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Washington Highlights: October 5 , 2007

President Signs Legislation Relieving IPPS Cuts, Delaying Medicaid Prescription Regulations

The President Sept. 29 signed the "TMA, Abstinence Education, and QI Programs Extension Act of 2007" (H.R. 3668, P.L. 110-90), which would prevent the Centers for Medicare and Medicaid Services (CMS) from fully implementing $20 billion in prospective payment cuts to Medicare hospital inpatient services over the next 5 years [see Washington Highlights, Sept. 28]. As part of the FY 2008 inpatient prospective payment system (IPPS) final rule, the cuts are an offset to payment increases associated with coding changes that CMS believes will occur with the change from the current DRG system to "Medicare-severity" DRGs (MS-DRGs).

The law reduces the prospective payment cuts in FYs 2008 and 2009 by half to 0.6 and 0.9 percent, respectively. The bill also gives CMS the authority to recoup any further "overpayments" starting in FY 2010. However, if no coding "creep" occurs, the bill directs CMS to pay back these amounts starting in FY 2010.

According to the American Hospital Association, the bill will restore $2.5 billion to hospitals over the first 2 years and $7 billion over 5 years, assuming no additional retrospective adjustments are made.

The law also institutes a 6-month delay in Medicaid's tamper-resistant prescription pad rule. Under the law, all written Medicaid prescriptions must be on tamper-resistant prescription pads as of April 1, 2008. The requirement applies to all outpatient drugs, including over-the-counter drugs in states that reimburse for such items.

Information:
Atul Grover, Assistant Vice President
AAMC Division of Biomedical and Health Science Research/Office of Governmental Relations
agrover@aamc.org
(202) 828-06666

Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

AAMC Signs Letter Supporting Medicaid Moratorium Bill

The AAMC Oct. 2 signed a hospital group letter of support for legislation to extend by one year the moratorium related to the May 29 Medicaid final rule on cost limits/units of government and the May 23 Medicaid proposed rule on graduate medical education (GME) payments [see Washington Highlights, May 25]. The "Public and Teaching Hospital Preservation Act" (H.R. 3533) was introduced Sept. 14 by Reps. Eliot Engel (D-N.Y.) and Sue Myrick (R-N.C.). Other signatories on the support letter include the American Hospital Association, Catholic Health Association of the United States, Federation of American Hospitals, National Association of Children's Hospitals, National Association of Public Hospitals and Health Systems, Premier Inc., and VHA Inc.

The letter states that cuts to Medicaid GME would impede the ability of teaching hospitals "to provide essential services including education of the next generation of medical professionals despite a shortage of medical professionals around the country." The letter also advises that the rules "would undermine the already fragile viability of the nation's healthcare safety net." As of Oct. 4, H.R. 3533 had 83 cosponsors.

Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

AAMC, FOVA Urge Research Facility Improvements at House VA Hearing

The House Veteran Affairs Subcommittee on Health Oct. 4 held a hearing on the U.S. Department of Veterans Affairs (VA) Research Programs. John R. Feussner, M.D., professor and chair of Medicine, Medical University of South Carolina, testified on behalf of Friends of VA Medical Care and Health Research (FOVA). The AAMC is a member of the FOVA executive committee.

Dr. Feussner, who was Chief Research and Development Officer at the VA from 1996 to 2002, thanked the committee for their $480 million recommendation for the VA Medical and Prosthetic Research program in FY 2008, but cautioned that this "only provides a starting point when consideration is given to long-term inflationary pressures." He noted that "research is a long-term ambition that cannot be fully successful in one funding cycle but must be sustained if treatments are to be discovered." FOVA recommends a planned growth of the VA research budget over 3 years to accommodate the standard 3-year VA research award.

Dr. Feussner also cautioned that "even with sustained growth, VA will be ineffectual in advancing new treatments if it does not have the appropriate infrastructure in place." Dr. Feussner pointed out that the current funding system pits VA research facilities against VA medical facilities. Despite a House VA Committee recommendation to appropriate $15 million for research facilities, the FY 2008 appropriations bills passed by the House (H.R. 2642) and the Senate (S. 1645) fail to address this issue [see Washington Highlights, Sept. 28]. For FY 2008, FOVA recommends at least $45 million dedicated to VA research facility improvements under the VA minor construction account.

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

Senate to Consider HHS Funding Bill

Senate Labor-HHS-Education Appropriations Chair Tom Harkin (D-Iowa) confirmed that the Senate will consider the FY 2008 Labor-HHS-Education appropriations bill (S. 1710; S. Rpt. 110-107) during the week of Oct. 15. Speaking at an Oct. 3 meeting of various health, education, and labor groups, Harkin said the Labor-HHS bill would be the first of the FY 2008 spending bills to be sent to the President. He predicted the debate on the Senate floor may last a week, but that the conference between the House and Senate would be completed quickly and that the final bill could go to the President by early November.

President Bush has threatened to veto a number of the domestic discretionary spending bills, including the Labor-HHS bill, because the Democrats want to add $23 billion to the discretionary spending total the President requested in his FY 2008 budget. Chairman Harkin noted the Senate Labor-HHS bill is $7.5 billion over the FY 2007 level and $11 billion over the President's request.

All programs funded by appropriations bills are currently operating under a continuing resolution (H.J.Res. 52; P.L. 110-92) that extends through Nov. 16. Chairman Harkin predicted there likely will be a second CR, perhaps lasting until Dec. 21, before the FY 2008 spending bills are enacted into law.

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

President Vetoes SCHIP Bill

President Bush Oct. 3 vetoed legislation (H.R. 976) to reauthorize the State Children's Health Insurance Program (SCHIP). The President stated that one in every three children "moving onto government coverage" under H.R. 976 "would be moving from private coverage." According to the President, the bill also raises taxes and does not fully offset its "true cost." Explaining that the reauthorization bill "moves our healthcare system in the wrong direction," President Bush invited Congress to work with him and "produce a good bill that puts poorer children first ... moves adults out of a program meant for children, and ... does not abandon the bipartisan tradition that marked enactment of SCHIP."

In response to the veto, House Majority Leader Steny Hoyer (D-Md.) stated that House Democrats will work to encourage "our Republican colleagues who insist on standing with the President" to "join the bipartisan majorities in both chambers ... in overriding this veto." A press release from Senate Majority Leader Harry Reid (D-Nev.) assured that his colleagues also "will fight hard" to override the "heartless veto." While the Senate Democrats were successful in securing a veto-proof majority vote on H.R. 976, House Democrats were not [see Washington Highlights, Sept. 28]. The House reportedly plans to attempt the override on Oct. 18.

Information:
Christiane Mitchell, Senior Legislative Analyst
AAMC Government Relations
cmitchell@aamc.org
(202) 828-0526

HHS Inspector General Issues FY 2008 Work Plan

The Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) Oct. 1 issued the Work Plan for fiscal year 2008. The Work Plan provides brief descriptions of various audits and investigations that OIG conducts. Some are ongoing from previous years, some are new, and some were concluded earlier and are being redone in 2008. Audits are conducted of selected programs that fall under the oversight of each HHS agency. Examples of audits from the Work Plan include examinations of:

  • Medicare hospitals (including a new audit of Medicare disproportionate share payments that will "determine whether the hospitals' classifications are appropriate, and examine the total amounts of uncompensated care costs that hospitals incur");
  • Provider bad debts;
  • The Centers for Medicare and Medicaid Services' (CMS) oversight of the JCAHO hospital accreditation process;
  • Compliance with Medicare secondary payer rules;
  • Medicare physicians;
  • The Food and Drug Administration's (FDA) adverse-event reporting system for medical devices;
  • Compliance with FDA's rules on disclosure of financial interests of clinical investigators; and
  • Reviews of compliance with selected aspects of OMB Circular A-21, "Cost Principles for Educational Institutions," at schools selected based on the dollar value of Federal grants received.

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

    HRSA Revises Title VII Guidance to Include Research Fellowships

    The Health Resources and Services Administration (HRSA) revised its FY 2008 Program Guidance for Title VII Primary Care Medicine and Dentistry grants this week to include competition for Primary Care Clinician Research Fellowships for faculty development. The original guidance had discontinued competition for the research fellowships, which provide training support for physicians who plan to teach in family medicine (including geriatrics), general internal medicine, and/or pediatrics training programs. The announcement estimates that $3.7 million will be designated for an expected 12 awards, pending final appropriations. Applications are due Dec. 10.

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

    House Subcommittee Examines Oversight of Biosafety Labs

    The House Energy and Commerce Subcommittee on Oversight and Investigations Oct. 4 convened the first in a series of hearings examining the rapid expansion of new high-containment biosafety laboratories that work with infectious disease agents classified as the most dangerous. Keith Rhodes, Ph.D., and Sushil K. Sharma, Ph.D., Dr.P.H., both of the Government Accountability Office (GAO), discussed preliminary findings from a GAO investigation of biosafety level (BSL)-3 and BSL-4 labs. The investigation was prompted by recent incidents at 3 high-containment labs, highlighting the potential for accidents and security breaches.

    According to Dr. Rhodes, since Sept. 11, 2001, an influx of federal funding for research and development of biodefense countermeasures has encouraged the construction of additional BSL-3 and BSL-4 labs, particularly in university settings. Yet, the federal oversight capacity has not grown at a similar pace. Moreover, while 15 federal agencies have funding authority for the labs, no one agency coordinates lab operations or is responsible for tracking the number and location of all BSL-3 and BSL-4 labs in the country. Dr. Rhodes testified that due to the highly sensitive nature of research conducted at the labs, proliferation in the face of such ambiguities may generate more risk without improved regulation and coordination of information sharing. GAO expects to release in Feb. 2008 a final report recommending which agency should fill that role.

    Other witnesses included Richard Besser, M.D., Director of the Coordinating Office for Terrorism Preparedness and Emergency Response at the Centers for Disease Control and Prevention (CDC), and Hugh Auchincloss, M.D., Deputy Director of the National Institute of Allergy and Infectious Diseases (NIAID). Dr. Auchincloss described the establishment of a Trans-Federal Task Force including the Departments of Health and Human Services, Agriculture, Homeland Security, and Defense, to recommend improvements to the existing biosafety framework.

    A complete list of witnesses and testimony is available on the Energy and Commerce Committee website.

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

    Letter Urges Implementation of Patient Safety Organizations

    Several health care organizations signed a Sept. 27 letter to Secretary of Health and Human Services Michael Leavitt urging publication of a proposed rule implementing Patient Safety Organizations (PSOs), as established by the AAMC-supported Patient Safety and Quality Improvement Act (PSQIA) of 2005 (P.L. 109-41). Under the PSQIA, providers may voluntarily and confidentially report patient safety data to PSOs for analysis and the development of quality improvement strategies.

    The letter was signed by the American College of Physicians, American College of Surgeons, American Dental Association, American Hospital Association, American Medical Association, and the Joint Commission. The organizations express concern that a proposed rule is "languishing in the review and clearance process." They state that improving patient safety is "too important" to allow further delays in the regulatory process.

    Information:
    Christiane Mitchell, Senior Legislative Analyst
    AAMC Government Relations
    cmitchell@aamc.org
    (202) 828-0526

    NASA Extends National Biomedical Research Institute

    The National and Aeronautics Space Administration (NASA) Oct. 1 announced that it was extending for another 5 years its cooperative agreement with the National Space Biomedical Research Institute (NSBRI), a 12-member consortium of medical schools and other research organizations led by Baylor College of Medicine. The space agency reported that the extension, valued at $120 million, will continue biomedical research in support of long-term human presence in space, including such health concerns as bone and muscle loss, radiation exposure, nutrition, cardiovascular function, and neurobehavioral and psychosocial factors. With the extension, NASA reports that total support for the NSBRI, from its inception in 1997 to 2012, is $362 million.

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