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Federal Register / Vol. 72, No.

189 / Monday, October 1, 2007 / Notices 55775

Dated: September 25, 2007. Centers for Medicare & Medicaid received before the close of the
Maryam I. Daneshvar, Services, Department of Health and comment period on the following Web
Acting Reports Clearance Officer, Centers for Human Services, Attention: CMS– site as soon as possible after they have
Disease Control and Prevention. 1399—GNC, P.O. Box 8013, Baltimore, been received: http://www.cms.hhs.gov/
[FR Doc. E7–19301 Filed 9–28–07; 8:45 am] MD 21244–8013. eRulemaking. Click on the link
BILLING CODE 4163–18–P Please allow sufficient time for mailed ‘‘Electronic Comments on CMS
comments to be received before the Regulations’’ on that Web site to view
close of the comment period. public comments.
DEPARTMENT OF HEALTH AND 3. By express or overnight mail. You Comments received timely will also
HUMAN SERVICES may send written comments (one be available for public inspection as
original and two copies) to the following they are received, generally beginning
Centers for Medicare & Medicaid address ONLY: Centers for Medicare & approximately 3 weeks after publication
Services Medicaid Services, Department of of a document, at the headquarters of
[CMS–1399–GNC] Health and Human Services, Attention: the Centers for Medicare & Medicaid
CMS–1399—GNC Mail Stop C4–26–05, Services, 7500 Security Boulevard,
RIN 0938–ZB02 7500 Security Boulevard, Baltimore, MD Baltimore, Maryland 21244, Monday
21244–1850. through Friday of each week from 8:30
Medicare Program; Criteria and 4. By hand or courier. If you prefer, a.m. to 4 p.m. To schedule an
Standards for Evaluating Intermediary you may deliver (by hand or courier) appointment to view public comments,
and Carrier Performance During Fiscal your written comments (one original phone 1–800–743–3951.
Year 2008 and two copies) before the close of the
comment period to one of the following I. Background
AGENCY: Centers for Medicare and
Medicaid Services (CMS), HHS. addresses. If you intend to deliver your A. Medicare Part A—Hospital Insurance
ACTION: General notice with comment comments to the Baltimore address, Under section 1816 of the Social
period. please call telephone number (410) 786– Security Act (the Act), public or private
7195 in advance to schedule your organizations and agencies participate
SUMMARY: This general notice with arrival with one of our staff members. in the administration of Part A (Hospital
comment period describes the criteria 7500 Security Boulevard, Baltimore, MD Insurance) of the Medicare program
and standards to be used for evaluating 21244–1850; or Room 445–G, Hubert H. under agreements with CMS. These
the performance of fiscal intermediaries Humphrey Building, 200 Independence agencies or organizations, known as
(FI) and carriers in the administration of Avenue, SW., Washington, DC 20201. fiscal intermediaries (FIs), determine
the Medicare program. (Because access to the interior of the
whether medical services are covered
The results of these evaluations are HHH Building is not readily available to
under Medicare, determine correct
considered whenever we enter into, persons without Federal Government
payment amounts and then make
renew, or terminate a FI agreement, identification, commenters are
payments to the health care providers
carrier contract, or take other contract encouraged to leave their comments in
(for example, hospitals, skilled nursing
actions, for example, assigning or the CMS drop slots located in the main
facilities (SNFs), and community mental
reassigning providers or services to a FI lobby of the building. A stamp-in clock
health centers) on behalf of the
or designating regional or national is available for persons wishing to retain
beneficiaries. Section 1816(f) of the Act
intermediaries. We are requesting public a proof of filing by stamping in and
requires us to develop criteria,
comment on these criteria and retaining an extra copy of the comments
standards, and procedures to evaluate
standards. being filed.)
an FI’s performance of its functions
DATES: Effective Date: The criteria and Comments mailed to the addresses
under its agreement.
standards are effective on October 1, indicated as appropriate for hand or
Section 1816(e)(4) of the Act requires
2007. courier delivery may be delayed and
us to designate regional agencies or
Comment Date: To be assured received after the comment period.
organizations, which are already
consideration, comments must be no For information on viewing public
Medicare FIs under section 1816 of the
later than 5 p.m. on November 30, 2007. comments, see the beginning of the
Act, to perform claim processing
SUPPLEMENTARY INFORMATION section.
ADDRESSES: In commenting, please refer functions for freestanding home health
to file code CMS–1399–GNC. Because of FOR FURTHER INFORMATION CONTACT: Lee agency (HHA) claims. We refer to these
staff and resource limitations, we cannot Ann Crochunis, (410) 786–3363. organizations as Regional Home Health
accept comments by facsimile (FAX) SUPPLEMENTARY INFORMATION: Intermediaries (RHHIs) under the 42
transmission. Submitting Comments: We welcome CFR 421.117.
You may submit comments in one of comments from the public on all issues The evaluation of FI, performance is
four ways (no duplicates, please): set forth in this notice to assist us in part of our contract management
1. Electronically. You may submit fully considering issues and developing process. These evaluations need not be
electronic comments on specific issues policies. You can assist us by limited to the current fiscal year (FY),
in this regulation to http:// referencing the file code CMS–1399— other fixed term basis, or agreement
www.cms.hhs.gov/eRulemaking. Click GNC and the specific ‘‘issue identifier’’ term.
on the link ‘‘Submit electronic that precedes the section on which you
comments on CMS regulations with an choose to comment. B. Medicare Part B—Supplementary
open comment period.’’ (Attachments Inspection of Public Comments: All Medical Insurance
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should be in Microsoft Word, comments received before the close of Under section 1842 of the Act, we are
WordPerfect, or Excel; however, we the comment period are available for authorized to enter into contracts with
prefer Microsoft Word.) viewing by the public, including any carriers to fulfill various functions in
2. By regular mail. You may mail personally identifiable or confidential the administration of Part B,
written comments (one original and two business information that is included in Supplementary Medical Insurance of
copies) to the following address ONLY: a comment. We post all comments the Medicare program. Beneficiaries,

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55776 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Notices

physicians, and suppliers of services impact on the criteria and standards evaluation is to ensure that contractors
submit claims to these carriers. The previously published, or that require the meet their contractual obligations. We
carriers determine whether the services addition of new criteria or standards, or measure contractor performance to
are covered under Medicare and the that cause the deletion of previously ensure that contractors do what is
amount payable for the services or published criteria and standards. If we required of them by statute, regulation,
supplies, and then make payment to the must make these changes, we will contract, and our directives.
appropriate party. publish an amended Federal Register We have developed a contractor
Under section 1842(b)(2) of the Act, notice before implementation of the oversight program for FY 2008 that
we are required to develop criteria, changes. In all instances, necessary outlines what is expected of the
standards, and procedures to evaluate a manual issuances will be published to contractor; measures the performance of
carrier’s performance of its functions ensure that the criteria and standards the contractor; evaluates the contractor’s
under its contract. Evaluations of are applied uniformly and accurately. performance against those expectations;
Medicare fee-for-service (FFS) Also, as in previous years, this Federal and provides for appropriate contract
contractor performance need not be Register notice will be republished and action based upon the evaluation of the
limited to the current Federal Fiscal the effective date revised if changes are contractor’s performance.
Year (FFY), other fixed term basis, or warranted as a result of the public As a means to monitor the accuracy
contract term. The evaluation of carrier comments received on the criteria and of Medicare FFS payments, we have
performance is part of our contract standards. established the Comprehensive Error
management process. The Medicare Prescription Drug, Rate Testing (CERT) program that
Improvement and Modernization Act of measures and reports error rates for
C. Development and Publication of
2003 (MMA) (Pub. L. 108–173) was claims payment decisions made by
Criteria and Standards
enacted on December 8, 2003. Section carriers and FIs. Since November 2003,
In addition to the statutory 911 of the MMA establishes the the CERT program has been measuring
requirements, § 421.120, § 421.122, and Medicare FFS Contracting Reform
§ 421.201, provide for publication of a and reporting claims payment error
(MCR) initiative that will be rates for each individual carrier. FI-
Federal Register notice to announce implemented over the next several
criteria and standards for FIs and specific rates became available
years. This provision requires that we November 2004.
carriers before the beginning of each use competitive procedures to replace
evaluation period. In the September 29, These rates measure not only how
our current FIs and carriers with well contractors are doing at
2006 Federal Register (71 FR 57513), we Medicare Administrative Contractors
published a general notice with implementing automated review edits
(MACs). The MMA requires that we and identifying which claims to subject
comment the current criteria and compete and transition all work to
standards for FIs and carriers. to manual medical review, but they also
MACs by October 1, 2011. measure the impact of the contractor’s
To the extent possible, we make every FIs and carriers will continue
effort to publish the criteria and provider outreach/education, as well as
administering Medicare FFS work as the effectiveness of the contractor’s
standards before the beginning of the may be required until the final
FFY, which is October 1. If we do not provider call center(s). We will use
competitively selected MAC is up and these contractor-specific error rates as a
publish a Federal Register notice before operating. We will continue to develop
the new FFY begins, readers may means to evaluate a contractor’s
and publish standards and criteria for performance.
presume that until and unless notified use in evaluating the performance of FIs
otherwise, the criteria and standards Several times throughout this notice,
and carriers as long as these types of
that were in effect for the previous FFY we refer to the appropriate reading level
contractors exist.
remain in effect. of letters, decisions, or correspondence
In those instances in which we are II. Analysis of and Response to Public that are mailed or otherwise transmitted
unable to meet our goal of publishing Comments Received on FY 2007 to Medicare beneficiaries from
the subject Federal Register notice Criteria and Standards intermediaries or carriers. In those
before the beginning of the FFY, we may We received five comments in instances, appropriate reading level is
publish the criteria and standards notice response to the September 29, 2006 defined as whether the communication
at any subsequent time during the year. Federal Register general notice with is below the eighth grade reading level
If we publish a notice in this manner, comment. All comments were reviewed, unless it is obvious that an incoming
the evaluation period for the criteria and but none necessitated reissuance of the request from the beneficiary contains
standards that are the subject of the FY 2007 Criteria and Standards. language written at a higher level. In
notice will be effective beginning on the Comments submitted did not pertain these cases, the appropriate reading
first day of the first month following specifically to the FY 2007 Criteria and level is tailored to the capacities and
publication of this notice in the Federal Standards. circumstances of the intended recipient.
Register. Any revised criteria and In addition to evaluating performance
standards will measure performance III. Criteria and Standards—General based upon our expectations for FY
prospectively; that is, any new criteria [If you choose to comment on issues 2008, we may also conduct follow-up
and standards in the notice will be in this section, please include the evaluations throughout FY 2008 of areas
applied only to performance after the caption ‘‘CRITERIA AND in which contractor performance was
effective date listed on the notice. STANDARDS—GENERAL’’ at the out of compliance with statute,
It is not our intention to revise the beginning of your comments.] regulations, and our performance
criteria and standards that will be used Basic principles of the Medicare expectations during prior review years
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during the evaluation period once this program are to pay claims promptly and where contractors were required to
information is published in a Federal accurately, and to foster good submit a Performance Improvement
Register notice. However, on occasion, beneficiary and provider relations. Plan (PIP).
either because of administrative action Contractors must administer the We may also utilize Statement of
or statutory mandate, there may be a Medicare program efficiently and Auditing Standards–70 (SAS–70)
need for changes that have a direct economically. The goal of performance reviews as a means to evaluate

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Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Notices 55777

contractors in some or all business performance may be evaluated in the activities criterion may include, but is
functions. areas of Medical Review (MR), Medicare not limited to, establishment,
In FY 2001, we established the Secondary Payer (MSP), Overpayments application, documentation, and
Contractor Rebuttal Process as a (OP), and Provider Enrollment (PE). In effectiveness of internal controls that are
commitment to continual improvement addition, FIs performance may be essential in all aspects of a contractor’s
of contractor performance evaluation evaluated in the area of Audit and operation, as well as the degree to
(CPE). We will continue the use of this Reimbursement (A&R). which the contractor cooperates with us
process in FY 2008. The Contractor In FY 1996, the Congress enacted the in complying with the Federal
Rebuttal Process provides the Health Insurance Portability and Managers’ Financial Integrity Act of
contractors an opportunity to submit a Accountability Act (HIPAA), Medicare 1982 (FMFIA). Administrative activities
written rebuttal of CPE findings of fact. Integrity Program, giving us the evaluations may also include reviews
Whenever we conduct an evaluation of authority to contract with entities other related to contractor implementation of
contractor operations, contractors have than, but not excluding, Medicare our general instructions and data and
7 calendar days from the date of the CPE carriers and intermediaries to perform reporting requirements.
review exit conference to submit a certain program safeguard functions. In We have developed separate measures
written rebuttal. The CPE review team situations where one or more program for RHHIs in order to evaluate the
or, if appropriate, the individual safeguard functions are contracted to distinct RHHI functions. These
reviewer considers the contents of the another entity, we may evaluate the functions include the processing of
rebuttal before the issuance of the final flow of communication and information claims from freestanding HHAs,
CPE report to the contractor. between a Medicare FFS contractor and hospital-affiliated HHAs, and hospices.
The FY 2008 CPE for FIs and carriers the payment safeguard contractor. All Through an evaluation using these
is structured into five criteria designed benefit integrity functions have been criteria and standards, we may
to meet the stated objectives. The first transitioned from the intermediaries and determine whether the RHHI is
criterion, claims processing, measures carriers to the program safeguard effectively and efficiently administering
contractual performance against claims contractors. the program benefit or whether the
processing accuracy and timeliness Mandated performance standards for
functions should be moved from one FIs
requirements, as well as activities in FIs in the payment safeguards criterion
to another in order to gain that
handling appeals. Within the claims include the accuracy of decisions on
assurance.
processing criterion, we have identified SNF demand bills and the timeliness of
those performance standards that are processing Tax Equity and Fiscal In sections IV. through VI. of this
mandated by legislation, regulation, or Responsibility Act (TEFRA) target rate notice, we list the criteria and standards
judicial decision. These standards adjustments, exceptions, and to be used for evaluating the
include claims processing timeliness, exemptions. There are no mandated performance of intermediaries, RHHIs,
the accuracy of Medicare Summary performance standards for carriers in and carriers.
Notices (MSNs), the timeliness of FI and the payment safeguards criterion. FIs IV. Criteria and Standards for Fiscal
carrier redeterminations, and the and carriers may also be evaluated on Intermediaries
appropriateness of the reading level and any Medicare Integrity Program (MIP)
content of FI and carrier activities if performed under their [If you choose to comment on issues in
redetermination letters. Further agreement or contract. this section, please include the caption
evaluation in the claims processing The fourth criterion, fiscal ‘‘Criteria and Standards for
criterion may include, but is not limited responsibility, evaluates the contractor’s Intermediaries’’ at the beginning of your
to, the accuracy of claims processing, efforts to protect the Medicare program comments.]
the percent of claims paid with interest, and the public interest. Contractors A. Claims Processing Criterion
the accuracy of redeterminations, must effectively manage Federal funds
timeliness of forwarding case files to for both the payment of benefits and the The claims processing criterion
and effectuation of Qualified costs of administration under the contains the following three mandated
Independent Contractor (QIC) decisions, Medicare program. Proper financial and standards:
and effectuation of administrative law budgetary controls, including internal Standard 1. Not less than 95.0 percent
judge (ALJ) decisions. controls, must be in place to ensure of clean electronically submitted
The second criterion, customer contractor compliance with its nonperiodic interim payment claims are
service, assesses the adequacy of the agreement with HHS and CMS. paid within statutorily specified
service provided to customers by the Additional functions reviewed under timeframes. Clean claims are defined as
contractor in its administration of the this criterion may include, but are not claims that do not require Medicare FIs
Medicare program. Functions that may limited to, adherence to approved to investigate or develop outside of their
be evaluated under this criterion budget, compliance with the Budget and Medicare operations on a prepayment
include, but will not be limited to, the Performance Requirements (BPRs), and basis. Specifically, the Act specifies that
following: (1) Timeliness and accuracy compliance with financial reporting clean nonperiodic interim payment
of all correspondence to providers; (2) requirements. electronic claims be paid no earlier than
monitoring the quality of replies The fifth and final criterion, the 14th day after the date of receipt,
provided by the contractor’s provider administrative activities, measures a and that interest is payable for any clean
telephone customer service contractor’s administrative management claims if payment is not issued by the
representatives (quality call of the Medicare program. A contractor 31st day after the date of receipt.
monitoring); and (3) provider outreach must efficiently and effectively manage Standard 2. Redetermination letters
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and education activities. its operations. Proper systems security prepared in response to beneficiary
The third criterion, payment (general and application controls), initiated appeal requests are written in
safeguards, evaluates whether the Automated Data Processing (ADP) a manner calculated to be understood by
Medicare Trust Fund is safeguarded maintenance, and disaster recovery the beneficiary. Letters must contain the
against inappropriate program plans must be in place. A contractor’s required elements as specified in
expenditures. Intermediary and carrier evaluation under the administrative § 405.956.

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Standard 3. All redeterminations must completion within 75 days after receipt • Adherence to approved program
be concluded and mailed within 60 by the contractor or returned to the management and MIP budgets.
days of receipt of the request, unless the hospitals as incomplete within 60 days • Compliance with the BPRs.
party submits documentation after the of receipt. • Compliance with financial
request, in which case the decision- FIs may also be evaluated on any MIP reporting requirements.
making timeframe is extended for up to activities if performed under their Part • Control of administrative cost and
14 calendar days for each submission. A contractual agreement. These benefit payments.
Because FIs process many claims for functions and activities include, but are E. Administrative Activities Criterion
benefits under the Part B portion of the not limited to, the following:
Medicare Program, we also may • Audit and Reimbursement We may measure an FI s
evaluate how well a FI follows the + Performing the activities specified administrative ability to manage the
procedures for processing appeals of in our general instructions for Medicare program. We may evaluate the
any claims for Part B benefits. conducting audit and settlement of efficiency and effectiveness of its
Additional functions that may be Medicare cost reports. operations, its system of internal
evaluated under this criterion include, + Establishing accurate interim controls, and its compliance with our
but are not limited to, the following: payments. directives and initiatives.
• Accuracy of claims processing. • Medical Review We may measure an FI’s efficiency
• Remittance advice transactions. + Increasing the effectiveness of and effectiveness in managing its
• Establishment and maintenance of a medical review activities. operations. Proper systems security
relationship with Common Working File + Exercising accurate and defensible (general and application controls), ADP
(CWF) Host. decision-making on medical reviews. maintenance, and disaster recovery
+ Collaborating with other internal plans must be in place. A FI must also
• Accuracy of redetermination
components and external entities to test system changes to ensure the
decisions.
• QIC case file requirements. ensure the effectiveness of medical accurate implementation of our
• Accuracy and timeliness of review activities. instructions.
• Medicare Secondary Payer Our evaluation of FI under the
processing appeals as set forth in part + Accurately following MSP claim
405, subpart I (§ 405.900 et seq.). administrative activities criterion may
development and edit procedures. include, but is not limited to, reviews of
B. Customer Service Criterion + Auditing hospital files and claims the following:
to determine that claims are being filed • Systems security.
Functions that may be evaluated
to Medicare appropriately. • ADP maintenance (configuration
under this criterion include, but are not + Supporting the Coordination of
limited to, the following: management, testing, change
Benefits Contractor’s efforts to identify
• Maintaining a properly management, and security).
responsible payers primary to Medicare. • Implementation of the Electronic
programmed interactive voice response + Supporting the MSP Recovery
system to assist with inquiries. Data Interchange (EDI) standards
functions for provider, physician or
• Performing quality call monitoring. other supplier debts and duplicate
adopted for use under HIPAA.
• Training customer service • Disaster recovery plan and systems
provider, physician or other supplier contingency plan. Data and reporting
representatives.
payments.
• Entering valid call center + Accurately reporting MSP savings.
requirements implementation.
performance data in the customer • Internal controls establishment and
• Overpayments use, including the degree to which the
service assessment and management + Collecting and referring Medicare
system or its successor the provider contractor cooperates with the Secretary
debts in a timely manner.
inquiry evaluation system. + Accurately reporting and collecting in complying with the FMFIA.
• Providing timely and accurate • Implementation of our general
overpayments.
written replies to providers that address + Adhering to our instructions for instructions.
the concerns raised and are written with management of Medicare Trust Fund V. Criteria and Standards for Regional
an appropriate customer-friendly tone debts. Home Health Intermediaries (RHHIs)
and clarity. • Provider Enrollment
• Ensuring written correspondence is + Complying with assignment of staff [If you choose to comment on issues in
evaluated for quality. to the provider enrollment function and this section, please include the caption
• Conducting provider outreach and training the staff in procedures and ‘‘Criteria and Standards for RHHIs’’ at
education-activities. verification techniques. the beginning of your comments.]
• Effectively maintaining an Internet + Complying with the operational The following three standards are
Web site dedicated to furnishing standards relevant to the process for mandated for the RHHI criterion:
providers and physicians timely, enrolling providers. Standard 1. Not less than 95.0 percent
accurate, and useful Medicare program of clean electronically submitted
D. Fiscal Responsibility Criterion nonperiodic interim payment home
information.
We may review the FI’s efforts to health and hospice claims are paid
C. Payment Safeguards Criterion establish and maintain appropriate within statutorily specified timeframes.
The Payment Safeguard criterion financial and budgetary internal Clean claims are defined as claims that
contains the following two mandated controls over benefit payments and do not require Medicare FIs to
standards: administrative costs. Proper internal investigate or develop them outside of
Standard 1. Decisions on SNF controls must be in place to ensure that their Medicare operations on a
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demand bills are accurate. contractors comply with their prepayment basis. Specifically, the
Standard 2. TEFRA target rate agreements with us. statute specifies that clean non-periodic
adjustments, exceptions, and Additional functions that may be interim payment electronic claims be
exemptions are processed within reviewed under the fiscal responsibility paid no earlier than the 14th day after
mandated timeframes. Specifically, criterion include, but are not limited to, the date of receipt, and that interest is
applications must be processed to the following: payable for any clean claims if payment

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is not issued by the 31st day after the making timeframe is extended for up to • Medicare Secondary Payer
date of receipt. 14 calendar days for each submission. + Accurately following MSP claim
Standard 2. Redetermination letters Additional functions that may be development/edit procedures.
prepared in response to beneficiary evaluated under this criterion include, + Supporting the Coordination of
initiated appeal requests are written in but are not limited to, the following: Benefits Contractor’s efforts to identify
a manner calculated to be understood by • Accuracy of claims processing. responsible payers primary to Medicare.
the beneficiary. Letters must contain the • Remittance advice transactions. + Supporting the Medicare
required elements as specified in • Establishment and maintenance of Secondary Payer Recovery functions for
§ 405.956. relationship with Common Working File provider, physician or other supplier
Standard 3: All redeterminations must (CWF) Host. debts and duplicate provider, physician
be concluded and mailed within 60 • Accuracy of redetermination or other supplier payments.
days of receipt of the request, unless the decisions. + Accurately reporting MSP savings.
party submits documentation after the • QIC case file requirements. • Overpayments
request, in which case the decision- • Accuracy and timeliness of + Collecting and referring Medicare
making timeframe is extended for up to processing appeals as set forth in part debts in a timely manner.
14 calendar days for each submission. 405, subpart I (§ 405.900 et seq.). + Accurately reporting and collecting
We may use this criterion to review overpayments.
B. Customer Service Criterion
an RHHI’s performance for handling the + Compliance with our instructions
HHA and hospice workload. This Contractors must meet our for management of Medicare Trust Fund
includes processing HHA and hospice performance expectations that providers debts.
claims timely and accurately, properly are served by prompt and accurate • Provider Enrollment
paying and settling HHA cost reports, administration of the program in + Complying with assignment of staff
and accurately processing accordance with all applicable laws, to the provider enrollment function and
redeterminations of initial regulations, and our general training staff in procedures and
determinations from beneficiaries, instructions. verification techniques.
HHAs, and hospices. Functions that may be evaluated + Complying with the operational
under this criterion include, but are not standards relevant to the process for
VI. Criteria and Standards for Carriers limited to, the following: enrolling suppliers.
[If you choose to comment on issues in • Maintaining a properly
programmed interactive voice response D. Fiscal Responsibility Criterion
this section, please include the caption
‘‘’Criteria and Standards for Carriers’’ at system to assist with inquiries. We may review the carrier’s efforts to
the beginning of your comments.] • Performing quality call monitoring. establish and maintain appropriate
• Training customer service financial and budgetary internal
A. Claims Processing Criterion representatives. controls over benefit payments and
The claims processing criterion • Entering valid call center administrative costs. Proper internal
contains the following four mandated performance data in the customer controls must be in place to ensure that
standards: service assessment and management contractors comply with their contracts.
Standard 1. Not less than 95.0 percent system or its successor the provider Additional functions that may be
of clean electronically submitted claims inquiry evaluation system. reviewed under the Fiscal
are processed within statutorily • Providing timely and accurate Responsibility criterion include, but are
specified timeframes. Clean claims are written replies to providers that address not limited to, the following:
defined as claims that do not require the concerns raised and are written with • Adherence to approved program
Medicare carriers to investigate or an appropriate customer-friendly tone management and MIP budgets.
develop outside of their Medicare and clarity. • Compliance with the BPRs.
operations on a prepayment basis. • Ensuring written correspondence is • Compliance with financial
Specifically, the Act specifies that clean evaluated for quality. reporting requirements.
non-periodic interim payment • Conducting provider outreach and • Control of administrative cost and
electronic claims be paid no earlier than education, activities. benefit payments.
the 14th day after the date of receipt, • Effectively maintaining an Internet
E. Administrative Activities Criterion
and that interest is payable for any clean Web site dedicated to furnishing
claims if payment is not issued by the providers timely, accurate, and useful We may measure a carrier’s
31st day after the date of receipt. Medicare program information. administrative ability to manage the
Standard 2. Ninety-eight percent of Medicare program. We may evaluate the
MSNs are properly generated. Our C. Payment Safeguards Criterion efficiency and effectiveness of its
expectation is that MSN messages are Carriers may be evaluated on any MIP operations, its system of internal
accurately reflecting the services activities if performed under their controls, and its compliance with our
provided. contracts. In addition, other carrier directives and initiatives.
Standard 3. Redetermination letters functions and activities that may be We may measure a carrier’s efficiency
prepared in response to beneficiary reviewed under this criterion include, and effectiveness in managing its
initiated appeal requests are written in but are not limited to the following: operations. Proper systems security
a manner calculated to be understood by • Medical Review (general and application controls), ADP
the beneficiary. Letters must contain the + Increasing the effectiveness of maintenance, and disaster recovery
required elements as specified in medical review activities. plans must be in place. Also, a carrier
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§ 405.956. + Exercising accurate and defensible must test system changes to ensure
Standard 4. All redeterminations must decision-making on medical reviews. accurate implementation of our
be concluded and mailed within 60 + Collaborating with other internal instructions.
days of receipt of the request, unless the components and external entities to Our evaluation of a carrier under this
party submits documentation after the ensure the effectiveness of medical criterion may include, but is not limited
request, in which case the decision- review activities. to, reviews of the following:

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55780 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Notices

• Systems security. in failure of the supplies or services, or be incurred by an efficiently and


• ADP maintenance (configuration to materially reduce the usability of the economically operated FIs or carrier,
management, testing, change supplies or services for their intended these high costs may also be grounds for
management, and security). purpose. A minor nonconformance is a adverse action.
• Disaster recovery plan/systems nonconformance that is not likely to
VIII. Collection of Information
contingency plan. materially reduce the usability of the
Requirements
• Data and reporting requirements supplies or services for their intended
implementation. purpose, or is a departure from This document does not impose
• Internal controls establishment and established standards having little information collection and record
use, including the degree to which the bearing on the effective use or operation keeping requirements. Consequently the
contractor cooperates with the Secretary of the supplies or services. The Office of Management and Budget need
in complying with the FMFIA. contractor will be required to develop not review it under the authority of the
• Implementation of the Electronic and implement PIPs for findings Paperwork Reduction Act of 1995 (44
Data Interchange (EDI) standards determined to be either a major or minor U.S.C. 3501 et seq.).
adopted for use under the HIPAA. nonconformance. The contractor will be IX. Response to Comments
• Implementation of our general monitored to ensure effective and
instructions. efficient compliance with the PIP, and Because of the large number of items
to ensure improved performance when of correspondence we normally receive
VII. Action Based on Performance on Federal Register documents
Evaluations requirements are not met.
The results of performance published for comment, we are unable
[If you choose to comment on this evaluations and assessments under all to acknowledge or respond to them
section, please include the caption criteria applying to FIs, carriers, and individually. We will consider all
‘‘Action Based on Performance RHHIs will be used for contract comments we receive by the date and
Evaluations’’ at the beginning of your management activities and will be time specified in the ‘‘Comment Date’’
comments.] published in the contractor’s annual section of this notice, and, if we proceed
Report of Contractor Performance (RCP). with a subsequent document, we will
We evaluate a contractor’s
We may initiate administrative actions respond to the comments in the section
performance against applicable program
as a result of the evaluation of entitled as ‘‘Analysis of and Response to
requirements for each criterion. Each
contractor performance based on these Public Comments Received on FY 2008
contractor must certify that all
performance criteria. Under sections Criteria and Standards’’ of that
information submitted to us relating to
1816 and 1842 of the Act, we consider document.
the contract management process,
including, without limitation, all files, the results of the evaluation in our Authority: Sections 1816(f), 1834(a)(12),
records, documents and data, whether determinations when— and 1842(b) of the Social Security Act (42
in written, electronic, or other form, is • Entering into, renewing, or U.S.C. 1395h(f), 1395m(a)(12), and 1395u(b)).
accurate and complete to the best of the terminating agreements or contracts (Catalog of Federal Domestic Assistance
contractor’s knowledge and belief. A with contractors; and Program No. 93.773, Medicare—Hospital
• Deciding other contract actions for Insurance, and Program No. 93.774,
contractor is required to certify that its
intermediaries and carriers (such as Medicare—Supplementary Medical
files, records, documents, and data are Insurance Program)
deletion of an automatic renewal
not manipulated or falsified in an effort
clause). These decisions are made on a Dated: May 24, 2007.
to receive a more favorable performance
case-by-case basis and depend primarily Leslie V. Norwalk,
evaluation. A contractor must further
on the nature and degree of Acting Administrator, Centers for Medicare
certify that, to the best of its knowledge
performance. More specifically, these & Medicaid Services.
and belief, the contractor has submitted,
decisions depend on the following:
without withholding any relevant Editorial Note: This document was
+ Relative overall performance
information, all information required to received at the Office of the Federal Register
compared to other contractors.
be submitted for the contract + Number of criteria in which on September 26, 2007.
management process under the nonconformance occurs. [FR Doc. 07–4826 Filed 9–28–07; 8:45 am]
authority of applicable law(s), + Extent of each nonconformance. BILLING CODE 4120–01–P
regulation(s), contract(s), or our manual + Relative significance of the
provision(s). Any contractor that makes requirement for which nonconformance
a false, fictitious, or fraudulent occurs within the overall evaluation DEPARTMENT OF HEALTH AND
certification may be subject to criminal program. HUMAN SERVICES
or civil prosecution, as well as + Efforts to improve program quality,
appropriate administrative action. This service, and efficiency. Food and Drug Administration
administrative action may include + Deciding the assignment or
debarment or suspension of the [Docket No. 2007N–0353]
reassignment of providers and
contractor, as well as the termination or designation of regional or national Drug Products Containing
nonrenewal of a contract. intermediaries for classes of providers. Hydrocodone; Enforcement Action
If a contractor meets the level of We make individual contract action
Dates
performance required by operational decisions after considering these factors
instructions, it meets the requirements in terms of their relative significance AGENCY: Food and Drug Administration,
of that criterion. When we determine a and impact on the effective and efficient HHS.
mstockstill on PROD1PC66 with NOTICES

contractor is not meeting performance administration of the Medicare program. ACTION: Notice.
requirements, we will use the terms In addition, if the cost incurred by the
‘‘major nonconformance’’ or ‘‘minor FIs, RHHI, or carrier to meet its SUMMARY: The Food and Drug
nonconformance’’ to classify our contractual requirements exceeds the Administration (FDA) is announcing its
findings. A major nonconformance is a amount that we find to be reasonable intention to take enforcement action, as
nonconformance that is likely to result and adequate to meet the cost that must described in this notice, against

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