PUBLIC POLICY COUNCIL LEGISLATIVE REPORT OVERVIEW The first session of the 106th Congress convened on January 6, 1999. Congress hopes to address a range of health care issues, including: FY 2000 appropriations, tax cuts, increased spending for education and defense, the Patients Bill of Rights, stem cell research, and confidentiality. Information on how to contact members of Congress and the President is provided at the end of this report. Issues that necessitate specific action are indicated below. Members of the American Pediatric Society, Society for Pediatric Research and the Association of Medical School Pediatric Department Chairs are urged to make their voices heard during this session of Congress. This report includes the following:
National Institutes of Health [Funding]: On January 19, 1999, Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) introduced S. Res. 19 to express the sense of the Senate that "federal investment in biomedical research should be increased by $2 billion in the fiscal year 2000." [Note: a "Sense of the Senate Resolution" is a non-binding statement of the Senate’s position on an issue.] At the time of writing, this resolution had gained twenty cosponsors. On March 2, 1999, Rep. George Gekas (R-PA) and five other members of Congress introduced H. Res. 89, the Biomedical Revitalization Resolution of 1999, a similar resolution in the Houses of Representatives with 52 cosponsors. On February 1, 1999, the President presented a very modest 2.1% increase in NIH funding as part of his FY 2000 budget proposal, bringing the total funding recommendation to $15.9 billion. In stark contrast to the FY 1999 increase of 15%, Donna Shalala, Secretary of the Department of Health and Human Services, stated that the President remains committed to increasing the NIH budget by 50% in 5 years. The FY 2000 budget conference report, approved on April 15, 1999, includes a sense of the senate resolution on increased funding for the NIH. The language includes an assumption that: (1) there shall be a continuation of the pattern of budgetary increases for biomedical research; and (2) additional resources should be targeted towards autism research. The Public Policy Council [PPC] will continue to work with the medical research community, including the Ad Hoc Group for Medical Research Funding and Research!America, to advocate for an National Institutes of Health [NIH] appropriations $18 billion in FY 2000. This 15% increase is the second step toward doubling the NIH by FY 2003. However, it is important this increase must not come at the expense of other vital public health services and programs. Pediatric Research Initiative: 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). Staff is currently working with the National Association of Children’s Hospitals and with congressional staff to seek authorizing language for the PRI. In addition, this year the pediatric research community will pursue adding funds to increase pediatric clinical research training and the number of pediatric researchers. On March 11, Senator Kit Bond (R-MO) included authorizing language for this initiative in his omnibus Healthy Kids 2000 Act (S.592) introduced without cosponsors. This legislation would retain the PRI in the Office of the NIH Director and authorize $100 million for FY 2000 and FY 2001. Senator Bond’s bill would also authorize $20 million, $25 million and $30 million in FY 2000, 2001 and 2002 respectively to be used through the National Institute of Child Health and Human Development to advance training and careers of pediatric researchers through various loan repayment opportunities. On May 20, Senator Mike Dewine (R-OH) introduced S. 1091 also to provide authorizing language for the PRI. Currently, Senators Ted Kennedy (D-MA) and Kit Bond (R-MO) have cosponsored this legislation. It is unclear at this time how these legislative proposals will proceed during this Congress.
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 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]. Prior to the release of the February 4, 1999, Federal Register notice, members of the research community, including the AAMC, the National Academy of Sciences, the Association of American Universities, as well as several members of Congress, submitted letters of concern about the potential adverse impact this provision could have on research. In addition, in January Representative George Brown (D-CA) introduced H.R. 88, a bill to repeal the legislative provision. This legislation currently has 27 cosponsors. It is unclear at this time if the bill will move independently or as part of another legislative proposal. While the OMB’s proposed revision was less damaging than rumors predicted, there is still substantial cause for concern about the potential adverse impact and detrimental effect that this provision could have on federal research, especially the potential premature or inappropriate release of research data as well as patient confidentiality. In response to this potentially dangerous provision, the American Academy of Pediatrics and the Public Policy Council prepared comments to the proposed revision recommending significant modifications to if not the repeal of the entire provision. The comments also raised concerns about patient confidentiality, the dangers of releasing unreviewed and potentially erroneous findings to the public, and the future risks to researchers who may do research on "controversial" issues. On the other side of the debate, groups such as the Chamber of Commerce generated substantial grassroots activity to support the proposed revision. Viewing this rule as an opportunity to hold government more accountable for expensive regulations, the Chamber advised its membership that "with such data in public hands, agencies will have a much harder time imposing regulations on the business community without substantial evidence." Bruce Alberts, President of the National Academy of Sciences, issued the NAS’s comments on April 5, in which he recommended that "instead of a one-sentence policy statement, OMB should develop comprehensive guidance for federal agencies on public access to federal grantee research data in a manner that fully provides for public access but does not damage or infringe upon equally important aspects of performing, and publishing the results of, federal grant-funded research." The comment period concluded on April 5, 1999, although many research groups advocated for an extension of the comment period. Representative James Walsh (R-NY) and David Price (D-NC) had planned to offer an amendment to the House Treasury-Postal Appropriations bill to address this issue during the mark-up of the bill in May. However, markup of the bill was postponed until June. Due to significant opposition to this amendment by some the amendment sponsors are reevaluating offering the amendment at all. The PPC will continue to closely monitor this issue.
Stem cell research: Last summer’s discoveries of human pluriopotent stem cells through non-Federally funded human embryo research have generated an extensive political, legal and ethical debate. President Clinton, also concerned about this issue, requested that the National Bioethics Advisory Committee [NBAC] convene and examine the issue closely. During the January 19 NBAC meeting, Harold Varmus, MD, Director, NIH, presented the determination of the Department of Health and Human Services [DHHS] General Counsel that the NIH could legally fund research with existing human stem cells under the current ban on human embryo research. Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) held hearings in the Senate Labor/Health and Human Services Appropriations Subcommittee in December 1998 and January 1999. Another hearing will be held in the Senate later this spring. The Senators remain very interested in the potential benefits of future stem cell research and are closely examining the value of permitting federally funded research in this field. However, opposition to stem cell research is gaining some momentum. In February, the Public Policy Council joined approximately 50 other organizations to endorse a sign-on letter, generated at the request of members of Congress, supporting the decision of the DHHS General Counsel. On April 8, the Working Group of the Advisory Committee to the NIH Director involving pluripotent stem cells met to discuss their draft NIH-wide guidelines and appropriate oversight mechanisms to advance Federally-funded research with existing stem cells. The draft guidelines outlined the procedures that providers of stem cells must follow so that cells may be used by federally funded scientists. The draft document addresses informed consent, ineligible research, the definition of stem cells and the derivation of cells. NIH has indicated its intent to finalize these guidelines by the fall 1999. The National Bioethics Advisory Commission (NBAC) continues to meet and discuss this issue. At the end of May, NBAC made its draft report on research and human stem cells available, although these findings have yet to be finalized. The report 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 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. NBAC Chair Harold Shapiro, PhD, anticipates that the Commission’s report on human stem cell research should be finalized by June 1999. The draft 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. 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 on August 21, 1996, by President Clinton. 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 must 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. As required by the legislation, the Department of HHS reviewed the issues surrounding medical records privacy and presented recommendations to the Senate Committee on Labor and Human Resources on September 11, 1997. During the 105th Congress several pieces of legislation were introduced in an attempt to meet the requirements of HIPAA, however, none were enacted. In general, members of Congress examined eight different areas: patient access, consent, notice, security, research, law enforcement access, preemption, and penalties. Preemption is shaping into the most controversial of these issues. Should new federal rules preempt protections already enacted in the states? Some would like to allow states to enact tougher rules than those developed at the federal level in order to provide maximum protection to consumers. However, in a health care system that operates across state lines, dealing with differing levels privacy requirements could prove excessively difficult for large employers, researchers, and payers. Another area of particular concern is in the area of research where identifiable health care information is required. A February 1999 report by the General Accounting Office, "Medical Records Privacy: Access Needed for Health Research, but Oversight of Privacy Protections Is Limited," noted that current arrangements for IRB review of research subject to the common rule might not be sufficient to guarantee confidentiality. Additionally, a great deal of private research is carried out with no federal regulations over the use of identifiable health care information. Final legislation will need to address the question of how much regulation of this research is required. Most of the bills proposed in the 105th Congress called for additional study of these issues. Researchers are particularly concerned with potentially excessive requirements on notification and/or consent of the patient before their individual medical record maybe used for research purposes. Proposals on consent range from a single, broad statutory consent through requiring the periodic consent of every individual. The GAO report is available at http://www.gao.gov/new.items/he99055.pdf. Following an initial hearing in the Senate Health, Education, Labor and Pensions Committee on February 24, legislation has been introduced. On March 10, 1999, Senators Jim Jeffords (R-VT) and Chris Dodd (D-CT) introduced S. 578, the Health Care Personal Information Nondisclosure Act of 1999 or the Health Care PIN Act. Similar to legislation introduced in the 105th Congress by Senator Bob Bennett (R-UT), this legislation upholds the Common Rule and FDA confidentiality procedures. In addition, under the Jeffords proposal, the Secretary of Health and Human Services is required to make recommendations on the Common Rule. The Secretary also has 12 months to develop specific recommendations on the privacy of individually identifiable health information. The Congress is to follow with legislation to deal with the privacy of individually identifiable health information with research within 24 months of the enactment of Jeffords’ bill. Senators Patrick Leahy (D-VT) and Edward Kennedy (D-MA) introduced S. 573, the Medical Information Privacy and Security Act, also on March 10, 1999. Leahy’s bill focuses more on the interaction between the Secretary of Health and Human Services and the IRBs under the Common Rule, requiring submission of the names of IRB members to the Secretary and requiring the Secretary’s periodic monitoring of and technical assistance to these boards. Assurance of confidentiality protection is on the researcher in Leahy’s legislation, which requires the researcher to remove identifiers at the earliest possible time consistent with the purpose of the research unless an IRB determines that there is reason to keep identifiers and the information is protected. Finally, the Secretary is required to make recommendations on informed consent for research purposes within 24 months of the enactment of this legislation. Senator Bob Bennett (R-UT) introduced S. 881, the Medical Information Protection Act of 1999, on April 27. Similar to confidentiality legislation introduced by Senator Bennett at the conclusion of the 105th Congress, the health research provision of S. 881 continues to employ the Common Rule for protected health information [the "Common Rule" or the Federal Policy for the Protection of Human Subjects was adapted in 1991 and subjects federally funded or regulated research to federal oversight requirements including local institutional review boards or IRBs]. Under Bennett’s bill, researchers examining health care records or medical archives may use protected health information if such procedures are consistent with the existing contracts or safeguards of the institution. Information may also be disclosed to a manufacturer of a drug, biologic or medical device for safety or efficacy studies. Finally, Bennett’s legislation would require the review of these safeguards by the Secretary after 18 months. The Senate Health, Education, Labor and Pensions Committee [HELP Committee] is scheduled to mark up S. 578 on in early June. Staff of the HELP Committee put together a substitute version of S. 578, in an effort to combine provisions from the three medical records privacy bills. At the time of this writing, Senators Leahy, Kennedy or Bennett have yet to endorsed the substitute bill. The measure, minus certain exceptions, would preempt state laws that are "less restrictive" than the federal bill. In addition, the substitute bill would codify the Common Rule for publicly funded research. It is very likely that this issue will be dealt with this year, although Congress does have the option of extending the deadline beyond August 21 and the House is clearly waiting to see how successful the Senate is on this issue. Staff will continue to monitor these and future legislative proposals. Clinical Research: On May 13, Representative Jim Greenwood (R-PA) reintroduced the Clinical Research Enhancement Act of 1999, H.R. 1798. The bill now has 22 cosponsors. During Representative Greenwood’s remarks on the floor of the House, he identified the members of the Public Policy Council and the American Academy of Pediatrics 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. 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 31 co-sponsors. 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: On February 26, 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 Public Policy Council will continue to work with both NABR and the animal research community to ensure that this program receives adequate funding.
FY 2000 Budget: On February 1, 1999, President Clinton submitted his FY 2000 budget proposal to Congress. The $1.77 trillion "balanced" budget plan projects a $117 billion surplus in FY 2000 expected to increase to $134 billion and $187 billion in FY 2001 and 2002 respectively. The President’s budget proposes using 62% of the surplus to "shore up" Social Security; 15% to "bolster" Medicare; 11% for individual retirement savings plans and another 11% for increased spending for defense and education. The President’s budget also includes additional discretionary appropriations of $240 billion over five years and increased mandatory spending for such initiatives as child care, education and health care. A 55-cent-per-pack cigarette tax, user fees and some offsetting cuts are also part of the president’s FY 2000 proposal. The few highlights of the President’s FY 2000 budget proposal are:
On March 25, 1999, the House, by a vote of 221 – 208, and Senate, by a vote of 55 – 45, adopted similar versions of the FY 2000 budget resolution (H.Con. Res. 68/S.Con.Res. 20). During the debate in the Senate members rejected an amendment by a vote of 47 to 52, offered by Senators Specter and Harkin to increase funding for the NIH. The amendment would have provided funds to NIH from revenue made available by disallowing tobacco companies from taking a federal income tax deduction "for any payment to the federal government or any state or local government in connection with any tobacco litigation or settlement…." If approved, this amendment would have provided an additional $1.4 billion for the NIH in FY 2000 above the $600 million increase in the NIH budget assumed by the Senate Budget Committee-passed version of the resolution. Determined to meet their statutory deadline, the Republican leadership met with the Budget Committee chairmen on April 12 to hammer out the minor differences between the two budget resolutions. The House passed the conference report by a vote of 220-208 on April 14 and the Senate followed on the 15th with a vote of 54-44. The report reflects the GOP goals of tax cuts, increased defense and education spending, reserved Social Security surplus dollars for debt reduction and retirement programs, and the preservation of the statutory spending caps. Given these priorities, unless something changes, it is currently estimated that, appropriators will be required to cut about $30 billion from discretionary spending in FY 2000. The FY 2000 budget resolution also directs that the Senate Finance Committee take up the Medicare reform proposal offered by the National Bipartisan Commission on the Future of Medicare. The PPC will continue to work aggressively with both the Administration and Congress to ensure that federal programs and services for children and adolescents maintain and receive adequate funding. In addition, the Academy joined with the Coalition for Health Funding and over 140 public health supporters to encourage the budgeters to adjust the spending caps for overall spending on public health programs such as the NIH, AHCPR, MCH etc.. FY 2000 Appropriations: Both the House and Senate Appropriations Committee staff have indicated a desire to keep the appropriations process on schedule. Fiscal Year 2000 begins on October 1, 1999. The Public Policy Council submitted a written statement for the record for both Appropriations Committees. On May 19, the House Appropriations Committee adopted discretionary funding levels [the so-called 302(b) allocations] by a vote of 31 to 23. The Labor/HHS/Education subcommittee was allocated $78.1 billion in budget authority and $78.8 billion in outlays for FY 2000. This is $10.9 billion (12.2%) less than FY 1999 appropriations. The members of the Public Policy Council, the APA and AAP signed on to a letter to all members of Congress concerning these dismal allocations. The Coalition for Health Funding and the Committee for Education Funding, who represent some of the largest public health and education groups, generated the letter. The letter, signed by hundreds of organizations in the health and education community, describes the current funding allocations and solid budget caps as "simply unacceptable." At this time, while appropriators have heralded their 302(b) allocations as politically unpassable, the House and Senate leadership still maintains that the budget caps are solid. The PPC is working together with a number of coalitions to increase funding for medical and health services research (including pediatric research), MCH Block Grant, health professions training to name just a few important programs for children and adolescents.
The Balanced Budget Act (BBA) of 1997 created the Medicare Payment Advisory Commission (MedPAC) and the National Bipartisan Commission on the Future of Medicare. Both are designed to closely examine Medicare and make recommendations to Congress to preserve and reform the program. For that reason, Medicare’s contribution to Graduate Medical Education (GME) is likely to see extensive discussion and possible activity this session of Congress. National Bipartisan Commission on the Future of Medicare: On March 16, the Bipartisan Commission sunsetted without making formal recommendations to Congress. The Commission’s 17 politically appointed members were instructed by the BBA of 1997 to provide their recommendations by March 1, 1999. The Commission required an 11-member majority to make formal recommendations to Congress but the final vote on Senator Breaux’s proposal was only 10 to 7. However, many of the Commissioners hold seats on the Senate Finance Committee and announced their intentions to continue to push the Breaux proposal as legislation. President Clinton, anticipating the failure of the Commission the afternoon before the final meeting, announced his own intentions to develop a plan to "strengthen Medicare for the 21st century" to present to Congress this year. Despite the failure of the Commission to formally make recommendations to Congress, the Breaux/Thomas proposal may remain politically alive. As mentioned above, the FY 2000 Congressional budget resolution directs Congress to consider the proposal, signaling the GOP’s interest in pursuing these policy alternatives. In addition, the Senate Finance Committee has been conducting a series of hearings to address various policy alternatives to improve Medicare, including Senator Breaux’s premium support model. The PPC will continue to work to maintain the safety of graduate medical education including freestanding children’s hospitals. For more information, please see the Commission’s web site at <medicare.commission.gov/medicare>. MedPAC: Also required to provide recommendations to Congress, Medicare Payment Advisory Commission [MedPAC] must produce its report by August 5, 1999. Gail Wilensky, former Administrator of the Health Care Financing Administration [HCFA] serves as the chair of MedPAC and has publicly stated that she remains unconvinced that GME should be funded by federal subsidies. [Note: MedPAC replaces the Prospective Payment Assessment and the Physician Payment Review Commissions.] Currently, MedPAC is grappling with a proposal from Vice Chair Joseph Newhouse, PhD, which would reform graduate medical education payments under Medicare. The concept, based on classical economic theory, recommends that Medicare cover only the added patient care costs embedded in the price of training residents. Dr. Newhouse’s theory has dramatic implications for the future financing of GME: DME and IME would be combined into one payment, tied to the inpatient setting. Training in outpatient settings would become increasingly difficult to finance and the Commission would level payments across training institutions. The Commission’s next meeting will be June 16. For more information, please see the Commission’s web site at <www.pprc.gov>. Graduate Medical Education/Children’s Hospitals: 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. In response to the proposals of the National Bipartisan Commission on the Future of Medicare, the pediatric community has joined the National Association of Children’s Hospitals in seeking interim federal support for GME programs for freestanding children’s hospitals. The Clinton Administration has 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, 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 in the pediatric community. As is protocol, the draft legislative proposal was delivered to Speaker of the House Dennis Hastert on May 12. Under the President’s budget proposal this new program is funded with discretionary dollars [as opposed to the Medicare trust fund] and it appears that it may come at the expense of other valuable HRSA health professions training programs, such as Title VII. The PPC will closely monitoring this issue. On February 8, 1999, Senators Bob Kerrey (D-NE) and Kit Bond (R-MO) introduced S. 391 the Children’s Hospitals Education and Research Act of 1999. This legislation currently has 21 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 their per resident costs and the complexity of their patient population." On April 27, Representative Nancy Johnson (R-CT) introduced H.R. 1579, a similar bill in the House, which currently has 77 cosponsors. Representative Johnson’s bill would authorize a two-year fund with $280 million in FY 2000 and $285 million in FY 2001. Other GME Legislation: Representative Ben Cardin (D-MD) along with nine other cosponsors has introduced H.R. 1224, the "All Payer Graduate Medical Education (GME) Act," a bill to fund graduate medical education through an all-payer fund. Similar to Representative Cardin’s bill from the 105th Congress, this legislation would fund GME through both the Medicare system and through a separate trust fund, with a 1% tax on all health care plans. This would produce approximately $3.2 billion in revenue for direct and indirect medical education. The bill would create a new formula for direct graduate medical education payments (DGME) using the total number of residents, a new per resident formula, and the private payers’ share of GME costs. The new per resident formula would use the national average of resident salaries and fringe benefits, adjusting for inflation and wage indices. The private payers’ share of the GME costs would be based on the ratio of a hospital’s private payer revenues to total revenues. After the direct graduate medical education payments are determined, the remainder of the total trust funds monies would be distributed as IME payments based on Medicare’s IME formula. Medicare’s contribution to GME would continue but the DGME formula would be changed. Medicare’s DGME payment would be based on a national average per resident amount. Faculty supervision costs would no longer be allowable cost to include in calculations for either Medicare or the trust funds per resident amount. Although 20% of the newly calculated DGME money from both the Medicare and the trust fund would be required to compensate physicians for teaching. The Cardin bill also reduces from 5.5% to 4.8% starting in FY 2001 the Medicare IME payments. The bill also includes a provision to reform DSH payments by including the costs of uncompensated care and redistribute the payments accordingly. H.R. 1224 directs the Secretary of Health and Human Services, along with others in the community, to develop and implement a plan to reduce the number of residency training positions by 110 percent of American medical school graduates by 2005. On January 19, Senator Patrick Moynihan (D-NY) introduced S. 210, the Medical Education Trust Fund Act of 1999, also in an effort to produce a viable education trust fund for GME. At this time, this legislation has one cosponsor, Sen. Barbara Mikulski (D-MD). It has been referred to the Senate Finance Committee. The bill proposes to establish a Medical Education Trust Fund. From this source, payments could be made to Medical Schools, Teaching Hospitals and non-Medicare Teaching Hospitals. A new 1.5% tax would be levied on health insurance policies to provide necessary funds. In addition, the legislation would mandate a transfer of funds from Medicare to the new Education Trust Fund. Finally, the bill would establish a Medical Education Advisory Commission to develop new and innovative ways to train medical school graduates. Council on Graduate Medical Education (COGME): Both the September and December 1998 meetings of COGME addressed two critical issues: increased training of residents in ambulatory settings and the growing pressure on the physician workforce from the nonphysician workforce. In discussing the Council’s 15th Draft Report at the December meeting, the Council determined that an in-depth look at training in ambulatory settings was required. In contrast to the Bipartisan Commission and MedPAC, COGME members stated their belief that GME was an obvious public good. It is unclear at this time what role COGME will play in the GME policy debate on the horizon. During COGME’s most recent meeting on April 14 and 15, council members examined the financing of ambulatory training programs and the 15th Draft Report. In addition, they examined the Administration’s interim solution and Senator Kerrey’s legislative fix for GME financing in independent children’s hospitals. Title VII – Health Professions Training Grants – Reauthorization: Members of the pediatric community, AMSPDC, the Ambulatory Pediatric Association, the Association of Pediatric Program Directors and the Academy, continue to actively be engaged in discussions with the Division of Medicine, Bureau of Health Professions, at Health Resources and Services Administration [HRSA] on the implementation of the Health Professions and Education Partnership Act of 1998 [PL 105-392], the reauthorization Title VII and VIII. Along with the general internal medicine community, the pediatric community has and will continue to participate in on-going conversations with the Division of Medicine to address such issues as: (1) how should the Division direct the limited funds for general internal medicine and general pediatrics; (2) how should the Division implement a number of newly mandated funding "priorities"; (3) what should be the charge to the new Advisory Committee on Primary Care Medicine and Dentistry. The pediatric community will continue to insure that Title VII is implemented in the most effective means possible. Title VII – Appropriations: Working with the Health Professions and Nursing Education Coalition, the pediatric academic societies recommend $316 million in FY 2000, for Titles VII and VIII, a modest 4 percent increase above current level funding [$304 million]. Moreover, the pediatric community is urging Congress to appropriate at least $30 million for general internal medicine/general pediatrics. Unfortunately, in President Clinton’s FY 2000 budget proposal, Title VII received a substantial cut, including zero funding for the primary care medicine/dentistry and public health workforce development "clusters." The primary care cluster includes general pediatrics training dollars. Staff is currently exploring other options with members of Congress to protect Title VII from such a devastating cut.
National Health Service Corps: On August 29, 1997, 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 Rural Health Coalition, a bipartisan caucus of members of Congress from rural areas, recently heralded the benefits of the NHSC program and announced that the Coalition intended to seek a correction. On February 1, in his FY 2000 Budget proposal, the President announced his intent 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. On January 21, 1998, 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 was introduced with seven cosponsors. On April 14, 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 29 cosponsors. In addition, Senator Kent Conrad (D-ND) has indicated his interest in improving incentives for NHSC participants and correcting unfair tax burdens as part of a larger bill dedicated to rural health to be introduced shortly. On May 19, by a vote of 12 to 8, the Finance Committee approved corrective legislation on this issue as part of a broader education tax break package compiled by Committee Chairman William Roth (R-DE). However, the Administration is likely to veto Senator Roth’s proposal due to a provision unrelated to NHSC. Staff will continue to work to eliminate this impediment to NHSC scholarship recipients.
Uniformed Services University of the Health Services [USUHS]: Once again Sen. Russ Feingold (D-WI) has introduced legislation, S. 126, the Uniformed Services University of the Health Sciences Termination and Deficit Reduction Act of 1999, to terminate the USUHS. This has been part of Sen. Feingold’s overall efforts to reduce the federal deficit. This bill at this time has no cosponsors and as in previous years it is not expected to pass. Health Professionals for Diversity Coalition: The Health Professionals for Diversity Coalition is continuing 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. Additional information can be found on the coalition at: <www.aamc.org/about/progemph/diverse>. The President’s FY 2000 budget proposed increased funding for health professional training programs designed to increase the diversity of the health care workforce. In particular, the Training for Diversity program, part of the Centers of Excellence and Health Careers Opportunity programs in the Bureau of Health Professions, saw a $16 million increase over FY 1999 funding, to a total recommendation of $109 million. The President commended these programs for their successful records of training and retaining traditionally underrepresented minority students in the health professions. In addition, the FY 2000 CDC Administration’s budget proposal includes $35 million to continue and expand new research/demonstration projects in communities across the country which address six health disparities: infant mortality, cancer, heart disease, diabetes, HIV infections and child/adult immunizations. MATERNAL AND CHILD HEALTH BLOCK GRANT On January 19, 1999, Sen. Patrick Moynihan introduced S. 207, Amendments to the Maternal and Child Health Services Block Grant. The legislation would increase the authorization of appropriations for Title V, the Maternal and Child Health Block Grant program to $840 million in FY 2000. Under current law, Title V is permanently authorized at $705 million. It was last extended in FY 1993. In addition, it would promote integrated physical and specialized mental health services for children and adolescents. The bill has been referred to the Senate Finance Committee. According to Sen. Moynihan statement on the senate floor the legislation introduced "proposes to focus on seriously emotionally disabled children and adolescents and their families. This includes adolescents with special health needs, those experiencing chronic physical , developmental, behavioral, or serious emotional problems and requiring additional health and related services such as assistance in moving from pediatric to adult health care, to post secondary education and employment." The PPC will closely monitor and participate in efforts to increase the authorization level. The PPC is joining with other Title V advocates in supporting a $100 million increase in funding (appropriations) for FY 2000. Current funding for the Maternal and Child Health Block Grant program is $700 million. [This includes $5 million for traumatic brain injury]. On January 28, 1999, President Clinton announced a $68 million initiative to attack childhood asthma. Most of the money ($50 million) would be used for competitive state grants to identify and treat poor children who have asthma and are served by Medicaid. The national strategy outlined by the White House includes new efforts to:
CLINICAL LABORATORY IMPROVEMENT ACT (CLIA) On February 3, 1998, 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 15 cosponsors and has been referred to the House Commerce Committee. Working with the American Academy of Pediatrics, the PPC will continue its involvement with other medical societies to seek meaningful CLIA relief in 1999. While headway has been made, there’s a long way to go in the tobacco control debate, both in Congress and in the States. The tobacco settlement announced on November 20 by several State Attorneys’ General and the tobacco industry is seen by the public health community as an incremental step toward achieving positive tobacco control throughout the nation. The settlement has made the debate more complicated. What was once a single front war at the federal level with the tobacco industry will now be a state-by-state battle to provide good public health measures related to tobacco control. The settlement does not provide guidance or requirements for states to use a portion of their payments to reduce or prevent tobacco use by children and youth. One thing is certain from the public health perspective, there continues to be a critical need to pass national tobacco control legislation in this Congress that will protect children and youth. Congress is expected to pass legislation in the 106th session that returns the federal portion of Medicaid dollars from the settlement agreement back to the states. The ENACT coalition is actively seeking to have Congress earmark at least 25 percent of the state tobacco settlement dollars for tobacco control efforts at the state level. In addition, among the other tobacco control issues the public health community is seeking is for Congress to affirm full FDA authority to regulate tobacco products. The debate will continue and will, no doubt be contentious. ENACT had sent a letter to Attorney General Janet Reno in October 1998 urging the Department of Justice to move forward on litigation to take the tobacco companies to court to recover hundreds of billions of dollars spent by Medicare for tobacco related illnesses. In his January 19, 1999, State of the Union Address, President Clinton announced that he has asked the Department of Justice to prepare such a litigation plan. FOOD and DRUG ADMINISTRATION MODERNIZATION ACT OF 1997 (FDAMA): The "List": A component of the Pediatric Studies provision (Section 111) of FDAMA was a requirement for the Food and Drug Administration (FDA) to compile a prioritized list of drugs for which additional pediatric studies were needed. That list of 500+ drugs was released on May 20, 1998. FDA deemed the entire list to be a priority for getting pediatric studies conducted. While the American Academy of Pediatrics [AAP] encouraged this interpretation by FDA, it has also proven to be difficult for FDA to issue written requests based on the most pressing therapeutic needs of children. Over the last several months, AAP has been working informally to prioritize the list by determining the top 20 drugs within various classes that need to have pediatric studies conducted in the short term. In order to reach a broad range of pediatric specialty/subspecialties, the Committee on Drugs asked a range of AAP Committees and Sections to identify and rank up to 20 drugs on the List that are most important for their patients. AAP should have an informal ranking by early spring. Generics Industry: On February 19, 1999 the generic industry took aggressive action against the pediatric studies provision within the Food and Drug Administration Modernization Act of 1997 (FDAMA) by filing a lawsuit on the grounds the new law allows major pharmaceutical firms to get unfair patent and market-exclusivity extensions on blockbuster medicines. While not entirely a surprise, the lawsuit does complicate the implementation of the pediatric studies provision. You will recall that in fall 1998 the Generic Pharmaceutical Industry Association (GPIA) and National Pharmaceutical Alliance (NPA) filed a citizens petition with FDA to suspend the FDAMA pediatric studies provision The American Academy of Pediatrics filed a brief on March 12, 1999 seeking to be an intervenor to the lawsuit filed by the generic drug industry to prohibit implementation of the pediatric studies provision within the Food and Drug Administration Modernization Act (FDAMA). A hearing on the generic drug industry's request for a preliminary injunction to immediately halt implementation of the pediatric studies provision of FDAMA was held on April 9, 1999. AAP counsel Steve Lawton, with Hogan & Hartson, presented oral arguments on behalf of the AAP at the hearing. On April 20, 1999, U.S. District Judge James Robertson handed down two decisions. The Judge denied the preliminary injunction sought by the generic drug industry. The court case will continue but efforts to immediately halt the implementation of FDAMA were denied. This decision is a positive and important step in the lawsuit. Judge Robertson also denied AAP's motion to intervene in the case, however he acknowledged, "AAP's brief and oral argument were fully considered by the Court and contributed to the Court's understanding of the public's interest in providing incentives for pediatric studies of new drugs. But AAP's interest is adequately represented by existing parties." The AAP brief was accepted as an amicus. As the generic drug industry lawsuit continues the AAP may wish to offer additional comments to the case. At this time however, we are in a position of awaiting further court action. BACTERIA’S RESISTANCE TO ANTIBIOTICS The issue of antibiotic resistance is on the congressional radar screen. The Senate Subcommittee on Public Health and Safety held a February 25, 1999 hearing on the growing concern that many bacteria are developing a resistance to antibiotics. In addition, a recent Government Accounting Office (GAO) report, "Food Safety: the Agricultural Use of Antibiotics and Its Implications for Human Health", addressed one facet of this debate. This report recommends that the departments of Agriculture and Health and Human Services work together to develop and implement a plan to address this issue with specific goals, time frames, and resources. Antibiotic resistant strains of bacteria is an issue of relevance for pediatric populations. CHILDREN’S HEALTH INSURANCE COVERAGE AND ACCESS TO CARE 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 must remain 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. Legislative Efforts concerning Health Insurance Coverage: Several Congressional proposals have surfaced that equalize the tax code by giving individuals a tax break on health insurance, eliminating the double standard in which they are not taxed if their employer provides the coverage, but are taxed if they have to pay for it themselves. House Majority Leader Richard Armey (R-TX): plans to introduce the "Fair Care for the Uninsured Act." It will provide an $800 tax credit per adult and a $400 credit per child up to a maximum of $2,400 for a family. Any tax credit funds that are unused would be given to states in the form of a new "safety net block grant" for the uninsured, which states could use in any number of ways, such as creating risk pools for high-risk individuals who cannot obtain health insurance anywhere else. Rep. Bill Thomas (R-CA): has discussed ending the employer-based health care system and replacing it with a tax credit to every American to help them buy insurance on their own. Rep. John Shadegg (R-Ariz): the "Patients’ Health Care Choice Act" calls for a $500 tax credit for individuals and a $1,000 credit for families. Employees could opt out of their employer’s health plan and receive a voucher instead, with no tax on the extra payment. They would have to use the voucher to buy health insurance that provides at least catastrophic coverage. Rep. Jim McDermott (D-WA): provides a 30% tax credit to individuals earning less than $25,000 and joint filers earning less than $40,000. STATE CHILDREN’S HEALTH INSURANCE PROGRAM (SCHIP) The State Children’s Health Insurance Program (SCHIP), part of the Balanced Budget Act of 1997 (PL 105-33) gives grants to states to provide health insurance coverage to uninsured children through age 18 up to 200% of the federal poverty level (FPL). States may provide this coverage by expanding Medicaid, expanding or creating a state children’s health insurance program, or doing a combination of both. Fifty-one plans have been approved and a total of 53 jurisdictions (Guam and Tennessee still pending) have submitted plans to HCFA. The two states that have not submitted plans are Wyoming and Washington. The National Governors’ Association reported on March 1, 1999, that 828,000 children were enrolled in SCHIP at the end of its first year, according to a new NGA survey of the states. On April 20, 1999, the Department of Health and Human Services announced that this number had increased to 982,000. Those children did not have insurance coverage as of September 1997, the time of the passage of the Balanced Budget Act creating SCHIP. The Congressional Budget Office has projected SCHIP enrollment of 2.5 million children three years after the program is fully implemented. 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. 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, "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 65 cosponsors. 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. H.R. 1843, "Safe and Healthy Motherhood Act": This legislation would allow states to use SCHIP dollars to provide health coverage to low-income pregnant women. "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 five 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. Democrats and Republicans reintroduced the bills they had proposed last year, but the legislation will go through the regular committee process this year and could see changes along the way. Senate Majority Leader Trent Lott (R-MS) said that the Senate will have to pass some kind of managed care reform bill this year. House Speaker Dennis Hastert (R-IL) has said that any legislation must make sure health care is "affordable and available." Republicans and Democrats are still divided over the right to sue health plans for damages, the scope of the patient protections, and issues such as the Republican effort to expand the availability of medical savings accounts. "The Patients’ Bill of Rights" (S. 6, H.R. 358) Introduced by Senator Thomas Daschle (D-SD) and Rep. John Dingell (D-MI): Similar to last year’s bill, this legislation includes the right to sue health plans for damages over delayed or denied benefits and a provision giving physicians, not health plans, the authority to determine whether medical care is medically necessary. The bill allows patients to recover damages when benefits are delayed or denied by eliminating the preemption in the Employee Retirement Income Security Act (ERISA) that prevents patients from suing under state malpractice laws. Under ERISA, patients who have had trouble getting coverage approved for needed medical care generally can recover only the value of the service or treatment they did not receive. The legislation also gives all patients the right to an external review of a health plan’s benefit decision by independent medical reviewers. It would guarantee coverage of emergency services if a "prudent layperson" would consider the patient’s condition an emergency, give patients’ direct access to specialists, provide continuity of care for certain patients whose specialists have left the network, and ban financial incentives for providers to withhold care. Republicans say the liability provision would raise costs and force people to lose their coverage. They also say the medically necessary provision would eliminate virtually all of the savings managed care can produce. The Senate bill has 31 cosponsors and the House bill has 178 cosponsors. "Patients’ Bill of Rights Plus Act" (S. 300) Introduced by Senator Trent Lott (R-MS): This legislation, with 49 cosponsors, applies its protections only to the 48 million Americans in self-insured plans, the one group that is not covered by state protection laws because they are preempted by the federal Employee Retirement Income Security Act (ERISA). The protections include guaranteed coverage of emergency services, a mandatory point-of-service option to allow consumers to use non-network providers, direct access to obstetrician-gynecologists, comparative information on health insurance options, a ban on gag-clauses in managed care contracts, and continuity of care for some patients whose specialists have left the network. The bill also gives patients and providers the right to an external appeal of health plans’ decisions if they turn down coverage as medically unnecessary or reject an experimental treatment when the patient’s life is in jeopardy. The appeals provision applies to the 75 million Americans in insured health plans as well as the 48 million in self-insured plans. Instead of last year’s $1,000 threshold for external review, this bill has new language that says that the cost involved must exceed "a significant financial threshold." (same as Democrats bill) The bill includes provisions to make medical savings accounts more available. Democrats have criticized this bill for not extending protections to all Americans and for not giving patients the right to sue, which they believe is needed to hold the managed care industry accountable. "Promoting Responsible Managed Care Act of 1999" (S. 374) Introduced by Senator John Chafee (R-RI) and Senator Bob Graham (D-FL): This legislation represents an attempt at a bipartisan approach to the managed care issue. It allows patients to sue but recover only economic damages, not punitive or "pain and suffering" damages. The idea is to leave out the most objectionable proposals in the Republican and Democratic Leadership bills. Senator William Roth (R-Del) and Senator Patrick Moynihan (D-NY) are considering a managed care reform proposal that focuses mainly on internal and external appeals. "Patient Protection Act of 1999" (H.R. 448) Introduced by Rep. Michael Bilirakis (R-FL): This bill is basically the same as the one that passed the House last year. It will provide easier access to medical savings accounts, it will include medical liability reform along with "Health Marts" a kind of supermarket of health plans, and association health plans, which would allow small businesses to pool together and self-insure like larger companies. The bill will also include the right to internal and external appeals of health plan decisions, guaranteed coverage of emergency services if a "prudent layperson" would consider the condition an emergency, disclosure of health plan information, and a ban on "gag clauses" in managed care contracts. "Managed Care Reform Act of 1999" (H.R. 719) Introduced by Rep. Greg Ganske (R-IA), this legislation allows patients to sue for damages under state laws but exempts health plans from punitive damages if they follow the recommendations of the external reviewers. Ganske’s bill would exempt employers and plan sponsors from the lawsuits unless they were involved in the benefit decision and it resulted in death or injury to the patient. His legislation, with 17 cosponsors, includes many of the pediatric provisions supported by the pediatric community. "Access to Quality Care Act of 1999" (H.R. 216): Introduced by Rep. Charles Norwood (R-GA), this legislation does not include medical necessity language. Instead, it leaves the medical necessity decision in the hands of the external reviewers, meaning any question of medical necessity would be decided by doctors who do not have a vested interest in providing the treatment. ****************** HOW TO CONTACT YOUR MEMBER OF CONGRESS The beginning of the first session of the 106th 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 for this session of Congress 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. CALL YOUR MEMBER OF CONGRESS 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. 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 1999 CONGRESSIONAL RECESS SCHEDULE
**************** 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: June 1999 |