramifications of Medicare payment reductions for dual-energy x-ray
(f) CONSULTATION. The Secretary shall consult with representatives of small
rural hospitals … regarding their participation in the pilot program …
in hospitals taking into consideration any difficulties as a result of the low
volume of services provided by such hospitals.
(g) APPLICATION OF PILOT PROGRAM TO CONTINUING CARE HOSPITALS. (1)
In conducting the pilot program, the Secretary shall apply the provisions of
the program so as to separately pilot test the continuing care hospital model.
3024 l HHS tics …
INDEPENDENCE AT HOME MEDICAL PRACTICE DEMONSTRATION PROGRAM.
(a) ESTABLISHMENT. (1) The Secretary shall conduct a demonstration pro-
gram … to test a payment incentive and service delivery model that utilizes
physician and nurse practitioner directed home-based primary care teams
designed to reduce expenditures and improve health outcomes ….
3024 l HHS (g) FIVE-YEAR EXTENSION OF DEMONSTRATION PROGRAM. (1) … the Sec-
(vii) meets such other criteria as the Secretary determines to be appropri-
quality measures (in such form, manner, and frequency as specified by the
Secretary … and report to the Secretary (in a form, manner, and frequency
as specified by the Secretary) such data as the Secretary determines ap-
propriate to monitor and evaluate the demonstration program.
(B) PHYSICIAN. The term “physician” includes, except as the Secretary may
otherwise provide, any individual who furnishes services for which payment
may be made as physicians’ services and has the medical training or experi-
ence to fulfill the physician’s role ….
3024 l HHS Secretary may specify, to discontinue such participation …
(4) QUALITY AND PERFORMANCE STANDARDS. The Secretary shall develop
quality performance standards for independence at home medical practices
(c) PAYMENT METHODOLOGY. (1) ESTABLISHMENT OF TARGET SPENDING
LEVEL. The Secretary shall establish an estimated annual spending target,
for the amount the Secretary estimates would have been spent in the ab-
sence of the demonstration … The spending targets may also be adjusted
for other factors as the Secretary determines appropriate.
3024 l HHS Advantage coordinated care plans, the Secretary shall extend the application
(2) INCENTIVE PAYMENTS. An incentive payment for such year shall be
equal to a portion (as determined by the Secretary) of the amount by which
actual expenditures … are estimated to be less than 5 percent less than the
estimated spending target ….
3024 l HHS (g) SPECIAL RULES FOR SENIOR HOUSING FACILITY PLANS. (1) In the case
(C) ... has 2 or more chronic illnesses, such as congestive heart failure,
diabetes, other dementias designated by the Secretary, chronic obstructive
pulmonary disease, ischemic heart disease, stroke, Alzheimer’s Disease and
neurodegenerative diseases, and other diseases and conditions designated
by the Secretary which result in high costs …
3024 l HHS factors that the Secretary considers to be relevant. … the Secretary may
(G) ... meets such other criteria as the Secretary determines appropriate.
3024 l HHS 3208 l HHS 3501 l HHS A FAM LY CAREG VER AND D RECT CARE PROV DER TRA N NG … The Sec e a y
(2) PATIENT ELECTION TO PARTICIPATE. The Secretary shall determine an
appropriate method of ensuring that applicable beneficiaries have agreed to
enroll in an independence at home medical practice under the demonstration
program...
3024 l HHS AUTHORITY TO DENY PLAN BIDS. (a) … the Social Security Act … is
(2) NO PHYSICIAN DUPLICATION IN DEMONSTRATION PARTICIPATION. The
Secretary shall not pay an independence at home medical practice … that
participates ….
3024 l HHS whether patient severity of illness and access to care could be measured by
(3) NO BENEFICIARY DUPLICATION IN DEMONSTRATION PARTICIPATION. The
Secretary shall ensure that no applicable beneficiary enrolled in an indepen-
dence at home medical practice … is participating …
3024 l HHS
(4) PREFERENCE. In approving an independence at home medical practice,
the Secretary shall give preference to practices ...
3024 l HHS (4) CONSULTATIONS. In conducting the study … the Secretary shall consult
(5) LIMITATION ON NUMBER OF PRACTICES. In selecting qualified indepen-
dence at home medical practices … the Secretary shall limit the number …
so that the number of applicable beneficiaries that may participate … does
not exceed 10,000.
(6) WAIVER. The Secretary may waive such provisions … as the Secretary
determines necessary in order to implement the demonstration program.
3024 l HHS (B) WAIVING BUDGET NEUTRALITY. The Secretary shall not reduce the stan-
(1) The Secretary shall evaluate each independence at home medical prac-
tice … to assess whether the practice achieved [established] results.
data on expenditures and quality of services … after an applicable benefi-
ciary discontinues receiving services ….
3024 l HHS
(i) TERMINATION. (1) MANDATORY TERMINATION. The Secretary shall
terminate an agreement with an independence at home medical practice if
(A) the Secretary estimates or determines that such practice will not receive
an incentive payment for the second of 2 consecutive years … or (B) such
practice fails to meet quality standards during any year … (2) PERMIS-
SIVE TERMINATION. The Secretary may terminate an agreement with an
independence at home medical practice for such other reasons determined
appropriate by the Secretary.
(ii) EXCLUSION OF CERTAIN READMISSIONS. … with respect to a hospital,
excess readmissions shall not include readmissions for an applicable condi-
tion for which there are fewer than a minimum number (as determined by
the Secretary) of discharges … for the applicable period ….
3025 l HHS appropriate.
(5) DEFINITIONS. … (A) APPLICABLE CONDITION. The term ”applicable Con-
dition” means … a condition or procedure selected by the Secretary among
conditions and procedures for which (i) readmissions … that represent con-
criteria specified by the Secretary); and (ii) measures of such readmissions (I)
have been endorsed by the entity … and (II) such endorsed measures have
exclusions for readmissions that are unrelated to the prior discharge …
3025 l HHS (E) The Secretary shall consult with hospice programs and the Medicare Pay-
(B) EXPANSION OF APPLICABLE CONDITIONS. Beginning with FY2015, the
beyond the 3 conditions … to the additional 4 conditions that have been
identified by the Medicare Payment Advisory Commission in its report to
Congress in June 2007 and to other conditions and procedures as deter-
mined appropriate by the Secretary. In expanding such applicable conditions,
without such an endorsement in the case of a specified area or medical
topic determined appropriate by the Secretary for which a feasible and
practical measure has not been endorsed by the entity … as long as due
consideration is given to measures that have been endorsed or adopted by a
consensus organization identified by the Secretary.
3025 l HHS all programs … the hospice care provided to such individual is medically
a fiscal year, such period as the Secretary shall specify.
3025 l HHS (I) ... who are uninsured in 2013, the last year before coverage expansion
(E) READMISSION. The term “readmission” means … the admission of the
individual to the same or another applicable hospital within a time period
3025 l HHS n so p esc b ng he numbe o pe sons o be g adua ed om he T ack he
(6) REPORTING HOSPITAL SPECIFIC INFORMATION. (A) The Secretary shall
make information available to the public regarding readmission rates of
SUBMIT CORRECTIONS. The Secretary shall ensure that a … hospital has the
opportunity to review, and submit corrections for, the information … prior to
such information being made public. Such information shall be posted on the
Hospital Compare Internet website in an easily understandable format.
3025 l HHS (C) FACTOR THREE. A factor equal to the percent, for each … hospital, that
(8) READMISSION RATES FOR ALL PATIENTS. (A) CALCULATION OF READMIS-
SION. The Secretary shall calculate readmission rates for all patients … for
a specified hospital … for an applicable condition … and other conditions
deemed appropriate by the Secretary for an applicable period … in the
same manner as used to calculate such readmission rates for hospitals with
respect to this title and posted on the CMS Hospital Compare website.
3025 l HHS 3134 l HHS 3301 l HHS improvement concepts in use in other Federal programs that have imple-
(B) POSTING OF HOSPITAL SPECIFIC ALL PATIENT READMISSION RATES.
available on the CMS Hospital Compare website in a form and manner
determined appropriate by the Secretary. The Secretary may also make
other information determined appropriate by the Secretary available on
such website.
3025 l HHS
(C) HOSPITAL SUBMISSION OF ALL PATIENT DATA. (i) … each hospital …
shall submit to the Secretary, in a form, manner and time specified by the
Secretary, data and information determined necessary by the Secretary for
the Secretary to calculate the all patient readmission rates …. (ii) Instead
may be submitted to the Secretary, on behalf of such a specified hospital, by
a state or an entity determined appropriate by the Secretary.
3025 l HHS ing risk-assessment tools developed and maintained by private and academic
determined feasible and appropriate by the Secretary, other hospitals not
otherwise described …
3025 l HHS services… conduct surveys or collect data, and make recommendations
QUALITY IMPROVEMENT PROGRAM FOR HOSPITALS WITH A HIGH SEVERITY
ADJUSTED READMISSION RATE. (a) ESTABLISHMENT. (1) Not later than 2
for eligible hospitals to improve their readmission rates through the use of
patient safety organizations … (2) ELIGIBLE HOSPITAL DEFINED. … the term
‘eligible hospital’ means a hospital that the Secretary determines has a high
rate of risk adjusted readmissions for the conditions … and has not taken
appropriate steps to reduce such readmissions and improve patient safety as
evidenced through historically high rates of readmissions, as determined by
the Secretary. (3) RISK ADJUSTMENT. The Secretary shall utilize appropriate
risk adjustment measures to determine eligible hospitals.
3025 l HHS ... as the Secretary determines to be appropriate.
(b) REPORT TO THE SECRETARY. As determined appropriate by the Secretary,
eligible hospitals and patient safety organizations … shall report to the
Secretary on the processes employed … and the impact of such processes
on readmission rates.
COMMUNITY-BASED CARE TRANSITIONS PROGRAM. (a) The Secretary shall
establish a Community-Based Care Transitions Program under which the
high-risk Medicare beneficiaries.
3026 l HHS formulary …
(1) ELIGIBLE ENTITY. The term ‘‘eligible entity’’ means the following: (A) A …
(2) HIGH-RISK MEDICARE BENEFICIARY. The term ‘‘high risk Medicare benefi-
cal condition category score, as determined by the Secretary …
3026 l HHS a regulation which includes a public notice and comment period.
(D) Any other chronic disease or risk factor as determined by the Secretary.
3026 l HHS (3) ADJUSTMENT FOR CERTAIN HOSPITALS IN FISCAL YEAR 2010. (A) In
the program, to the extent determined appropriate by the Secretary, if the
Secretary determines (and the Chief Actuary of CMS … certifies) that such
expansion would reduce spending under this title without reducing quality.
3026 l HHS an additional payment that reflects the difference between the wage index
seeking to participate in the program shall submit an application to the
Secretary at such time, in such manner, and containing such information as
the Secretary may require.
(3) SELECTION. In selecting eligible entities to participate, the Secretary shall
give priority to eligible entities that...
3026 l HHS The Secretary shall conduct a study to determine if, under the system…
tary may implement the provisions … by program instruction or otherwise.
(e) WAIVER AUTHORITY. The Secretary may waive such requirements … as
3102 l HHS reflect those higher costs effective … on or after January 1, 2011.
(iv) ANALYSIS. The Secretary shall analyze current methods of establishing
and reliably establishes distinctions in the costs of operating a medical
practice in the different fee schedule areas.
3102 l HHS and any other items … from funds otherwise paid …
(v) REVISION FOR 2012 AND SUBSEQUENT YEARS. … the Secretary shall,
not later than January 1, 2012, make appropriate adjustments … to ensure
3109 l HHS (2) CONSIDERATIONS IN MAKING GRANTS. … (a) SUBSTANTIAL UNCOMPEN-
(B) ... by inserting ‘‘, except that the Secretary shall not require a pharmacy
to have submitted to the Secretary such evidence of accreditation prior to
January 1, 2011’’ before the semicolon at the end.
(II) the Secretary may apply to such pharmacies an alternative accreditation
requirement established by the Secretary if the Secretary determines such
alternative accreditation requirement is more appropriate for such pharma-
cies.
3109 l HHS have been expended … if the demonstration program … had not been
(ii) PHARMACIES DESCRIBED. A pharmacy … meets each of the following
criteria: (I) The total billings by the pharmacy … are less than 5 percent of
total pharmacy sales, as determined based on the average total pharmacy
sales for the previous 3 calendar years, 3 fiscal years, or other yearly period
specified by the Secretary … (III) The pharmacy submits to the Secretary an
attestation, in a form and manner, and at a time, specified by the Secretary,
that the pharmacy meets the criteria described … (IV) The pharmacy agrees
an audit conducted on a random sample of pharmacies selected annually, to
verify that the pharmacy meets the criteria … Materials submitted … shall
include a certification by an accountant … or the submission of tax returns
filed … as requested by the Secretary.
3109 l HHS (d) WEBSITE. The Secretary … shall maintain or enter into a contract to maintain
retary may implement the amendments made … by program instruction or
otherwise.
3110 l HHS/DoD/SSA level, as determined by the Secretary.
(5) The Secretary shall ensure that the materials relating to coverage
… provided … prior to the individual’s initial enrollment period contain
Defense shall collaborate with the Secretary of HHS and the Commissioner
of Social Security to provide for the accurate identification of individuals …
The Secretary of Defense shall provide such individuals with notification with
respect to this subsection. The Secretary of Defense shall collaborate with
the Secretary of HHS and the Commissioner of Social Security to ensure ap-
propriate follow up pursuant to any notification provided …
(2) IMPLEMENTATION. Notwithstanding any other provision of law, the
Secretary may implement the amendments … by program instruction or
otherwise.
3112 l HHS 3401 l HHS States to award grants to eligible entities …
(b) STUDY AND REPORT BY THE INSTITUTE OF MEDICINE. (1) The Secretary
of HHS is authorized to enter into an agreement with IOM to conduct a study
absorptiometry … on beneficiary access to bone mass density tests.
3113 l HHS 3205 l HHS b NURS NG FAC L T ES 1 Sec on 1919 2 A
(a) DEMONSTRATION PROJECT. (1) The Secretary … shall conduct a
demonstration project … under which separate payments are made … for
complex diagnostic laboratory tests … the Secretary shall establish appro-
3113 l HHS (C) EXCEPTION. The Secretary shall provide for an exception to the transition
(B) ...that is determined by the Secretary to be a laboratory test for which
there is not an alternative test having equivalent performance characteris-
3113 l HHS (D) TIMELINE FOR INITIAL TRANSITION. The Secretary shall ensure that
(b) DURATION. … the Secretary shall conduct the demonstration project …
for the 2-year period beginning on July 1, 2011.
3123 l HHS 1 The Sec e a y sha mp emen a ans on p ocess unde wh ch by no a e
retary shall conduct the demonstration program … for an additional 5-year
period … (2) EXPANSION OF DEMONSTRATION STATES. … during the 5-year
extension period, the Secretary shall expand the number of States with low
population densities determined by the Secretary … to 20. In determining
which States to include in such expansion, the Secretary shall use the same
criteria and data that the Secretary used to determine the States … for
purposes of the initial 5-year period.
3123 l HHS ALS WITH CHRONIC HEALTH CONDITIONS. (I) For 2011 and subsequent
(4) HOSPITALS IN DEMONSTRATION PROGRAM ON DATE OF ENACTMENT…
the Secretary (A) shall provide for the continued participation of such rural
community hospital … during the 5-year extension period unless the rural
community hospital makes an election, in such form and manner as the
3125 l HHS factor… the Secretary shall reduce such increase factor by the productivity
(D) TEMPORARY APPLICABLE PERCENTAGE INCREASE. For discharges oc-
curring in FY 2011 and 2012, the Secretary shall determine an applicable
percentage increase …
3129 l HHS produced with grants or contracts … are available to the public. (4) NON-
(1) … such as value-based purchasing programs, accountable care organi-
zations under section 1899, the National pilot program on payment bundling
under section 1866D, and other delivery system reform programs deter-
mined appropriate by the Secretary …
3129 l HHS of such waiver policy to employers who contract directly with the Secretary
(B) by inserting ‘and to participate in delivery system reforms under the
provisions of and amendments made by the Patient Protection and Affordable
Care Act … as determined appropriate by the Secretary’ before the period at
3131 l HHS of a Medicare Advantage senior housing facility plan… notwithstanding any
(iii) ADJUSTMENT FOR 2014 AND SUBSEQUENT YEARS. (I) … the amount
… shall be adjusted by a percentage determined appropriate by the
Secretary to reflect such factors as changes in the number of visits in an
episode, the mix of services in an episode, the level of intensity of services
consider differences between hospital-based and freestanding agencies,
between for-profit and nonprofit agencies, and between the resource costs
of urban and rural agencies …
3131 l HHS established by the Secretary under which such a plan was offered for not
such adjustment being fully implemented for 2017…
3131 l HHS (4) GUIDANCE. The Secretary may issue guidance to eligible grantees … on
(D) ... Other items determined appropriate by the Secretary.
3131 l HHS
(2) CONSIDERATIONS. In conducting the study … the Secretary may consider
factors, such as . . . (E) other factors determined appropriate by the Secretary.
3131 l HHS tional labeling or print advertising of such drugs would improve health care
(3) REPORT. Not later than March 1, 2014, the Secretary shall submit to Con-
gress a report on the study … together with recommendations for legislation
and administrative action as the Secretary determines appropriate.
3131 l HHS packages …
with appropriate stakeholders ….
3131 l HHS drugs … of a manufacturer, the manufacturer must (1) participate in the
(A) … taking into account the results of the study … the Secretary may, as
program would substantially improve access …
3131 l HHS 3301 l HHS by clinicians and patients and consumers, then the Secretary, not later
dard prospective payment amount … to home health services … to offset
any increase in payments … resulting from the application of the payment
adjustments ….
3131 l HHS 31, 2011, there were extenuating circumstances.
(D) DURATION. If the Secretary determines it appropriate to conduct the
demonstration project under this subsection, the Secretary shall conduct the
project for a four year period beginning not later than January 1, 2015.
3131 l HHS enter into agreements … with manufacturers and provide for the perfor-
conduct the demonstration project under this subsection, the Secretary shall
(i) provide for an evaluation of the project; and (ii) submit to Congress, by a
date specified by the Secretary, a report on the project.
3132 l HHS ment in effect … shall collect and have available appropriate data, as deter-
(6)(A) The Secretary shall collect additional data and information as the Sec-
retary determines appropriate to revise payments for hospice care … and for
3132 l HHS Each manufacturer … shall comply with requirements imposed by the
(C) The Secretary may collect the additional data and information … on cost
reports, claims, or other mechanisms as the Secretary determines to be
3132 l HHS (B) TERMINATION. (i) BY THE SECRETARY. The Secretary may provide for
(D)(i) … not earlier than October 1, 2013, the Secretary shall, by regulation,
implement revisions to the methodology for determining the payment rates
for routine home care and other services included in hospice care … as the
Secretary determines to be appropriate.
3132 l HHS 5207
ment Advisory Commission regarding the additional data and information to
be collected … and the payment revisions …
3132 l HHS behalf of applicable beneficiaries as the Secretary may specify.
(2) ...by adding at the end the following new subparagraph: (D) on and after
January 1, 2011 (i) a hospice physician or nurse practitioner has a face-to-
face encounter with the individual to determine continued eligibility of the
individual for hospice care prior to the 180th-day recertification and each
subsequent recertification …and attests that such visit took place (in ac-
cordance with procedures established by the Secretary); and (ii) in the case
of hospice care provided an individual for more than 180 days by a hospice
program for which the number of such cases … comprises more than a
percent (specified by the Secretary) of the total number of such cases for
reviewed (in accordance with procedures established by the Secretary) …
3133 l HHS distribute any funds of a manufacturer under the program. (B) EXCEPTION.
under the PPACA (as calculated by the Secretary based on the most recent
estimates available from the Director of CBO before a vote in either House on
the Health Care and Education Reconciliation Act of 2010 that, if determined
in the affirmative, would clear such Act for enrollment) …
3133 l HHS 3503 l HHS 3509 l HHS 5301
(I) ... who are uninsured in 2013 (as estimated by the Secretary, based on
data from the Census Bureau or other sources the Secretary determines
appropriate, and certified by the Chief Actuary of CMS); and (II) ...who are un-
insured in the most recent period for which data is available (as so estimated
represents the quotient of (i) the amount of uncompensated care for such
hospital for a period selected by the Secretary (as estimated by the Secre-
tary, based on appropriate data (including, in the case where the Secretary
costs of … hospitals for treating the uninsured, the use of such alternative
data) …
(K) POTENTIALLY MISVALUED CODES. (i) The Secretary shall (I) periodically
identify services as being potentially misvalued using criteria specified in
clause (ii); and (II) review and make appropriate adjustments to the relative
values established … for services identified as being potentially misvalued …
3134 l HHS
(ii) IDENTIFICATION OF POTENTIALLY MISVALUED CODES … the Secretary
shall examine (as the Secretary determines to be appropriate) … codes
which have not been subject to review since the implementation of the
RBRVS … and such other codes determined to be appropriate by the
Secretary.
3134 l HHS 3303 l HHS 3504 l HHS Council to be known as the ‘‘Advisory Group on Prevention, Health Promotion,
(II) The Secretary may conduct surveys, other data collection activities,
studies, or other analyses as the Secretary determines to be appropriate to
facilitate the review and appropriate adjustment ….
3134 l HHS or MA–PD plan that has waived the monthly beneficiary premium for such
(III) The Secretary may use analytic contractors to identify and analyze
on the review and appropriate adjustment of services … (IV) The Secretary
may coordinate the review and appropriate adjustment … with the periodic
review … (V) As part of the review and adjustment … including with respect
to codes with low relative values … the Secretary may make appropriate
coding revisions ….
3134 l HHS Secretary to a new prescription drug plan, provide the individual, within 30
(L) VALIDATING RELATIVE VALUE UNITS. (i) The Secretary shall establish a
process to validate relative value units under the fee schedule …
3134 l HHS (g) SECRETARIAL AUTHORITY TO ENLIST SUPPORT IN CONDUCTING CERTAIN
(iv) METHODS. The Secretary may conduct the validation … using methods
(v) ADJUSTMENTS. The Secretary shall make appropriate adjustments to the
work relative value units under the fee schedule …
(C) ADJUSTMENT IN IMAGING UTILIZATION RATE … the Secretary shall use a
75 percent assumption instead of the utilization rates otherwise established
in such final rule …
(D) ADJUSTMENT IN TECHNICAL COMPONENT DISCOUNT ON SINGLE-SES-
SION IMAGING INVOLVING CONSECUTIVE BODY PARTS. For services furnished
on or after July 1, 2010, the Secretary shall increase the reduction in pay-
ments attributable to the multiple procedure payment reduction applicable to
3137 l HHS The Secretary shall use criteria established by the Secretary in making any
(B) EXCEPTION. Beginning on April 1, 2010, in determining the wage index
applicable to hospitals that qualify for wage index reclassification, the Secre-
tary shall include the average hourly wage data of hospitals …
3137 l HHS 3504 l HHS Government health objectives and related target setting for health improvement;
the case of a … hospital … with respect to which (i) a reclassification of
its wage index … was extended … and (ii) the wage index applicable for
such hospital for the period beginning on October 1, 2009, and ending on
March 31, 2010, was lower than for the period beginning on April 1, 2010,
and ending on September 30, 2010 … the Secretary shall pay such hospital
for such periods. (B) TIMEFRAME FOR PAYMENTS. The Secretary shall make
payments required … not later than December 31, 2010.
3137 l HHS x REGULAT ONS — PROPOSED REGULAT ON —No a e han 1 yea a e
3138 l HHS nity Preventive Services Task Force and the Advisory Committee on Immunization
(18) AUTHORIZATION OF ADJUSTMENT FOR CANCER HOSPITALS. (A) STUDY.
costs incurred by hospitals … with respect to ambulatory payment …
exceed those costs incurred by other hospitals furnishing services … (as
determined appropriate by the Secretary). In conducting the study … the
… that costs incurred by hospitals … exceed those costs incurred by other
hospitals … the Secretary shall provide for an appropriate adjustment … to
3140 l HHS Safety Net Care Pool established through a waiver …
(a) ESTABLISHMENT. (1) The Secretary of HHS ... shall establish a Medicare
Hospice Concurrent Care demonstration program at participating hospice
programs under which Medicare beneficiaries are furnished … hospice care
3140 l HHS trauma patients regardless of their ability to pay …
(3) SITES. The Secretary shall select not more than 15 hospice programs
at which the demonstration program … Such hospice programs shall be
located in urban and rural areas.
3140 l HHS 3311 l HHS EDUCATION AND OUTREACH CAMPAIGN REGARDING PREVENTIVE BENEFITS. (a)
(b) INDEPENDENT EVALUATION AND REPORTS. (1) INDEPENDENT EVALUA-
TION. The Secretary shall provide for the conduct of an independent evalua-
(c) BUDGET NEUTRALITY. With respect to the 3-year period of the demonstra-
tion program … the Secretary shall ensure that the aggregate expenditures
… for such period shall not exceed the aggregate expenditures that would
3141 l HHS (b) TRAUMA CARE REGISTRY. The Secretary may require the trauma center
In the case of discharges occurring on or after October 1, 2010 … the Sec-
retary … shall administer … in the same manner as … through a uniform,
national adjustment to the area wage index …
3201 l HHS 3505 l HHS RESEARCH-BASED DENTAL CARIES DISEASE MANAGEMENT. (a) The Secretary,
(C) PERIODIC RANKING. … (i) in 1 of the 50 States or the District
of Columbia, the Secretary shall rank such area in each year … based upon
the level of the amount … for such areas; or (ii) in a territory, the Secretary
shall rank such areas in each such year based upon the level of the amount
… for such area relative to quartile rankings ….
3201 l HHS 3505 l HHS a website to provide science-based information on guidelines for nutrition, regu-
(o) APPLICABLE PERCENTAGE QUALITY INCREASES. (1) … Subject to the
succeeding paragraphs, in the case of a qualifying plan … beginning with
2012, the applicable percentage … shall be increased on a plan or contract
3021 l HHS 3505 l HHS 6005
(ii) APPLICATION OF INCREASES TO LOW ENROLLMENT PLANS. (I) 2012.
For 2012, the term ‘qualifying plan’ includes a MA plan that the Secretary
determines is not able to have a quality rating … because of low enroll-
ment. (II) 2013 AND SUBSEQUENT YEARS. For 2013 and subsequent years,
for purposes of determining whether an MA plan with low enrollment (as
defined by the Secretary) is included as a qualifying plan, the Secretary shall
establish a method to apply to MA plans with low enrollment (as defined by
the Secretary) the computation of quality rating and the rating system ….
3201 l HHS 3505 l HHS se v ces and supp e s… he Sec e a y de e m nes such mo a o um s necessa y
(iii) APPLICATION OF INCREASES TO NEW PLANS. (I) A new MA plan that
meets criteria specified by the Secretary shall be treated as a qualifying
3202 l HHS o n a a n ng and he Sec e a y de e m nes app op a e n he case o ongo ng
(IV) Such other services that the Secretary determines appropriate (including
services that the Secretary determines require a high level of predictability
and transparency for beneficiaries).
(6) TRANSITION AND EXCEPTION REGARDING RESTRICTION ON ENROLL-
MENT. (A) … the Secretary shall establish procedures for the transition of
applicable individuals to...
3205 l HHS shall divide such funding evenly among only those States that have 1 or
… for a limited period of time for individuals enrolled under a specialized MA
plan for special needs individuals …
3205 l HHS determined appropriate by the Secretary for which a feasible and practical
applicable individuals enrolled in a specialized MA plan for special needs
individuals … prior to January 1, 2010, are transitioned to a plan … by not
later than January 1, 2013.
3205 l HHS financ a ass s ance
(7) AUTHORITY TO REQUIRE SPECIAL NEEDS PLANS BE NCQA APPROVED.
For 2012 and subsequent years, the Secretary shall require that a Medicare
Advantage organization offering a specialized MA plan for special needs
individuals be approved by the National Committee for Quality Assurance
(based on standards established by the Secretary).
3205 l HHS website of the CMS.
years … the Secretary shall use a risk score that reflects the known underly-
ing risk profile and chronic health status of similar individuals.
3205 l HHS (d) PROGRAM TO DEVELOP, UPDATE AND PATIENT DECISION AIDS TO ASSIST
(III) EVALUATION. For 2011 and periodically thereafter, the Secretary shall
evaluate and revise the risk adjustment system …
3205 l HHS adjustment…
(IV) PUBLICATION OF EVALUATION AND REVISIONS. The Secretary shall pub-
year and any revisions made … as a result …
3207 l HHS (i) for 2012 and subsequent years, by the productivity adjustment … and
TECHNICAL CORRECTION TO MA PRIVATE FEE-FOR-SERVICE PLANS. For plan
year 2011 and subsequent plan years, to the extent that the Secretary …
is applying the 2008 service area extension waiver policy … to Medicare
as a Medicare Advantage private fee-for-service plan … and that had enroll-
ment as of October 1, 2009.
3208 l HHS patients of their medical treatment options.
other provision of this part to the contrary and in accordance with regula-
tions of the Secretary, the service area … may be limited to a senior housing
facility in a geographic area.
3208 l HHS 3506 l HHS cen e ha s sponso ng he cou se … o o he hea h p o ess ons schoo s ap-
(B) ...provides primary care services onsite and has a ratio of accessible
physicians to beneficiaries that the Secretary determines is adequate.
(D) ...has participated (as of December 31, 2009) in a demonstration project
less than 1 year.
3209 l HHS … (2) RESEARCH REQUIREMENTS. The research conducted shall (A) address
amended by adding at the end the following … (C) REJECTION OF BIDS.
accept any or every bid submitted by an MA organization under this subsec-
tion. (ii) AUTHORITY TO DENY BIDS THAT PROPOSE SIGNIFICANT INCREASES
IN COST SHARING OR DECREASES IN BENEFITS. The Secretary may deny a
bid submitted by an MA organization for an MA plan if it proposes significant
3210 l HHS (2) LINKAGE TO HEALTH INFORMATION TECHNOLOGY. The Secretary shall
(y) DEVELOPMENT OF NEW STANDARDS FOR CERTAIN MEDICARE SUPPLE-
MENTAL POLICIES. (1) The Secretary shall request the National Association
of Insurance Commissioners to review and revise the standards for benefit
(a) In order for coverage to be available under this part for covered part D
Medicare coverage gap discount program …(2) have entered into … an
agreement … with the Secretary; and(3) have entered into … under terms
and conditions specified by the Secretary, a contract with a third party that
the Secretary has entered into a contract with ….
(c) AUTHORIZING COVERAGE FOR DRUGS NOT COVERED UNDER AGREE-
MENTS.… shall not apply to the dispensing of a covered part D drug if (1)
the Secretary has made a determination that the availability of the drug is
essential to the health of beneficiaries under this part; or (2) the Secretary
determines that in the period beginning on January 1, 2011, and December
3301 l HHS … B s emp oyed w h a Fede a S a e oca o ba pub c hea h agency o n
(a) ESTABLISHMENT. The Secretary shall establish a Medicare coverage gap
discount program … by not later than January 1, 2011 …the Secretary shall
mance of the duties … The Secretary shall establish a model agreement for
use … by not later than 180 days after the date of the enactment …
3301 l HHS staffing requirements, and timeline for implementation; and (ii) pre- and
(2) PROVISION OF APPROPRIATE DATA. Each manufacturer with an agree-
mined by the Secretary, to ensure that it can demonstrate to the Secretary
compliance with the requirements …
3301 l HHS ns u on ha o e s a cou se o s udy ce fica e p og am o p o ess ona a n-
(3) COMPLIANCE WITH REQUIREMENTS FOR ADMINISTRATION OF PROGRAM.
Secretary or a third party with a contract … for purposes of administering
the program …
3301 l HHS and disseminate the results of such evaluations on as wide a basis as is
termination of an agreement … The Secretary shall provide, upon request,
a manufacturer with a hearing concerning such a termination, and such
hearing shall take place prior to the effective date of the termination with
mines appropriate.
3301 l HHS (3) … with priority given to those amenable to prevention and with chronic
(v) the establishment of procedures to ensure that the discounted price for
an applicable drug … is applied before any coverage or financial assistance
under other health benefit plans or programs that provide coverage or finan-
cial assistance for the purchase or provision of prescription drug coverage on
3301 l HHS priority given to those amenable to prevention and with chronic diseases or
(C) COLLECTION OF DATA FROM PRESCRIPTION DRUG PLANS AND MA–PD
PLANS. The Secretary may collect appropriate data from prescription drug
plans and MA–PD plans in a timeframe that allows for discounted prices to
be provided …
3301 l HHS requested by the Secretary, the activities carried out by the entity …
(d) ADMINISTRATION. (1) … the Secretary shall provide for the implemen-
tation… including the performance of the duties …(2) LIMITATION. (A)
… in providing for such implementation, the Secretary shall not receive or
dispensed during the period beginning on January 1, 2011, and ending on
December 31, 2011, but only if the Secretary determines that the exception
… is necessary in order for the Secretary to begin implementation …
3301 l HHS 1, 2010.
with 1 or more third parties to administer the requirements established
by the Secretary … At a minimum, the contract with a third party …shall
require that the third party (A) receive and transmit information between
the Secretary, manufacturers, and other individuals or entities the Secretary
determines appropriate.
(4) PERFORMANCE REQUIREMENTS. The Secretary shall establish perfor-
mance requirements … and safeguards to protect the independence and
integrity of the activities carried out by the third party….
3301 l HHS … other stakeholders involved with the research, dissemination, and
(5) IMPLEMENTATION. The Secretary may implement the program …by
program instruction or otherwise.
(2) CIVIL MONEY PENALTY. (A) The Secretary shall impose a civil money
penalty on a manufacturer that fails to provide applicable beneficiaries
discounts for applicable drugs … in an amount the Secretary determines is
commensurate with the sum of ...
3303 l HHS
(5) WAIVER OF DE MINIMIS PREMIUMS. The Secretary shall, under proce-
dures established by the Secretary, permit a prescription drug plan or an
MA–PD plan to waive the monthly beneficiary premium … if the amount …
is de minimis. If such premium is waived under the plan, the Secretary shall
not reassign subsidy eligible individuals enrolled in the plan to other plans …
(D) SPECIAL RULE FOR PLANS THAT WAIVE DE MINIMIS PREMIUMS. The
process … may include, in the case of a part D eligible individual who is
a subsidy eligible individual … who has failed to enroll in a prescription
drug plan or an MA–PD plan, for the enrollment in a prescription drug plan
subsidy eligible individual …. If there is more than one such plan available,
the Secretary shall enroll such an individual … on a random basis among all
such plans in the PDP region …
3305 l HHS 3504 l HHS (g) NATIONAL PREVENTION AND HEALTH PROMOTION STRATEGY. Not later than
(d) FACILITATION OF REASSIGNMENTS. Beginning not later than January 1,
2011, the Secretary shall, in the case of a subsidy eligible individual who is
enrolled in one prescription drug plan and is subsequently reassigned by the
days of such reassignment...
3306 l HHS (i) PERIODIC REVIEWS. The Secretary and the Comptroller General shall jointly
OUTREACH ACTIVITIES. The Secretary may request that an entity awarded a
grant support the conduct of outreach activities aimed at preventing disease
and promoting wellness. Notwithstanding any other provision …, an entity
may use a grant awarded under this subsection to support the conduct of
activities …
tion drug plan shall be required to include all covered part D drugs in the
categories and classes identified by the Secretary … (II) EXCEPTIONS. The
Secretary may establish exceptions that permit a PDP sponsor offering a
prescription drug plan to exclude from its formulary a particular covered part
3307 l HHS (a) PREVENTIVE SERVICES TASK FORCE. (1) ESTABLISHMENT AND PURPOSE.
(ii) IDENTIFICATION OF DRUGS IN CERTAIN CATEGORIES AND CLASSES. (I) …
the Secretary shall identify, as appropriate, categories and classes of drugs
for which the Secretary determines are of clinical concern. (II) CRITERIA.
determination under subclause (I). (iii) IMPLEMENTATION. The Secretary shall
establish the criteria … and any exceptions … through the promulgation of
3308 l SSA ca e ac es o he pu pose o ass s ng such en es
(D) DETERMINATION BY COMMISSIONER OF SOCIAL SECURITY. The Commis-
sioner of Social Security shall make any determination necessary to carry out
the income-related increase in the base beneficiary premium …
3308 l SSA medical care systems and pediatric emergency medicine …
necessary to carry out the income-related increase in the base beneficiary
premium …
3308 l SSA mentation of coordinated emergency care systems.
(B) AGREEMENTS. In the case where the monthly benefit payments of an
individual that are withheld … are insufficient … the Commissioner of Social
Security shall enter into agreements with the Secretary, the Director of OPM,
and the Railroad Retirement Board as necessary in order to allow other
agencies to collect the amount described …
3309 l HHS Practices, including the examination of how each task force’s recommendations
ELIMINATION OF COST SHARING FOR CERTAIN DUAL ELIGIBLE INDIVIDUALS.
… the Social Security Act is amended by inserting ‘‘or, effective on a date
specified by the Secretary (but in no case earlier than January 1, 2012), who
would be such an institutionalized individual or couple, if the full-benefit dual
eligible individual were not receiving services under a home and community-
based waiver authorized for a State under section 1115 or subsection (c) or
(d) of section 1915 or under a State plan amendment under subsection (i) of
such section or services provided through enrollment in a medicaid managed
care organization with a contract under section 1903(m) or under section
1932’’ after ‘‘1902(q)(1)(B))’’.
3310 l HHS (c) ROLE OF AGENCY. The Director shall provide ongoing administrative, research,
(3) REDUCING WASTEFUL DISPENSING OF OUTPATIENT PRESCRIPTION
DRUGS IN LONG-TERM CARE FACILITIES. The Secretary shall require PDP
sponsors of prescription drug plans to utilize specific, uniform dispensing
techniques, as determined by the Secretary, in consultation with … any
other stakeholders the Secretary determines appropriate ... when dispensing
covered part D drugs to enrollees who reside in a long-term care facility in
order to reduce waste associated with 30-day fills.
(a) The Secretary shall develop and maintain a complaint system, that is
widely known and easy to use, to collect and maintain information on MA–
PD plan and prescription drug plan complaints that are received … by the
Secretary … through the date on which the complaint is resolved.
3311 l HHS 4004 l HHS d ug dev ce b o og ca o med ca supp y
(b) MODEL ELECTRONIC COMPLAINT FORM. The Secretary shall develop a
model electronic complaint form to be used for reporting plan complaints …
3312 l HHS comparable levels to the prior year during the grant period.
(i) ...use a single, uniform exceptions and appeals process (including, to the
extent the Secretary determines feasible, a single, uniform model form for
use under such process) with respect to the determination of prescription
drug coverage for an enrollee under the plan …
3401 l HHS College of Surgeons, and as the Secretary may otherwise require.
(II) The productivity adjustment … with respect to a percentage, factor, or
update for a fiscal year, year, cost reporting period, or other annual period, is
a productivity adjustment equal to the 10-year moving average of changes in
annual economy-wide private nonfarm business multi-factor productivity (as
projected by the Secretary for the 10-year period ending with the applicable
fiscal year, year, cost reporting period, or other annual period).
(ii) ADJUSTMENT. For FY 2012 and each subsequent fiscal year, after
determining the percentage described … , the Secretary shall reduce such
percentage by the productivity adjustment … The application … may result
in such percentage being less than 0.0 for a fiscal year, and may result in
payment rates … for a fiscal year being less than such payment rates for the
preceding fiscal year.
3401 l HHS priorities, to health care providers who participate in Federal programs …
(ii) PRODUCTIVITY AND OTHER ADJUSTMENT. After establishing the increase
factor … for a fiscal year, the Secretary shall reduce such increase factor (I)
for FY 2012 and each subsequent fiscal year, by the productivity adjustment
… and (II) for each of FYs 2010 through 2019, by the other adjustment
described …
3401 l HHS basis … to each eligible trauma center.
(vi) ADJUSTMENTS. After determining the home health market basket per-
centage increase … the Secretary shall reduce such percentage (I) for 2015
and each subsequent year, by the productivity adjustment … and (II) for each
of 2011, 2012, and 2013, by 1 percentage point.
(B) NONCUMULATIVE APPLICATION. Any reduction … shall apply only with
respect to the rate year involved and the Secretary shall not take into ac-
count such reduction in computing the payment amount … for a subsequent
rate year.
3401 l HHS b NAT ONAL CENTER FOR HEALTH CARE WORKFORCE ANALYS S 1 The Sec e-
(C) SUBMISSION OF QUALITY DATA. For rate year 2014 and each subsequent
rate year, each psychiatric hospital and psychiatric unit shall submit to the
Secretary data on quality measures … Such data shall be submitted in a
3401 l HHS pu poses o A co ec ng ana yz ng and epo ng da a … and B p ov d ng
(D) QUALITY MEASURES. (i) … any measure specified by the Secretary
… must have been endorsed by the entity with a contract under section
1890(a). (ii) EXCEPTION. In the case of a specified area or medical topic
measure has not been endorsed by the entity … the Secretary may specify
a measure that is not so endorsed as long as due consideration is given to
measures that have been endorsed or adopted by a consensus organization
identified by the Secretary.
3401 l HHS 3506 l HHS commun y den a hea h coo d na o s advance p ac ce den a hyg en s s nde-
(E) PUBLIC AVAILABILITY OF DATA SUBMITTED. The Secretary shall establish
procedures for making data submitted … available to the public. Such pro-
opportunity to review the data … prior to such data being made public. The
Secretary shall report quality measures that relate to services furnished in
3401 l HHS (B) TIMING FOR FIRST CONTRACT. As soon as practicable after … enactment
(bb) ...the total percentage of the non-elderly insured population for such
preceding fiscal year (as estimated by the Secretary); exceeds (II) 5 percent-
age points …
3401 l HHS 5203
(II) For 2012 and each subsequent year, after determining the increase
3401 l HHS J TREATMENT OF CERTA N NONPROV DER AND D DACT C ACT V T ES … a me
(F) PRODUCTIVITY AND OTHER ADJUSTMENT. After determining the OPD fee
schedule increase factor … the Secretary shall reduce such increase factor
(ii) for each of 2010 through 2019, by the adjustment described in subpara-
graph (G).
3401 l HHS 5204
(iv) After determining the adjustment to the fee schedules, the Secretary
shall reduce such adjustment (I) for 2011 and each subsequent year, by the
productivity adjustment … and (II) for each of 2011 through 2015, by 1.75
percentage points.
3403 l HHS A … a ge a c educa on cen e ha ece ves an awa d unde h s subsec on
(e) IMPLEMENTATION OF PROPOSAL. (1) Notwithstanding any other provision
of law, the Secretary shall … implement the recommendations contained
in a proposal submitted by the Board or the President to Congress … on
August 15 of the year in which the proposal is so submitted.
3403 l HHS 5204
(B) INTERIM FINAL RULEMAKING. The Secretary may use interim final rule-
making to implement any recommendation …
(b) GENERAL FUNCTIONS OF THE CENTER. The Center for Quality Improve-
ment and Patient Safety of the Agency for Healthcare Research and Quality
… or any other relevant agency or department designated by the Director,
shall ... (1) support … research on health care delivery system improvement
the priorities identified by the Secretary in the national strategic plan …
3501 l HHS 3507 l HHS 5403
(d) DISSEMINATION OF RESEARCH FINDINGS. (1) PUBLIC AVAILABILITY. The
Director shall make the research findings … available to the public through
multiple media and appropriate formats to reflect the varying needs of health
care providers and consumers and diverse levels of health literacy.
3501 l HHS decisionmaking by clinicians and patients and consumers.
ensure that research findings and results generated by the Center are shared
with the Office of the National Coordinator of HIT and used to inform the
activities of the HIT extension program …
3501 l HHS
(e) PRIORITIZATION. The Director shall identify and regularly update a list of
processes or systems on which to focus research and dissemination activi-
ties of the Center …
3501 l HHS ALL ED HEALTH WORKFORCE RECRU TMENT AND RETENT ON PROGRAMS a
(a) The Director, through the Center for Quality Improvement and Patient
Safety of the Agency for Healthcare Research and Quality … shall award ...
3501 l HHS than 3 years after the date of submission of the report … shall promulgate
(A) may be a hospital or other health care provider or consortium or provid-
ers, as determined by the Secretary.
3501 l HHS DEMONSTRATION PROGRAM TO INTEGRATE QUALITY IMPROVEMENT AND
(1) TECHNICAL ASSISTANCE AWARD. To receive a technical assistance grant
or contract … an eligible entity shall submit an application to the Secretary
at such time …
3501 l HHS education of health professionals …
(2) IMPLEMENTATION AWARD. To receive a grant or contract … an eligible
entity shall submit an application to the Secretary at such time, in such
manner, and containing (A) a plan for implementation of a model or practice
identified in the research conducted by the Center including (i) financial cost,
projected post-implementation quality measure performance data in targeted
improvement areas identified by the Secretary …
3501 l HHS consortium … only if the entity or consortium agrees to make available non-
(e) EVALUATION. (1) The Director shall evaluate the performance of each
entity that receives a grant or contract …
3501 l HHS … A has subm ed o he Sec e a y an app ca on a such me n such
(2) EFFECT OF EVALUATION. Based on the outcome of the evaluation of
the entity… the Director shall determine whether to renew a grant or
contract …
3502 l HHS practicable.
(a) The Secretary …shall establish a program to provide grants to or enter
into contracts to establish community-based interdisciplinary, interprofes-
sional teams … to support primary care practices, including obstetrics and
gynecology practices …
3502 l HHS tion to the Secretary … (3) monitor HHS offices, agencies, and regional
diseases or conditions identified by the Secretary …
3502 l HHS women’s health programs and policies with the private sector; and (7)
interdisciplinary, interprofessional care plans that integrate clinical and
community preventive and health promotion services for patients … with a
conditions identified by the Secretary …
3502 l HHS Secretary may make grants to, and enter into cooperative agreements,
(e) REPORTING TO SECRETARY. An entity that receives a grant or contract
… shall submit to the Secretary a report that describes and evaluates, as
3503 l HHS (2) EVALUATION AND DISSEMINATION. The Secretary shall directly or
(a) The Secretary, acting through the Patient Safety Research Center estab-
lished … shall establish a program to provide grants or contracts to eligible
entities to implement medication management … services provided by
licensed pharmacists, as a collaborative, multidisciplinary, inter-professional
approach to the treatment of chronic diseases for targeted individuals, to
improve the quality of care and reduce overall cost in the treatment of such
diseases. The Secretary shall commence the program … not later than May
(5) ...submit to the Secretary such other information as the Secretary may
require.
3503 l HHS 5507
(4) ...have undergone a transition of care, or other factors, as determined
problems.
3503 l HHS 3510 l HHS 2 TRA N NG AND CERT F CAT ON PROGRAMS FOR PERSONAL AND HOME CARE
(e) CONSULTATION WITH EXPERTS. … the Secretary shall consult with
implementation of pharmacist-delivered MTM services, as the Secretary
determines appropriate. The Secretary, in collaboration with this group,
shall determine whether it is possible to incorporate rapid cycle process
mented MTM services.
3503 l HHS Sec e a y sha awa d g an s o e g b e en es o enab e such en es o p ov de
(f) REPORTING TO THE SECRETARY. An entity that receives a grant or contract
…shall submit to the Secretary a report that describes and evaluates, as
requested by the Secretary, the activities carried out … including quality
measures … as determined by the Secretary.
3504 l HHS
(a) The Secretary, acting through the Assistant Secretary for Prepared-
ness and Response, shall award not fewer than 4 multiyear contracts or
competitive grants … to support pilot projects that design, implement, and
evaluate innovative models of regionalized, comprehensive, and accountable
emergency care and trauma systems.
(c) PILOT PROJECTS. The Secretary shall award a contract or grant … that
proposes a pilot project to design, implement, and evaluate an emergency
medical and trauma system …
3504 l HHS recommendations and advise the Council on lifestyle-based chronic disease
(d) APPLICATION. (1) An eligible entity that seeks a contract or grant … shall
submit to the Secretary an application at such time and in such manner as
the Secretary may require.
(e) REQUIREMENT OF MATCHING FUNDS. (1) The Secretary may not make
a grant … unless the State … involved agrees, with respect to the costs to
be incurred by the State(s) in carrying out the … grant … to make available
non-Federal contributions (in cash or in kind…) toward such costs in an
amount equal to not less than $1 for each $3 of Federal funds provided in the
grant …
3504 l HHS conduct periodic reviews, not less than every 5 years, and evaluations of every
(f) PRIORITY. The Secretary shall give priority for the award of the contracts
or grants… to any eligible entity that serves a population in a medically
underserved area …
3504 l HHS Health Fund ... to be administered through the HHS, Office of the Secretary, to
(h) DISSEMINATION OF FINDINGS. The Secretary shall, as appropriate, dis-
the information contained in a report …
3504 l HHS 6001
(d) AUTHORITY. … beginning on the date of enactment of the PPACA, the
Secretary shall transfer authority in administering grants and related authori-
ties under such parts from the Administrator of the Health Resources and
Services Administration to the Assistant Secretary for Preparedness and
Response.
3504 l HHS a TRANSPARENCY REPORTS 1 PAYMENTS OR OTHER TRANSFERS OF VALUE A
(a) EMERGENCY MEDICAL RESEARCH. The Secretary shall support Federal
programs administered by NIH, the Agency for Healthcare Research and
Quality, the Health Resources and Services Administration, the CDC, and
other agencies involved in improving the emergency care system to expand
and accelerate research in emergency medical care systems and emergency
medicine …
(b) PEDIATRIC EMERGENCY MEDICAL RESEARCH. The Secretary shall support
Federal programs administered by NIH, the Agency for Healthcare Research
and Quality, the Health Resources and Services Administration, the CDC, and
other agencies to coordinate and expand research in pediatric emergency
3504 l HHS TRANSFORMAT ON PLAN —The D ec o sha p ov de app op a e eedback and
(c) IMPACT RESEARCH. The Secretary shall support research to determine
the estimated economic impact of, and savings that result from, the imple-
3505 l HHS eva ua on
(a) The Secretary shall establish 3 programs to award grants to qualified
public, nonprofit IHS, Indian tribal, and urban Indian trauma centers.
3505 l HHS respect to an SBHC for not to exceed 2 years; and (2) upon a showing of good
(b) MINIMUM QUALIFICATIONS OF TRAUMA CENTERS. (1) PARTICIPATION
IN TRAUMA CARE SYSTEM OPERATING UNDER CERTAIN PROFESSIONAL
GUIDELINES. … the Secretary may not award a grant to a trauma center
… unless … is a participant in a trauma system that substantially complies
with section 1213.
3505 l HHS ated with expanding and modernizing existing buildings for use as an SBHC,
(4) TRAUMA CENTERS IN 1115 WAIVER STATES. … the Secretary may award
a substantial uncompensated care grant to a trauma center under subsec-
tion (a)(1) if the trauma center qualifies for funds under a Low Income Pool or
3505 l HHS ... for any fiscal year for the SBHC if the Secretary determines that applying the
(c) ADDITIONAL REQUIREMENTS. The Secretary may not award a grant to a
trauma center …unless …it (1) submits to the Secretary a plan satisfac-
tory to the Secretary that demonstrates a continued commitment to serving
3505 l HHS Task Force and the Advisory Committee on Immunization Practices ...
SATED CARE AWARDS. (1) The Secretary shall establish an award basis for
each eligible trauma center for grants …
3505 l HHS nc ud ng hose ha
(c) EMERGENCY AWARDS. In awarding grants … the Secretary shall (1) give
preference to …
3505 l HHS (b) REQUIREMENTS. In establishing the campaign, the Secretary shall (1) ensure
(a) MAINTENANCE OF FINANCIAL SUPPORT. The Secretary may require a
trauma center receiving a grant …to maintain access to trauma services at
3505 l HHS agemen o da a co ec ed and B deve op n e ope ab y and secu y sys ems
receiving a grant … to provide data to a national and centralized registry
of trauma cases, in accordance with guidelines developed by the American
(a) APPLICATION. The Secretary may not award a grant to a trauma center …
unless such center submits an application for the grant to the Secretary and
the application is in such form, is made in such manner, and contains such
agreements, assurances, and information as the Secretary determines to be
necessary to carry out this part.
(b) LIMITATION ON DURATION OF SUPPORT. The period during which a
trauma center receives payments under a grant … shall be for 3 fiscal years,
except that the Secretary may waive such requirement for a center and
authorize such center to receive such payments for 1 additional fiscal year.
(g) SUBSTANTIAL UNCOMPENSATED CARE AWARD DISTRIBUTION AND PRO-
PORTIONAL SHARE. … of the amount appropriated for substantial uncom-
pensated care grants for a fiscal year, the Secretary shall (1) make available
(A) 50 percent of such funds for category A trauma center grantees; (B) 35
percent of such funds for category B trauma center grantees; and (C) 15
percent of such funds for category C trauma center grantees; and (2) provide
available funds within each category in a manner proportional to the award
GRANTS TO STATES. (a) ESTABLISHMENT. To promote universal access to
trauma care services provided by trauma centers and trauma-related physi-
3505 l HHS 5002
(2) MAINTENANCE OF EFFORT. The Secretary may not provide funding to a
State under this part unless the State agrees that such funds will be used to
supplement and not supplant State funding …
3505 l HHS a y sha es ab sh he Na ona Cen e o Hea h Wo k o ce Ana ys s …
(f) DISTRIBUTION OF FUNDS. The following shall apply with respect to grants
provided in this part: (1) LESS THAN $10,000,000. If the amount of appro-
priations for this part in a fiscal year is less than $10,000,000, the Secretary
more trauma centers eligible for funding … (2) LESS THAN $20,000,000.
If the amount of appropriations in a fiscal year is less than $20,000,000,
the Secretary shall divide such funding evenly among only those States
that have 1 or more trauma centers eligible for funding … (3) LESS THAN
$30,000,000. If the amount of appropriations for this part in a fiscal year is
less than $30,000,000, the Secretary shall divide such funding evenly among
only those States that have 1 or more trauma centers eligible for funding …
(4) $30,000,000 OR MORE. If the amount of appropriations for this part in a
fiscal year is $30,000,000 or more, the Secretary shall divide such funding
evenly among all States.
(c) ESTABLISHMENT OF INDEPENDENT STANDARDS FOR PATIENT DECISION
AIDS FOR PREFERENCE SENSITIVE CARE. (1) CONTRACT WITH ENTITY TO
ESTABLISH STANDARDS AND CERTIFY PATIENT DECISION AIDS. (A) … the
Secretary shall have in effect a contract with the entity with a contract under
the Social Security Act …
3506 l HHS 5203
… the Secretary shall enter into the first contract …
3506 l HHS he Sec e a y sha en e n o con ac s … unde wh ch 2 he Sec e a y ag ees
HEALTH CARE PROVIDERS AND PATIENTS. (1) The Secretary, acting through
the Director, and in coordination with heads of other relevant agencies, such
as the Director of the CDC and the Director of NIH, shall establish a program
to award grants or contracts.
3506 l HHS Sec e a y sha g ve p o y o app can s who …
(3) DISTRIBUTION. The Director shall ensure that patient decision aids
DUPLICATION OF EFFORTS. The Director shall ensure that the activities of
the Agency and other agencies, including the CDC and the NIH, are free of
unnecessary duplication of effort.
3506 l HHS 5305
(e) GRANTS TO SUPPORT SHARED DECISIONMAKING IMPLEMENTATION. (1)
The Secretary shall establish a program to provide for the phased-in devel-
opment, implementation, and evaluation of shared decision making using
patient decision aids to meet the objective of improving the understanding of
3506 l HHS 5204
(2) SHARED DECISIONMAKING RESOURCE CENTERS. (A) The Secretary shall
provide grants for the establishment and support of Shared Decisionmaking
Resource Centers …
(3) SHARED DECISIONMAKING PARTICIPATION GRANTS. (A) The Secre-
tary shall provide grants to health care providers for the development and
implementation of shared decisionmaking techniques and to assess the use
of such techniques. (B) PREFERENCE. In order to facilitate the use of best
practices, the Secretary shall provide a preference in making grants under
this subsection to health care providers who participate in training by Shared
Decisionmaking Resource Centers or comparable training.
3506 l HHS 5305
the use of patient decision aids.
PRESENTATION OF PRESCRIPTION DRUG BENEFIT AND RISK INFORMA-
TION. (a) The Secretary … acting through the Commissioner of FDA, shall
determine whether the addition of quantitative summaries of the benefits
and risks of prescription drugs in a standardized format… to the promo-
3507 l HHS REQU REMENT HOSP TAL L KELY TO F LL POS T ON W TH N CERTA N T ME
(b) REVIEW AND CONSULTATION. …The Secretary shall review all available
scientific evidence and research on decisionmaking and social and cognitive
psychology and consult with drug manufacturers, clinicians, patients and
minorities, and experts in women’s and pediatric health.
3507 l HHS 5205
(d) AUTHORITY. If the Secretary determines … that the addition of quantita-
tive summaries of the benefits and risks of prescription drugs in a standard-
ized format (such as a table or drug facts box) to the promotional labeling or
print advertising of such drugs would improve health care decisionmaking
proposed regulations as necessary to implement such format.
3508 l HHS … B n a se ng whe e pa en s m gh equ e hea h ca e se v ces…as ecog-
PATIENT SAFETY TRAINING INTO CLINICAL EDUCATION OF HEALTH PROFES-
SIONALS. (a) The Secretary may award grants to eligible entities or consortia
… to carry out demonstration projects to develop and implement academic
curricula that integrates quality improvement and patient safety in the clinical
3508 l HHS A EL G BLE ENT T ES An e g b e en y awa ded a g an o conduc a dem-
(b) ELIGIBILITY. To be eligible to receive a grant, an entity or consortium shall
(1) submit to the Secretary an application at such time, in such manner, and
containing such information as the Secretary may require …
3508 l HHS
(c) MATCHING FUNDS. (1) The Secretary may award a grant to an entity or
Federal contributions toward the costs of the program to be funded under
the grant in an amount that is not less than $1 for each $5 of Federal funds
provided under the grant.
3508 l HHS Sec e a y has app oved such app ca on
(d) EVALUATION. The Secretary shall take such action as may be necessary
to evaluate the projects funded …and publish, make publicly available,
3509 l HHS 5207
(b) DUTIES. The Secretary, acting through the Office, with respect to the
health concerns of women, shall... (1) establish short-range and long-range
goals 6 and objectives within HHS … (2) provide expert advice and consulta-
activities regarding women’s health and identify needs … (4) establish a
HHS Coordinating Committee on Women’s Health … (5) establish a National
Women’s Health Information Center … (6) coordinate efforts to promote
through publications and any other means appropriate, provide for the ex-
change of information between the Office and recipients of grants, contracts,
and agreements …
3509 l HHS Cong ess a epo on he n a mp emen a on o ac v es conduc ed unde
(c) GRANTS AND CONTRACTS REGARDING DUTIES. (1) AUTHORITY. … the
contracts, and interagency agreements with, public and private entities,
agencies, and organizations.
3509 l HHS 5301
through contracts with public and private entities, agencies, and organiza-
tions, provide for evaluations of projects … and for the dissemination of
information …
3509 l HHS 5301
(a) ESTABLISHMENT. The Secretary shall establish within the Office of the
Administrator of the Health Resources and Services Administration, an office
to be known as the Office of Women’s Health …
(j) RULE OF CONSTRUCTION. Nothing in this section … shall be construed to
limit the authority of the Secretary with respect to women’s health, or with
respect to activities carried out through the HHS on the date of enactment …
3510 l HHS 5301
(3) LIMITATIONS ON GRANT PERIOD. … the Secretary shall ensure that the
total period of a grant does not exceed 4 years.
(3) MINIMUM CORE PROFICIENCIES. The Secretary shall not award a grant
… unless such entity provides assurances that patient navigators recruited,
assigned, trained, or employed using grant funds meet minimum core
proficiencies …
4
4001 l Executive
Title IV Chronic Disease and Public Health (171 Delegations)
(a) ESTABLISHMENT. The President shall establish, within HHS, a council to be
known as the ‘‘National Prevention, Health Promotion and Public Health Council.
4001 l Executive prevention plan tool.
(f) ADVISORY GROUP. (1) The President shall establish an Advisory Group to the
and Integrative and Public Health’’ ...
4001 l Executive entities.
(3) PURPOSES AND DUTIES. The Advisory Group shall develop policy and program
prevention and management, integrative health care practices, and health
promotion.
4001 l Executive related services that are available to Medicaid enrollees, including obesity
1 year after the date of enactment of this Act, the Chairperson, in consultation
with the Council, shall develop and make public a national prevention, health
promotion and public health strategy, and shall review and revise such strategy
periodically ...
4001 l HHS
Federal disease prevention and health promotion initiative, program, and agency.
4002 l HHS that funds awarded under the grant shall not be used to provide any service that
(a) PURPOSE. It is the purpose of this section to establish a Prevention and Public
provide for expanded and sustained national investment in prevention and public
health programs to improve health and help restrain the rate of growth in private
and public sector health care costs.
4002 l HHS e emen s desc bed …
(c) USE OF FUND. The Secretary shall transfer amounts in the Fund to accounts
within the HHS to increase funding, over FY 2008 level, for programs authorized
by the Public Health Service Act …
4003 l HHS 4103
The Director shall convene an independent Preventive Services Task Force to be
composed of individuals with appropriate expertise.
4003 l HHS Secretary.
(2) DUTIES. The duties of the Task Force shall include (A) the development of
additional topic areas for new recommendations and interventions ... (B) at least
once during every 5-year period, review interventions and update recommen-
dations related to existing topic areas ... (C) improved integration with Federal
(D) the enhanced dissemination of recommendations; (E) the provision of techni-
cal assistance to those health care professionals, agencies and organizations
that request help in implementing ... recommendations; and (F) the submission of
yearly reports to Congress and related agencies …
4003 l HHS Ep dem o ogy and Labo a o y Capac y G an P og am o awa d g an s o S a e
(3) ROLE OF AGENCY. The Agency shall provide ongoing administrative, research,
and technical support for the operations of the Task Force, including coordinating
and supporting the dissemination of the recommendations of the Task Force, en-
suring adequate staff resources, and assistance to those organizations request-
ing it for implementation of ... recommendations.
4003 l HHS 4101 l HHS 4103
(4) COORDINATION WITH COMMUNITY PREVENTIVE SERVICES TASK FORCE. The
Task Force shall take appropriate steps to coordinate its work with the Commu-
interact at the nexus of clinic and community.
4003 l HHS o and po en a ea men s o pa n
COMMUNITY PREVENTIVE SERVICES TASK FORCE. (a) ESTABLISHMENT AND
PURPOSE. The Director of the CDC shall convene an independent Community
Preventive Services Task Force ... Such Task Force shall review the scientific
evidence related to the effectiveness, appropriateness, and cost-effectiveness of
community preventive interventions for the purpose of developing recommenda-
tions, to be published in the Guide to Community Preventive Services ...
4003 l HHS (2) WAIVER. The Secretary may waive all or part of the matching requirement
and technical support for the operations of the Task Force …
4003 l HHS echno ogy o a d n he deve opmen o se -managemen sk s and manage-
(d) COORDINATION WITH PREVENTIVE SERVICES TASK FORCE. The Task Force
shall take appropriate steps to coordinate work with the U.S. Preventive Services
4004 l HHS 4 CONSULTAT ON The Sec e a y sha consu w h he nspec o Gene a o he
The Secretary shall provide for the planning and implementation of a national
public–private partnership for a prevention and health promotion outreach and
education campaign to raise public awareness of health improvement across the
life span ...
(b) CONSULTATION. In coordinating the campaign ... the Secretary shall consult
with the IOM to provide ongoing advice on evidence-based scientific information
for policy, program development, and evaluation.
4004 l HHS 4102 l HHS made unde h s e o a p even ve se v ce ha has no ece ved a g ade o
(c) MEDIA CAMPAIGN. (1) Not later than 1 year after the date of enactment of
this Act, the Secretary, acting through the Director of the CDC, shall establish and
implement a national science-based media campaign on health promotion and
4004 l HHS and s au ho zed o ece ve paymen o o he se v ces unde h s e o s
(3) EVALUATION. The Secretary shall ensure that the campaign ... is subject to an
independent evaluation every 2 years and shall report every 2 years to Congress
on the effectiveness of such campaigns towards meeting science-based metrics.
4004 l HHS 4102 l HHS women n “T ea ng Tobacco Use and Dependence 2008 Upda e A C n ca
lar exercise, obesity reduction, smoking cessation, and specific chronic disease
prevention.
4004 l HHS 4108
(e) DISSEMINATION OF INFORMATION THROUGH PROVIDERS. The Secretary, act-
ing through the CDC, shall develop and implement a plan for the dissemination
of health promotion and disease prevention information consistent with national
5
HHS
a 15 CULTURAL COMPETENCY —The e m cu u a compe ency sha be defined
by he Sec e a y n a manne cons s en w h sec on 1707 d 3
5103 Labor
5103 Labor
c STATE AND REG ONAL CENTERS FOR HEALTH WORKFORCE ANALYS S 1 The
Sec e a y sha awa d g an s o o en e n o con ac s w h e g b e en es o
echn ca ass s ance … 2 B subm o he Sec e a y an app ca on a such
me n such manne and con a n ng such n o ma on as he Sec e a y may
equ e
5103 Labor
d NCREASE N GRANTS FOR LONG TUD NAL EVALUAT ONS 1 The Sec e a y
sha nc ease he amoun awa ded o an e g b e en y unde h s e o a
ong ud na eva ua on o nd v dua s who have ece ved educa on a n ng o
5201 HHS
b STUDENT LOAN GU DEL NES The Sec e a y sha no equ e pa en a financ a
n o ma on o an ndependen s uden o de e m ne financ a need … The
Sec e a y sha amend gu de nes ssued by he Hea h Resou ces and Se v ces
Adm n s a on n acco dance w h he p eced ng sen ence
Labor
Subpa 3—Rec u men and Re en on P og ams SEC 775 NVESTMENT N
TOMORROW S PED ATR C HEALTH CARE WORKFORCE a The Sec e a y sha
es ab sh and ca y ou a ped a c spec a y oan epaymen p og am … b …
o make paymen s on…educa on oans o p o ess ona s desc bed above …
Labor
c 2 ADD T ONAL EL G B L TY REQU REMENTS … C he nd v dua s en o ed
n a g adua e p og am he p og am s acc ed ed and he nd v dua has an ac-
cep ab e eve o academ c s and ng as de e m ned by he Sec e a y d … he
5204 Labor
PUBL C HEALTH WORKFORCE RECRU TMENT AND RETENT ON PROGRAMS SEC
776 PUBL C HEALTH WORKFORCE LOAN REPAYMENT PROGRAM a ESTABL SH-
MENT —The Sec e a y sha es ab sh he Pub c Hea h Wo k o ce Loan Repay-
men P og am e e ed o n h s sec on as he P og am
Labor
b EL G B L TY To be e g b e o pa c pa e n he P og am an nd v dua sha —
be emp oyed by o have accep ed emp oymen w h a Fede a S a e oca
o ba pub c hea h agency o a e a ed a n ng e owsh p as ecogn zed by
he Sec e a y … and 3 A subm an app ca on o he Sec e a y …
Labor
c CONTRACT —The w en con ac … be ween he Sec e a y and an nd -
v dua sha con a n 1 an ag eemen … ha he Sec e a y w epay on beha
o he nd v dua oans ncu ed by he nd v dua n he pu su o he e evan
deg ee o ce fica e…
Labor
… B such onge pe od o me as de e m ned app op a e by he Sec e a y and
he nd v dua …
5204 Labor
… 3 an ag eemen as app op a e on he pa o he nd v dua o e oca e o
a p o y se v ce a ea as de e m ned by he Sec e a y n exchange o an ad-
d ona oan epaymen ncen ve amoun o be de e m ned by he Sec e a y …
5204 Labor
… 6 such o he s a emen s o he gh s and ab es o he Sec e a y and o
he nd v dua no ncons s en w h h s sec on
5204 Labor
2 PAYMENTS FOR YEARS SERVED … c he Sec e a y may pay up o $35 000
on beha o he nd v dua o oans desc bed n pa ag aph 1 … he Sec e a y
sha pay an amoun ha does no exceed 1 3 o he e g b e oan ba ance …
5204 Labor
3 TAX L AB L TY … he Sec e a y sha n add on o such paymen s make pay-
men s o he nd v dua n an amoun no o exceed 39 pe cen o he o a amoun
o oan epaymen s made o he axab e yea nvo ved
5204 Labor
e POSTPON NG OBL GATED SERV CE … he da e o he n a on o he pe od o
ob ga ed se v ce may be pos poned as app oved by he Sec e a y
HHS
The pu pose o h s sec on s o assu e an adequa e supp y o a ed hea h
p o ess ona s … n se ngs whe e pa en s m gh equ e hea h ca e se v ces
nc ud ng acu e ca e ac es ambu a o y ca e ac es pe sona es dences and
o he se ngs as ecogn zed by he Sec e a y by au ho z ng an A ed Hea h
Loan Fo g veness P og am
5205 HHS
n zed by he Sec e a y o HHS
5205 HHS
a se ng whe e pa en s m gh equ e hea h ca e se v ces … as ecogn zed by
he Sec e a y o HHS
5206 HHS
TRA N NG FOR M D-CAREER PUBL C AND ALL ED HEALTH PROFESS ONALS a
The Sec e a y may make g an s o o en e n o con ac s w h any e g b e en y
… o he pu pose o enab ng m d-ca ee p o ess ona s n he pub c hea h and
a ed hea h wo k o ce o ece ve add ona a n ng n he fie d o pub c hea h
and a ed hea h
5206 HHS
1 EL G BLE ENT TY The e m e g b e en y nd ca es an acc ed ed educa ona
ng p og am n pub c o a ed hea h o a e a ed d sc p ne as de e m ned by he
Sec e a y
5207 HHS
b AUTHOR TY TO AWARD GRANTS —The Sec e a y sha awa d g an s o he
cos o he ope a on o nu se managed hea h c n cs ha mee he equ emen s
o h s sec on
HHS
… 2 subm o he Sec e a y an app ca on a such me n such manne and
con a n ng …
HHS
d GRANT AMOUNT —The amoun o any g an made unde h s sec on o any
fisca yea sha be de e m ned by he Sec e a y ak ng n o accoun …
5207 HHS
… 2 o he ac o s as he Sec e a y de e m nes app op a e
5301 HHS
1 The Sec e a y may make g an s o o en e n o con ac s w h an acc ed ed
pub c o nonp ofi p va e hosp a schoo o med c ne o os eopa h c med c ne
academ ca y a fi a ed phys c an ass s an a n ng p og am o a pub c o p va e
nonp ofi en y wh ch he Sec e a y has de e m ned s capab e o ca y ng ou
such g an o con ac …
HHS
… 3 A o p an deve op ope a e o pa c pa e n an acc ed ed p o ess ona
a n ng p og am … n he fie d o am y med c ne gene a n e na med c ne o
gene a ped a cs o med ca s uden s n e ns es den s o p ac c ng phys -
c ans as defined by he Sec e a y …
HHS
p ov d ng a n ng o p ma y ca e phys c ans e evan o p ov d ng ca e h ough
pa en -cen e ed med ca homes as defined by he Sec e a y o pu poses o h s
sec on
HHS
b CAPAC TY BU LD NG N PR MARY CARE 1 The Sec e a y may make g an s
o o en e n o con ac s w h acc ed ed schoo s o med c ne o os eopa h c
med c ne o es ab sh ma n a n o mp ove …
HHS
2 PREFERENCE N MAK NG AWARDS UNDER TH S SUBSECT ON — n mak ng
awa ds o g an s and con ac s he Sec e a y sha g ve p e e ence o any qua -
fied app can o such an awa d ha ag ees o expend he awa d o he pu pose
o …
5301 HHS
3 PR OR T ES N MAK NG AWARDS — n awa d ng g an s o con ac s he Sec-
e a y sha g ve p o y o qua fied app can s ha …
5302 HHS
TRA N NG OPPORTUN T ES FOR D RECT CARE WORKERS nse ng he o ow ng
SEC 747A TRA N NG OPPORTUN T ES FOR D RECT CARE WORKERS a The
new a n ng oppo un es o d ec ca e wo ke s who a e emp oyed n…any
o he se ng he Sec e a y de e m nes o be app op a e
5302 HHS
… 2 subm o he Sec e a y an app ca on a such me n such manne and
con a n ng such n o ma on as he Sec e a y may equ e
5303 HHS
TRA N NG N GENERAL PED ATR C AND PUBL C HEALTH DENT STRY a 1 The
Sec e a y may make g an s o o en e n o con ac s w h a schoo o den s y
pub c o nonp ofi p va e hosp a o a pub c o p va e nonp ofi en y wh ch he
Sec e a y has de e m ned s capab e o ca y ng ou such g an o con ac …
9
9001 Treasury
no y a such me and n such manne as he Sec e a y may p esc be
he Sec e a y and each cove age p ov de o he amoun so de e m ned o he
p ov de
9001 Treasury
D ALLOCAT ON ON A MONTHLY BAS S cos s de e m ned on o he han a
mon h y bas s he cos sha be a oca ed o mon hs n a axab e pe od on such
bas s as he Sec e a y may p esc be
9001 Treasury
A PENALTY NOT TO APPLY WHERE FA LURE NOT D SCOVERED EXERC S NG REA-
SONABLE D L GENCE No pena y sha be mposed on any a u e o p ope y
ca cu a e he excess benefi du ng any pe od o wh ch s es ab shed o he
sa s ac on o he Sec e a y ha he emp oye o p an sponso ne he knew no
exe c s ng easonab e d gence wou d have known ha such a u e ex s ed
9001 Treasury
C WA VER BY SECRETARY n he case o any such a u e wh ch s due o eason-
ab e cause and no o w u neg ec he Sec e a y may wa ve pa o a o he
pena y o he ex en ha he paymen o such pena y wou d be excess ve o
o he w se nequ ab e e a ve o he a u e nvo ved
4004 l HHS 4102 l HHS 4108
(f) PERSONALIZED PREVENTION PLANS. (1) CONTRACT. The Secretary, acting
through the Director of the CDC, shall enter into a contract with a qualified entity
for the development and operation of a Federal Internet website personalized
4004 l HHS (d) UPDATING NATIONAL ORAL HEALTHCARE SURVEILLANCE ACTIVITIES. (1)
(g) INTERNET PORTAL. The Secretary shall establish an Internet portal for access-
4004 l HHS (2) NATIONAL HEALTH AND NUTRITION EXAMINATION SURVEY. The Secretary shall
(i) PUBLIC AWARENESS OF PREVENTIVE AND OBESITY-RELATED SERVICES. (1)
INFORMATION TO STATES. The Secretary shall provide guidance and relevant
information to States and health care providers regarding preventive and obesity-
screening and counseling for children and adults.
4101 l HHS 4102 l HHS 4108
SEC. 4101. SCHOOL-BASED HEALTH CENTERS. (a) GRANTS FOR THE ESTABLISH-
MENT OF SCHOOL-BASED HEALTH CENTERS. (1) PROGRAM. The Secretary shall
establish a program to award grants to eligible entities to support the operation
of school-based health centers.
4101 l HHS 4102 l HHS v ews o ecommenda ons o he Task Fo ce on Commun y P even ve Se v ces
(B) ... submit an application at such time, in such manner, and containing such
information as the Secretary may require, including at a minimum an assurance
is not authorized or allowed by Federal, State, or local law.
4101 l HHS 4108
(3) PREFERENCE. In awarding grants ... the Secretary shall give preference to ...
school-based health centers that serve a large population of children eligible for
medical assistance under ... Medicaid ... or ... the State child health plan ...
4101 l HHS 4108
(4) LIMITATION ON USE OF FUNDS. An eligible entity shall use … only for expen-
ditures for facilities, … equipment, or similar expenditures, as specified by the
Secretary ...
4101 l HHS 3 A hea h p o ess ona
(B) CRITERIA. The Secretary shall prescribe criteria for determining the specific
shortages of personal health services for medically underserved children and
adolescents ... that shall … and other factors as determined appropriate by the
4101 l HHS 4 A The Sec e a y no a e han 1 yea a e enac men o h s subsec on
(b) AUTHORITY TO AWARD GRANTS. The Secretary shall award grants for the
costs of the operation of school-based health centers (“SBHCs”).
4101 l HHS v
(c) APPLICATIONS. To be eligible to receive a grant ... an entity shall (1) be an
SBHC ... and (2) submit to the Secretary an application at such time, in such
manner, and containing … (D) such other information as the Secretary may
require.
4101 l HHS 4103
(d) PREFERENCES AND CONSIDERATION. In reviewing applications: (1) The Sec-
retary may give preference to applicants who demonstrate an ability to serve the
following: … (2) The Secretary may give consideration to whether an applicant
has received a grant under ... the PPACA.
(e) WAIVER OF REQUIREMENTS. The Secretary may (1) under appropriate
circumstances, waive the application of all or part of the requirements ... with
cause, waive the requirement that the SBHC provide all required comprehensive
primary health services for a designated period of time to be determined by the
Secretary.
4101 l HHS hea h sk assessmen s a e access b e o benefic a es and p ov de app op -
2) CONSTRUCTION. The Secretary may award grants ... to pay the costs associ-
including the purchase of trailers or manufactured buildings to install on the
school property.
4101 l HHS 4305
matching requirement to the SBHC would result in serious hardship or an inability
to carry out the purposes ...
4101 l HHS men o and adhe ence o p ov de ecommenda ons n o de o mp ove he
(i) EVALUATION. The Secretary shall develop and implement a plan for evaluating
SBHCs and monitoring quality performance under the awards made ...
4102 l HHS H The Sec e a y sha ssue gu dance ha
(a) ESTABLISHMENT. The Secretary, acting through the Director of the CDC and
in consultation with professional oral health organizations, shall, subject to
the availability of appropriations, establish a 5-year national, public education
campaign ...
that activities are targeted towards specific populations such as children,
pregnant women, ... (2) utilize science-based strategies to convey oral health
prevention messages …
(c) PLANNING AND IMPLEMENTATION. Not later than 2 years after the date of
enactment of this section, the Secretary shall begin implementing the 5-year
campaign …
4102 l HHS such se v ces unde S a e aw … o he S a e n wh ch he se v ces a e u n shed
acting through the Director of the CDC, shall award demonstration grants to
eligible entities to demonstrate the effectiveness of research-based dental caries
disease management activities.
(2) ... submit to the Secretary an application at such time, in such manner, and
containing such information as the Secretary may require.
4102 l HHS 4204
(d) USE OF INFORMATION. The Secretary shall utilize information generated from
grantees ... in planning and implementing the public education campaign ...
Title V: Health Care Workforce (189 Delegations)
5303 HHS
c PR OR T ES N MAK NG AWARDS W h espec o a n ng p ov ded o unde
h s sec on he Sec e a y sha g ve p o y n awa d ng g an s o con ac s o
he o ow ng
5303 HHS
d APPL CAT ON An e g b e en y des ng a g an unde h s sec on sha subm
o he Sec e a y an app ca on a such me n such manne and con a n ng
such n o ma on as he Sec e a y may equ e
5303 HHS
e DURAT ON OF AWARD … The p ov s on o such paymen s sha be sub ec o
annua app ova by he Sec e a y and sub ec o he ava ab y o app op a ons
o he fisca yea nvo ved o make he paymen s
5304 HHS
DEMONSTRAT ON PROGRAM a 1 AUTHOR ZAT ON The Sec e a y s au ho zed
o awa d g an s
5304 HHS
2 DEF N T ON —The e m “a e na ve den a hea h ca e p ov de s” nc udes
penden den a hyg en s s supe v sed den a hyg en s s p ma y ca e phys c ans
den a he ap s s den a hea h a des and any o he hea h p o ess ona ha he
Sec e a y de e m nes app op a e
5304 HHS
3 sha subm an app ca on o he Sec e a y a such me n such manne and
con a n ng such n o ma on as he Sec e a y may equ e
5304 HHS
2 D SBURSEMENT OF FUNDS A … he Sec e a y may d spe se o any en y
ece v ng a g an unde h s sec on no mo e han 20 pe cen o he o a und ng
awa ded o such en y unde such g an o he pu pose o enab ng he en y o
p an he demons a on p o ec
5304 HHS
EVALUAT ON The Sec e a y sha con ac w h he D ec o o he ns u e o
Med c ne o conduc a s udy o he demons a on p og ams conduc ed unde
h s sec on ha sha p ov de ana ys s based upon quan a ve and qua a ve
da a ega d ng access o den a hea h ca e n he U S
5305 HHS
1 The Sec e a y sha awa d g an s o con ac s unde h s subsec on o en es
ha ope a e a ge a c educa on cen e pu suan o subsec on a 1
HHS
2 APPL CAT ON … an en y desc bed n such pa ag aph sha subm o he
Sec e a y an app ca on a such me n such manne and con a n ng such
n o ma on as he Sec e a y may equ e
5305 HHS
sha use such unds o o e sho - e m n ens ve cou ses … o o he hea h
d sc p nes as app oved by he Sec e a y
5305 HHS
B LOCAT ON A e owsh p sha be o e ed e he a he ge a c educa on
p oved by he Sec e a y w h wh ch he ge a c educa on cen e s a e a fi a ed
5305 HHS
sha equ e such Cen e s o wo k w h app op a e commun y pa ne s o de-
ve op a n ng p og am con en and o pub c ze he ava ab y o a n ng cou ses
n he se v ce a eas
HHS
6 TARGETS A ge a c educa on cen e ha ece ves an awa d unde h s
subsec on sha mee a ge s app oved by he Sec e a y o p ov d ng ge a c
a n ng o a ce a n numbe o acu y o p ac one s du ng he e m o he
awa d as we as o he pa ame e s es ab shed by he Sec e a y
5305 HHS
8 MA NTENANCE OF EFFORT A ge a c educa on cen e ha ece ves an
awa d…sha p ov de assu ances o he Sec e a y ha unds p ov ded…w be
used on y o supp emen no o supp an he amoun o Fede a S a e and oca
unds o he w se expended by he ge a c educa on cen e
5305 HHS
e GER ATR C CAREER NCENT VE AWARDS 1 The Sec e a y sha awa d g an s
o con ac s unde h s sec on o nd v dua s desc bed n pa ag aph 2 o os e
g ea e n e es among a va e y o hea h p o ess ona s n en e ng he fie d o
ge a cs ong- e m ca e and ch on c ca e managemen
5305 HHS
… B subm o he Sec e a y an app ca on a such me n such manne and
con a n ng such n o ma on as he Sec e a y may equ e
5305 HHS
3 COND T ON OF AWARD…an nd v dua sha ag ee ha o ow ng comp e on
o he awa d pe od he nd v dua w each o p ac ce n he fie d o ge a cs
ong- e m ca e o ch on c ca e managemen o a m n mum o 5 yea s unde
gu de nes se by he Sec e a y
5305 HHS
… A be boa d ce fied o boa d e g b e n n e na med c ne am y p ac ce
psych a y o censed den s y o have comp e ed any equ ed a n ng n a d s-
c p ne and emp oyed n an acc ed ed hea h p o ess ons schoo ha s app oved
by he Sec e a y
5305 HHS
… B have comp e ed an app oved e owsh p p og am n ge a cs o have
comp e ed spec a y a n ng n ge a cs as equ ed by he d sc p ne and any
add on ge a cs a n ng as equ ed by he Sec e a y
5305 HHS
… C have a un o non- enu ed acu y appo n men a an acc ed ed as
de e m ned by he Sec e a y schoo o med c ne os eopa h c med c ne nu s ng
soc a wo k psycho ogy den s y pha macy o o he a ed hea h d sc p nes n
an acc ed ed hea h p o ess ons schoo ha s app oved by he Sec e a y
5305 HHS
manne and con a n ng such n o ma on as he Sec e a y may equ e and he
5305 HHS
… B p ov des n such o m and manne as he Sec e a y may equ e as-
su ances ha he nd v dua w mee he se v ce equ emen desc bed n
pa ag aph …
5305 HHS
… C p ov des n such o m and manne as he Sec e a y may equ e assu -
ances ha he nd v dua has a u - me acu y appo n men … and documen ed
comm men … o spend 75 pe cen o he o a me o such nd v dua on each-
ng and deve op ng sk s n n e d sc p na y educa on n ge a cs
5305 HHS
4 MA NTENANCE OF EFFORT An e g b e nd v dua ha ece ves an Awa d sha
p ov de assu ances o he Sec e a y ha unds p ov ded o he e g b e nd v dua
unde h s subsec on w be used …
5305 HHS
… by nse ng a e he pe od a he end he o ow ng The Sec e a y sha
de e m ne he amoun o an Awa d unde h s sec on o nd v dua s who a e no
phys c ans …
5305 HHS
C PAYMENT TO NST TUT ON —The Sec e a y sha make paymen s o ns u-
ons wh ch nc ude schoo s o med c ne os eopa h c med c ne nu s ng soc a
wo k psycho ogy den s y and pha macy o o he a ed hea h … ha s ap-
p oved by he Sec e a y
5306 HHS
MENTAL AND BEHAV ORAL HEALTH EDUCAT ON AND TRA N NG GRANTS a
GRANTS AUTHOR ZED The Sec e a y may awa d g an s o e g b e ns u ons o
h ghe educa on o suppo he ec u men o s uden s o and educa on and
c n ca expe ence o he s uden s …
5306 HHS
… 4 he ns u on w p ov de o he Sec e a y such da a assu ances and
n o ma on as he Sec e a y may equ e …
5306 HHS
… 5 w h espec o any v o a on o he ag eemen be ween he Sec e a y and
he ns u on he ns u on w pay such qu da ed damages as p esc bed by
he Sec e a y by egu a on
5306 HHS
1 n se ec ng he g an ec p en s n soc a wo k unde subsec on a 1 he
Sec e a y sha g ve p o y o app can s …
5306 HHS
2 n se ec ng he g an ec p en s n g adua e psycho ogy unde subsec on a
2 he Sec e a y sha g ve p o y o ns u ons n wh ch a n ng ocuses on
he needs o vu ne ab e g oups
5306 HHS
3 n se ec ng he g an ec p en s n a n ng p og ams n ch d and ado escen
men a hea h unde subsec ons a 3 and a 4 he Sec e a y sha g ve p o y
o app can s ha …
5307 HHS
… B n pa ag aph 1 by s k ng o he pu pose o and a ha o ows
h ough he pe od a he end and nse ng o he deve opmen eva ua on and
d ssem na on o esea ch…and o o he pu poses de e m ned as app op a e by
he Sec e a y …
9001 Treasury
A HEALTH NSURANCE COVERAGE The e m “hea h nsu ance cove age” has
he mean ng g ven excep as p ov ded by he Sec e a y n egu a ons
9001 Treasury
8 TAXABLE PER OD The e m “ axab e pe od” means he ca enda yea o such
sho e pe od as he Sec e a y may p esc be The Sec e a y may have d e en
axab e pe ods o emp oye s o va y ng s zes
9001 Treasury
g REGULAT ONS The Sec e a y sha p esc be such egu a ons as may be
necessa y o ca y ou h s sec on
9001 Treasury
REGULAT ONS The Sec e a y may p esc be such egu a ons and o he gu d-
ance as may be app op a e o necessa y o ca y ou spec fied asks nc ud ng
u es o p even dup ca ve epo ng
9007 Treasury
any o he o gan za on wh ch he Sec e a y de e m nes has he p ov s on o
hosp a ca e as s p nc pa unc on cons u ng he bas s o s exemp on
(d) ORAL HEALTH INFRASTRUCTURE. (1) COOPERATIVE AGREEMENTS. The Secre-
tary, acting through the CDC, shall enter into cooperative agreements with State,
territorial, and Indian tribes or tribal organizations ...
4102 l HHS 4108
PRAMS. (A) The Secretary shall carry out activities to update and improve the
Pregnancy Risk Assessment Monitoring System as it relates to oral healthcare.
4102 l HHS ach eve one o mo e o he o ow ng …
develop oral healthcare components that shall include tooth-level surveillance
for inclusion in the National Health and Nutrition Examination Survey … the term
‘tooth-level surveillance’ means a clinical examination where an examiner looks
at each dental surface, on each tooth in the mouth and as expanded by the Divi-
sion of Oral Health of the Centers for Disease Control and Prevention.
(3) MEDICAL EXPENDITURES PANEL SURVEY. The Secretary shall ensure that the
Medical Expenditures Panel Survey by the Agency for Healthcare Research and
Quality includes the verification of dental utilization, expenditure, and coverage
findings through conduct of a look-back analysis.
(B) REQUIREMENTS. The Secretary shall ensure that the National Oral Health
Surveillance Sys em nc ude he measu emen o ea y ch dhood ca es
4103 HHS
h 1 The e m “pe sona zed p even on p an se v ces” means he c ea on o a
p an o an nd v dua A ha nc udes a hea h sk assessmen ha mee s he
gu de nes es ab shed by he Sec e a y o he nd v dua ha s comp e ed p o
o o as pa o he same v s w h a hea h p o ess ona and B ha akes
n o accoun he esu s o he hea h sk assessmen and may con a n he
4103 HHS
G Any o he e emen de e m ned app op a e by he Sec e a y
HHS
s A a phys c an B a p ac one desc bed e se-
whe e o C a med ca p o ess ona nc ud ng a hea h educa o eg s e ed
d e an o nu on p o ess ona o a eam o med ca p o ess ona s as de e -
m ned app op a e by he Sec e a y unde he supe v s on o a phys c an
4103 HHS
sha es ab sh pub c y ava ab e gu de nes o hea h sk assessmen s Such
gu de nes sha be deve oped n consu a on w h e evan g oups and en es and
sha p ov de ha a hea h sk assessmen
4103 HHS
V h ough any o he means he Sec e a y de e m nes app op a e o max -
m ze access b y and ease o use by benefic a es wh e ensu ng he p vacy o
such benefic a es
HHS
B No a e han 1 yea enac men he Sec e a y sha es ab sh s anda ds
o n e ac ve e ephon c o web-based p og ams used o u n sh hea h sk
assessmen s The Sec e a y may u ze any hea h sk assessmen o he
PPACA as pa o he equ emen o deve op a pe sona zed p even on p an
HHS
C No a e han 18 mon hs a e enac men he Sec e a y sha deve op
and make ava ab e o he pub c a hea h sk assessmen mode Any hea h
sk assessmen ha mee s he gu de nes and s app oved by he Sec e a y
may be used o mee he equ emen …
4103 HHS
D The Sec e a y may coo d na e w h commun y-based … o ensu e ha
a e suppo o he comp e on o hea h sk assessmen s by benefic a es
4103 HHS
E The Sec e a y sha es ab sh p ocedu es o make benefic a es and p ov de s
awa e o he equ emen ha a benefic a y comp e e a hea h sk assessmen
p o o o a he same me as ece v ng pe sona zed p even on p an se v ces
4103 HHS
F To he ex en p ac cab e he Sec e a y sha encou age he use o n eg a on
w h and coo d na on o H T and may expe men w h he use o pe sona zed
hea h s a us o benefic a es
4103 HHS
den fies e emen s ha a e
equ ed o be p ov ded o a benefic a y as pa o he fi s v s o pe sona zed
p even on p an se v ces and es ab shes a yea y schedu e o app op a e
p ov s on o such e emen s he ea e
4105 HHS
SERV CES E ec ve Janua y 1 2010 he Sec e a y de e m nes app op -
a e he Sec e a y may 1 mod y A he cove age o any p even ve se v ce o
he ex en ha such mod fica on s cons s en w h he ecommenda ons o he
U S P even ve Se v ces Task Fo ce and B he se v ces nc uded n he n a
p even ve phys ca exam na on and 2 p ov de ha no paymen sha be
A B C o by such Task Fo ce
4107 HHS
B by any o he hea h ca e p o ess ona who s ega y au ho zed o u n sh
des gna ed by he Sec e a y o h s pu pose
4107 HHS
2 Such e m s m ed o A se v ces ecommended w h espec o p egnan
P ac ce Gu de ne ” pub shed by he Pub c Hea h Se v ce n May 2008 o any
subsequen mod fica on o such Gu de ne and B such o he se v ces ha he
Sec e a y ecogn zes o be e ec ve o cessa on o obacco use by p egnan
women
HHS
a N T AT VES 1 ESTABL SHMENT A The Sec e a y sha awa d g an s o
S a es o ca y ou n a ves o p ov de ncen ves o Med ca d benefic a es
who success u y pa c pa e n he p og am and upon comp e on
demons a e changes n hea h sk and ou comes nc ud ng he adop on and
ma n enance o hea hy behav o s
5307 HHS
b COLLABORAT ON… he Sec e a y sha co abo a e w h hea h p o ess ona
soc e es … and o he o gan za ons as de e m ned app op a e by he Sec e a y
The Sec e a y sha coo d na e w h cu cu a and esea ch and demons a on
p o ec s deve oped unde sec on 807
5307 HHS
2 EVALUAT ON The Sec e a y sha eva ua e he adop on and he mp emen a-
on o cu u a compe ency p even on and pub c hea h and wo k ng w h
nd v dua s w h a d sab y a n ng cu cu a and he ac a e nc us on o hese
compe ency measu es n qua y measu emen sys ems as app op a e
5307 HHS
… B by s k ng … o he pu pose o and a ha o ows h ough hea h
ca e and nse ng o he deve opmen eva ua on and d ssem na on o
esea ch demons a on p o ec s and mode cu cu a … and o o he pu poses
de e m ned as app op a e by he Sec e a y
5307 HHS
b COLLABORAT ON n ca y ng ou subsec on a he Sec e a y sha co abo-
a e w h he en es desc bed n sec on 741 b The Sec e a y sha coo d -
na e w h cu cu a and esea ch and demons a on p o ec s …
5309 HHS
NURSE RETENT ON GRANTS a RETENT ON PR OR TY AREAS The Sec e a y may
awa d g an s o and en e n o con ac s w h e g b e en es o enhance he
nu s ng wo k o ce by n a ng and ma n a n ng nu se e en on p og ams pu su-
an o subsec on b o c
5309 HHS
b GRANTS FOR CAREER LADDER PROGRAM The Sec e a y may awa d g an s
o and en e n o con ac s w h e g b e en es o p og ams …
5309 HHS
c ENHANC NG PAT ENT CARE DEL VERY SYSTEMS 1 GRANTS —The Sec e a y
may awa d g an s o e g b e en es o mp ove he e en on o nu ses and
enhance pa en ca e
5309 HHS
2 PR OR TY … he Sec e a y sha g ve p e e ence o app can s ha have no
p ev ous y ece ved an awa d unde h s subsec on …
5309 HHS
3 CONT NUAT ON OF AN AWARD The Sec e a y sha make con nua on o any
awa d beyond he second yea o such awa d con ngen on he ec p en o
such awa d hav ng demons a ed o he Sec e a y measu ab e and subs an ve
mp ovemen n nu se e en on o pa en ca e
5309 HHS
d OTHER PR OR TY AREAS The Sec e a y may awa d g an s o o en e n o
con ac s w h e g b e en es o add ess o he a eas ha a e o h gh p o y o
nu se e en on as de e m ned by he Sec e a y
5309 HHS
e REPORT —The Sec e a y sha subm o he Cong ess be o e he end o each
fisca yea a epo on he g an s awa ded and he con ac s en e ed n o unde
h s sec on
5311 HHS
EL G BLE ND V DUAL STUDENT LOAN REPAYMENT a The Sec e a y ac ng
h ough he Adm n s a o o he Hea h Resou ces and Se v ces Adm n s a-
on may en e n o an ag eemen w h e g b e nd v dua s o he epaymen o
educa on oans
5311 HHS
c AGREEMENT PROV S ONS Ag eemen s en e ed n o pu suan o subsec on
b sha be en e ed n o on such e ms and cond ons as he Sec e a y may
de e m ne …
5311 HHS
1 … he Sec e a y sha beg n mak ng paymen s o and on beha o ha nd -
v dua on he ou s and ng p nc pa o and n e es on any oan o ha nd v dua
ob a ned o pay o such deg ee
5311 HHS
2 WA VER OR SUSPENS ON OF L AB L TY … he Sec e a y sha p ov de o
he wa ve o suspens on o ab y unde such pa ag aph comp ance by he
nd v dua w h he ag eemen nvo ved s mposs b e o wou d nvo ve ex eme
ha dsh p o he nd v dua o en o cemen o he ag eemen w h espec o he
nd v dua wou d be unconsc onab e
5311 HHS
4 AVA LAB L TY —Amoun s ecove ed sha be ava ab e o he Sec e a y o
mak ng oan epaymen s and sha ema n ava ab e o such pu pose un
expended
5313 HHS
GRANTS TO PROMOTE POS T VE HEALTH BEHAV ORS AND OUTCOMES a
GRANTS AUTHOR ZED The D ec o o he Cen e s o D sease Con o and P e-
ven on n co abo a on w h he Sec e a y sha awa d g an s o e g b e en es
o p omo e pos ve hea h behav o s and ou comes o popu a ons n med ca y
unde se ved commun es h ough he use o commun y hea h wo ke s
5313 HHS
c APPL CAT ON —Each e g b e en y ha des es o ece ve a g an sha sub-
m an app ca on o he Sec e a y a such me n such manne and accompa-
n ed by such n o ma on as he Sec e a y may equ e
5313 HHS
d PR OR TY n awa d ng g an s he Sec e a y sha g ve p o y o app can s
ha …
5313 HHS
e COLLABORAT ON W TH ACADEM C NST TUT ONS AND THE ONE-STOP DEL V-
ERY SYSTEM The Sec e a y sha encou age commun y hea h wo ke p og ams
ece v ng unds unde h s sec on o co abo a e w h academ c ns u ons
5313 HHS
g QUAL TY ASSURANCE AND COST EFFECT VENESS The Sec e a y sha
es ab sh gu de nes o assu ng he qua y o he a n ng and supe v s on o
commun y hea h wo ke s
5313 HHS
h MON TOR NG The Sec e a y sha mon o commun y hea h wo ke p og ams
den fied n app oved app ca ons unde h s sec on and sha de e m ne
whe he such p og ams a e n comp ance …
5313 HHS
TECHN CAL ASS STANCE The Sec e a y may p ov de echn ca ass s ance o
commun y hea h wo ke p og ams
5314 HHS
FELLOWSH P TRA N NG N APPL ED PUBL C HEALTH EP DEM OLOGY PUBL C
HEALTH LABORATORY SC ENCE PUBL C HEALTH NFORMAT CS AND EXPAN-
S ON OF THE EP DEM C NTELL GENCE SERV CE a The Sec e a y may ca y ou
ac v es o add ess documen ed wo k o ce sho ages n S a e and oca hea h
depa men s …
5314 HHS
b SPEC F C USES… he Sec e a y sha p ov de o he expans on o ex s -
ng e owsh p p og ams ope a ed h ough he Cen e s o D sease Con o and
P even on …
5314 HHS
c OTHER PROGRAMS The Sec e a y may p ov de o he expans on o o he
app ed ep dem o ogy a n ng p og ams ha mee ob ec ves s m a o he ob ec-
ves o he p og ams desc bed n subsec on b
5315 HHS
PART D—UN TED STATES PUBL C HEALTH SC ENCES TRACK SEC 271 ES-
TABL SHMENT a 1 He eby au ho zed o be es ab shed a U S Pub c Hea h
Sc ences T ack … a s es o be se ec ed by he Sec e a y w h au ho y o g an
app op a e advanced deg ees n a manne ha un que y emphas zes eam-
based se v ce pub c hea h ep dem o ogy and eme gency p epa edness and
esponse …
5315 HHS
b NUMBER OF GRADUATES Excep as p ov ded n subsec on a he numbe
o pe sons o be g adua ed om he T ack sha be p esc bed by he Sec e a y
Sec e a y sha ns u e ac ons necessa y o ensu e he max mum numbe o
fi s -yea en o men s
5315 HHS
c DEVELOPMENT The deve opmen o he T ack may be by such phases as he
Sec e a y may p esc be sub ec o he equ emen s o subsec on a
5315 HHS
1 Membe s o he acu y and s a sha be emp oyed unde sa a y schedu es
and g an ed e emen and o he e a ed benefi s p esc bed by he Sec e a y …
5315 HHS
… D such o he s a emen s o he gh s and ab es o he Sec e a y and o
he nd v dua no ncons s en w h he p ov s ons o h s pa
5315 HHS
e EL TE FEDERAL D SASTER TEAMS The Su geon Gene a n consu a on w h
he Sec e a y he D ec o o he Cen e s o D sease Con o and P even on
and o he app op a e m a y and Fede a gove nmen agenc es sha deve op
c e a o he appo n men o h gh y qua fied T ack acu y …
5315 HHS
Beg nn ng w h fisca yea 2010 he Sec e a y sha ans e om he Pub c
Hea h and Soc a Se v ces Eme gency Fund such sums …
5401 HHS
… he Sec e a y sha make ava ab e $12 000 000 o g an s unde subsec-
on a o hea h p o ess ons schoo s ha mee he cond ons desc bed n
subsec on c 2 A …
9007 Treasury
7 REGULATORY AUTHOR TY The Sec e a y sha ssue such egu a ons and
gu dance as may be necessa y nc ud ng gu dance e a ng o wha cons u es
easonab e e o s o de e m ne he e g b y o a pa en unde a financ a as-
s s ance po cy
9007 Treasury
c MANDATORY REV EW OF TAX EXEMPT ON FOR HOSP TALS The Sec e a y o
he T easu y o he Sec e a y s de ega e sha ev ew a eas once eve y 3 yea s
he commun y benefi ac v es o each hosp a o gan za on
9008 Treasury
2 ANNUAL PAYMENT DATE The e m annua paymen da e means w h e-
spec o any ca enda yea he da e de e m ned by he Sec e a y bu n no even
a e han Sep embe 30 o such ca enda yea
9008 Treasury
3 SECRETAR AL DETERM NAT ON The Sec e a y o he T easu y sha ca cu a e
he amoun o each cove ed en y s ee o any ca enda yea n ca cu a ng
such amoun he Sec e a y o he T easu y sha de e m ne such b anded
p esc p on d ug sa es on he bas s o subm ed epo s and h ough he use o
any o he sou ce o n o ma on ava ab e o he Sec e a y o he T easu y
HHS
2 DURAT ON A N T AT ON OF PROGRAM RESOURCES The Sec e a y sha
awa ds g an s o S a es … The Sec e a y sha deve op p og am c e a o
n a ves us ng e evan ev dence-based esea ch and esou ces …
HHS
A A p og am desc bed n h s pa ag aph s a comp ehens ve ev dence-based
w de y ava ab e and eas y access b e p og am p oposed by he S a e and ap-
p oved by he Sec e a y ha s des gned and un que y su ed o add ess he needs
o Med ca d benefic a es and has demons a ed success n he p ng nd v dua s
4108 HHS
C WA VER AUTHOR TY The Sec e a y may wa ve he equ emen s o he So-
c a Secu y Ac o a S a e awa ded a g an o conduc an n a ve and sha
ensu e ha a S a e makes any p og am ava ab e and access b e o Med ca d
benefic a es
HHS
4 APPL CAT ON Fo ow ng he deve opmen o p og am c e a by he Sec e a y
a S a e may subm an app ca on n such manne and con a n ng such n o ma-
on as he Sec e a y may equ e ha sha nc ude a p oposa o p og ams
and a p an o make Med ca d benefic a es and p ov de s pa c pa ng n Med c-
a d who es de n he S a e awa e and n o med abou such p og ams
4108 HHS
b EDUCAT ON AND OUTREACH CAMPA GN — 1 STATE AWARENESS —The
Sec e a y sha conduc an ou each and educa on campa gn o make S a es
awa e o he g an s
HHS
d EVALUAT ONS AND REPORTS — 1 NDEPENDENT ASSESSMENT —The
Sec e a y sha en e n o a con ac w h an ndependen en y o o gan za on o
conduc an eva ua on and assessmen o he n a ves ca ed ou by S a es …
HHS
2 STATE REPORT NG —A S a e awa ded a g an o ca y ou n a ves sha sub-
m epo s o he Sec e a y on a sem -annua bas s … Such epo sha nc ude
n o ma on as spec fied by he Sec e a y ega d ng
4201 HHS
COMMUN TY TRANSFORMAT ON GRANTS a The Sec e a y ac ng h ough he
D ec o o he CDC sha awa d compe ve g an s …
4201 HHS
2 subm o he D ec o an app ca on a such me n such a manne and
con a n ng such n o ma on as he D ec o may equ e nc ud ng a desc p on
o he p og am o be ca ed ou unde he g an
4201 HHS
o he ac o s as de e m ned by he Sec e a y
4201 HHS
d TRA N NG — 1 The D ec o sha deve op a p og am o p ov de a n ng
on e ec ve s a eg es o he p even on and con o o ch on c d sease and
he nk be ween phys ca emo ona and soc a we -be ng 2 COMMUN TY
echn ca ass s ance o g an ees o es ab sh commun y ans o ma on p ans 3
EVALUAT ON —The D ec o sha p ov de a e a u e ev ew and amewo k o
he eva ua on o p og ams conduc ed as pa o he g an p og am n add on
o wo k ng w h academ c ns u ons o o he en es w h expe se n ou come
4202 HHS
a HEALTHY AG NG L V NG WELL — 1 The Sec e a y ac ng h ough he D ec-
o o he CDC sha awa d g an s o S a e o oca hea h depa men s and nd an
bes o ca y ou 5-yea p o p og ams …
4202 HHS
B subm o he Sec e a y an app ca on a such me n such manne and
con a n ng such n o ma on as he Sec e a y may equ e nc ud ng a desc p on
o he p og am o be ca ed ou unde he g an
4202 HHS
any o he measu es deemed app op a e by he Sec e a y
4202 HHS
4 P LOT PROGRAM EVALUAT ON —The Sec e a y sha conduc an annua
eva ua on o he e ec veness o he p o p og am
4202 HHS
b EVALUAT ON AND PLAN FOR COMMUN TY-BASED PREVENT ON AND WELL-
NESS PROGRAMS FOR MED CARE BENEF C AR ES — 1 The Sec e a y sha
conduc an eva ua on o commun y-based p even on and we ness p og ams
and deve op a p an o p omo ng hea hy es y es and ch on c d sease se -
managemen o Med ca e benefic a es
4202 HHS
A The Sec e a y sha eva ua e commun y p even on and we ness p og ams
educe he sk o d sease d sab y and n u y by mak-
ng hea hy es y e cho ces nc ud ng exe c se d e and se -managemen o
ch on c d seases
4202 HHS
EV DENCE REV EW —The Sec e a y sha ev ew ava ab e ev dence e a u e
bes p ac ces and esou ces ha a e e evan o p og ams ha p omo e hea hy
es y es and educe sk ac o s o he Med ca e popu a on The Sec e a y may
de e m ne he scope o he ev dence ev ew and such ssues o be cons de ed
4202 HHS
NDEPENDENT EVALUAT ON OF EV DENCE-BASED COMMUN TY PREVENT ON
AND WELLNESS PROGRAMS — The Adm n s a o o CMS n consu a on w h
he Ass s an Sec e a y o Ag ng sha o he ex en eas b e and p ac cab e
conduc an eva ua on o ex s ng commun y p even on and we ness p og ams
ha a e sponso ed by he Adm n s a on on Ag ng o assess he ex en o wh ch
Med ca e benefic a es who pa c pa e n such p og ams
4202 HHS
4 FUND NG — The Sec e a y sha p ov de o he ans e om he Fede a
Hosp a nsu ance T us Fund and he Fede a Supp emen a Med ca nsu ance
T us Fund n such p opo on as he Sec e a y de e m nes app op a e o
$50 000 000 o he CMS P og am Managemen Accoun …
HHS
AUTHOR TY TO PURCHASE RECOMMENDED VACC NES FOR ADULTS — 1 The
Sec e a y may nego a e and en e n o con ac s w h manu ac u e s o vacc nes
o he pu chase and de ve y o vacc nes o adu s
5401 HHS
C amoun s app op a ed unde subsec on o a fisca yea exceed
$30 000 000 bu a e ess han $40 000 000 he Sec e a y sha make ava ab e …
5401 HHS
A … he Sec e a y may no make such a g an … un ess he cen e ag ees o
ma n a n expend u es o non-Fede a amoun s o such ac v es a a eve ha
s no ess han he eve o such expend u es ma n a ned by he cen e o he
fisca yea p eced ng he fisca yea o wh ch he schoo ece ves such a g an
5401 HHS
B USE OF FEDERAL FUNDS … he cen e sha be o e expend ng he g an
expend he Fede a amoun s ob a ned om sou ces o he han he g an un ess
g ven p o app ova om he Sec e a y
5403 HHS
AREA HEALTH EDUCAT ON CENTERS a ESTABL SHMENT OF AWARDS The
Sec e a y sha make he o ow ng 2 ypes o awa ds n acco dance w h h s
sec on 1 NFRASTRUCTURE DEVELOPMENT AWARD The Sec e a y sha make
awa ds o e g b e en es o enab e such en es o n a e hea h ca e wo k o ce
educa ona p og ams 5
5403 HHS
2 PO NT OF SERV CE MA NTENANCE AND ENHANCEMENT AWARD The Sec e-
a y sha make awa ds o e g b e en es o ma n a n and mp ove he e ec ve-
ness and capab es o an ex s ng a ea hea h educa on cen e p og am and
make o he mod fica ons o he p og am ha a e app op a e
5403 HHS
A NFRASTRUCTURE DEVELOPMENT … he Sec e a y may awa d a g an o
con ac unde subsec on a 1 o a schoo o nu s ng
5403 HHS
2 APPL CAT ON An e g b e en y des ng o ece ve an awa d unde h s sec on
sha subm o he Sec e a y an app ca on a such me n such manne and
con a n ng such n o ma on as he Sec e a y may equ e
5403 HHS
1 AREA HEALTH EDUCAT ON CENTER PROGRAM The Sec e a y sha ensu e
ha an en y ha ece ves an awa d … sha conduc a eas 10 pe cen o
c n ca educa on … n commun y se ngs ha a e emoved om he p ma y
each ng ac y … he Sec e a y sha a e na ve y ensu e ha he nu s ng
schoo conduc s a eas 10 pe cen o c n ca educa on … n commun y se -
ngs ha a e emo e om he p ma y each ng ac y … he en y ece v ng
he awa d ma n a ns a w en ag eemen
5403 HHS
2 AREA HEALTH EDUCAT ON CENTER The Sec e a y sha ensu e ha each…
p og am nc udes a eas 1 a ea hea h educa on cen e and ha each cen e s
A a pub c o p va e o gan za on … B no a schoo o med c ne o os eopa h c
med c ne … C des gna es an unde se ved a ea … D os e s ne wo k ng … E
se ves commun es … F add esses he hea h ca e wo k o ce needs … G has
5403 HHS
e MATCH NG FUNDS An en y may app y o he Sec e a y o a wa ve o no
mo e han 75 pe cen o he ma ch ng und amoun equ ed by he en y o
each o he fi s 3 yea s he en y s unded …
5403 HHS
L M TAT ON … he Sec e a y may wa ve he equ emen n he sen ence o
he fi s 2 yea s o a new a ea hea h educa on cen e p og am
5403 HHS
g AWARD … he Sec e a y may educe he pe cen e amoun p ov ded …
5403 HHS
CONT NU NG EDUCAT ONAL SUPPORT FOR HEALTH PROFESS ONALS SERV NG N
UNDERSERVED COMMUN T ES a The Sec e a y sha make g an s o and en e
n o con ac s w h e g b e en es
HHS
c APPL CAT ON —An e g b e en y des ng o ece ve an awa d unde h s
sec on sha subm o he Sec e a y an app ca on a such me n such manne
and con a n ng such n o ma on as he Sec e a y may equ e
5404 HHS
1 AUTHOR TY … and o he o gan za ons de e m ned app op a e by he Sec e-
a y…
5405 HHS
1 The Sec e a y ac ng h ough he D ec o o he Agency o Hea hca e Re-
sea ch and Qua y sha es ab sh a P ma y Ca e Ex ens on P og am
5405 HHS
1 GRANTS —The Sec e a y sha awa d compe ve g an s o S a es o he
es ab shmen o S a e- o mu s a e- eve p ma y ca e P ma y Ca e Ex ens on
P og am S a e Hubs
5405 HHS
… A subm o he Sec e a y a p an o coo d na e unc ons w h qua y m-
p ovemen o gan za ons and a ea hea h educa on cen e s such en es a e
membe s o he Hub no desc bed n subsec on b 2 A …
5405 HHS
… v pa c pa e n o he ac v es as de e m ned app op a e by he Sec e a y
5405 HHS
2 APPL CAT ONS To be e g b e o a g an unde subsec on b a S a e o mu -
s a e en y sha subm o he Sec e a y an app ca on a such me n such
manne and con a n ng such n o ma on as he Sec e a y may equ e
5405 HHS
3 EVALUAT ON A S a e ha ece ves a g an unde subsec on b sha be
eva ua ed a he end o he g an pe od by an eva ua on pane appo n ed by he
Sec e a y
5405 HHS
4 CONT NU NG SUPPORT … he S a e may ece ve add ona suppo unde h s
sec on he S a e p og am has ece ved sa s ac o y eva ua ons w h espec
o p og am pe o mance and he me s o he S a e sus a nab y p an as de e -
m ned by he Sec e a y
5405 HHS
e REQU REMENTS ON THE SECRETARY n ca y ng ou h s sec on he Sec e-
a y sha consu w h he heads o o he Fede a agenc es w h demons a ed
expe ence and expe se n hea h ca e and p even ve med c ne … as he
Sec e a y de e m nes app op a e
5501 HHS
… o whom p ma y ca e se v ces accoun ed o a eas 60 pe cen o he
a owed cha ges unde h s pa o such phys c an o p ac one n a p o
pe od as de e m ned app op a e by he Sec e a y
5501 HHS
1 n he case o ma o su g ca p ocedu es u n shed on o a e Janua y 1 2011
and be o e Janua y 1 2016 … n an a ea ha s des gna ed…as a hea h p o es-
s ona sho age a ea as den fied by he Sec e a y …
5501 HHS
c BUDGET-NEUTRAL TY ADJUSTMENT F y pe cen o he add ona expen-
d u es … as es ma ed by he Sec e a y sha be aken n o accoun … he
Sec e a y sha app y such budge -neu a y ad us men s o he conve s on ac o
o he w se de e m ned o he yea … he Sec e a y sha nc ease he ncen ve
paymen o he w se app cab e …
5502 HHS
A The Sec e a y sha deve op a p ospec ve paymen sys em o paymen o
Fede a y qua fied hea h se v ces u n shed by Fede a y qua fied hea h cen e s
5502 HHS
B COLLECT ON OF DATA AND EVALUAT ON The Sec e a y sha equ e Fede -
a y qua fied hea h cen e s o subm o he Sec e a y such n o ma on as he
Sec e a y may equ e …
5502 HHS
A … he Sec e a y sha p ov de o cos epo ng pe ods beg nn ng on o a e
Oc obe 1 2014 o paymen s o Fede a y qua fied hea h se v ces u n shed
by Fede a y qua fied hea h cen e s n acco dance w h he p ospec ve paymen
sys em deve oped by he Sec e a y
5503 HHS
… he hosp a demons a es o he Sec e a y ha has a spec fied p an
n p ace o fi ng he unused pos ons by no a e han 2 yea s a e he da e o
enac men o h s pa ag aph …
5503 HHS
The Sec e a y sha nc ease he o he w se app cab e es den m o each
qua y ng hosp a ha subm s an app ca on unde h s subpa ag aph by such
numbe as he Sec e a y may app ove The agg ega e numbe o nc eases…
sha be equa o he agg ega e educ on n such m s a bu ab e o subpa a-
g aph A as es ma ed by he Sec e a y
5503 HHS
… he numbe o u - me equ va en p ma y ca e es den s as defined n
pa ag aph 5 H as de e m ned by he Sec e a y … s no ess han he ave age
numbe o u - me equ va en p ma y ca e es den s as so de e m ned du ng
he 3 mos ecen cos epo ng pe ods…
5503 HHS
… no ess han 75 pe cen o he pos ons a bu ab e o such nc ease a e
n a p ma y ca e o gene a su ge y es dency as de e m ned by he Sec e a y
5503 HHS
… The Sec e a y may de e m ne whe he a hosp a has me he equ emen s
unde h s c ause du ng such 5-yea pe od n such manne and a such me as
he Sec e a y de e m nes app op a e nc ud ng a he end o such 5-yea pe od
9008 Treasury
g REPORT NG REQU REMENT No a e han he da e de e m ned by he Sec e-
a y o he T easu y o ow ng he end o any ca enda yea he Sec e a y o HHS
he Sec e a y o VA and he Sec e a y o De ense sha epo o he Sec e a y
o he T easu y n such manne as he Sec e a y o he T easu y p esc bes he
o a b anded p esc p on d ug sa es o each cove ed en y w h espec o each
spec fied gove nmen p og am unde such Sec e a y s u sd c on
9008 Treasury
1 MED CARE PART D PROGRAM The Sec e a y sha epo o each cove ed
en y and each b anded p esc p on d ug cove ed by he Med ca e Pa
D p og am he p oduc o A he pe -un ng ed en cos as epo ed o he
Sec e a y by p esc p on d ug p ans and Med ca e Advan age p esc p on d ug
p ans m nus any pe -un eba e d scoun o o he p ce concess on p ov ded by
he cove ed en y as epo ed o he Sec e a y by he p esc p on d ug p ans and
Med ca e Advan age p esc p on d ug p ans and B he numbe o un s o he
b anded p esc p on d ug pa d o unde he Med ca e Pa D p og am
4204 HHS
2 STATE PURCHASE —A S a e may ob a n add ona quan es o such adu
vacc nes … h ough he pu chase o vacc nes om manu ac u e s a he ap-
p cab e p ce nego a ed by he Sec e a y unde h s subsec on
4204 HHS
1 The Sec e a y ac ng h ough he D ec o o he CDC sha es ab sh a
demons a on p og am o awa d g an s o S a es o mp ove he p ov s on o ec-
ommended mmun za ons o ch d en ado escen s and adu s h ough he use
o ev dence based popu a on-based n e ven ons o h gh- sk popu a ons
4202 HHS
2 STATE PLAN —To be e g b e o a g an a S a e sha subm o he Sec e-
a y an app ca on a such me n such manne and con a n ng such n o ma-
on as he Sec e a y may equ e
4202 HHS
3 USE OF FUNDS —Funds ece ved unde a g an sha be used o mp emen
n e ven ons ha a e ecommended by he Task Fo ce on Commun y P even ve
Se v ces as es ab shed by he Sec e a y ac ng h ough he D ec o o he CDC
o o he ev dence-based n e ven ons
4202 HHS
4 CONS DERAT ON — n awa d ng g an s he Sec e a y sha cons de any e-
4205 HHS
bb a succ nc s a emen conce n ng sugges ed da y ca o c n ake as spec -
fied by he Sec e a y by egu a on and pos ed p om nen y on he menu …
4205 HHS
v MENU VAR AB L TY AND COMB NAT ON MEALS —The Sec e a y sha es ab sh
by egu a on s anda ds o de e m n ng and d sc os ng he nu en con en o
s anda d menu ems …
4205 HHS
v ADD T ONAL NFORMAT ON — he Sec e a y de e m nes ha a nu en
shou d be d sc osed o he pu pose o p ov d ng n o ma on o ass s consume s
n ma n a n ng hea hy d e a y p ac ces he Sec e a y may equ e by egu a on
d sc osu e o such nu en n he w en o m
4205 HHS
cc … such o he ood ha s pa o a cus oma y ma ke es appea ng on
he menu o ess han 90 days unde e ms and cond ons es ab shed by he
Sec e a y
4205 HHS
An au ho zed o fic a o any es au an o s m a e a ood es ab shmen o
vend ng mach ne ope a o no sub ec o he equ emen s o h s c ause may
e ec o be sub ec o he equ emen s o such c ause by eg s e ng b annua y
he name and add ess o such es au an o s m a e a ood es ab shmen o
vend ng mach ne ope a o w h he Sec e a y as spec fied by he Sec e a y by
egu a on
4205 HHS
REG STRAT ON —W h n 120 days o enac men he Sec e a y sha pub sh
a no ce n he Fede a Reg s e spec y ng he e ms and cond ons o mp e-
men a on pend ng p omu ga on o egu a ons
4205 HHS
enac men he Sec e a y sha p omu ga e p oposed egu a ons o ca y ou h s
c ause CONTENTS — n p omu ga ng egu a ons he Sec e a y sha — aa
cons de s anda d za on o ec pes and me hods o p epa a on easonab e va a-
on n se v ng s ze and o mu a on o menu ems … and o he ac o s as he
Sec e a y de e m nes and REPORT NG —The Sec e a y sha subm o he
Comm ee on Hea h Educa on Labo and Pens ons o he Sena e and he Com-
m ee on Ene gy and Comme ce o he House o Rep esen a ves a qua e y epo
ha desc bes he Sec e a y s p og ess owa d p omu ga ng fina egu a ons
4206 HHS
s DEMONSTRAT ON PROGRAM FOR ND V DUAL ZED WELLNESS PLANS — 1
The Sec e a y sha es ab sh a p o p og am o es he mpac o p ov d ng a -
sk popu a ons who u ze commun y hea h cen e s 2 AGREEMENTS —The
Sec e a y sha en e n o ag eemen s w h no mo e han 10 unded commun y
hea h cen e s o conduc ac v es unde he p o p og am
4301 HHS
a The Sec e a y ac ng h ough he D ec o o he CDC sha p ov de und ng
o esea ch n he a ea o pub c hea h se v ces and sys ems
4302 HHS
a DATA COLLECT ON — 1 The Sec e a y sha ensu e ha by no a e han 2
yea s a e enac men any ede a y conduc ed o suppo ed hea h ca e o
pub c hea h p og am ac v y o su vey … co ec s and epo s o he ex en
p ac cab e
4302 HHS
D any o he demog aph c da a as deemed app op a e by he Sec e a y
ega d ng hea h d spa es
4302 HHS
2 COLLECT ON STANDARDS — n co ec ng da a he Sec e a y o des gnee
sha
4302 HHS
3 DATA MANAGEMENT — n co ec ng da a he Sec e a y ac ng h ough he
Na ona Coo d na o o H T sha — A deve op na ona s anda ds o he man-
o da a managemen
4302 HHS
c DATA REPORT NG AND D SSEM NAT ON — 1 The Sec e a y sha make he
ana yses ava ab e o … o he en es as de e m ned app op a e by he
Sec e a y
4302 HHS
2 REPORT NG OF DATA —The Sec e a y sha epo da a and ana yses
h ough— A pub c pos ngs on webs es o HHS and B any o he epo ng
o d ssem na on mechan sms de e m ned app op a e by he Sec e a y
4302 HHS
3 AVA LAB L TY OF DATA —The Sec e a y may make da a ava ab e o
add ona esea ch ana yses and d ssem na on o o he Fede a agenc es non-
gove nmen a en es and he pub c n acco dance w h any Fede a agency s
da a use ag eemen s
5503 HHS
RED STR BUT ON OF POS T ONS F HOSP TAL NO LONGER MEETS CERTA N
REQU REMENTS Whe e he Sec e a y de e m nes ha a hosp a … does no
mee e he o he equ emen s … he Sec e a y sha educe he o he w se
app cab e es den m o he hosp a … and p ov de o he d s bu on o
pos ons a bu ab e o such educ on n acco dance w h he equ emen s
5503 HHS
C CONS DERAT ONS N RED STR BUT ON … he Sec e a y sha ake n o accoun
he demons a on ke hood o he hosp a fi ng he pos ons made ava ab e
unde h s pa ag aph w h n he fi s 3 cos epo ng pe ods beg nn ng on o a e
Ju y 1 2011 as de e m ned by he Sec e a y and whe he he hosp a has an
acc ed ed u a a n ng ack
5503 HHS
D PR OR TY FOR CERTA N AREAS … he Sec e a y sha d s bu e he nc ease
o hosp a s based on … Whe he he hosp a … has a es den - o-popu-
a on a o n he owes qua e as de e m ned by he Sec e a y Whe he
he hosp a s oca ed n an a ea ha s among he op 10 S a es e o es o
D s c s … as de e m ned by he Sec e a y
5503 HHS
E RESERVAT ON OF POS T ONS FOR CERTA N HOSP TALS … he Sec e a y
sha ese ve he pos ons ava ab e o d s bu on unde h s pa ag aph as o -
ows … n he case whe e he Sec e a y does no d s bu e pos ons o hosp a s
… he Sec e a y sha d s bu e such pos ons o o he hosp a s
5503 HHS
REFERENCE RES DENT LEVEL The e m “ e e ence es den eve ” means … he
h ghes es den eve o any o he 3 mos ecen cos epo ng pe ods … o he
hosp a o wh ch a cos epo has been se ed o no subm ed sub ec o
aud as de e m ned by he Sec e a y
5504 HHS
4 … Any hosp a c a m ng unde h s subpa ag aph o me spen n a nonp o-
v de se ng sha ma n a n and make ava ab e o he Sec e a y eco ds ega d-
ng he amoun o such me and such amoun n compa son w h amoun s o
such me n such base yea as he Sec e a y sha spec y
5505 HHS
spen by an n e n o es den n an app oved med ca es dency a n ng p og am
… as such me and ac v es a e defined by he Sec e a y sha be coun ed
owa d he de e m na on o u - me equ va ency
5505 HHS
K TREATMENT OF CERTA N OTHER ACT V T ES … a he me ha s spen by an
n e n o es den n an app oved med ca es dency a n ng p og am on vaca on
s ck eave o o he app oved eave as such me s defined by he Sec e a y …
5505 HHS
K NONPROV DER SETT NG THAT S PR MAR LY ENGAGED N FURN SH NG PA-
T ENT CARE The e m nonp ov de se ng ha s p ma y engaged n u n sh ng
pa en ca e means a nonp ov de se ng n wh ch he p ma y ac v y s he
ca e and ea men o pa en s as defined by he Sec e a y
5505 HHS
… a he me spen by an n e n o es den n an app oved med ca
es dency a n ng p og am n esea ch ac v es ha a e no assoc a ed w h
he ea men o d agnos s o a pa cu a pa en as such me and ac v es a e
defined by he Sec e a y …
5505 HHS
1 … he Sec e a y o HHS sha mp emen he amendmen s made by h s
sec on n a manne so as o app y o cos epo ng pe ods beg nn ng on o a e
Janua y 1 1983
5506 HHS
… he Sec e a y sha by egu a on es ab sh a p ocess unde wh ch … he
Sec e a y sha nc ease he o he w se app cab e es den m o o he hosp a s
n acco dance w h h s c ause
5506 HHS
PR OR TY FOR HOSP TALS N CERTA N AREAS … he Sec e a y sha d s bu e
he nc ease o hosp a s n he o ow ng p o y o de w h p e e ence g ven
w h n each ca ego y o hosp a s ha a e membe s o he same a fi a ed g oup
as defined by he Sec e a y …
5506 HHS
PER OD The Sec e a y may on y nc ease he o he w se app cab e es den m
o a hosp a unde such p ocess he Sec e a y de e m nes he hosp a has
demons a ed a ke hood o fi ng he pos ons made ava ab e unde h s c ause
w h n 3 yea s
5506 HHS
d EFFECT ON TEMPORARY FTE CAP ADJUSTMENTS The Sec e a y o HHS sha
g ve cons de a on o he e ec o he amendmen s made by h s sec on on any
empo a y ad us men o a hosp a s FTE cap… n o de o ensu e ha he e s no
dup ca on o FTE s o s …
5507 HHS & Labor
1 AUTHOR TY TO AWARD GRANTS The Sec e a y n consu a on w h he Sec-
e a y o Labo sha awa d g an s o e g b e en es o conduc demons a on
p o ec s ha a e des gned o p ov de e g b e nd v dua s w h he oppo un y o
ob a n educa on and a n ng
5507 HHS
C ASSURANCE OF OPPORTUN T ES FOR ND AN POPULAT ONS The Sec e a y
sha awa d a eas 3 g an s unde h s subsec on o an e g b e en y ha s an
nd an be ba o gan za on o T ba Co ege o Un ve s y
5507 HHS
ons a on p o ec unde h s subsec on sha subm n e m epo s o he
Sec e a y
5507 HHS
B EVALUAT ON The Sec e a y sha by g an con ac o n e agency ag ee-
men eva ua e he demons a on p o ec s conduc ed unde h s subsec on
5507 HHS
1 AUTHOR TY TO AWARD GRANTS … he Sec e a y sha awa d g an s o e g b e
en es The Sec e a y sha A eva ua e he e ficacy o he co e a n ng compe-
enc es … and B ensu e ha he numbe o hou s o a n ng … a e no ess han
he numbe o hou s o a n ng equ ed
5507 HHS
CONSULTAT ON AND COLLABORAT ON W TH COMMUN TY AND VOCAT ONAL
COLLEGES The Sec e a y sha encou age pa c pa ng S a es o consu w h
commun y and voca ona co eges
5507 HHS
S a e seek ng o pa c pa e n he p o ec sha subm an app ca on o he
Sec e a y con a n ng such n o ma on and a such me as he Sec e a y may
spec y
5507 HHS
A EVALUAT ON —The Sec e a y sha deve op an expe men a o con o
g oup es ng p o oco n consu a on w h an ndependen eva ua on con ac o
se ec ed by he Sec e a y
5507 HHS
REPORT ON N T AL MPLEMENTAT ON … he Sec e a y sha subm o
he demons a on p o ec nc ud ng … such ecommenda ons o eg s a on o
adm n s a ve ac on as he Sec e a y de e m nes app op a e
5507 HHS
F NAL REPORT … he Sec e a y sha subm o Cong ess a epo con a n ng
… oge he w h such ecommenda ons o eg s a on o adm n s a ve ac on
as he Sec e a y de e m nes app op a e
5507 HHS
A EL G BLE HEALTH AND LONG-TERM CARE PROV DER The e m e g b e hea h
and ong- e m ca e p ov de means a pe sona o home ca e agency … o any
o he hea h ca e p ov de he Sec e a y de e m nes app op a e …
5507 HHS
C PERSONAL OR HOME CARE A DE The e m pe sona o home ca e a de
means an nd v dua who he ps … e de y d sab ed o men a y d sab ed …
o ve n he own home o a es den a ca e ac y such as a nu s ng home
ass s ed v ng ac y o any o he ac y he Sec e a y de e m nes app op a e
… P an” means he benefi p an deve oped and des gna ed by he Sec e a y n ac-
HHS
1 … ou o any unds n he T easu y no o he w se app op a ed he e a e ap-
p op a ed o he Sec e a y o ca y ou …
5507 HHS
A DES … he Sec e a y sha use $5 000 000 o he amoun app op a ed unde
pa ag aph 1 o each o fisca yea s 2010 h ough 2012 o ca y ou such
p o ec s
5508 HHS
a PROGRAM AUTHOR ZED The Sec e a y may awa d g an s unde h s sec on
o each ng hea h cen e s o he pu pose o es ab sh ng new acc ed ed o
expanded p ma y ca e es dency p og ams
5508 HHS
d APPL CAT ON A each ng hea h cen e seek ng a g an unde h s sec on
sha subm an app ca on o he Sec e a y a such me n such manne and
con a n ng such n o ma on as he Sec e a y may equ e
5508 HHS
a SERV CE N FULL-T ME CL N CAL PRACT CE … each nd v dua who has en e ed
n o a w en con ac w h he Sec e a y unde sec on 338A o 338B sha p ov de
se v ce n he u me c n ca p ac ce o such nd v dua s p o ess on as a membe
o he Co ps o he pe od o ob ga ed se v ce p ov ded n such con ac
9008 HHS
Title IX: Revenue Provisions (55 Delegations)
2 MED CARE PART B PROGRAM The Sec e a y sha epo o each cove ed en-
y and o each b anded p esc p on d ug A he pe -un ave age sa es p ce
o he pe -un Pa B paymen a e o a sepa a e y pa d b anded p esc p on
d ug w hou a epo ed ave age sa es p ce and B he numbe o un s o he
b anded p esc p on d ug pa d o unde he Med ca e Pa B p og am The Cen-
e s o Med ca e and Med ca d Se v ces sha es ab sh a p ocess o de e m n ng
he un s and he a oca ed p ce o hose b anded p esc p on d ugs ha a e
no sepa a e y payab e o o wh ch Na ona D ug Codes a e no epo ed
9008 HHS
3 MED CA D PROGRAM The Sec e a y sha epo o each cove ed en y
and o each b anded p esc p on d ug o he cove ed en y cove ed unde he
Med ca d p og am
9008 VA spec o any ca enda yea he da e de e m ned by he Sec e a y bu n no even
4 DEPARTMENT OF VETERANS AFFA RS PROGRAMS The Sec e a y o VA sha
epo o each cove ed en y and o each b anded p esc p on d ug o he
cove ed en y he o a amoun pa d o each such b anded p esc p on d ug
p ocu ed by he VA
4302 HHS
e PROTECT ON AND SHAR NG OF DATA — 1 PR VACY AND OTHER SAFE-
GUARDS —The Sec e a y sha ensu e … ha — A a da a co ec ed s
p o ec ed— unde p vacy p o ec ons ha a e a eas as b oad as hose ha
he Sec e a y app es o o he hea h da a unde he egu a ons p omu ga ed
unde H PPA
4302 HHS
2 DATA SHAR NG —The Sec e a y sha es ab sh p ocedu es o sha ng da a
co ec ed measu es e a ng o such da a and ana yses o such da a w h
o he e evan Fede a and S a e agenc es nc ud ng he agenc es cen e s and
en es w h n HHS
4302 HHS
DATA ON RURAL UNDERSERVED POPULAT ONS —The Sec e a y sha ensu e
ha any da a ega d ng ac a and e hn c m no y g oups a e a so co ec ed
ega d ng unde se ved u a and on e popu a ons
4302 HHS
CONSULTAT ON —The Sec e a y sha consu w h he D ec o o OPM he
Sec e a y o De ense he Sec e a y o VA he D ec o o he Bu eau o he
Census he Comm ss one o Soc a Secu y and he head o o he app op a e
Fede a agenc es n ca y ng ou h s sec on
4302 HHS
a EVALUAT NG DATA COLLECT ON APPROACHES —The Sec e a y sha eva ua e
app oaches o he co ec on o da a ha a ow o he ongo ng accu a e and
me y co ec on and eva ua on o da a on d spa es n hea h ca e se v ces and
pe o mance n conduc ng such eva ua on he Sec e a y sha cons de he
4302 HHS
c MPLEMENT NG EFFECT VE APPROACHES —No a e han 24 mon hs a e
enac men he Sec e a y sha mp emen he app oaches o he ongo ng ac-
cu a e and me y co ec on and eva ua on o da a on hea h ca e d spa es …
4303 HHS
n o de o expand he u za on o ev dence-based p even on and hea h
p omo on app oaches n he wo kp ace he D ec o sha 1 p ov de emp oye s
nc ud ng sma med um and a ge emp oye s as de e m ned by he D ec o
w h echn ca ass s ance consu a on oo s and o he esou ces … 2 bu d
eva ua on capac y among wo kp ace s a by a n ng emp oye s on how o
eva ua e emp oye -based we ness p og ams …
4303 HHS
a … he D ec o sha conduc a na ona wo ks e hea h po c es and p og ams
su vey o assess emp oye -based hea h po c es and p og ams
4303 HHS
The Sec e a y sha eva ua e a p og ams unded h ough he CDC be o e
conduc ng such an eva ua on o p va e y unded p og ams un ess an en y w h
a p va e y unded we ness p og am eques s such an eva ua on
4304 HHS
a … he Sec e a y ac ng h ough he D ec o o he CDC sha es ab sh an
hea h depa men s as we as oca hea h depa men s and ba u sd c ons
ha mee such c e a as he D ec o de e m nes app op a e Academ c cen-
e s ha ass s S a e and e g b e oca and ba hea h depa men s may a so be
e g b e o und ng as he D ec o de e m nes app op a e
4305 HHS
a NST TUTE OF MED C NE CONFERENCE ON PA N — 1 CONVEN NG —No
a e han 1 yea a e unds a e app op a ed he Sec e a y sha seek o en e
n o an ag eemen w h OM o convene a Con e ence on Pa n
4305 HHS
1 The D ec o o N H s encou aged o con nue and expand h ough he Pa n
Conso um an agg ess ve p og am o bas c and c n ca esea ch on he causes
4305 HHS
1 ESTABL SHMENT —The Sec e a y sha es ab sh no a e han 1 yea a e
enac men and as necessa y ma n a n a comm ee o be known as he
n e agency Pa n Resea ch Coo d na ng Comm ee …
HHS
2 MEMBERSH P — A The Comm ee sha be composed o he o ow ng vo ng
membe s No mo e han 7 vo ng Fede a ep esen a ves appo n by he Sec-
e a y … B ADD T ONAL MEMBERS —The Comm ee sha nc ude add ona
vo ng membe s appo n ed by he Sec e a y as o ows … C NONVOT NG MEM-
BERS —The Comm ee sha nc ude such nonvo ng membe s as he Sec e a y
de e m nes o be app op a e
4305 HHS
a The Sec e a y may make awa ds o g an s coope a ve ag eemen s and
con ac s o hea h p o ess ons schoo s hosp ces and o he pub c and p va e
en es o he deve opmen and mp emen a on o p og ams o p ov de educa-
on and a n ng o hea h ca e p o ess ona s n pa n ca e
4305 HHS
c EVALUAT ON OF PROGRAMS —The Sec e a y sha … p ov de o he eva u-
a on o p og ams mp emen ed … n o de o de e m ne he e ec o such
p og ams on know edge and p ac ce o pa n ca e
4402 HHS
To de e m ne whe he ex s ng Fede a hea h and we ness n a ves a e e ec-
ve n ach ev ng he s a ed goa s he Sec e a y o HHS sha —
5508 HHS
B L M TAT ON The Sec e a y sha m he und ng o u - me equ va en es -
den s n o de o ensu e he d ec and nd ec paymen s as de e m ned unde
subsec on c and d …
5508 HHS
A DETERM NAT ON OF QUAL F ED TEACH NG HEALTH CENTER PER RES DENT
AMOUNT The Sec e a y sha compu e o each nd v dua qua fied each ng
hea h cen e a pe es den amoun
5508 HHS
B UPDAT NG RATE —The Sec e a y sha upda e such pe es den amoun o
each such qua fied each ng hea h cen e as de e m ned app op a e by he
Sec e a y
5508 HHS
1 The amoun de e m ned unde h s subsec on … s equa o an amoun
de e m ned app op a e by he Sec e a y
5508 HHS
2 FACTORS n de e m n ng he amoun unde pa ag aph 1 he Sec e a y
sha — A eva ua e nd ec a n ng cos s … and B based on h s eva ua-
on assu e ha he agg ega e o he paymen s … do no exceed he amoun
app op a ed o such expenses as de e m ned n subsec on g
5508 HHS
3 NTER M PAYMENT … he Sec e a y may p ov de o qua fied each ng hea h
cen e s a paymen … o expec ed nd ec expenses assoc a ed w h he ad-
d ona cos s o each ng es den s o a fisca yea based on an es ma e by he
Sec e a y
5508 HHS
RECONC L AT ON The Sec e a y sha de e m ne any changes o he numbe o
es den s epo ed by a hosp a Based on such de e m na on he Sec e a y sha
ecoup any ove paymen s made o pay any ba ance due o he ex en poss b e
5508 HHS
1 ANNUAL REPORT The epo equ ed unde h s pa ag aph o a qua fied each-
ng hea h cen e o a fisca yea s a epo ha nc udes n a o m and manne
spec fied by he Sec e a y he o ow ng n o ma on …
5508 HHS
… D o he n o ma on as deemed app op a e by he Sec e a y
5508 HHS
A AUD T AUTHOR TY The Sec e a y may aud a qua fied each ng hea h cen e
o ensu e he accu acy and comp e eness o he n o ma on
5508 HHS
B L M TAT ON ON PAYMENT A each ng hea h cen e may on y ece ve paymen
n a cos epo ng pe od o a numbe o such es den pos ons ha s g ea e
han he base eve o p ma y ca e es den pos ons as de e m ned by he
Sec e a y
5508 HHS
A The amoun … sha be educed by a eas 25 pe cen he Sec e a y
de e m nes ha he qua fied each ng hea h cen e has a ed o p ov de he
Sec e a y… he epo equ ed unde pa ag aph 1 o he p ev ous fisca yea
o such epo a s o p ov de comp e e and accu a e n o ma on …
5508 HHS
B NOT CE AND OPPORTUN TY TO PROV DE ACCURATE AND M SS NG NFORMA-
T ON … he Sec e a y sha p ov de no ce o he each ng hea h cen e o such
a u e and he Sec e a y s n en on o mpose such educ on and sha p ov de he
each ng hea h cen e w h he oppo un y o p ov de he equ ed n o ma on
5508 HHS
REGULAT ONS The Sec e a y sha p omu ga e egu a ons o ca y ou h s
sec on
5508 HHS
A pa c pa on n wh ch may be coun ed owa d ce fica on n a spec a y o
subspec a y and nc udes o ma pos g adua e a n ng p og ams n ge a c
med c ne app oved by he Sec e a y …
5509 HHS
A The Sec e a y sha es ab sh a g adua e nu se educa on demons a on
5509 HHS
B L M TAT ON W h espec o a yea he amoun e mbu sed unde subpa a-
g aph A may no exceed he amoun o cos s desc bed n subpa ag aph A …
as de e m ned by he Sec e a y
5509 HHS
3 WA VER AUTHOR TY The Sec e a y may wa ve such equ emen s o es X
and XV o he Soc a Secu y Ac as may be necessa y o ca y ou he demon-
s a on
5509 HHS
c EVALUAT ON No a e han Oc obe 17 2017 he Sec e a y sha subm o
Cong ess a epo on he demons a on
5509 HHS
1 The e s he eby app op a ed o he Sec e a y ou o any unds n he T easu y
no o he w se app op a ed $50 000 000 o each o fisca yea s 2012 h ough
2015
5509 HHS
2 PRORAT ON … he Sec e a y sha p o a e he paymen amoun s o each
e g b e hosp a n o de o ensu e ha he agg ega e paymen s do no exceed
such amoun
5509 HHS
2 APPL CABLE NON-HOSP TAL COMMUN TYBASED CARE SETT NG The e m
app cab e nonhosp a commun y-based ca e se ng means a nonhosp a
commun y-based ca e se ng … as de e m ned app op a e by he Sec e a y
5509 HHS
B WA VER OF REQU REMENT HALF OF TRA N NG BE PROV DED N NON-HOSP -
TAL COMMUN TY-BASED CARE SETT NG N CERTA N AREAS The Sec e a y may
wa ve he equ emen …
5602 HHS
a 1 The Sec e a y … sha es ab sh h ough a nego a ed u emak ng p ocess
unde subchap e 3 o chap e 5 o e 5 U S Code a comp ehens ve me hod-
o ogy and c e a o des gna on …
5602 HHS
2 FACTORS TO CONS DER … he Sec e a y A sha consu w h e evan s ake-
ho de s … B sha ake n o accoun he me y ava ab y and app op a e-
ness o da a … he mpac o he me hodo ogy and c e a … he deg ee
o ease o d ficu y ha w ace po en a app can s … v he ex en o wh ch
he me hodo ogy accu a e y measu es va ous ba e s …
5602 HHS
b PUBL CAT ON OF NOT CE … he Sec e a y sha pub sh he no ce p ov ded
o unde sec on 564 a o e 5 U S Code by no a e han 45 days a e he
da e o he enac men o h s Ac
5602 HHS
d APPO NTMENT OF NEGOT ATED RULEMAK NG COMM TTEE AND FAC L TATOR
The Sec e a y sha p ov de o 1 he appo n men o a nego a ed u emak ng
comm ee … and 2 he nom na on o a ac a o unde sec on 566 c o such
e 5 by no a e han 10 days a e he da e o appo n men o he comm ee
5602 HHS
e PREL M NARY COMM TTEE REPORT The nego a ed u emak ng comm ee…
sha epo o he Sec e a y by no a e han Ap 1 2010 ega d ng he com-
m ee s p og ess he Sec e a y may e m na e such p ocess and p ov de o
he pub ca on o a u e unde h s sec on h ough such o he me hods as he
Sec e a y may p ov de
5602 HHS
g NTER M F NAL EFFECT The Sec e a y sha pub sh a u e unde h s sec on
n he Fede a Reg s e by no a e han he a ge pub ca on da e… he Sec e-
a y sha spec y he p ocess o he me y ev ew and app ova o app ca ons
o such des gna ons pu suan o such u es and cons s en w h h s sec on
5602 HHS
h PUBL CAT ON OF RULE AFTER PUBL C COMMENT The Sec e a y sha p ov de
o cons de a on o such commen s and epub ca on o such u e by no a e
han 1 yea a e he a ge pub ca on da e
5604 HHS
b PROGRAM AUTHOR ZED The Sec e a y ac ng h ough he Adm n s a o
sha awa d g an s and coope a ve ag eemen s o e g b e en es o es ab sh
demons a on p o ec s
5604 HHS
e EVALUAT ON…an e g b e en y sha subm o he Sec e a y he esu s o
an eva ua on o be conduc ed by he en y conce n ng he e ec veness o he
ac v es ca ed ou unde he g an o ag eemen
5701 HHS
a REPORTS BY SECRETARY OF HEALTH AND HUMAN SERV CES… he Sec e a y
o HHS sha subm o he app op a e Comm ees o Cong ess a epo on he
ac v es ca ed ou unde he amendmen s made by h s e and he e ec ve-
ness o such ac v es
5701 HHS
b REPORTS BY REC P ENTS OF FUNDS The Sec e a y o HHS may equ e…
ha he en y ece v ng such awa d subm o such Sec e a y such epo s as he
Sec e a y may equ e…
9008 DoD
5 DEPARTMENT OF DEFENSE PROGRAMS AND TR CARE The Sec e a y o De-
ense sha epo o each cove ed en y and o each b anded p esc p on d ug
o he cove ed en y he sum o
9008 Treasury
GU DANCE The Sec e a y o he T easu y sha pub sh gu dance necessa y o
ca y ou he pu poses o h s sec on
9009 HHS
D any o he med ca dev ce de e m ned by he Sec e a y o be o a ype wh ch
s gene a y pu chased by he gene a pub c a e a o nd v dua use
9010 HHS
2 ANNUAL PAYMENT DATE The e m annua paymen da e means w h e-
a e han Sep embe 30 o such ca enda yea
6001
6 HHS
The hosp a has p ocedu es n p ace o equ e ha any e e ng phys c an
Title VI Transparency and Program Integrity (336 Delegations)
owne o nves o d sc oses o he pa en be ng e e ed by a me ha pe m s he
pa en o make a mean ng u dec s on ega d ng he ece p o ca e as de e m ned
by he Sec e a y
6001 HHS
2 PUBL CAT ON OF NFORMAT ON REPORTED The Sec e a y sha pub sh and
upda e on an annua bas s he n o ma on subm ed by hosp a s
6001 HHS
A PROCESS ESTABL SHMENT The Sec e a y sha es ab sh and mp emen a
p ocess unde wh ch a hosp a …may app y o an excep on om he equ emen
unde pa ag aph 1 B
6001 HHS
T M NG FOR MPLEMENTAT ON The Sec e a y sha mp emen he p ocess on
Feb ua y 1 2012 v REGULAT ONS No a e han Janua y 1 2012 he Sec e a y
sha p omu ga e egu a ons o ca y ou he p ocess unde c ause
6001 HHS
100 PERCENT NCREASE L M TAT ON The Sec e a y sha no pe m an nc ease
n he numbe o ope a ng ooms p ocedu e ooms and beds … o he ex en such
nc ease wou d esu n he numbe o ope a ng ooms p ocedu e ooms and
6001 HHS
H PUBL CAT ON OF F NAL DEC S ONS … he Sec e a y sha pub sh n he Fede a
Reg s e he fina dec s on w h espec o such app ca on
6001 HHS
6 CLAR F CAT ON No h ng n h s subsec on sha be cons ued as p even ng he
Sec e a y om evok ng a hosp a s p ov de ag eemen no n comp ance w h
egu a ons mp emen ng sec on 1866
HHS
b ENFORCEMENT 1 ENSUR NG COMPL ANCE The Sec e a y o HHS sha es ab sh
po c es and p ocedu es o ensu e comp ance w h he equ emen s … 2 AUD TS
… he Sec e a y sha conduc aud s o de e m ne hosp a s v o a e he equ e-
men s e e ed o n pa ag aph 1
6002 HHS
On Ma ch 31 2013 and on he 90 h day o each ca enda yea beg nn ng he ea e
any app cab e manu ac u e ha p ov des a paymen o o he ans e o va ue o
a cove ed ec p en o o an en y o nd v dua a he eques o o des gna ed on
beha o a cove ed ec p en sha subm o he Sec e a y n such e ec on c o m
as he Sec e a y sha equ e he o ow ng n o ma on w h espec o he p eced-
ng ca enda yea
6002 HHS
… V any o he o m o paymen o o he ans e o va ue as defined by he
Sec e a y
6002 HHS
… XV any o he na u e o he paymen o o he ans e o va ue as defined by he
Sec e a y
6002 HHS
… v Any o he ca ego es o n o ma on ega d ng he paymen o o he ans e
o va ue he Sec e a y de e m nes app op a e
6002 HHS
2 PHYS C AN OWNERSH P…sha subm o he Sec e a y n such e ec on c o m
as he Sec e a y sha equ e he o ow ng n o ma on ega d ng any owne sh p o
nves men n e es … D Any o he n o ma on ega d ng he owne sh p o nves -
men n e es he Sec e a y de e m nes app op a e
6002 HHS
c PROCEDURES FOR SUBM SS ON OF NFORMAT ON AND PUBL C AVA LAB L TY —
1 A ESTABL SHMENT he Sec e a y sha es ab sh p ocedu es o app cab e
manu ac u e s and app cab e g oup pu chas ng o gan za ons o subm n o ma-
on o he Sec e a y unde subsec on a and o he Sec e a y o make such
n o ma on subm ed ava ab e o he pub c
6002 HHS
… v con a ns any o he n o ma on he Sec e a y de e m nes wou d be he p u o
he ave age consume …
6002 HHS
2 CONSULTAT ON… he Sec e a y sha consu w h he nspec o Gene a o he
Depa men o HHS a ec ed ndus y consume s consume advoca es and o he
n e es ed pa es n o de o ensu e ha he n o ma on made ava ab e o he
pub c unde such pa ag aph s p esen ed n he app op a e ove a con ex
6002 HHS
Depa men o HHS on he mp emen a on o h s sec on
6002 HHS
e 1 APPL CABLE GROUP PURCHAS NG ORGAN ZAT ON The e m app cab e g oup
pu chas ng o gan za on means a g oup pu chas ng o gan za on as defined by he
Sec e a y ha pu chases a anges o o nego a es he pu chase o a cove ed
6003 HHS
a Sec on 1877 b 2 o he Soc a Secu y Ac 42 U S C 1395nn b 2 s amended
by add ng… Such equ emen s sha w h espec o magne c esonance
mag ng compu ed omog aphy pos on em ss on omog aphy and any o he
des gna ed hea h se v ces spec fied unde subsec on h 6 D ha he Sec e a y
de e m nes app op a e…
6004 HHS
a No a e han Ap 1 o each yea beg nn ng w h 2012 each manu ac u e and
au ho zed d s bu o o eco d o an app cab e d ug sha subm o he Sec e a y
n a o m and manne spec fied by he Sec e a y he o ow ng n o ma on w h
espec o he p eced ng yea …
6004 HHS
… B any o he ca ego y o n o ma on de e m ned app op a e by he Sec e a y
HHS
a PROV S ON OF NFORMAT ON 2 a qua fied hea h benefi s p an o e ed
h ough an exchange…sha p ov de he n o ma on desc bed n subsec on b
o he Sec e a y and n he case o a PBM o he p an w h wh ch he PBM s un-
de con ac w h a such mes and n such o m and manne as he Sec e a y
sha spec y
HHS
c CONF DENT AL TY n o ma on…sha no be d sc osed…excep ha he Sec-
e a y may d sc ose he n o ma on n a o m wh ch does no d sc ose he den y
o a spec fic PBM p an o p ces cha ged o d ugs o he o ow ng pu poses
1 As he Sec e a y de e m nes o be necessa y o ca y ou h s sec on o pa D
o e XV
6101 HHS
A … n he case whe e he Sec e a y he nspec o Gene a he S a e o he S a e
ong- e m ca e ombudsman eques s such n o ma on …
6101 HHS
3 REPORT NG A … he Sec e a y sha p omu ga e fina egu a ons equ ng…a
ac y o epo he n o ma on o he Sec e a y n a s anda d zed o ma and such
o he egu a ons as a e necessa y o ca y ou h s subsec on
6101 HHS
B GU DANCE The Sec e a y sha p ov de gu dance and echn ca ass s ance o
S a es on how o adop he s anda d zed o ma unde subpa ag aph A
6101 HHS
… v any o he pe son o en y such n o ma on as he Sec e a y de e m nes
app op a e
6101 HHS
b PUBL C AVA LAB L TY OF NFORMAT ON… he Sec e a y o HHS sha make he
n o ma on epo ed n acco dance w h such fina egu a ons ava ab e o he
pub c n acco dance w h p ocedu es es ab shed by he Sec e a y
6102 HHS
2 DEVELOPMENT OF REGULAT ONS A … he Sec e a y…sha p omu ga e egu a-
ons o an e ec ve comp ance and e h cs p og am o ope a ng o gan za ons
wh ch may nc ude a mode comp ance p og am
6102 HHS
C EVALUAT ON… he Sec e a y sha comp e e an eva ua on o he comp ance and
e h cs p og ams equ ed o be es ab shed unde h s subsec on…The Sec e a y
sha subm o Cong ess a epo and sha nc ude ecommenda ons ega d-
ng changes n he equ emen s o such p og ams as he Sec e a y de e m nes
app op a e
6102 HHS
c QUAL TY ASSURANCE AND PERFORMANCE MPROVEMENT PROGRAM 1 …
he Sec e a y sha es ab sh and mp emen a qua y assu ance and pe o mance
mp ovemen p og am… he Sec e a y sha es ab sh s anda ds e a ng o qua y
assu ance and pe o mance mp ovemen and p ov de echn ca ass s ance o ac -
es… A ac y mus subm o he Sec e a y a p an o he ac y o mee such
s anda ds and mp emen such bes p ac ces…
6102 HHS
c 2 REGULAT ONS The Sec e a y sha p omu ga e egu a ons o ca y ou h s
subsec on
6103 HHS
NURS NG HOME COMPARE WEBS TE 1 A The Sec e a y sha ensu e ha HHS
nc udes as pa o he n o ma on p ov ded o compa son o nu s ng homes…
common y e e ed o as he Nu s ng Home Compa e Med ca e webs e… he
o ow ng n o ma on …
6103 HHS
B DEADL NE FOR PROV S ON OF NFORMAT ON … he Sec e a y sha ensu e
ha he equ ed n o ma on desc bed n subpa ag aph A s nc uded…no a e
han 1 yea a e he da e o he enac men o h s subsec on The Sec e a y
sha ensu e ha he n o ma on s nc uded no a e han he da e on wh ch he
equ emen s a e mp emen ed
6103 HHS
2 REV EW AND MOD F CAT ON OF WEBS TE A The Sec e a y sha es ab sh a
p ocess o ev ew he accu acy c a y o p esen a on me ness and com-
p ehens veness o n o ma on…and no a e han 1 yea a e he da e o he
enac men o h s subsec on o mod y o evamp such webs e…
6103 HHS
B CONSULTAT ON n conduc ng he ev ew unde subpa ag aph A he Sec e-
a y sha consu w h S a e ong- e m ca e ombudsman p og ams consume
advocacy g oups p ov de s akeho de g oups and v any o he ep esen a-
ves o p og ams o g oups he Sec e a y de e m nes app op a e
6103 HHS
E SUBM SS ON OF SURVEY AND CERT F CAT ON NFORMAT ON TO THE SECRE-
TARY…each S a e sha subm n o ma on… o he Sec e a y no a e han he
da e on wh ch he S a e sends such n o ma on o he ac y The Sec e a y sha
use he n o ma on subm ed unde he p eced ng sen ence o upda e he n o ma-
on p ov ded on he Nu s ng Home Compa e Med ca e webs e
6103 HHS
8 SPEC AL FOCUS FAC L TY PROGRAM A The Sec e a y sha conduc a spec a
ocus ac y p og am o en o cemen o equ emen s o sk ed nu s ng ac es
ha he Sec e a y has den fied as hav ng subs an a y a ed o mee app cab e
equ emen o h s Ac
6103 HHS
d GU DANCE TO STATES ON FORM 2567… 1 GU DANCE The Sec e a y sha
p ov de gu dance o S a es on how S a es can es ab sh e ec on c nks o Fo m
2567 S a e nspec on epo s…and he Sec e a y sha poss b e nc ude such
n o ma on on Nu s ng Home Compa e
7
7002 HHS 7002
DETERM NAT ON BY SECRETARY The Sec e a y may de e m ne n he Sec-
e a y s d sc e on ha an e emen desc bed e sewhe e s unnecessa y n a
subm ed app ca on
7002 HHS ava ab e ha he Sec e a y w use o de e m ne whe he a b o og ca p oduc
3 EVALUAT ON BY SECRETARY Upon ev ew o an app ca on o a supp emen
o an app ca on he Sec e a y sha cense he b o og ca p oduc A he
Sec e a y de e m nes ha he n o ma on subm ed n he app ca on o he
supp emen s su fic en o show ha he b o og ca p oduc s b os m a o he
e e ence p oduc o mee s he s anda ds desc bed e sewhe e and he e o e
s n e changeab e w h he e e ence p oduc and B he app can o o he ap-
p op a e pe son consen s o he nspec on o he ac y
7002 HHS Sec e a y no fies he app can ha he app ca on has been accep ed o ev ew
4 SAFETY STANDARDS FOR DETERM N NG NTERCHANGEAB L TY Upon ev ew
o an app ca on he Sec e a y sha de e m ne he b o og ca p oduc o be
n e changeab e w h he e e ence p oduc he Sec e a y de e m nes ha he
n o ma on subm ed n he app ca on o a supp emen o such app ca on s
su fic en o show ha
7002 HHS no ce o a comp a n ece ved unde c ause
C R SK EVALUAT ON AND M T GAT ON STRATEG ES The au ho y o he Sec e a y
w h espec o sk eva ua on and m ga on s a eg es unde he Fede a Food
D ug and Cosme c Ac sha app y o b o og ca p oduc s s ed
7002 HHS b os m a b o og ca p oduc app ca ons o he fi s 5 fisca yea s a e fisca
7 EXCLUS V TY FOR REFERENCE PRODUCT A EFFECT VE DATE OF B OS M LAR
APPL CAT ON APPROVAL App ova o an app ca on may no be made e ec ve
by he Sec e a y un 12 yea s a e he e e ence p oduc was fi s censed
7002 HHS ndus y he Sec e a y sha p esen he ecommenda ons o he spec fied
8 GU DANCE DOCUMENTS A The Sec e a y may a e oppo un y o pub c
commen ssue gu dance w h espec o he censu e o a b o og ca p oduc
B PUBL C COMMENT The Sec e a y sha p ov de he pub c an oppo un y
o commen on any p oposed gu dance be o e ssu ng fina gu dance NPUT
REGARD NG MOST VALUABLE GU DANCE The Sec e a y sha es ab sh a p ocess
h ough wh ch he pub c may p ov de he Sec e a y w h npu ega d ng p o es
o ssu ng gu dance
8
8002 HHS
5 EL G B L TY ASSESSMENT SYSTEM —The e m “E g b y Assessmen Sys em”
means he en y es ab shed by he Sec e a y o make unc ona e g b y de e -
m na ons o he CLASS p og am
8002 HHS
C REGULAT ONS The Sec e a y sha p omu ga e egu a ons spec y ng excep ons
o he m n mum ea n ngs equ emen s o be cons de ed e g b e
8002 HHS
9 CLASS NDEPENDENCE BENEF T PLAN The e m “CLASS ndependence Benefi
co dance w h sec on 3203
8002 HHS
a PROCESS FOR DEVELOPMENT 1 The Sec e a y n consu a on w h app op a e
ac ua es and o he expe s sha deve op a eas 3 ac ua a y sound benefi p ans
as a e na ves o cons de a on o des gna on by he Sec e a y as he CLASS
ndependence Benefi P an
8002 HHS
A PREM UMS Beg nn ng w h he fi s yea o he CLASS p og am and o each
yea he ea e he Sec e a y sha es ab sh a p em ums o be pa d by en o ees
o he yea based on an ac ua a ana ys s o he 75-yea cos s o he p og am ha
ensu es so vency h oughou such 75-yea pe od
8002 HHS
NOM NAL PREM UM FOR POOREST ND V DUALS AND FULL-T ME STUDENTS
The mon h y p em um o en o men n he CLASS p og am sha no exceed he
app cab e do a amoun pe mon h de e m ned o aa any nd v dua whose
ncome does no exceed he pove y ne and bb any nd v dua who has no a -
a ned age 22 and s ac ve y emp oyed du ng any pe od n wh ch he nd v dua s
a u - me s uden as de e m ned by he Sec e a y
8002 HHS
CLASS NDEPENDENCE FUND RESERVES Once CLASS has been n ope a on
o 10 yea s he Sec e a y sha es ab sh a p em ums o be pa d by en o ees o
he yea based on an ac ua a ana ys s ha accumu a ed ese ves n he CLASS
ndependence Fund wou d no dec ease n ha yea A such me as he Sec e-
a y de e m nes he CLASS p og am demons a es a sus a ned ab y o finance
expec ed yea y expenses w h expec ed yea y p em ums and n e es c ed ed o
he CLASS ndependence Fund he Sec e a y may dec ease he equ ed amoun o
CLASS ndependence Fund ese ves
9010 Treasury
3 SECRETAR AL DETERM NAT ON The Sec e a y sha ca cu a e he amoun o
each cove ed en y s ee o any ca enda yea n ca cu a ng such amoun he
Sec e a y sha de e m ne such cove ed en y s ne p em ums w en w h espec
o any U S hea h sk on he bas s o epo s subm ed by he cove ed en y
and h ough he use o any o he sou ce o n o ma on ava ab e o he Sec e a y
9010 Treasury
1 No a e han he da e de e m ned by he Sec e a y o ow ng he end o any
ca enda yea each cove ed en y sha epo o he Sec e a y n such man-
ne as he Sec e a y p esc bes he cove ed en y s ne p em ums w en w h
espec o hea h nsu ance o any U S hea h sk o such ca enda yea
9010 Treasury
he amoun o he cove ed en y s ee o he ca enda yea he Sec e a y
de e m nes shou d have been pa d n he absence o any such unde s a emen
ove he amoun o such ee he Sec e a y de e m ned based on such unde -
s a emen
9010 Treasury
GU DANCE The Sec e a y sha pub sh gu dance and sha p esc be such
egu a ons as a e necessa y o app op a e ega d ng h s sec on
6103 HHS
… D ha he S a e ma n a n a consume -o en ed webs e p ov d ng use u
n o ma on o consume s ega d ng a sk ed nu s ng ac es and a nu s ng
ac es n he S a e… ha he S a e o he Sec e a y cons de s use u n ass s ng
he pub c…
6103 HHS
e DEVELOPMENT OF CONSUMER R GHTS NFORMAT ON PAGE ON NURS NG HOME
COMPARE WEBS TE… he Sec e a y sha ensu e ha … he Nu s ng Home Compa e
Med ca e webs e deve ops and nc udes a consume gh s n o ma on page…
6104 HHS
2 MOD F CAT ON OF FORM The Sec e a y n consu a on w h p va e sec o
accoun an s expe enced w h Med ca e and Med ca d nu s ng ac y home cos
epo s sha edes gn such epo s o mee he equ emen o pa ag aph 1
6104 HHS
3 CATEGOR ZAT ON BY FUNCT ONAL ACCOUNTS he Sec e a y wo k ng n
consu a on w h MedPAC he Med ca d and CH P Paymen and Access Comm s-
s on he HHS nspec o Gene a and o he expe pa es he Sec e a y de e m nes
app op a e sha ake he expend u es s ed on cos epo s… n o he o ow ng
unc ona accoun s on an annua bas s
6104 HHS
4 AVA LAB L TY OF NFORMAT ON SUBM TTED The Sec e a y sha es ab sh p oce-
du es o make n o ma on on expend u es subm ed unde h s subsec on ead y
ava ab e o n e es ed pa es upon eques sub ec o such equ emen s as he
Sec e a y may spec y unde he es ab shed p ocedu es unde h s pa ag aph
6105 HHS
STANDARD ZED COMPLA NT FORM 1 The Sec e a y sha deve op a s anda d-
zed comp a n o m o use by a es den … n fi ng a comp a n w h a S a e su vey
and ce fica on agency and a S a e ong- e m ca e ombudsman p og am w h
espec o a ac y
6106 HHS
g SUBM SS ON OF STAFF NG NFORMAT ON BASED ON PAYROLL DATA N A UN -
FORM FORMAT a e consu ng w h … pa es he Sec e a y deems app op -
a e he Sec e a y sha equ e a ac y o e ec on ca y subm o he Sec e a y
d ec ca e s a fing n o ma on…acco d ng o spec fica ons es ab shed by he
Sec e a y…
6106 HHS
No h ng n h s subsec on sha be cons ued as p even ng he Sec e a y om
equ ng subm ss on o such n o ma on w h espec o spec fic ca ego es such
as nu s ng s a be o e o he ca ego es o ce fied emp oyees
6111 HHS
REDUCT ON OF C V L MONEY PENALT ES N CERTA N C RCUMSTANCES… he
Sec e a y may educe he amoun o he pena y mposed by no mo e han 50
pe cen
6111 HHS
V COLLECT ON OF C V L MONEY PENALT ES — n he case o a c v money pen-
a y mposed unde h s c ause he Sec e a y sha ssue egu a ons…
6111 HHS
… cc may p ov de o he co ec on o such c v money pena y and he p ace-
men o such amoun s co ec ed n an esc ow accoun unde he d ec on o he
Sec e a y…
6111 HHS
… ac y mp ovemen n a ves app oved by he Sec e a y nc ud ng o n
a n ng o ac y s a and su veyo s echn ca ass s ance o ac es mp emen -
ng qua y assu ance p og ams he appo n men o empo a y managemen fi ms
and o he ac v es app oved by he Sec e a y
6112 HHS
a ESTABL SHMENT 1 The Sec e a y…sha conduc a demons a on p o ec o
deve op es and mp emen an ndependen mon o p og am o ove see n e s a e
and a ge n as a e cha ns o sk ed nu s ng ac es and nu s ng ac es
6112 HHS
2 SELECT ON The Sec e a y sha se ec cha ns o sk ed nu s ng ac es and
nu s ng ac es… om among hose cha ns ha subm an app ca on o he
Sec e a y a such me n such manne and con a n ng such n o ma on as he
Sec e a y may equ e
6112 HHS
3 DURAT ON The Sec e a y sha conduc he demons a on p o ec unde h s
sec on o a 2-yea pe od
6112 HHS
4 MPLEMENTAT ON The Sec e a y sha mp emen he demons a on p o ec
unde h s sec on no a e han 1 yea a e he da e o he enac men o h s Ac
6112 HHS
b REQU REMENTS The Sec e a y sha eva ua e cha ns se ec ed o pa c pa e
n he demons a on p o ec unde h s sec on based on c e a se ec ed by he
Sec e a y
6112 HHS
c RESPONS B L T ES An ndependen mon o ha en e s n o a con ac w h he
Sec e a y o pa c pa e n he conduc o he demons a on p o ec unde h s sec-
on sha …
6112 HHS
e COST OF APPO NTMENT…The cha n sha pay such po on o he Sec e a y n
an amoun and n acco dance w h p ocedu es es ab shed by he Sec e a y
6112 HHS
WA VER AUTHOR TY The Sec e a y may wa ve such equ emen s o es XV
and X X o he Soc a Secu y Ac
6112 HHS
1 EVALUAT ON The Sec e a y n consu a on w h he nspec o Gene a o he
Depa men o HHS sha eva ua e he demons a on p o ec conduc ed unde h s
sec on
6113 HHS
… h NOT F CAT ON OF FAC L TY CLOSURE 1 A n he case o a ac y whe e
he Sec e a y e m na es he ac y s pa c pa on unde h s e no a e han he
da e ha he Sec e a y de e m nes app op a e …
6113 HHS
B CONT NUAT ON OF PAYMENTS UNT L RES DENTS RELOCATED The Sec e a y
may as he Sec e a y de e m nes app op a e con nue o make paymen s unde
h s e w h espec o es den s o a ac y ha has subm ed a no fica on
6114 HHS
a The Sec e a y sha conduc 2 demons a on p o ec s 1 o he deve opmen o
bes p ac ces n sk ed nu s ng ac es and nu s ng ac es ha a e nvo ved n
he cu u e change movemen and 1 o he…use o T o mp ove es den ca e
6114 HHS
b CONDUCT OF DEMONSTRAT ON PROJECTS 1 … he Sec e a y sha awa d
desc bed n subsec on a w h espec o he demons a on p o ec nvo ved
6121 HHS
a SK LLED NURS NG FAC L T ES 1 Sec on 1819 2 A o he Soc a Secu y
Ac 42 U S C 1395 –3 2 A s amended by nse ng nc ud ng n he case
a n ng demen a managemen a n ng and pa en abuse p even on a n ng
be o e
6121 HHS
o he Soc a Secu y Ac
42 U S C 1396 2 A s amended by nse ng nc ud ng n he case o
n a a n ng and he Sec e a y de e m nes app op a e n he case o ongo ng
a n ng demen a managemen a n ng and pa en abuse p even on a n ng
be o e
6201 HHS
a The Sec e a y sha es ab sh a p og am o den y e fic en e ec ve and eco-
nom ca p ocedu es o ong e m ca e ac es o p ov de s o conduc backg ound
checks on p ospec ve d ec pa en access emp oyees on a na onw de bas s
6201 HHS
1 AGREEMENTS A NEWLY PART C PAT NG STATES The Sec e a y sha en e
n o ag eemen s w h each S a e… ha subm s an app ca on o he Sec e a y
con a n ng such n o ma on and a such me as he Sec e a y may spec y
6201 HHS
B CERTA N PREV OUSLY PART C PAT NG STATES —The Sec e a y sha en e n o
ag eemen s w h each S a e… ha subm s an app ca on o he Sec e a y
con a n ng such n o ma on and a such me as he Sec e a y may spec y
6201 HHS
… A equ e ha he ong- e m ca e ac y o p ov de o he des gna ed agen
o he ong- e m ca e ac y o p ov de ob a n S a e and na ona c m na h s o y
backg ound checks on he p ospec ve emp oyee h ough such means as he
Sec e a y de e m nes app op a e…
6201 HHS
C … equ e ha c m na h s o y backg ound checks conduc ed unde he na on-
w de p og am ema n va d o a pe od o me spec fied by he Sec e a y
6201 HHS
v A es den a ca e p ov de ha a anges o o d ec y p ov des ong- e m ca e
se v ces nc ud ng an ass s ed v ng ac y ha p ov des a eve o ca e es ab shed
by he Sec e a y
6301 HHS
3 DATA COLLECT ON A The Sec e a y sha w h app op a e sa egua ds o
p vacy make ava ab e o he Pa en -Cen e ed Ou comes Resea ch ns u e such
da a co ec ed by CMS…
6301 HHS
a 1 D SSEM NAT ON The O fice o Commun ca on and Know edge T ans e …
a he Agency o Hea hca e Resea ch and Qua y…sha b oad y d ssem na e he
esea ch find ngs ha a e pub shed by he Pa en Cen e ed Ou comes Resea ch
ns u e The O fice sha c ea e n o ma ona oo s ha o gan ze and d ssem na e
esea ch find ngs
6301 HHS
a 1 …The O fice sha a so deve op a pub c y ava ab e esou ce da abase ha co -
ec s and con a ns gove nmen - unded ev dence and esea ch om pub c p va e
no - o p ofi and academ c sou ces
6301 HHS
2 REQU REMENTS The O fice sha p ov de o he d ssem na on o he ns u e s
esea ch find ngs and gove nmen - unded esea ch e evan o compa a ve c n ca
e ec veness esea ch…
6301 HHS
b NCORPORAT ON OF RESEARCH F ND NGS —The O fice…sha ass s use s o
hea h n o ma on echno ogy ocused on c n ca dec s on suppo o p omo e he
me y nco po a on o esea ch find ngs… n o c n ca p ac ces and o p omo e he
ease o use o such nco po a on
6301 HHS
c FEEDBACK The O fice sha es ab sh a p ocess o ece ve eedback om phys -
c ans hea h ca e p ov de s pa en s and vendo s o hea h n o ma on echno -
ogy…abou he va ue o he n o ma on d ssem na ed and he ass s ance p ov ded
unde h s sec on
6301 HHS
e TRA N NG OF RESEARCHERS The Agency o Hea h Ca e Resea ch and Qua y
n consu a on w h he N H sha bu d capac y o compa a ve c n ca e ec ve-
ness esea ch by es ab sh ng a g an p og am ha p ov des o he a n ng o
esea che s n he me hods used o conduc such esea ch…
Title VII: Access to Medical Therapies (50 Delegations)
HHS 7002
D REQU REMENT FOR PRODUCT CLASS-SPEC F C GU DANCE he Sec e a y s-
sues p oduc c ass-spec fic gu dance such gu dance sha nc ude a desc p on o
he c e a ha he Sec e a y w use o de e m ne whe he a b o og ca p oduc
s h gh y s m a o a e e ence p oduc n such p oduc c ass and he c e a
mee s he s anda ds E CERTA N PRODUCT CLASSES GU DANCE The Sec e-
a y may nd ca e ha he sc ence and expe ence does no a ow app ova o
an app ca on o a cense o such p oduc o p oduc c ass MOD F CAT ON
OR REVERSAL The Sec e a y may ssue a subsequen gu dance documen o as demons a ed n such manne as he Sec e a y de e m nes app op a e has
mod y o eve se a gu dance documen
7002 HHS 7002
2 SUBSECT ON k APPL CAT ON NFORMAT ON No a e han 20 days a e he
he app can A sha p ov de o he e e ence p oduc sponso a copy o he
app ca on subm ed o he Sec e a y and such o he n o ma on ha desc bes
he p ocess used o manu ac u e he b o og ca p oduc
7002 HHS ALTERAT ON OF USER FEE he aud pe o med nd ca es ha he a os
PUBL CAT ON BY SECRETARY The Sec e a y sha pub sh n he Fede a Reg s e
7002 HHS
A Beg nn ng no a e han Oc obe 1 2010 he Sec e a y sha deve op ecom-
menda ons o p esen o Cong ess w h espec o he goa s o he ev ew o
yea 2012 n deve op ng such ecommenda ons he Sec e a y sha consu w h
7002 HHS a new b o og ca p oduc n he ped a c popu a on may p oduce hea h benefi s
B PUBL C REV EW OF RECOMMENDAT ONS A e nego a ons w h he egu a ed
Cong ess ona comm ees pub sh such ecommenda ons n he Fede a Reg-
se p ov de o a pe od o 30 days o he pub c o p ov de w en commen s
on such ecommenda ons v ho d a mee ng a wh ch he pub c may p esen s
v ews on such ecommenda ons and v a e cons de a on o such pub c v ews
and commen s ev se such ecommenda ons as necessa y
Title VIII: Long-Term Care CLASS Act (59 Delegations)
8002 HHS
The nd v dua s de e m ned o be unab e o pe o m a eas he m n mum
numbe o ac v es o da y v ng as a e equ ed unde he p an o he p ov s on
o benefi s w hou subs an a ass s ance as defined by he Sec e a y om ano he
nd v dua The nd v dua equ es subs an a supe v s on o p o ec he nd v dua
om h ea s o hea h and sa e y due o subs an a cogn ve mpa men The
nd v dua has a eve o unc ona m a on s m a as de e m ned unde egu a-
ons p esc bed by he Sec e a y o he eve o unc ona m a on
8002 HHS
3 DES GNAT ON BY THE SECRETARY No a e han Oc obe 1 2012 he Sec e-
a y ak ng n o cons de a on he ecommenda on o he CLASS ndependence
Adv so y Counc sha des gna e a benefi p an as he CLASS ndependence
Benefi P an The Sec e a y sha pub sh such des gna on a ong w h de a s o
he p an and he easons o he se ec on by he Sec e a y n a fina u e w h a
pe od o pub c commen
8002 HHS
he Sec e a y de e m nes based on he mos ecen epo o he Boa d o
T us ees o he CLASS ndependence Fund he adv ce o he CLASS ndependence
Adv so y Counc and he annua epo o he nspec o Gene a o HSS and was e
aud and abuse o such o he n o ma on as he Sec e a y de e m nes app op -
a e ha he mon h y p em ums and ncome o he CLASS ndependence Fund o
a yea a e p o ec ed o be nsu fic en o he o hcom ng 20 yea s he Sec e a y
sha ad us he mon h y p em ums o en o ed nd v dua s as necessa y
8002 HHS
an amoun ha he Sec e a y de e m nes s ac ua a y sound o each
mon h ha occu s du ng he pe od ha beg ns w h he fi s mon h o wh ch he
nd v dua a ed o pay he mon h y p em um equ ed o ma n a n he nd v dua s
en o men n he CLASS p og am and ends w h he mon h p eced ng he mon h n
wh ch he eeno men s e ec ve
8002 HHS
2 ADM N STRAT VE EXPENSES n de e m n ng he mon h y p em ums o he
CLASS p og am he Sec e a y may ac o n adm n s a ve cos s no o exceed
an amoun equa o 3 pe cen o a p em ums pa d du ng he yea
9014 Treasury
H REGULATORY AUTHOR TY The Sec e a y may p esc be such gu dance u es
o egu a ons as a e necessa y o ca y ou he pu poses o h s pa ag aph
9023 Labor
who a e cove ed unde an ag eemen wh ch he Sec e a y o Labo finds
o be a co ec ve ba ga n ng ag eemen he e s ev dence ha he benefi s cov-
e ed unde he ca e e a p an we e he sub ec o good a h ba ga n ng be ween
emp oyee ep esen a ves and he emp oye
9023 Treasury
2 L M TAT ON The amoun wh ch s ea ed as qua fied nves men o a ax-
ab e yea s w h espec o any qua y ng he apeu c d scove y p o ec sha no
exceed he amoun ce fied by he Sec e a y as e g b e o he c ed
9023 Treasury
E o any o he expense as de e m ned by he Sec e a y as app op a e o
ca y ou he pu poses o h s sec on
6301 HHS
BU LD NG DATA FOR RESEARCH The Sec e a y sha p ov de o he coo d na on
o e evan Fede a hea h p og ams o bu d da a capac y o compa a ve c n ca
e ec veness esea ch nc ud ng he deve opmen and use o c n ca eg s es
and hea h ou comes esea ch da a ne wo ks n o de o deve op and ma n a n a
comp ehens ve n e ope ab e da a ne wo k o co ec nk and ana yze da a on ou -
comes and e ec veness om mu p e sou ces nc ud ng e ec on c hea h eco ds
6301 HHS
c The Sec e a y may on y use ev dence and find ngs om esea ch conduc ed
unde sec on 1181 o make a de e m na on ega d ng cove age unde e XV
such use s h ough an e a ve and anspa en p ocess wh ch nc udes pub c
commen and cons de s he e ec on subpopu a ons
6301 HHS
b No h ng n sec on 1181 sha be cons ued as 1 supe ced ng o mod y ng he
cove age o ems o se v ces unde e XV ha he Sec e a y de e m nes a e ea-
sonab e and necessa y unde sec on 1862 1 o 2 au ho z ng he Sec e a y o
deny cove age o ems o se v ces unde such e so e y on he bas s o compa a-
ve c n ca e ec veness esea ch
6301 HHS
c 2 Pa ag aph 1 sha no be cons ued as p even ng he Sec e a y om
us ng ev dence o find ngs om such compa a ve c n ca e ec veness esea ch
n de e m n ng cove age e mbu semen o ncen ve p og ams unde e XV
based upon a compa son o he d e ence n he e ec veness o a e na ve
ea men s n ex end ng an nd v dua s e due o he nd v dua s age d sab y
o e m na ness
6301 HHS
2 A Pa ag aph 1 sha no be cons ued o p even he Sec e a y om us ng
ev dence o find ngs om such compa a ve c n ca e ec veness esea ch n
de e m n ng cove age e mbu semen o ncen ve p og ams unde such e based
upon a compa son o he d e ence n he e ec veness o a e na ve hea h ca e
ea men s n ex end ng an nd v dua s e due o ha nd v dua s age d sab y o
e m na ness
6301 HHS
a The Sec e a y sha p ov de o he ans e om he Fede a Hosp a nsu ance
T us Fund… n p opo on as es ma ed by he Sec e a y o he o a expend u es
du ng such fisca yea ha a e made unde e XV om he espec ve us und
o he Pa en -Cen e ed Ou comes Resea ch T us Fund…
6301 HHS
C REQU REMENTS… he Sec e a y o HHS sha d s bu e 80 pe cen o he
O fice o Commun ca on and Know edge T ans e o AHRQ… and 20 pe cen o
he Sec e a y o ca y ou he desc bed ac v es n such sec on 937
6401 HHS
2 PROV DER SCREEN NG A PROCEDURES… he Sec e a y n consu a on w h
he HHS nspec o Gene a sha es ab sh p ocedu es unde wh ch sc een ng s
conduc ed w h espec o p ov de s o med ca o o he ems o se v ces and sup-
p e s unde he p og am unde h s e he Med ca d p og am unde e X X and
he CH P p og am unde e XX
6401 HHS
B LEVEL OF SCREEN NG The Sec e a y sha de e m ne he eve o sc een ng
conduc ed unde h s pa ag aph acco d ng o he sk o aud was e and abuse as
de e m ned by he Sec e a y Such sc een ng sha nc ude a censu e check…
and may as he Sec e a y de e m nes app op a e based on he sk o aud
was e and abuse desc bed n he p eced ng sen ence nc ude …and V such
o he sc een ng as he Sec e a y de e m nes app op a e
6401 HHS
C APPL CAT ON FEES NST TUT ONAL PROV DERS… he Sec e a y sha mpose
a ee on each ns u ona p ov de o med ca o o he ems o se v ces o supp e
such as a hosp a o sk ed nu s ng ac y w h espec o wh ch sc een ng s
conduc ed unde h s pa ag aph…
6401 HHS
HARDSH P EXCEPT ON WA VER FOR CERTA N MED CA D PROV DERS The Sec e-
a y may on a case by- case bas s exemp a p ov de o med ca o o he ems o
se v ces o supp e om he mpos on o an app ca on ee unde h s subpa a-
g aph he Sec e a y de e m nes ha he mpos on o he app ca on ee wou d
esu n a ha dsh p… o he ee wou d mpede benefic a y access o ca e
6401 HHS
USE OF FUNDS Amoun s co ec ed as a esu o he mpos on o a ee unde
h s subpa ag aph sha be used by he Sec e a y o p og am n eg y e o s
nc ud ng o cove he cos s o conduc ng sc een ng unde h s pa ag aph and o
ca y ou h s subsec on and sec on 1128J
6401 HHS
E EXPED TED RULEMAK NG The Sec e a y may p omu ga e an n e m fina u e o
ca y ou h s pa ag aph
6401 HHS
3 PROV S ONAL PER OD OF ENHANCED OVERS GHT FOR NEW PROV DERS OF
SERV CES AND SUPPL ERS A The Sec e a y sha es ab sh p ocedu es…wh ch
new p ov de s o med ca o o he ems o se v ces and supp e s as he Sec e a y
de e m nes app op a e…wou d be sub ec o enhanced ove s gh … B MPLE-
MENTAT ON The Sec e a y may es ab sh by p og am ns uc on o o he w se he
p ocedu es unde h s pa ag aph
6401 HHS
4 90-DAY PER OD OF ENHANCED OVERS GHT FOR N T AL CLA MS OF DME SUP-
PL ERS As added by sec on 1304 o HCERA … he Sec e a y de e m nes ha
he e s a s gn fican sk o audu en ac v y… he Sec e a y sha no w hs and ng
sec ons 1816 c 1842 c and 1869 a 2 w hho d paymen unde such e w h
espec o du ab e med ca equ pmen u n shed by such supp e …
6401 HHS
5 NCREASED D SCLOSURE REQU REMENTS A D SCLOSURE A p ov de o med -
ca o o he ems o se v ces o supp e …sha d sc ose n a o m and manne and
a such me as de e m ned by he Sec e a y any cu en o p ev ous a fi a on d -
ec y o nd ec y w h a p ov de o med ca o o he ems o se v ces o supp e
ha has unco ec ed deb has been o s sub ec o a paymen suspens on unde a
Fede a hea h ca e p og am…
6401 HHS
5 B AUTHOR TY TO DENY ENROLLMENT he Sec e a y de e m nes ha such
p ev ous a fi a on poses an undue sk o aud was e o abuse he Sec e a y may
deny such app ca on
6401 HHS
A … he Sec e a y may make any necessa y ad us men s o paymen s o he ap-
p cab e p ov de o se v ces o supp e unde he p og am unde h s e n o de
o sa s y any pas -due ob ga ons desc bed n subpa ag aph B o an ob ga ed
p ov de o se v ces o supp e
6401 HHS
OBL GATED PROV DER OF SERV CES OR SUPPL ER The e m ob ga ed p ov de
o se v ces o supp e means a p ov de o se v ces o supp e ha owes a pas -
due ob ga on unde he p og am unde h s e as de e m ned by he Sec e a y
6401 HHS
6 TEMPORARY MORATOR UM ON ENROLLMENT OF NEW PROV DERS A The Sec-
e a y may mpose a empo a y mo a o um on he en o men o new p ov de s o
o p even o comba aud was e o abuse unde e he such p og am
6401 HHS
8 COMPL ANCE PROGRAMS A On o a e he da e o mp emen a on de e -
m ned by he Sec e a y unde subpa ag aph C a p ov de o med ca o o he
ems o se v ces…sha as a cond on o en o men n he p og am…es ab-
sh a comp ance p og am ha con a ns he co e e emen s es ab shed unde
subpa ag aph B
6401 HHS
B ESTABL SHMENT OF CORE ELEMENTS The Sec e a y n consu a on w h he
HHS nspec o Gene a sha es ab sh co e e emen s o a comp ance p og am
unde subpa ag aph A o p ov de s o supp e s w h n a pa cu a ndus y o
ca ego y
6401 HHS
C T MEL NE FOR MPLEMENTAT ON The Sec e a y sha de e m ne he me ne
o he es ab shmen o he co e e emen s…and he da e o he mp emen a-
on The Sec e a y sha n de e m n ng such da e o mp emen a on cons de
he ex en o wh ch he adop on o comp ance p og ams… s w desp ead n a
pa cu a ndus y sec o
6401 HHS
PROV DER AND SUPPL ER SCREEN NG OVERS GHT AND REPORT NG REQU RE-
MENTS 1 SCREEN NG The S a e comp es w h he p ocess o sc een ng
p ov de s and supp e s unde h s e as es ab shed by he Sec e a y…The S a e
comp es w h p ocedu es o p ov de o a p ov s ona pe od o enhanced ove s gh
o new p ov de s and supp e s unde h s e as es ab shed by he Sec e a y…
3 The S a e equ es p ov de s and supp e s unde he S a e p an o unde a
wa ve o he p an o comp y w h he d sc osu e equ emen s es ab shed by he
Sec e a y unde sec on 1886 4
6401 HHS
A TEMPORARY MORATOR UM MPOSED BY THE SECRETARY — Sub ec o
c ause he S a e comp es w h any empo a y mo a o um on he en o men o
new p ov de s o supp e s mposed by he Sec e a y unde sec on 1886 6
6401 HHS
B MORATOR UM ON ENROLLMENT OF PROV DERS AND SUPPL ERS A he op on
o he S a e he S a e mposes o pu poses o en e ng n o pa c pa on ag ee-
men s w h p ov de s o supp e s unde he S a e p an o unde a wa ve o he
p an pe ods o en o men mo a o a o nume ca caps o o he m s o p ov d-
e s o supp e s den fied by he Sec e a y as be ng a h gh- sk o aud was e o
abuse as necessa y o comba aud was e o abuse
6401 HHS
6 REPORT NG OF ADVERSE PROV DER ACT ONS The S a e comp es w h he
na ona sys em o epo ng c m na and c v conv c ons sanc ons nega ve
censu e ac ons and o he adve se p ov de ac ons o he Sec e a y h ough he
Adm n s a o o CMS n acco dance w h egu a ons o he Sec e a y
6401 HHS
8 OTHER STATE OVERS GHT No h ng n h s subsec on sha be n e p e ed o
p ec ude o m he ab y o a S a e o engage n p ov de and supp e sc een-
ng o enhanced p ov de and supp e ove s gh ac v es beyond hose equ ed
by he Sec e a y
6401 HHS
2 D SCLOSURE OF MED CARE TERM NATED PROV DERS AND SUPPL ERS TO
STATES —The Adm n s a o o CMS sha es ab sh a p ocess o mak ng ava ab e
o he each S a e agency w h espons b y o adm n s e ng a S a e Med ca d p an
o a wa ve o such p an unde e X X o he Soc a Secu y Ac o a ch d hea h
p an unde e XX he name na ona p ov de den fie and o he den y ng
n o ma on o any p ov de o med ca o o he ems o se v ces o supp e unde
he Med ca e p og am
6402 HHS
B DATA SHAR NG AND MATCH NG The Sec e a y sha en e n o ag eemen s
w h he nd v dua s desc bed n c ause unde wh ch such nd v dua s sha e and
ma ch da a n he sys em o eco ds o he espec ve agenc es o such nd v dua s
w h da a n he sys em o eco ds o he Depa men o HHS
6402 HHS
2 ACCESS TO CLA MS AND PAYMENT DATABASES…sub ec o any n o ma on
sys ems secu y equ emen s unde such aws o o he w se equ ed by he Sec-
e a y he nspec o Gene a o HHS and he A o ney Gene a sha have access
o c a ms and paymen da a o HHS and s con ac o s e a ed o es XV X X
and XX
6402 HHS
1 n add on o any o he app cab e emed es an app cab e nd v dua has
know ng y pa c pa ed n a Fede a hea h ca e aud o ense o a consp acy o
comm a Fede a hea h ca e aud o ense he Sec e a y sha mpose an app op -
a e adm n s a ve pena y commensu a e w h he o ense o consp acy
HHS 7002
C TRANSM TTAL OF RECOMMENDAT ONS No a e han Janua y 15 2012 he
Sec e a y sha ansm o Cong ess he ev sed ecommenda ons a sum-
ma y o ece ved commen s and any changes made o he ecommenda ons n
esponse
7002 HHS and he epo s he eo a e subm ed and accep ed
B EVALUAT ON OF COSTS OF REV EW NG B OS M LAR B OLOG CAL PRODUCT AP-
PL CAT ONS Du ng he pe od beg nn ng on enac men and end ng on Oc obe
1 2010 he Sec e a y sha co ec and eva ua e da a ega d ng he cos s o ev ew-
ng app ca ons o b o og ca p oduc s
HHS 7002 HHS p ces ca cu a ed by he Sec e a y w h he qua e y p c ng da a ha s epo ed by
C AUD T On he da e ha s 2 yea s a e fi s ece v ng a use ee app cab e
o an app ca on o a b o og ca p oduc and on a b enn a bas s he ea e un
Oc obe 1 2013 he Sec e a y sha pe o m an aud o he cos s o ev ew ng such
app ca ons
7002 HHS he o ow ng P ov d ng he Sec e a y w h an exp ana on o why and how he
d e by mo e han 5 pe cen hen he Sec e a y sha a e he app ca on use
ee o mo e app op a e y accoun o he cos s o ev ew ng such app ca ons
ACCOUNT NG STANDARDS The Sec e a y sha pe o m an aud n con o mance
w h he accoun ng p nc p es s anda ds and equ emen s p esc bed by he
Comp o e Gene a o ensu e he va d y o any po en a va ab y
7002 HHS have mu p e op ons o pu chas ng cove ed d ugs o npa en s nc ud ng by
2 MARKET EXCLUS V TY FOR NEW B OLOG CAL PRODUCTS p o o app ova o
an app ca on he Sec e a y de e m nes ha n o ma on e a ng o he use o
n ha popu a on he Sec e a y makes a w en eques o ped a c s ud es
he app can ag ees o he eques such s ud es a e comp e ed and he epo s
he eo a e subm ed and accep ed
8002 HHS
c SELF-ATTESTAT ON AND VER F CAT ON OF NCOME The Sec e a y sha es ab sh
p ocedu es o— 1 pe m an nd v dua who s e g b e o he nom na p em um
equ ed as pa o he au oma c en o men n he CLASS p og am 2 ve y
he va d y o such se -a es a on and 3 equ e an nd v dua o confi m ha
he ncome does no exceed he pove y ne
8002 HHS/Treasury
a AUTOMAT C ENROLLMENT 1 The Sec e a y n coo d na on w h he Sec e-
a y o he T easu y sha es ab sh p ocedu es unde wh ch each nd v dua may
be au oma ca y en o ed n he CLASS p og am by an emp oye
8002 HHS/ Treasury
3 ADM N STRAT ON A The Sec e a y and he Sec e a y o he T easu y sha
by egu a on es ab sh p ocedu es o ensu e ha an nd v dua s no au oma ca y
en o ed by mo e han 1 emp oye B FORM En o men sha be made n such
manne as he Sec e a y may p esc be n o de o ensu e ease o adm n s a on
8002 HHS
b ELECT ON TO OPT-OUT An nd v dua may e ec o wa ve en o men n he
CLASS p og am a any me n such o m and manne as he Sec e a y and he
Sec e a y o he T easu y sha p esc be
8002 HHS/ Treasury
e PAYMENT 1 PAYROLL DEDUCT ON An amoun equa o he mon h y p em um
o en o ed CLASS nd v dua sha be deduc ed om he wages o se -emp oy-
men ncome n acco dance w h such p ocedu es as he Sec e a y n coo d na-
on w h he Sec e a y o he T easu y sha es ab sh o emp oye s who e ec o
deduc and w hho d such p em ums on beha o en o ed emp oyees 2 ALTER-
NAT VE PAYMENT MECHAN SM The Sec e a y n coo d na on w h he Sec e a y
o he T easu y sha es ab sh a e na ve p ocedu es o he paymen o mon h y
p em ums
8002 HHS / Treasury
2 TRANSFERS BASED ON EST MATES The amoun depos ed sha be ans-
e ed n a eas mon h y paymen s o he CLASS ndependence Fund on he bas s
o es ma es by he Sec e a y and ce fied o he Sec e a y o he T easu y o he
amoun s co ec ed
9023 Treasury 1
d QUAL FY NG THERAPEUT C D SCOVERY PROJECT PROGRAM 1 ESTABL SH-
MENT A No a e han 60 days a e enac men he Sec e a y n consu -
a on w h he Sec e a y o HHS sha es ab sh a qua y ng he apeu c d scove y
p o ec p og am o cons de and awa d ce fica ons o qua fied nves men s
9023 Treasury
2 CERT F CAT ON A APPL CAT ON PER OD Each app can o ce fica on
sha subm an app ca on con a n ng such n o ma on as he Sec e a y may
equ e du ng he pe od beg nn ng on he da e he Sec e a y es ab shes he p o-
g am B T ME FOR REV EW OF APPL CAT ONS The Sec e a y sha ake ac on
o app ove o deny any app ca on w h n 30 days o he subm ss on
9023 Treasury
3 SELECT ON CR TER A n de e m n ng wh ch qua y ng he apeu c d scove y
p o ec s o ce y he Sec e a y A sha ake n o cons de a on on y hose
p o ec s ha show easonab e po en a o esu n new he ap es o ea
a eas o unme med ca need o o p even de ec o ea ch on c o acu e
d seases and cond ons o educe ong- e m hea h ca e cos s n he U S o
o s gn fican y advance he goa o cu ng cance w h n he 30-yea pe od
and B sha ake n o cons de a on wh ch p o ec s have he g ea es po en a
o c ea e and sus a n h gh qua y h gh-pay ng obs and o advance U S
compe veness n he fie ds o e b o og ca and med ca sc ences
6402 HHS
e NCLUS ON OF NAT ONAL PROV DER DENT F ER ON ALL APPL CAT ONS AND
CLA MS The Sec e a y sha p omu ga e a egu a on ha equ es no a e han
Janua y 1 2011 a p ov de s o med ca o o he ems o se v ces and supp e s
unde he p og ams unde es XV and X X ha qua y o a na ona p ov de
den fie o nc ude he na ona p ov de den fie on a app ca ons…
6402 HHS
b ACCESS TO DATA 1 MED CARE PART D —Sec on 1860D–15 2 o he Soc a
Secu y Ac 42 U S C 1395w–116 2 s amended by … add ng a he end he
o ow ng new c ause x ma ches pe o med by he Sec e a y o HHS o he n-
spec o Gene a o HHS w h espec o po en a aud was e and abuse nc ud ng
ma ches o a sys em o eco ds w h non-Fede a eco ds
6402 HHS
9 A The Comm ss one o Soc a Secu y sha upon he eques o he Sec e a y
o he nspec o Gene a o HHS en e n o an ag eemen w h he Sec e a y o
such nspec o Gene a o he pu pose o ma ch ng da a n he sys em o eco ds o
he Soc a Secu y Adm n s a on and he sys em o eco ds o HHS …
6402 HHS
… 25 w h espec o any amoun s expended o med ca ass s ance o nd v du-
a s o whom he S a e does no epo en o ee encoun e da a as defined by he
Sec e a y o he Med ca d S a s ca n o ma on Sys em MS S n a me y manne
as de e m ned by he Sec e a y
6402 HHS
… F any o he emune a on wh ch p omo es access o ca e and poses a ow
sk o ha m o pa en s and Fede a hea h ca e p og ams as defined n sec on
1128B and des gna ed by he Sec e a y unde egu a ons …
6402 HHS
… e ec ve on a da e spec fied by he Sec e a y bu no ea e han Janua y 1
2011 he wa ve by a PDP sponso o a p esc p on d ug p an unde pa D o e
XV o an MA o gan za on o e ng an MA–PD p an unde pa C o such e o any
copaymen o he fi s fi o a cove ed pa D d ug…
6402 HHS
4 The p ov s ons o subsec ons d and e o sec on 205 sha app y w h espec
o h s sec on o he same ex en as hey a e app cab e w h espec o e The
Sec e a y may de ega e he au ho y g an ed by sec on 205 d as made app cab e
o h s sec on o he nspec o Gene a o HHS…
6402 HHS
g SURETY BOND REQU REMENTS 1 DURABLE MED CAL EQU PMENT Sec on
1834 a 16 B o he Soc a Secu y Ac 42 U S C 1395m a 16 B s amended
by nse ng ha he Sec e a y de e m nes s commensu a e w h he vo ume o
he b ng o he supp e …Sec on 1861 o 7 C o he Soc a Secu y Ac 42
U S C 1395x o 7 C s amended by nse ng ha he Sec e a y de e m nes s
commensu a e w h he vo ume o he b ng o he home hea h agency be o e
he sem co on a he end
6402 HHS
n REQU REMENT OF A SURETY BOND FOR CERTA N PROV DERS OF SERV CES AND
SUPPL ERS 1 The Sec e a y may equ e a p ov de o se v ces o supp e o
p ov de he Sec e a y on a con nu ng bas s w h a su e y bond n a o m spec fied
by he Sec e a y n an amoun no ess han $50 000 ha he Sec e a y de e -
m nes s commensu a e w h he vo ume o he b ng o he p ov de o se v ces
o supp e The Sec e a y may wa ve he equ emen o a bond… 2 A p ov de o
se v ces o supp e desc bed n h s pa ag aph s a p ov de o se v ces o supp e
he Sec e a y de e m nes app op a e…
6402 HHS
o SUSPENS ON OF PAYMENTS PEND NG NVEST GAT ON OF CRED BLE AL-
LEGAT ONS OF FRAUD 1 The Sec e a y may suspend paymen s o a p ov de
o se v ces o supp e pend ng an nves ga on o a c ed b e a ega on o aud
aga ns he p ov de o se v ces o supp e un ess he Sec e a y de e m nes he e
s good cause no o suspend such paymen s 2 The Sec e a y sha consu w h
he nspec o Gene a o HHS n de e m n ng whe he he e s a c ed b e a ega on o
aud 3 The Sec e a y sha p omu ga e egu a ons o ca y ou …
6402 HHS
C by any nd v dua o en y o whom he S a e has a ed o suspend paymen s
unde he p an du ng any pe od when he e s pend ng an nves ga on o a c ed-
b e a ega on o aud aga ns he nd v dua o en y as de e m ned by he S a e n
acco dance w h egu a ons p omu ga ed by he Sec e a y…
6402 HHS
… 4 he en y ag ees o p ov de he Sec e a y and he nspec o Gene a o HHS
w h such pe o mance s a s cs…as he Sec e a y o he nspec o Gene a may
eques …
6402 HHS
EVALUAT ONS AND ANNUAL REPORT 1 EVALUAT ONS The Sec e a y sha
conduc eva ua ons o e g b e en es wh ch he Sec e a y con ac s w h unde he
P og am no ess equen y han eve y 3 yea s
6402 HHS
D The en y ag ees o p ov de he Sec e a y and he nspec o Gene a o HHS w h
such pe o mance s a s cs nc ud ng he numbe and amoun o ove paymen s
ecove ed he numbe o aud e e a s and he e u n on nves men o such
ac v es by he en y as he Sec e a y o he nspec o Gene a may eques
6402 HHS
4 EVALUAT ONS The Sec e a y sha conduc eva ua ons o e g b e en es
wh ch he Sec e a y con ac s w h unde he P og am no ess equen y han
eve y 3 yea s
6403 HHS
a The Sec e a y sha ma n a n a na ona hea h ca e aud and abuse da a co -
ec on p og am unde h s sec on o he epo ng o ce a n fina adve se ac ons
no nc ud ng se emen s n wh ch no find ngs o ab y have been made aga ns
hea h ca e p ov de s supp e s o p ac one s as equ ed by subsec on b w h
access as se o h n subsec on d and sha u n sh he n o ma on co ec ed
unde h s sec on o he Na ona P ac one Da a Bank …
6403 HHS
2 FEES FOR D SCLOSURE The Sec e a y may es ab sh o app ove easonab e ees
o he d sc osu e o n o ma on unde h s sec on The amoun o such a ee may
no exceed he cos s o p ocess ng he eques s o d sc osu e and o p ov d ng such
n o ma on Such ees sha be ava ab e o he Sec e a y o cove such cos s
6403 HHS
APPROPR ATE COORD NAT ON n mp emen ng h s sec on he Sec e a y sha
p ov de o he max mum app op a e coo d na on w h pa B o he Hea h Ca e
Qua y mp ovemen Ac o 1986 …
6403 HHS
A L CENS NG OR CERT F CAT ON ACT ONS The S a e mus have n e ec a sys em
o epo ng he o ow ng n o ma on w h espec o o ma p oceed ngs as
defined by he Sec e a y n egu a ons conc uded aga ns a hea h ca e p ac one
o en y by a S a e cens ng o ce fica on agency …
6403 HHS
1 D SCLOSURE —W h espec o n o ma on epo ed pu suan o subsec on a
1 he Sec e a y sha A p ov de o d sc osu e o he n o ma on upon eques o
he hea h ca e p ac one who o he en y ha s he sub ec o he n o ma on
epo ed and B es ab sh p ocedu es o he case whe e he hea h ca e p ac o-
ne o en y d spu es he accu acy o he n o ma on epo ed
6403 HHS
2 CORRECT ONS Each S a e cens ng o ce fica on agency and S a e aw o
aud en o cemen agency sha epo co ec ons o n o ma on a eady epo ed
abou any o ma p oceed ng o fina adve se ac on desc bed n subsec on a n
such o m and manne as he Sec e a y p esc bes by egu a on
6403 HHS
PROTECT ON FROM L AB L TY FOR REPORT NG No pe son o en y nc ud ng any
agency des gna ed by he Sec e a y n subsec on b sha be he d ab e n any c v
ac on w h espec o any epo ng o n o ma on as equ ed unde h s sec on
w hou know edge o he a s y o he n o ma on con a ned n he epo
6403 HHS
… v any o he ad ud ca ed ac ons o dec s ons ha he Sec e a y sha es ab sh
by egu a on
6403 HHS
4 n subsec on h as so edes gna ed by s k ng The Sec e a y and a ha o -
ows h ough he pe od a he end and nse ng n mp emen ng h s sec on he
Sec e a y sha p ov de o he max mum app op a e coo d na on w h pa B o he
Hea h Ca e Qua y mp ovemen Ac o 1986 …
6403 HHS
han he end o he ans on pe od desc bed n pa ag aph 5 he Sec e a y
sha … ans e a da a co ec ed n he Hea hca e n eg y and P o ec on Da a
Bank o he Na ona P ac one Da a Bank Du ng such ans on p ocess he
Sec e a y sha have n e ec app op a e p ocedu es o ensu e ha da a co ec on
and access o he Hea hca e n eg y and P o ec on Da a Bank and he Na ona
P ac one Da a Bank a e no d s up ed 2 REGULAT ONS The Sec e a y sha
p omu ga e egu a ons o ca y ou he amendmen s made …
6403 HHS
3 FUND NG A AVA LAB L TY OF FEES Fees co ec ed…sha be ava ab e o he
Sec e a y…Any such ees ema n ng a e he ans on pe od s comp e e sha be
ava ab e o he Sec e a y w hou fisca yea m a on… B AVA LAB L TY OF ADD -
T ONAL FUNDS…any unds ava ab e o he Sec e a y o o he nspec o Gene a o
he Depa men o HHS o a pu pose e a ed o comba ng hea h ca e aud was e
o abuse sha be ava ab e o he ex en necessa y o ope a ng he Hea hca e
n eg y and P o ec on Da a Bank du ng he ans on pe od
6404 HHS
… B by add ng a he end he o ow ng new sen ence n app y ng pa ag aph
1 he Sec e a y may spec y excep ons o he 1 ca enda yea pe od spec fied n
such pa ag aph
6404 HHS
… by add ng a he end he o ow ng new sen ence n app y ng subpa ag aph
B he Sec e a y may spec y excep ons o he 1 ca enda yea pe od spec fied n
such subpa ag aph ”
6404 HHS
… by add ng a he end he o ow ng new sen ence n app y ng pa ag aph
1 he Sec e a y may spec y excep ons o he 1 ca enda yea pe od spec fied n
such pa ag aph
6405 HHS
c APPL CAT ON TO OTHER TEMS OR SERV CES The Sec e a y may ex end he
equ emen app ed by he amendmen s made by subsec ons a and b o du ab e
med ca equ pmen and home hea h se v ces
6406 HHS
9 The Sec e a y may evoke en o men … such phys c an o supp e a s o
ma n a n and upon eques o he Sec e a y p ov de access o documen a on…as
spec fied by he Sec e a y
6406 HHS
… 3 by add ng a he end he o ow ng new subpa ag aph W ma n a n and
upon eques o he Sec e a y p ov de access o documen a on e a ng o w en
o de s o eques s o paymen o du ab e med ca equ pmen ce fica ons o
home hea h se v ces o e e a s o o he ems o se v ces w en o o de ed by
he p ov de unde h s e as spec fied by he Sec e a y
6407 HHS
… B by nse ng a e ca e o a phys c an he o ow ng … sub ec o he
equ emen s n sec on 1834 m and o he han w h espec o encoun e s ha a e
nc den o se v ces nvo ved w h he nd v dua w h n a easonab e me ame as
de e m ned by he Sec e a y
HHS 7102
3 MARKET EXCLUS V TY FOR ALREADY-MARKETED B OLOG CAL PRODUCTS he
Sec e a y de e m nes ha n o ma on e a ng o he use o a censed b o og ca
p oduc n he ped a c popu a on may p oduce hea h benefi s n ha popu a-
on and makes a w en eques o he ho de o an app oved app ca on o
ped a c s ud es he ho de ag ees o he eques such s ud es a e comp e ed
7002 HHS p ces ca cu a ed by manu ac u e s and cha ged o cove ed en es wh ch sha
4 EXCEPT ON The Sec e a y sha no ex end a pe od e e ed o e sewhe e he
de e m na on s made a e han 9 mon hs p o o he exp a on o such pe od
h ORPHAN PRODUCTS a e e ence p oduc has been des gna ed o a a e
d sease o cond on a b o og ca p oduc seek ng app ova o such d sease o
cond on as b os m a o o n e changeab e w h such e e ence p oduc may
be censed by he Sec e a y on y a e he exp a on o such e e ence p oduc o
he a e o
7101 HHS ove cha ge occu ed how he e unds w be ca cu a ed and o whom he e unds
EXCEPT ONS The Sec e a y sha es ab sh easonab e excep ons o c ause
… accu a e y and w h n a easonab e pe od o me bo h n ou ne ns ances o
7101 HHS as e oneous o n en ona ove cha g ng o cove ed d ugs
v PURCHAS NG ARRANGEMENTS FOR NPAT ENT DRUGS The Sec e a y sha
ensu e ha a hosp a en o ed o pa c pa e n he d ug d scoun p og am sha
u z ng a g oup pu chas ng o gan za on o o he g oup pu chas ng a angemen
es ab sh ng and u z ng s own g oup pu chas ng p og am pu chas ng d ec y
om a manu ac u e and any o he pu chas ng a angemen s ha he Sec e a y
de e m nes s app op a e o ensu e access o d ug d scoun p c ng o npa en
d ugs ak ng n o accoun he pa cu a needs o sma and u a hosp a s
7101 HHS v The mpos on o sanc ons n he o m o c v mone a y pena es wh ch sha
c MED CA D CRED T No a e han 90 days a e he da e o fi ng o he hosp a s
mos ecen y fi ed Med ca e cos epo he hosp a sha ssue a c ed as de e -
m ned by he Sec e a y o he S a e Med ca d p og am o npa en cove ed d ugs
p ov ded o Med ca d ec p en s
8002 HHS / Treasury
g OTHER ENROLLMENT AND D SENROLLMENT OPPORTUN T ES The Sec e a y n
coo d na on w h he Sec e a y o he T easu y sha es ab sh p ocedu es unde
wh ch 1 an nd v dua s e g b e o en o n he p og am n such o m and
manne as he Sec e a es sha es ab sh du ng an open en o men pe od
es ab shed by he Sec e a es and 2 an nd v dua sha on y be pe m ed o d s-
en o om he p og am o he han o nonpaymen o p em ums du ng an annua
d sen o men pe od es ab shed by he Sec e a es and n such o m and manne
as he Sec e a es sha es ab sh
8002 HHS
a DETERM NAT ON OF EL G B L TY 1 APPL CAT ON FOR RECE PT OF BENEF TS
The Sec e a y sha es ab sh p ocedu es unde wh ch an ac ve en o ee sha app y
o CLASS benefi s
8002 HHS
2 EL G B L TY ASSESSMENTS A No a e han Janua y 1 2012 he Sec e a y
sha … es ab sh an E g b y Assessmen Sys em en e n o an ag eemen
w h he P o ec on and Advocacy Sys em en e n o an Ag eemen w h pub c
and p va e en es o p ov de adv ce and ass s ance counse ng …
8002 HHS
B REGULAT ONS The Sec e a y sha p omu ga e egu a ons o deve op an expe-
d ed na ona y equ ab e e g b y de e m na on p ocess an appea s p ocess
and a ede e m na on p ocess
8002 HHS
D APPEALS The Sec e a y sha es ab sh p ocedu es unde wh ch an app can s
gua an eed he gh o appea an adve se de e m na on
8002 HHS
b BENEF TS An e g b e benefic a y sha ece ve he o ow ng CLASS benefi s 1
CASH BENEF T A cash benefi es ab shed by he Sec e a y
8002 HHS
c PAYMENT OF BENEF TS 1 L FE NDEPENDENCE ACCOUNT A The Sec e a y
sha es ab sh p ocedu es o adm n s e ng benefi s nc ud ng he paymen o
he cash benefi n o a L e ndependence Accoun es ab shed by he Sec e a y
on beha o each benefic a y
9023 Treasury
4 D SCLOSURE OF ALLOCAT ONS The Sec e a y sha pub c y d sc ose he
den y o he app can and he amoun o he c ed w h espec o such app can
9023 Treasury
e GRANTS FOR QUAL F ED NVESTMENTS N THERAPEUT C D SCOVERY PROJ-
ECTS N L EU OF TAX CRED TS 1 Upon app ca on he Sec e a y o he T easu y
sha p ov de a g an o each pe son who makes a qua fied nves men n a
he apeu c d scove y p o ec n he amoun o 50 pe cen o such nves men
No g an sha be made un ess such nves men s made du ng a axab e yea
beg nn ng n 2009 o 2010
9023 Treasury
C NFORMAT ON TO BE SUBM TTED An app ca on o a g an sha nc ude such
n o ma on and be n such o m as he Sec e a y may equ e o s a e he amoun
o he c ed a owab e o he axab e yea o he qua fied nves men
6407 HHS
REQU REMENT FOR FACE TO FACE ENCOUNTER The Sec e a y sha equ e ha
such an o de be w en pu suan o he phys c an documen ng ha a phys c an
a phys c an ass s an a nu se p ac one o a c n ca nu se spec a s …has had a
ace- o- ace encoun e …du ng he 6-mon h pe od p eced ng such w en o de
o o he easonab e me ame as de e m ned by he Sec e a y
6407 HHS
c APPL CAT ON TO OTHER AREAS UNDER MED CARE The Sec e a y may app y
he ace- o- ace encoun e equ emen desc bed n he amendmen s made by
subsec ons a and b o o he ems and se v ces
6408 HHS
9 a s o g an me y access upon easonab e eques as defined by he Sec e-
a y n egu a ons o he nspec o Gene a o HHS o he pu pose o aud s nves-
ga ons eva ua ons o o he s a u o y unc ons o he nspec o Gene a o HHS
6408 HHS
C by add ng a he end he o ow ng new sen ence The Sec e a y may p ov de n
add on o any o he emed es au ho zed by aw o any o he emed es desc bed
n pa ag aph 2 he Sec e a y de e m nes ha any emp oyee o agen o such
o gan za on o any p ov de o supp e who con ac s w h such o gan za on has
engaged n any conduc …
6409 HHS
a DEVELOPMENT OF SELF-REFERRAL D SCLOSURE PROTOCOL 1 The Sec e a y
n coope a on w h he nspec o Gene a o HHS sha es ab sh no a e han 6
mon hs a e he da e o he enac men o h s Ac a p o oco o enab e hea h ca e
p ov de s o se v ces and supp e s o d sc ose an ac ua o po en a v o a on…
6409 HHS
2 PUBL CAT ON ON NTERNET WEBS TE OF SRDP NFORMAT ON The Sec e a y
sha pos n o ma on on he pub c n e ne webs e o CMS o n o m e evan
s akeho de s o how o d sc ose ac ua o po en a v o a ons pu suan o an SRDP
6409 HHS
b REDUCT ON N AMOUNTS OWED The Sec e a y s au ho zed o educe he
amoun due and ow ng o a v o a ons unde sec on 1877 o he Soc a Secu y
Ac o an amoun ess han ha spec fied n subsec on g o such sec on… he
Sec e a y may cons de he o ow ng ac o s…
6409 HHS
… 4 Such o he ac o s as he Sec e a y cons de s app op a e
6410 HHS
… he Sec e a y sha nc ude he nex 21 a ges me opo an s a s ca a eas
by o a popu a on a e hose se ec ed unde subc ause o such ound…
6410 HHS
n he case o cove ed ems u n shed on o a e Janua y 1 2016 he Sec e-
a y sha con nue o make such ad us men s desc bed n c ause
6411 HHS
… es ab sh a p og am unde wh ch he S a e con ac s cons s en w h S a e
aw and n he same manne as he Sec e a y en e s n o con ac s w h ecove y
aud con ac o s unde sec on 1893 h sub ec o such excep ons o equ emen s
as he Sec e a y may equ e…
6411 HHS
… p ov de assu ances sa s ac o y o he Sec e a y…
6411 HHS
… V such p og am s ca ed ou n acco dance w h such equ emen s as he
Sec e a y sha spec y …
6411 HHS
2 COORD NAT ON REGULAT ONS A The Sec e a y ac ng h ough he Adm n-
s a o o CMS sha coo d na e he expans on o he Recove y Aud Con ac o
p og am o Med ca d w h S a es… B The Sec e a y sha p omu ga e egu a-
ons o ca y ou h s subsec on and he amendmen s made by h s subsec on
nc ud ng w h espec o cond ons o Fede a financ a pa c pa on as spec fied
by he Sec e a y
6411 HHS
9 SPEC AL RULES RELAT NG TO PARTS C AND D The Sec e a y sha en e n o
con ac s unde pa ag aph 1 o equ e ecove y aud con ac o s o… D e-
v ew es ma es subm ed by p esc p on d ug p ans by p va e p ans w h espec
o he en o men o h gh cos benefic a es as defined by he Sec e a y and o
compa e such es ma es w h he numbe s o such benefic a es ac ua y en o ed
by such p ans
6502 HHS
A has unpa d ove paymen s as defined by he Sec e a y unde h s e du ng
such pe od de e m ned by he Sec e a y o he S a e agency o be de nquen
6503 HHS
79 p ov de ha any agen c ea nghouse o o he a e na e payee as defined by
he Sec e a y ha subm s c a ms on beha o a hea h ca e p ov de mus eg s e
w h he S a e and he Sec e a y n a o m and manne spec fied by he Sec e a y
6504 HHS
a Sec on 1903 1 F o he Soc a Secu y Ac 42 U S C 1396b 1 F s
amended by nse ng a e necessa y he o ow ng and nc ud ng o da a
subm ed o he Sec e a y on o a e Janua y 1 2010 da a e emen s om
he au oma ed da a sys em ha he Sec e a y de e m nes o be necessa y o
p og am n eg y p og am ove s gh and adm n s a on a such equency as
he Sec e a y sha de e m ne
6504 HHS
b MANAGED CARE ORGAN ZAT ONS 1 Sec on 1903 m 2 A x o he Soc a
Secu y Ac 42 U S C 1396b m 2 A x s amended by nse ng and o he
p ov s on o such da a o he S a e a a equency and eve o de a o be spec fied
by he Sec e a y a e pa en s
6506 HHS
b CORRECT VE ACT ON —The Sec e a y sha p omu ga e egu a ons ha equ e
S a es o co ec Fede a y den fied c a ms ove paymen s…
6507 HHS
… v e ec ve o c a ms fi ed on o a e Oc obe 1 2010 nco po a e compa -
b e me hodo og es o he Na ona Co ec Cod ng n a ve adm n s e ed by he
Sec e a y…and such o he me hodo og es o ha n a ve…as he Sec e a y
den fies …
6507 HHS
4 Fo pu poses o pa ag aph 1 B v he Sec e a y sha … A den y hose
me hodo og es o he Na ona Co ec Cod ng n a ve adm n s e ed by he Sec e-
a y … den y hose me hodo og es o such n a ve … No y S a es …
6603 HHS
The Sec e a y sha eques he Na ona Assoc a on o nsu ance Comm ss one s o
deve op a mode un o m epo o m o p va e hea h nsu ance ssue seek ng o
e e suspec ed aud and abuse o S a e nsu ance depa men s o o he espon-
s b e S a e agenc es o nves ga on The Sec e a y sha eques ha he NA C
deve op ecommenda ons o un o m epo ng s anda ds o such e e a s
6604 Labor
The Sec e a y may…adop egu a o y s anda ds es ab sh ng o ssue an o de
e a ng o a spec fic pe son es ab sh ng ha a pe son engaged n he bus ness o
p ov d ng nsu ance h ough a mu p e emp oye we a e a angemen desc bed n
sec on 3 40 s sub ec o he aws o he S a es n wh ch such pe son ope a es…
6605 Labor
a The Sec e a y may ssue a cease and des s ex pa e o de unde h s e e a y an app ca on a such me n such manne and con a n ng such n o ma on as
appea s o he Sec e a y ha he a eged conduc … s audu en
6605 Labor
b HEAR NG…The Sec e a y may equ e ha a p oceed ng unde h s sec on n-
c ud ng a e a ed n o ma on and ev dence be conduc ed n a confiden a manne
6605 Labor
d DETERM NAT ON he cease and des s o de nvo ved may be a fi med mod -
fied o se as de by he Sec e a y n who e o n pa e SE ZURE The Sec e a y
may ssue a summa y se zu e o de REGULAT ONS The Sec e a y may
p omu ga e such egu a ons o o he gu dance as may be necessa y o app op a e
o ca y ou h s sec on
6606 Labor
Sec on 101 g o he Emp oyee Re emen ncome Secu y Ac o 1974 29
U S C 1021 g s amended 1 by s k ng Sec e a y may and nse ng Sec e-
a y sha …
6607 Labor
8 Any o he Fede a o S a e au ho y ha he Sec e a y de e m nes s app op a e
o he pu poses o en o c ng he p ov s ons o h s e
6702 HHS
A The e m ong- e m ca e means suppo ve and hea h se v ces spec fied by he
Sec e a y o nd v dua s who need ass s ance because he nd v dua s have a oss
o capac y o se -ca e due o ness d sab y o vu ne ab y
6702 HHS
B LOSS OF CAPAC TY FOR SELF-CARE… oss o capac y o se -ca e means an
nab y o engage n…o he ac v es he Sec e a y de e m nes app op a e
6703 HHS
a PROTECT ON OF PR VACY… he Sec e a y sha ensu e he p o ec on o nd -
v dua hea h p vacy cons s en w h he egu a ons p omu ga ed unde sec on
264 c o he H PPA o 1996 and app cab e S a e and oca p vacy egu a ons
6703 HHS
b COMPOS T ON The Adv so y Boa d sha be composed o 27 membe s appo n ed
by he Sec e a y c SOL C TAT ON OF NOM NAT ONS The Sec e a y sha pub sh
a no ce n he Fede a Reg s e so c ng nom na ons o he appo n men o mem-
be s o he Adv so y Boa d
6703 HHS
h TRAVEL EXPENSES… he Sec e a y may accep he vo un a y and uncompen-
sa ed se v ces o he membe s o he Adv so y Boa d
6703 HHS
a GU DEL NES The Sec e a y sha p omu ga e gu de nes o ass s esea che s
wo k ng n he a ea o e de abuse neg ec and exp o a on w h ssues e a ng o
human sub ec p o ec ons
6703 HHS
a The Sec e a y n consu a on w h he A o ney Gene a sha make g an s o
e g b e en es o es ab sh and ope a e s a ona y and mob e o ens c cen e s o
deve op o ens c expe se ega d ng and p ov de se v ces e a ng o e de abuse
neg ec and exp o a on
6703 HHS
b STAT ONARY FORENS C CENTERS The Sec e a y sha make 4 o he g an s
desc bed n subsec on a o ns u ons o h ghe educa on w h demons a ed
expe se n o ens cs c MOB LE CENTERS The Sec e a y sha make 6 o he
g an s desc bed n subsec on a o app op a e en es o es ab sh and ope a e
mob e o ens c cen e s
6703 HHS
3 COLLECT ON OF EV DENCE The Sec e a y n coo d na on w h he A o ney
Gene a sha use da a made ava ab e by g an ec p en s unde h s sec on o
deve op he capac y o ge a c hea h ca e p o ess ona s and aw en o cemen o
co ec o ens c ev dence
6703 HHS
e APPL CAT ON To be e g b e o ece ve a g an unde h s sec on an en y sha
subm an app ca on o he Sec e a y a such me n such manne and con a n ng
such n o ma on as he Sec e a y may equ e
6703 HHS
1 The Sec e a y sha ca y ou ac v es … o p ov de ncen ves o nd v dua s o
a n o seek and ma n a n emp oymen p ov d ng d ec ca e n ong- e m ca e
HHS 7102
A The Sec e a y sha p ov de o mp ovemen s n comp ance by manu ac u -
e s n o de o p even ove cha ges and o he v o a ons o he d scoun ed p c ng
equ emen s
7102 HHS v The mpos on o sanc ons n app op a e cases as de e m ned by he Sec e a y
B MPROVEMENTS The mp ovemen s sha nc ude he o ow ng The
deve opmen o a sys em o enab e he Sec e a y o ve y he accu acy o ce ng
nc ude he o ow ng Deve op ng and pub sh ng h ough an app op a e po cy o
egu a o y ssuance p ec se y defined s anda ds and me hodo ogy o he ca cu a-
on o ce ng p ces unde such subsec on Compa ng egu a y he ce ng
manu ac u e s o he Sec e a y
7102 HHS a e enac men o he PPACA he Sec e a y sha p omu ga e egu a ons o
The es ab shmen o p ocedu es o manu ac u e s o ssue e unds o cove ed
en es n he even ha he e s an ove cha ge by he manu ac u e s nc ud ng
w be ssued Ove s gh by he Sec e a y o ensu e ha he e unds a e ssued
e oac ve ad us men o e evan p c ng da a and excep ona c cums ances such
7102 HHS 10323 HHS
The p ov s on o access h ough he HHS webs e o he app cab e ce ng
p ces o cove ed d ugs as ca cu a ed and ve fied by he Sec e a y n a manne
such as h ough he use o passwo d p o ec on ha m s such access o cove ed
en es and adequa e y assu es secu y and p o ec on o p v eged p c ng da a
om unau ho zed e-d sc osu e
7102 HHS … B s d agnosed w h a med ca cond on caused by he exposu e o he nd v dua
be assessed acco d ng o s anda ds es ab shed n egu a ons o be p omu ga ed by
he Sec e a y no a e han 180 days a e he da e o enac men o he PPACA
8002 HHS
C ELECTRON C MANAGEMENT OF FUNDS The Sec e a y sha es ab sh p oce-
du es o c ed ng an accoun w h he benefic a y s cash da y benefi
a ow ng access deb ca ds and accoun ng o w hd awa s
8002 HHS
2 AUTHOR ZED REPRESENTAT VES A The Sec e a y sha es ab sh p ocedu es o
a ow access o a cash benefi s by an au ho zed ep esen a ve o he benefi-
c a y B QUAL TY ASSURANCE AND PROTECT ON AGA NST FRAUD AND ABUSE
The p ocedu es sha ensu e ha au ho zed ep esen a ves comp y w h
s anda ds o conduc es ab shed by he Sec e a y nc ud ng s anda ds equ ng
ha ep esen a ves p ov de qua y se v ces do no have confl c s o n e es
and do no m suse benefi s o o he w se engage n aud o abuse
8002 HHS
B NCLUS ON OF NCREASED BENEF TS The Sec e a y sha es ab sh p ocedu es
unde wh ch cash benefi s ha nc ease o dec ease as a esu o a change n
he unc ona s a us o he benefic a y be o e he end o a 12-mon h benefi pe od
sha be nc uded n he annua benefi pa d
8002 HHS / Treasury
C RECOUPMENT OF UNPA D ACCRUED BENEF TS The Sec e a y n coo d na-
on w h he Sec e a y o he T easu y sha ecoup any acc ued benefi s n he
even o
8002 HHS
6 REQU REMENT TO RECERT FY EL G B L TY FOR RECE PT OF BENEF TS An e g b e
benefic a y sha pe od ca y as de e m ned by he Sec e a y
8002 HHS
6 such o he se v ces as he Sec e a y by egu a on may equ e
8002 HHS
h PROTECT ON AGA NST CONFL CT OF NTERESTS The Sec e a y sha es ab sh
p ocedu es o ensu e ha he E g b y Assessmen Sys em he P o ec on and Ad-
vocacy Sys em o a S a e advocacy counse o s o benefic a es and any o he
en es ha p ov de se v ces o ac ve en o ees and e g b e benefic a es unde he
CLASS p og am comp y w h spec fied s anda ds
8002 Treasury
b NVESTMENT OF FUND BALANCE The Sec e a y o he T easu y sha nves
and manage he CLASS ndependence Fund n he same manne and o he same
ex en as he Fede a Supp emen a y Med ca nsu ance T us Fund may be nves ed
and managed
9023 Treasury
3 T ME FOR PAYMENT OF GRANT A The Sec e a y o he T easu y sha make
paymen o he amoun o any g an du ng he 30-day pe od beg nn ng on he
ae o he da e o he app ca on o such g an o he da e he qua fied
nves men o wh ch he g an s be ng made s made B REGULAT ONS n he
case o nves men s o an ongo ng na u e he Sec e a y sha ssue egu a ons
o de e m ne he da e on wh ch a qua fied nves men sha be deemed o have
been made
9023 Treasury
5 APPL CAT ON OF CERTA N RULES A n mak ng g an s he Sec e a y o he
T easu y sha app y u es s m a o he RS code n app y ng such u es any
nc ease n ax unde chap e 1 o such Code by eason o an nves men ceas ng
o be a qua fied nves men sha be mposed on he pe son o whom he g an
was made
6703 HHS
A COORD NAT ON W TH SECRETARY OF LABOR TO RECRU T AND TRA N LONG-
TERM CARE STAFF The Sec e a y sha coo d na e ac v es unde h s subsec on
w h he Sec e a y o Labo n o de o p ov de ncen ves o nd v dua s o a n o
and seek emp oymen p ov d ng d ec ca e n ong- e m ca e
6703 HHS
The Sec e a y sha make g an s o e g b e en es o ca y ou p og ams…
6703 HHS
APPL CAT ON … an e g b e en y sha subm an app ca on o he Sec e a y
a such me n such manne and con a n ng such n o ma on as he Sec e a y
may equ e
6703 HHS
AUTHOR TY TO L M T NUMBER OF APPL CANTS No h ng n h s subpa ag aph
sha be cons ued as p oh b ng he Sec e a y om m ng he numbe o ap-
p can s o a g an
6703 HHS
A The Sec e a y sha make g an s o e g b e en es o enab e he en es o
p ov de a n ng and echn ca ass s ance
6703 HHS
C APPL CAT ON To be e g b e o ece ve a g an an e g b e en y sha subm
an app ca on o he Sec e a y a such me n such manne and con a n ng such
n o ma on as he Sec e a y may equ e
6703 HHS
D AUTHOR TY TO L M T NUMBER OF APPL CANTS No h ng n h s pa ag aph sha
be cons ued as p oh b ng he Sec e a y om m ng he numbe o app can s o
a g an unde h s pa ag aph
6703 HHS
4 ACCOUNTAB L TY MEASURES The Sec e a y sha deve op accoun ab y mea-
su es o ensu e ha he ac v es conduc ed us ng unds made ava ab e benefi
nd v dua s who p ov de d ec ca e and nc ease he s ab y o he ong- e m ca e
wo k o ce
6703 HHS
5 DEF N T ONS The e m commun y-based ong- e m ca e has he mean ng
g ven such e m by he Sec e a y
6703 HHS
B EL G BLE ENT TY The e m e g b e en y means he o ow ng… A commu-
n y-based ong- e m ca e en y as defined by he Sec e a y
6703 HHS
1 GRANTS AUTHOR ZED The Sec e a y s au ho zed o make g an s o ong- e m
6703 HHS
3 APPL CAT ON A … a ong- e m ca e ac y sha subm an app ca on o he
Sec e a y a such me n such manne and con a n ng such n o ma on as he
Sec e a y may equ e B No h ng n h s subsec on sha be cons ued as p oh b -
ng he Sec e a y om m ng he numbe o app can s o a g an unde h s
subsec on
6703 HHS
4 PART C PAT ON N STATE HEALTH EXCHANGES A ong- e m ca e ac y ha
ece ves a g an unde h s subsec on sha whe e ava ab e pa c pa e n ac v es
conduc ed by a S a e o a qua fied S a e-des gna ed en y… o coo d na e ca e and
o o he pu poses de e m ned app op a e by he Sec e a y
6703 HHS
5 ACCOUNTAB L TY MEASURES The Sec e a y sha deve op accoun ab y mea-
su es o ensu e ha he ac v es conduc ed us ng unds made ava ab e unde h s
subsec on he p mp ove pa en sa e y and educe adve se even s and hea h ca e
comp ca ons esu ng om med ca on e o s
6703 HHS
1 STANDARDS AND COMPAT B L TY The Sec e a y sha adop e ec on c s anda ds
o he exchange o c n ca da a by ong- e m ca e ac es…
6703 HHS
2 ELECTRON C SUBM SS ON OF DATA TO THE SECRETARY A No a e han 10
yea s a e he da e o enac men o he E de Jus ce Ac o 2009 he Sec e a y
sha have p ocedu es n p ace o accep he op ona e ec on c subm ss on o
c n ca da a by ong- e m ca e ac es pu suan o he s anda ds adop ed unde
pa ag aph 1
6703 HHS
a SECRETAR AL RESPONS B L T ES 1 The Sec e a y sha ensu e ha HHS A
p ov des und ng au ho zed by h s pa … B co ec s and d ssem na es da a
annua y… C deve ops and d ssem na es n o ma on on bes p ac ces… D con-
duc s esea ch e a ed o he p ov s on o adu p o ec ve se v ces … E p ov des
echn ca ass s ance o S a es and o he en es
6703 HHS
1 ESTABL SHMENT The e s es ab shed an adu p o ec ve se v ces g an p og am
unde wh ch he Sec e a y sha annua y awa d g an s o S a es n he amoun s
ca cu a ed unde pa ag aph 2
6703 HHS
B GUARANTEED M N MUM PAYMENT AMOUNT … he Sec e a y sha nc ease
such de e m ned amoun so ha he o a amoun pa d unde h s subsec on o he
S a e o he yea s equa o 0 75 pe cen o he amoun so app op a ed
6703 HHS
C PRO RATA REDUCT ONS The Sec e a y sha make such p o a a educ ons o
he amoun s desc bed n subpa ag aph A as a e necessa y o comp y w h he
equ emen s o subpa ag aph B
6703 HHS
c STATE DEMONSTRAT ON PROGRAMS 1 ESTABL SHMENT The Sec e a y sha
awa d g an s o S a es o he pu poses o conduc ng demons a on p og ams n
acco dance w h pa ag aph 2
6703 HHS
3 APPL CAT ON … a S a e sha subm an app ca on o he Sec e a y a such
me n such manne and con a n ng such n o ma on as he Sec e a y may
equ e
6703 HHS
4 STATE REPORTS Each S a e ha ece ves unds unde h s subsec on sha
subm o he Sec e a y a epo a such me n such manne and con a n ng such
n o ma on as he Sec e a y may equ e…
6703 HHS
a GRANTS TO SUPPORT THE LONG-TERM CARE OMBUDSMAN PROGRAM 1 The
Sec e a y sha make g an s o e g b e en es w h e evan expe se and expe -
ence n abuse and neg ec n ong- e m ca e ac es o ong- e m ca e ombuds-
man p og ams and espons b es…
6703 HHS
b OMBUDSMAN TRA N NG PROGRAMS 1 The Sec e a y sha es ab sh p og ams
o p ov de and mp ove ombudsman a n ng w h espec o e de abuse neg ec
and exp o a on …
6703 HHS
2 n he case o an app can o a g an unde sec on 2041 b o p ov de he Sec-
e a y w h such n o ma on as he Sec e a y may equ e o conduc an eva ua on
o aud unde subsec on c
6703 HHS
1 EVALUAT ONS REQU RED… he Sec e a y sha A ese ve a po on no ess
han 2 pe cen o he unds app op a ed w h espec o each p og am ca ed ou
unde h s pa and B use he unds ese ved unde subpa ag aph A o p ov de
ass s ance o e g b e en es
6703 HHS
4 APPL CAT ONS…an en y sha subm an app ca on o he Sec e a y a such
me n such manne and con a n ng such n o ma on as he Sec e a y may
equ e nc ud ng a p oposa o he eva ua on
6703 HHS
1 EVALUAT ONS The Sec e a y sha conduc an eva ua on o he ac v es unded
unde he ce fied EHR echno ogy g an p og am unde sec on 2041 b …
6703 HHS
2 AUD TS The Sec e a y sha conduc app op a e aud s o g an s made unde
sec on 2041 b
6703 HHS
A N GENERAL The Sec e a y sha en e n o a con ac w h an en y o he
pu pose o es ab sh ng and ope a ng a Na ona T a n ng ns u e o Fede a and
S a e su veyo s
6703 HHS
v To he ex en app oved by he Sec e a y p ov de a na ona 24 hou s pe day 7
days a week nc ud ng ho days back-up sys em o S a e comp a n n ake sys ems
n o de o ensu e op mum na ona espons veness o comp a n s o such abuse
neg ec and m sapp op a on o p ope y
6703 HHS
A The Sec e a y o HHS sha make g an s o S a e agenc es ha pe o m su veys
o sk ed nu s ng ac es…
6703 HHS
1 a cove ed nd v dua v o a es subsec on b … B he Sec e a y may make
a de e m na on n he same p oceed ng o exc ude he cove ed nd v dua om
pa c pa on n any Fede a hea h ca e p og am
6703 HHS
2 NCREASED HARM a cove ed nd v dua v o a es subsec on b and he v o a-
on exace ba es he ha m o he v c m… B he Sec e a y may make a de e m na-
on n he same p oceed ng o exc ude he cove ed nd v dua om pa c pa on n
any Fede a hea h ca e p og am
6703 HHS
4 EXTENUAT NG C RCUMSTANCES A The Sec e a y may ake n o accoun he
financ a bu den on p ov de s w h unde se ved popu a ons n de e m n ng any
pena y o be mposed unde h s subsec on
6703 HHS
B UNDERSERVED POPULAT ON DEF NED The e m unde se ved popu a on
means he popu a on o an a ea des gna ed by he Sec e a y as an a ea w h
a sho age o e de us ce p og ams o a popu a on g oup des gna ed by he
Sec e a y
6703 HHS
2 PENALT ES FOR RETAL AT ON a ong- e m ca e ac y v o a es subpa ag aph
A o B o pa ag aph 1 he ac y sha be sub ec o a c v money pena y o no
mo e han $200 000 o he Sec e a y may c ass y he en y as an exc uded en y
o a pe od o 2 yea s
6703 HHS
3 REQU REMENT TO POST NOT CE Each ong- e m ca e ac y sha pos con-
sp cuous y n an app op a e oca on a s gn n a o m spec fied by he Sec e a y
spec y ng he gh s o emp oyees
6703 HHS
A The Sec e a y n consu a on w h app op a e gove nmen agenc es and
p va e sec o o gan za ons sha conduc a s udy on es ab sh ng a na ona
nu se a de eg s y
6703 HHS
C CONS DERAT ONS n conduc ng he s udy and p epa ng he epo equ ed
unde h s subsec on he Sec e a y sha ake n o cons de a on he find ngs and
conc us ons o e evan epo s and o he e evan esou ces…
HHS g ams be budge neu a
A The Sec e a y sha p ov de o mp ovemen s n comp ance n o de o
p even d ve s on and v o a ons o he dup ca e d scoun p ov s on
7102 HHS Comm ss one o Soc a Secu y n consu a on w h he Sec e a y sha de e m ne
h ough one o mo e o he o ow ng ac ons Whe e a cove ed en y know ng y
and n en ona y v o a es u es he cove ed en y sha be equ ed o pay a mon-
e a y pena y o a manu ac u e Whe e he Sec e a y de e m nes a v o a on
was sys ema c and eg eg ous as we as know ng and n en ona emov ng he
cove ed en y om he d ug d scoun p og am and d squa y ng he en y om
e-en y o a easonab e pe od o me o be de e m ned by he Sec e a y
7102 HHS 10323 HHS
3 ADM N STRAT VE D SPUTE RESOLUT ON PROCESS A No a e han 180 days
es ab sh and mp emen an adm n s a ve p ocess o he eso u on o c a ms o
ove cha ge o d ugs and c a ms by manu ac u e s a e he conduc o aud s
o v o a ons nc ud ng app op a e p ocedu es o he p ov s on o emed es and en-
o cemen o de e m na ons made pu suan o such p ocess h ough mechan sms
and sanc ons desc bed above
8002 HHS
B a ma o y o whom sha be ep esen a ves o nd v dua s who pa c pa e o
a e ke y o pa c pa e n he CLASS p og am and sha nc ude ep esen a ves
o o de and younge wo ke s nd v dua s w h d sab es am y ca eg ve s
nd v dua s w h expe se n ong- e m ca e o d sab y nsu ance ac ua a sc ence
econom cs and o he e evan d sc p nes as de e m ned by he Sec e a y
8002 HHS
a SOLVENCY The Sec e a y sha egu a y consu w h he Boa d o T us ees o
he CLASS ndependence Fund and he CLASS ndependence Adv so y Counc o
pu poses o ensu ng ha en o ees p em ums a e adequa e o ensu e he financ a
so vency o he CLASS p og am bo h w h espec o fisca yea s occu ng n he
nea - e m and ove 20- and 75-yea pe ods
8002 HHS
c REGULAT ONS The Sec e a y sha p omu ga e such egu a ons as a e neces-
sa y o ca y ou CLASS Such egu a ons sha nc ude p ov s ons o p even aud
and abuse unde he p og am
8002 HHS
81 p ov de ha he S a e w comp y w h such egu a ons ega d ng he ap-
p ca on o p ma y and seconda y payo u es w h espec o nd v dua s who a e
e g b e o med ca ass s ance and a e e g b e benefic a es unde CLASS as
he Sec e a y sha es ab sh
8002 HHS
c PERSONAL CARE ATTENDANTS WORKFORCE ADV SORY PANEL 1 ESTAB-
L SHMENT No a e han 90 days a e enac men o h s Ac he Sec e a y sha
es ab sh a Pe sona Ca e A endan s Wo k o ce Adv so y Pane o he pu pose o
exam n ng and adv s ng he Sec e a y and Cong ess on wo k o ce ssues e a ed o
pe sona ca e a endan wo ke s
8002 HHS
2 MEMBERSH P n appo n ng membe s o he Pe sona Ca e A endan s
Wo k o ce Adv so y Pane he Sec e a y sha ensu e ha such membe s nc ude
he o ow ng A nd v dua s w h d sab es o a ages B Sen o nd v dua s
C Rep esen a ves o nd v dua s w h d sab es D Rep esen a ves o sen o
nd v dua s E Rep esen a ves o wo k o ce and abo o gan za ons F Rep e-
sen a ves o home and commun y-based se v ce p ov de s G Rep esen a ves
o ass s ed v ng p ov de s
9023 Treasury
6 EXCEPT ON FOR CERTA N NON-TAXPAYERS The Sec e a y o he T easu y
sha no make any g an o A any Fede a S a e o oca gove nmen o any
po ca subd v s on agency o ns umen a y he eo B any o gan za on de-
sc bed n sec on 501 c o he n e na Revenue Code o 1986 and exemp om
ax unde sec on 501 a o such Code C any en y e e ed o n pa ag aph
4 o sec on 54 o such Code o D any pa ne sh p o o he pass- h u en y
any pa ne o o he ho de o an equ y o p ofi s n e es n he case o a
pa ne sh p o o he pass- h u en y pa ne s and o he ho de s o any equ y o
p ofi s n e es sha p ov de o such pa ne sh p o en y such n o ma on as he
Sec e a y o he T easu y may equ e
9023 Treasury
11 TERM NAT ON The Sec e a y o he T easu y sha no make any g an o any
pe son un ess he app ca on s ece ved be o e Janua y 1 2013
10 Title X: Medicaid, CHIP,
Women’s Health, Indian Health
10108 Treasury
2 NDEX NG n he case o any ca enda yea beg nn ng a e 2014 he Sec e a y
sha ad us he 8 pe cen and 9 8 pe cen o eflec he a e o p em um g ow h
be ween he p eced ng ca enda yea and 2013 ove he a e o ncome g ow h o
such pe od
10108 Treasury
B DETERM NAT ON OF COST The cos o any hea h p an sha be de e m ned unde
he u es o he Pub c Hea h Se v ce Ac excep ha such amoun sha be ad us ed
o age and ca ego y o en o men n acco dance w h egu a ons es ab shed by he
Sec e a y
10109 Treasury
5 CONS DERAT ON OF STANDARD ZAT ON OF ACT V T ES AND TEMS A The
Sec e a y sha so c no a e han Janua y 1 2012 and no ess han eve y 3
yea s he ea e npu on whe he he e cou d be g ea e un o m y n financ a
and adm n s a ve ac v es and ems as de e m ned app op a e by he Sec e a y
and whe he such ac v es shou d be cons de ed financ a and adm n s a ve
ansac ons
10109 Treasury
B SOL C TAT ON OF NPUT The Sec e a y sha seek npu om he Na ona
Comm ee on V a and Hea h S a s cs he H T Po cy Comm ee and he H T
S anda ds Comm ee and s anda d se ng o gan za ons and s akeho de s as
de e m ned app op a e by he Sec e a y
10109 HHS
b ACT V T ES AND TEMS FOR N T AL CONS DERAT ON The Sec e a y sha no
a e han Janua y 1 2012 seek npu on ac v es and ems e a ng o
10109 HHS
3 Whe he s anda d zed o ms cou d app y o financ a aud s equ ed by hea h
p ans Fede a and S a e agenc es and o he e evan en es as de e m ned ap-
p op a e by he Sec e a y
10109 HHS
c CD COD NG CROSSWALKS 1 CD–9 TO CD–10 CROSSWALK The Sec e a y sha
ask he CD–9–CM Coo d na on and Ma n enance Comm ee o convene a mee ng
no a e han Janua y 1 2011 o ece ve npu om app op a e s akeho de s
ega d ng he c osswa k be ween he N n h and Ten h Rev s ons o he n e na ona
C ass fica on o D seases pos ed on he CMS webs e and make ecommenda ons
abou app op a e ev s ons o such c osswa k 2 REV S ON OF CROSSWALK Fo
pu poses o he c osswa k 1 he Sec e a y sha make app op a e ev s ons and
pos any such ev sed c osswa k on he CMS webs e 3 USE OF REV SED CROSS-
WALK Any ev sed c osswa k sha be ea ed as a code se o wh ch a s anda d
has been adop ed by he Sec e a y 4 SUBSEQUENT CROSSWALKS Fo subse-
quen ev s ons o he n e na ona C ass fica on o D seases ha a e adop ed by he
Sec e a y as a s anda d code se he Sec e a y sha a e consu a on w h he
app op a e s akeho de s pos on he CMS webs e a c osswa k be ween he p ev ous
and subsequen ve s on
10201 HHS
B A S a e desc bed n h s subpa ag aph s a S a e ha s an expans on S a e
desc bed e sewhe e he Sec e a y de e m nes w no ece ve any paymen s
on he bas s o an nc eased FMAP o expend u es o med ca ass s ance o new y
e g b e nd v dua s and has no been app oved by he Sec e a y o d ve a
po on o he DSH a o men o a S a e o he cos s o p ov d ng med ca ass s ance o
o he hea h benefi s cove age unde a wa ve ha s n e ec on Ju y 2009
10201 HHS
CERTA N HOSP TAL PAYMENTS The Sec e a y may no mpose a m a on on he
o a amoun o paymen s made o hosp a s unde he QUEST sec on 1115 Demon-
s a on P o ec excep o he ex en ha such m a on s necessa y o ensu e ha a
hosp a does no ece ve paymen s o as necessa y o ensu e ha such paymen s
do no n he agg ega e n any yea exceed he amoun ha he Sec e a y de e m nes
s equa o he FMAP componen a bu ab e o DSH paymen ad us men s o such
yea ha s eflec ed n he budge neu a y p ov s on o he QUEST Demons a on
P o ec
10201 HHS
d 1 An app ca on o enewa o any expe men a p o o demons a on p o ec
unde aken n a S a e ha wou d esu n an mpac on e g b y en o men ben-
efi s cos -sha ng o financ ng sha be cons de ed by he Sec e a y n acco dance
w h he egu a ons equ ed o be p omu ga ed
10201 HHS
2 No a e han 180 days a e he da e o enac men he Sec e a y sha
p omu ga e egu a ons e a ng o app ca ons o and enewa s o a demons a on
p o ec ha p ov de o A a p ocess o pub c no ce and commen a he S a e eve
nc ud ng pub c hea ngs su fic en o ensu e a mean ng u eve o pub c npu B
equ emen s e a ng o he goa s o he p og am o be mp emen ed o enewed
he expec ed S a e and Fede a cos s and cove age p o ec ons and he
spec fic p ans o he S a e o ensu e ha he demons a on p o ec w be n comp -
ance w h e X X o XX C a p ocess o p ov d ng pub c no ce and commen a e
he app ca on s ece ved by he Sec e a y ha s su fic en o ensu e a mean ng u
eve o pub c npu D a p ocess o he subm ss on o he Sec e a y o pe od c
epo s by he S a e conce n ng mp emen a on and E a p ocess o he pe od c
eva ua on by he Sec e a y
10202 Treasury
b BALANC NG NCENT VE PAYMENT STATE A ba anc ng ncen ve paymen S a e s
a S a e 1 n wh ch ess han 50 pe cen o he o a expend u es unde he S a e
Med ca d p og am o a fisca yea o ong- e m se v ces and suppo s as defined by
he Sec e a y a e o non- ns u ona y based ong- e m se v ces and suppo s
2 ha subm s an app ca on and mee s he cond ons and 3 ha s se ec ed by
he Sec e a y o pa c pa e n he S a e ba anc ng ncen ve paymen p og am
10202 HHS
c COND T ONS The cond ons a e he o ow ng 1 APPL CAT ON The S a e sub-
m s an app ca on o he Sec e a y ha nc udes n add on o such o he n o ma on
as he Sec e a y sha equ e
10202 HHS
6 DATA COLLECT ON The S a e ag ees o co ec om p ov de s he o ow ng da a
A SERV CES DATA Se v ces da a om p ov de s o non- ns u ona y-based ong-
e m se v ces and suppo s on a pe -benefic a y bas s and n acco dance w h such
s anda d zed cod ng p ocedu es as he S a e sha es ab sh n consu a on w h he
Sec e a y B QUAL TY DATA Qua y da a on a se ec ed se o co e qua y measu es
ag eed upon by he Sec e a y and he S a e ha a e nked o popu a on-spec fic ou -
comes measu es and access b e o p ov de s C OUTCOMES MEASURES Ou comes
measu es da a on a se ec ed se o co e popu a on-spec fic ou comes measu es
ag eed upon by he Sec e a y and he S a e ha a e access b e o p ov de s
10202 HHS
DEF N T ONS 1 LONG-TERM SERV CES AND SUPPORTS DEF NED The e m ong-
e m se v ces and suppo s has he mean ng g ven ha e m by Sec e a y and may
nc ude any o he o ow ng
10203 HHS
B F SCAL YEARS 2013 AND 2014 Fo FYs 2013 and 2014 espec ve y he Sec e-
a y sha compu e a S a e a o men o each S a e
10212 HHS
ESTABL SHMENT OF PREGNANCY ASS STANCE FUND a The Sec e a y n co abo a-
on and coo d na on w h he Sec e a y o Educa on sha es ab sh a P egnancy
Ass s ance Fund o be adm n s e ed by he Sec e a y o he pu pose o awa d ng
compe ve g an s o S a es o ass s p egnan and pa en ng eens and women
10212 HHS
c APPL CAT ONS To be e g b e o ece ve a g an a S a e sha subm o he Sec-
he Sec e a y may equ e nc ud ng a desc p on o he pu poses o wh ch he g an
s be ng eques ed and he des gna on o a S a e agency o ece p and adm n s a-
on o und ng
10221 HHS
B ACT ON BY SECRETARY On an e ec on by an nd an be o ba o gan za on
he Sec e a y ac ng h ough he Se v ce sha ac a e mp emen a on o he
se v ces e ec ed
10221 HHS
4 VACANC ES The Sec e a y sha no fi any vacancy o a ce fied den s n a
p og am ope a ed by he Se v ce w h a den a hea h a de he ap s
10302 HHS
4 DENT F CAT ON A The Sec e a y sha con ac w h he ns u e o emp oy he
esu s o he s udy and he bes me hods den fied by he ns u e o he pu pose
o den y ng ex s ng and new c n ca p ac ce gu de nes ha we e deve oped us ng
such bes me hods nc ud ng gu de nes s ed n he Na ona Gu de ne C ea nghouse
B CONSULTAT ON n ca y ng ou he den fica on p ocess he Sec e a y sha
a ow o consu a on w h p o ess ona soc e es vo un a y hea h ca e o gan za ons
and expe pane s
10322 HHS
C SUBM SS ON OF QUAL TY DATA Fo a e yea 2014 and each subsequen a e
yea each psych a c hosp a and un sha subm o he Sec e a y da a on qua y
measu es Such da a sha be subm ed n a o m and manne and a a me spec -
fied by he Sec e a y
10322 HHS
D QUAL TY MEASURES Any measu e spec fied by he Sec e a y mus have been
endo sed by he con ac ed en y EXCEPT ON n he case o a spec fied a ea o
med ca op c de e m ned app op a e by he Sec e a y o wh ch a eas b e and p ac -
ca measu e has no been endo sed he Sec e a y may spec y a measu e ha s
no so endo sed as ong as due cons de a on s g ven o measu es ha have been
endo sed o adop ed by a consensus o gan za on den fied by he Sec e a y T ME
FRAME No a e han Oc obe 1 2012 he Sec e a y sha pub sh he measu es
ha w be app cab e w h espec o a e yea 2014
10322 HHS
E PUBL C AVA LAB L TY OF DATA SUBM TTED The Sec e a y sha es ab sh p oce-
du es o mak ng da a ava ab e o he pub c Such p ocedu es sha ensu e ha
a psych a c hosp a and un has he oppo un y o ev ew he da a p o o
be ng made pub c The Sec e a y sha epo qua y measu es ha e a e o se v ces
u n shed n npa en se ngs n psych a c hosp a s and un s on he CMS webs e
10323 HHS
2 D SCRET ONARY DEEM NG The Sec e a y may deem an nd v dua o be an
env onmen a exposu e a ec ed nd v dua o mee he cond ons
10323 HHS
b P LOT PROGRAM FOR CARE OF CERTA N ND V DUALS RES D NG N EMERGENCY
DECLARAT ON AREAS 1 PROGRAM PURPOSE A PR MARY P LOT PROGRAM
The Sec e a y sha es ab sh a p o p og am o p ov de nnova ve app oaches o
u n sh ng comp ehens ve coo d na ed and cos -e ec ve ca e B OPT ONAL P LOT
PROGRAMS The Sec e a y may es ab sh a sepa a e p o p og am w h espec o
each geog aph c a ea sub ec o an eme gency dec a a on o he han he dec a a on
o June 17 2009 n o de o u n sh such comp ehens ve coo d na ed and cos -
e ec ve ca e o nd v dua s 2 ND V DUAL DESCR BED An nd v dua desc bed
n h s pa ag aph s an nd v dua who en o s n pa B subm s o he Sec e a y an
app ca on o pa c pa e n he app cab e p o p og am
10323 HHS
mee s such o he c e a o cond ons o pa c pa on n a p o p og am as
he Sec e a y spec fies
10323 HHS
3 FLEX BLE BENEF TS AND SERV CES A p o p og am unde h s subsec on may
p ov de o he u n sh ng o benefi s ems o se v ces no o he w se cove ed o au-
ho zed he Sec e a y de e m nes ha u n sh ng such benefi s ems o se v ces
w u he he pu poses o such p o p og am
10323 HHS
4 NNOVAT VE RE MBURSEMENT METHODOLOG ES Fo pu poses o he p o p o-
g am he Sec e a y A sha deve op and mp emen app op a e me hodo og es o
e mbu se p ov de s o u n sh ng benefi s ems o se v ces o wh ch paymen s
no o he w se cove ed o au ho zed and B may deve op and mp emen nnova ve
app oaches o e mbu s ng p ov de s o any benefi s ems o se v ces
10323 HHS
6 WA VER AUTHOR TY The Sec e a y may wa ve such p ov s ons as a e necessa y
o ca y ou p o p og ams
10323 HHS
7 FUND NG Fo pu poses o ca y ng ou p o p og ams he Sec e a y sha p ov de
o he ans e om he Fede a Hosp a nsu ance T us Fund and he Fede a
Supp emen a y Med ca nsu ance T us Fund n such p opo on as he Sec e a y
de e m nes app op a e o such sums as he Sec e a y de e m nes necessa y o he
CMS P og am Managemen Accoun
10323 HHS
8 WA VER OF BUDGET NEUTRAL TY The Sec e a y sha no equ e ha p o p o-
10323 HHS
c DETERM NAT ONS 1 BY THE COMM SS ONER OF SOC AL SECUR TY The
whe he nd v dua s a e env onmen a exposu e a ec ed nd v dua s 2 BY THE SEC-
RETARY The Sec e a y sha de e m ne e g b y o p o p og ams
10323 HHS
been p esen o an agg ega e o a o 6 mon hs n he geog aph c a ea sub ec o an
eme gency dec a a on
Asbes os s p eu a h cken ng o p eu a p aques as es ab shed by n e p e a on
by a “B Reade ” qua fied phys c an o a p a n ches x- ay o n e p e a on o a com-
pu ed omog aph c ad og aph o he ches by a qua fied phys c an as de e m ned by
he Sec e a y o such o he d agnos c s anda ds as he Sec e a y spec fies
10323 HHS
Meso he oma o ma gnanc es o he ung co on ec um a ynx s omach esoph-
agus pha ynx o ova y as es ab shed by pa ho og c exam na on o b opsy ssue
cy o ogy om b onch oa veo a avage o such o he d agnos c s anda ds as
he Sec e a y spec fies
Any o he d agnos s wh ch he Sec e a y n consu a on w h he Comm ss one o
Soc a Secu y de e m nes s an asbes os- e a ed med ca cond on as es ab shed
by such d agnos c s anda ds as he Sec e a y spec fies
10323 HHS
3 OTHER ND V DUAL DESCR BED An nd v dua A s no an nd v dua desc bed
o a pub c hea h haza d o wh ch an eme gency dec a a on app es based on such
med ca cond ons d agnos c s anda ds and o he c e a as he Sec e a y spec fies
C as demons a ed n such manne as he Sec e a y de e m nes app op a e has
been p esen o an agg ega e o a o 6 mon hs n he geog aph c a ea sub ec o
he eme gency dec a a on nvo ved du ng a pe od de e m ned app op a e by he
Sec e a y
10323 HHS
PROGRAM FOR EARLY DETECT ON OF CERTA N MED CAL COND T ONS RELATED TO
ENV RONMENTAL HEALTH HAZARDS a PROGRAM ESTABL SHMENT The Sec e a y
sha es ab sh a p og am o make compe ve g an s o e g b e en es
10323 HHS
1 An e g b e en y s an en y wh ch subm s an app ca on o he Sec e a y
n such o m and manne and con a n ng such n o ma on and assu ances as he
Sec e a y de e m nes app op a e
10323 HHS
G Any o he en y he Sec e a y de e m nes app op a e
10323 HHS
1 AT-R SK ND V DUAL The e m “a - sk nd v dua ” means an nd v dua who A
as demons a ed n such manne as he Sec e a y de e m nes app op a e has
been p esen o an agg ega e o a o 6 mon hs n he geog aph c a ea sub ec o
an eme gency dec a a on du ng a pe od end ng no ess han 10 yea s p o
o he da e o such nd v dua s app ca on p o o he mp emen a on o a he
emed a and emova ac ons spec fied n he Reco d o Dec s on o Ope a ng Un
4 and he Reco d o Dec s on o Ope a ng Un 7 o mee s such o he c e a as
he Sec e a y de e m nes app op a e cons de ng he ype o env onmen a hea h
cond on a ssue
10323 HHS
A asbes os s p eu a h cken ng o p eu a p aques as es ab shed by n e p e-
a on by a “B Reade ” qua fied phys c an o a p a n ches x- ay o n e p e a on
o a compu ed omog aph c ad og aph o he ches by a qua fied phys c an as
de e m ned by he Sec e a y o such o he d agnos c s anda ds as he Sec e a y
spec fies
10323 HHS
B meso he oma o ma gnanc es o he ung co on ec um a ynx s omach esoph-
agus pha ynx o ova y as es ab shed by pa ho og c exam na on o b opsy ssue
cy o ogy om b onch oa veo a avage o such o he d agnos c s anda ds as
he Sec e a y spec fies
10323 HHS
C any o he med ca cond on wh ch he Sec e a y de e m nes s caused by exposu e
o a haza dous subs ance o po u an o con am nan a a Supe und s e o wh ch
an eme gency dec a a on app es based on such c e a and as es ab shed by such
d agnos c s anda ds as he Sec e a y spec fies
Health Care and Education Afford-
ability Reconciliation Act (16 Delegations)
1102 HHS
C PER OD C RANK NG
spec fied e sewhe e o
n 1 o he 50 S a es o D C he Sec e a y sha ank
such a ea n each yea spec fied e sewhe e based upon he eve o he amoun
n a e o y he Sec e a y sha ank such a eas n
each such yea based upon he eve o he amoun spec fied e sewhe e o such
a ea e a ve o qua e ank ngs compu ed
1102 HHS
1 n he case o a qua y ng p an beg nn ng w h 2012 he app cab e
pe cen age sha be nc eased on a p an o con ac eve as de e m ned by he
Sec e a y A o 2012 by 1 5 pe cen age po n s B o 2013 by 3 0 pe cen age
po n s and C o 2014 o a subsequen yea by 5 0 pe cen age po n s
1102 HHS
APPL CAT ON OF NCREASES TO LOW ENROLLMENT PLANS 2012 Fo 2012
he e m “qua y ng p an” nc udes an MA p an ha he Sec e a y de e m nes s no
ab e o have a qua y a ng because o ow en o men
1102 HHS
2013 AND SUBSEQUENT YEARS Fo 2013 onwa d o de e m n ng whe he
an MA p an w h ow en o men as defined by he Sec e a y s nc uded as a
qua y ng p an he Sec e a y sha es ab sh a me hod o app y o MA p ans w h ow
en o men as defined by he Sec e a y he compu a on o qua y a ng and he
a ng sys em
10325 HHS
a TEMPORARY DELAY OF RUG– V No w hs and ng any o he p ov s on o aw he
Sec e a y ha no p o o Oc obe 1 2011 mp emen Ve s on 4 o he Resou ce
U za on G oups RUG– V pub shed n he Fede a Reg s e on Augus 11 2009
en ed P ospec ve Paymen Sys em and Conso da ed B ng o Sk ed Nu s ng
Fac es o FY 2010 M n mum Da a Se Ve s on 3 0 o Sk ed Nu s ng Fac es and
Med ca d Nu s ng Fac es Beg nn ng Oc obe 1 2010 he Sec e a y sha mp e-
men he change spec fic o he apy u n shed on a concu en bas s and changes
o he ookback pe od o ensu e ha on y hose se v ces u n shed a e adm ss on o
a sk ed nu s ng ac y a e used as ac o s n de e m n ng a case m x c ass fica on
10326 HHS
a No a e han Janua y 1 2016 he Sec e a y sha conduc a sepa a e p o p o-
g am o es he mp emen a on o a va ue-based pu chas ng p og am o p ov de
paymen s
10326 HHS
c WA VER AUTHOR TY The Sec e a y may wa ve such equ emen s as may be
necessa y so e y o pu poses o ca y ng ou he p o p og ams
10326 HHS
d NO ADD T ONAL PROGRAM EXPEND TURES Paymen s sha be es ab shed n a
manne ha does no esu n spend ng mo e unde each such va ue based pu chas-
ng p og am o such yea han wou d o he w se be expended o such p ov de
ype o such yea he p o p og am we e no mp emen ed as es ma ed by he
Sec e a y
10326 HHS
e EXPANS ON OF P LOT PROGRAM The Sec e a y may a any po n a e Janua y 1
2018 expand he du a on and scope o a p o p og am o he ex en de e m ned
app op a e by he Sec e a y 1 he Sec e a y de e m nes ha such expans on s
expec ed o A educe spend ng w hou educ ng he qua y o ca e o B mp ove
he qua y o ca e and educe spend ng 2 he Ch e Ac ua y o CMS ce fies ha
such expans on wou d educe p og am spend ng and 3 he Sec e a y de e m nes
ha such expans on wou d no deny o m he cove age o benefi s o Med -
ca e benefic a es
10327 HHS
bb an a e na ve o m and manne de e m ned app op a e by he Sec e a y
10327 HHS
A Ma n enance o Ce fica on p og am subm s o he Sec e a y on beha o he
e g b e p o ess ona n o ma on n a o m and manne spec fied by he Sec e a y
ha he e g b e p o ess ona has success u y me he equ emen s eques ed
by he Sec e a y on he su vey o pa en expe ence w h ca e and as he
Sec e a y may equ e on he me hods measu es and da a used unde he Ma n e-
nance o Ce fica on P og am and he qua fied Ma n enance o Ce fica on P og am
p ac ce assessmen
10327 HHS
The e m “Ma n enance o Ce fica on P og am” means a con nuous assessmen
p og am such as qua fied Ame can Boa d o Med ca Spec a es Ma n enance o
Ce fica on p og am o an equ va en p og am as de e m ned by he Sec e a y ha
advances qua y and he e ong ea n ng and se -assessmen o boa d ce fied spe-
c a y phys c ans by ocus ng on he compe enc es o pa en ca e med ca know edge
p ac ce-based ea n ng n e pe sona and commun ca on sk s and p o ess ona sm
10328 HHS
C REQU RED NTERVENT ONS Fo p an yea s beg nn ng on o a e he da e ha s
2 yea s a e he da e o he enac men o PPACA p esc p on d ug p an sponso s
sha o e med ca on he apy managemen se v ces o a ge ed benefic a es ha
nc ude a a m n mum he o ow ng o nc ease adhe ence o p esc p on med ca-
ons o o he goa s deemed necessa y by he Sec e a y An annua comp ehens ve
med ca on ev ew u n shed pe son- o-pe son o us ng e ehea h echno og es as
defined by he Sec e a y by a censed pha mac s o o he qua fied p ov de
10328 HHS
The Sec e a y n consu a on w h e evan s akeho de s sha deve op a s anda d zed
o ma o he ac on p an and summa y
10328 HHS
Fo ow-up n e ven ons as wa an ed based on he find ngs o he annua
med ca on ev ew o he a ge ed med ca on en o men and wh ch may be p ov ded
pe son- o-pe son o us ng e ehea h echno og es as defined by he Sec e a y
10328 HHS
b RULE OF CONSTRUCT ON No h ng n h s sec on sha m he au ho y o he
Sec e a y o mod y o b oaden equ emen s o a med ca on he apy managemen
p og am o o s udy new mode s o med ca on he apy managemen
10329 HHS
a DEVELOPMENT The Sec e a y n consu a on w h e evan s akeho de s nc ud ng
hea h nsu ance ssue s hea h ca e consume s emp oye s hea h ca e p ov de s
and o he en es de e m ned app op a e by he Sec e a y sha deve op a me hodo -
ogy o measu e hea h p an va ue Such me hodo ogy sha ake n o cons de a on
whe e app cab e— 1 he ove a cos o en o ees unde he p an 2 he qua y o
he ca e p ov ded o unde he p an 3 he e fic ency o he p an n p ov d ng ca e
4 he e a ve sk o he p an s en o ees as compa ed o o he p ans 5 he ac ua a
va ue o o he compa a ve measu e o he benefi s cove ed unde he p an and 6
o he ac o s de e m ned e evan by he Sec e a y
10330 HHS
a The Sec e a y sha deve op a p an and de a ed budge o he esou ces needed
o mp emen such p an o mode n ze he compu e and da a sys ems o CMS
10330 HHS
b CONS DERAT ONS n deve op ng he p an he Sec e a y sha cons de how such
mode n zed compu e sys em cou d
10331 HHS
a 1 DEVELOPMENT No a e han Janua y 1 2011 he Sec e a y sha deve op a
Phys c an Compa e webs e w h n o ma on on phys c ans en o ed n Med ca e
and o he e g b e p o ess ona s who pa c pa e n he Phys c an Qua y Repo ng
n a ve
10331 HHS
2 PLAN No a e han Janua y 1 2013 and w h espec o epo ng pe ods ha
beg n no ea e han Janua y 1 2012 he Sec e a y sha a so mp emen a p an o
mak ng pub c y ava ab e h ough Phys c an Compa e n o ma on on Med ca e
phys c an pe o mance ha p ov des compa ab e n o ma on o he pub c on qua y
and pa en expe ence measu es
10331 HHS
G o he n o ma on as de e m ned app op a e by he Sec e a y
10331 HHS
b OTHER REQU RED CONS DERAT ONS n deve op ng and mp emen ng he p an
he Sec e a y sha o he ex en p ac cab e nc ude 1 p ocesses o assu e ha
da a made pub c e he by CMS o by o he en es s s a s ca y va d and e ab e
nc ud ng sk ad us men mechan sms used by he Sec e a y 2 p ocesses by wh ch
a phys c an o o he e g b e p o ess ona whose pe o mance on measu es s be ng
pub c y epo ed has a easonab e oppo un y as de e m ned by he Sec e a y o
ev ew h s o he nd v dua esu s be o e hey a e made pub c 3 p ocesses by he
Sec e a y o assu e ha he mp emen a on o he p an and he da a on Phys c an
Compa e p ov de a obus and accu a e po aya o a phys c an s pe o mance 4
da a ha eflec s he ca e p ov ded o a pa en s seen by phys c ans unde bo h he
Med ca e p og am and o he ex en p ac cab e o he paye s 5 p ocesses o en-
su e app op a e a bu on o ca e when mu p e phys c ans and o he p ov de s a e
nvo ved 6 p ocesses o ensu e me y s a s ca pe o mance eedback s p ov ded
o phys c ans conce n ng he da a sub ec o pub c epo ng and 7 mp emen a-
on o compu e and da a sys ems o CMS ha suppo va d e ab e and accu a e
pub c epo ng ac v es
10331 HHS
c ENSUR NG PAT ENT PR VACY The Sec e a y sha ensu e ha n o ma on on phys -
c an pe o mance and pa en expe ence s no d sc osed n a manne ha v o a es
he p vacy o nd v dua y den fiab e hea h n o ma on
10331 HHS
d FEEDBACK FROM MULT -STAKEHOLDER GROUPS The Sec e a y sha ake n o
cons de a on npu p ov ded by mu -s akeho de g oups n se ec ng qua y
measu es
10331 HHS
e CONS DERAT ON OF TRANS T ON TO VALUE-BASED PURCHAS NG n deve op ng
he p an he Sec e a y sha as he Sec e a y de e m nes app op a e cons de
he p an o ans on o a va ue-based pu chas ng p og am o phys c ans and o he
p ac one s
10331 HHS
g EXPANS ON A any me be o e he epo s subm ed he Sec e a y may
expand he n o ma on made ava ab e on such webs e
10331 HHS
h F NANC AL NCENT VES TO ENCOURAGE CONSUMERS TO CHOOSE H GH QUAL TY
PROV DERS The Sec e a y may es ab sh a demons a on p og am no a e han
Janua y 1 2019 o p ov de financ a ncen ves o Med ca e benefic a es who a e
u n shed se v ces by h gh qua y phys c ans as de e m ned by he Sec e a y n
no case may Med ca e benefic a es be equ ed o pay nc eased p em ums o cos
sha ng o be sub ec o a educ on n benefi s as a esu o such demons a on
p og am The Sec e a y sha ensu e ha any such demons a on p og am does no
d sadvan age hose benefic a es w hou easonab e access o h gh pe o m ng phys -
c ans o c ea e financ a nequ es
10332 HHS
e AVA LAB L TY OF MED CARE DATA 1 The Sec e a y sha make ava ab e o
qua fied en es da a o he eva ua on o he pe o mance o p ov de s o
se v ces and supp e s
10332 HHS
2 QUAL F ED ENT T ES The e m “qua fied en y” means a pub c o p va e en y
ha A s qua fied as de e m ned by he Sec e a y o use c a ms da a o eva ua e he
pe o mance o p ov de s o se v ces and supp e s on measu es o qua y e fic ency
e ec veness and esou ce use and B ag ees o mee he equ emen s desc bed
e sewhe e and mee s such o he equ emen s as he Sec e a y may spec y such as
ensu ng secu y o da a
10332 HHS
3 DATA DESCR BED The da a a e s anda d zed ex ac s as de e m ned by he
Sec e a y o c a ms da a unde pa s A B and D o ems and se v ces The Sec e-
a y sha ake such ac ons as he Sec e a y deems necessa y o p o ec he den y
o nd v dua s en ed o o en o ed o benefi s unde such pa s
10332 HHS
use a e na ve measu es he Sec e a y n consu a on w h app op a e s ake-
ho de s de e m nes ha wou d be mo e va d e ab e espons ve o consume
p e e ences cos -e ec ve o e evan o d mens ons o qua y and esou ce use no
add essed by such s anda d measu es
10332 HHS
on y nc ude n o ma on on a p ov de o se v ces o supp e n an agg ega e o m
as de e m ned app op a e by he Sec e a y
10332 HHS
D APPROVAL AND L M TAT ON OF USES The Sec e a y sha no make da a ava -
ab e o a qua fied en y un ess he qua fied en y ag ees o e ease he n o ma on
on he eva ua on o pe o mance o p ov de s o se v ces and supp e s
10333 HHS
a The Sec e a y may awa d g an s o e g b e en es o suppo commun y-based
co abo a ve ca e ne wo ks
10333 HHS
b COMMUN TY-BASED COLLABORAT VE CARE NETWORKS 1 DESCR PT ON A
commun y-based co abo a ve ca e ne wo k sha be a conso um o hea h ca e
p ov de s w h a o n gove nance s uc u e ha p ov des comp ehens ve coo d na -
ed and n eg a ed hea h ca e se v ces as defined by he Sec e a y o ow- ncome
popu a ons
10333 HHS
3 PR OR TY n awa d ng g an s he Sec e a y sha g ve p o y o ne wo ks ha
nc ude
10333 HHS
c APPL CAT ON 1 APPL CAT ON A ne wo k sha subm an app ca on o he
Sec e a y 2 RENEWAL n subsequen yea s based on he pe o mance o g an ees
he Sec e a y may p ov de enewa g an s o p o yea g an ec p en s
10333 HHS
2 GRANT FUNDS TO HRSA GRANTEES The Sec e a y may m he pe cen o g an
und ng ha may be spen on d ec ca e se v ces p ov ded by g an ees o p og ams
adm n s e ed by he Hea h Resou ces and Se v ces Adm n s a on o mpose o he
equ emen s on such g an ees deemed necessa y
10333 HHS
A n subsec on a by s k ng … and nse ng … sha be ans e ed o he O fice
o he Sec e a y n such manne ha he e s es ab shed n he O fice o he Sec e a y
he O fice o M no y Hea h wh ch sha be headed by he Depu y Ass s an Sec e a y
o M no y Hea h who sha epo d ec y o he Sec e a y … n ca y ng ou h s
subsec on he Sec e a y ac ng h ough he Depu y Ass s an Sec e a y sha awa d
g an s con ac s en e n o memo anda o unde s and ng coope a ve n e agency
n a-agency and o he … and o he a eas as de e m ned by he Sec e a y
10333 HHS
e FUND NG 1 ALLOCAT ONS O he amoun s app op a ed o a spec fied agency
o a fisca yea he Sec e a y mus des gna e an app op a e amoun o unds o he
pu pose o ca y ng ou ac v es h ough he m no y hea h o fice o he agency n
ese v ng an amoun o a m no y hea h o fice o a fisca yea he Sec e a y sha
educe by subs an a y he same pe cen age he amoun ha o he w se wou d be
ava ab e o each o he p og ams o he des gna ed agency nvo ved
10407 HHS
b NAT ONAL D ABETES REPORT CARD 1 The Sec e a y n co abo a on w h he
D ec o o CDC sha p epa e on a b enn a bas s a na ona d abe es epo ca d
and o he ex en poss b e o each S a e
10407 HHS
3 AVA LAB L TY The Sec e a y n co abo a on w h he D ec o sha make each
Repo Ca d pub c y ava ab e nc ud ng by pos ng he Repo Ca d on he n e ne
10407 HHS
c MPROVEMENT OF V TAL STAT ST CS COLLECT ON 1 N GENERAL The Sec e a y
ac ng h ough he D ec o o CDC and n co abo a on w h app op a e agenc es and
S a es sha A p omo e he educa on and a n ng o phys c ans on he mpo ance o
b h and dea h ce fica e da a and how o p ope y comp e e hese documen s B
encou age S a e adop on o he a es s anda d ev s ons o b h and dea h ce fi-
ca es and C wo k w h S a es o e-eng nee he v a s a s cs sys ems n o de o
p ov de cos -e ec ve me y and accu a e v a sys ems da a
10407 HHS
2 DEATH CERT F CATE ADD T ONAL LANGUAGE The Sec e a y may p omo e
mp ovemen s o he co ec on o d abe es mo a y da a nc ud ng he add on o
a ques on o he nd v dua ce y ng he cause o dea h ega d ng whe he he
deceased had d abe es
10407 HHS
1 The Sec e a y sha n co abo a on w h he oM and app op a e assoc a ons and
counc s conduc a s udy o he mpac o d abe es on he p ac ce o med c ne and
he app op a eness o he eve o d abe es med ca educa on ha shou d be equ ed
p o o censu e boa d ce fica on and boa d ece fica on
10408 HHS
a ESTABL SHMENT The Sec e a y sha awa d g an s o e g b e emp oye s o p ov de
he emp oyees w h access o comp ehens ve wo kp ace we ness p og ams
10408 HHS
c COMPREHENS VE WORKPLACE WELLNESS PROGRAMS 1 CR TER A The Sec e-
a y sha deve op p og am c e a o comp ehens ve wo kp ace we ness p og ams
based on and cons s en w h ev dence based esea ch and bes p ac ces
10408 HHS
d APPL CAT ON An e g b e emp oye des ng o pa c pa e n he g an p og am sha
subm an app ca on o he Sec e a y n such manne and con a n ng such n o ma-
on as he Sec e a y may equ e wh ch sha nc ude a p oposa o a comp ehens ve
wo kp ace we ness p og am ha mee he c e a and equ emen s
10409 HHS
CHA RPERSON AND V CE CHA RPERSON The Sec e a y sha des gna e om
among he 24 membe s one Cha pe son o he Boa d and one V ce Cha pe son
10409 HHS
C QUAL F CAT ONS The Sec e a y sha appo n nd v dua s o he Boa d based
so e y upon he nd v dua s es ab shed eco d o d s ngu shed se v ce Each nd -
v dua appo n ed o he Boa d sha be o d s ngu shed ach evemen and have a b oad
ange o d sc p na y n e es s EXPERT SE The Sec e a y sha se ec nd v dua s
based upon he o ow ng equ emen s Fo each o he fie ds o aa bas c esea ch
bb med c ne cc b opha maceu ca s dd d scove y and de ve y o med ca
p oduc s ee b o n o ma cs and gene he apy med ca ns umen a on and gg
egu a o y ev ew and app ova o med ca p oduc s he Sec e a y sha se ec a eas
1 nd v dua who s em nen n such fie ds
10409 HHS
3 EX-OFF C O MEMBERS A APPO NTMENT n add on o he 24 Boa d membe s
he Sec e a y sha appo n as ex-o fic o membe s o he Boa d
10410 HHS
b GRANT PROGRAM 1 The Sec e a y ac ng h ough he Adm n s a o sha awa d
g an s on a compe ve bas s o e g b e en es o es ab sh na ona cen e s o exce -
ence o dep ess on
1102 HHS
A new MA p an ha mee s c e a spec fied by he Sec e a y sha be ea ed as
a qua y ng p an excep ha he app cab e pe cen age sha be nc eased aa
o 2012 by 1 5 pe cen age po n s bb o 2013 by 2 5 pe cen age po n s and cc
o 2014 o a subsequen yea by 3 5 pe cen age po n s
1102 HHS
B PLANS THAT FA LED TO REPORT An MA p an wh ch does no epo da a ha
enab es he Sec e a y o a e he p an sha be coun ed as hav ng a a ng o
ewe han 3 5 s a s
1102 HHS
V Such ad us men sha be app ed o sk sco es un he Sec e a y mp emen s
sk ad us men us ng Med ca e Advan age d agnos c cos and use da a
1103 HHS
4 REQU REMENT FOR M N MUM MED CAL LOSS RAT O he Sec e a y de e m nes
o a con ac yea beg nn ng w h 2014 ha an MA p an has a ed o have a med ca
oss a o o a eas 85 A he MA p an sha em o he Sec e a y an amoun equa
o he p oduc o he o a evenue o he MA p an o he con ac yea and
he d e ence be ween 85 and he med ca oss a o B o 3 consecu ve con ac
yea s he Sec e a y sha no pe m he en o men o new en o ees du ng he
second succeed ng con ac yea and C he Sec e a y sha e m na e he p an con-
ac he p an a s o have such a med ca oss a o o 5 consecu ve con ac yea s
(148 Delegations)
10410 HHS
2 ALLOCAT ON OF AWARDS he unds au ho zed unde subsec on a e app op -
a ed n he amoun s p ov ded o unde such subsec on he Sec e a y sha a oca e
such amoun s so ha
10410 HHS
3 GRANT PER OD A A g an sha be o a pe od o 5 yea s B RENEWAL A
g an may be enewed on a compe ve bas s o 1 add ona 5-yea pe od a he
d sc e on o he Sec e a y n de e m n ng whe he o enew a g an he Sec e a y
sha cons de he epo ca ds
10410 HHS
A REQU REMENTS To be e g b e o ece ve a g an an en y sha be an ns u-
on o h ghe educa on o a pub c o p va e nonp ofi esea ch ns u on and
subm an app ca on o he Sec e a y a such me and n such manne as he
Sec e a y may equ e
10410 HHS
such o he n o ma on as he Sec e a y may equ e
10410 HHS
C PR OR T ES n awa d ng g an s he Sec e a y sha g ve p o y o e g b e en -
es ha mee 1 o mo e o he o ow ng c e a
10410 HHS
6 NAT ONAL COORD NAT NG CENTER A The Sec e a y ac ng h ough he
Adm n s a o sha des gna e 1 g an ec p en o be he coo d na ng cen e o
exce ence o dep ess on The Sec e a y sha se ec such coo d na ng cen e on a
compe ve bas s based upon he demons a ed capac y o such cen e o pe o m
he du es desc bed e sewhe e B APPL CAT ON A Cen e ha has been awa ded a
g an may app y o des gna on as he coo d na ng cen e by subm ng an app -
ca on o he Sec e a y a such me n such manne and con a n ng such n o ma on
as he Sec e a y may equ e
10410 HHS
7 MATCH NG FUNDS The Sec e a y may no awa d a g an o con ac o an en y
un ess he en y ag ees ha w make ava ab e d ec y o h ough con bu ons
om o he pub c o p va e en es non-Fede a con bu ons owa d he ac v es
o be ca ed ou unde he g an o con ac n an amoun equa o $1 o each $5 o
Fede a unds
10410 HHS
D o he n o ma on as he Sec e a y may equ e
10410 HHS
e ESTABL SHMENT OF STANDARDS REPORT CARDS AND RECOMMENDAT ONS
TH RD PARTY REV EW 1 ESTABL SHMENT OF STANDARDS The Sec e a y ac ng
h ough he Adm n s a o sha es ab sh pe o mance s anda ds o A each Cen e
and B he ne wo k o Cen e s as a who e 2 REPORT CARDS The Sec e a y ac ng
h ough he Adm n s a o sha A o each Cen e no a e han 3 yea s a e he
da e on wh ch such cen e o exce ence s es ab shed and annua y he ea e ssue
a epo ca d o he coo d na ng cen e o a e he pe o mance o such Cen e and
B no a e han 3 yea s a e he da e on wh ch he fi s g an s awa ded unde
subsec on b 1 and annua y he ea e ssue a epo ca d o Cong ess o a e he
pe o mance o he ne wo k o cen e s o exce ence as a who e
10410 HHS
3 RECOMMENDAT ONS Based upon he epo ca ds he Sec e a y sha no
a e han Sep embe 30 2015 A make ecommenda ons o he Cen e s ega d ng
mp ovemen s such cen e s sha make and B make ecommenda ons o Cong ess
o expand ng he Cen e s o se ve nd v dua s w h o he ypes o men a d so de s
10410 HHS
4 TH RD PARTY REV EW No a e han 3 yea s a e he da e on wh ch he fi s g an
s awa ded and annua y he ea e he Sec e a y sha a ange o an ndependen
h d pa y o conduc an eva ua on o he ne wo k o Cen e s o ensu e ha such
cen e s a e mee ng he goa s
10410 HHS
2 ALLOCAT ON OF FUNDS AUTHOR ZED O he amoun app op a ed o a fisca
yea he Sec e a y sha de e m ne he a oca on o each Cen e bu n no case may
he a oca on be mo e han $5 000 000 excep ha he Sec e a y may a oca e no
mo e han $10 000 000 o he coo d na ng cen e
10411 HHS
a The Sec e a y ac ng h ough he D ec o o CDC may 1 enhance and expand
n as uc u e o ack he ep dem o ogy o congen a hea d sease and o o gan ze
such n o ma on n o a na ona y- ep esen a ve popu a on-based su ve ance
sys em ha comp es da a conce n ng ac ua occu ences o congen a hea d sease
o 2 awa d a g an o one e g b e en y o unde ake he desc bed ac v es
10411 HHS
e PAT ENT PR VACY The Sec e a y sha ensu e ha he Congen a Hea D sease
Su ve ance Sys em s ma n a ned n a manne ha comp es w h he egu a ons
o H PPA
10411 HHS
2 subm o he Sec e a y an app ca on a such me n such manne and
con a n ng such n o ma on as he Sec e a y may equ e
10413 HHS
a PUBL C EDUCAT ON CAMPA GN 1 The Sec e a y ac ng h ough he D ec o
o CDC sha conduc a na ona ev dence-based educa on campa gn o nc ease
awa eness o young women s know edge ega d ng
10413 HHS
3 MED A CAMPA GN n conduc ng he educa on campa gn he Sec e a y sha
awa d g an s o en es o es ab sh na ona mu med a campa gns o en ed o young
women ha may nc ude adve s ng h ough e ev s on ad o p n med a b boa ds
pos e s a o ms o ex s ng and espec a y eme g ng soc a ne wo k ng med a o he
n e ne med a and any o he med um de e m ned app op a e by he Sec e a y
10413 HHS
4 ADV SORY COMM TTEE A ESTABL SHMENT No a e han 60 days a e he
da e o he enac men o h s sec on he Sec e a y ac ng h ough he D ec o o
CDDDC sha es ab sh an adv so y comm ee o ass s n c ea ng and conduc -
ng he educa on campa gns B MEMBERSH P The Sec e a y ac ng h ough
he D ec o o CDC sha appo n o he adv so y comm ee such membe s as
deemed necessa y o p ope y adv se he Sec e a y and sha nc ude o gan za ons
and nd v dua s w h expe se n b eas cance d sease p even on ea y de ec on
d agnos s pub c hea h soc a ma ke ng gene c sc een ng and counse ng ea -
men ehab a on pa a ve ca e and su v vo sh p n young women
10413 HHS
b HEALTH CARE PROFESS ONAL EDUCAT ON CAMPA GN The Sec e a y ac ng
h ough he D ec o o CDC and n consu a on w h he Adm n s a o o he Hea h
Resou ces and Se v ces Adm n s a on sha conduc an educa on campa gn among
phys c ans and o he hea h ca e p o ess ona s o nc ease awa eness
10413 HHS
c PREVENT ON RESEARCH ACT V T ES The Sec e a y ac ng h ough 1 he D ec o
o CDC sha conduc p even on esea ch on b eas cance n younge women 2
he D ec o o N H sha conduc esea ch o deve op and va da e new sc een ng es s
and me hods o p even on and ea y de ec on o b eas cance n young women
10413 HHS
d SUPPORT FOR YOUNG WOMEN D AGNOSED W TH BREAST CANCER 1 The Sec e-
a y sha awa d g an s o o gan za ons and ns u ons o p ov de hea h n o ma on
om c ed b e sou ces and subs an ve ass s ance d ec ed o young women d agnosed
w h b eas cance and p e-neop as c b eas d seases 2 PR OR TY n mak ng g an s
he Sec e a y sha g ve p o y o app can s ha dea spec fica y w h young
women d agnosed w h b eas cance and p e-neop as c b eas d sease
10413 HHS
MEASUREMENT REPORT NG The Sec e a y ac ng h ough he D ec o o CDC
sha 1 measu e 2 no ess han eve y 3 yea s measu e he mpac o such ac v -
es and 3 subm epo s o he Cong ess on he esu s o such measu emen s
10501 HHS
a The Sec e a y ac ng h ough he D ec o o CDC sha es ab sh a na ona
d abe es p even on p og am a ge ed a adu s a h gh sk o d abe es n o de o
e m na e he p even ab e bu den o d abe es
10501 HHS
c EL G BLE ENT T ES To be e g b e o a g an an en y sha be a S a e o oca
hea h depa men a ba o gan za on a na ona ne wo k o commun y-based
nonp ofi s ocused on hea h and we be ng an academ c ns u on o o he en y as
he Sec e a y de e m nes
10501 HHS
o DEVELOPMENT AND MPLEMENTAT ON OF PROSPECT VE PAYMENT SYSTEM 1
DEVELOPMENT A The Sec e a y sha deve op a p ospec ve paymen sys em o
paymen o Fede a y qua fied hea h cen e se v ces Such sys em may nc ude
ad us men s nc ud ng geog aph c ad us men s de e m ned app op a e by he
Sec e a y
10501 HHS
B COLLECT ON OF DATA AND EVALUAT ON By no a e han Janua y 1 2011 he
Sec e a y sha equ e Fede a y qua fied hea h cen e s o subm o he Sec e a y
such n o ma on as he Sec e a y may equ e n o de o deve op and mp emen he
p ospec ve paymen sys em
10501 HHS
2 MPLEMENTAT ON A The Sec e a y sha p ov de o cos epo ng pe ods
beg nn ng on o a e Oc obe 1 2014 o paymen s o p ospec ve paymen a es o
Fede a y qua fied hea h cen e se v ces
10501 HHS
B PAYMENTS N T AL PAYMENTS The Sec e a y sha mp emen such p ospec-
ve paymen sys em so ha he es ma ed agg ega e amoun o p ospec ve paymen
a es s equa o 100 pe cen o he es ma ed amoun o easonab e cos s ha
wou d have occu ed o such se v ces he sys em had no been mp emen ed
10501 HHS
C PREPARAT ON FOR PPS MPLEMENTAT ON The Sec e a y may es ab sh and
mp emen by p og am ns uc on o o he w se he paymen codes o be used unde
he p ospec ve paymen sys em
10501 HHS
a The Sec e a y ac ng h ough he Adm n s a o o he Hea h Resou ces and
Se v ces Adm n s a on sha es ab sh a g an p og am o he pu poses o ass s ng
e g b e en es n ec u ng s uden s mos ke y o p ac ce med c ne n unde se ved
u a commun es p ov d ng u a - ocused a n ng and expe ence and nc eas ng he
numbe o ecen a opa h c and os eopa h c med ca schoo g adua es who p ac ce n
unde se ved u a commun es
10501 HHS
c PR OR TY n awa d ng g an unds he Sec e a y sha g ve p o y o e g b e
en es ha 1 demons a e a eco d o success u y a n ng s uden s as de e -
m ned by he Sec e a y who p ac ce med c ne n unde se ved u a commun es 2
demons a e ha an ex s ng academ c p og am o he e g b e en y p oduces a h gh
pe cen age as de e m ned by he Sec e a y o g adua es om such p og am who
p ac ce med c ne n unde se ved u a commun es
10501 HHS
A c n ca o a ons n unde se ved u a commun es and n app cab e spec a es
o o he cou sewo k o c n ca expe ence deemed app op a e by he Sec e a y
10501 HHS
e ANNUAL REPORT NG An e g b e en y ece v ng a g an sha subm an annua
epo o he Sec e a y on he success o he P og am based on c e a he Sec e a y
de e m nes app op a e nc ud ng he es dency p og am se ec on o g adua ng
s uden s who pa c pa ed n he P og am
10501 HHS
REGULAT ONS No a e han 60 days a e he da e o enac men he Sec e a y
sha by egu a on define “unde se ved u a commun y”
10501 HHS
a GRANTS The Sec e a y ac ng h ough he Adm n s a o o he Hea h Resou ces
and Se v ces Adm n s a on and n consu a on w h he D ec o o CDC sha awa d
g an s o o en e n o con ac s w h e g b e en es o p ov de a n ng o g adua e
med ca es den s n p even ve med c ne spec a es
10501 HHS
A n pa ag aph 1 by s k ng n ca y ng ou subpa and a ha o ows h ough
he pe od and nse ng n ca y ng ou subpa he Sec e a y may n acco dance
w h h s subsec on ssue wa ve s o nd v dua s who have en e ed n o a con ac o
ob ga ed se v ce unde he Scho a sh p P og am o he Loan Repaymen P og am un-
de wh ch he nd v dua s a e au ho zed o sa s y he equ emen o ob ga ed se v ce
h ough p ov d ng c n ca p ac ce ha s ha me
10501 HHS
4 Sec on 338B g 2 A o he Pub c Hea h Se v ce Ac 42 U S C 254 –1 g 2 A
s amended by s k ng $35 000 and nse ng $50 000 p us beg nn ng w h fis-
ca yea 2012 an amoun de e m ned by he Sec e a y on an annua bas s o eflec
10503 HHS
b FUND NG The e s au ho zed o be app op a ed and he e s app op a ed ou
o any mon es n he T easu y no o he w se app op a ed o he CHC Fund 1 o be
ans e ed o he Sec e a y o p ov de enhanced und ng o he commun y hea h
cen e p og am
10504 HHS
a No a e han 6 mon hs a e he da e o enac men o h s Ac he Sec e a y
ac ng h ough he Hea h Resou ces and Se v ces Adm n s a on sha es ab sh a
3 yea demons a on p o ec n up o 10 S a es o p ov de access o comp ehens ve
hea h ca e se v ces o he un nsu ed a educed ees The Sec e a y sha eva ua e he
eas b y o expand ng he p o ec o add ona S a es
10504 HHS
b EL G B L TY To be e g b e an en y sha be a S a e-based nonp ofi pub c-
p va e pa ne sh p ha p ov des access o comp ehens ve hea h ca e se v ces o
he un nsu ed a educed ees Each S a e n wh ch a pa c pan se ec ed by he
Sec e a y s oca ed sha ece ve no mo e han $2 000 000 o es ab sh and ca y
ou he p o ec o he 3-yea demons a on pe od
10607 HHS
a The Sec e a y s au ho zed o awa d demons a on g an s o S a es o he
deve opmen mp emen a on and eva ua on o a e na ves o cu en o ga on
o eso v ng d spu es ove n u es a eged y caused by hea h ca e p ov de s o hea h
ca e o gan za ons n awa d ng such g an s he Sec e a y sha ensu e he d ve s y
o he a e na ves so unded b DURAT ON The Sec e a y may awa d g an s o a
pe od no o exceed 5 yea s
10607 HHS
5 PREFERENCE N AWARD NG DEMONSTRAT ON GRANTS n awa d ng g an s unde
subsec on a he Sec e a y sha g ve p e e ence o S a es
10607 HHS
d APPL CAT ON 1 Each S a e des ng a g an sha subm o he Sec e a y an
app ca on a such me n such manne and con a n ng such n o ma on as he
Sec e a y may equ e
10607 HHS
2 REV EW PANEL A n ev ew ng app ca ons he Sec e a y sha consu w h a
ev ew pane composed o e evan expe s appo n ed by he Comp o e Gene a
10607 HHS
1 The Sec e a y sha p ov de echn ca ass s ance o he S a es app y ng o o
awa ded g an s
10607 HHS
g EVALUAT ON 1 The Sec e a y sha en e n o a con ac w h an app op a e
esea ch o gan za on o conduc an ove a eva ua on o he e ec veness o g an s
and o annua y p epa e and subm a epo o Cong ess
10607 HHS
OPT ON TO PROV DE FOR N T AL PLANN NG GRANTS O he unds app op a ed
he Sec e a y may use a po on no o exceed $500 000 pe S a e o p ov de p ann ng
g an s o such S a es o he deve opmen o demons a on p o ec n se ec ng
S a es o ece ve such p ann ng g an s he Sec e a y sha g ve p e e ence o hose
S a es n wh ch S a e aw a he me o he app ca on wou d no p oh b he adop on
o an a e na ve o cu en o ga on
10609 HHS
he app ca on s o he w se e g b e o app ova bu o exp a on o pa en an
exc us v y pe od o o a de ay n app ova and a ev s on o he abe ng o he
s ed d ug has been app oved by he Sec e a y w h n 60 days o such exp a on
he abe ng ev s on does no nc ude a change o he “Wa n ngs” sec on o he
abe ng he sponso o he app ca on ag ees o subm ev sed abe ng o he
d ug ha s he sub ec o such app ca on no a e han 60 days a e he no fica on
o any changes o such abe ng equ ed by he Sec e a y and v such app ca on
o he w se mee s he app cab e equ emen s o app ova
10609 HHS
B a e a abe ng ev s on he Sec e a y de e m nes ha he con nued p esence
n n e s a e comme ce o he abe ng o he s ed d ug adve se y mpac s he sa e
use o he d ug no app ca on sha be e g b e o app ova w h such abe ng
10907 HHS
2 COLLECT ON Eve y pe son ece v ng a paymen o se v ces on wh ch a ax s
mposed sha co ec he amoun o he ax om he nd v dua on whom he se v ce
s pe o med and em such ax qua e y o he Sec e a y a such me and n such
manne as p ov ded by he Sec e a y
1405 HHS
D … any o he med ca dev ce de e m ned by he Sec e a y o be o a ype wh ch
s gene a y pu chased by he gene a pub c a e a o nd v dua use
1409 Treasury
B TREATMENT OF FEES AND FORE GN TAXES Fees and o he ansac on expenses
sha be aken n o accoun as expenses n de e m n ng p e- ax p ofi The Sec-
e a y sha ssue egu a ons equ ng o e gn axes o be ea ed as expenses n
de e m n ng p e ax p ofi n app op a e cases
1409 Treasury
3 SPEC AL RULE FOR AMENDED RETURNS n no even sha any amendmen o
supp emen o a e u n o ax be aken n o accoun fi ed a e he ea e o
he da e he axpaye s fi s con ac ed by he Sec e a y ega d ng he exam na on
o he e u n o such o he da e as s spec fied by he Sec e a y
1409 HHS
e EXCLUS ON OF ORPHAN DRUGS FOR CERTA N COVERED ENT T ES Fo cove ed
en es he e m ”cove ed ou pa en d ug” sha no nc ude a d ug des gna ed by
he Sec e a y unde sec on 526 o he Fede a Food D ug and Cosme c Ac o a
a e d sease o cond on