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Policy Watch: September 1999
Congress Looking to Provide Coverage for Clinical Trials

ASCO President Addresses Congressional Members and Staff on Clinical Trials

HCFA Publishes Proposed 2000 Physician Fee Schedule

ASCO Statement on Federal Funding for Stem Cell Research


Congress Looking to Provide Coverage for Clinical Trials

The House was expected to debate managed care reform before the August recess, but disagreements within the Republican Conference over key components of the measure (including clinical trials) have delayed consideration of a bill until at least September.

ASCO has been working for several months with Representative Brian Bilbray (R-CA) to develop a clinical trials amendment should a health care reform bill be considered in the House of Representatives. Other members who have been committed to this effort are Representatives Charlie Norwood (R-GA), Rick Lazio (R-NY), and Matt Salmon (R-AZ).

ASCO supports language calling for coverage of routine patient-care costs for patients with serious or life-threatening illnesses who are enrolled in an approved clinical trial. According to ASCO policy, qualified trials include those approved by the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Department of Veterans’ Affairs, the Department of Defense, or a qualified nongovernmental research entity identified in the guidelines issued by the NIH for center support grants.

On July 15, 1999, the Senate passed a measure that included coverage of clinical trials for cancer patients who belong to an ERISA plan, which covers roughly 48 million of the 161 million Americans with health insurance. Senator Connie Mack (R-FL) was instrumental in facilitating the inclusion of a clinical trials provision. The measure excludes FDA-sponsored trials. Furthermore, the measure requires an expedited negotiated rule-making process to establish standards for determining routine patient costs associated with clinical trial participation instead of referring to the design of the protocol. Finally, the provision requires a study to measure the financial impact on group health plans for covering routine patient-care costs of those patients enrolled in an approved cancer clinical trial.

Please visit ASCO’s Grassroots Action Center on ASCO OnLine (www.asco.org) to learn more about this important issue and how you can help.

ASCO President Addresses Congressional Members and Staff on Clinical Trials

On August 3, 1999, ASCO President Joseph S. Bailes, MD, was among three speakers at a Congressional Briefing on the importance of Medicare coverage for cancer clinical trials. Sponsored by the National Coalition for Cancer Research, the briefing focused on the need to pass the "Medicare Cancer Clinical Trials Coverage Act" introduced by Senators John D. Rockefeller (D-WV) and Connie Mack (R-FL) and Representatives Nancy Johnson (R-CT) and Ben Cardin (D-MD). Senator Mack is urging Senate Finance Committee Chairman William Roth (R-DE) to include the measure in his Medicare reform package expected to be considered in September.

HCFA Publishes Proposed 2000 Physician Fee Schedule

The July 22, 1999, Federal Register contains the Health Care Financing Administration’s (HCFA) proposed rule for the fiscal year 2000 Medicare physician fee schedule. This proposal includes implementation of resource-based malpractice expense components, plans for refinement of practice expense components, and new requirements for the use of modifier-25. ASCO will submit comments on the proposal before the HCFA’s deadline of September 20, 1999. Following is a summary of the proposed rule and its impact on oncology services.

Resource-Based Malpractice Expense Components

As required by law, HCFA is proposing to make the malpractice components of the physician fee schedule resource-based. HCFA assigned each specialty a risk factor on the basis of malpractice insurance data from the twenty largest specialties. The malpractice costs for a specialty were allocated to the CPT codes used by each specialty in proportion to the physician work values of each code by multiplying physician work by the specialty risk factor. This method assumes that malpractice risk for the code is related to the amount of physician work for the code; HCFA recognizes that this assumption is questionable and is asking for suggestions on a better methodology. For CPT codes without a physician work value (e.g., chemotherapy administration) HCFA simply kept the current relative value. The final result was then adjusted for budget neutrality.

HCFA estimates that the net effect of the revised malpractice components would be to increase Medicare payments to hematology-oncology by 0.3% and to decrease payments to radiation oncology by 0.4%. Since there is no transition period, the revised components would fully take effect in the year 2000.

Practice Expense (PE) Components

HCFA did not propose any significant refinements in the calculation of the PE components. However, HCFA is proposing to exclude from PE calculations all costs attributable to clinical staff employed by the physician but assisting the physician in a hospital. This proposal would disadvantage surgeons in particular but is predicted to have a negligible effect on hematologists and oncologists. Radiation oncology would be unchanged.

Since 2000 is the second year of the transition of the PE components, the relative values for chemotherapy codes will increase slightly; for example, 96408, 96410, and 96412 will each increase by 0.01 relative value units.

Use of Modifier-25

HCFA is proposing to require that any Evaluation & Management (E&M) service billed on the same day as a procedure would have to be billed using modifier-25 to show that an E&M service distinct from a procedure was provided. This would require oncologists to use modifier-25 for all visit and consultations on the same day as chemotherapy administration. The basis for this proposal is HCFA’s statement that "every procedure has an inherent E&M component." This is incorrect, and ASCO will provide comments stating that this proposal should not apply to procedures that lack a physician work component (e.g., chemotherapy administration).

ASCO Statement on Federal Funding for Stem Cell Research

The ASCO Board of Directors recently approved a statement developed by the Public Issues Committee supporting federal funding for research using embryonic stem cells. The ASCO statement does not address the issue of funding for research on the derivation of stem cells. This issue has been one of significant interest by the biomedical research community and Congress over the last year.

While restrictions in the NIH appropriations bill prohibit federal funding of research involving derivation of stem cells from embryos, the Department of Health and Human Services has issued a legal opinion that this restriction would not prohibit funding of research utilizing those stem cells.

The NIH is currently drafting guidelines on the conduct of federally funded research on stem cells (the stem cells themselves would have to come from privately funded sources). These guidelines will be subject to public comment, and no federal funds will be awarded for such research until the guidelines have been finalized. The National Bioethics Advisory Commission issued a report recommending that federal funding should be allowed for research on the use and derivation of stem cells. The report also stipulated that the source of those stem cells should be from surplus embryos from fertility clinics after proper informed consent of the donors.

There is broad consensus in the biomedical research community that federal funding for research on the use of stem cells is needed to ensure that adequate resources are available, but more important, to guarantee that such research is conducted ethically and under appropriate controls.

The ASCO statement will be used to guide the Society’s response to inquiries from members of Congress and other organizations engaged in this important issue. A copy of the statement is available on ASCO OnLine (www.asco.org), under the Policy and Practice section.