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.
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