PUBLIC
POLICY COUNCIL LEGISLATIVE REPORT OVERVIEW At the time of this writing, Congress is scheduled to recess in early to mid-November. A range of important issues remain on the agenda for these final weeks of the first session of the 106th Congress, including managed care reform, gun control and completing all 13 FY 2000 spending bills. Issues that necessitate specific action are indicated below. Information on how to contact members of Congress and the White House is provided at the end of this legislative report. Members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to continue to make your voices heard in Congress. This report contains the following information:
****************** FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997 (FDAMA): On October 21, 1999, the Senate Health, Education, Labor and Pensions Committee conducted an oversight hearing of the "Implementation of the Food and Drug Administration Modernization Act of 1997," Public Policy Council Chair, Myron Genel, MD, FAAP, presented testimony on behalf of the American Academy of Pediatrics and the Public Policy Council (PPC). Dr. Genel highlighted the progress that the Food and Drug Administration (FDA) has made in implementing FDAMA’s five-year demonstration program (section 111, PL 105-115) that provides incentives to encourage pharmaceutical companies to produce sufficient data to lead to improvements in pediatric drug labeling. In addition, Dr. Genel described several challenges that lie ahead for the FDA, as the agency continues to improve information for pediatric health care providers:
Dr. Genel also encouraged "communication and collaboration" between the FDA and the research and academic community to assist FDA in the continued implementation of these efforts to improve medical care for infants, children and adolescents. National Institutes of Health [Funding]: In the remaining weeks of the appropriations process, the PPC continues to work with the medical research community, including the Ad Hoc Group for Medical Research Funding and Research!America, to support and advocate for a National Institutes of Health [NIH] appropriations of a 15% increase as the second step toward doubling the NIH by FY 2003. However, the PPC maintains it is important that this increase does not come at the expense of other vital public health services and programs. The Senate-passed version of the FY 2000 Labor/HHS/Education appropriations bill, S. 1650, included an increase of $2 billion [12.8%] for NIH -- $17.6 billion -- over FY 1999. The House Appropriations Committee version of the bill included an 8.3% increase over FY 1999 -- $16.9 billion -- for the NIH. The conference agreement passed by the House on October 28, awaiting passage by the Senate the week of November 1, and then a certain veto by the president, includes $17.913 billion for the NIH, an increase of $2.3 billion (14.7 percent) over FY 1999. [It also includes funding for NICHD of $862 million.] The across-the-board cut would reduce the NIH appropriation by $174 million to $17.739 billion, which represents a 13.6 percent increase. The conference agreement also delays the obligations of $7.5 billion of the NIH budget until September 29, 2000. The Senate had proposed delaying $3 billion; the House Committee bill had no such provision. The conference agreement also provides $75 million for extramural research facilities construction, an increase of $45 million over FY 1999. The House Committee had proposed $30 million. The Senate bill provided $60 million; however, $30 million would not have been available for obligation until FY 2001. The conference agreement also raises the NIH salary cap from the current Executive Level III ($125,900) to Executive Level II ($136,700). Pediatric Research Initiative/Appropriations: Now in its fourth year, the Pediatric Research Initiative (PRI) provides money to fund new NIH extramural research devoted to the illnesses and conditions of children. Currently, the money is located in the Office of the NIH Director. In FY 1999, report language instructed NIH to fund the PRI at a level greater than FY 1998 ($38.5 million). Working with the March of Dimes, the Juvenile Diabetes Foundation and NACH, the Public Policy Council continues to advocate for adequate appropriations for the PRI in FY 2000, including $50 million for the Initiative, $20 million for pediatric research loan repayments, and $10 million in additional funds for pediatric research training grants. The later two programs, both new in FY 2000 and to be housed in the National Institute for Child Health and Human Development (NICHD), are valuable to train the future pediatric researchers needed to realize the investment in pediatric research. The Senate Appropriations Committee report for the L/HHS bill included language from the Committee "to encourage the NIH to strengthen its portfolio of basic, behavioral, and clinical research for children overall so that children can participate fully in this period of growth in funding and scientific opportunity in biomedical research." The Committee also "requests that the NIH Director provide by May 2000, an update from FY 1997 to the present on the amount of funding devoted to pediatric research, including extramural research." The PPC and the National Association of Children’s Hospitals [NACH] worked with congressional staff to include this important language in the appropriations committee report. On October 7, during a colloquy on the Senate floor between Senators Mike Dewine (R-OH) and Arlen Specter (R-PA), the two Senators clarified that the Senate appropriations committee encourages the Director of the NIH to "expand extramural research directly related to the illnesses and conditions affecting children" in FY 2000. In addition, the committee encourages the NICHD to provide "additional support for institutional and individual research training grants for medical schools’ departments of pediatrics." While no specific funding level was named, this dialogue highlights the Senate appropriations committee’s continued support for the Pediatric Research Initiative. Pediatric Research Initiative/Authorization: Staff is currently working with the National Association of Children’s Hospitals and with congressional staff to seek authorizing language for the PRI. In July, Representative Jim Greenwood (R-PA) joined Senators Kit Bond (R-MO) and Mike DeWine (R-OH) by introducing the House companion bill to S.592/S.1091. H.R. 2621, the Pediatric Research Act of 1999, provides similar authorizing legislative language to S. 1091 for the PRI and the NICHD pediatric research training grants. This bill currently has four cosponsors and is awaiting action in the House Commerce Committee. It is unclear at this time how these legislative proposals will proceed during this session of Congress. In October during the annual meeting of the American Academy of Pediatrics, Harold Varmus, MD, NIH Director, in his plenary session address, stressed the importance of attracting and training more pediatricians to conduct more research including supporting new investigators and mentor training programs. Research data availability under the Freedom of Information Act – OMB Circular A-110: Included in Public Law 105-227, the Omnibus Appropriations bill from the 105th Congress, was a provision written by Senator Richard Shelby (R-AL) to instruct the Office of Management and Budget [OMB] to amend Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and other Non-Profit Organizations) "to ensure that all data produced under a [research] award will be made available to the public through the Freedom of Information Act" [FOIA]. Several legislative initiatives have been proposed to postpone or repeal the Shelby provision. In January, the late Representative George Brown (D-CA) introduced H.R. 88, a bill to repeal the legislative provision. This legislation currently has 54 cosponsors. In July, the House Appropriations Committee, by a vote of 25 to 33, rejected an amendment to the House Treasury-Postal Appropriations bill offered by Representatives James Walsh (R-NY) and David Price (D-NC) to delay by one year the OMB provision. On July 26, Senator Patrick Moynihan (D-NY) introduced S. 1437, the Thomas Jefferson Researcher’s Privilege Act of 1999, that also contains language that would repeal the Shelby provision. It is unclear at this time if the Brown or Moynihan bills will move independently or as part of another legislative proposal. In August, OMB issued a "request for comments on clarifying changes to the proposed revision" on public access to research data, with comments due on September 10. The pediatric academic societies and the Academy submitted comments recommending the following: the affected regulations should be limited to those with the greatest impact on society; the definition of releasable data should include protections for patients, researchers, and industries collaborating in research; and the researcher and research institution should have control over what data is released. After substantial effort by OMB to limit the scope of the "Shelby provision", the final revision to OMB Circular A-110 was released on October 8 (64 FR 54926). Slightly altered from the August 11 policy, the final revision limits FOIA requests to data cited by a federal agency in an "action that has the force and effect of law". In addition, OMB defended their decision to allow researchers and research institutions to determine what data could be released under a FOIA request. Unfortunately, OMB declined at this time to limit affected regulations to so-called "major rules" or those with greater than $100 million effect on society. This revision takes effect 30 days after publication. The challenge now falls to the individual agencies, such as the National Institutes of Health, to develop their policies to accommodate this revision. This process should be completed within a year. Despite the narrow interpretation of the original Shelby language, the PPC remains concerned that the OMB’s revision will not stand a test in court. For that reason, staff continues to press for a repeal of this troublesome provision.
Stem cell research: In September, the National Bioethics Advisory Commission (NBAC) issued its report on human embryonic stem cells and research, "The Ethical Use of Human Stem Cells in Research." The report, currently under review by President Clinton, recommends that, with adequate consent procedures and federal oversight, stem cells for use in research may be taken from discarded embryos from IVF clinics or from elective abortions. The Commission advises that embryos should not be created solely for research purposes, thereby discouraging the use of somatic cell nuclear transfer to create stem cell lines at this time. Finally, the report advocates that the federal fetal tissue ban be partially rescinded so that research with embryonic stem cells may be conducted and supported. The executive summary of the final report can be found on the Commission’s web site at bioethics.gov/nbac.html. Several patient-groups, such as the Juvenile Diabetes Foundation, the Aging Alliance and others are actively encouraging the pursuit of this promising research. However, this remains an up-hill battle. Senator Arlen Specter (R-PA) initially included language in S. 1650, the Senate version of the Labor, Health and Human Services, Education appropriations bill, to allow federal funds to be used for the derivation of human stem cells for further research into this potential field. However, to avoid further controversy on the Senate floor, Senator Specter removed this language at the committee level. As of this time, no riders have been included on either the House or Senate versions of the appropriations bill to ban human stem cell research. Given the current fluidity of the appropriations process, the fate of stem cell research remains unclear. Staff will continue to closely monitor this issue. [Note: Background information is available on the NIH web-site at www.nih.gov.] Medical Records Privacy: The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was signed into law three years ago. This legislation required the Department of Health and Human Services to issue numerous regulations on administrative simplification of health care transactions. Additionally, the law mandated that the Congress enact legislation dealing with the privacy of the medical record within three years, otherwise the Secretary of HHS would have the authority to issue regulations addressing that issue. Congress missed their deadline – August 21, 1999 -- to enact privacy protections. While it is unclear if this issue will be resolved in this session of Congress, on October 29, President Clinton and HHS Secretary Donna Shalala issued new guidelines on medical records privacy. According to the White House these guidelines will "cover health information that is transmitted or maintained electronically, would limit the use and release of private health information without a patient's consent; restrict the disclosure of protected health information to the minimum amount of information necessary; and establish new requirements for disclosure of information to researchers and others seeking access to health records." A copy of the guidelines will be available in the Federal Register on or about by November 3, 1999. These can be accessed at: www.access.gpo.gov/su_docs/fedreg/frcont99.html Agency for Health Care Policy and Research/Reauthorization: On September 28, the House voted 417 to 7 in favor of legislation to reauthorize and to rename the Agency for Health Care Policy and Research. The bill, H.R. 2506, was introduced by House Commerce Health and Environment Subcommittee Chair Michael Bilirakis (R-FL). H.R. 2506 would change the Agency’s name to the "Agency for Health Research and Quality" and authorize $250 million for the agency in FY 2000 and "such sums as necessary" in fiscal years 2001 to 2004. The legislation would redefine the Agency’s mission to "emphasize its role as a partner to the private sector with responsibility for promoting health care quality through research, analyzing and disseminating scientific evidence, and advancing private and public efforts to improve health care quality." [Please note: during the House floor debate on the AHCPR reauthorization legislation, Rep. Nancy Johnson (R-CT) offered and had accepted an amendment to include her pediatric GME legislation to the bill.] The Senate legislation, S. 580, introduced by Senator Bill Frist (R-TN), is similar to the House bill. S. 580 renames the agency the "Agency for Healthcare Research and Quality" and authorizes the agency through 2006. This legislative language was included as part of the Senate Patients’ Bill of Rights, S. 1344, passed by the Senate on July 15.
Agency for Health Care Policy and Research/Appropriations: Congressional support for the funding of health services research and the AHCPR remains strong. The Senate Labor, Health and Human Services and Education bill funded the Agency at $211 million, $38 million above current funding levels. The Senate appropriations committee also included report language "supportive of the Agency’s efforts to establish a children’s health services research agenda." The House Appropriations Committee funded the Agency at $175 million for FY 2000. The conference agreement passed by the House on October 28 includes $195 million in FY 2000 for AHCPR. The PPC will continue, as part of the Friends of AHCPR and independently, to advocate for continued investment in health services research. Clinical Research: In May, Representative Jim Greenwood (R-PA) reintroduced the Clinical Research Enhancement Act of 1999, H.R. 1798. The bill now has 36 cosponsors. During Representative Greenwood’s remarks on the floor of the House, he identified the members of the Public Policy Council as supporters of his legislation. This bill is designed to help reverse the pattern of "the clinical investigator as an endangered species" by authorizing funds to improve the peer review process for clinical research grants, to establish general clinical research centers, to make new training awards focused on clinical investigators, and to expand the existing intramural loan repayment program. Senator Ted Kennedy (D-MA) has indicated his interest in introducing a similar Senate version shortly. The Senate proposal will also include a provision establishing a training program for medical student who are interested in pursuing careers in clinical or translational research. The PPC and the Academy have also endorsed these efforts on the Senate side. Staff will continue to work to correct the disincentives that guide physicians away from much-needed clinical research careers.
Animal Research/Legislation: For the third time, Representative Charles Canady (R-FL) has re-introduced the Pet Safety and Protection Act of 1999, H.R. 453. The bill currently has 64 cosponsors. Executive comment was requested from the United States Department of Agriculture on this issue by the House Agriculture Subcommittee on Horticulture and Livestock, with the legislation in currently awaiting further action. This legislation is based on the erroneous notion that research institutions obtain stolen pets for use in research activities. The bill would have an adverse impact on the ability of medical schools to obtain random-source animals for research and teaching.
Animal Research/Appropriations: In February, the PPC joined with the National Association for Biomedical Research [NABR], American Veterinary Medical Association, the AAMC and others to request a $3.825 million increase to $13 million for FY 2000 funding for the USDA’s Animal Care unit of the Animal and Plant Health Inspection Service (APHIS). This essential program is dedicated to requiring minimum standards of humane care and treatment for animals bred for commercial sale, used in research, transported commercially, or exhibited to the public. Funding for the Animal Care unit has fallen below the levels appropriated at the beginning of the decade. The Senate Appropriations Committee approved a $2 million increase in FY 2000 funding for Animal Welfare Act enforcement – one million more than is proposed in the House-passed agriculture funding measure and $1.5 million over the President’s budget. The Senate report accompanying the agriculture appropriations bill to the Senate floor calls for the additional funds to be used to increase the number of field inspectors and to conduct follow-up inspections for non-compliance. Unfortunately, the $2 million increase was not maintained in conference between the House and Senate. The conference report, H. Rept. 106-354, was passed by both the House and Senate and was signed by the President on October 22. Graduate Medical Education/Medicare Reform: Medicare and Social Security remain central issues within the budget debates between Congress and the White House this year and will probably be an election year issue in 2000 as well. Similarly, Medicare’s solvency and payments have come under close scrutiny in the past year as several commissions and the White House have issued proposals for Medicare reform, including coverage of prescription drugs for seniors. Graduate medical education payments to teaching hospitals have been a part of that larger debate and, as a result, GME still continues to be a hotly contested issue. Medicare Payment Advisory Commission: The September MedPAC meeting briefly addressed payments to teaching hospitals. The principle message was that it might be difficult for MedPAC staff to complete their analyses on the new Enhanced Patient Care (EPC) adjustment in time for the March 2000 report. Several commissioners raised questions about the rationale behind removing the education label from the adjustment, suggesting that the Commissioners may not all be as united as they were before. In addition, Commission Chair Gail Wilensky also voiced that "there's no such thing as a lock box" on the EPC. Although she has announced that the creation of the EPC is not to create budgetary savings, she said the new adjustment is not protected from decreases in the future. During the October MedPAC meeting, Commissioners were unable to agree on appropriate proxy measures, although resident to bed ratio was identified as the "default" measurement. Some wanted greater emphasis on quality of care, others highlighted appropriateness of care, still others raised the issue of complexity of case mix. Commission staff strongly stressed that they would be unable to examine all proxy measures in time for the March 2000 report to Congress. MedPAC Commissioner Jack Rowe raised perhaps the most valuable issue of the discussion – if MedPAC divorces these payments from the teaching missions of institutions by choosing a proxy measure unrelated to teaching, non-teaching hospitals will be able to claim that they provide "enhanced patient care" and lobby for these additional payments. It is important to note that this was a principle concern raised by AAMC President Jordan Cohen's response to the Commission's August 5 report. During the November MedPAC meeting, Commission staff will present: (1) the new cost function – the product of folding in DME and reestimating IME; and (2) the new case mix index values. [For background and additional information on MedPAC visit the Commission’s web site at www.pprc.gov.] Graduate Medical Education/Children’s Hospitals: As you know, freestanding children’s hospitals, those that do not share a Medicare provider number with an adult health care institution, do not qualify for the substantial GME support afforded to teaching institutions through the Medicare program. The Clinton Administration offered a proposal in its FY 2000 budget submission to Congress to address the problem of underfunded graduate medical education programs in freestanding children’s hospitals. The President’s FY 2000 budget proposal included a $40 million temporary fix to provide GME payments to children’s hospitals as part of the Health Resources and Services Administration [HRSA], Department of Health and Human Services. This proposal requires authorizing legislation, which has been developed with consultation of the National Association of Children’s Hospitals as well as some members of the pediatric community. The draft legislative proposal was delivered to Speaker of the House Dennis Hastert in May. To date, no legislative action has been taken on this specific proposal. Under the President’s proposal, if approved by Congress, education payments to independent children’s hospitals would be funded with discretionary dollars [as opposed to the Medicare trust fund]. This would mean that every year in the annual appropriations process new funding would need to be pursued in contrast to the "automatic" GME funding through the Medicare trust fund for other teaching hospitals under the current system. Moreover, as currently drafted it appears that this proposal could come at the expense of other valuable HRSA health professions training programs, such as Title VII. However, it should be noted that this issue – pediatric GME – is finally gaining recognition and momentum in Congress and at the White House. The Public Policy Council continues to closely monitor this issue. HRSA has issued a contract with RAND Health to survey nine children’s hospitals throughout the nation. HRSA has asked RAND to:
The pediatric community has provided HRSA invaluable assistance and guidance throughout this process. The nine participating hospitals are: Texas Children’s Hospital – Houston; Children’s Hospital of Philadelphia; Children’s Hospital – Boston; Children's National Medical Center in Washington, DC; St. Louis Children's Hospital; Children's Hospital – Los Angeles; Children's Hospital Denver; Children's Hospital & Regional Medical Center in Seattle; and Children’s Hospital in Columbus. Congress: On September 28, the House passed PPC-supported pediatric GME relief as an amendment to a larger bill. The legislation, H.R. 1579, was introduced by Representative Nancy Johnson (R-CT) and would authorize a two-year fund for pediatric GME with $280 million in FY 2000 and $285 million in FY 2001. H.R. 1579 was attached to H.R. 2506, the Health Research and Quality Act of 1999, bipartisan legislation to reauthorize the Agency for Health Care Policy and Research. A similar Senate version of H.R. 1579 legislation has not yet passed the Senate although it is possible that it may be included in the conference report of the AHCPR reauthorization bill. Introduced in February by Senators Bob Kerrey (D-NE) and Kit Bond (R-MO), S. 391 the Children’s Hospitals Education and Research Act of 1999 currently has 41 cosponsors. The bill would provide general revenues for graduate medical education for time-limited support for independent children’s teaching hospitals. The bill establishes a four-year fund "which will provide children’s hospitals with Federal teaching payments that are based on the per resident costs and the complexity of their patient population." The FY 2000 conference agreement on the L/HHS/Education appropriations bill includes $20 million in funding for the pediatric GME if the legislation is authorized. AMSPDC and NACH have been working together to pursue passage of and funding for this important pediatric GME legislation in this session of Congress. Other members of the Public Policy Council and the Academy have been closely involved in these activities as well.
Other GME Legislation: Both the Senate Finance and the House Ways and Means Committees marked up and passed legislative proposals to provide corrections to the Balanced Budget Act of 1997. The packages do include freezes of the on-going reductions in the Indirect Medical Education [IME] adjustment and Disproportionate Share Hospital [DSH] payments and limit losses under the outpatient prospective payment system [PPS]. The Senate Finance Committee’s proposal would freeze the IME cuts at 6.5% in FY 2000 through FY 2004, and a one year DSH freeze in FY 2001 at FY 2000 levels. Alternatively, the House Ways and Means Committee’s mark would freeze IME payments at 6.0% for FY 2001 and a one year DSH freeze in FY 2001 at FY 2000 levels. According to the AAMC, "the provisions would respectively provide approximately $1.85 billion over 10 years and $550 million over 5 years to teaching hospitals." In addition, both bills include GME provisions that would allow hospital to change their resident caps in order to encourage rural training programs. Both bills are awaiting floor action before the end of this session of Congress. In addition, President Clinton announced on October 19 that he would direct the Health Care Financing Administration (HCFA) to address BBA relief as well. In a letter to Senate Finance Committee Chairman William Roth (R-DE), President Clinton provided 25 administrative items the White House has or will take to ease "the financial burden placed on Medicare providers since enactment of the BBA of 1997." These include: a cap on hospital transfer policy at 10 DRGs for 2 years; a freeze on the recoupment of DSH payments; delay of implementation of the outpatient volume control mechanism for 2 years; a transition to the outpatient PPS with a delay for cancer hospitals until additional data are collected; and refinement of the ambulatory payment classification system. Title VII – Health Professions Training Grants/Appropriations: Working with the Health Professions and Nursing Education Coalition, the Public Policy Council recommended $316 million in FY 2000, for Titles VII and VIII, a modest 4 percent increase above current level funding [$304 million]. The conference agreement passed by the House and pending before the Senate, at the time of this writing, includes $324.2 million for Titles VII and VIII; this includes $20 million for children’s hospitals’ GME if the legislation is authorized. Also included is $79.9 million [the same as last year] for consolidated training in primary care that supports funding for general pediatrics and internal medicine. Created by the reauthorization of the Title VII and VII program last year, the Advisory Committee on Training in Primary Care Medicine and Dentistry, was formed to provide advice and recommendations to the Department of Health and Human Services on policy development in these areas of training, will meet for the first time in November. Among the 23 members are three pediatricians: Billie Wright Adams, M.D., clinical associate professor, University of Illinois, Chicago College of Medicine; Past president of the APA, Thomas G. DeWitt, M.D., professor and associate chair for Primary Care programs, University of Cincinnati School of Medicine; and past president of the Ambulatory Pediatric Association, Thomas G. DeWitt, M.D., professor and associate chair for Primary Care programs, University of Cincinnati School of Medicine; Senior Vice President, American Board of Pediatrics, Walter W. Tunnessen, Jr., M.D., clinical professor of Pediatrics, University of North Carolina School of Medicine. National Health Service Corps: Two years ago, the National Health Service Corps sent notification to health professions schools and students of its intention to begin withholding federal taxes on the entire amount of scholarships awards to NHSC scholarship recipients. The scholarship consists of funds for tuition, fees, and other reasonable educational expenses and a monthly stipend for living expenses. The President’s FY 2000 budget included a provision to "amend current law to provide that any amounts received by an individual under the National Health Service Corps (NHSC) … are ‘qualified scholarships’ excludable from income, without regard to the recipient’s future service obligation." Several legislative corrections have been introduced. Senator Jim Jeffords (R-VT) introduced S. 288, to amend the IRS code to exempt NHSC scholarship payments from income for tax purposes. This legislation currently has ten cosponsors. Representative Nancy Johnson (R-CT), who took the lead on this issue on the 105th Congress, introduced H.R. 1414, the Health Care Access Promotion Act of 1999, to exempt NHSC payments from taxes. H.R. 1414 currently has 31 cosponsors. The $792 billion tax bill, H.R. 2488, included a provision that exempts payments for tuition and education-related expenses from gross income for tax purposes under the NHSC Scholarship Program. However, on September 23, President Clinton vetoed the tax package. The Public Policy Council will continue to work with other groups to eliminate this impediment to NHSC scholarship recipients.
Health Professionals for Diversity Coalition: The Health Professionals for Diversity Coalition continues its efforts to maintain and promote affirmative action in health professional education. This coalition is coordinated by the AAMC and is comprised of 51 medical, health and education organizations including the AMA, ACP-ASIM, AAFP, NMA, the Academy. The coalition is continuing to monitor activities at the state level to dismantle affirmative action programs such as the state of Washington’s anti-affirmative initiative that was approved by the voters last year and the recent challenges to the University of Michigan’s undergraduate and law school admissions policies. Additional information can be found on the coalition at: www.aamc.org/about/progemph/diverse. Representative Jesse Jackson, Jr. (D-IL) introduced H.R. 2391, the National Center for Research on Domestic Health Disparities Act on June 30 with 70 cosponsors. The bill would establish a national center for research on domestic health disparities at the National Institutes of Health. The Center would also be crucial to promoting research endowment programs through the centers of excellence and the legislation will establish an Advisory Council to the Center Director. H.R. 2391 is currently awaiting action by the House Commerce Committee. Appropriations: The Senate Appropriations Committee included $35 million for new demonstration projects through the Centers for Disease Control and Prevention to address racial health disparities in its version of the FY 2000 Labor, Health and Human Services, and Education Appropriations bill. In its report (S. Rept. 106-166), the committee directs these funds to address health disparities in infant mortality, cancer, heart disease, diabetes, HIV infections, and child and adult immunizations. [Note: these were the issues that the White House had identified in FY 1999.] The House Appropriations Committee did not fund the health disparities demonstration projects nearly as high, providing $10 million for FY 2000. Specifically, the House committee stated its concerns in its report (H. Rept. 106-370) that there are "no specific GPRA goals and measurement data accompanying these demonstrations". The conference agreement, passed by the House on October 28 and awaiting action in the Senate the week of November 1, included $30 million for these demonstrations. [Please note: this figure is the funding level prior to the .97% across-the-board spending cut.] The Senate passed S. 1650, the FY 2000 Labor, HHS, Education bill, by a vote of 73 to 25 on October 7. The House Appropriations Committee approved H.R. 3037, its version of the FY 2000 Labor, HHS, Education appropriations bill on September 30, by a party-line vote. The House was unable to get it to the floor as a freestanding bill. However, by a vote of 218 – 211, a conference agreement on the FY 2000 L/HHS/Education spending bill was passed as part of the DC Appropriations bill. The FY 2000 L/HHS/Education conference agreement includes the following spending recommendations: Community Health Centers: $1.02 billion; National Health Services Corp: $116.9 million; MCH Block Grant: $710 million [it does not appear to consolidate the Healthy Start program, funded at $90 million, but does appear to include traumatic brain injury; Universal Newborn Hearing: $3.5 million; Poison Control: $3 million; Emergency Medical Services for Children: $17 million; Ryan White AIDS programs [total]: $1.55 billion; Pediatric Demonstration - $51 million; Family Planning – Title X: $214.9 million; STDs: $129 million; Preventive Health Services Block Grant: $135 million; SAMHSA [total]: $2.5 billion and for Children’s Mental Health - $83 million; Child Care Development Block Grant: $1.18 billion and $1.7 billion for the Social Services Block Grant. The L/HHS/Education conference agreement includes delayed obligations – funding not available until September 29, 2000 -- for several agencies. These include: $7.5 billion in the NIH; $1.12 billion in HRSA; $925 million in CDC; $400 million for Children and Families Services; $425 million for SSBG and $450 million for SAMHSA. In addition, an across-the-board spending cut of 0.97% in all discretionary spending, including those appropriations bills that have already been signed into law has been included by the congressional leadership to ensure that none of the Social Security surplus is touched in FY 2000. At the time of this writing, the president is expected to veto this bill. Currently, eight of thirteen appropriations bill have been passed by the Congress and signed into law by the President. In addition, the President has vetoed three spending bills and has threatened to veto the Labor/HHS/Education if it comes to him in the current form. While the new fiscal year began on October 1, Congress delayed their fiscal deadline by passing three continuing resolutions [temporary spending bills] extending current spending levels through November 5. At the time of this writing, the President’s chief budget negotiators are continuing to meet with the House and Senate members to bring an end to the budgetary stalemate, including the Labor/HHS/Education appropriations bill. The pediatric community continues to work with a number of coalitions to increase funding for biomedical and health services research (including pediatric research), MCH Block Grant, health professions training, childhood immunizations, EMSC, family planning to name just a few important programs for children and adolescents. In addition, the pediatric academic societies, the National Association of Children’s Hospitals, the Society for Adolescent Medicine and the Academy submitted a letter on October 15 to the House and Senate leadership and appropriators, recommending specific funding levels for several valuable child and adolescent health programs and services. "The Children’s Health Insurance Accountability Act of 1998," S.636 was introduced by Senator Jack Reed (D-RI) on March 16. It currently has seven cosponsors. This legislation establishes a set of managed care standards that are specific and unique to children, including:
This legislation is designed to serve as the children’s piece to any other larger managed care legislation moving through Congress. House Action on Managed Care: On October 7, the House passed managed care legislation introduced by Reps. Charlie Norwood (R-GA) and John Dingell (D-MI), H.R. 2723, "The Bipartisan Consensus Managed Care Improvement Act." Despite the House leadership’s efforts to pass an alternate bill, which failed by a vote of 193 to 238, 68 Republicans broke ranks. The Norwood-Dingell bill passed 275 to 151. President Clinton has indicated his support of this legislation. This legislation contains several of the pediatric-specific provisions that the pediatric community supports. For example, the bill includes access to pediatric specialists, and provides for choice of a pediatrician as the primary care provider. Specifically, the bill states, "If a group health plan, or a health insurance issuer in connection with the provision of health insurance coverage, requires or provides for an enrollee to designate a participating primary care provider for a child of such enrollee, the plan or issuer shall permit the enrollee to designate a physician who specializes in pediatrics as the child’s primary care provider." The Norwood-Dingell bill (or the "Dingwood bill" as some call it!) would allow patients to sue health plans for damages over delayed or denied benefits but would exempt the health plans from punitive damages if they follow the recommendations of external reviewers. The bill emphasizes its external appeals process, which would allow patients to appeal benefit denials to independent medical reviewers. The bill does not include the legal definition of "medical necessity" that Democrats included in their bill, opting instead to leave the final decisions on medical necessity to the physicians who conduct the external reviews. Senate Action on Managed Care: On July 15, 1999, the Senate approved, by a vote of 53-47, S. 1334, the Republican "Patients’ Bill of Rights Plus Act." President Clinton promised to veto the bill. The Republican bill rejected the Democrats effort to allow patients to sue health plans in state court if they are injured as a result of denied or delayed benefits. The Senate bill also does not let physicians decide what medical care in medically necessary. The bill limits most of its protections to the 48 million Americans who cannot be helped by state patient protection laws because they are self-insured health plans. President Clinton and the Democrats believe that any bill must cover all 161 million Americans with private health insurance. S. 1334 does not include a number of important pediatric provisions such as the ability to choose a pediatrician as a primary care provider and access to pediatric specialists. Given the stark differences between the House and Senate versions of managed care reform, it remains unclear how the pediatric-specific reforms will fare in conference. For up-to-date advocacy and "take action" information on managed care, visit the American Academy of Pediatrics’ Member’s Only web site at www.aap.org click Members Only and then Federal Affairs. CHILDREN’S HEALTH INSURANCE COVERAGE AND ACCESS TO CARE During the American Academy of Pediatrics’ 1999 Annual Meeting in October, Academy president Joel J. Alpert, MD announced a "bold" new proposal to insure all America’s children. The Academy’s Task Force on Health Insurance Coverage and Access to Care developed this proposal. The proposal reaffirms the Academy’s commitment that all of America’s children must have health insurance and recommends, while preserving the best of the private sector, "we pursue a new national children’s program that will replace Medicaid and SCHIP." A copy of the proposal can be found at the end of this document or on the Academy’s web site at www.aap.org. All members of the APS, SPR and AMSPDC are encouraged to review and comment on this far-reaching proposal at kidsdocs@aap.org. STATE CHILDREN’S HEALTH INSURANCE PROGRAM (SCHIP) The pediatric community continues to play a major role in the implementation phase of the State Children’s Health Insurance Program (SCHIP). While SCHIP is an important first step in meeting the health care needs for all children and adolescents, even if it is implemented perfectly, at least 3.2 million children will remain uninsured. The pediatric community remains committed to the goal of establishing a system where all children, regardless of their family income, employment status or state of residence, have quality health care coverage. National SCHIP Outreach Campaign: On February 23, 1999, President Clinton, along with the National Governor’s Association, unveiled a national SCHIP outreach campaign that features a toll-free hotline. The nationwide, toll-free number is (877) KIDS NOW. Other outreach initiatives include public service announcements and corporate distribution of information on the insurance program to their customers. In a survey released on July 30, 1999, by the Kaiser Commission on Medicaid, currently the number of children participating in the State Child Health Insurance Program is 1.3 million. Though much of the activity surrounding Title XXI has moved to the states, there is still legislation pending at the federal level concerning Title XXI: H.R. 827/S.1646 "Improved Maternal and Children’s Health Coverage Act of 1999:" Introduced by Rep. Diana DeGette (D-CO) with Rep. Connie Morella (R-MD), this legislation now has 113 cosponsors. The Senate version was introduced by Senators Blanche Lincoln (D-AR), Mary Landrieu (D-LA), Gordon Smith (R-OR) and Diane Feinstein (D-CA). It requires states to use a uniform application to determine eligibility for both Medicaid and their SCHIP program. It also requires states to participate in a toll-free number being established to improve coordinated outreach efforts. The bill assures coordination of pediatric providers within a family. It also provides expanded coverage options, such as giving states the option to provide coverage to pregnant women. S. 206, "CHIP Data and Evaluation Improvement Act of 1999": Introduced by Senator Patrick Moynihan (D-NY) and Senator John Chafee (R-RI), this legislation provides for improved data collection and evaluations of State Children’s Health Insurance Programs. While it is unclear if this bill will move independently, S. 206 was included in the Senate Finance Committee’s corrections to the Balanced Budget Act of 1997 (BBA), marked up and awaiting further action. The fate of the omnibus bill – the Balanced Budget Adjustment Act of 1999 – remains uncertain, but it does have strong support from the Medicare provider community. While a BBA correction bill has also passed the House Ways and Means Committee, this Committee does not have jurisdiction over the SCHIP program and a House version of S. 206 has not been attached thus far. Congressional Hearings: Congress has held three hearings on childhood immunizations and currently plans to hold several more throughout the coming year. The Criminal Justice, Drug Policy and Human Resources Subcommittee of the House Government Reform Committee, chaired by Rep. John Mica (R-FL) convened the first hearing, held in May. The focus of this hearing was on the Hepatitis B vaccine. Sam Katz, MD, testified at the hearing representing the Infectious Disease Society of America (IDSA) and the Academy. In August, the House Government Reform Committee Chairman Dan Burton (R-IN) held a full committee hearing entitled "Vaccines: Finding the Balance between Public Health and Personal Choice." Dr. Katz once again provided testimony before the Committee on behalf of the Academy and the IDSA. He stressed three key points in his testimony. First, vaccines are highly effective and safe, but the diseases they prevent are still spreading through many other parts of the world. Second, the system of research and development of clinical testing, of licensing, of recommendation and monitoring of vaccine use is in place and working well. Finally, there is a need to continue the education of parents and clinicians about diseases they no longer see because these diseases have been prevented so effectively by our immunization policies, but they are only a jet plane ride away. In addition to Dr. Katz, the lead witness was U.S. Surgeon General David Satcher, MD, Ph.D. A copy of Dr. Katz’s testimony may be found at www.aap.org. In September, the Criminal Justice, Drug Policy and Human Resources House Subcommittee, chaired by Rep. John Mica (R-FL), held a hearing entitled "Compensating Vaccine Injuries: Are Reforms Needed?" The focus of the hearing was on the Vaccine Injury Compensation Program. The goal of the hearing was to address the following questions.
Testimony from the Sept. 28, 1999, House Government Reform Subcommittee hearing on the vaccine injury compensation program is available on the web at: www.house.gov/reform/cj/hearings/9.28.99. The congressional staff of the House Government Reform Committee has advised the staff that Chairman Burton is planning a series of immunization hearings in 2000 at the full committee. The topics include:
Section 317: As part of its ongoing appropriations activities, the pediatric academic societies have joined with the Academy in pursuing additional funding for the Section 317 [Public Health Service Act] immunization program for the coming fiscal year. Current funding is $449.5 million. At the time of this writing, the FY 2000 L/HHS/Education conference agreement includes $461 million for the section 317 program. The PPC is working with the Academy to bring together several organizations such as the American Public Health Association, the American Medical Association, American Academy of Family Medicine, the National Association of WIC Director and the Association of State and Territorial Health Officials and others to galvanize additional congressional support for this important program. Vaccine Excise Tax : Senator Jim Bunning (R-KY) and Representative Phil English (R-PA) have reintroduced legislation, Vaccinate America’s Children Now Act [S.85/H.R.587], to amend the Internal Revenue Service Code of 1986 to reduce the tax on vaccines to 25 cents per dose. Similar legislation was introduced in the 105th Congress. At this time, S. 85 now has 6 cosponsors, including Senators John Chafee (R-RI), John Breaux (D-LA), Connie Mack (R-FL), Kent Conrad (D-ND), Tom Harkin (D-IA) and Thad Cochran (R-MS) and H.R. 587 has no cosponsors. There has been no action on these two bills to date. However, the tax bill passed by Congress in August and vetoed by the President in September did include a provision to lower the excise tax to 50 cents per dose by December 31, 2004. On October 20, the Senate Finance Committee approved by voice vote its tax extenders bill that includes adding streptococcus pneumoniae to the list of taxable vaccines. There is also language directing the GAO to report to the Ways and Means and Finance Committee on the operation and management of expenditures from the vaccine injury compensation trust fund and to advise the committees on the adequacy of the trust fund - by January 31, 2000. At the time of this writing the Senate has passed the tax bill and is now awaiting the House to act. SCHIP and Vaccines: In September Rep. Nancy Pelosi [HR 2976 with 52 cosponsors] and Sen. Diane Feinstein [S.1656] introduce legislation to provide free vaccinations for low-income children. The measure, which would expand the Children's Health Insurance Program (CHIP), would help to ensure that all children in state CHIPs would receive vaccines. Currently, federally purchased vaccines are used to give children who are uninsured, on Medicaid, or of American Indian or Alaskan heritage free vaccinations under the Vaccines for Children program; but 28 states do not offer the free vaccines because they formed a new program instead of expanding their Medicaid offering via CHIP. According to the Department of Health and Human Services, however, the new, non-Medicaid programs are equal to private insurance, so children who are covered by them cannot receive the free immunizations. CLINICAL LABORATORY IMPROVEMENT ACT (CLIA) On February 3, 1999, Representative Bill Archer (R-TX) reintroduced the Clinical Laboratory Improvement Act Amendments of 1999, HR 528. Identical to earlier legislative attempts to eliminate the burden of CLIA, H.R. 528 seeks to exempt physicians’ office labs from the clinical lab requirements under CLIA but maintains oversight of pap smear testing (the initial impetus for CLIA’s enactment). H.R. 528 currently has 21 cosponsors and has been referred to the House Commerce Committee. The Public Policy Council will continue to seek meaningful CLIA relief in 1999.
The Public Policy Council in conjunction with the Ambulatory Pediatric Association is assembling a "state of the art" symposium entitled "Pediatrics in the New Millennium: Compelling Issues in Public Policy" which will be held Monday, May 15, 2000, from 10:15 to 11:45 a.m. This is the 7th year that this session will be held. Three broad topics have been selected: (1) Children's Access to Health Care –Removing the Financial Barrier; (2) Testing and Access of Children to Drugs and Devices; (3) The Pipeline for Pediatric Physician-Investigators and the Future of Academic Pediatrics. Our confirmed speakers are: Joel Alpert, MD, President American Academy of Pediatrics (1998 – 1999); Jane Henney, MD, Commissioner, Food and Drug Administration and Leon Rosenberg, MD, formerly dean of the Yale School of Medicine and president of the Bristol-Myers Squibb Pharmaceutical Research Institute. The Research and Child Health Advocacy educational seminar will be on Friday, May 12, 2000, from 1:00 to 3:00 p.m. This session is aimed at helping academicians to become more comfortable in approaching public officials as well as learning some techniques that enhance the odds of success for these encounters. The Washington, DC "scene" will be reviewed with an update on issues relevant to academic pediatrics. We will also emphasize advocacy efforts at the local and state levels. Speakers include: Steve Berman, MD, Vice President, American Academy of Pediatrics (invited) and Myron Genel, MD, Chair, Public Policy Council, James Pawelski, MS, Director, Division of State Government Affairs, American Academy of Pediatrics, and Karen M. Hendricks, JD, Washington Coordinator, Public Policy Council. The Public Policy Forum Legislative Breakfast, is scheduled for Sunday, May 14, 7 a.m. - 8 a.m. The session is entitled "Medical Science and the Brave New World of Electronic Publishing." Speakers are: Jerold F. Lucey, M.D., Editor-in-Chief, Pediatrics and Alvin Zipursky, M.D., Editor, Pediatric Research. James Perrin, M.D., Editor, Journal of the Ambulatory Pediatric Association will moderate this exciting legislative breakfast meeting. *************** HOW TO CONTACT YOUR MEMBER OF CONGRESS
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. Phone: 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. E-mail: Most members of Congress 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 web site at www.aap.org for this information. 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. HOW TO CONTACT THE PRESIDENT Phone: 202-456-1111 (You can enter by push-button your opinions on certain topics, or press ‘O’ to speak to an operator.) The Honorable William J. Clinton, The White House,
1600 Pennsylvania Avenue Additional information and resource materials on these or other issues related to child health are available from the Washington Coordinator for the Societies: Karen M. Hendricks, JD, (khendricks@aap.org) or Jennifer Stevens, Legislative Assistant (jstevens@aap.org) at 601 13th Street, NW, Suite 400 North, Washington, DC 20005; phone: 800/336-5475; fax: 202/393-6137. ****************** PUBLIC POLICY COUNCIL:
SUBMITTED BY: Myron Genel, MD, Chairman November 1999 The American Academy of Pediatrics’ Proposal to Insure American’s Children The American Academy of Pediatrics reaffirms its commitment that all of America’s children (through age 21) must have health insurance. The implementation of Title XXI (SCHIP) has been an important step toward reaching this goal. However, the Academy believes that now is the time to take an even bolder step forward to extend coverage to all children. The Academy recommends that while preserving the best of the private sector, we pursue a new national children’s program that will replace Medicaid and SCHIP. This proposal would create a health care system with uniform eligibility, benefits and administrative procedures. The key elements of this proposal would include:
Enactment of this proposal would increase societal spending on child health by about $44 billion in the year 2000. The major reason for this increase in spending is the need to have all private plans meet quality standards. PRINCIPLES:
Send your comments and suggestions on this proposal to kidsdocs@aap.org. |
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