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Washington Highlights: October 8, 2004

Senate Approves VA Pay Bill

The Senate Oct. 5 approved by unanimous consent S. 2484, the "Department of Veterans Affairs Health Care Personnel Enhancement Act of 2004," also known as the VA Physician Pay Bill. The version passed by the Senate includes new provisions negotiated with veterans and physician groups and through discussions with the House Veterans' Affairs Committee. The AAMC Oct. 6 sent a letter to House Veterans' Affairs Committee Chairman Chris Smith (R-N.J.) urging him to support swift passage of the legislation.

Specifically, the Senate-passed version includes three major components: base pay, market pay, and performance pay. Base pay would be set according to the VA physician's longevity in the VA health care system and would include automatic pay ncreases every two years. Market pay would be based on specialty and assignment, with "pay bands" determined by the Secretary of Veterans Affairs based on consultation with at least two national surveys every two years. The Secretary's findings from these surveys would be published in the Federal Register and open for public comment. An individual physician's total pay would be determined by an "appropriate panel or board composed of physicians" at the local facility. The performance pay portion of the proposed system would allow for individuals to receive up to the lesser of $15,000 or 7.5 percent of the physician's salary for meeting specific goals or performance objectives as set by the Secretary. An individual physician's total pay could not be decreased unless a specialty or assignment changed; however, there would be an appeals process for involuntary changes. The new system would take effect on Jan. 1, 2006; in the interim, all pay will be determined as if the current system was continued.

Information:
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Government Relations
jfishburn@aamc.org
(202) 828-0525

GAO Assesses Impact of Privacy Rule's First Year

The Government Accountability Office (GAO) Oct. 4 released a report summarizing the experiences of providers and health organizations during the first year of implementing the federal rule governing health information privacy. Issued under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) [PL 104-191], the privacy rule provided new protections regarding the confidentiality of health information and established new responsibilities for providers, health plans, and other entities to protect such information. In addition to the experience of providers and health plans, the report also documents the difficulties of public health entities, researchers, and representatives of patients in obtaining access to health information under the rule, and the extent to which patients appear to be aware of their rights.

Organizations representing providers and health plans reported that implementation of the privacy rule went more smoothly than expected during the first year most entities were required to be compliant. However, provider and health plan representatives also raised a variety of issues about provisions that continue to be problematic. In particular, many organizations emphasized that two provisions - the requirement to account for certain information disclosures and the requirement to develop agreements with business associates that extend privacy protections "downstream" - are unnecessarily burdensome. Some organizations suggested that difficulties with these provisions could be ameliorated with modification of certain provisions and further guidance from the Department of Health and Human Services' (HHS) Office for Civil Rights (OCR), the agency responsible for enforcing the privacy rule.

The report also outlines a number of challenges faced by entities that rely on access to health information for public health monitoring, research, and patient advocacy. Public health entities noted that some states have had to take concerted action to ensure that providers' concerns about complying with the privacy rule do not impede the flow of important information to state health departments and disease registries. Some research groups asserted that the rule has delayed clinical and health services research by reducing access to data. Some consumer advocacy groups reported that patients' families, friends, and other representatives have experienced unnecessary difficulty in assisting patients. These groups perceived that while providers and plans are allowed, in certain cases, to disclose health information without written patient authorization, they are reluctant to do so.

GAO recommends that HHS require that patients be informed of mandatory disclosures to public health authorities in privacy notices and exempt such disclosures from the accounting requirement, and conduct a public information campaign to improve patients' awareness of their rights. GAO also remains concerned about the burden of accounting for disclosures to public health authorities and believes it is important that HHS more effectively disseminate information about the privacy rule.

In preparing the report, which was requested by the Senate Health, Education, Labor and Pensions (HELP) Committee, GAO interviewed representatives of 23 national organizations representing health care consumers, health care providers, health plans, state officials, public health agencies, researchers, and privacy professionals, including the AAMC, the American Hospital Association, the American Medical Association and the Joint Commission on Accreditation of Healthcare Organizations.

Information:
Susan Ehringhaus, Sr. Director & Regulatory Counsel
AAMC Biomedical Health Sciences Research
sehringhaus@aamc.org
(202) 828-0543
Ivy Baer, Director & Regulatory Counsel
AAMC Health Care Affairs
ibaer@aamc.orc
(202) 828-0490

AAMC and FASEB Issue Second Letter on HHS "WHO" Policy

AAMC President Jordan Cohen, M.D., and Paul Kincade, Ph.D., President of the Federation of American Societies for Experimental Biology (FASEB), Oct. 6 restated their organizations' objection to a policy that requires central clearance for HHS-employed scientists invited to international meetings. "[W]hen government scientists are invited to participate in international forums not as official representatives or spokespersons of the United States government, but rather solely as scientists on the basis of their expertise, contributions and international stature, those invitations should not be mediated through the Office of the Secretary at all." The statement was made in a letter replying to William Steiger, Ph.D., special assistant for international affairs to Health and Human Services (HHS) Secretary Tommy Thompson.

Earlier, Dr. Steiger had responded to the first AAMC-FASEB letter on this issue [see Washington Highlights, July 23], which revolves around NIH and CDC scientists invited to serve as "technical consultants" participating in meetings of the World Health Organization (WHO). Dr. Steiger noted that the HHS policy was intended to ensure that appropriately qualified experts from the Department's considerable pool of scientific talent were selected for these assignments. Dr. Steiger also believes that the policy would provide for transparency and better accountability within the Department, and he specifically contrasted the policy with any process that would seek to "politicize" the appointment of scientific experts. But the AAMC and FASEB disagree, arguing that judging the requisite scientific qualifications of invitees is best done by the forum's sponsors, and an employee's availability for assignment is best assessed by their supervisors. In such circumstances, Drs. Cohen and Kincade state, "the newly articulated interposition of the Office of the Secretary…only raises fears of political litmus tests that we would deplore."

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

House Approves One-Year "Clean" Reauthorization of HEA

The House of Representatives Oct. 6 approved by voice vote a "clean" one-year extension of programs authorized under the Higher Education Act (HEA). The legislation, H.R. 5185, makes no policy changes, and allows uninterrupted administration of the programs through FY 2005 while the Congress continues to debate a longer reauthorization. The House Oct. 7 also approved by a vote of 414-0 legislation (H.R. 5186) to close for one year a loophole in lending rules that allows lenders to collect a significant profit on certain types of loans. The savings associated with closing the loophole would be used to increase loan forgiveness for elementary and secondary school teachers of math, science and special education.

Information:
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Government Relations
jfishburn@aamc.org
(202) 828-0525

CMS Changes Stance on 1011 Funds

Centers for Medicare and Medicaid Services (CMS) Administrator Mark McClellan, M.D., Ph.D., issued an Oct. 1 letter stating "providers will not be asked - and should not ask - about a patient's citizenship status in order to receive payment" under Section 1011 of the Medicare Modernization Act (MMA), which provides $250 million per year for fiscal years 2005-08 to reimburse eligible providers for emergency health services for emergency care for undocumented aliens. In its proposed methodology for distribution of these funds, the CMS required providers to ask about a patient's citizenship status. The AAMC and many other organizations objected to this requirement, as it would likely discourage undocumented aliens from seeking needed care. Due to this change, a previously published data collection instrument that was to be used by all providers seeking Section 1011 funds will not be part of the final policy.

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

Legislation Proposes Federal Regulation of Hospital Group Purchasing Industry

Legislation introduced Oct. 1 would give the Department of Health and Human Services (HHS) oversight authority over hospital group purchasing organizations. "The Medical Device Competition Act, S. 2880, introduced by Sens. Herb Kohl (D-Wisc.) and Mike DeWine (R-Ohio) would, according to Sen. Kohl's introductory statement, direct HHS to draft regulations to prevent hospital group purchasing organizations from "unethical conduct, anti-competitive practices, or practices which preclude products necessary for patient care or worker safety from reaching physicians and patients."

The introduction of the legislation is a follow up to a hearing held Sept. 14 by the Senate Judiciary Antitrust Subcommittee where representatives from the group purchasing industry and medical device companies testified.

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

House Approves 2-Year Extension of J-1 Visa Waiver Program

The House of Representatives Oct. 6 approved legislation (H.R. 4453) extending for two years the J-1 Visa Waiver Program, which provides each state with authority to sponsor waivers permitting foreign physicians who complete their residency training in this country to avoid the two-year home country requirement associated with the J-1 visa program. In return, the foreign physicians are required to provide health care in underserved areas for a minimum of three years. An amendment offered in the House Judiciary Committee would allow up to five physicians in each state to work in areas that are not designated as underserved. Additionally, the bill, as approved, would clarify that physicians that transfer into the H-1B visa program do not count against the statutory cap on H-1B visas. The program expired on May 31.

Information:
Jonathan Fishburn, Director, Research, Education and Veterans' Legislative Affairs
AAMC Government Relations
jfishburn@aamc.org
(202) 828-0525

House-Passed Bill Would Create Drug Monitoring Program

The House Oct. 5 passed by voice vote legislation that would establish an electronic prescription drug monitoring program. The "National All Schedules Prescription Electronic Reporting Act of 2004" (NASPER) (H.R. 3015) would create a database to help states, providers, and other entities compile the information needed to identify the abuse or diversion of Schedule II, III, or IV controlled substances. NASPER was introduced by Rep. Ed Whitfield (R-Ky.) and incorporates amendments by Reps. Charles Norwood (R-Ga.) and Frank Pallone (D-N.J.). The amendments were intended to assure that HIPAA privacy provisions applied to the collected data.

According to statements made during the floor debate, 21 states already have such monitoring programs in place, including Rep. Whitfield's home state of Kentucky. Rep. Bart Stupak (D-Mich.) stated that a 2002 report from the General Accounting Office (GAO) concluded the programs "are useful tools" in preventing the abuse of prescription drugs. Speaking in opposition to the bill, Rep. Ron Paul (R-Texas) expressed concern that the program would discourage physicians from prescribing "an adequate amount of pain medication, or even any pain medication, for their suffering patients." Rep. Paul also argued that NASPER threatened patient privacy by increasing government access to patient records.

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

House Calls for Study of NIH Roadmap

A report on the NIH Roadmap's activities related to spinal cord injury and paralysis is one of four studies mandated by the "Research Review Act of 2004" (H.R. 5213), which the House passed Oct. 7 under a suspension of the rules. The bill calls for the Secretary of Health and Human Services, in coordination with the NIH Director, to prepare a report outlining the methods by which the NIH Roadmap "has advanced the use of multidisciplinary research teams and consortia of research institutions to advance treatments, develop new therapies, and collaborate on clinical trials, including with respect to spinal cord injury and paralysis research." The report is due to Congress by Feb. 1, 2005.

The bill also calls for three studies related to inflammatory bowel disease. The bill directs the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to prepare a report "outlining the epidemiological studies currently underway at [CDC], future planned studies, the criteria involved in determining what epidemiological studies to conduct, defer, or suspend, and the scope of those studies, including with respect to the inflammatory bowel disease epidemiological study." The Government Accountability Office (GAO) is asked to study the coverage standards under Medicare and Medicaid, respectively, that apply to patients with inflammatory bowel disease undergoing various therapies. The bill also directs GAO to study the problems patients encounter when applying for disability insurance benefits under Social Security, including recommendations for improving the application process for patients with inflammatory bowel disease.

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