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Washington Highlights: March 4, 2005

MedPAC Releases Report on Medicare Payment Policy

The Medicare Payment Advisory Commission (MedPAC) March 1 released its March 2005 "Report to the Congress: Medicare Payment Policy." The report makes several recommendations for the Medicare program to begin differentiating among providers when making payments, and recommends updates and policy improvements to Medicare payment systems. The recommendations were initially approved at the Commission's January meeting [see Washington Highlights, Jan. 14].

Specific recommendations include:

  • Medicare should pay more for higher quality performance from hospitals, home health agencies, and physicians;
  • The Centers for Medicare and Medicaid Service (CMS) should include quality measures that reflect the use and functions of Information Technology (IT) systems, beginning in physicians' offices;
  • Providers who perform imaging studies and physicians who interpret them should meet quality standards as a condition of Medicare payment; and
  • CMS should measure resource use of physicians serving Medicare beneficiaries and provide information about practice patterns confidentially to physicians.

With regard to payment updates and policy improvements, MedPAC recommended:

  • An update equal to a market basket minus 0.4 percent for the hospital inpatient and outpatient prospective payment systems and the outpatient dialysis payment system, and an extension of the hospital outpatient hold harmless provision for small, isolated rural hospitals;
  • An update equal to market basket less an allowance of 0.8 percent for productivity for the physician fee schedule;
  • No update for the skilled nursing facility (SNF) and home health payment systems.

Information:
Karen Fisher, Sr. Director, Health Care Affairs
AAMC Health Care Affairs
kfisher@aamc.org
(202) 862-6140

Health Providers Urge Action on Payment for Resident Training at Non-Hospital Sites

The AAMC Feb. 18 joined with 29 other healthcare provider organizations in urging the Centers for Medicare and Medicaid Services (CMS) to recognize volunteer supervisory physicians at non-hospital sites for purposes of direct graduate medical education and indirect medical education payment. The letter, addressed to CMS Administrator Mark McClellan, M.D., Ph.D., is in reaction to a Dec. 8 report from the Department of Health and Human Services Office of Inspector General on alternative payment methods for the costs of training medical residents in non-hospital settings. The letter asks Administrator McClellan to "immediately undertake regulatory actions that acknowledge volunteerism and permit hospitals and non-hospital sites to determine jointly the amount of supervisory costs, if any, that must be paid by the hospital."

Specifically, the letter calls on CMS to clarify that where supervising physicians volunteer as "faculty at a nonhospital site and the teaching hospital pays the residents' stipends and benefits and other training costs, if any, as agreed to by the parties, the hospital has incurred 'all or substantially all' of the costs of the program and is entitled to count the residents for DGME and IME purposes." Until the clarification is implemented, the letter calls on CMS to "extend, through regulatory action, the moratorium established by Section 713 of the Medicare Modernization Act (MMA) and expand its coverage to all residency programs regardless of specialty. While the initial moratorium was mandated legislatively, we believe strongly that CMS can implement a moratorium on its current authority." An attachment to the letter supporting this authority was included.

In addition, the provider groups asked CMS to reaffirm that the level of payment, if any, should be determined by the parties; policy initially established by CMS in 1998. The letter states, "In those cases where the parties agree that supervisory costs exist, the parties should have the flexibility to decide how this amount should be determined. If using physicians' salaries is the only option allowed by CMS, there could be a significant chilling effect on ambulatory training because many physicians believe their salary arrangements and determinations are, and should be, a private matter. Rather than reveal this information as a prerequisite to being a supervisor some physicians might simply choose not to take on this important role."

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

AAMC Endorses Bill to Expand Stem Cell Lines

In a March 2 letter to Reps. Mike Castle (R-Del.) and Diana DeGette (D-Colo.), AAMC President Jordan J. Cohen, M.D. endorsed their legislation to expand Federal support for stem cell research while adhering to strict federal oversight and standards. The letter states the "Stem Cell Research Enhancement Act of 2005" (H.R. 810) "recognizes the need to expand Federal support of research on pluripotent stem cells so that the tremendous scientific and medical benefits of their use may one day become available to the millions of patients who so desperately need them."

The AAMC letter affirms, "The discovery of human pluripotent stem cells is a significant research advance and Federal support to American researchers is essential both to translate this discovery into novel therapies for a range of serious and intractable diseases, and to ensure that this research is conducted under a rigorous and credible ethical regime." In accordance with current law, H.R. 810 prohibits Federal funding to derive stem cells or destroy embryos.

The AAMC letter also notes, "We recognize the significant ethical issues that are raised about embryonic stem cell research and we respect the view of those who oppose such research, including some in our own medical school community. However, we are persuaded otherwise by what we believe is an equally compelling ethical consideration, namely, that it would be tragic to waste the unique potential afforded by embryonic stem cells, destined to be discarded in any case, to alleviate human suffering and enhance the quality of human life."

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

Dodd Introduces Clinical Trials Data Bank Bill

Senator Christopher Dodd (D-Conn.) introduced legislation Feb. 28 to create a clinical trials data bank for drugs, biological products and medical devices. The Fair Access to Clinical Trials (FACT) Act (S. 470) would expand the National Library of Medicine's existing clinicaltrials.gov registry of clinical trials for drugs and biological products to treat serious and life-threatening conditions and for the first time include clinical trials for medical devices. The registry would include information for "all clinical trials conducted to test the safety or effectiveness (including comparative effectiveness) of any drug, biological product, or device (including those drugs, biological products, or devices approved or cleared by the Secretary) intended to treat serious or life-threatening diseases and conditions." Phase I clinical trials conducted "to test solely the safety of an unapproved drug or unlicensed biological product, or pilot or feasibility studies conducted to confirm the design and operating specifications of an unapproved or not yet cleared medical device" would not be required to be submitted but could be voluntarily included in the registry.

The bill also would establish a clinical trials results database. Included in the information to be submitted to the database are a "summary of the results of the trial in a standard, non-promotional summary format (such as ICHE3 template form), including the trial design and methodology, results of the primary and secondary outcome measures…, [and] summary data tables with respect to the primary and secondary outcome measures, including information on the statistical significance or lack thereof of such results." Also required for submission are safety data "including a summary of all adverse events specifying the number and type of such events, data on prespecified adverse events, data on serious adverse events, and data on overall deaths."

The information to be submitted to the registry and the data bank "shall be in a format that can be readily accessed and understood by members of the general public, including patients seeking to enroll as subjects in clinical trials." Registration of a clinical trial in registry would be required as a condition for Institutional Review Board (IRB) approval. In addition, researchers or manufacturers would be required to submit the results of the trial upon its completion or face monetary penalties or, in the case of federally funded research, restriction on future federal funding.

Senators Charles Grassley (R-Iowa), Tim Johnson (D-S.D.), and Ron Wyden (D-Ore.) are original co-sponsors of the bill.

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

GAO Announces Citizen's Health Care Working Group

Comptroller General of the United States David Walker Feb. 28 announced the appointment of 14 members to the Citizen's Health Care Working Group. The Working Group was created by Congress to hold hearings and community meetings across the country on health care coverage and cost issues, and to issue a "Health Report to the American People" within two years. Mr. Walker, who heads the Government Accountability Office (GAO), selected Randall Johnson, director of Human Resources Strategic Initiatives for Motorola, as the chairman of the Working Group. Catherine McLaughlin, Ph.D., professor in the Department of Health Management and Policy at the University of Michigan will serve as vice-chair. Other members of the Working Group include:

  • Frank Baumeister, Jr., M.D., past president of the Oregon Medical Association and past chairman of the Oregon Health Resources Commission;
  • Dorothy Bazos, R.N., Ph.D., health policy consultant and adjunct professor at Dartmouth College;
  • Montye Conlan, advocate for the diabled;
  • Richard Frank, Ph.D., professor of health economics at Harvard Medical School;
  • Joseph Hansen, president of the United Food and Commercial Workers International Union;
  • Therese Hughes, government relations and legislative analyst at the Venice Family Clinic;
  • Brent James, M.D., vice president of Intermountain Health Care and clinical professor at the University of Utah Medical School;
  • Patricia Maryland, president of St. Vincent Hospitals and Health Services, Inc.;
  • Rosario Perez, R.N., director of community outreach at CHRISTUS St. Joseph Hospital;
  • Aaron Shirley, M.D., associate professor in pediatrics at the University of Mississippi Medical Center;
  • Deborah Stehr, health care advocate; and
  • Christine Wright, R.N., director of Cancer Services and Radiation Oncology at Sioux Valley Hospital USD Medical Center.

Senate Appropriations Committee Announces Reorganization

Senate Appropriations Committee Chairman Thad Cochran (R-Miss.) March 2 announced a reorganization of the committee's subcommittee structure. The reorganization is similar, but not identical, to the reorganization of the House Appropriations Committee announced last month [see Washington Highlights, Feb. 18]. Under the new Senate plan, the VA-HUD subcommittee would be eliminated, with jurisdiction over the Department of Veterans Affairs moving to join the Military Construction subcommittee, which will be chaired by Sen. Kay Bailey Hutchison (R-Texas). The National Science Foundation would be shifted to the Commerce, Justice and Science Subcommittee, chaired by Sen. Richard Shelby (R-Ala.). The Labor-HHS-Education Subcommittee remains intact with the addition of the Corporation for National and Community Service from the former VA-HUD Subcommittee.