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Washington Highlights: May 22, 2009

AAMC Comments on Finance Committee's Health Reform Options

The AAMC May 16 and May 20 submitted comments on the first and second of three health reform "policy options papers" issued by the Senate Finance Committee. The three papers, as well as public comments on the documents, will guide the panel as it works to draft comprehensive health care reform legislation.

The initial set of policy options focus on improving the delivery and reducing the cost of patient care [see Washington Highlights, April 24]. In its May 16 comments, the AAMC applauds the committee's recognition that the physician workforce must be expanded. However, the AAMC advises that the committee's proposal to redistribute unused Medicare-supported graduate medical education (GME) training slots will "fall short of what is needed" to resolve a growing shortage of more than 100,000 physicians "in multiple specialties." To address this significant and growing need, the AAMC strongly urges the inclusion of the AAMC-supported "Resident Physician Shortage Reduction Act of 2009" (S. 973/H.R. 2251) in any health reform legislation [see Washington Highlights, May 8].

The AAMC comments also:

  • Urge cautious and incremental movement toward hospital value-based purchasing (VBP), with no more than 1 percent of hospital payments used to reward performance;

  • Commend the committee's acknowledgment that certain conditions should be excluded from initiatives to reduce hospital readmissions. The comments encourage the committee to consider 7-day readmission rates (versus 30-day readmission rates);

  • Advise that proposals to bundle payments for acute and post-acute care should be fully tested and defined before being implemented. The comments encourage similar evaluations of the "accountable care organization" (ACO) concept included in the options paper;

  • Advocate for a full repeal of the Sustainable Growth Rate (SGR), along with implementation of a physician payment system that links updates to an inflationary index; and

  • Applaud the committee's interest in comparative effectiveness research and support its policy option regarding greater transparency in the relationships between physicians and manufacturers of drugs, devices, biologicals, and medical supplies. The AAMC notes that the committee's policy option reflects MedPAC's recommendation to distinguish between industry payments made directly to physicians, versus payments made to hospitals, medical schools, and universities for sponsored research (including clinical trials).

The AAMC's May 20 comments respond to the committee's second policy options paper, "Expanding Health Care Coverage: Proposals to Provide Affordable Coverage to All Americans." The paper focuses on options to provide affordable health coverage to all Americans [see Washington Highlights, May 15]. The AAMC comments recognize and support the need for change, noting that the Finance Committee's coverage objectives "align closely with those of the AAMC." However, the AAMC states that "current programs should be supported until we are sure that the replacements ... are better and more rational than the systems they would be replacing." The AAMC advises that "We must avoid the lure of terminating existing programs" (e.g., current mechanisms that finance care for the poor) "before new ones are proven and established."

The Finance Committee May 20 publicly released its third and final set of policy options, which focuses on ways to finance comprehensive health system reform. The AAMC plans to comment on several options in the document, including a reduction in Medicare and Medicaid support for GME, as well as cuts to Medicare and Medicaid disproportionate share hospital (DSH) payment levels. According to the May 20 document, the need for DSH payments decreases "as more individuals become insured as a result of health care reform." The document also states that another option is "to consolidate Medicare and Medicaid payments to hospitals as a way to streamline and better account for and coordinate funding within the DSH and GME payment areas."

According to the three policy option papers, the proposals have been "offered for discussion," and "not all the options in this document have the support of Chairman Baucus or Ranking Member Grassley." The option papers also reiterate the committee's plan to mark-up health reform legislation in June.

Information:
Atul Grover, M.D., Ph.D., Chief Advocacy Officer
AAMC Government Relations
agrover@aamc.org
(202) 828-0410

Christiane Mitchell, Director, Federal Affairs
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

President Signs FCA Amendments

The President May 20 signed the "Fraud Enforcement and Recovery Act" (FERA, S. 386). The House May 18 passed the bill (338-52) following House and Senate amendments to the original legislation, which primarily addresses mortgage fraud, but also amends the federal False Claims Act (FCA) [see Washington Highlights, May 8]. The Senate May 14 approved the House-amended version of the bill, while adding an additional amendment that addresses Department of Justice subpoenas in FCA cases.

The final measure expands S. 386 as introduced, adding amendments that were previously considered under broader FCA reform bills such as the "False Claims Act Correction Act of 2009" (H.R. 1788) and "False Claims Act Clarification Act of 2009" (S. 458). The House and Senate Judiciary Committees reportedly have agreed that S. 386 will complete action on FCA legislation in this Congress.

Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116

AAMC Comments on HHS Proposal on Breach Notification of Unsecured PHI

The AAMC submitted a May 21 comment letter on guidance issued April 17 by the Department of Health and Human Services (HHS) regarding ways to render protected health information (PHI) secure. Such information is considered to be secure - and therefore is not subject to breach notification requirements established under the American Recovery and Reinvestment Act (ARRA, P.L. 111-5) - if it is protected through the methods and technologies outlined in the HHS guidance [see Washington Highlights, April 24].

The AAMC comment letter:

  • Calls for consistency between the principles that guide requirements for breach notification of unsecured protected health information and those in the HIPAA Security regulation;

  • Agrees with the HHS proposal that following the guidance should be the equivalent of a safe harbor; and

  • Strongly supports the proposal that PHI in limited data set form should be treated as unusable, unreadable, or indecipherable.

Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490

ONCHIT, CMS Release HIT Implementation Plans

The Office of the National Coordinator for Health Information Technology (ONCHIT) and the Centers for Medicare and Medicaid Services (CMS) May 18 released their work plans for implementing the health information technology (HIT) provisions of the American Recovery and Reinvestment Act (ARRA, P.L. 111-5). The CMS plan is clear that in 2010, the agency will finalize payment incentive policies. The agency plan also states that Medicare hospital incentives will be paid no sooner than Oct. 2010, Medicaid hospital incentives will be paid no sooner than Jan. 2011, and Medicare and Medicaid physician incentives will be paid no sooner than Jan. 2011. Both plans suggest that meeting ARRA-imposed deadlines will be a challenge.

ONCHIT's plan sets forth a funding table that allocates roughly $24 million to enhancing privacy and security (including $9.5 million for audits by the Office for Civil Rights and CMS), $20 million to the National Institute of Standards and Technology (NIST) to test technical standards and establish a conformance testing infrastructure, and $300 million for a regional HIT exchange. ONCHIT indicates that it will issue extensive regulations regarding the HIPAA Privacy Rule on Feb. 18, 2010. No specific timeline is given for the release of a definition of "meaningful use" of an electronic health record (EHR). The plan also indicates that providers that receive grants or contracts can expect the HHS Office of Inspector General (OIG) to perform audits to ensure their financial stability and that they have auditable financial systems.

The CMS plan sets forth a funding table that allocates approximately $23 billion to Medicare incentives, $21.6 billion to Medicaid incentives, $1 billion to State Medicaid administration, and $1 billion to CMS administrative costs. The plan suggests that the development of an infrastructure for health information exchange may take place at the state level (CMS's list of the types of programs and activities eligible for Medicaid Administrative funds to the States includes developing an infrastructure for health information exchange). CMS also indicates that the agency is planning extensive provider education and outreach efforts regarding the incentive payment programs.

Information:
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.org
(202) 828-0490

Lori K. Mihalich-Levin, J.D., Senior Policy Analyst
AAMC Health Care Affairs
lmlevin@aamc.org
(202) 828-0599

Senate Subcommittee Holds Hearing on NIH FY 2010 Budget

The Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education May 21 held a hearing to discuss the Administration's FY 2010 budget for the National Institutes of Health (NIH). NIH Acting Director Raynard Kington, M.D., Ph.D., and three institute directors (Anthony Fauci, M.D., Director of the National Institute of Allergy and Infectious Diseases, Elizabeth Nabel, M.D., Director of the National Heart, Lung and Blood Institute, and John Niederhuber, M.D., Director of the National Cancer Institute) testified before the panel. In addition to the FY 2010 budget, the group discussed the American Recovery and Reinvestment Act (ARRA, P.L. 111-5), comparative effectiveness research (CER), and conflicts of interest (COI).

Much of the hearing focused on ARRA funding, and the possibility of NIH "falling off a cliff" when that funding ends in FY 2011. Dr. Kington spoke about the research community's overwhelming response to ARRA grant opportunities, such as the newly created Challenge Grants and Grand Opportunity (GO) grants [see Washington Highlights, March 27]. He anticipates NIH spending more on these funding opportunities than originally proposed.

Subcommittee Chair Tom Harkin (D-Iowa) asked the witnesses what their reaction would be if NIH were granted an extension to ARRA funding and given four years instead of two. All stated that NIH would be able to spend the funds responsibly in two years, but would appreciate the flexibility given with extra time. Chairman Harkin suggested this might be a solution to softening the cliff that NIH likely will face when ARRA funding runs out.

The President's budget directs a significant portion of the proposed increase to NIH in FY 2010 to cancer and autism research. Chairman Harkin expressed his concern that this specification does not leave adequate money for critical research on other diseases. Dr. Kington testified that both are important public health concerns that must be addressed, and that additional research into these areas also will lead to basic advances for all diseases.

The panel also discussed CER and COI. Dr. Nabel noted that an NIH committee is currently looking into opportunities for spending the CER money in ARRA. The NIH CER committee is considering payline expansions and supplements for clinical trials, and anticipates CER related applications for Challenge and GO Grants. Additionally, a CER committee at the Department of Health and Human Services (HHS) is looking into a uniform definition of CER to use across the department.

Regarding conflicts of interest, Chairman Harkin expressed his concern that an NIH official recently was quoted as saying NIH may not change its policies regarding COI, despite the HHS efforts in this area. Dr. Kington expressed NIH's commitment to objective, high quality research, and welcomed the opportunity to strengthen NIH's policies and oversight system.

Information:
Abigail Schopick, Legislative Analyst
AAMC Government Relations
aschopick@aamc.org
(202) 828-0525

House Education Committee Examines Student Loan Reform

The House Committee on Education and Labor May 21 held a hearing titled "Increasing Student Aid through Loan Reform." The committee examined President Obama's FY 2010 budget proposal, which would end the Family Federal Education Loan (FFEL) program that provides subsidies to private lenders for federally-insured ("guaranteed") student loans. The President's proposal assumes the federal Direct Loan program would originate all future Stafford loans and redirects savings to other student aid [see Washington Highlights, May 8].

In his opening statement, House Education Committee Chair George Miller (D-Calif.) stated that "the economic crisis has exposed serious vulnerabilities in the current FFEL structure," and "FFEL is on life support."

Robert Shireman, Deputy Under Secretary, Department of Education, testified that through the department's FFEL purchase authority, FFEL participation interest purchase, conduit programs, and Direct Loans, the "2010 Budget estimates that the Federal government will finance nearly three quarters of all student loans in both 2009-2010 and 2010-2011 academic years" without any changes to current policy. Additionally, Mr. Shireman indicated that in the future, Direct Loan servicers will be assessed based on default prevention and customer satisfaction to determine their proportionate share of the federal student loan portfolio.

Information:
Matthew Shick, Senior Legislative Analyst
AAMC Government Relations
mshick@aamc.org
(202) 862-6116

CMS Seeks Feedback on ICD-9 and ICD-10 Transition

The Centers for Medicare and Medicaid Services (CMS) May 19 hosted a national provider conference call to provide information on ICD-10-CM/PCS implementation and General Equivalence Mappings (GEMs), a data conversion tool designed to aid in converting applications and systems from ICD-9 to ICD-10.

The final regulation allows health plans and providers until Oct. 1, 2013, to adopt and implement ICD-10-CM (diagnosis) and ICD-10-PCM (procedure) codes. ICD-9 codes will not be accepted for services provided on or after the Oct. 1, 2013, deadline.

CMS staff request feedback from providers on whether ICD-10 and/or ICD-9-CM codes should be frozen prior to final implementation of ICD-10, and if so, when the freeze should be instituted. Public comments should be sent to CMS via a form on the CMS Web site. Feedback will be discussed at the Sept. 16, 2009, meeting of the CMS ICD-9 Coordination and Maintenance Committee.

To assist in the conversion of coding data, CMS staff provided call participants with an overview of GEMs, created by CMS and the Centers for Disease Control and Prevention (CDC) to assist in converting policies, edits, and trend data from ICD-9-CM to ICD-10-CM/PCS.

More information about the ICD-10 transition and GEMs can be found online.

Information:
Will Dardani, Constituent Services Specialist
AAMC Health Care Affairs
wdardani@aamc.org
(202) 828-0541

HIT Policy and Standards Committees Hold First Meetings

Two committees established by the American Recovery and Reinvestment Act (ARRA, P.L. 111-5) to advise the Office of the National Coordinator for Health Information Technology (ONCHIT) held their inaugural meetings. Together, the two committees will develop recommendations regarding how providers can demonstrate "meaningful use" of health information technology (HIT) to be eligible for federal Recovery Act funding [see Washington Highlights, May 8]. The committees also will make recommendations for other issues related to the nation's HIT infrastructure.

The HIT Policy Committee met May 11 and decided to form three working groups dedicated to (1) certification and adoption; (2) meaningful use; and (3) health information exchange. HIT National Coordinator David Blumenthal, M.D., M.P.P., chairs the Policy Committee [see Washington Highlights, April 10].

The HIT Standards Committee met May 15 and formed three working groups to focus on (1) clinical operations; (2) clinical quality; and (3) privacy and security. Healthcare Corporation of America's Chief Medical Officer Jonathan Perlin, M.D., serves as the Standards Committee's chair and John Halamka, M.D., M.S., serves as the committee's vice chair. Dr. Halamka is Chief Information Officer (CIO) of the CareGroup Health System, and CIO and Associate Dean for Educational Technology at Harvard Medical School.

The Standards Committee will receive direction for action through Policy Committee recommendations, but to begin work immediately, the Standards Committee agreed to work within "contingencies" of options the Policy Committee is likely to recommend. The Standards Committee decided to hold itself to a 90-day timeline for responding to Policy Committee recommendations, though committee members recognized the need to act more quickly in the initial stages.

Information:
Lori K. Mihalich-Levin, J.D., Senior Policy Analyst
AAMC Health Care Affairs
lmlevin@aamc.org
(202) 828-0599

Groups Discuss Public Health Workforce

AAMC Chief Academic Officer John Prescott, M.D., May 21 participated in a panel discussion before Congressional staff and other attendees on the preparedness of the public health workforce to deal with H1N1 influenza. At the event, organized by the Association of Schools of Public Health (ASPH), Dr. Prescott stressed the role that physicians play in public health and highlighted ongoing activities at the AAMC and its member institutions to promote public health awareness among aspiring and practicing physicians. Dr. Prescott also noted that federal support for public health workforce development, such as the Title VII health professions training programs, has been unreliable.

Linda Rosenstock, M.D., M.P.H., Dean, UCLA School of Public Health, and Chair of the ASPH Board of Directors, moderated the session. Other panelists included: Georges Benjamin, M.D., FACP, FACEP, Executive Director, American Public Health Association; Robert Pestronk, M.P.H., Executive Director, National Association of County and City Health Officials; and Daniel Sosin, M.D., M.P.H., FACP, Acting Director, Coordinating Office for Terrorism Preparedness and Emergency Response, Centers for Disease Control and Prevention.

Information:
Tannaz Rasouli, Senior Legislative Analyst
AAMC Government Relations
trasouli@aamc.org
(202) 828-0525

President Names CDC Director, Senate Confirms FDA Head

The President May 15 appointed New York City Health Department Commissioner Thomas Frieden, M.D., M.P.H., as head of the Centers for Disease Control and Prevention (CDC). Dr. Frieden, who served at CDC between 1990 and 2002, received his M.D. and M.P.H. degrees from Columbia University and completed infectious disease training at Yale University. The position does not require Senate confirmation, and according to the President's announcement, Dr. Frieden will assume his new role at the CDC in early June.

The Senate May 18 voted unanimously to confirm Margaret "Peggy" Hamburg, M.D., as Commissioner of the Food and Drug Administration (FDA). Dr. Hamburg served as the Nuclear Threat Initiative's founding Vice President for the Biological Program; Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services; New York City Health Commissioner; and as the Assistant Director of the NIH's National Institute of Allergy and Infectious Diseases. She earned her M.D. from Harvard Medical School and completed her training at the New York Hospital/Cornell University Medical Center.