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Federal Document Clearing House
Congressional Testimony
June 7, 2000, Wednesday
SECTION: CAPITOL HILL HEARING TESTIMONY
LENGTH: 5534 words
HEADLINE:
TESTIMONY June 07, 2000 JEFFREY KANG DIRECTOR OFFICE OF CLINICAL STANDARDS AND
QUALITY HOUSE GOVERNMENT REFORM CANCER CARE FOR THE FUTURE
BODY:
June 7, 2000 Statement of JEFFREY KANG, MD
DIRECTOR OFFICE OF CLINICAL STANDARDS AND QUALITY HEALTH CARE FINANCING
ADMINISTRATION Before the HOUSE COMMITTEE ON GOVERNMENT REFORM on ALTERNATIVE
CANCER TREATMENTS Chairman Burton, Congressman Waxman, distinguished Committee
members, thank you for inviting us to discuss Medicare coverage
for alternative and experimental therapies, as well as efforts to address racial
disparities in health care. The Social Security Act authorizes Medicare
coverage of defined categories of medical services provided by
specific types of practitioners when such treatments are "reasonable and
necessary for the diagnosis or treatment of illness or injury or to improve the
functioning or a malformed body member." It authorizes the Health & Human
Services Secretary to specify what is covered and under what circumstances, and
we try to strike the appropriate balance between providing timely access to
medical advances and ensuring that treatments are "reasonable and necessary." To
do so, we rely on scientific evidence, including medical literature and data,
discussions with medical experts, and technology assessments. We are well aware
of the increasing integration of alternative therapies into conventional
treatment for patients with cancer and other conditions. I have referred my own
patients for treatments such as acupuncture. Hospices, hospitals, and managed
care plans in Medicare can provide alternative treatments under discretion they
have through per diem, prospective, and capitated payment systems, respectively.
And the law specifically provides for Medicare coverage of
chiropractic spinal manipulation by chiropractors, as well as massage
therapy by physical therapists when the treatment can be demonstrated to help
improve a patients health status. For other alternative therapies, we will move
quickly . to provide coverage throughout Medicare when there is
sufficient scientific evidence to meet the statutory requirement that Medicare
fee- for-service treatments be reasonable and necessary.
Coverage for alternative modalities to date has been limited
because of the paucity of reliable scientific evidence to support their use.
Without such scientific evidence, we are limited in our ability to determine
that these treatments meet the statutory requirement of being "reasonable and
However, thanks to the work of my colleague Dr. Straus and others at the
National necessary. Center for Complementary and Alternative Medicine, as well
as work by colleagues at the Ageric" for Healthcare Research and Quality (Af4RQ)
and elsewhere, we may be better able to make these determinations soon. For
experimental therapies, Medicare historically has not covered them because they
do not meet the requirement of being feasonable and necessary. However, as the
President announced this morning, we have reviewed our legal authority and
determined that we can cover the routine services provided to Medicare
beneficiaries who are participating in clinical trials. We will move quickly to
implement this new policy by formally and explicitly instructing our contractors
to provide such coverage. We also will launch education efforts
to make sure beneficiaries and providers know that they are entitled to such
coverage. Our new, open and accountable
coverage determination process will help facilitate prompt
coverage determinations for all experimental and alternative
treatments as scientific evidence of their efficacy becomes available. This new
process, implemented last year after extensive review of how we could improve
our coverage determination process, allows any member of the
public to request a coverage determination or submit new
evidence that might justify a redetermination. There are time lines for action
on such requests, data are reviewed by expert panels in open meetings. The
status of determination proceedings is posted on the Internet. And we will work
with our National Institutes of Health colleagues to help researchers design
trials to evidence needed for coverage determinations, which
should help to further speed up the approval process. We also have several
initiatives underway to address racial disparities in care. And we look forward
to working with our NIH colleagues to develop a comprehensive strategy to
address this important issue. NEW COVERAGE DETERMINATION
PROCESS The new coverage process helps ensure that the public
is fully informed and can track the status of any determination under
consideration. We now publish on our @nvvi-.h@fa.gov web site: -a list of
coverage issues under review, -the stage of review each issue
is in, -the major scientific questions that need to be resolved prior to a
coverage decision; -an estimate of when the next action will
occur-, -a complete, indexed record of issues reviewed for each decision,
including evidence examined, major steps taken in the review, and the rationale
for decisions. Any member of the public may request a review of a national
coverage policy determination at any time. Individuals
requesting such a review need only submit the request in writing, along with new
medical and scientific evidence that merits consideration, or an analysis of
Medicare's decision demonstrating that a material misinterpretation was made in
the evaluation of evidence. We also regularly review new medical and scientific
information on our own initiative to assess whether modifications to national
coverage policy may be appropriate. We generally respond within
90 days to a coverage review request by: -referring the request
to the new Medicare Coverage Advisory Committee; -referring the
request to an independent technology assessment body, such as those that
contract with the Agency for Health Care Research and Quality, -notifying the
requester that coverage is warranted and will be granted;
-notifying the requester that coverage is not warranted and
will not be granted; -notifying the requester that coverage is
warranted, but only under certain limitations, -notifying the requester that
coverage will be left to local contractor discretion,
-notifying the requester that the request duplicates and will therefore be
combined with another pending request; or -notifying the requester that the
request duplicates an earlier request for which a decision has already been
rendered and available evidence does not warrant reconsideration. The
coverage determination process features a Medicare
Coverage Committee which reviews requests in open public
meetings. Its 120 members include nationally recognized experts in a broad range
of medical, scientific and professional disciplines as well as consumer and
industry representatives. The Committee is divided into six panels, organized to
roughly parallel Medicare benefit categories -Medical and Surgical Procedures,
-Laboratory and Diagnostics Services-, -Drugs, Biologics, and Therapeutics,
-Medical Devices and Prosthetics, -Durable Medical Equipment-, and -Diagnostic
Imaging. Each panel includes a consumer representative and an industry
representative. These panels review and evaluate medical literature, technology
assessments, and other data on the effectiveness and appropriateness of medical
items and services. Based on the evidence reviewed, the Committee advises and
makes recommendations to HCFA. We are now beginning to use this new process to
review whether acupuncture meets the C, reasonable and necessary" criteria for
coverage. Since our agency testified before you last fall, we
have thoroughly reviewed all the studies cited in the National Institutes of
Health Consensus Conference report on acupuncture. The report concluded that
scientific evidence suggests that acupuncture is "promising" for several
conditions, including treatment of chemotherapy related nausea. Our extensive
analysis of literature cited in the NIH consensus report will serve as the
starting point in the coverage determination process, and we
are making an open request for any and all additional scientific data.
Coverage Criteria To further improve and clarify, our
coverage process, last month we issued a Federal Register
notice proposing to develop national criteria for whether a service or treatment
meets the "reasonable and necessary" requirement. The notice describes two
criteria that could be applied: -Medical Benefit. An item or service is shown
through objective clinical evidence to have medical benefit -- i.e. produce a
health outcome better than the natural course of illness or disease with
customary medical management of symptoms, and -Added Value. An item or service
provides added value compared o existing treatments - - i.e. it substantially
improves health outcome, provides access to a beneficial treatment of a
different type (medication instead of surgery), or substitutes for an existing
treatment at lower cost. The notice invites public comment, which may be
received through June 15. Public comments will be considered in the drafting of
a proposed rule. The public will then have an additional opportunity to comment
on the criteria before they become final. CLINICAL TRIAL
COVERAGE This morning the President announced that we will
change Medicare policy to explicitly authorize coverage for
routine patient care costs provided to Medicare beneficiaries participating in
clinical trials. Before today, Medicare reimbursement policies often discouraged
seniors from participating in clinical trials. Because clinical trial
investigators could not guarantee that Medicare would pay for the routine care
associated with participation in their clinical trial, seniors considering
whether to enter these trials had to assume that they may be responsible for
costs simply because they were participating in a clinical trial. In addition,
investigators and research centers were often reluctant to recruit them because
of the uncertainty of Medicare coverage. Promoting biomedical
research and ensuring that Medicare beneficiaries receive the highest quality
care possible are long- standing priorities for this Administration. And we have
been greatly concerned that only about one percent of seniors now participate in
clinical trials, even though the elderly are most likely to have conditions
being studied. For cancer, seniors constitute 63 percent of cases but only 25
percent of those in clinical trials For breast cancer the disparity is worse -
half of all patients are seniors, but seniors represent less than 2 percent of
those in clinical trials. These low participation rates hinder development of
new therapies, as often takes between 3 and 5 years to enroll enough
participants a trial. In fact, one reason for the stunning advances in pediatric
cancer care has been that more than half of pediatric cancer patients were
enrolled in clinical trials over the last twenty years, and today, 75 percent of
cancers in children are curable. To address these problems, the President has
instructed us to -Immediately revise Medicare program guidance to explicitly
authorize coverage for routine patient care costs and costs due
to medical complications arising after trials. -Inform beneficiaries and
providers about this new coverage option. -Help researchers
design trials to produce data needed for Medicare coverage
decisions. -Review the feasibility and advisability of additional action to
promote research, including: -providing financial support for monitoring,
evaluation, and other non-routine, non- -covered costs for those trials of
particular relevance to Medicare beneficiaries-, -establishing a system to track
spending in trials that Medicare supports-, and -exploring further efforts to
increase participation of seniors in clinical trials and ensure that researchers
can determine the best therapies for older as well as younger patients.
ADDRESSING RACIAL DISPARITIES We are working diligently to address disturbing
disparities in access to care, morbidity, and mortality among racial and ethnic
minorities. As President Clinton said when announcing his goal to eliminate
disparities by 2010: "We do not know all the reasons for these disturbing gaps.
Perhaps inadequate education, disproportionate poverty, discrimination in the
delivery of health services, and cultural differences are all contributing
factors. But we do know this no matter what the reason, racial and ethnic
disparities in health are unacceptable in a country that values equality and
equal opportunity for all. And that is ,why we must act now with a comprehensive
initiative that focuses on health care and prevention for racial and ethnic
minorities," At HCFA, we co-sponsored a conference last fall that brought
together leading researchers to help us develop a research agenda on what causes
disparities and what helps in eliminating them. Papers we commissioned at the
conference should be published later this year. We also have new contracts with
Medicare's physician-led Peer Review Organizations that include projects with
local groups to reduce disparities. And we have many initiatives that
concentrate on making health care and health care information understandable and
attainable for all populations. For example, our HORIZONS program targets
African-American, Hispanic, Asian-American and Pacific Islander, and American
Indian and Alaska Native beneficiaries as we work to overcome language and
cultural barriers that inhibit these groups 1rom understanding and receiving
health care and information. We also are working with the Office of Minority
Health to improve our health communication efforts and to develop strategies to
reach vulnerable and underserved populations. And we are working to increase the
materials translated into other languages on our wwwmedicare.gov beneficiary web
site-, currently, information on Medicare contacts, quality comparisons, and
other useful resources is available in Spanish and Chinese on the web site.
Furthermore, the latest versions of our final Medicare+Choice regulations and
the final Quality Improvement System for Managed Care Standards and Guidelines
considerably expand cultural competency requirements. A growing body of
knowledge demonstrates that when care is provided in both a clinically competent
and culturally appropriate fashion, it is more readily understood and accepted
by the patient. A key part of cultural competency is recognizing and respecting
use of traditional treatments and beliefs, and working to integrate them into
conventional medical care. As a result, patient compliance is enhanced, outcomes
are improved, and health care costs and expenses are reduced by diminished
illness and mortality. Our efforts not only enable these populations to better -
understand Medicare and Medicaid materials, but they help us to receive survey
information and other feedback from these populations, further enhancing our
ability to provide the information and care they need. Beyond producing
materials that can be understood by a broader range of people, we are striving
to put these materials in the hands of beneficiaries, especially those in
underserved populations. Our Regional Education About Choices in Health (REACH)
campaign is the localized outreach component of the National Medicare Education
Program. It has activities tailored to reach minority groups using demographic
maps and partnering with local organizations that represent these groups. It
concentrates on educating beneficiaries on basic Medicare and their options
under the Medicare+Choice program, as well as raising beneficiary awareness of
our information channels, including Medicare.gov and 1-800-NfEDICARE. In
addition to these communication efforts, for the last two fiscal years we have
been working with the Indian Health Service to establish cost reporting for its
49 hospitals. While Medicare is moving to prospective payment systems, cost
reports may remain the final claim for payment in Medicaid. Prior to our
involvement, these facilities were not filing any cost reports for either
Medicare or Medicaid. We have been working to enhance their reporting
capabilities so they can receive Medicaid payment, and so far, 16 of the 49
hospitals are filing annual cost reports. We plan to continue working until all
49 hospitals are completing cost reports. Communications and payment are
important, but we also are working to improve minority involvement in the health
care system. Beyond our own equal opportunity programs, we serve as training
site for a number of the fellows in the American Association of Health Plans'
Minority Management Development Program. The Program is designed to expand the
number of minority managers and executives in managed care organizations. In FY
2000, three Program fellows participated in a six-week rotation at the HCFA
central office and two fellows performed a similar rotation in our California
regional office. All of our Initiatives are taking place within the broader
context of the President's goal of eliminating long-standing racial health
disparities, The Department of Health and Human Services has worked to close
these gaps in health through a plan that sets a national goal of eliminating
health disparities in six primary areas by the year 20 I 0. These areas include:
infant mortality" cancer screening and management-, cardiovascular disease,
diabetes, H1V/AlDS rates-, and child and adult immunization levels. The
Department's initiatives are spearheaded by a sweeping outreach campaign led by
Surgeon General David Satcher. This includes developing new approaches and
encouraging local, innovative strategies to address racial and ethnic health
disparities. We also are developing a new Foundation/Public Sector collaboration
to work on this initiative, and we are looking at more effective ways to target
existing federal programs to address health disparities. Perhaps most
importantly, the Department has issued a challenge to involve communities,
foundations, advocacy organizations, and businesses in developing strategies to
diminish these gaps in health. With a collaborative, national focus on this
important issue, we are moving towards raising the health levels of all
Americans - we are moving in the right direction. CONCLUSION We greatly
appreciate the desire of this Committee for wider coverage of
alternative and experimental therapies, and steps to address racial disparities
in care. We will continue to work closely with the NIH to develop the scientific
knowledge we need for coverage of alternative therapies. We
will move quickly to implement the new clinical trials coverage
policy announced today by the President. And we are committed to working to
address racial disparities in care. I thank you for holding this hearing, and I
am happy to answer your questions.
LOAD-DATE: June 15,
2000, Thursday 
