The Public Policy Council The Public Policy Council (PPC) was created to combine the legislative advocacy efforts of the American Pediatric Society, the Association of Medical School Pediatric Department Chairmen and the Society for Pediatric Research to "speak with one voice." Each society has two representatives on the PPC. Business is generally conducted through monthly telephone conference calls as well as e-mails and faxes. Current members of the PPC are APS: Myron Genel, M.D.; Jimmy Simon, M.D. SPR: Ora Pescovitz, M.D.; Sam Hawgood, M.D. AMSPDC: Russell Chesney, M.D.; Jon Abramson, M.D During the Pediatric Academic Societies annual meeting, the PPC sponsors an early morning legislative symposium on a current research topic of interest to the pediatric academic community. The PPC also sponsors the annual public policy plenary at the Pediatric Academic Societies annual meeting. Each year the American Academy of Pediatrics holds a Legislative Conference. It is an excellent opportunity to develop or sharpen your child advocacy skills necessary to advance child and adolescent health issues through legislation and regulation on both the federal and state levels. The PPC is a member of the Council of Academic Societies, Association of American Medical Colleges and the Council on Government Affairs, American Academy of Pediatrics. Chaired by Myron Genel, MD, Associate Dean, School of Medicine, Yale University, the PPC has provided a view from Capital Hill for over twelve years.

The conclusion of the second session of the 105^th Congress was particularly dramatic, replete with last minute legislative initiatives. On October 21, 1998, Congress adjourned sine die. This is a mid-term congressional election year -- all 435 members of the House of Representatives and one-third of the Senate are up for election so Congress has anxiously returned to their districts and states.

Given that this is the conclusion of this session of Congress, this update does not request advocacy action of members of the Public Policy Council. However, please keep in mind that many of the issues discussed in this report will continue to be hot topics in the 106^th scheduled to begin on January 6, 1999.

FY 1999 BUDGET and APPROPRIATIONS

FY 1999 Budget Resolution: Both the House and Senate chambers completed work on their respective versions of the FY 1999 budget resolution. However, for the first time in 24 years, Congress did not pass a final budget resolution, causing the appropriations process to proceed with little guidance. [Note: The budget resolution is a non-binding blueprint that provides the overall spending and revenue targets for the 13 appropriations committees. It does not need the signature of the president.] The two critical issues of contention were: how large should proposed tax cuts be and how should they be funded. The House had initially suggested that tax cuts should be funded with approximately $26 billion in savings from Medicaid and welfare programs. The Academy and other members of the pediatric community voiced their strong objection to any cuts in Medicaid or the State Child Health Insurance Program (SCHIP). The House eventually backed off on this proposal. Although the House passed a $80.1 billion tax-cut package using some of the surplus, the Senate failed to pass a tax bill. The Republican leadership has indicated that they will redouble their efforts to implement such tax cuts next session.

FY 1999 Appropriations: The final FY 1999 Labor/HHS/Education appropriations bill was not completed before the new fiscal year – October 1, 1998. Six short-term continuing resolutions were passed to circumvent a potential government shut down (H J Res 128, H J Res 133, H J Res 134, H J Res 135, H J Res 136, and H J Res 137). Together, these bills provided level funding for programs and services through October 21 at midnight. Congress failed to pass all thirteen appropriations bills in time and, instead, passed a large omnibus spending bill (a giant collection of funding legislation, with many additional legislative riders) before the members returned to

their home districts to campaign. The final agreement was reached between the White House and the Republican leadership on October 15. Because of the legislation’s enormous size (the bill itself weighed 40 pounds, was 16 inches high and contained 4,000 pages), the House and Senate delayed action. On October 20, the House voted 333 to 95 to pass the legislation. Two out of every three "no" votes were cast by Republicans. On the morning of October 21, the Senate passed the omnibus bill 65 to 29 and agreed to adjourn the 105^th Congress.

The Public Policy Council’s (PPC) advocacy efforts have been instrumental in supporting increased funding for several important child and adolescent health programs. The final bill included 10% increase over all for the Department of Health and Human Services. Specifically the omnibus bill included: a 14% increase ($15.6 billion) for the National Institutes of Health (NIH); a $222 million increase for the Centers for Disease and Prevention (including increases for childhood immunizations, prevention of sexually transmitted diseases and breast and cervical cancer); an increase of $18 million above FY 1998 ($700 million) for the Maternal and Child Health Block Grant (Title V). The Health Professions program received funding levels at higher than both the Senate and House recommendations, $304.3 million with the provision for general internal medicine/general pediatrics receiving $18.29 million; a $25 million increase ($171 million) for the Agency for Health Care Policy and Research and Family Planing (Title X) received $215 million. The omnibus-spending bill dropped the parental notification language on Family Planning (Title X) provisions, included in the House version of the bill. This was the provision that stalled progress on the FY 1999 Labor/HHS/Education appropriations bill.

In addition the omnibus spending bill prohibits the use of federal funding for embryo research, prohibits federal funding for needle exchange programs and prohibits the implementation of the Administration’s organ procurement and transplantation regulations for one year and requires a the Institute of Medicine, under contract with and subject to review by the Comptroller General, in consultation with the Secretary of Health and Human Services, to conduct a study on various aspects of the organ transplantation policy. The omnibus bill does not include a provision initially approved by the House of Representatives barring the Food and Drug Administration from testing and developing any drugs that chemically induce abortion such as the RU-486 pill.

PEDIATRIC RESEARCH

National Institutes of Health Funding: Throughout the 105^th Congress, the concept of doubling the National Institutes of Health (NIH) budget over the next five years had strong support both in Congress and the research advocacy community. The PPC joined almost 200 organizations in the Ad Hoc Group for Medical Research Funding, including the pediatric academic societies, in recommending a 15% increase above current year funding in FY 1999 for the NIH. This support, however, was predicated on encouraging Congress to explore all possible options to identify additional sources of funding to support this increase without harming other public health service programs such as, immunizations, health services research, health professions education and MCH Block Grant.

President Clinton's FY 1999 budget proposed an 8.4% increase for NIH. The House Appropriations Committee recommended an increase of 9.1% in FY 1999 and the Senate included an unprecedented 14.7% increase. In the final omnibus spending bill, the NIH received a 14% increase, the largest in its history.

NIH Council on Public Representatives: On July 8, the Institute of Medicine’s Committee on the National Institutes of Health Research-Priority Setting Process announced 12 recommendations on the NIH including establishing a Council of Public Representatives (COPR, pronounced "copper"). Congress ordered the report in the FY 1998 Labor-HHS-Education Appropriations bill. [Note: The report, "Scientific Opportunities and Public Needs: Improving Priority Setting and Public Input at the National Institutes of Health" is available on the Internet at <http://www.nap.edu/readingroom/books/nih/>. Printed copies can be ordered by calling 202-334-3313 or 1-800-624-6242.]

In an effort to gain greater public input into the creation of COPR, NIH Director Harold Varmus, M.D., held a meeting Enhancing Public Participation in NIH Activities on September 23. Dr. Varmus invited a panel of 24 guests from patient advocacy groups, academic institutions, and the private sector.

The conversation revolved around two proposed goals of the new COPR:

1. Provide a forum for the public and potential beneficiaries of NIH research to express their concerns and viewpoints to the NIH.
2. Communicate the value and legitimacy of the NIH to the general public.

Participants felt strongly that the COPR should not be a decision-making or a political entity, both of which would detract from the Council’s legitimacy to the general public and to Congress. Rashi Fein, Ph.D., Professor of the Economics of Medicine at Harvard, was a key participant. In particular, Dr. Fein emphasized the value of using the COPR to examine and correct the "gaps in the sensitivity of the medical and scientific community," rather than focus on any one disease.

Future members of the COPR will be limited in number to approximately twenty. They will represent a range of interested people, including those of different races, educational backgrounds and those who would not traditionally have a direct stake in the health care debate.

NIH Pediatric Research Initiative: For the past two years, the pediatric academic community have worked closely with the offices of Senators Mike DeWine (R-OH) and Kit Bond (R-MO) to obtain funding for a pediatric research initiative in the Labor/HHS/Education appropriations bill. Working with the National Association of Children's Hospitals (NACH), the March of Dimes, the Juvenile Diabetes Foundation, the American Academy of Pediatrics (AAP) and other child health research advocates, the PPC requested $50 million in FY 1999. [Note: In FY 1998, the pediatric research community was successful in obtaining $38.5 million for this initiative.] In addition, throughout this Congress the pediatric community continued to urge passage of S.484/H.R.1883, legislation to mandate the establishment of a pediatric research initiative at the NIH. Although at the time of this writing we have not seen the exact report language, it is our understanding that the FY 1999 omnibus spending bill includes funding for the pediatric research initiative above FY 1998 levels with a focus on the NIH director’s "areas of research emphasis."

Health Services Research [Reauthorization]: In June, Sen. Bill Frist (R-TN) introduced, S.2208, the Healthcare Quality Enhancement Act of 1998, a bill to reauthorize AHCPR. In addition, the bill was incorporated into the Senate Republican version of the Patient’s Bill of Rights. The legislation changed the name of the agency to the Agency for Healthcare Quality Research. The legislation expanded Medical Expenditure Panel Survey (MEPS) to include outcome and patient satisfaction as well as the oversampling of special populations (including children).

The bill proposed to have the Agency coordinate the federal government's quality improvement efforts, although the Department of Health and Human Services has expressed some "concerns" about the coordinating" role for the Agency. The legislation created a Foundation for Healthcare Quality Research and changes the title of the head of the Agency from administrator to director. Both provisions are similar to those at the NIH. The legislation also included statutory language supporting "primary care delivery research."

Sen. Frist incorporated several provisions of a bill introduced earlier in the year by Sen. DeWine, the Child Health Care Quality Research Improvement Act of 1998 (S.1866). However, none of the provisions specifically focused on child health as was specified in Sen. DeWine’s original bill. The intent of the DeWine bill was to authorize the federal government to invest up to $45 million annually to support grants for research training programs that are dedicated to child health services research; grants to develop child health improvement research centers and provider-based research networks; additional funds for research in high priority pediatric quality and outcomes research; and improvement of child health data. Sen. Frist strongly opposes what he perceives to be an earmark. However, he was willing to accept some of the health care quality research recommendations proposed in Senator DeWine’s original bill, S.1866.

The senate freestanding AHCPR reauthorization bill had eight cosponsors. There was not a House companion bill. Congress will take this issue up again next year.

PEDIATRIC WORKFORCE:

Title VII [reauthorization]: Senator Bill Frist (R-TN), Chairman of the Subcommittee on Public Health and Safety, Senate Labor and Human Resources Committee, introduced and the Committee approved S.1754, the Health Professions Education Partnership Act of 1998. The bill reauthorized several public health service programs, including Title VII, health professions training and education. Senator Frist circulated multiple draft legislative proposals which the Academy and other members of the pediatric community reviewed and had the opportunity to make comments.

The bill does not consolidate Title VII primary care programs in the same manner as previous reauthorization drafts proposed. Rather, each primary care program is authorized separately with a funding level (a "floor") of $17.7 million roughly the FY 1998 levels. The Committee Report that accompanies the Senate bill included language proposed by staff [see language below] that amplifies the importance of the Title VII health professions program to community-based pediatrics [and internal medicine] including the emphasis on internal medicine/pediatric combined residency programs.

The committee recognizes that the primary care combined specialty of Medicine/Pediatrics continues to be the fastest growing primary care specialty in the United States. Medicine and Pediatrics physicians are fully educated and trained in two primary care areas. These primary care physicians are able to provide cost effective, preventive, episodic and continuing care to both pediatric and adult patients who may suffer from complicated and disabling diseases. Three quarters of general internal medicine and pediatrics graduates practice primary care after graduation. The committee recognizes that our nation needs more generalists internists and pediatricians in underserved areas.

On July 31, 1998, by unanimous consent (no debate and no roll call vote) the Senate passed S.1754, the bill to reauthorize Title VII and VIII, the health professions education bill. Two amendments were agreed to:

Senate Labor and Human Resources Public Health and Safety Subcommittee Chairman Sen. Frist: to strike the reauthorization of the HEAL (Health Education Assistance Loan) program [apparently according to the budget analysis it costs too much]

Senate Minority Leader Daschle: to initiate a coordinated national effort to prevent, detect, and educate the public concerning FAS and FAE and to identify effective interventions for children, adolescents, and adults with FAS and FAE.

On October 13, the House considered S. 1754 in a flurry of legislative action at the conclusion of this congressional session. An additional amendment was included regarding the allocation of money to nursing groups to ensure they also serve areas with the greatest needs. The final vote on this legislation was 303-102 and the Senate cleared the measure by a voice vote. At the time of this writing, the President is expected to sign the legislation into law.

GME/National Bipartisan Commission on the Future of Medicare: On September 29, 1998, David S. Weiner, president and CEO of Children’s Hospital in Boston, testified on behalf of the National Association of Children’s Hospitals before the Bipartisan Commission’s GME Study Group. His testimony focused on his growing concern for the future of independent children’s hospitals. While only numbering about 55 institutions in total, free-standing children’s hospitals educate 25 percent of the pediatric workforce. Medicare payments are provided to these institutions, however, only to compensate care for End Stage Renal Disease (ESRD) patients and, as a result, these institutions must finance their residency programs either from revenue from private payers, Medicaid payments or philanthropy. Mr. Weiner expressed his concern that these children’s hospitals were running their budgets with increasing deficits, a severe weakness in the face of the growing competition between hospitals.

Mr. Weiner expressed NACH’s view that a broad-based financing system should be established to provide for the public good of graduate medical education. In the short term, Mr. Weiner advocated for a time-limited fund with a fixed amount of dollars paid from general revenues. Representative Bill Thomas (R-CA) assured Mr. Weiner that such a short-term solution was unlikely and urged NACH to form "positive cooperative networks" to educate Congress about the issue of graduate medical education.

GME/Medicare Payment Advisory Commission (MedPAC): In its March 1998 report to the Congress, MedPAC (a commission created by the Balanced Budget Act of 1997 to examine the future of Medicare) recommended carving DSH payments out of the rates Medicare pays to health plans and making them directly to DSH hospitals when they treat Medicare+Choice enrollees. DSH hospitals could receive payments "using a mechanism analogous to that adopted in the BBA" for distributing the funds. The commission states that "plans are overpaid to the extent that they do not pass on DSH payments to the appropriate hospitals."

The outline for MedPAC’s August 1999 report to Congress on GME was presented on September 18. A major issue of debate was the degree to which the Medicare trust fund would receive some sort of "payback" for its investment in GME. Most Commission members wanted to see more accountability and greater focus on geriatrics. Pediatrics was targeted as being the only training area that does not incorporate training of geriatrics in some form. There was also concern that the presented report was too ambitious and that the report exceeded the congressional mandate.

Issues to be included in the report:

• Historical background for the payment system and the future of the health care system;
• IMGs and physician supply issues;
• Medicare’s role as payer versus GME as a public good;
• Incentives and accountability in the current system;
• Workforce issues, including debates surround supply and demand, future issues and nonphysician health care providers;

The report will conclude with objectives (means to create better accountability, prominence of US medical schools, and the value of a well-trained workforce) and options and recommendations (financing, payment methods, and workforce).

GME Legislation in the 105^th Congress (second session): 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. Until comprehensive GME reform efforts are completed by both the MedPAC and the Bipartisan Commission, the pediatric community has joined the National Association of Children’s Hospitals’ recommendation to seek interim federal support for GME programs for freestanding, independent children’s hospitals.

In May 1998, the Senate and House introduced the bipartisan Children’s Hospitals Education and Research Act of 1998 (S.2049/H.R.3855) to provide direct and indirect payments to children’s hospitals beginning in FY 1999. The Senate version of the bill would make payments from appropriations of $100 million in FY 1999, increasing to $285 million annually in FY 2000 through FY 2002. The House version would have authorized $285 million in payments until FY 2000. The Senate bill had 21 cosponsors and the House bill had over 75 cosponsors. While this piece of legislation did not pass in this session, a significant foundation has been laid for next year with several key and critically important members of the House and Senate supporting this legislation.

On October 8, Representative Ben Cardin (D-MD) introduced the All-Payer Graduate Medical Education Act. This legislation would create an all-payer trust fund, based on a 1 percent fee on all health plan premiums and self-insured plans while excluding Medicare, Medicaid and veteran’s health plans from the fee. Some revisions would be made to the direct graduate medical education and indirect graduate medical education formulas. The DGME payment would conform to the private plan methodology, including the national training amount. The IME formula would be reduced from 5.5 percent in FY2001 (established by the Balanced Budget Act of 1997) to 4.8 percent.

In other significant changes, the DSH payments made to health plans would be "carved out" and paid, instead, to the hospitals that incur the costs from serving low-income populations. Finally, HHS and others would be commissioned to develop and implement a plan by 2003 to reduce residency-training positions to 110 percent of American medical graduates.

Drafts of this legislation were circulated to the PPC before the bill’s introduction. Representative Pete Stark (D-CA) and Representative William Jefferson (D-LA) joined Representative Cardin in sponsoring the bill. While these efforts did not move this late in the session of Congress, Representative Cardin was anxious to place the bill at the top of the legislative agenda for the 106^th Congress. Members of the Medicare Payment Advisory Commission said they find the proposal an interesting one.

In June 1998, Senator Susan Collins (R-ME) introduced S. 2216, the Graduate Medical Education Technical Amendments of 1998, and gathered 3 cosponsors. Subsequently, Senator Frank Murkowski (R-AK) introduced an identical bill, S. 2259, and gained a total of 5 cosponsors. This legislation sought to correct GME funding difficulties resulting from the Balanced Budget Act of 1997 for small residency programs. In essence, the bill provided exception to the hospital-by-hospital caps for residency positions to include community and rural settings. This bill did not pass Congress this session.

On April 2, 1998, Senators Al D’Amato and Daniel Patrick Moynihan introduced S. 1908, the Managed Care Fair Payment Act of 1998, a companion bill to H.R.2701, introduced last year by Rep. Charles Rangel (D-NY). The legislation would have required disproportionate share (DSH) payments to be removed from the rates that the Medicare program pays to Medicare+Choice organizations and paid directly to DSH hospitals when they care for a Medicare beneficiary enrolled in Medicare+Choice. The 1997 Balanced Budget Act removed the DGME and IME (Medicare payments with an education label) over five years from the rates paid to health plans. DSH payments, however, remained in the rate. S.1908/H.R.2701 would carve-out a percentage of the DSH amounts over a specified period of time. The Senate bill had 3 and the House bill had 54 cosponsors at the conclusion of this congressional session.

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. Senator Jim Jeffords (R-VT) and Congresswomen Nancy Johnson (R-CT) and Karen L. Thurman (D-FL) introduced S.1286/H.R. 2951 to rectify this situation. While the legislative language passed as an amendment to the Parent and Student Savings Account Plus Act (S. 1133/H.R. 2646), the President vetoed it on July 21 for reasons unrelated to NHSC.

HEALTH DISPARITIES:

President’s Initiative on Race: One America in the 21^st Century: Forging a New Future, the report prepared by the Advisory Board on the President’s Initiative on Race, included a brief section focusing on Race and Health. The report was released Friday, September 18.

Of note is the references to and recommendation of several programs that the Academy supports and/or has been a part of its initial enactment. These include:

• Expanding medical insurance coverage to all Americans
• Recognition of CHIP as a mechanism to increase children’s access to health care
• Full funding of the Race and Ethnic Health Disparities Initiative in the President’s FY 1999 budget. [Infant mortality, cancer screening and management, heart disease, immunizations, AIDS]
• Increased funding for such program as: Indian Health Service, community health centers National Health Service Corps.
• A review of Medicaid procedures and community health clinic funding mechanisms with the specific goal of changing regulations that unduly impede the expansion and increased understanding of cultural competent services.
• The need for medical training institutions and accrediting associations to require students receive some training in cultural competency.

Healthy People 2010: Health and Human Services Secretary Donna Shalala released "A Health People 2010 Objectives: Draft for Public Comment". This document proposes "the prevention agenda for the Nation" in an effort to promote better public health through information. The report outlines 500 national health objectives. Secretary Shalala announced a public comment period between September 15 and December 15, 1998. The final draft will be presented in January 2000.

Elimination of health disparities has become a central goal of this project. The current draft suggests the project will focus on six key health areas, consistent with the President’s FY1999 budget request for full funding of the Race and Ethnic Disparities Initiative: infant mortality; cancer screening and management; cardiovascular disease; diabetes; HIV/AIDS rates; and child and adult immunization levels. The draft of this document is available on the Internet at http://web.health.gov/healthypeople.

CHILDREN’S HEALTH COVERAGE:

Title XXI Implementation: [the following is an update provided by the American Academy of Pediatrics]: In the one year since the Balanced Budget Act of 1997 created the State Children Health Insurance Program, most states have submitted Title XXI proposals. Many of these states have already implemented their plans.

• In 30 states, children are already receiving health insurance coverage under Title XXI through Medicaid expansions or separate programs.
• 4 states plan to implement programs in November 1998.
• 4 states expect to begin coverage in January 1999.
• 3 states have already implemented the second phase of their plans

Update from HCFA: On October 20, the Department of Health and Human Services approved Louisiana’s plan to expand health care coverage to an estimated over 28,000 children in the CHIP program by the end of fiscal year September 2000. Louisiana, like all states with CHIP plans, will receive federal matching funds only for actual expenditures to insure children. Louisiana's plan is the 43rd CHIP plan to be approved in the first year of the CHIP program. Together, these plans anticipate providing health insurance coverage for more than 2.3 million currently uninsured children within the next three years. On October 13, the Department of Health and Human Services approved Nebraska's amendment to their state plan. The state will expand Medicaid coverage, under the name "Kids Connection," to children through age 18 up to 185% of the federal poverty level.

The three states that have not submitted a plan are Hawaii, Wyoming and Washington.

PATIENT CONFIDENTIALITY:

The 1996 Health Insurance Portability and Accountability Act required HHS Secretary Donna Shalala to formulate standards for the privacy and protection of individually identifiable health information, in consultation with the National Committee on Vital and Health Statistics. Congress has until August 20, 1999, to enact privacy legislation. Should they fail, HHS must issue privacy regulations before February 20, 2000.

Administrative Action: Secretary Shalala, testified in September 1997 before the Senate Labor and Human Resources Committee on the "Confidentiality of Individually-Identifiable Health Information." The Secretary’s legislative recommendations were encompassed in five principles: boundaries, security, consumer control, accountability and public responsibility. The intent of the legislative proposal is to:

• draw clear limits on who has access to health information,
• define the responsibilities of those entities who possess health information to ensure that such information is protected from misuse and disclosure,
• establish patient’s rights to be advised as to how payers and providers will use their health information, to limit disclosure of health information in certain cases, to obtain a copy of their records, and to propose corrections in their records,
• invoke strict criminal penalties for the improper disclosure and misuse of health information,
• authorize the disclosure of health information without explicit patient consent for use related to four national priority activities including audits and investigations of the health care system, public health tracking and medical emergencies, health research and law enforcement.

These principles will be included in legislation that the Health Care Quality Commission -- a Subcommittee of the National Committee on Vital Statistics -- will be developing. Updates of the Commission’s activities are available at <http://www/hcqualitycommission.gov>. The Secretary’s report is available at <http://aspe.os.dhhs.gov/admnsimp/>.

Congressional Action: Senators James Jeffords (R-VT) and Robert Bennett (R-UT) have worked on draft medical records privacy legislation that has not yet been introduced. Their proposed legislation would prescribe federal safeguards for handling personal health information and impose civil and criminal penalties for wrongful disclosure and mishandling of protected medical records. Individuals would be allowed access to health information about themselves and providers would have to give clear written notice to individuals about this right.

Under the legislation, an individual’s personally identifiable health information could be disclosed without consent during emergency circumstances; to any public entity investigating or enforcing health care fraud or abuse; to health researchers when the use is approved by a certified institutional review board; in judicial and administrative procedures where the individual’s health condition is at issue in a lawsuit; in response to a subpoena in a civil lawsuit or to a law enforcement authority; and to a certified health information service for the purposes of removing personal identifiers from the information and for the subsequent creation of non-identifiable health information.

The draft Bennett-Jeffords bill would preempt state law, but would not preempt, supersede or modify the operation of any state law that provides for the reporting of vital statistics such as birth or death information; requires the reporting of abuse or neglect information about any individual; regulates the disclosure of information concerning a communicable disease status; or authorizes the collecting, analysis, or dissemination of information from an entity for the purpose of developing cost effectiveness, performance, or quality data.

On major concern is that under the Bennett proposal, parents would exercise all rights to their children’s medical records - limiting the confidentiality of care provided to adolescents.

On April 3, Sen. Jeffords introduced his own privacy legislation (S.1921) with Sen. Chris Dodd (D-CT). Sen. Jeffords new bill provides greater flexibility for states to impose stricter privacy laws than the Bennett proposal would allow. While Bennett would propose a national "ceiling" on privacy, Jeffords would impose a "floor". The Jeffords legislation would also allow the records of adolescents between that ages of 14 and 18 to keep private medical records of health care that they sought out themselves - but other medical records would still be controlled by the parent.

Senators Patrick Leahy (D-VT) and Edward Kennedy (D-MA) are cosponsors of S. 1368, which was introduced November 4, 1997 and hearings were held on February 26, 1998. S. 1368 would close the existing gaps in federal privacy law to protect the privacy of medical records. Little action is expected on this bill.

At the end of the 105^th Congress, Senator Bob Bennett (R-UT) introduced S. 2609, the Medical Information Protection Act, as a revised version of the draft legislation he had been circulating. Bennett has said that he intends to reintroduce the bill in January so that it may be considered at the top of the legislative agenda. Industry has been highly receptive of the bill and claims the legislation is superior to Leahy and Jeffords’ proposals as it allows for a freer flow of information.

Finally, medical record confidentiality provisions were included in a number of the managed care reform bills. The "Patient Protection Act of 1998" (H.R. 4250), the Republican version that passed the House on July 24, included an incentive for using nonidentifiable health information. The Senate’s "Patient’s Bill of Rights Act", S. 2330, established a prohibition in the group and individual health insurance markets for the use of predictive genetic information concerning an individual or a family member to adjust premium or contribution amounts. However, managed care reform did not pass in this Congress.

While no action was taken on this issue at the conclusion of this 105^th Congress, it is clear that medical records privacy legislation will return in the next.

CLONING:

The dramatic surge of legislative and administrative proposals surrounding the cloning of human embryos has died down. No action has taken place in Congress since the House Commerce Subcommittee on Health and the Environment held hearings on February 12, 1998. This issue has not gone away, however. The National Institutes of Health is overdue for reauthorization and it is likely that human cloning will come up in this context in the next Congress.

In February 1997, Scottish scientists announced the groundbreaking discovery of cloning technology that produced a live-born sheep. Later in 1997, Richard Seed, a Chicago physicist, communicated his intentions to pursue human cloning. The White House and Congress quickly began to move on a variety of proposals to prohibit cloning technology, although no legislation has been passed.

On March 4, 1997, President Clinton issued a directive banning the use of any federal funds for any cloning of humans and asked for a voluntary moratorium on the cloning of human beings in the private sector. Meanwhile, the National Bioethics Advisory Committee (NBAC) issued a report on June 9, 1997. The Committee recommended that the moratorium continue on federal funds used for human somatic cell nuclear transfer procedures and suggested the inclusion of a sunset clause to ensure that Congress review the issue in three to five years.

A series of legislative proposals also arose surrounding the issue, although no action occurred at the end of this congressional session. These include:

H.R. 922 (Ehlers) prohibits federal funds for cloning research.
H.R. 923 (Ehlers) prohibits use of a somatic cell to make a human clone.
S. 368 (Bond) prohibits federal funds for cloning research.
S. 1601 (Lott/Bond/Frist) outlaws the cloning of human beings by banning outright the use of the human somatic cell nuclear transfer technique.
S. 1602 (Kennedy/Feinstein) bans the cloning of human beings but it would allow the specific procedure to be used for human embryo research that may lead to medical breakthroughs against disease.

CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988:

Throughout this Congress much like previous years, the Academy worked on the passage of CLIA legislation (H.R.2250/S.1068). The House bill had 85 cosponsors and the Senate bill had three cosponsors. The Academy maintained its involvement with other medical specialty societies, such as, the American Academy of Dermatology, the AMA, the American Academy of Family Physicians and the American College of Physicians, to seek meaningful CLIA relief and will continue to do so in the next session of Congress.

TOBACCO:

Congress, the courts and the states continue to struggle over solutions to address tobacco control in the United States. There have been suggestions that a settlement may soon be reached soon between the tobacco companies and the coalition of state Attorneys General that could be worth as much as $200 billion. The efforts are far from over and the outcome is far from certain.

The Congress: Despite the best efforts of an enthusiastic army of AAP and other health advocates, national comprehensive tobacco legislation was not completed in the 105^th Congress. In the Senate chambers, the four-week May/June debate was passionate, the lobbying was fierce and the outcome was disappointing. Senator John McCain (R-AZ) championed a bill that was in need of a number of public health improvements but was a solid attempt to reach comprehensive tobacco control legislation.

On the House side Rep. Deborah Pryce (R-OH) headed a House tobacco task force designated by Speaker Gingrich to develop comprehensive tobacco control legislation. Though Rep. Pryce had stated she wanted to move legislation forward in the last few days remaining in this Congress, the task force only released a set of principles.

The Courts: The U.S. 4^th Circuit Court of Appeals' recent decision that the FDA does not have the authority to regulate tobacco is disappointing, but it is hardly the end of the matter. The Court’s decision reversed last year’s decision by a Federal district judge in North Carolina. The Justice Department immediately announced that it would appeal the 2-1 decision by the three-judge panel to the entire 4^th Circuit of roughly a dozen judges. Several options remain at the lower court level: If the Court decides to hear the case before the entire panel of the 4^th Circuit, they would decide whether to simply review the briefs or to review the brief with oral arguments.

Regardless of what the full Circuit Court does, its final decision will most likely be appealed to the U.S. Supreme Court; and we believe that the FDA will ultimately prevail.

It is important to note that the youth access provisions of the FDA rule which have been in effect since February of 1997 will continue to be fully operational while the full Circuit Court considers the government's appeal. These provisions include a nationwide minimum age of 18 for the purchase of tobacco products, along with the requirement that retailers ask for proof of age from tobacco purchasers who appear to be under age 27. The FDA provides funding to the states to enforce these provisions and also conducts retailer and consumer education efforts.

The States: For the last couple of months, efforts to develop a settlement among several state Attorney’s General and leading tobacco companies have been underway. Depending upon the day, reports on the negotiations fluctuate between statements that an agreement is close-at-hand and that talks have fallen apart. To date, two of the top five tobacco companies have pulled away from the negotiations. In addition, Massachusetts’s Attorney General bowed out of the negotiations, fearing among other things that the negotiations would not yield strong public health provisions to protect youth from tobacco. It appears the settlement negotiations raise more questions than they answer at this time. Only a handful of AG’s are participating in the negotiations. Will other states agree to the negotiated terms? With only the top three tobacco companies participating in the talks how, or will, the terms be applied to the rest of the tobacco industry? Will states keep all the money from the settlement or will they need to pay back the federal share of the Medicaid dollars?

COALITION FOR AMERICA’S CHILDREN:

The Coalition for America’s Children (of which the pediatric societies are members) has several exciting projects underway:

• A series of election forums scheduled through next year to provide child advocates with new, important information to help them push children’s issues to the top of the policy agenda and to hold candidates accountable after they are elected. The first forum occurred June 23rd. Top pollsters explained how children’s issues are faring in the election process. AAP members can obtain a white paper with highlights from the forum either through the Academy or via the web: www.kidscampaigns.org. A brochure with questions for candidates is also available. The second election forum--Sept. 23—brought together journalists to discuss how the media covers children’s issues. Materials will be available to AAP members.
• A one-year, $125,000 grant from the Annie E. Casey Foundation. The Coalition for America’s Children will be providing Kids Count grantees, most of whom are Coalition members, with strategic communications research to help them effectively convey children’s issues at the local level. We will be conducting focus groups and a public opinion survey to identify what issues resonate with the public and why. Once we determine this, we will offer insight into the potential for reframing children’s issues in such a way that they maximize public understanding and support. All information gathered through this grant will also be shared with the greater CAC membership, including AAP chapters.
• A new series of public service ads for our joint "Whose Side Are You On" campaign with the Ad Council. These new ads, with a Help Wanted theme, allow organizations to localize the ad by promoting volunteer opportunities in their community. The ads were distributed to local broadcast stations and newspapers in May.

AAP’S 1999 LEGISLATIVE CONFERENCE:

Mark your calendars! The annual American Academy of Pediatrics’ 1999 Legislative Conference will be held on May 16-18, 1999 in Washington, DC. Designed to arm pediatricians with the tools to become active participants in the political process, the conference includes an exciting series of practical workshops, role-playing scenarios and speakers and concludes with a congressional office visit. For more information and a conference brochure, please contact the Academy’s Washington Office at 800/336-5475 or 202/347-8600 or visit the Academy’s web site at <www.aap.org>.

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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:
APS: Myron Genel, MD; Jimmy Simon, MD
SPR: Ora Pescovitz, MD; Sam Hawgood, MD
AMSPDC: Russell Chesney, MD; Jon Abramson, MD

SUBMITTED BY:
Myron Genel, MD, Chairman
Karen M. Hendricks, JD, Washington Coordinator
Jennifer Stevens, Legislative Assistant

October 23, 1998

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