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NEWS AND SPECIAL REPORTS |
Senior Director, Pharmacia Corporation Marguerite.D.Baxter{at}pharmacia.com
ATTACK ON AMERICA RE-FOCUSES LEGISLATIVE AGENDA OF THE 107TH CONGRESS
The terrorist attacks in New York, Washington, and Pennsylvania that occurred on September 11, 2001 have altered the legislative priorities of Congress for the immediate future. Current Congressional priorities include emergency relief, anti-terrorist initiatives to protect Americans domestically and internationally, economic stimulus, and completion of the appropriations bills. President Bush has requested Cabinet officials to identify high priority domestic issues unrelated to the events of September 11th, and the White House and Congressional leadership are considering the best approaches to these priorities in the near term. It is widely anticipated that many priorities, such as Medicare Reform, a Medicare Prescription Drug Benefit, and other domestic initiatives will not be addressed this Fall by the 107th Congress.
NATIONAL CANCER LEGISLATIVE ADVISORY COMMITTEE RELEASES RECOMMENDATIONS
The National Cancer Legislative Advisory Committee (NCLAC) was created roughly 18 months ago at the request of Senator Dianne Feinstein. Drs. Vincent T. DeVita, Jr. and John R. Seffrin serve as co-chairs of NCLAC. Since its creation, members of NCLAC have completed interviews and Roundtable meetings with over 100 experts including cancer survivors, advocates, leaders in science and academic institutions, representatives of government agencies and the private sector. In addition, as a part of the deliberative process several federal agencies, including the Food and Drug Administration, the National Institutes of Health, and the Health Care Financing Administration (HCFA), have also presented their cancer action plans to the committee for consideration as part of NCLAC's report.
In its report, NCLAC presents twelve challenges to the Congress and the President [1]. These challenges include:
Goal 1: Fund the National Cancer Institute (NCI) Bypass Budget in this and future years and provide additional supplemental funding for critical research that is not adequately covered in the Bypass Budget.
Goal 2: Increase the pool of talented and well-trained biomedical researchers.
Goal 3: Increase National Institute for Environmental Health Sciences (NIEHS) and NCI funding for cancer research that examines the interaction of genes and the environment.
Goal 4: Enhance our cancer research centers (and other cancer-focused efforts) to build a multidisciplinary network of "translational centers" to move new drugs and technologies forward into clinical trials, and ultimately develop new methods and products to prevent and cure cancer.
Goal 5: Streamline and accelerate the FDA's approval system for cancer drugs, biologics, devices, and technologies.
Goal 6: Empower federal agencies to build public/private partnerships across the entire continuum of cancer research to ultimately develop new cancer treatments, preventatives, and technologies.
Goal 7: Provide adequate health insurance coverage for all Americans concerned about or diagnosed with cancer.
Goal 8: Significantly increase the pool of health care professionals trained to conquer cancer.
Goal 9: Launch a National Cancer Screening Initiative to substantially increase the early detection of cancer.
Goal 10: Implement comprehensive state-based cancer action plans, in collaboration with all relevant experts in the region.
Goal 11: Develop, communicate, and use universal guidelines and practice standards to provide quality cancer care to all cancer patients, and monitor progress through improved quality care surveillance systems.
Goal 12: Implement a National Cancer Prevention Initiative that focuses on eliminating tobacco use, increasing physical activity, and improving nutrition.
There is a series of recommendations to successfully implement each of these goals. In addition, the NCLAC report urges the development of accountability measures for the recommendations in the report. The measures cited by NCLAC include responsibility for planning and implementation; a decision-making process that embraces a broad range of views; implementation that builds on both quantitative and qualitative measures; a process for public reporting; and full disclosure of successes and setbacks.
NATIONAL BIOETHICS ADVISORY COMMISSION ISSUES ITS SIXTH REPORT
On September 7, 2001 the National Bioethics Advisory Commission (NBAC) issued its sixth report, Ethical and Policy Issues in Research Involving Human Participants. The Commission has spent over four years examining the oversight system for the protection of human subjects involved in clinical research. In its report, NBAC outlines 30 recommendations and calls for a major revamping of the system that oversees the integrity of clinical trials. The recommendations address initiatives in the following areas:
GAO REPORT: MEDICARE—PAYMENT FOR COVERED OUTPATIENT DRUGS EXCEED PROVIDERS' COST
On September 21, 2001 the General Accounting Office (GAO) issued its DRAFT report to Congress. In the DRAFT Report, the GAO identified the 20 drugs with the highest total Medicare expenditures and the 20 drugs with the highest volume for analysis. They have found that 35 different drugs accounted for 82% of total Medicare drug spending. Of these physician-administered drugs, the average discount from average wholesale pricing (AWP) ranged from 13%-34%; while two physician-administered drugs had discounts of 65% and 86%.
The GAO Report does not highlight a specific resolution for Medicare pricing policies. It outlines the following recommendations to guide future policies:
Medicare payments to oncologists will be the subject of a second report issued in October 2001. The report, "Medicare Physician Fee Schedule: Practice Expense Payments to Oncologists Indicate Need for Overall Refinement," will conclude that the basic methodology HCFA used to establish the fees is sound and that payment to oncologists is 8% higher than they would have been under other HCFA fee schedule calculations (prior-charge basis). GAO did find that modifications to the basic method substantially lowered payments for certain services, such as chemotherapy administration. It is expected that the GAO will make recommendations with regard to how to address this shortfall.
HOUSE COMMERCE COMMITTEE HOLDS HEARING ON REFORM OF THE MEDICARE REIMBURSEMENT SYSTEM
On September 21, 2001 the House Commerce Committee held a joint Oversight and Investigations Subcommittee and Health Subcommittee hearing on the issue of Medicare reimbursement. The hearing examined the current reimbursement practices using AWP, affecting a number of subspecialties including oncology. The outcome of the hearing is that the Centers for Medicare and Medicaid Services (CMS, formerly HCFA) and the House will work together on a bipartisan legislative solution, which Chairman Greenwood indicated would be enacted this year.
The legislative solution will be based upon five principles that the Chairman put forward at the hearing to which CMS Director Scully agreed:
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