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Washington Highlights: September 14, 2007

AAMC, Health Professions Groups Hold Title VII Capitol Hill Day

Health professions leaders representing the range of disciplines supported by the Title VII and VIII programs Sept. 12 participated in a Congressional advocacy day, organized by the Health Professions and Nursing Education Coalition (HPNEC). Participants visited more than a dozen congressional offices to urge Congress to provide full funding for the health professions training programs, which were cut by 51 percent 2 years ago.

A lunch briefing for participants and Congressional staff featured presentations by Title VII and VIII grantees who shared firsthand accounts of what the programs have accomplished. Angela Jackson, M.D., Director of the Boston University Medical Center Primary Care Residency Training Program, and Anthony Miller, M.Ed., PA-C, Program Director of Shenandoah University's Division of Physician Assistant Studies, offered their perspectives on how funding cuts will impact the primary care pipeline in their communities. Evelyn Simpkins, M.D., described how her participation in a Health Careers Opportunity Program (HCOP) at the Michigan State University College of Human Medicine led to a fellowship in adolescent medicine at the Johns Hopkins School of Medicine. Karen Capen Stearns, R.N., C.C.R.N., spoke of how Title VIII helped guide her career path in nursing.

The AAMC coordinates HPNEC, which is an alliance of more than 70 national organizations representing providers, institutions, and community partnerships dedicated to educating the nation's health personnel.

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

AAMC Comments to IRS on Schedule H and Form 990

The AAMC Sept. 12 submitted a comment letter to the Internal Revenue Service (IRS) on proposed revisions to Form 990, which must be completed by all not-for-profit entities seeking tax-exemption, and on a new form (Schedule H) for hospitals to report on their community benefit and other activities.

The AAMC reminded the IRS that Revenue Ruling 69-545, which established the standards for tax exempt hospitals, recognized education and research as tax exempt purposes. The letter noted that "while the 21st century teaching hospital has changed in many ways from its progenitors, the commitments to education, research, and patient care remain just as strong and continue to reaffirm that it merits its tax exempt status."

The AAMC also proposed revisions to the worksheets on education and research that are to be used for completing Schedule H. The IRS has said that it expects to finalize the forms by the end of this year and that they will be used for the 2008 tax reporting year. The AAMC commented that "revisions of the magnitude proposed . . . may require more time to finalize than has been suggested."

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

Group Letter Urges Senate to Include Physician Relief in SCHIP Agreement

The AAMC and 130 physician organizations sent a Sept. 10 letter to all Senators urging that the pending conference agreement on State Children's Health Insurance Plan (SCHIP) reauthorization include 2 years of positive Medicare physician updates. Although the House-passed SCHIP reauthorization bill (H.R. 3162) provides a positive 0.5 percent update in both calendar year (CY) 2008 and CY 2009, the Senate bill does not. Without legislative action, Medicare expects to reduce physician payments by 10 percent in CY 2008 and 5 percent in CY 2009.

The sign-on letter expresses concern that postponing physician payment legislation "until later this year" will put Medicare providers and beneficiaries "in an untenable position of uncertainty about Congress' commitment to provide needed relief." Stating that "Congress has the chance to break with business as usual," the letter advises that "the time for action is now."

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

Senate Letter to President Bush Opposes SCHIP Regulatory Clarifications

Senators Gordon Smith (R-Ore.), Robert Menendez (D-N.J.), and 42 of their Senate colleagues signed a Sept. 10 letter to President Bush opposing the Administration's new regulatory "clarifications" related to State Children's Health Insurance Program (SCHIP) expansions. The Centers for Medicare and Medicaid Services (CMS) outlined the clarifications (minimum enrollment levels and certain "crowd-out procedures') in an Aug. 17 letter to state health officials [see Washington Highlights, Sept. 7].

The bipartisan Senate letter urges President Bush to withdraw the new requirements, or "[a]t the very least...propose this policy as a formal rule...with a notification and comment period."

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

AAMC Comments on NCRR Strategic Plan

In response to a request for input on the NIH National Center for Research Resources' (NCRR) 2009-2013 strategic plan, the AAMC Sept. 10 sent a letter recommending that NCRR re-dedicate itself to providing balanced support for shared facilities and other collaborative resources.

The AAMC describes the NCRR as serving "a unique role in creating, supporting and sustaining research resources and infrastructure that broadly serve biomedical research, which is distinct from the topical focuses of most other NIH institutes and centers." The Association argues that access to shared resources will become especially important in the future, as research institutions look to collaborate in response to constrained NIH budgets. "Regional resources and national hubs connected by informatics networks will become especially important to the nation's biomedical research infrastructure," the letter states, noting that several NCRR programs, such as the Clinical and Translational Science Awards (CTSAs), animal research facilities, and the Biomedical Informatics Research Network (BIRN), are already "exemplars" of the potential effectiveness of such collaboration.

NCRR's schedule for developing its next strategic plan also was discussed at its advisory council meeting Sept 11. NCRR Director Barbara Alving, M.D., discussed the status of the Administration's budget request ($1.11 billion) for FY 2008. Sherine Gabriel, M.D., professor of Medicine and Epidemiology at the Mayo Clinic, presented on current training and career development programs at institutions that received the first round of CTSAs. Dr. Gabriel described signs of progress and innovation in training interdisciplinary clinical researchers among the 12 initial awardees, but she noted that many trainees remain apprehensive about whether stable career paths will be available to them. She noted for example, the difficulty students encounter finding appropriate journals to publish interdisciplinary clinical and translational research. Steven Hirschfeld, M.D., Ph.D., Associate Director for Clinical Research at the National Institute of Child Health and Development, presented on regulatory obstacles in IRB review of pediatric research.

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

District Court Invalidates IRS FICA Rule

The U.S. District Court for the District of Minnesota Aug. 3 granted the Mayo Foundation's motion for summary judgment against the United States. Mayo sued the federal government for a refund of Federal Insurance Contributions Act (FICA) taxes withheld from medical residents' stipends in 2005. Mayo contended that the regulations issued by the IRS in 2004 that govern whether FICA taxes must be paid under the Student Exception were invalid. The Court agreed, saying that the regulatory requirements imposed by the IRS were contrary to the plain meaning of the statute.

Under the IRS regulations, qualification for the student exception requires that an individual be "employed" by a "school, college, or university" and that the individual qualify as a "student." In the regulation the IRS added a "primary function test" to the standard that defines "school, college, or university" so that the primary function of the "employer" must be education. The Court found that the term "school, college, or university" in the statute is "not ambiguous," so that if a primary function test is to be used as a standard for defining these terms, Congress must amend the law.

Mayo also argued that the term "student" is not ambiguous, so that the IRS's addition of a full-time employee exception - whereby no one who works more than 40 hours per week is considered a student - is inconsistent with the statute and congressional intent. Again, the Court agreed and stated that the IRS-imposed requirement "denies 'student' status to medical residents even though the services they provide are primarily for educational purposes and essential to becoming fully qualified physicians."

It is unclear whether this decision will have any affect on the IRS regulations for institutions located outside of Minnesota. Other institutions that believe their residents should not pay FICA taxes should consult with tax counsel on possible next steps.

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

House Passes Patent Reform Bill

The House Sept. 4 passed, 220-175, the "Patent Reform Act of 2007" (H.R. 1908). The legislation is intended to improve clarity and objectivity in patent law, lessening cause for protracted litigation, and to bring aspects of the U.S. patent system into harmony with those of other nations. Key provisions of the bill include switching from a "first-to-invent" to a "first-inventor-to-file" standard for establishing priority for an invention and extending a post-grant review process within the Patent and Trademark Office that permits third parties to contest a patent's validity.

The bill as passed includes revisions that were requested by a coalition of university associations, including the AAMC, seeking to secure public benefits from university technology transfer [see Washington Highlights, May 18]. The university associations were successful in defeating a provision that sought to expand "prior user right" that unduly favored trade secrecy over open disclosure in the patent system.

In a Statement of Administration Policy, the White House Sept. 6 announced its overall approval of H.R. 1908, except notably for the bill's provision on the apportionment of damages, which also was the source of much of the debate on Capitol Hill. For patent reform to be enacted into law this year, it is likely that the damages provisions will be revised in conference. A companion bill, S. 1145, has been approved by the Senate Judiciary Committee.

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

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

Grassley, Kohl Introduce Bill to Require Public Database of Drug Company Payments to Doctors

Senators Charles Grassley (R-Iowa) and Herb Kohl (D-Wis.) introduced legislation Sept. 6 to require drug and medical device manufacturers to disclose their payments to physicians. The "Physician Payments Sunshine Act" (S. 2029) requires manufacturers of drugs, devices, or medical supplies for which payments are made under Medicare, Medicaid, or SCHIP to disclose to the Secretary of Health and Human Services, on a quarterly basis, anything of value given to doctors, such as payments, gifts, honoraria, or travel. Companies must also submit annual summaries of the information reported.

The bill requires companies with $100 million or more in annual gross revenues to report the name of the physician, the address of the physician's office, any facility with which the physician is affiliated, the value and the date of the payment or gift, its purpose, and what, if anything, was received in exchange. If a payment or other transfer of value was provided to an entity that the physician is employed by, has tenure with, or has an ownership interest in, the company must report the entity and its primary place of business or headquarters. Companies that fail to report are subject to penalties ranging from $10,000 to $100,000 for each violation.

The bill also requires the Secretary to establish no later than June 1, 2008, procedures to ensure that the information and summary reports submitted are readily accessible to the public through an internet website that is easily searchable, downloadable, and understandable.

Senators Claire McCaskill (D-Mo.), Chuck Schumer (D-N.Y.), Amy Klobuchar (D-Minn.) and Ted Kennedy (D-Mass.) are original cosponsors of S. 2029, which is based on similar state initiatives in Minnesota, Vermont, Maine and West Virginia.

Senator Grassley is Ranking Member of the Committee on Finance, where he has conducted oversight of educational grants awarded to doctors by drug companies. Senator Kohl chairs the Special Committee on Aging, which held a hearing in June to examine the financial relationship between physicians and the pharmaceutical industry.

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