The Oncologist, Vol. 8, No. 2, 214–215,
April 2003
© 2003 AlphaMed Press
Capitol Report
Marguerite Donoghue Baxter, R.N., M.N.
Senior Director, Pharmacia Corporation, Marguerite.D.Baxter{at}pharmacia.com
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108th CONGRESS WRAPS UP THE WORK OF THE 107TH CONGRESS
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The 108th Congress has wrapped up several open legislative issues left over from the 107th Congress. The President signed into law an Omnibus bill that includes a reversal to the scheduled 4.4% reduction in Medicare payments to physicians. The legislation instructs the Centers for Medicare and Medicaid Services (CMS), the federal agency with oversight relative to Medicare, to reconfigure the growth rates. While the legislation does not restore reductions in the fee schedule that went into effect last year, it precludes the reduction that was slated for this year from going into effect. Overall, the legislation is expected to increase physician payments by $54 billion over the next 10 years and have the immediate effect of increasing 2003 payments by 1.6%.
Eleven of the 13 required appropriations bills were included in the Omnibus Bill. The Congress included the final funding increase for the National Institutes of Health (NIH) 5-year doubling initiative.
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ADMINISTRATION RELEASES BUDGET PROPOSAL
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On February 3, 2003 the Bush Administration released its FY 04 budget proposal. The Administration proposed a total of $27.9 billion for FY 04, a 2% increase. This is a net increase of $549 million. In a move typical of other Administrations accounting for their budget proposals, the Bush Administration indicated that the true program increase for the NIH is $1.9 billion, or 7.5%, as the budget provides instruction to convert approximately $1.4 billion from one-time nonrecurring costs in FY 2003 for facilities construction and anthrax vaccine procurement, and direct those resources to research programs across the NIH.
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ADMINISTRATION PROPOSES SOLUTION FOR A MEDICARE DRUG BENEFIT
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On March 4, 2003 the Bush Administration released its proposal for a Medicare Prescription Drug Benefit for seniors that builds on proposals that have been made over the past 2 years by the same Administration. Specifically, the current proposal creates incentives for the private sector while ensuring a stop-loss mechanism for catastrophic illness, as well as new initiatives for low-income seniors. Thus, the Administration has met its objective of providing an integrated drug benefit in the context of underlying reform of the Medicare program.
Under the Administration’s proposal, one option would be for seniors to stay with the traditional Medicare system and receive a drug discount card estimated to achieve savings of 10%–25%. In addition, a catastrophic benefit would be provided at no extra premium cost to the beneficiary. Existing sources of drug coverage would remain available and be augmented by two new Medigap plans.
An enhanced Medicare system would establish a private-sector-driven system, similar to that provided to federal employees, whereby multiple providers compete for the Medicare beneficiaries business, thus creating a competitive marketplace for the beneficiary. The prescription drug benefit would be subsidized with a monthly premium and an annual deductible, with the government underwriting the catastrophic coverage. Low-income seniors would receive drug coverage for no additional premium and would be provided subsidies to limit their copayment exposure under this plan. Numerous other Medicare components would be provided including more balanced cost sharing for Part A and B and protection from high out-of-pocket costs among other options
It is expected that the President will request Congress to authorize immediately the drug discount program and that the other program components will then move through the legislative process. Plans for hearings on the proposal are under way in the relevant Committees of jurisdiction.
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HOUSE OF REPRESENTATIVES PASSES FULL CLONING BAN
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On February 27, 2003 the U.S. House of Representatives passed HR. 534, the Human Cloning Prohibition Act, by a margin of 241 to 155. The legislation bans both somatic cell nuclear transfer and reproductive cloning. Similar legislation passed last year by a vote of 261 to 162; however, a companion measure in the U.S. Senate was not passed prior to the adjournment of the 107th Congress. Senators Brownback (R-KS) and Landrieu (D-LA) have reintroduced the companion measure in the U.S. Senate, S. 245, and have garnered 26 cosponsors. Further, Senator Hatch has reintroduced S. 303, a compromise measure that would ban human reproductive cloning but enable somatic nuclear cell transfer to continue for purposes of medical research.
HR 534 imposes fines of at least $1 million and penalties of up to 10 years in prison for scientists who attempt cloning. Further, it would also ban the importation of human embryos cloned abroad or any products derived from such embryos. Therefore, it precludes the use of cell lines developed overseas for purposes of medical research in this country.
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CONGRESSWOMAN DEGETTE PLANS TO REINTRODUCE HUMAN SUBJECTS PROTECTION LEGISLATION
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Congresswoman Diane DeGette (D-OH) and Congressman Jim Greenwood (R-PA) have indicated that they plan to reintroduce legislation to protect human research participants. Last year, these members jointly authored HR 4697, the Human Subjects Protection Act. The legislation proposed to extend Common Rule protections outside the realm of federally funded research, set guidelines and authorize resources for institutional review boards and address weaknesses in informed consent.
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MEDICAL LIABILITY REFORM IN THE 108TH CONGRESS?
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While it is early in the legislative season, it is very apparent that the issue of medical liability reform is likely to be hotly debated. HR 5, introduced by Congressman Jim Greenwood (R-PA), is receiving scrutiny in many quarters, and the Senate HELP Committee Chairman, Judd Gregg (R-NH) is on recording stating that he anticipates similar legislation in the Senate. It is widely believed that bills addressing caps on noneconomic damages, punitive damages, and attorneys’ fees will be hotly debated in both chambers. The national crisis in patient access coupled with dramatically increasing medical malpractice liability fees are combining to make the debate one of the most hotly contested in the 108th Congress. The leadership of each chamber is evaluating the effectiveness of California’s model Medical Injury Compensation Reform Act (MICRA) of 1975 to shape approaches to this dilemma at the federal level.
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REIMPORTATION BACK ON THE BLOCK
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The issue of reimporting pharmaceuticals across U.S. borders is front and center in Congressional debates regarding access to pharmaceuticals in the 108th Congress, in spite of strong concerns that have been raised by the Food and Drug Administration (FDA) in the past. Congressman Bernie Sanders (I-VT) has introduced legislation that would fine pharmaceutical manufacturers up to $1 million for actions that lead to halting reimportation of pharmaceuticals from Canada. HR 847, the Preserving Access to Safe, Affordable Canadian Medicines Act of 2003, was introduced in response to pharmaceutical companies taking action that would prevent Canadian pharmacies and wholesalers from selling unregulated pharmaceuticals in the U.S.
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108th Congress Wraps Up...
Administration Releases Budget...
