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Health Policy Report

October 7, 2010

HHS Awards Grants to 48 States for Health Insurance Exchanges

The Department of Health and Human Services (HHS) awarded nearly $49million to help 48 states and the District of Columbia plan for theestablishment of health insurance exchanges. Starting in 2014, health

insurance exchanges will put greater control and greater choice in thehands of individuals and small businesses. The state-based exchanges willmake purchasing health insurance easier by providing eligible consumersand businesses with one place where they can compare and purchasehealth insurance coverage. These grants of up to $1 million each will givestates the resources they need to conduct the research and planning neededto build a better health insurance marketplace and determine how theirexchanges will be operated and governed. Alaska and Minnesota were theonly two states to turn down the grants. (HHS Press Release 09/30) (Hill09/30)

Schedule for the Week AheadHearings 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 October14.

Week of October 4, 2010News:

Health Reform ImplementationHHS Plans to Address Unique Needs of Mini-Med PlansHHS Receives Comments on Health Insurance ExchangesCMS Announces Resources to Combat Abuse in LTC FacilitiesNearly 3,000 Organizations Accepted Into Early Retiree Reinsurance ProgramLawmakers Fear Health Reforms CER Board Could Influence NIH and AHRQWorkRepublicans Ask States for Input on Cost of Implementing Health Care LawGAO Announces New National Health Care Workforce CommissionCRS: HHS Misses One-Third of Deadlines Under Health Reform LawSchwarzenegger Signs Major Health Care BillsInsurers Protest HHS Web Portals Denials Data

Other Le islative Issues


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Harkin Criticizes HHS Plan to Redirect Flu Funds to DODIndustry Raises Concerns With Draft Drug Safety Bills Fees and DataConfidentialityAdministrationU.S. Increases AIDS Fund DonationHHSHHS Hosts National Summit on Health Care Quality and ValueOIG Issues Fiscal Year 2011 Work PlanHHS Awards $473 Million in Patient-Centered Outcomes Research FundingHHS Urges States to Improve Medicaid and CHIP Well-Child VisitsSenate Democrats Ask Sebelius to Investigate Medigap Premium IncreasesCMSCMS Introduces New Resource to Help Providers Avoid Medicare ComplianceIssuesMedicare Fraud Patrols Get $9 Million BoostHealth Insurance Counseling Programs Receive $1.5 Million in PerformanceAwards

FDAFDA Issues Strategic Action PlanFDA Issues Report Outlining Plans to Advance Regulatory ScienceFDA to Hold Public Hearing in November on Implementing Biosimilars PathwayFDA Deploys Import Safety SystemStakeholders Push for FDA Drug Insert ReviewDEADEA Issues Guidance to Ease Delay of Pills for ElderlyOff-the-Hill ItemsStudy Predicts Medicare Prescription Drug Costs to Rise

Data Firm Sees 2011 Drug Sales Rising2010 ElectionsGeneric Ballot and Voter Enthusiasm

Senate RacesArkansas Senate RaceCalifornia Senate RaceColorado Senate RaceConnecticut Senate RaceDelaware Senate RaceFlorida Senate RaceIllinois Senate RaceIndiana Senate Race

Missouri Senate RaceNevada Senate RaceOhio Senate RacePennsylvania Senate RaceWisconsin Senate RaceWest Virginia Senate Race

House RacesHearing and Public Meetings:MedPAC Meeting on Medicares Shared Savings Program for ACOsMedPAC Public Meeting on Least Costly Alternative Policies


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CMS Hospital & Hospital Quality Open Door ForumRegulatory Activity:FDA: MDUFMA: Notice to Public of Web site Location of FY 2011 Proposed GuidanceDevelopmentFDA:Notice: Request for Comments on the FDA FY 20112015 Strategic PrioritiesDocument

News:

Administration Holds Stakeholder Meeting on ACOsThe 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 fraudand anti-kickback statutes. Representatives from provider and payer organizationssaid that they would like guidance from the government about whether theirpolicies of negotiating prices would be protected in a safe harbor from federalantitrust and anti-kickback statutes. Stakeholders also discussed whether thegovernment should grant ACOs waivers and/or exemptions from those statutes.

Inspector General Daniel Levinson said The fraud and abuse rules enforced byour office should not stand in the way of improving quality and reducing coststhrough ACOs. As the Medicare and Medicaid programs incorporate and test newpayment 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 addedthat the OIG is listening to stakeholders suggestions and will work to ensure ACOssucceed. (BNA 10/06) (Inside Health Policy 10/07)

Top

HHS Plans to Address Unique Needs of Mini-Med PlansThe Department of Health and Human Services (HHS) said that it would givelimited benefit plans or mini-med plans special consideration as it implements the

medical loss ratio (MLR) requirements of health reform. This comes after a newsreport indicated that McDonalds might drop the coverage it provides to someemployees because its plan would likely not meet the new MLR standards. A HHSofficial said the department would accommodate the special circumstancespresented by limited benefit plans. We understand that some employers mustsoon make decisions regarding coverage options for 2011. As such, we fully intendto exercise (our) discretion under the new law to address the specialcircumstances of mini-med plans in the medical loss ratio calculations, said JayAngoff, the director of HHS Office of Consumer Information and InsuranceOversight. The National Association of Insurance Commissioners is working on adraft MLR regulation, which will eventually serve as the model for HHS regulationson the provision. Although that work is still ongoing, Angoff said that the statuteitself clearly provides flexibility for mini-med plans. Obama Administration officialshave been granting dozens of waivers to maintain even minimal coverage far

below the health reform laws standards in an effort to address threats by somehealth insurers to abandon markets, drop out of the business altogether or refuseto 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)TopHHS Receives Comments on Health Insurance ExchangesIn comments to the Department of Health and Human Services (HHS), physicianand 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 marketconcentration. The American Medical Association (AMA) also requested insurersfollow their Insurer Code of Conduct and that the governance structure of theexchange include patient and doctor representatives. Americas Health InsurancePlans (AHIP) agreed that all plans that meet the criteria should be allowed toparticipate in the exchanges. AHIP called on states to pass legislation so that theycan operate the exchanges. States are best suited to design an exchangeinfrastructure that delivers high value, high quality care meeting the unique needs

of their specific population, AHIP said in its comment letter. AHIP and the BlueCross and Blue Shield Association said that consumers should be able to getcoverage inside and outside of exchanges. Insurance rate reviews should behandled by existing state regulatory agencies and not duplicated through theexchanges, AHIP said. (BNA 10/06)TopCMS Announces Resources to Combat Abuse in LTC FacilitiesThe Centers for Medicare & Medicaid Services (CMS) awarded more than $13million to six states to design comprehensive applicant criminal background checkprograms 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 jobseeker has any kind of criminal history or other disqualifying information that couldmake him or her unsuitable to work directly with residents. The states included inthe first round of the program are: Alaska, Connecticut, Delaware, Florida,Missouri, and Rhode Island. They each will share a portion of $13.7 million. Anadditional 11 states applied and may be funded beginning in October orNovember. (HHS Press Release 10/06)TopNearly 3,000 Organizations Accepted Into Early Retiree Reinsurance ProgramThe Department of Health and Human Services (HHS) said nearly 3,000 employersand unions have been accepted into the Early Retiree Reinsurance Program. Sincethe first round of nearly 2,000 approvals in August, another 1,000 businesses,state and local governments, educational institutions, nonprofit organizations, andunions have been accepted into the program and will begin to receivereimbursements for their early retirees medical claims this fall. The AffordableCare Act provides $5 billion in financial assistance to help employers maintaincoverage for early retirees ages 55 and older who are not yet eligible for Medicare.(BNA 10/05)TopLawmakers Fear Health Reforms CER Board Could Influence NIH and AHRQWorkDemocratic leaders on the House Energy and Commerce Committee are worriedthat the health reform laws Patient-Centered Outcomes and Research Institute

(PCORI) could influence comparative effectiveness research (CER) studiesconducted at the National Institutes of Health (NIH) and the Agency for HealthcareResearch and Quality (AHRQ). Committee staff plan to meet with NIH officials todiscuss the concerns. They also hope the Government Accountability Office willseek ways to mute special interest groups influence when it selects members forPCORIs Methodology Committee. The health overhaul law that created PCORI didnot say much about the methodology boards authority. Many say the methodscommittee has the potential to be extremely influential because it has a hand indeveloping the standards for comparing how well treatments work. It could bemerely advisory or it could be the panel that does most of the work. (Inside HealthPolicy 10/04)


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TopRepublicans Ask States for Input on Cost of Implementing Health Care LawThree Republican members of the House Energy and Commerce Committee areasking states how they plan to deal with the cost of implementing the new healthcare law. Representative Joe Barton (R-TX), Michael Burgess (R-TX), and JohnShimkus (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 andtheir families, and create and operate insurance exchanges. The lawmakers alsoasked the states to let them know how they expect to cover the expenses resultingfrom the laws implementation. (CQ 10/05)TopGAO Announces New National Health Care Workforce CommissionThe Government Accountability Office (GAO) announced the appointment of 15members to the new National Health Care Workforce Commission. The AffordableCare Act created the Commission to serve as a national resource for Congress,the President, and states and localities; to communicate and coordinate withfederal 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 encourageinnovations that address population needs, changing technology, and otherenvironmental 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 forMedicine 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 theCommission.

o Brian J. Isetts, PhD, Professor, Department of PharmaceuticalCare and Health Systems, University of Minnesota College ofPharmacy.

o Harold M. Maurer, MD, Chancellor, University of Nebraska MedicalCenter.

o Thomas Ricketts, PhD, Professor, Department of Health Policy andManagement, University of North Carolina Gillings School ofGlobal 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 andResearch.

o Kim Gillan, Workforce Development and Training Coordinator,


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Montana State Universitys Billings (MSUB) College ofProfessional Studies and Lifelong Learning.

o Lisa Renee Holderby, Director of Health Equity, CommunityCatalyst.

o Deborah King, Executive Director, 1199SEIU Training andEmployment Funds.

o Richard Krugman, MD, Vice Chancellor for Health Affairs,University of Colorado Denver and Dean, University of ColoradoSchool of Medicine.

(GAO 09/30)TopCRS: HHS Misses One-Third of Deadlines Under Health Reform LawAccording to a memo by the Congressional Research Services (CRS), theDepartment of Health and Human Services (HHS) failed to meet a third of itsdeadlines implementing provisions of the new health care law before September23. CRS said HHS failed to fulfill its requirements in seven of 22 deadlines beforeSeptember 23. HHS spokeswoman Jessica Santillo said that HHS has met andbeaten deadlines required by the health care reform law. She said CRS in thememo incorrectly reported several missed deadlines, including one to establish a

Medicare prescription drug coverage gap discount program. (BNA 10/05)TopSchwarzenegger Signs Major Health Care BillsCalifornia Governor Arnold Schwarzenegger signed seven major health reformbills, including legislation establishing a Web-based insurance exchange that willallow consumers to comparison shop for coverage. California is now the first stateto implement an oversight board for insurance exchange marketplaces since thenew federal health care law was enacted earlier this year. Massachusettsimplemented its exchange prior to reform. Additional bills signed prohibit insurersfrom denying coverage to children because of a preexisting condition and allowyoung adults to stay on their parents health care plans until age 26. (AP 09/30)

TopInsurers Protest HHS Web Portals Denials DataThe Department of Health and Human Services (HHS) unveiled the second phaseof the new web portal, which provides price estimates for private insurancepolicies. Insurers raised concerns with the sites description of coverage denials.The web portals second iteration required insurance companies to provide thepercentage of people who applied for insurance and were denied coverage, alongwith the percentage of people who were charged higher premiums because oftheir health status. Robert Zirkelbach, a spokesman for Americas HealthInsurance Plans, said the definitions that HHS uses to describe denials are notaccurate and present a skewed image of the industrys denials of coverage. Thenew version of the site includes: monthly premium estimates; cost-sharinginformation; major categories of services covered; consumers share of cost forthese services; percent of people who pay more than base premium estimate; andpercent of people denied coverage. (Inside Health Policy 10/04)TopHarkin Criticizes HHS Plan to Redirect Flu Funds to DODSenator Tom Harkin (D-IA) criticized the Department of Health and HumanServices (HHS) for its plan to redirect Project Bioshield procurement funds to theDepartment of Defense (DOD). He raised concerns that the U.S. is falling behindin developing cell-based vaccine technologies, while agreeing with HHS aim to


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strengthen its medical countermeasures enterprise. Harkin said he would be hard-pressed to support a recent White House budget amendment to reallocate HHSbiodefense funds to DOD. Im not going to sign off on it, he said, referring to aproposed $200 million transfer from the Project Bioshield Special Reserve Fund toDOD to establish a Technical Center of Excellence for Advanced Development andManufacturing. The proposed HHS budget amendment calls for Project Bioshieldand pandemic flu dollars to be reallocated toward initiatives outlined in acountermeasures report released in August to improve HHS medical

countermeasure enterprise. (Inside Health Policy 10/05)TopIndustry Raises Concerns With Draft Drug Safety Bills Fees and DataConfidentialityThe pharmaceutical industry trade groups have informed lawmakers they haveconcerns with Democrats draft drug safety legislation. Of particular concern is thatthe bill permits collected fees to be used for non-foreign inspection-related issues,leaves many elements of the fees unanswered, and does not fully protectconfidential information. The groups urged lawmakers to consider exemptingcertain investigational products from the legislations requirements and said a third-party audit program and improved international coordination could help support the

bills foreign inspection program. Safety advocates praised the measure, but aconsumer advocate said the registration fees should not sunset, because a failedreauthorization could undermine the foreign inspection program. (Inside HealthPolicy 10/04)TopU.S. Increases AIDS Fund DonationThe Obama Administration announced a large increase in its pledge to the GlobalFund to Fight AIDS, Tuberculosis, and Malaria. The Administration also called forreform of the organization. The U.S. is pressing the Global Fund to develop anaction agenda with timelines and measurements in order to ensure accountability.The U.S. will measure progress annually. The pledge of $4 billion over the nextthree fiscal years comes as governments and donors around the world haveslowed increases in spending to combat HIV/AIDS, with weaker economiesstraining 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) (NYT10/05)TopHHS Hosts National Summit on Health Care Quality and ValueDepartment of Health and Human Services (HHS) hosted the National Summit onHealth Care Quality and Value this week. At the event, HHS Secretary KathleenSebelius urged Congress to turn its attention away from politics and partisansniping and to focus on how it can successfully reform the nations health deliverysystem. 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 manyyears Lee helped lead efforts of the Pacific Business Group on Health which is abusiness coalition focused on health care. Centers for Medicare & MedicaidServices (CMS) Administrator Donald Berwick also spoke at the summit. He saidthroughout the nation there are stunning examples of health care providers whohave leapt over the fear of studying variations in health care quality andoutcomes. Providers who have low costs and better-quality outcomes are lookingfor more recognition and additional Medicare payments, said Berwick. Health carein the United States can and should be improved with the triple aim of bettercare, 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


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care, he said. Berwick also laid out five principles that he said could guide qualityimprovement: health care in America can and should improve; providers and othersshould learn from each other, including the variations among their processes andoutcomes; within any subset of providers, there is variation; the risks oftransparency are worth taking; and partnerships are essential. (Politico 10/05) (CQ10/04) (BNA 10/05)Top

OIG Issues Fiscal Year 2011 Work PlanThe Health and Human Services (HHS) Office of Inspector General (OIG) issuedits work plan for fiscal year 2011. OIG indicated that among other activities it willissue reports on the Food and Drug Administrations 510(k) device clearanceprocess, as well as hospital payments and readmissions. The work plan providesbrief descriptions of activities that the OIG plans to initiate or continue with respectto the programs and operations of HHS. For each review, the work plan describesthe subject, primary objective, and criteria related to the topic. (BNA 10/04)TopHHS Awards $473 Million in Patient-Centered Outcomes Research Funding

The Department of Health and Human Services (HHS) Agency for HealthcareResearch and Quality (AHRQ) announced the award of $473 million in grants andcontracts to support comparative effectiveness research projects. The Recovery Actprovided AHRQ $300 million and HHS $400 million. The funding announced coversall of AHRQs allocation and $173 million administered for the HHS Secretary byAHRQ. The projects will support patient-centered outcomes research efforts inmany areas, including health care interventions in real world settings, advanceduse of the research findings by diverse populations, development of effectivepatient registries and training and career development for the next generation ofresearchers. The funded grants and contracts fall into several categories. For theawards funded by the Office of the Secretary, they are: Data Infrastructure;Dissemination, Translation and Implementation; Research; and Inventory andEvaluation. The awards funded by the AHRQ allocation are categorized under:Horizon Scanning; Evidence Synthesis; Evidence Gap Identification; Translationand Dissemination; Evidence Generation; Training and Career Development; andthe Community Forum. (HHS Press Release 09/30)TopHHS Urges States to Improve Medicaid and CHIP Well-Child VisitsAccording to a report by the Department of Health and Human Services (HHS),states need to substantially improve the percentage of well-child visits for thosethree to six years old covered under Medicaid and the Childrens Health InsuranceProgram (CHIP). The report also showed mixed results in the use of qualitymeasures and reporting by states, according to an analysis of Medicaid managedcare data done by the National Committee for Quality Assurance (NCQA) under acontract with HHS. States, lacking a standardized format for collecting quality

measures, have implemented various approaches to assessing quality, includingdeveloping state-specific quality metrics, the HHS concluded. Although all statescollect some quality data; there is wide variance in the information and theprocesses 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 percentof children in that age group received the check-up nationwide, 2008 data show.(Inside Health Policy 10/04)Top


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Senate Democrats Ask Sebelius to Investigate Medigap Premium IncreasesTop Senate Democrats are asking Department Health and Human Services (HHS)Secretary Kathleen Sebelius to investigate recent premium rate increases forMedigap plans. Senate Majority Leader Harry Reid (D-NV), Senate FinanceCommittee Chairman Max Baucus (D-MT), and Senator John Kerry (D-MA) said ahealth insurer recently raised its premium for Medigap coverage by 40 percent,raising serious concerns about premium-setting practices and rate reviewprocedures in place for Medigap policies. The lawmakers also asked Sebelius to

work with state governors and insurance commissioners to conduct thoroughannual rate reviews to prevent unnecessary premium increases and to conduct astudy of Medigap trends and costs to provide a benchmark against which proposedrates can be measured. (BNA 10/07)TopCMS Introduces New Resource to Help Providers Avoid Medicare ComplianceIssuesThe Centers for Medicare & Medicaid Services (CMS) announced the first editionof the Medicare Quarterly Provider Compliance Newsletter, a publication designedto help providers identify and prevent Medicare billing errors and other complianceissues.The first edition provides recommendations for avoiding eight billing error

situations, including an inpatient hospital or skilled nursing facility failing to submitthe required documents for a claim and subsequently being contacted by aRecovery Audit Contractor (RAC) with a document request.Other issues includephysicians 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 facingproviders that quarter, as identified by a variety of sources, such as reports fromthe Department of Health and Human Services Office of Inspector General as wellas RAC and other CMS contractor reviews. Some editions may include billingissues related to one provider type or regarding one particular service. (BNA 10/07)TopMedicare Fraud Patrols Get $9 Million BoostThe Centers for Medicare & Medicaid Services (CMS) issued $9 million in grantsto volunteers to help seniors make sure they are not victims of Medicare fraud. Themoney will go to 51 Senior Medicare Patrol programs whose mission it is tocombat Medicare fraud by educating beneficiaries, their family members andcaregivers about such things as reviewing their Medicare notices to ensure the billsare correct. The grants will be jointly administered by CMS and the Administrationon Aging. (CQ 10/01)TopHealth Insurance Counseling Programs Receive $1.5 Million in PerformanceAwards

The Centers for Medicare & Medicaid Services (CMS) said most state healthinsurance assistance programs (SHIPs) will share in $1.5 million in awards fordemonstrating achievement in beneficiary outreach. Eligibility for a performanceaward is based on timely data submission in the SHIP performance reportingsystem for the annual reporting period and attainment of certain performancelevels. The agency spokesman said that the latest grants ranged from $412 to$356,000, based on weighted performance measures and the size of theMedicare population within six defined geographic areas in each state. Theperformance measures include achievement of such objectives as individualizedcounseling to an increasing number and diversity of beneficiaries unable to accessother channels of information, conducting targeted outreach in public forums,


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raising awareness of opportunities for assistance with benefit and plan selection,enhancing beneficiary access to a counselor workforce, and participating in CMSeducation and communication activities. (BNA 10/04)TopFDA Issues Strategic Action PlanThe Food and Drug Administration (FDA) issued its strategic action plan that

identifies several regulatory, scientific, enforcement and oversight priorities for thenext five years, focusing on rapidly evolving science and increased globalization.Separately, the FDA device center also released a list of guidance documents thatit intends to consider developing in fiscal year 2011. The report identifies appliedresearch, regenerative medicine, combination products, robotics, systems biology,cell- and tissue-based products, mobile healthcare technologies, medical imagingand nanotechnology as its regulatory science priorities. (Inside Health Policy 10/04)TopFDA Issues Report Outlining Plans to Advance Regulatory ScienceThe Food and Drug Administration (FDA) released a report outlining the agencysplans 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 anddevices. The report provides examples of current FDA activities in regulatoryscience and also considers how advancements in the field can help deliver better,safer, and more innovative products to Americans in seven different public healthareas. These seven areas are: accelerating the delivery of new medical treatmentsto patients, improving pediatric health, protecting against emerging infectiousdiseases and terrorism, enhancing safety and health through informatics, protectingthe food supply, modernizing safety testing, and meeting the challenges ofregulating tobacco. (BNA 10/07)TopFDA to Hold Public Hearing in November on Implementing BiosimilarsPathwayThe Food and Drug Administration (FDA) announced that it will hold a two-daypublic hearing November 2-3 to seek comments on implementing the abbreviatedapproval pathway for biosimilars. The Biologics Price Competition and Innovation(BPCI) Act of 2009 establishes an abbreviated approval pathway for biologics thatare demonstrated to be highly similar to or interchangeable with an FDA-licensedbiological product. The act was part of the Patient Protection and Affordable CareAct (PPACA). The FDA said the purpose of the hearing is to receive input on theacts implementation from the public, health care professionals, health careinstitutions, manufacturers of biomedical products, industry and professionalassociations, patients and patient associations, third-party payers, and current andprospective biological license application and new drug application holders. (BNA10/05)

TopFDA Deploys Import Safety SystemThe Food and Drug Administration (FDA) has refurbished the informationtechnology infrastructure on its import safety systems and is on track to deploy thetools to additional ports. The system has also begun inspecting drug and deviceimports. The Mission Accomplishments and Regulatory Compliance Service(MARCS) and Predictive Risk-based Evaluation for Dynamic Import ComplianceTargeting (PREDICT) systems have long been touted by the FDA as improving thesafety of imported products. PREDICT, which is software incorporated into the


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MARCS system, analyzes the safety profile and risk associated with importedgoods, and makes improved safety determinations over time. Deployment of thesystems was suspended earlier this year after the agencys legacy informationtechnology could not support the import safety tools. (Inside Health Policy 10/06)TopStakeholders Push for FDA Drug Insert Review

Stakeholders, including members of the drug industry, consumers and drug stores,are resisting the Food and Drug Administrations (FDA) position that the agencycannot pre-review all drug information inserts under a new plan to develop a singledocument that would be distributed with medications, they told agency officials thisweek. Instead of lacking an FDA review of the proposed single document PatientMedication Information (PMI) inserts, stakeholders suggested examining new userfees or a tiered approach that would gradually review the consumer-orientedinformation based on risk and usage. Stakeholders differed, though, on who shoulddraft the PMI, with industry calling for drug makers to develop the inserts andconsumer advocates arguing that industry language will result in skewedinformation reaching patients. (Inside Health Policy 10/07)Top

DEA Issues Guidance to Ease Delay of Pills for ElderlyThe Drug Enforcement Administration (DEA) has issued new guidelines intended tohelp ease the delay some nursing home residents face in receiving certainpainkillers and anti-anxiety medications. Physicians may now authorize nursesemployed by long-term care facilities to phone in their oral prescriptions for thesecontrolled substances to pharmacies. The DEA had not previously recognizednurses employed by nursing homes as the legal agents of doctors in conveyingcontrolled substances prescriptions to pharmacists. The agency previouslycounseled pharmacists who dispensed such drugs to nursing home patients to doso only via direct oral or written communication with a doctor. Senate SpecialCommittee on Aging Chairman Herb Kohl (D-WI) called the new policy a step inthe right direction. However, he said the changes still did not give nurses theability to transmit prescriptions for other important medications, including morphine.(NYT 10/06)TopStudy Predicts Medicare Prescription Drug Costs to RiseA Kaiser Family Foundation study found that premiums for Medicare Part Dprescription drug plans will rise by 10 percent on average in 2011 for seniors whostick with their current plans. The Kaiser report also says that the averagebeneficiary will be able to choose among 33 stand-alone Part D plans, even thoughthe number of plans will drop by a third nationally. Premiums will rise to $40.72 amonth on average for those who stay with their current plans, up from $36.90 in2010. Some plans will have slight decreases in premium costs. (CQ 10/04)

TopData Firm Sees 2011 Drug Sales RisingAccording to IMS Health, revenue from global prescription drug sales shouldincrease 5 percent to 7 percent next year, reaching at least $880 billion. The IMSMarket Prognosis report attributes the expected revenue increase to the anticipatedlaunch of new potential blockbusters, rising gross domestic product in about twodozen of the top developed and emerging markets, and strong economic growth inChina and other emerging markets, which are spending more on health care.Spending on prescription drugs next year is expected to rise, on average, about 16percent in China and 16 other emerging countries now heavily targeted by drug


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manufacturers. Prescription revenues in Canada and in Europes five biggestmarkets - Germany, France, Italy, Spain, and the United Kingdom - will grow atjust 1 percent to 3 percent next year. In the U.S., growth is expected to be about 4percent, for a total of about $325 billion next year. (AP 10/07)TopGeneric Ballot and Voter Enthusiasm

According to a new Washington Post-ABC News poll, Democrats have mademodest improvements with voters since their late-summer low point, butRepublicans still have an advantage. Democrats have made small gains on thequestion of which party people trust to handle big issues, such as the economyand health care. Despite signs of improvement, the new poll suggests thatDemocrats remain at a significant disadvantage. Among likely voters, Republicanshold a six-point edge, 49 percent to 43 percent, on the congressional ballot. Arecent Gallup Poll analysis shows that Republicans have a huge enthusiasmadvantage. Under Gallups traditional voter model, 56 percent of likely voters saythey are inclined to vote for a Republican; 38 percent for a Democrat. If slightlyhigher turnout is assumed, the Republican leads 53 percent to 40 percent. AZogby Interactive poll shows the generic ballot tied at 43 percent. (WashPost10/05) (USA TODAY 10/05) (WH Bulletin 10/05)

TopArkansas Senate RaceA new Rasmussen Reports poll shows Representative John Boozman (R) leadingArkansas Senator Blanche Lincoln (D) 55 percent to 37 percent. (WH Bulletin10/04)TopCalifornia Senate Race

A SurveyUSA poll shows California Senator Barbara Boxer (D) leading challengerCarly Fiorina (R) 46 percent to 43 percent. Fiorina leads 49 percent to 34 percentamong independents. A Rasmussen Reports poll shows Boxer ahead 49 percent to45 percent. An Ipsos/Reuters survey shows Boxer leading 47 percent to 43percent. (WH Bulletin 10/05, 10/06)Top

Colorado Senate Race

A Marist/McClatchy survey shows challenger Ken Buck (R) leading ColoradoSenator Michael Bennet (D) 50 percent to 42 percent. A Denver Post/SurveyUSApoll shows Buck leading Bennet 48 percent to 43 percent. A Rasmussen Reportssurvey shows Buck leading 50 percent to 45 percent while a new Public PolicyPolling survey shows Bennet leading Buck 46 percent to 45 percent. (WH Bulletin10/04, 10/05, 10/06)TopConnecticut Senate RaceA 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 seatof retiring Connecticut Senator Chris Dodd (D). A Fox News/Pulse OpinionResearch poll shows Blumenthal leading 52 percent to 42 percent. A recentMerriman River Group poll shows a slightly closer race, with Blumenthal up 52percent 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 ChristineODonnell (R) 53 percent to 36 percent in the open Delaware Senate contest. (WHBulletin 10/06)Top

Florida Senate RaceA Florida Chamber of Commerce/Public Opinion Strategies poll shows MarcoRubio (R) leading the open Florida Senate race with 40 percent, followed byGovernor Charlie Crist (I) with 33 percent, and Representative Kendrick Meek (D)with 16 percent. A Zogby International survey shows Rubio leading with 39percent, followed by Crist with 33 percent, and Meek with 18 percent. (WH Bulletin10/05)Top

Illinois Senate Race

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

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

Missouri Senate RaceA Fox News/Pulse Opinion Research poll shows Representative Roy Blunt (R)leading Secretary of State Robin Carnahan (D) 50 percent to 42 percent in theopen Missouri Senate contest. Blunt leads 52 percent to 27 percent amongindependents. (WH Bulletin 10/05)TopNevada Senate RaceA Fox News/Pulse Opinion Research poll shows challenger Sharron Angle (R)leading Senate Majority Leader Harry Reid (D) 49 percent to 46 percent in theNevada Senate race. The poll shows Reids approval rating at 42 percent with 56percent disapproving. (WH Bulletin 10/05)TopOhio Senate RaceA Fox News/Pulse Opinion Research poll shows former Representative RobPortman (R) leading Lt. Governor Lee Fisher (D) 53 percent to 37 percent in therace for the seat of retiring Senator George Voinovich (R). A Quinnipiac Universitysurvey shows Portman Fisher 55 percent to 36 percent (WH Bulletin 10/05, 10/06)Top


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Pennsylvania Senate RaceA Marist/McClatchy survey shows former Representative Pat Toomey (R) leadingRepresentative Joe Sestak (D) 51 percent to 42 percent. A MuhlenbergCollege/Allentown Morning Call survey shows Toomey leading Sestak 45 percentto 38 percent. (WH Bulletin 10/04, 10/06)TopWisconsin Senate RaceA Marist/McClatchy poll shows challenger Ron Johnson (R) leading WisconsinSenator Russ Feingold (D) 52 percent to 45 percent. (WH Bulletin 10/04)TopWest Virginia Senate RaceA Fox News/Pulse Opinion Research poll shows John Raese (R) leading GovernorJoe Manchin (D) 48 percent to 43 percent in the West Virginia special Senateelection. (WH Bulletin 10/05)Top

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 41percent.

! Delaware-At Large: A Fairleigh Dickinson University Public Mind pollshows ex-Lt. Governor John Carney (D) leading businessman GlenUrquhart (R) 51 percent to 36 percent in the race for the seat currentlyheld 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 47percent. 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 31percent.

! Louisiana-2: A Public Policy Polling/Daily Kos survey shows Louisianastate Representative Cedric Richmond (D) leading LA-2 RepresentativeAnh 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 40percent.

! Michigan-1: An ANGA/The Hill survey shows MI-1 Representative MarkSchauer (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 RepresentativeSteve Pearce (R) leading NM-2 Representative Harry Teague (D) 46percent 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.

! Penns lvania-3: An ANGA/The Hill surve shows challen er Mike Kell


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(R) leading PA-3 Representative Kathy Dahlkemper (D) 49 percent to 36percent.

! 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)

Top

Hearing and Public Meetings: For detailed summaries contact AAPPO

MedPAC Meeting on Medicares Shared Savings Program for ACOsOn October 7, the Medicare Payment Advisory Commission (MedPAC) held apublic meeting on accountable care organizations (ACOs). ACOs are defined asorganizations whose primary care physicians are accountable for coordinating carefor at least 5,000 Medicare beneficiaries. Patients are assigned to ACOs usingprimary care claims. MedPAC staff presented different model options for ACOsregarding bonus payments and beneficiary assignment. Commissioners discusseda two-sided risk model as an alternative to the bonus only model. The discussionand recommendations will be used as the basis for the MedPAC comment letter to

HHS on ACOs.Top

MedPAC Public Meeting on Least Costly Alternative PoliciesOn October 7, the Medicare Payment Advisory Commission (MedPAC) held apublic meeting titled Clarifying Medicares Authority to Apply Least CostlyAlternative Policies. MedPAC staff provided background information on least costlyalternative (LCA) policies. Under LCA policies, Medicare sets the payment rate fora group of clinically similar items based on the least costly item in the group.Commissioners discussed the potential of and controversies surrounding thesepolicies.

TopCMS Hospital & Hospital Quality Open Door ForumOn October 07, the Centers for Medicare & Medicaid Services (CMS) held aHospital & Hospital Quality Open Door Forum. The topics covered included: aHospital Quality Update; HITECH Update; and the 3-Day Payment Window FollowUp.Top

Regulatory Activity:

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


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Top

Food and Drug AdministrationNotice: Request for Comments on the Food and Drug Administration FiscalYear 20112015 Strategic Priorities Document; Request for CommentsOn October 1, the Food and Drug Administration (FDA) issued a notice requesting

public comment on its draft Strategic Priorities Fiscal Years 20112015. The FDAhas identified these strategic priorities and goals that will guide its efforts toachieve its public health mission. The FDA is seeking public comment to helpfurther refine these priorities and goals. Comments are due by November 1, 2010.Top

American Association of Preferred Provider Organizationsoffice: 222 South First Street, Suite 303, Louisville, KY 40202

phone: (502) 403-1122

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