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Washington Highlights: October 14, 2005

AAMC Supports Increased Funding For VA Research, Opposes Earmarks

As a member of the Executive Committee of the Friends of VA Medical Care and Health Research (FOVA), the AAMC Oct. 5 sent a letter to Congress requesting FY 2006 funding of at least $412 million for the Department of Veterans Affairs (VA) Medical and Prosthetic Research Program during the upcoming conference on the related bills. Additionally, FOVA encouraged the removal of the proposed House and Senate earmarks from the final legislation.

The House provided $393 million, a 2.3 percent decrease from FY 2005 and the same as the President's budget request, of which 20 percent is dedicated to research dealing with the issues of mental health diagnosis and treatment. The Senate approved $412 million, which falls short of the $15 million needed to provide an inflationary increase for the program. Of the $412 million, $15 million is devoted this fiscal year solely to Gulf War Illness research. Earlier this year, the AAMC and FOVA recommended $460 million, a $58 million increase, for VA Medical and Prosthetic Research in FY 2006.

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

AAMC Urges DoD to Reject Proposed Research Contract Clause

The AAMC Oct. 12 sent a comment letter to the U.S. Department of Defense (DoD) concerning its proposed rule, "Defense Federal Acquisition Regulation Supplement; Export-Controlled Information and Technology," which amends DoD policy regarding research contracts with universities and medical schools. The new language would require, among other things, that the contractor maintain "unique badging requirements for foreign nationals and foreign persons and segregated work areas for export-controlled information and technology."

The proposed rule comes on the heels of the U.S. Department of Commerce's Advance Notice of Proposed Rulemaking (ANPR) defining the use of controlled technology in fundamental research by a foreign national as a "deemed export" that requires licensure. The AAMC and much of the higher education community commented on this ANPR when it was released in late March [see Washington Highlights, April 1].

The DoD proposed rule is especially ominous in its absence of reference to the fundamental research exclusion and in its potential for expanding the reach of the export control regulations by contract, to the detriment of science. The AAMC urged DoD to substitute for its proposal a clause that simply refers the contractor to its existing responsibilities under applicable export control law and regulations.

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

Senate Finance Proposal Would Cut Both Medicare and Medicaid

Congressional Quarterly Oct. 13 reports that a budget reconciliation proposal by Senate Finance Committee Chair Charles Grassley (R-Iowa) includes $12 billion over 5 years in cuts to both the Medicare and Medicaid programs, $2 billion more than currently required by the FY 2006 budget resolution.

Of particular concern to hospitals is a proposal reportedly under consideration that would reduce Medicare outpatient payments by $400 million. Other provider proposals under consideration include a home health market basket freeze and reducing the amount of bad debt nursing homes can write off. Much of the proposal's Medicare savings would be achieved through proposals that would affect Medicare Advantage plans.

The proposal would avert a 4.4 percent cut to Medicare physician payments by freezing them at 2005 levels for one year at a cost of $6.6 billion. The proposal would also include legislation to implement "pay for performance" programs for all providers.

Concerning Medicaid, the Finance package reportedly would revise methodologies for prescription drug reimbursements, require drug manufacturers to pay additional rebates, make it more difficult for individuals to transfer their assets in order to qualify for long-term care, and reduce managed care provider taxes.

The proposal also includes Medicaid spending for a scaled-back version of Grassley's Katrina relief package (S. 1716) [see Washington Highlights, Sept. 23] and legislation (S. 183) allowing middle-income families to buy in Medicaid on a sliding premium scale to cover disabled children.

Information:
Lynne Davis Boyle, Assistant Vice President
AAMC Government Relations
ldavisboyle@aamc.org
(202) 828-0526

House Postpones Reconciliation Again, Support for Hurricane Offsets Grows

The House GOP leadership Oct. 11 again postponed the deadlines for budget reconciliation to provide more time for authorizing committees to meet a new target of at least $50 billion in savings over 5 years from mandatory spending. The authorizing committees now have until Oct. 28 to present their spending reduction proposals to the House Budget Committee. The House Budget Committee would then mark up the reconciliation bill the week of Oct. 31.

Under the terms of the FY 2006 budget resolution (H.Con.Res. 95), the authorizing committees originally were to recommend a total of $34.7 billion in spending cuts to the budget committees by Sept. 16. In the wake of Hurricane Katrina, the congressional leadership decided to postpone that deadline to the week of Oct. 17.

The latest delay resulted from House Speaker Dennis Hastert (R-Ill.) Oct. 6 agreeing with a proposal by House Budget Committee Chair Jim Nussle (R-Iowa) to amend the budget resolution to call for at least $50 billion in mandatory spending cuts.

The Senate, which so far has rejected the idea of amending the budget resolution, remains on schedule for an Oct. 26 markup by its Budget Committee. Senate authorizing committees are to meet the week of Oct. 17 to finalize their proposed spending cuts, with the Senate Finance Committee tentatively scheduled to meet Oct. 19.

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

House Panel Holds Hearing on Gainsharing

The House Ways and Means Subcommittee on Health Oct. 7 held a hearing on the subject of gainsharing, arrangements in which a hospital gives physicians a share of any reduction in the hospital's costs attributable in part to the physicians' efforts. Current law prohibits a majority of such arrangements. Subcommittee Chair Nancy Johnson (R-Conn.) is supportive of better aligning physician and hospital incentives and is currently circulating a draft legislative proposal to allow gainsharing arrangements between physicians and hospitals without violating current law.

Lewis Morris, Chief Counsel to the Office of the Inspector General (OIG), U.S. Department of Health and Human Services, described how gainsharing arrangements implicate the Civil Money Penalty (CMP) law, federal anti-kickback statutes, and potentially physician self-referral law.

Morris also described the guidance OIG has issued with respect to gainsharing arrangements. Since 1999, the OIG issued approval of 7 arrangements that fall under the following categories: product standardization; product substitution; opening packaged items only as needed; or limiting the use of certain supplies or devices. OIG has approved these individual gainsharing arrangements based on "accountability; quality controls that ensure that patient care is not compromised and safeguards against payment for referrals." Stated Morris, "Properly structured, gainsharing arrangements may offer opportunities for hospitals to reduce costs without causing inappropriate reductions in medical services or rewarding referral of Federal health care program patients."

Upon completion of Morris' testimony, Rep. Johnson suggested that CMP law should include medical necessity or quality of care as a condition for evaluating whether the CMP provisions should apply. Rep. Johnson also challenged the OIG's position that gainsharing arrangements should be considered on a case-by-case basis.

Rep. Johnson's legislative proposal circulating for comment is modeled after a New Jersey demonstration that was unable to be carried forward due to legal challenges. Witness Gary Carter, President and CEO of the New Jersey Hospital Association, recommended that "if re-implemented in some form, hospital participation…should remain voluntary with opportunities to opt-out at the end of year's one and two of the project, if the participating hospital is unhappy for any reason, is not achieving an appropriate level of physician buy-in, quality improvement or cost saving success." Carter also recommended that any guaranteed savings required by hospitals be less than 2 percent of a hospital's Medicare payments (to encourage greater hospital participation) and that such a guarantee begin no sooner than the second year.

Echoing similar concerns, American Hospital Association representative Stuart Fine, CEO of Grand View Hospital, Sellersville, Pa., recommended that the panel "reach beyond demonstration projects and amend current federal laws to eliminate inconsistent and counterproductive provisions." Further, Fine expressed that gainsharing should not be a substitute for "the much needed ban on physician self-referral to limited service hospitals.

Other witness included representatives from the medical device and consumer community. Martin Emerson, President and CEO of American Medical Systems, testifying on behalf of the Advanced Medical Technology Association, raised concerns that gainsharing could have a negative impact on advances in technology development and diffusion. "If not designed with adequate safeguards for patients, gainsharing could easily reward cheaper treatments, not better treatments."

Andrew Imparato, President and CEO, American Association of People with Disabilities (AAPD), cautioned that gainsharing could jeopardize the trust between patients and physicians and suggested that patient access to the best care could be compromised if "physicians who have developed highly specialized skills and experience might find themselves penalized for having a practice that produces high per-patient costs associated with more expensive diagnostics and care." Ways and Means Ranking Minority Member Pete Stark (D-Calif.) echoed AAPD's concerns, suggesting that Medicare beneficiaries and taxpayers "will suffer" and that we would "turn back time" if Congress were to allow gainsharing.

Information:
Lynne Davis Boyle, Assistant Vice President
AAMC Government Relations
ldavisboyle@aamc.org
(202) 828-0526

Academies Warns of "Gathering Storm" in U.S. Science and Competitiveness

As other nations improve their science, engineering, and educational capacity, disturbing trends in U.S. education and R&D threaten to undermine this nation's competitiveness and future prosperity, the National Academies warned in a report, Rising Above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future, issued Oct. 12. A distinguished committee chaired by Norman Augustine, former Lockheed Martin Chairman and CEO, and including three Nobel Laureates among other industry and academic leaders, released its report in response to a request by Senators Lamar Alexander (R-Tenn.) and Jeff Bingaman (D-N.M.). The senators, with endorsement from Representatives Sherwood Boehlert (R-N.Y.) and Bart Gordon (D-Tenn.), specifically asked for ten recommendations-in priority order-that the United States should take to ensure prosperity and security in the 21st Century.

The chief national priority, according to the Augustine Committee, is to improve K-12 science and mathematics education by, among other actions, annually recruiting 10,000 new teachers in these fields. The committee also called for 25,000 new competitive four-year undergraduate scholarships and 5,000 new graduate fellowships in science and engineering fields for U.S. citizens. The nation should further provide automatic visa extensions for international students receiving science and engineering doctorates in the United States; should double federal funding for basic research over seven years (focused particularly on the physical and mathematical sciences); and should provide tax incentives and reform the patent system to encourage further capital investment in R&D.

In his remarks on release of the report, Mr. Augustine noted that there is "no Pearl Harbor, no Sputnik" to underscore a crisis in American science, yet the nation is now a net importer of high technology products, and U.S. 12th graders perform below the international average for 21 countries on a test of general knowledge in mathematics and science. China, India and other nations are producing science and engineering workforces that are more affordable and "only a mouse click away" in the global labor market. U.S. industry, meanwhile, spends more on tort litigation than on R&D.

Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488

Congress Approves Homeland Security Appropriations, Revises First Responder Funding

The House Oct. 6 and the Senate Oct. 7 passed the FY 2006 Homeland Security Appropriations conference report (H.R. 2360, H. Rpt. 109-241), clearing it to be signed by the President. Included in the $31.9 billion bill is a new distribution formula for first responder grants. The new plan gives the Secretary of Homeland Security the flexibility to distribute some of the funding based on risk, rather than population.

Authorizers have struggled to resolve this issue, as legislators from less populated states pushed to retain a minimum level of funding. Lawmakers from states that face a higher risk of terrorist attack objected to small states receiving a higher per capita rate. While the revamped formula only applies to FY 2006 funding, it is likely to set a precedent to be followed in future years. Under the new formula, 37.5 percent of total available funds are reserved for the states (0.75 percent for each state), and the rest is distributed based on risk as determined by the Secretary.

As amended by a Dec. 17, 2003, Presidential Directive, the definition of first responder includes hospitals and non-emergency personnel, making them eligible for federal first responder funding.

Information:
Erica Froyd, Director, Public Health and Research Legislative Affairs
AAMC Government Relations
efroyd@aamc.org
(202) 828-0525