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Washington Highlights: May 1, 2009

Congress Approves FY 2010 Budget Framework

The House (233-193) and Senate (53-43) April 29 approved a conference agreement (H.Rept. 111-89) for the FY 2010 budget resolution. No Republicans voted for the measure in either chamber. The budget resolution provides a framework for House and Senate appropriators to fund programs through the annual appropriations process later this year.

The $3.56 trillion budget resolution includes reconciliation instructions that would allow health care reform to move through Congress without the roadblock of a Senate filibuster. Similar reconciliation instructions would allow the elimination of the Federal Family Education Loan (FFEL) program.

For "non-emergency, non-defense" discretionary spending, the conference agreement provides $530 billion, a 0.1 percent increase over FY 2009, but $10 billion less than the President's budget outline. According to the conference report accompanying the final agreement, discretionary funding levels for Function 550 (Health) include "increased funding above the 2010 baseline level consistent with the President's health priorities" for the National Institutes of Health (NIH), the Health Resources and Services Administration (HRSA), the Center for Disease Control and Prevention (CDC), the Indian Health Service (IHS), and the Food and Drug Administration (FDA). In addition, the conference agreement "assumes significant increases" for Community Health Centers, health professions, and the National Health Service Corps within HRSA.

The conference agreement assumes $38 billion in new Medicare spending to address the scheduled 21 percent reduction in Calendar Year (CY) 2010 physician payments. According to the conference report, new funds would permit a payment freeze (0 percent update) in CYs 2010 and 2011 "and at least part of 2012." While the final agreement does not require the House to identify an offset for physician payment relief, it does require the Senate to do so.

The final agreement includes reconciliation instructions for the committees that oversee the Medicare, Medicaid, and other health programs. In the Senate, the Committees on Finance and Health, Education, Labor, and Pensions (HELP) must each identify (by Oct. 15) $1 billion in saving over 5 years. Similarly, the House Committees on Ways and Means, Energy and Commerce, and Education and Labor must each identify (also by Oct. 15) $1 billion in savings over 5 years. The House reconciliation measures are specifically identified as support for health care reform, while the Senate reconciliation instructions are not.

The budget resolution includes a non-binding deficit-neutral Senate reserve fund to "transform and modernize" the nation's health care system. The fund must be used to "reduce excess cost growth in health care spending" and be "fiscally sustainable over the long term." It also may be used to increase Medicare physician reimbursement, promote an increase in primary care physicians, and "address geographic variations" in Medicare spending. A non-binding, deficit-neutral House reserve fund for health care reform would permit "improvements to health care" that may include public/private coverage expansions, and quality improvement, among other options. The House reserve fund does not address Medicare physician payments.

The final conference agreement includes more funding than FY 2009 for VA to research and treat mental health, post-traumatic stress disorder, and traumatic brain injury. According the conference report, the measure "supports increasing the number of healthcare professionals in the Veterans Health Administration (VHA) to meet the needs of the expanding number of veterans and to fill vacant healthcare professional positions at VHA." The conference agreement also supports enhanced incentives for healthcare professionals of the VHA who serve in rural areas. A provision in the Senate budget resolution that would have provided advanced funding for VA Medical and Prosthetic Research was not included in the conference agreement.

The White House is expected to release President Obama's proposed budget for FY 2010 the week of May 4.

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

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

 

AAMC, Hospital Groups Urge Congressional Support for Medicare and Medicaid DSH Programs

The AAMC signed an April 27 letter urging continued congressional support for Medicare and Medicaid Disproportionate Share Hospital (DSH) programs. The letter was sent to all members of the House and Senate and also was signed by the American Hospital Association, the Catholic Health Association of the United States, the Federation of American Hospitals, the National Association of Children's Hospitals, and the National Association of Public Hospitals and Health Systems. The letter recommends the preservation of federal support for DSH payments until "coverage expansions are universal and fully implemented and Medicare and Medicaid payment shortfalls are addressed."

Information:
Travis W. Crytzer, Legislative Analyst
AAMC Government Relations
tcrytzer@aamc.org
(202) 828-0418

AAMC Comments on OMB Recovery Act Standard Data Elements

The AAMC provided comments April 29 to the Office of Management and Budget (OMB) on the standard data elements for reports under the American Recovery and Reinvestment Act of 2009 (P.L. 111-5). Section 1512 of the Recovery Act requires standardized reporting for recipients of federal grants, cooperative agreements, and loan funds under the Act. In addition to basic identifiers about a particular grant, evaluation of completion status, and amounts expended, the standard data elements include, by quarter, by grant, a narrative description of the employment impact of the Recovery Act funded work (e.g., types and numbers of jobs created and jobs retained).

Urging that reporting requirements be standardized across agencies without agency-specific requirements, the AAMC asked that reporting be deferred until Oct. 10 in anticipation of the proposed electronic central government-wide portal. The AAMC expressed particular concern with the reporting period end date, ten days after the end of the calendar quarter, and also with the fact that the reports are built on FTEs based on hours rather than as a percentage of total.

Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543

Baucus, Grassley Unveil Policy Options for Reforming Health Care Delivery System

Senate Finance Committee Chair Max Baucus (D-Mont.) and Ranking Member Charles Grassley (R-Iowa) April 28 released the first in a series of policy options intended to guide the panel as it works to draft comprehensive health care reform legislation. The initial set of policy options were issued as follow-up to the committee's April 21 roundtable discussion on improving the delivery and reducing the cost of patient care [see Washington Highlights, April 24]. Additional policy options will be issued in conjunction with two future roundtable discussions scheduled for May 5 and 14 on health care coverage and financing, respectively.

Among the April 28 policy options are several of particular interest to medical schools and teaching hospitals, including a proposal to redistribute unused graduate medical education (GME) training positions currently funded under Medicare. Similar to the redistribution program established under the Medicare Modernization Act (P.L. 108-173), the committee proposes a redistribution of slots that have gone unused for more than 3 years. Preferences would be given to hospitals that use the slots for primary care and general surgery training, as well as those caring for underserved populations.

Additionally, the options include AAMC-supported proposals to eliminate current restrictions on the counting of didactic time for GME payment purposes and to ease the regulatory burdens associated with the voluntary supervision of resident training in non-hospital settings.

Other options for health care reform include proposals to:

  • Reduce "avoidable and preventable" hospital readmissions;
  • Establish "accountable care organizations";
  • Provide bonus payments for certain primary care and general surgery services;
  • Implement value-based purchasing for hospital services; and
  • Bundle payments for acute and post-acute care

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

House, Senate Move False Claims Act Amendments

The House Judiciary Committee April 28 approved (20-6) the "False Claims Act Corrections Act of 2009" (H.R. 1788). The bill addresses a number of court rulings that proponents claim stray from the original intent of 1986 False Claims Act (FCA) amendments. The AAMC April 21 joined 16 organizations in letters to the House Judiciary committee noting concerns with the bill [see Washington Highlights, April 24]. The coalition letter states that the current statute is working appropriately and that new legislation is unwarranted.

In his opening remarks at the House Judiciary Committee consideration of H.R. 1788, Ranking Member Lamar Smith (R-Texas) noted the past success of the FCA and its ongoing importance for oversight of the Recovery Act spending, but questioned whether the proposed reforms were needed. He specifically mentioned the opposition of the AAMC, the Association of AmericanUniversities, and the American Hospital Association. In response, Rep. Berman noted that the Department of Health and Human Services Inspector General found that up to 6.3 percent of Medicare payments are overpayments caused by fraud, waste, or abuse.

Rep. Dan Maffei (D-N.Y.) outlined the funding process of grants from the National Institutes of Health and university controls to prevent fraud, as well as the process that hospitals use to reconcile Medicare overpayment. Rep. Maffei also submitted the coalition letter for the record.

During the mark-up, Rep. Maffei and Zoe Lofgren (D-Calif.) offered an amendment to H.R. 1788 that would prohibit FCA suits while a process for overpayment reconciliation is still open. Though House Judiciary Committee Chair John Conyers (D-Mich.) urged the amendment's passage, Reps. Maffei and Lofgren previously agreed to withdraw the amendment and work with Rep. Howard Berman (D-Calif.) on this issure before H.R.1788 reaches the House Floor. Ranking Member Smith and Rep. Darrell Issa (R-Calif.) also spoke in favor of the amendment.

The Senate April 28 passed (92-4) the "Fraud Enforcement and Recovery Act" (S. 386), which primarily addresses mortgage fraud, but would also amend the FCA. Before passing S. 386, the Senate adopted an amendment offered by Sen. Jon Kyl (R-Ariz.) to help clarify that the legislation only imposes liability under FCA for knowing and improper "retention" of an overpayment, as opposed to mere "receipt" of an overpayment. The AAMC April 21 joined the same group of 16 organizations in a coalition letter that supported adoption of the Kyl amendment.

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

Senate Panel Examines NHSC's Role in Health Care Reform

The Senate Committee on Health, Education, Labor, and Pensions April 29 held a hearing entitled, "Primary Health Care Access Reform: Community Health Centers and the National Health Service Corps." In his opening statement, Sen. Bernie Sanders (I-Vt.) noted the importance of addressing the health professionals shortage in health care reform and lauded the steps made under the "American Recovery and Reinvestment Act of 2009" (P.L. 111-5) to triple funding for the National Health Service Corps (NHSC).

Fitzhugh Mullan, M.D., Murdock Head Professor of Medicine and Health Policy, The George Washington University, discussed physician distribution problems and testified strongly in support of increased funding for the NHSC, referring to its current size as only a "demonstration project." Dr. Mullen's written statement notes, "The NHSC is a proven program that delivers primary care clinicians to needy communities in return for student debt reduction. It is a brilliant and successful strategy that has always been under funded. It is time to radically increase its budget toward the end of fully staffing Community Health Centers and addressing the oncoming needs for clinical service in the U.S."

Dr. Mullen briefly noted his support for the "Access for All America Act" (S. 486, H.R. 1296) introduced by Sen. Sanders Feb. 26 and Rep. James Clyburn (D-S.C.) March 4. The bills would authorize over $1 billion for the NHSC by FY 2015. In FY 2009, NHSC receieved an appropriation of $135 million.

John Matthew, M.D., a primary care physician from Vermont, echoed Dr. Mullen's NHSC recommendations: "Expansion of the National Health Service Corps will be one mechanism to address the need to replace the nation's aging cadre of primary care medical and dental providers."

The AAMC plans to submit to the committee a statement for the record in support of increasing the size of the NHSC. In coordination with a group of 30 concerned NHSC stakeholder associations, the AAMC has recommended a $235 million FY 2010 appropriation for the NHSC, a $100 million (74 percent) increase over the comparable FY 2009 funding.

A Webcast of the hearing and witness testimony is available on the committee's Website.

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

Specter Introduces Bill to Accelerate Translational Research

Sen. Arlen Specter (D-Pa.) April 28 introduced legislation to provide federal funds to "accelerate the development of cures and treatments." The bill also requires the National Institutes of Health (NIH) to develop and enforce conflict of interest policies, affords the National Center on Minority Health and Health Disparities institute status, and provides a simple reauthorization of NIH.

"The Cures Acceleration Network and National Institutes of Health Reauthorization Act of 2009" (S. 914) would create an independent agency - the Cures Acceleration Network (CAN) - outside of the Department of Health and Human Services to "identify and promote revolutionary advances in basic research, translating scientific discoveries from bench to bedside."

The CAN would award grants and contracts to "independent investigators, research organizations, biotechnology companies, academic research institutions, and other entities to develop medical products for the treatment and cure of diseases and disorders." Funds provided through the CAN could be used "to accelerate the development of cures and treatments, including through the development of medical products, behavioral therapies, and biomarkers that demonstrate the safety or effectiveness of medical products." CAN funds also could be used to help "establish protocols that comply with Food and Drug Administration [FDA] standards and otherwise permit the recipient to meet regulatory requirements at all stages of development, manufacturing, review, approval, and safety surveillance of a medical product."

The bill authorizes two types of grant awards, each with a $1 billion funding authorization in the first year. The Cures Acceleration Grant Awards would provide up to $15 million per year per project, with out-year funding available, to applicants that do not have access to private matching funds. The Cures Acceleration Partnership Awards also provide up to $15 million per year, but require grantees to match one dollar for every three federal dollars to offset partially development costs.

The bill creates a 24-member board, appointed by the president, to evaluate grant proposals. The board would include at least one individual "who is eminent" in each of the following fields: basic research, medicine, biopharmaceuticals, discovery and delivery of medical products, bioinformatics and gene therapy, medical instrumentation, and regulatory review and approval of medical products. The board also would include at least 4 leaders in professional venture capital or private equity organizations who have demonstrated experience in private equity investing and at least 8 individuals representing disease advocacy organizations. Representatives from NIH, the Assistant Secretary of Defense for Health Affairs, the Veterans Health Administration, the National Science Foundation, and the FDA would serve as ex officio members.

The board chair would be authorized to enter into an interagency agreement with NIH's Center for Scientific Review to utilize panels to review applications and make recommendations to the CAN.

In addition, the bill requires the Director of NIH to develop and enforce conflict of interest policies and to "respond in a timely manner" when these policies have been violated by a grant or contract recipient. In cases where the principal investigator on a grant or contract over $250,000 "has a conflict of interest," NIH must require the recipient to provide information on the "degree of the primary investigator's financial interest, estimated to the nearest $1,000" and a "detailed report explaining how the recipient will manage the primary investigator's conflict of interest."

S. 914 also elevates the National Center on Minority Health and Health Disparities to institute status and authorizes appropriations for NIH at $40 billion for FY 2010 and "such sums as may be necessary" for FYs 2011 and 2012.

Information:
Dave Moore, Senior Director
AAMC Government Relations
dbmoore@aamc.org
(202) 828-0525

NCVHS Hosts Hearing on "Meaningful Use" of Health Information Technology

The Executive Subcommittee of the National Committee on Vital and Health Statistics (NCVHS), an advisory body to the Department of Health and Human Services, hosted on April 28-29 a hearing about what should be considered "meaningful use" of health information technology (HIT). The "American Recovery and Reinvestment Act of 2009" (P.L. 111-5) requires the establishment of "meaningful use" criteria related to HIT. While the final definition of the term will be determined through the regulatory process, the NCVHS hearing provided important information into the development of a proposed definition.

After brief introductory remarks by NCVHS Chair Harry Reynolds, Jr., and David Blumenthal, M.D., National Coordinator for Health Information Technology, members of various panels presented their testimony. Testimony covered topics including the urgent need for a coordinated, national effort to implement health information technology, how high to set the bar for implementation by 2011, and how technology can be used to improve the quality and efficiency of the nation's health system. Many individuals who testified supported the notion that "meaningful use" requirements should be incremental, with initial requirements being set so that many physicians can meet them, and stricter requirements being imposed over a number of years.

All materials from the meeting will be posted on the NCVHS Website.

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

On the Hill...

Senator Arlen Specter (Pa.) April 28 announced he is joining the Democratic Party and plans to run for reelection in 2010 in the Democratic primary. Citing "a schism which makes our differences irreconcilable," Sen. Specter issued a statement defending his vote in favor of the American Recovery and Reinvestment Act (P.L. 111-5). He also emphasized that "much more needs to be done," particularly with respect to funding for the National Institutes of Health.

The switch will cement a filibuster-proof 60-seat majority for Democrats, pending a victory for Al Franken (D) against incumbent Sen. Norm Coleman (R-Minn.). Senate Appropriations Ranking Member Thad Cochran (R-Miss.) reportedly will assume Sen. Specter's duties as Ranking Member for the Labor-HHS-Education Appropriations Subcommittee until a permanent replacement is named.

Also on April 28, the Senate confirmed Kansas Governor Kathleen Sebelius as Secretary of Health and Human Services. The 65-31 vote included the approval of 8 Republicans.

Democrat Scott Murphy (N.Y.) was sworn into the House of Representatives April 29 to fill the seat vacated when N.Y. Governor David Paterson (D) appointed former Rep. Kirsten Gillibrand (D) to the Senate