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Health Policy Report

October 7, 2010
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HHS Awards Grants to 48 States for Health Insurance Exchanges
Forums The Department of Health and Human Services (HHS) awarded nearly $49
million to help 48 states and the District of Columbia plan for the
establishment of health insurance exchanges. Starting in 2014, health
AAPPO Academy insurance exchanges will put greater control and greater choice in the
hands of individuals and small businesses. The state-based exchanges will
make purchasing health insurance easier by providing eligible consumers
PPO
Information
and businesses with one place where they can compare and purchase
health insurance coverage. These grants of up to $1 million each will give
states the resources they need to conduct the research and planning needed
to build a better health insurance marketplace and determine how their
exchanges will be operated and governed. Alaska and Minnesota were the
only two states to turn down the grants. (HHS Press Release 09/30) (Hill
09/30)

Schedule for the Week Ahead…

Hearings and public meetings scheduled for the week of October 11:
! The Centers for Medicare & Medicaid Services will hold a Special Open Door
Forum on Ambulatory Surgery Center Value-Based Purchasing on October
14.

Week of October 4, 2010

News:
Health Reform Implementation
HHS Plans to Address Unique Needs of ‘Mini-Med’ Plans
HHS Receives Comments on Health Insurance Exchanges
CMS Announces Resources to Combat Abuse in LTC Facilities
Nearly 3,000 Organizations Accepted Into Early Retiree Reinsurance Program
Lawmakers Fear Health Reform’s CER Board Could Influence NIH and AHRQ
Work
Republicans Ask States for Input on Cost of Implementing Health Care Law
GAO Announces New National Health Care Workforce Commission
CRS: HHS Misses One-Third of Deadlines Under Health Reform Law
Schwarzenegger Signs Major Health Care Bills
Insurers Protest HHS Web Portal’s Denials Data

Other Legislative Issues

Page 2 of 17
 Other Legislative Issues
Harkin Criticizes HHS Plan to Redirect Flu Funds to DOD
Industry Raises Concerns With Draft Drug Safety Bill’s Fees and Data
Confidentiality

Administration
U.S. Increases AIDS Fund Donation

HHS
HHS Hosts National Summit on Health Care Quality and Value
OIG Issues Fiscal Year 2011 Work Plan
HHS Awards $473 Million in Patient-Centered Outcomes Research Funding
HHS Urges States to Improve Medicaid and CHIP Well-Child Visits
Senate Democrats Ask Sebelius to Investigate Medigap Premium Increases

CMS
CMS Introduces New Resource to Help Providers Avoid Medicare Compliance
Issues
Medicare Fraud Patrols Get $9 Million Boost
Health Insurance Counseling Programs Receive $1.5 Million in Performance
Awards

FDA
FDA Issues Strategic Action Plan
FDA Issues Report Outlining Plans to Advance Regulatory Science
FDA to Hold Public Hearing in November on Implementing Biosimilars Pathway
FDA Deploys Import Safety System
Stakeholders Push for FDA Drug Insert Review

DEA
DEA Issues Guidance to Ease Delay of Pills for Elderly

Off-the-Hill Items
Study Predicts Medicare Prescription Drug Costs to Rise
Data Firm Sees 2011 Drug Sales Rising

2010 Elections
Generic Ballot and Voter Enthusiasm
Senate Races
Arkansas Senate Race
California Senate Race
Colorado Senate Race
Connecticut Senate Race
Delaware Senate Race
Florida Senate Race
Illinois Senate Race
Indiana Senate Race
Missouri Senate Race
Nevada Senate Race
Ohio Senate Race
Pennsylvania Senate Race
Wisconsin Senate Race
West Virginia Senate Race
House Races

Hearing and Public Meetings:

MedPAC Meeting on Medicare’s Shared Savings Program for ACOs
MedPAC Public Meeting on Least Costly Alternative Policies

Page 3 of 17
CMS Hospital & Hospital Quality Open Door Forum

Regulatory Activity:
FDA: MDUFMA: Notice to Public of Web site Location of FY 2011 Proposed Guidance
Development
FDA: Notice: Request for Comments on the FDA FY 2011–2015 Strategic Priorities
Document

News:

Administration Holds Stakeholder Meeting on ACOs

The Centers for Medicare & Medicaid Services (CMS), Federal Trade Commission
(FTC), and the Health and Human Services Office of the Inspector General (OIG)
held a stakeholder meeting this week on accountable care organizations (ACOs).
Stakeholders said ACOs need to be done in such a way to avoid violating fraud
and anti-kickback statutes. Representatives from provider and payer organizations
said that they would like guidance from the government about whether their
policies of negotiating prices would be protected in a “safe harbor” from federal
antitrust and anti-kickback statutes. Stakeholders also discussed whether the
government should grant ACOs waivers and/or exemptions from those statutes.
Inspector General Daniel Levinson said “The fraud and abuse rules enforced by
our office should not stand in the way of improving quality and reducing costs
through ACOs. As the Medicare and Medicaid programs incorporate and test new
payment and delivery models there is a need for fresh thinking about program
integrity and the type of risks faced by our programs and beneficiaries.” He added
that the OIG is listening to stakeholders’ suggestions and will work to ensure ACOs
succeed. (BNA 10/06) (Inside Health Policy 10/07)

Top

HHS Plans to Address Unique Needs of ‘Mini-Med’ Plans

The Department of Health and Human Services (HHS) said that it would give
limited benefit plans or “mini-med” plans special consideration as it implements the
medical loss ratio (MLR) requirements of health reform. This comes after a news
report indicated that McDonald’s might drop the coverage it provides to some
employees because its plan would likely not meet the new MLR standards. A HHS
official said the department would accommodate the “special circumstances”
presented by limited benefit plans. “We understand that some employers must
soon make decisions regarding coverage options for 2011. As such, we fully intend
to exercise (our) discretion under the new law to address the special
circumstances of mini-med plans in the medical loss ratio calculations,” said Jay
Angoff, the director of HHS’ Office of Consumer Information and Insurance
Oversight. The National Association of Insurance Commissioners is working on a
draft MLR regulation, which will eventually serve as the model for HHS’ regulations
on the provision. Although that work is still ongoing, Angoff said that the statute
itself clearly provides flexibility for mini-med plans. Obama Administration officials
have been granting dozens of waivers to maintain even minimal coverage far
below the health reform law’s standards in an effort to address threats by some
health insurers to abandon markets, drop out of the business altogether or refuse
to sell certain policies. The Administration has given about 30 insurers, employers,
and union plans one-year waivers on the new rules that phase out annual limits on
coverage for mini-med plans. (Inside Health Policy 10/01) (NYT 10/06)

Top

HHS Receives Comments on Health Insurance Exchanges

In comments to the Department of Health and Human Services (HHS), physician
and insurer associations said that all qualified health plans should be able to
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participate in health insurance exchanges to alleviate the effects of market
concentration. The American Medical Association (AMA) also requested insurers
follow their Insurer Code of Conduct and that the governance structure of the
exchange include patient and doctor representatives. America’s Health Insurance
Plans (AHIP) agreed that all plans that meet the criteria should be allowed to
participate in the exchanges. AHIP called on states to pass legislation so that they
can operate the exchanges. States “are best suited to design an exchange
infrastructure that delivers high value, high quality care meeting the unique needs
of their specific population,” AHIP said in its comment letter. AHIP and the Blue
Cross and Blue Shield Association said that consumers should be able to get
coverage inside and outside of exchanges. Insurance rate reviews should be
handled by existing state regulatory agencies “and not duplicated through the
exchanges,” AHIP said. (BNA 10/06)

Top

CMS Announces Resources to Combat Abuse in LTC Facilities

The Centers for Medicare & Medicaid Services (CMS) awarded more than $13
million to six states to design comprehensive applicant criminal background check
programs for jobs at long-term care (LTC) facilities involving direct patient care.
Created by the Affordable Care Act, the new National Background Check Program
will help identify best practices for LTC providers to determine whether a job
seeker has any kind of criminal history or other disqualifying information that could
make him or her unsuitable to work directly with residents. The states included in
the first round of the program are: Alaska, Connecticut, Delaware, Florida,
Missouri, and Rhode Island. They each will share a portion of $13.7 million. An
additional 11 states applied and may be funded beginning in October or
November. (HHS Press Release 10/06)

Top

Nearly 3,000 Organizations Accepted Into Early Retiree Reinsurance Program

The Department of Health and Human Services (HHS) said nearly 3,000 employers
and unions have been accepted into the Early Retiree Reinsurance Program. Since
the first round of nearly 2,000 approvals in August, another 1,000 businesses,
state and local governments, educational institutions, nonprofit organizations, and
unions have been accepted into the program and will begin to receive
reimbursements for their early retirees’ medical claims this fall. The Affordable
Care Act provides $5 billion in financial assistance to help employers maintain
coverage for early retirees ages 55 and older who are not yet eligible for Medicare.
(BNA 10/05)

Top

Lawmakers Fear Health Reform’s CER Board Could Influence NIH and AHRQ
Work
Democratic leaders on the House Energy and Commerce Committee are worried
that the health reform law’s Patient-Centered Outcomes and Research Institute
(PCORI) could influence comparative effectiveness research (CER) studies
conducted at the National Institutes of Health (NIH) and the Agency for Healthcare
Research and Quality (AHRQ). Committee staff plan to meet with NIH officials to
discuss the concerns. They also hope the Government Accountability Office will
seek ways to mute special interest group’s influence when it selects members for
PCORI’s Methodology Committee. The health overhaul law that created PCORI did
not say much about the methodology board’s authority. Many say the methods
committee has the potential to be extremely influential because it has a hand in
developing the standards for comparing how well treatments work. It could be
merely advisory or it could be the panel that does most of the work. (Inside Health
Policy 10/04)
Page 5 of 17
Top

Republicans Ask States for Input on Cost of Implementing Health Care Law
Three Republican members of the House Energy and Commerce Committee are
asking states how they plan to deal with the cost of implementing the new health
care law. Representative Joe Barton (R-TX), Michael Burgess (R-TX), and John
Shimkus (R-IL) sent a letter to states asking nine questions, including how much it
will cost to expand Medicaid coverage, provide insurance for state employees and
their families, and create and operate insurance exchanges. The lawmakers also
asked the states to let them know how they expect to cover the expenses resulting
from the law’s implementation. (CQ 10/05)

Top

GAO Announces New National Health Care Workforce Commission

The Government Accountability Office (GAO) announced the appointment of 15
members to the new National Health Care Workforce Commission. The Affordable
Care Act created the Commission to serve as a national resource for Congress,
the President, and states and localities; to communicate and coordinate with
federal departments; to develop and commission evaluations of education and
training activities; to identify barriers to improved coordination at the federal, state,
and local levels and recommend ways to address them; and to encourage
innovations that address population needs, changing technology, and other
environmental factors. The Act requires GAO to appoint the Commission members.
! Commissioners whose first term will expire in September 2013 are:
o Peter Buerhaus, PhD, RN, Professor of Nursing and Director,
Center for Interdisciplinary Health Workforce Studies, Institute for
Medicine and Public Health, Vanderbilt University Medical Center.
Dr. Buerhaus will serve as Chair of the Commission.
o Sheldon Retchin, MD, MSPH, Vice President for Health Sciences,
Virginia Commonwealth University and Chief Executive Officer,
VCU Health System. Dr. Retchin will serve as Vice Chair of the
Commission.
o Brian J. Isetts, PhD, Professor, Department of Pharmaceutical
Care and Health Systems, University of Minnesota College of
Pharmacy.
o Harold M. Maurer, MD, Chancellor, University of Nebraska Medical
Center.
o Thomas Ricketts, PhD, Professor, Department of Health Policy and
Management, University of North Carolina Gillings School of
Global Public Health, and Deputy Director for Policy Analysis,
Cecil G. Sheps Center for Health Services Research.
! Commissioners whose first term will expire in September 2012 are:
o Mary Mincer Hansen, RN, PhD, Director, Masters in Public Health
Program, College of Health Sciences, Des Moines University.
o John E. Maupin, Jr., DDS, President, Morehouse School of
Medicine.
o Neil M. Meltzer, MPH, President and Chief Operating Officer, Sinai
Hospital, Baltimore, MD.
o Fitzhugh Mullan, MD, Professor of Public Health and Pediatrics,
George Washington University.
o Steven Zatkin, JD, consultant to health plans.
! Commissioners whose first term will expire in September 2011 are:
o Katherine A. Flores, MD, Director of the University of California
(UCSF) Fresno Latino Center for Medical Education and
Research.
o Kim Gillan, Workforce Development and Training Coordinator,
Page 6 of 17
 o
Montana State University’s Billings (MSUB) College of
Professional Studies and Lifelong Learning.
o Lisa Renee Holderby, Director of Health Equity, Community
Catalyst.
o Deborah King, Executive Director, 1199SEIU Training and
Employment Funds.
o Richard Krugman, MD, Vice Chancellor for Health Affairs,
University of Colorado Denver and Dean, University of Colorado
School of Medicine.
(GAO 09/30)

Top

CRS: HHS Misses One-Third of Deadlines Under Health Reform Law

According to a memo by the Congressional Research Services (CRS), the
Department of Health and Human Services (HHS) failed to meet a third of its
deadlines implementing provisions of the new health care law before September
23. CRS said HHS failed to fulfill its requirements in seven of 22 deadlines before
September 23. HHS spokeswoman Jessica Santillo said that HHS “has met and
beaten deadlines required” by the health care reform law. She said CRS in the
memo incorrectly reported several missed deadlines, including one to establish a
Medicare prescription drug coverage gap discount program. (BNA 10/05)

Top

Schwarzenegger Signs Major Health Care Bills

California Governor Arnold Schwarzenegger signed seven major health reform
bills, including legislation establishing a Web-based insurance exchange that will
allow consumers to comparison shop for coverage. California is now the first state
to implement an oversight board for insurance exchange marketplaces since the
new federal health care law was enacted earlier this year. Massachusetts
implemented its exchange prior to reform. Additional bills signed prohibit insurers
from denying coverage to children because of a preexisting condition and allow
young adults to stay on their parents’ health care plans until age 26. (AP 09/30)

Top

Insurers Protest HHS Web Portal’s Denials Data

The Department of Health and Human Services (HHS) unveiled the second phase
of the new web portal, which provides price estimates for private insurance
policies. Insurers raised concerns with the site’s description of coverage denials.
The web portal’s second iteration required insurance companies to provide the
percentage of people who applied for insurance and were denied coverage, along
with the percentage of people who were charged higher premiums because of
their health status. Robert Zirkelbach, a spokesman for America’s Health
Insurance Plans, said the definitions that HHS uses to describe denials are not
accurate and present a skewed image of the industry’s denials of coverage. The
new version of the site includes: monthly premium estimates; cost-sharing
information; major categories of services covered; consumer’s share of cost for
these services; percent of people who pay more than base premium estimate; and
percent of people denied coverage. (Inside Health Policy 10/04)

Top

Harkin Criticizes HHS Plan to Redirect Flu Funds to DOD

Senator Tom Harkin (D-IA) criticized the Department of Health and Human
Services (HHS) for its plan to redirect Project Bioshield procurement funds to the
Department of Defense (DOD). He raised concerns that the U.S. is falling behind
in developing cell-based vaccine technologies, while agreeing with HHS’ aim to
Page 7 of 17
strengthen its medical countermeasures enterprise. Harkin said he would be hard-
pressed to support a recent White House budget amendment to reallocate HHS
biodefense funds to DOD. “I’m not going to sign off on it,” he said, referring to a
proposed $200 million transfer from the Project Bioshield Special Reserve Fund to
DOD to establish a Technical Center of Excellence for Advanced Development and
Manufacturing. The proposed HHS budget amendment calls for Project Bioshield
and pandemic flu dollars to be reallocated toward initiatives outlined in a
countermeasures report released in August to improve HHS’ medical
countermeasure enterprise. (Inside Health Policy 10/05)

Top

Industry Raises Concerns With Draft Drug Safety Bill’s Fees and Data
Confidentiality
The pharmaceutical industry trade groups have informed lawmakers they have
concerns with Democrats’ draft drug safety legislation. Of particular concern is that
the bill permits collected fees to be used for non-foreign inspection-related issues,
leaves many elements of the fees unanswered, and does not fully protect
confidential information. The groups urged lawmakers to consider exempting
certain investigational products from the legislation’s requirements and said a third-
party audit program and improved international coordination could help support the
bill’s foreign inspection program. Safety advocates praised the measure, but a
consumer advocate said the registration fees should not sunset, because a failed
reauthorization could undermine the foreign inspection program. (Inside Health
Policy 10/04)

Top

U.S. Increases AIDS Fund Donation

The Obama Administration announced a large increase in its pledge to the Global
Fund to Fight AIDS, Tuberculosis, and Malaria. The Administration also called for
reform of the organization. The U.S. is pressing the Global Fund to develop an
“action agenda” with timelines and measurements in order to ensure accountability.
The U.S. will measure progress annually. The pledge of $4 billion over the next
three fiscal years comes as governments and donors around the world have
slowed increases in spending to combat HIV/AIDS, with weaker economies
straining budgets. The Fund failed to reach the target funding level of $13 billion.
Three-year pledges from 40 countries amounted to $11.7 billion. (WSJ 10/05) (NYT
10/05)

Top

HHS Hosts National Summit on Health Care Quality and Value

Department of Health and Human Services (HHS) hosted the National Summit on
Health Care Quality and Value this week. At the event, HHS Secretary Kathleen
Sebelius urged Congress to turn its attention away from politics and partisan
sniping and to focus on how it can successfully reform the nation’s health delivery
system. In her remarks Sebelius noted the recent appointment of Peter Lee as
director of delivery system reform in the HHS Office of Health Reform. For many
years Lee helped lead efforts of the Pacific Business Group on Health which is a
business coalition focused on health care. Centers for Medicare & Medicaid
Services (CMS) Administrator Donald Berwick also spoke at the summit. He said
throughout the nation there are “stunning examples” of health care providers who
have “leapt over the fear” of studying variations in health care quality and
outcomes. Providers who have low costs and better-quality outcomes are looking
for more recognition and additional Medicare payments, said Berwick. Health care
in the United States can and should be improved with the “triple aim” of better
care, better health and lower costs, Berwick said. Transparency is also needed,
which takes courage, because “we have to learn our way to a new future for health
Page 8 of 17
care,” he said. Berwick also laid out five principles that he said could guide quality
improvement: health care in America can and should improve; providers and others
should learn from each other, including the variations among their processes and
outcomes; within any subset of providers, there is variation; the risks of
transparency are worth taking; and partnerships are essential. (Politico 10/05) (CQ
10/04) (BNA 10/05)

Top

OIG Issues Fiscal Year 2011 Work Plan

The Health and Human Services (HHS) Office of Inspector General (OIG) issued
its work plan for fiscal year 2011. OIG indicated that among other activities it will
issue reports on the Food and Drug Administration’s 510(k) device clearance
process, as well as hospital payments and readmissions. The work plan provides
brief descriptions of activities that the OIG plans to initiate or continue with respect
to the programs and operations of HHS. For each review, the work plan describes
the subject, primary objective, and criteria related to the topic. (BNA 10/04)

Top

HHS Awards $473 Million in Patient-Centered Outcomes Research Funding

The Department of Health and Human Services (HHS) Agency for Healthcare
Research and Quality (AHRQ) announced the award of $473 million in grants and
contracts to support comparative effectiveness research projects. The Recovery Act
provided AHRQ $300 million and HHS $400 million. The funding announced covers
all of AHRQ’s allocation and $173 million administered for the HHS Secretary by
AHRQ. The projects will support patient-centered outcomes research efforts in
many areas, including health care interventions in real world settings, advanced
use of the research findings by diverse populations, development of effective
patient registries and training and career development for the next generation of
researchers. The funded grants and contracts fall into several categories. For the
awards funded by the Office of the Secretary, they are: Data Infrastructure;
Dissemination, Translation and Implementation; Research; and Inventory and
Evaluation. The awards funded by the AHRQ allocation are categorized under:
Horizon Scanning; Evidence Synthesis; Evidence Gap Identification; Translation
and Dissemination; Evidence Generation; Training and Career Development; and
the Community Forum. (HHS Press Release 09/30)

Top

HHS Urges States to Improve Medicaid and CHIP Well-Child Visits

According to a report by the Department of Health and Human Services (HHS),
states need to “substantially improve” the percentage of well-child visits for those
three to six years old covered under Medicaid and the Children’s Health Insurance
Program (CHIP). The report also showed mixed results in the use of quality
measures and reporting by states, according to an analysis of Medicaid managed
care data done by the National Committee for Quality Assurance (NCQA) under a
contract with HHS. “States, lacking a standardized format for collecting quality
measures, have implemented various approaches to assessing quality, including
developing state-specific quality metrics,” the HHS concluded. “Although all states
collect some quality data; there is wide variance in the information and the
processes used for quality reviews under managed care,” HHS officials wrote,
adding that even less is known about care provided in fee-for-service programs.
When it came to well-child visits for those ages three to six, less than 60 percent
of children in that age group received the check-up nationwide, 2008 data show.
(Inside Health Policy 10/04)

Top

Page 9 of 17
Senate Democrats Ask Sebelius to Investigate Medigap Premium Increases
Top Senate Democrats are asking Department Health and Human Services (HHS)
Secretary Kathleen Sebelius to investigate recent premium rate increases for
Medigap plans. Senate Majority Leader Harry Reid (D-NV), Senate Finance
Committee Chairman Max Baucus (D-MT), and Senator John Kerry (D-MA) said a
health insurer recently raised its premium for Medigap coverage by 40 percent,
raising “serious concerns about premium-setting practices and rate review
procedures in place for Medigap policies.” The lawmakers also asked Sebelius to
work with state governors and insurance commissioners to conduct thorough
annual rate reviews to prevent unnecessary premium increases and to “conduct a
study of Medigap trends and costs to provide a benchmark against which proposed
rates can be measured.” (BNA 10/07)

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CMS Introduces New Resource to Help Providers Avoid Medicare Compliance

Issues
The Centers for Medicare & Medicaid Services (CMS) announced the first edition
of the Medicare Quarterly Provider Compliance Newsletter, a publication designed
to help providers identify and prevent Medicare billing errors and other compliance
issues. The first edition provides recommendations for avoiding eight billing error
situations, including an inpatient hospital or skilled nursing facility failing to submit
the required documents for a claim and subsequently being contacted by a
Recovery Audit Contractor (RAC) with a document request. Other issues include
physicians submitting the wrong procedure codes for pharmaceutical injectables,
inappropriate inpatient admission for patients experiencing heart failure and shock,
and implanting pacemakers in an inpatient setting when not medically necessary.
Each edition of the newsletter will include the top compliance issues facing
providers that quarter, as identified by a variety of sources, such as reports from
the Department of Health and Human Services Office of Inspector General as well
as RAC and other CMS contractor reviews. Some editions may include billing
issues related to one provider type or regarding one particular service. (BNA 10/07)

Top

Medicare Fraud Patrols Get $9 Million Boost

The Centers for Medicare & Medicaid Services (CMS) issued $9 million in grants
to volunteers to help seniors make sure they are not victims of Medicare fraud. The
money will go to 51 Senior Medicare Patrol programs whose mission it is to
combat Medicare fraud by educating beneficiaries, their family members and
caregivers about such things as reviewing their Medicare notices to ensure the bills
are correct. The grants will be jointly administered by CMS and the Administration
on Aging. (CQ 10/01)

Top

Health Insurance Counseling Programs Receive $1.5 Million in Performance

Awards
The Centers for Medicare & Medicaid Services (CMS) said most state health
insurance assistance programs (SHIPs) will share in $1.5 million in awards for
demonstrating achievement in beneficiary outreach. Eligibility for a performance
award is based on timely data submission in the SHIP performance reporting
system for the annual reporting period and attainment of certain performance
levels. The agency spokesman said that the latest grants ranged from $412 to
$356,000, based on “weighted performance measures and the size of the
Medicare population within six defined geographic areas in each state.” The
performance measures include achievement of such objectives as individualized
counseling to an increasing number and diversity of beneficiaries unable to access
other channels of information, conducting targeted outreach in public forums,
Page 10 of 17
raising awareness of opportunities for assistance with benefit and plan selection,
enhancing beneficiary access to a counselor workforce, and participating in CMS
education and communication activities. (BNA 10/04)

Top

FDA Issues Strategic Action Plan

The Food and Drug Administration (FDA) issued its strategic action plan that
identifies several regulatory, scientific, enforcement and oversight priorities for the
next five years, focusing on rapidly evolving science and increased globalization.
Separately, the FDA device center also released a list of guidance documents that
it intends to consider developing in fiscal year 2011. The report identifies applied
research, regenerative medicine, combination products, robotics, systems biology,
cell- and tissue-based products, mobile healthcare technologies, medical imaging
and nanotechnology as its regulatory science priorities. (Inside Health Policy 10/04)

Top

FDA Issues Report Outlining Plans to Advance Regulatory Science

The Food and Drug Administration (FDA) released a report outlining the agency’s
plans to advance regulatory science. Regulatory science is the science of
developing new tools, standards, and approaches for assessing the safety,
efficacy, quality, and performance of FDA-regulated products including drugs and
devices. The report provides examples of current FDA activities in regulatory
science and also considers how advancements in the field can help deliver better,
safer, and more innovative products to Americans in seven different public health
areas. These seven areas are: accelerating the delivery of new medical treatments
to patients, improving pediatric health, protecting against emerging infectious
diseases and terrorism, enhancing safety and health through informatics, protecting
the food supply, modernizing safety testing, and meeting the challenges of
regulating tobacco. (BNA 10/07)

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FDA to Hold Public Hearing in November on Implementing Biosimilars

Pathway
The Food and Drug Administration (FDA) announced that it will hold a two-day
public hearing November 2-3 to seek comments on implementing the abbreviated
approval pathway for biosimilars. The Biologics Price Competition and Innovation
(BPCI) Act of 2009 establishes an abbreviated approval pathway for biologics that
are demonstrated to be highly similar to or interchangeable with an FDA-licensed
biological product. The act was part of the Patient Protection and Affordable Care
Act (PPACA). The FDA said the purpose of the hearing is to receive input on the
act’s implementation from the public, health care professionals, health care
institutions, manufacturers of biomedical products, industry and professional
associations, patients and patient associations, third-party payers, and current and
prospective biological license application and new drug application holders. (BNA
10/05)

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FDA Deploys Import Safety System

The Food and Drug Administration (FDA) has refurbished the information
technology infrastructure on its import safety systems and is on track to deploy the
tools to additional ports. The system has also begun inspecting drug and device
imports. The Mission Accomplishments and Regulatory Compliance Service
(MARCS) and Predictive Risk-based Evaluation for Dynamic Import Compliance
Targeting (PREDICT) systems have long been touted by the FDA as improving the
safety of imported products. PREDICT, which is software incorporated into the
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MARCS system, analyzes the safety profile and risk associated with imported
goods, and makes improved safety determinations over time. Deployment of the
systems was suspended earlier this year after the agency’s legacy information
technology could not support the import safety tools. (Inside Health Policy 10/06)

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Stakeholders Push for FDA Drug Insert Review

Stakeholders, including members of the drug industry, consumers and drug stores,
are resisting the Food and Drug Administration’s (FDA) position that the agency
cannot pre-review all drug information inserts under a new plan to develop a single
document that would be distributed with medications, they told agency officials this
week. Instead of lacking an FDA review of the proposed single document Patient
Medication Information (PMI) inserts, stakeholders suggested examining new user
fees or a tiered approach that would gradually review the consumer-oriented
information based on risk and usage. Stakeholders differed, though, on who should
draft the PMI, with industry calling for drug makers to develop the inserts and
consumer advocates arguing that industry language will result in skewed
information reaching patients. (Inside Health Policy 10/07)

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DEA Issues Guidance to Ease Delay of Pills for Elderly

The Drug Enforcement Administration (DEA) has issued new guidelines intended to
help ease the delay some nursing home residents face in receiving certain
painkillers and anti-anxiety medications. Physicians may now authorize nurses
employed by long-term care facilities to phone in their oral prescriptions for these
controlled substances to pharmacies. The DEA had not previously recognized
nurses employed by nursing homes as the legal agents of doctors in conveying
controlled substances prescriptions to pharmacists. The agency previously
counseled pharmacists who dispensed such drugs to nursing home patients to do
so only via direct oral or written communication with a doctor. Senate Special
Committee on Aging Chairman Herb Kohl (D-WI) called the new policy a step in
the right direction. However, he said the changes still did not give nurses the
ability to transmit prescriptions for other important medications, including morphine.
(NYT 10/06)

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Study Predicts Medicare Prescription Drug Costs to Rise

A Kaiser Family Foundation study found that premiums for Medicare Part D
prescription drug plans will rise by 10 percent on average in 2011 for seniors who
stick with their current plans. The Kaiser report also says that the average
beneficiary will be able to choose among 33 stand-alone Part D plans, even though
the number of plans will drop by a third nationally. Premiums will rise to $40.72 a
month on average for those who stay with their current plans, up from $36.90 in
2010. Some plans will have slight decreases in premium costs. (CQ 10/04)

Top

Data Firm Sees 2011 Drug Sales Rising

According to IMS Health, revenue from global prescription drug sales should
increase 5 percent to 7 percent next year, reaching at least $880 billion. The IMS
Market Prognosis report attributes the expected revenue increase to the anticipated
launch of new potential blockbusters, rising gross domestic product in about two
dozen of the top developed and emerging markets, and strong economic growth in
China and other emerging markets, which are spending more on health care.
Spending on prescription drugs next year is expected to rise, on average, about 16
percent in China and 16 other emerging countries now heavily targeted by drug
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manufacturers. Prescription revenues in Canada and in Europe’s five biggest
markets - Germany, France, Italy, Spain, and the United Kingdom - will grow at
just 1 percent to 3 percent next year. In the U.S., growth is expected to be about 4
percent, for a total of about $325 billion next year. (AP 10/07)

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Generic Ballot and Voter Enthusiasm

According to a new Washington Post-ABC News poll, Democrats have made
modest improvements with voters since their late-summer low point, but
Republicans still have an advantage. Democrats have made small gains on the
question of which party people trust to handle big issues, such as the economy
and health care. Despite signs of improvement, the new poll suggests that
Democrats remain at a significant disadvantage. Among likely voters, Republicans
hold a six-point edge, 49 percent to 43 percent, on the congressional ballot. A
recent Gallup Poll analysis shows that Republicans have a huge “enthusiasm”
advantage. Under Gallup’s traditional voter model, 56 percent of likely voters say
they are inclined to vote for a Republican; 38 percent for a Democrat. If slightly
higher turnout is assumed, the Republican leads 53 percent to 40 percent. A
Zogby Interactive poll shows the generic ballot tied at 43 percent. (WashPost
10/05) (USA TODAY 10/05) (WH Bulletin 10/05)

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Arkansas Senate Race

A new Rasmussen Reports poll shows Representative John Boozman (R) leading
Arkansas Senator Blanche Lincoln (D) 55 percent to 37 percent. (WH Bulletin
10/04)

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California Senate Race

A SurveyUSA poll shows California Senator Barbara Boxer (D) leading challenger
Carly Fiorina (R) 46 percent to 43 percent. Fiorina leads 49 percent to 34 percent
among independents. A Rasmussen Reports poll shows Boxer ahead 49 percent to
45 percent. An Ipsos/Reuters survey shows Boxer leading 47 percent to 43
percent. (WH Bulletin 10/05, 10/06)

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Colorado Senate Race

A Marist/McClatchy survey shows challenger Ken Buck (R) leading Colorado
Senator Michael Bennet (D) 50 percent to 42 percent. A Denver Post/SurveyUSA
poll shows Buck leading Bennet 48 percent to 43 percent. A Rasmussen Reports
survey shows Buck leading 50 percent to 45 percent while a new Public Policy
Polling survey shows Bennet leading Buck 46 percent to 45 percent. (WH Bulletin
10/04, 10/05, 10/06)

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Connecticut Senate Race

A Public Policy Polling survey shows state Attorney General Richard Blumenthal
(D) leading Linda McMahon (R) 53 percent to 41 percent in the race for the seat
of retiring Connecticut Senator Chris Dodd (D). A Fox News/Pulse Opinion
Research poll shows Blumenthal leading 52 percent to 42 percent. A recent
Merriman River Group poll shows a slightly closer race, with Blumenthal up 52
percent to 45 percent. (WH Bulletin 10/05)

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Top

Delaware Senate Race

A new Fairleigh Dickinson University poll shows Chris Coons (D) leading Christine
O’Donnell (R) 53 percent to 36 percent in the open Delaware Senate contest. (WH
Bulletin 10/06)

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Florida Senate Race

A Florida Chamber of Commerce/Public Opinion Strategies poll shows Marco
Rubio (R) leading the open Florida Senate race with 40 percent, followed by
Governor Charlie Crist (I) with 33 percent, and Representative Kendrick Meek (D)
with 16 percent. A Zogby International survey shows Rubio leading with 39
percent, followed by Crist with 33 percent, and Meek with 18 percent. (WH Bulletin
10/05)

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Illinois Senate Race

A Chicago Tribune/WGN-TV poll shows Alexi Giannoulias (D) leading
Representative Mark Kirk (R) 38 percent to 36 percent in the Illinois Senate
contest. A Suffolk University poll shows Kirk leading 42 percent to 41 percent while
a Rasmussen Reports poll shows Kirk leading Giannoulias 45 percent to 41
percent. (WH Bulletin 10/04, 10/05, 10/06)

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Indiana Senate Race

A new WISH-TV/EPIC-MRA survey shows former Senator Dan Coats (R) leading
Representative Brad Ellsworth (D) 51 percent to 33 percent. (WH Bulletin 10/06)

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Missouri Senate Race

A Fox News/Pulse Opinion Research poll shows Representative Roy Blunt (R)
leading Secretary of State Robin Carnahan (D) 50 percent to 42 percent in the
open Missouri Senate contest. Blunt leads 52 percent to 27 percent among
independents. (WH Bulletin 10/05)

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Nevada Senate Race

A Fox News/Pulse Opinion Research poll shows challenger Sharron Angle (R)
leading Senate Majority Leader Harry Reid (D) 49 percent to 46 percent in the
Nevada Senate race. The poll shows Reid’s approval rating at 42 percent with 56
percent disapproving. (WH Bulletin 10/05)

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Ohio Senate Race

A Fox News/Pulse Opinion Research poll shows former Representative Rob
Portman (R) leading Lt. Governor Lee Fisher (D) 53 percent to 37 percent in the
race for the seat of retiring Senator George Voinovich (R). A Quinnipiac University
survey shows Portman Fisher 55 percent to 36 percent (WH Bulletin 10/05, 10/06)

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Pennsylvania Senate Race
A Marist/McClatchy survey shows former Representative Pat Toomey (R) leading
Representative Joe Sestak (D) 51 percent to 42 percent. A Muhlenberg
College/Allentown Morning Call survey shows Toomey leading Sestak 45 percent
to 38 percent. (WH Bulletin 10/04, 10/06)

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Wisconsin Senate Race

A Marist/McClatchy poll shows challenger Ron Johnson (R) leading Wisconsin
Senator Russ Feingold (D) 52 percent to 45 percent. (WH Bulletin 10/04)

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West Virginia Senate Race

A Fox News/Pulse Opinion Research poll shows John Raese (R) leading Governor
Joe Manchin (D) 48 percent to 43 percent in the West Virginia special Senate
election. (WH Bulletin 10/05)

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House Races
! Arizona 1: A Hill/ANGA poll shows AZ-1 Representative Ann Kilpatrick
(D) trailing Challenger Paul Gosar (R) 46 percent to 39 percent.
! Colorado 4: A new ANGA/The Hill survey shows challenger Cory Gardner
(R) leading CO4 Representative Betsey Markey (D) 44 percent to 41
percent.
! Delaware-At Large: A Fairleigh Dickinson University Public Mind poll
shows ex-Lt. Governor John Carney (D) leading businessman Glen
Urquhart (R) 51 percent to 36 percent in the race for the seat currently
held by DE-AL Representative Mike Castle (R).
! Hawaii-1: A Public Policy Polling/Daily Kos poll shows Colleen Hanabusa
(D) leading HI-1 Representative Charles Djou (R) 48 percent to 47
percent. Djou leads 61 percent to 31 percent among independents.
! Illinois-11: A new ANGA/The Hill survey shows challenger Adam Kinziger
(R) leading IL-11 Representative Debbie Halvorson (D) 49 percent to 31
percent.
! Louisiana-2: A Public Policy Polling/Daily Kos survey shows Louisiana
state Representative Cedric Richmond (D) leading LA-2 Representative
Anh “Joseph” Cao (R) 49 percent to 38 percent.
! Maryland-1: A new ANGA/The Hill survey shows challenger Andy Harris
(R) leading MD-1 Representative Frank Kratovil (D) 43 percent to 40
percent.
! Michigan-1: An ANGA/The Hill survey shows MI-1 Representative Mark
Schauer (D) and challenger Tim Walberg (R) tied at 41 percent.
! Nevada-3: An ANGA/The Hill survey shows challenger Joe Heck (R)
leading NV-3 Representative Dina Titus (D) 47 percent to 44 percent.
Among independents, Heck leads 57 percent to 33 percent.
! New Mexico-2: An ANGA/The Hill survey shows former Representative
Steve Pearce (R) leading NM-2 Representative Harry Teague (D) 46
percent to 42 percent.
! Ohio-15: An ANGA/The Hill survey shows challenger Steven Stivers (R)
leading OH-15 Representative Mary Jo Kilroy (D) 47 percent to 38 percent.
Among independents, Stivers leads 46 percent to 25 percent.
! Ohio-16: An ANGA/The Hill survey shows challenger Jim Renacci (R)
leading OH-16 Representative John Boccieri (D) 42 percent to 39 percent.
! Pennsylvania-3: An ANGA/The Hill survey shows challenger Mike Kelly
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 !
Pennsylvania-3: An ANGA/The Hill survey shows challenger Mike Kelly
(R) leading PA-3 Representative Kathy Dahlkemper (D) 49 percent to 36
percent.
! Virginia-2: An ANGA/The Hill survey shows challenger Scott Rigell (R)
leading VA-2 Representative Glenn Nye (D) 42 percent to 36 percent.
! Virginia-5: An ANGA/The Hill survey shows challenger Robert Hurt (R)
leading VA-5 Representative Tom Perriello (D) 45 percent to 44 percent.
(WH Bulletin 10/06)

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Hearing and Public Meetings: For detailed summaries contact AAPPO

MedPAC Meeting on Medicare’s Shared Savings Program for ACOs

On October 7, the Medicare Payment Advisory Commission (MedPAC) held a
public meeting on accountable care organizations (ACOs). ACOs are defined as
organizations whose primary care physicians are accountable for coordinating care
for at least 5,000 Medicare beneficiaries. Patients are assigned to ACOs using
primary care claims. MedPAC staff presented different model options for ACOs
regarding bonus payments and beneficiary assignment. Commissioners discussed
a two-sided risk model as an alternative to the bonus only model. The discussion
and recommendations will be used as the basis for the MedPAC comment letter to
HHS on ACOs.

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MedPAC Public Meeting on Least Costly Alternative Policies

On October 7, the Medicare Payment Advisory Commission (MedPAC) held a
public meeting titled “Clarifying Medicare’s Authority to Apply Least Costly
Alternative Policies.” MedPAC staff provided background information on least costly
alternative (LCA) policies. Under LCA policies, Medicare sets the payment rate for
a group of clinically similar items based on the least costly item in the group.
Commissioners discussed the potential of and controversies surrounding these
policies.

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CMS Hospital & Hospital Quality Open Door Forum

On October 07, the Centers for Medicare & Medicaid Services (CMS) held a
Hospital & Hospital Quality Open Door Forum. The topics covered included: a
Hospital Quality Update; HITECH Update; and the 3-Day Payment Window Follow
Up.

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Regulatory Activity:

Food and Drug Administration

Notice: Medical Device User Fee and Modernization Act: Notice to Public of
Web site Location of Fiscal Year 2011 Proposed Guidance Development
On October 1, the Food and Drug Administration (FDA) announced the web site
location where it will post a list of guidance documents the Center for Devices and
Radiological Health is considering for development. The FDA has established a
docket where stakeholders may provide comments and/or draft language for those
topics as well as suggestions for new or different guidances.

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 Top

Food and Drug Administration

Notice: Request for Comments on the Food and Drug Administration Fiscal
Year 2011–2015 Strategic Priorities Document; Request for Comments
On October 1, the Food and Drug Administration (FDA) issued a notice requesting
public comment on its draft Strategic Priorities Fiscal Years 2011–2015. The FDA
has identified these strategic priorities and goals that will guide its efforts to
achieve its public health mission. The FDA is seeking public comment to help
further refine these priorities and goals. Comments are due by November 1, 2010.

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American Association of Preferred Provider Organizations

office: 222 South First Street, Suite 303, Louisville, KY 40202
phone: (502) 403-1122

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