The following is an update and summary of recent federal legislative and regulatory activities of interest to the pediatric academic community. Members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to make your views heard throughout this session of Congress.

This report includes information on the following issues:

• 107th Congress
• Pediatric Research
• Pediatric Workforce
• FY 2002 Appropriations
• MCH Block Grant
• Immunizations
• Managed Care
• PAS Annual Meeting 2001
• How to contact Congress/White House
• Congressional Calendar

The 107^th Congress was sworn-in on January 3, 2001. Election 2000 results left the Senate evenly split between Republicans and Democrats, with Vice-President Dick Cheney to serve as the tiebreaker vote. Majority Leader Trent Lott (R-MS) and Minority Leader Tom Daschle (D-SD) subsequently reached what is termed an historic power-sharing agreement, awarding both parties an equal number of committee and subcommittee assignments, with Republicans retaining their chairmanships.

In the House, changes and post-election developments have left the House with 220 Republicans, 211 Democrats and 2 Independents. Two vacancies currently exist as result of the death of Representative Julian Dixon (D-CA) in December and the retirement of Representative Bud Shuster (R-PA) on February 2, 2001. Initially House leaders did not change the committee ratios in place from the 106^th Congress. However, six-year committee chairmanship term-limits enacted in 1995 kicked-in 2001, meaning many committees, such as the Budget and Ways and Means Committees now have new chairmen. Additionally, the House Commerce Committee was split into two committees – a new Committee on Financial Services and the Committee on Energy and Commerce, the original name of this committee prior to 1995. The latter Committee will have jurisdiction over many of the medical and health care issues of interest to the pediatric and child health community.

White House: With President Bush’s arrival on January 20, 2001, new officials were nominated and/or named throughout the federal government. Of interest to the pediatric community are those involved in health care related matters. For example, Tommy Thompson, the governor of Wisconsin, was nominated and confirmed to be Secretary of the Department of Health and Human Services, Mitchell E. Daniels, former senior executive at Eli Lilly is the Director of the Office of Management and Budget and Anne Phelps, former health care staffer for Senator Bill Frist (R-TN) was tapped to handle health issues at the White House. Appointments for several key executive branch positions, including Health Care Financing Administration (HCFA) Administrator and Director of the National Institutes of Health (NIH), remain to be filled, however. Surgeon General David Satcher, MD, Ph.D., Centers for Disease Control and Prevention (CDC) Director Jeffery Koplan, MD and the Agency of Heathcare Research and Quality (AHRQ) Director John Eisenberg, MD were asked to remain in their positions, although Dr. Satcher did not retain the dual position as Assistant Secretary of Health, a position he had held under the Clinton Administration.

National Institute of Health (NIH)/Appropriations: President Bush outlined his FY 2002 budget during a speech before a Joint Session of Congress on February 27, 2001, and released a 100-page budget overview the following day. The President is expected to submit his more detailed budget proposal to Congress on April 3^rd. The Bush FY 2002 budget proposal includes his $1.6 trillion 10-year tax cut, as well as an 11% increase for the Department of Education. Consequently, funds for other discretionary programs – including NIH – may face new challenges. As of this writing, the President proposed funding level for NIH is an increase of $2.8 billion over current year funding of $20.3 billion. The Public Policy Council (PPC) has joined other medical research advocates including Research!America in supporting the Ad Hoc Group for Medical Research Funding’s recommendation of a 16.5% increase for NIH in FY 2002 as the fourth installment in doubling the NIH by 2003. The PPC also supports $1.7 billion in FY 2002 for the National Institute of Child Health and Human Development (NICHD).

NIH/Legislation: Early this Congress, Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) introduced the Biomedical Revitalization Resolution of 2001, S. Res. 19. This resolution expresses the Sense of the Senate that the funding for the NIH should be increased by $3.4 billion in FY 2002. At the time of introduction, Senator Specter stated that he believes America’s substantial investment in biomedical research is paying off, and that increased funding must be continued in order to convert scientific advances into treatments and cures. He also called on his colleagues to cosponsor his resolution and join him in the fight to accomplish the vital goal of doubling NIH funding by fiscal year 2003. The measure currently has 13 bipartisan cosponsors. A similar resolution will be introduced in the House.

Pediatric Research Initiative: The Children’s Health Act of 2000, P.L. 106-310 (H.R. 4365), signed into law by President Clinton on October 17, 2000, authorizes the NIH Director to establish a Pediatric Research Initiative to "conduct and support research that is directly related to diseases, disorders, and other conditions in children." The Act specifies that the NIH Director in consultation with the Director of the NICHD and the Administrator of the Health Resources and Services Administration will head the initiative. It also provides for increased training grants for pediatric training, additional career development awards for health professionals intending to build careers in pediatric basic and clinical research, and a pediatric research loan repayment program of up to $35,000 per year for qualified health professionals who "agree to conduct pediatric research."

At the time of this writing, NICHD Director Duane Alexander, MD is part of a planning committee chaired by Claude Lenfant, MD, Director, NHLBI, to develop an administrative structure for the pediatric research loan repayment consistent with the other existing loan repayment programs. Other members of this internal NIH committee are: Anthony Fauci, MD, NIAID, Steven Hyman, MD, NIMH, Stephen Katz, MD, Ph.D. NIAMS, Dr.Yvonne Maddox , Acting Deputy Director, NIH, Audrey Penn, MD, Acting Director, NINDS, Dr. John Ruffin, Center on Health Disparities Research and Alan Spiegel, MD, NIDDK. The PPC has joined the Academy’s and the National Association of Children’s Hospitals in supporting the recommendation of $50 million for the Pediatric Research Initiative and sufficient funding for the pediatric training grant and pediatric research loan repayment programs in FY 2002.

National Human Research Protections Advisory Committee: Established in December 2000, the National Human Research Protections Advisory Committee serves as HHS’s principal advisory body on issues pertaining to human subjects protections and responsible conduct of human research. It is chaired by Mary Faith Marshall, Ph.D., Director of the program in bioethics at the University of Kansas Medical Center in Kansas City. Its original members include Mark Barnes, J.D, LL.M., Partner-Proskauer Rose LLP , and Chairman-Committee on Health Care Providers for the New York State Bar Association, New York City, Sanford Chodosh, M.D., President-Public Responsibility in Medicine and Research, Wayland, Mass., Elliot N. Dorff, Ph.D., Rector and Distinguished Professor of Philosophy, University of Judaism, Los Angeles, Jennie R. Joe, Ph.D., M.P.H., R.N., Professor-Family and Community Medicine, University of Arizona–Tucson, Robert Levine, M.D., Professor of Medicine, Yale University School of Medicine, New Haven, Conn., Abbey S. Meyers, President-National Organization for Rare Disorders, New Fairfield, Conn., Mary Z. Pelias, Ph.D., J.D., Professor-Department of Genetics, Louisiana State University Health Sciences Center, New Orleans, Robert R. Rich, M.D., Executive Associate Dean of Research, Emory University School of Medicine, Atlanta, Adil E. Shamoo, Ph.D., Professor-Department of Biochemistry and Molecular Biology, University of Maryland School of Medicine-Baltimore, Judith L. Siegel, Ph.D., Vice President/Head US Clinical Operations, Hoffmann-La Roche, Inc., Caldwell, N.J., and Denyse Thornley-Brown, M.D., Assistant Professor-Division of Nephrology, University of Alabama at Birmingham.

Following the announcement of the Committee’s roster, the Academy sent a letter to HHS Secretary Shalala expressing concern regarding the absence of pediatric representation. APS/SPR member, Alan Fleischman, MD, FAAP, Senior Vice President, New York Academy of Medicine, was subsequently named to the Committee, along with several social scientists who had similar concerns on the lack of representation of their discipline on the Advisory Committee.

At its first meeting, the Committee commissioned two reports from the Institute of Medicine. The first, due April 2001, will examine the process and standards for Institutional Review Boards. The second, expected in fall 2002, will look at the overall framework for the human research protection process. The Committee also established a four-point action plan, to address the following issues: non-biomedical research under the common rule, financial relationships in research, the Declaration of Helsinki, and research involving children. Additional issues may be added to this plan as the Committee proceeds with its work. The Advisory Committee is scheduled to meet again in April 2001. Further information on the Office for Human Research Protections and the National Human Research Protections Advisory Committee is available at www.ohrp.osophs.dhhs.gov.

Stem Cell Research/Federal Guidelines: The NIH published its final guidelines for research using human pluripotent stem cells on August 25, 2000. At that time, President Clinton and the medical research community, including the pediatric academic societies, heralded the guidelines that allow the first federal funding of human embryonic stem cell lines. However, President Bush has remained critical of the guidelines since their release, and recently followed through on a campaign promise to instruct HHS Secretary Tommy Thompson to review NIH’s decision. Of note, the current deadline for NIH stem cell grant applications is March 15, 2001, and the Human Pluripotent Stem Cell Review Group is scheduled to review these applications in April. This activity could cause some action on the part of the White House including, as recently rumored, a possible Executive Order restricting or repealing the August 2000 guidelines. Staff will continue to work with the American Society for Cell Biology and others to monitor the issue closely and ensure the Administration is aware of the research community’s strong support for the new guidelines and moreover, for stem cell research.

Stem Cell Research/Legislation: Representatives Carolyn Maloney (D-NY) and Connie Morella (R-MD) have reintroduced a resolution, H. Con. Res. 17, supporting federal funding of pluripotent stem cell research. The bipartisan resolution currently has 7 co-sponsors. The PPC, along with several others in the research community, endorsed a similar measure that was not acted upon in the 106^th Congress.

In addition, Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) are expected to reintroduce and hold hearings on legislation to permit federal funds to be used for research with human pluripotent stem cells generated from early human embryos in excess of clinical need at IVF clinics, and with the informed consent of the donor.

Agency for Healthcare Research and Quality (AHRQ)/Appropriations: In the wake of the Institute of Medicine’s To Error is Human report, significant public and congressional attention emerged around the issues of medical errors and patient safety. Congress responded to this development in several ways, including by providing $270 million in funding for AHRQ in FY 2001 - $51 million more than that agency received in FY 2000 and $20 million more than President Clinton had requested in his budget proposal. The $270 million figure included an earmark for programs designed to reduce medical errors. This year, the PPC is joining with the Friends of AHRQ in requesting $400 million for AHRQ in FY 2002. This proposed funding request, if enacted, would support additional investigator initiated grants as well as additional funding for patient safety.

Animal Research/Rats, Mice and Birds: The House-Senate Agriculture appropriations conference committee added language to the FY 2001 Agriculture appropriations bill prohibiting the USDA from moving forward on efforts to amend the definition of animal under the Animal Welfare Act. The USDA’s plan, as required by a legal settlement with the ARDF, was to "to initiate and complete" a rulemaking on changing the definition to include rats, mice and birds. Given the temporary nature of the Appropriations fix, however, additional action is expected this year. PPC Staff will continue to work with the National Association for Biomedical Research on securing a more permanent solution.

GME Financing in Children’s Hospitals/Appropriations: Independent children’s hospitals received $235 million in FY 2001, $50 million less than the fully authorized amount requested by the PPC and other children’s hospital advocates but a significant increase above the $40 million appropriated in FY 2000. Early information regarding the Bush budget proposal indicates the program may face serious funding threats in FY 2002. The PPC, together National Association of Children’s Hospitals, and with the Ambulatory Pediatric Association, and the American Academy of Pediatrics, is recommending the program be funded at the fully authorized amount of $285 million in FY 2002.

GME/Legislation: Legislation to improve payments for direct graduate medical education was introduced early in the 107^th Congress by Sen. Dianne Feinstein (D-CA) and four other senators. It currently has nine co-sponsors including Senators Jim Jeffords (R-VT), Jeff Bingamen (D-NM), Max Cleland (D-GA), Patrick Leahy (D-VT), Barbara Boxer (D-CA), Thad Cochran (R-MS), Mary Landrieu (D- LA), Patty Murray (D-WA) and Daniel Inouye (D-HI). Specifically, the Direct Graduate Medical Education Improvement Act of 2001, S. 135, would increase the payment of the floor for the locality adjusted national average per resident amount of direct graduate medical education (DGME) payments. This floor would be phased in over five years - starting at the current 70% of average in FY 2001 and reaching 100% in FY 2006. No action has occurred on the bill since its introduction, and no companion measure has yet been introduced in the House.

Medicare Payment Advisory Commission (MedPAC): At the January 2001, meeting of MedPAC, committee members reviewed two draft recommendations regarding direct GME payments. Following a short deliberation, the group concluded that Congress should eliminate the weighting factors (currently 0.5 FTE and 1.0 FTE ) that are now a part of Medicare’s direct GME payments. Under the MedPAC recommendations all residents would be counted at the 1.0 level through the completion of a residents first specialty or combined program and subspecialty if one is pursued. Indirect medical education payments would not be affected by the MedPAC recommendation. MedPAC expects to publish the final recommendations in March 2001.

Titles VII and VIII-Health Professions Training Grants/Appropriations: The PPC, together with the Ambulatory Pediatric Association and the American Academy of Pediatrics, has joined with the Health Professional and Nursing Education Coalition (HPNEC) in requesting $440 million for Titles VII and VIII in FY 2002. This figure represents the first step in a two-year effort to increase funding to $550 million, which HPNEC has determined to be necessary for the programs to improve the quality, geographic distribution and racial/ethnic diversity of the public health care workforce, particularly in underserved communities. Of this $440 million, the pediatric and internal medicine communities support $35 million is dedicated to General Pediatrics and General Internal Medicine programs. Titles VII and VIII received $353 million in FY 2001.

HHS PRIVACY REGULATIONS:

The Department of Health and Human Services released on December 28, 2000, a final rule to establish Standards for Privacy of Individually Identifiable Health Information. Among other things, this rule sets restrictions on the use and release of medical records and gives patients certain rights with respect to their health information. When President Bush assumed office, however, he ordered the review of all regulations issued in the final sixty days of the Clinton Administration. With an issue date of late December, HHS’s new privacy regulation was one of those set aside for further review.

President Bush outlined his FY 2002 budget during a speech before a Joint Session of Congress on February 27, 2001, and released a 200-page budget overview on February 28^th. The more detailed budget proposal to Congress is expected April 3^rd.

A preliminary review indicates that the President has proposed that the Department of Education receive the largest percentage increase of any department in the federal government, at just over 11% from current funding. An increase of $23 billion was also proposed for Medicare next year that includes funding for a prescription drug plan. In addition, increases in defense spending have also been proposed, sufficient funding to create more then 1,200 new community health centers and as noted previously, an increase of $2.8 billion for the NIH. President Bush has stated that the rate of growth in federal programs seen last year was "excessive," and that he intends to "slow the rate of growth of the budget down." It is estimated that this overall growth will be approximately 4 percent. With these funding pledges, a smaller growth rate and a $1.6 trillion 10-year tax cut serving as one of the Administration’s signature provisions, it is unclear how overall discretionary programs, in particular public health programs, will fair under the President’s proposal. The PPC will submit written testimony to both the Senate and the House Appropriations Subcommittees on Labor, Health and Human Services and Education. Staff will continue to work throughout the 107^th Congress to ensure programs of particular interest to the PPC receive adequate federal support.

The Maternal and Child Health (MCH) Block Grant program received $714 million in FY 2001, a very modest $4 million increase over FY 2000. The PPC, the March of Dimes and several other MCH Block Grant advocates are recommending that Congress appropriate the fully authorized amount of $850 million for the MCH Block Grant program in FY 2002.

Vaccine Safety/Congressional Hearings: It is anticipated that Representative Dan Burton (R-IN), Chairman of the House Government Reform Committee, who held numerous hearings on vaccines and vaccine safety during the 106^th Congress, will continue in the 107^th Congress. It is rumored at this time although unclear what form it might take that the first hearing could be on the new vaccine Prevnar.

Vaccine Programs/Appropriations: The CDC received $529 million in funding for immunization programs in FY 2001 (Section 317 program). Despite this increase, however, the program continues to face significant challenges, including critical infrastructure needs coupled with the high cost of new vaccines. As such, the PPC has joined the immunization community in requesting at least $664 million for CDC’s Section 317 immunization program and an additional $70 million for CDC’s global immunization initiatives that includes funding for polio eradication and the elimination of measles and rubella in FY 2002.

Bipartisan Patient Protection Act of 2001: Legislation building on last year’s Patient’s Bill of Rights was introduced early this Congress by a bipartisan group of legislators led by Senators John McCain (R-AZ) and Ted Kennedy (D-MA) in the Senate and Representatives Greg Gankse (R-IA) and John Dingell (D-MI) in the House. As introduced, the Bipartisan Patient Protection Act of 2001, S. 283/H.R. 526 includes provisions on such issues as internal and external review procedures, access to emergency room and specialty care, access to obstetrical, gynecological and pediatric services, and the right to sue medical plans in state and federal court. The bipartisan legislation currently has 17 cosponsors in the Senate and 70 cosponsors in the House.

Of particular interest to the pediatric community, S. 283/H.R. 526 would provide for the use pediatric-specific criteria in utilization reviews; the inclusion of pediatric expertise in internal and external reviews; timely access to pediatric specialists; and the right to choose a pediatrician as a child’s primary care provider. It also would require that plans adhere to determinations made by independent external reviewers.

President Bush has raised concerns about the bill’s liability provisions, specifically the bill’s $5 million cap on punitive "civil assessments" awarded by federal courts and its lifting of the ERISA-shield to allow patients to seek redress in state court for certain medically reviewable decisions. This provision does not establish caps for state awards, however, as existing state-by-state caps on damages would apply to any award issued at the state level. While he has not announced a formal proposal, Bush did outline what the White House termed "Principles for a Bipartisan Patients’ Bill of Rights" following the introduction of S. 283/H.R. 526. These principles include the following: patient protections should apply to all Americans; patients protections should be comprehensive; patients should a rapid medical review process for denials of care; federal remedies should be expanded to hold health plans accountable; and patient protection legislation should encourage, not discourage, employers to offer health care.

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The Public Policy Plenary session sponsored by the PPC and the Ambulatory Pediatric Association on Sunday, April 29, 2001, at 2:00 p.m. will be an exciting two-hour panel presentation - Entrepreneurism and Conflicts of Interest in Academic Medicine. This session will examine entrepreneurism, intellectual property and conflicts of interest in academia, particularly with relevance to pediatric education, research and the availability of appropriate tests and therapeutics. Presenters, all of whom have been confirmed, include: Greg Koski, Ph.D., MD, Director, Office for Human Research Protections, U.S. Department of Health and Human Services, Office of Public Health and Science; Marcia Angell, MD, Emeritus Editor New England Journal of Medicine, Robert P. Kelch, MD, Dean, College of Medicine, University of Iowa Hospital and Clinic, and Stephen Spielberg, MD a pediatric pharmacologist, Johnson & Johnson. Ora Pescovitz, MD, SPR President will moderate this session.

The Public Policy Forum’s 15^th annual legislative breakfast, Vaccine Funding - Conflicts between Markets and Regulation, will feature, AAP vice president Louis Cooper, MD who will discuss a variety of current and controversial immunization issues. This breakfast session is tentatively scheduled for Monday, April, 30, 2001 at 7:00 a.m.

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The beginning of the first session of the 107th Congress provides an excellent opportunity to contact your members of Congress. The following provides you the necessary information to make these contacts. Also consider using the district work periods (Congressional recess) to invite your member of congress (and/or their staff) to your facility, office or community-based pediatric program. The congressional recess schedule is listed below.

Be courteous, to the point, and include key information, using examples, if possible, to support your position. Address only one issue in each letter and, if possible, keep the length to one page.

You can contact your Senators and Representative's office by calling the Capitol Hill Switchboard at (202) 224-3121. If you do not know who your Representative is, the switch board operator will be able to direct you to the proper office. Ask to speak to the staff member who works on health care issues. Be prepared to leave a very short message as well as your name and address.

Fax: Most offices have fax machines, so you can call and ask for the fax number if you would like to fax your letter. Some offices do not give out their fax numbers, however.

Email: All of members of Congress now have e-mail addresses, but there is no set format for them. We suggest calling the member's office to get an accurate e-mail address or visit the AAP Members Only web site. This may not be the quickest or most effective mechanism to contact members offices because of the incredible volume of e-mails Congressional offices receive and each office's response to e-mails varies greatly. However, there are some members of Congress and a great number of congressional staff who appear to prefer e-mails and once you have an established a relationship with the office and staff this may prove to be an expeditious and efficient means of communication.

Phone: 202-456-1414 (Voice)

The Honorable George W. Bush
The White House
1600 Pennsylvania Avenue
Washington, DC 20500
Fax: 202-456-2461
e-mail: president@whitehouse.gov 

April 9 – 20 Congress not in session
May 28 – June 1 Congress not in session
July 2- 6 Congress not in session
Aug. 6 – Sept. 5 Congress not in session
Oct. 5 Target adjournment

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Additional information and resource material on these and other pediatric and child health issues are available from:

601 13^th Street, NW
Suite 400 North
Washington, D.C. 20005
ph: 800/336-5475
fax: 202/393-6137

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Myron Genel, MD, Chairman
Karen M. Hendricks, JD, Washington Coordinator
Molly A. Hicks, MPA, Legislative Assistant

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