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Washington Highlights: May 18, 2007

Congress Clears Budget Resolution

The House and Senate May 17 passed the FY 2008 budget resolution conference agreement (S. Con. Res. 21), which was hammered out by conferees a day earlier. The conference agreement assumes $54.965 billion for Function 550 discretionary health spending, $2.9 billion (5.5 percent) above last year and $3 billion (5.8 percent) above the President's request. It sets the overall non-defense discretionary spending cap at $450 billion, which is $23 billion above the final FY 2007 level and $21 billion above the President's request.

The House approved the conference agreement by a vote of 214 - 209, while the Senate cleared it 52-40. Both chambers cleared their respective bills in March [see Washington Highlights, March 30]. The White House has threatened to veto individual spending bills that exceed the President's request.

The budget agreement does not call for cuts in Medicare or Medicaid provider payments. It includes reconciliation instructions requiring the Senate HELP Committee and House Committee on Education to identify $750 million in savings, presumably from changes to student loan policies. In a trade off for these cuts, the budget agreement also includes procedural protections that allow the Senate to reauthorize certain higher education programs (including those affecting student loans) through the budget reconciliation process, which bars amendments and filibusters and allows a bill to pass with a simple majority (51 votes).

The budget agreement includes several non-binding, deficit neutral reserve funds for FY 2007 through FY 2012 in support of:

  • State Children's Health Insurance Program legislation (up to $50 billion for the maintenance or expansion of state programs);
  • Legislation to delay the January 18 proposed rule on Medicaid cost limits/units of government and prohibit proposals to reduce Medicaid GME funding;
  • "Medicare improvements" including physician payment increases that would not impact beneficiary premiums, as well as improvements in provider quality and efficiency. The improvements also allow the Senate to reform the hospital area wage index;
  • Solutions to encourage physicians to "train in primary care residencies and attract more physicians... to States that face a shortage of health care providers;"
  • Incentives or "other support" for the adoption of health information technology; and
  • Incentives to comply with "best practices" or other clinical guidelines.

The budget resolution also sets aside $383 million in FY 2008 for health care fraud and abuse initiatives.

The House Appropriations Subcommittees are marking up appropriations bills immediately, beginning with the Homeland Security Appropriations bill on May 18. The Labor, Health and Human Services, and Education Appropriations Subcommittee is scheduled to take up its bill after the Memorial Day recess.

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

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 Testifies Before House Panel on Medicare Hospital Payments

The AAMC May 15 testified at a House Ways and Means Health Subcommittee hearing on the importance of Medicare's special payments to teaching hospitals. The AAMC was represented by Stanley Brezenoff, president and chief executive officer of Continuum Health Partners, a four-hospital system in New York City. Mr. Brezenoff, also representing Greater New York Hospital Association, urged the committee to oppose the President's proposals to eliminate teaching hospitals' indirect medical education (IME) payments for treating Medicare Advantage beneficiaries and all Medicaid funding for graduate medical education. He told the committee that the timing of these proposed cuts could not be worse in light of the nation's physician shortage and teaching hospitals' current financial conditions.

The hearing focused on issues related to payment accuracy and legislative and regulatory payment refinements for the Medicare inpatient and outpatient hospital prospective payment system. It also addressed home health, long-term care hospital, inpatient rehabilitation facility, and skilled nursing facility payment systems.

Also testifying from the hospital community were Rich Umbdenstock president and CEO of the American Hospital Association, and Chip Kahn, president of the Federation of American Hospitals. Both encouraged lawmakers to reject cuts proposed by the President's FY 2008 budget as well as $25 billion in "unwarranted" and "unnecessary" cuts to hospital services included in the proposed FY 2008 inpatient rule.

Citing the committee's plan to be involved with the reauthorization of the State Children's Health Program (SCHIP) and legislation fixing Medicare physician payment reductions, Chairman Pete Stark (D-Calif.) encouraged the provider panel to help the committee "sort the wheat from the chaff" in determining fair payment adjustments to providers. In his opening statement, Chairman Stark stated that "no program or payment system, no matter how big or small, is above review. Everything is on the table in terms of refinement and other adjustments."

Specifically, Chairman Stark asked the hospital and post-acute care panel to comment on their experience related to the Medicare Advantage program and to offer suggestions within the program that could be cut. Mr. Brezenoff replied that teaching hospitals do get less money from Medicare Advantage plans than Medicare fee-for-service and urged the committee to review what the plans were doing with the extra payments they receive. He also suggested that one area of savings could be the IME payment included in the Medicare Advantage rate, since teaching hospitals already receive a direct payment from Medicare when they treat Medicare Advantage enrollees.

In addition to commenting on the President's FY 2008 proposals that specifically impact teaching hospitals, the AAMC/GNYHA written testimony:

  • Opposes the Medicare Payment Advisory Commission's recommendation to reduce the Medicare Indirect Medical Education adjustment;
    Supports lifting the Medicare resident cap;
  • Urges Congress to work with CMS to clarify in statute that the Medicare statute is intended to support all resident training time; and
  • Supports the implementation of a stabl AAMC Government Relations
    e and equitable Medicare physician payment formula.

Information:
AAMC Government Relations

AAMC Testifies at VA Under Secretary for Health Nomination Hearing

AAMC President Darrell G. Kirch, M.D., May 16 testified before the Senate Committee on Veteran Affairs in support of Michael J. Kussman, M.D.'s nomination as Department of Veterans Affairs (VA) Under Secretary for Health. In his statement, Dr. Kirch praised VA's academic affiliations and Dr. Kussman's work with the VA-AAMC Deans Liaison Committee. In particular, he lauded the VA's decision to increase support for graduate medical education with an additional 2,000 residency positions over the next 5 years. Dr. Kirch also stressed the importance of the VA Medical and Prosthetic Research program in preserving the success of these affiliations and urged Dr. Kussman, the Administration, and Congress to increase funding for VA research.

The hearing focused on Dr. Kussman's role in overseeing the transition of veterans from the Department of Defense into the VA system. Chairman Daniel Akaka (D-Hawaii) stated, "With each passing day, more and more servicemembers are returning with serious traumas and injuries, which for some will mean a lifetime of care from VA… From my vantage point, VA was not prepared to deal with the types of injuries stemming from this war. Capacity must be rebuilt. And the next Under Secretary will have this challenge."

The committee is scheduled to vote May 22 on Dr. Kussman's nomination.

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

House Approves New Supplemental Appropriations Bill

The House May 10 approved, 221-205, a new FY 2007 emergency supplemental spending bill (H.R. 2206), days after the President vetoed a previous version due to provisions related to the Iraq war [see Washington Highlights, May 4]. As in the previous version, the supplemental includes provisions to delay implementation of Medicaid rules regarding cost limits and restricting graduate medical education programs; eliminates FY 2007 State Children's Health Insurance Plan shortfalls; and provides additional FY 2007 funding for VA research, pandemic flu preparedness and biodefense.

The Senate May 17 approved by voice vote a placeholder measure - expressing support for the armed forces, but not including appropriations or other provisions - to begin conference negotiations. Senate conferees include Majority Leader Harry Reid (D-Nev.), Minority Leader Mitch McConnell (R-Ky.), Sen. Robert Byrd (D-W.Va.), Sen. Thad Cochran (R-Miss.), and Sen. Daniel Inouye (D-Hawaii). Though the President again has threatened a veto, House and Senate leadership are working with the White House to reach agreement on the more contentious provisions.

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

AAMC Comments on Patent Reform Legislation

The AAMC and 4 leading educational organizations May 16 released a consensus position on the "Patent Reform Act of 2007" introduced in both the House (H.R. 1908) and Senate (S. 1145). The House Judiciary Subcommittee on Courts, the Internet, and Intellectual Property May 16 approved H.R. 1908 by a voice vote. A manager's amendment is expected as the bill moves to the full committee.

The consensus position addresses the major provisions that affect university research, teaching, and technology transfer operations. The authoring organizations include the AAMC, the Association of American Universities (AAU), the American Council on Education (ACE), the National Association of State Universities and Land-Grant Colleges (NASULGC), and the Council on Governmental Relations (COGR).

The associations support the goals of the legislation to add greater clarity to the patent system by replacing certain subjective elements (which may lead to lengthy and expensive litigation) with more objective standards and to improve the overall quality of patents issued in the United States. These goals are in line with the recommendations of a 2004 report issued by the National Research Council (NRC). The academic associations also recognize the critical role of the patent system in promoting technology transfer from universities, medical schools and research organizations, a mission that has become stronger since the 1980 Bayh-Dole Act.

Among the major provisions of the associations' consensus statement are the following:

  • First Inventor to File: The associations do not oppose the proposed change from the current "first to invent" system in the United States to a "first (inventor) to file" system. However, given the duties of university faculty to publish and otherwise communicate research discoveries broadly, the associations call for several conditions in the proposed system including a stronger "grace period" than is reflected in the current bills within which an inventor's or collaborators' publications would not count as prior art disqualifying a patent, an inventor's oath (currently in both bills), and continuation of provisional applications (also included in the bills);
  • Post Grant Opposition Procedure: The associations support an administrative opposition procedure, but oppose a "second window" opposition that would continue across the life of a patent;
  • Prior User Rights: The associations oppose extension of prior user rights as proposed in the legislation, or creation of a new standard for "substantial preparation for commercial use;"
  • The CREATE Act: The associations support provisions of the proposed legislation that protect inventions arising under research collaborations (enacted in the 2003 CREATE Act, P.L. 108-453); and
  • Experimental Research Exemption: The associations support inclusion of an experimental use exemption (not included in the proposed legislation) as recommended by the 2004 NRC report.

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

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

AAMC Criticizes Homeland Security "Chemical Facility" Rule

In a May 9 comment letter to the Department of Homeland Security (DHS), the AAMC criticized a new rule that could include universities and academic medical centers among a broad definition of "chemical facilities," subjecting them to more stringent security requirements. The interim final rule on "Chemical Facility Anti-Terrorism Standards," published in the April 9 Federal Register, includes for the first time an appendix listing "chemicals of interest" and threshold quantities that would make an organization possessing such substances subject to the rule.

The AAMC argued that the list broadly includes many chemicals found at universities and academic medical centers, although often in relatively small amounts distributed within laboratories across their campuses. If considered in aggregate, the volume of these chemicals would make the university a "chemical facility" subject to extra security requirements. The AAMC noted that such requirements, which may be effective for an industrial facility, would be far less effective in the environment of a research university. Moreover, the requirements for inventorying and assessing risk of these materials would also be far more burdensome to administer for academic institutions than was estimated in the rule.

The Association asked the DHS specifically to exempt universities, medical schools, and affiliated hospitals from the rule, and to extend the deadline for comments beyond the 30 days originally provided to permit institutions time to comment on new sections of the rule.

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

AAMC Comments on CMS Proposed Clinical Research Policy Revisions

The AAMC May 8 submitted comments to the Centers for Medicaid and Medicare Services (CMS) on proposed revisions to the Clinical Research Policy (CRP). This policy governs the Medicare payment eligibility requirements for clinical trials in which Medicare beneficiaries are enrolled. The proposed policy contains many requirements supported by the AAMC, such as mandatory registration on ClinicalTrials.gov.

In its comment letter, the AAMC suggests additional clarifications-such as less cumbersome requirements about what must be discussed in the protocol-that will allow CMS to issue a clear, understandable policy to help allay institutions' fears of inadvertently submitting an incorrect bill to Medicare for the items and services covered by the CRP.

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

House Panel Authorizes New VA Research Centers

The House Committee on Veterans Affairs (VA) May 15 approved the "Traumatic Brain Injury Health Enhancement and Long-Term Support Act of 2007" (H.R. 2199), among a slate of 6 veterans health care bills. Of particular importance to academic medicine, H.R. 2199 authorizes up to 5 new VA traumatic brain-injury (TBI) research centers, as well as education and training of health care professionals. TBI is broadly recognized as the signature injury of the Iraq and Afghanistan wars.

The bill, sponsored by VA Health Subcommittee Chair Michael Michaud (D-Maine), is based in part on a bill (H.R. 1944) introduced April 19 by Rep. Jason Altmire (D-Pa.). H.R. 2199 authorizes $10 million for FY 2008 and $20 million for each of FYs 2009-2011. Additionally, the VA is instructed to allocate funds from the VA Medical Services and the VA Medical and Prosthetics Research accounts as necessary.

VA facilities wishing to host the proposed centers must develop "an arrangement with an accredited medical school that provides education and training in traumatic brain injury care." The bill will establish a peer review panel to "assess the scientific and clinical merit of proposals."

The bill is expected to reach the House floor before the Memorial Day recess, according to a committee aide.

Senate VA Committee Chair Daniel Akaka (D-Hawaii) April 26 introduced, a similar bill, the "Veterans Traumatic Brain Injury Rehabilitation Act of 2007" (S.1233), to establish an education, research, and clinical care program for severe TBI. For this program, S. 1233 authorizes $15 million for FY 2008 through FY 2012. The bill also requires the VA to collaborate with institutions that receive grants for TBI research from the National Institute on Disability and Rehabilitation Research of the Department of Education.

Senator Barack Obama (D- Ill.) May 2 introduced the "Homecoming Enhancement Research and Oversight (HERO) Act" (S. 1271), which requires a joint study by the VA, the Department of Defense, and the National Academy of Sciences on the physical and mental health needs of Iraq and Afghanistan veterans.

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

Subcommittee Considers Options for Improving Physician Efficiencies

A May 10 hearing of the House Ways and Means Subcommittee on Health focused on strategies to ensure the appropriate volume and intensity of Medicare physician services. In his opening statement, Subcommittee Chairman Pete Stark (D-Calif.) remarked that "a solution to curb growth in volume and intensity of physician services still eludes us." He urged a closer review of "promising strategies" to "more efficiently reward appropriate medical care."

Testifying on behalf of the Government Accountability Office (GAO), Health Care Director Bruce Steinwald recommended that CMS use claims data to "profile" the efficiency of individual physicians. As outlined in the April 30 GAO report "Medicare: Focus on Physician Practice Patterns Can Lead to Greater Program Efficiency," CMS could then provide individual physicians with reports comparing their practice efficiency with that of their peers. The GAO encouraged Congress to link such an approach with "financial or other incentives" to "curb inefficiencies."

Herb Kuhn, acting deputy administrator of the Centers for Medicare and Medicaid Services (CMS), reported that the agency was "in the early stages of a long-term effort to properly measure physician resource use." According to Kuhn, an efficiency-based payment system would require extensive analysis before implementation. Advising that such an approach poses "significant technical and operational challenges," Kuhn reported that CMS was "exploring the possibilities" of compiling quality data via existing clinical databases and registries. "Such use," Kuhn explained, "could decrease the burden of quality reporting...while increasing the quality and usefulness of the data."

Also testifying was American Academy of Family Physicians President Rick Kellerman, M.D., who advocated for payments that support the delivery of coordinated care via "medical homes." Medicare Payment Advisory Commission Chair Glenn Hackbarth reiterated the Commission's recommendations for Medicare physician payment reform [see Washington Highlights, March 2]: revising payments for "misvalued services"; measuring quality and resource use; better coordinating/managing care; focusing on primary care; and "bundling" payments for hospital and physician services.

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