Clinical Trials and Insurance Coverage - A Resource Guide
Basics
Strategies
Initiatives to Expand Coverage
Clinical Trials and Insurance Coverage - A Resource Guide
As you consider enrolling in a clinical trial, you will face the critical issue
of how to cover the costs of care. Even if you have health insurance, your coverage
may not include some or all of the patient care costs associated with a clinical
trial. This is because some health plans define clinical trials as "experimental"
or "investigational" procedures.
A growing number of states have passed legislation or instituted special agreements requiring health plans to pay the cost of routine medical care you receive as a participant in a clinical trial. For more information, see States That Require Health Plans to Cover Patient Care Costs in Clinical Trials 1.
Because lack of coverage for these costs can keep people from enrolling in
trials, the National Cancer Institute is working with major health plans and
managed care groups to find solutions. In the meantime, there are strategies
that may help you deal with cost and coverage barriers. This guide answers frequently
asked questions about insurance coverage for clinical trial participation and
directs you to additional information resources.
The material here is mainly concerned with treatment clinical trials, since
other types of trials (prevention, screening, etc.) are newer and generally
not covered by health insurance at all. However, this guide may become more
relevant for prevention and other types of trials as these trials grow more
common.
In 2000, Medicare began covering beneficiaries' patient care costs in clinical
trials. Up-to-date information about what Medicare will cover can be found on
the Web site of the Centers for
Medicare & Medicaid 2 (formerly the Health Care Financing Administration).
A summary of Medicare coverage as of January 2001 is included in this guide.
If you do not have any health insurance, you may find this section helpful
for understanding some of the costs that trials involve.
Basics
There are two types of costs associated with a clinical trial: patient care costs and research
costs.
Patient care costs fall into two categories:
Usual care costs, such as doctor visits, hospital stays, clinical
laboratory tests, x-rays, etc., which occur whether you are participating
in a trial or receiving standard treatment. These costs have usually been
covered by a third-party health plan, such as Medicare or private insurance.
Extra care costs associated with clinical trial participation, such
as the additional tests that may or may not be fully covered by the clinical
trial sponsor and/or research institution. The sponsor and the participant's
health plan need to resolve coverage of these costs for particular trials.
Research costs are those associated with conducting the trial, such
as data collection and management, research physician and nurse time, analysis
of results, and tests purely performed for research purposes. Such costs are
usually covered by the sponsoring organization, such as the National Cancer Institute (NCI) or a pharmaceutical
company.
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Health insurance companies and managed care companies decide which health care
services they will pay for by developing a coverage policy regarding the specific
services. In general, the most important factor determining whether something
is covered is a health plan's judgment as to whether the service is established
or investigational. Health plans usually designate a service as established
if there is a certain amount of scientific data to show that it is safe and
effective. If the health plan does not think that such data exist in sufficient
quantity, the plan may label the service as investigational.
Health care services delivered within the setting of a clinical trial are very
often categorized as investigational and not covered. This is because the health
plan thinks that the major reason to perform the clinical trial is that there
is not enough data to establish the safety and effectiveness of the service
being studied. Thus, for some health plans, any mention of the fact that the
patient is involved in a clinical trial results in a denial of payment.
Your health plan may define specific criteria that a trial must meet before
extending coverage, such as:
Trial phase and type:
Some plans may cover patient care costs only for the clinical trials they
judge to be "medically necessary" on a case-by-case basis. Trial
phase may also affect coverage; for example, while a plan may be willing to
cover costs associated with phase III trials, which include treatments that
have already been successful with a certain number of people, the plan may
require some documentation of effectiveness before covering a phase I or phase II
trial.
While health plans are interested in efforts to improve prevention and
screening, they currently seem less likely to have a review process in place
for these trials. Therefore, it may be more difficult to get coverage for
the care costs associated with them.
See
What is a Clinical Trial? 3
for a description of the phases of cancer clinical trials.
Some plans, especially smaller ones, will not cover any costs associated
with a clinical trial. Policies vary widely, but in most cases your best bet
is to have your doctor start discussions with the health plan.
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For up-to-date information about Medicare coverage of clinical trials, go to
the Web site for the Centers for
Medicaid & Medicare 4 (formerly the Health Care Financing Administration).
As of January 2001, the following information was accurate:
If I'm in a clinical trial, what will Medicare pay?
Anything normally covered is still covered when it is part of a clinical
trial. This includes test, procedures, and doctor visits that are ordinarily
covered.
Anything normally covered even if it is a service or item associated with
the experimental treatment. For example, Medicare will pay for the intravenous
administration of a new chemotherapy drug being tested in a trial, including
any therapy to prevent side effects from the new drug.
Anything normally covered even if it resulted from your being in the clinical
trial. For example, a test or hospitalization resulting from a side effect
of the new treatment that Medicare would ordinarily cover.
What costs are not covered?
Investigational items or services being tested in a trial. Sponsors of clinical
trials often provide the new drug free, but make sure you ask your doctor
before you begin.
Items or services used solely for the data collection needs of the
trial.
Anything being provided free by the sponsor of the trial.
What kinds of clinical trials are covered?
The National Cancer Institute's Cancer Information Service has provided a fact sheet for Medicare beneficiaries
(see More Choices in Cancer Care: Information for Beneficiaries on Medicare Coverage of Cancer Clinical Trials 5). In general, cancer treatment and
diagnosis trials are covered if:
They are funded by the National Cancer Institute (NCI), NCI-Designated Cancer
Centers, NCI-Sponsored Clinical Trials Cooperative Groups and all other federal
agencies that fund cancer research. Other trials may be eligible for coverage
and doctors can ask Medicare to pay the patients' costs. Ask your doctor about
this before you begin.
They are designed to treat or diagnose your cancer.
The purpose or subject of the trial is within a Medicare benefit category.
For example, cancer diagnosis and treatment are Medicare benefits, so these
trials are covered. Cancer prevention trials are not currently covered.
Strategies
There are several steps you can follow to deal with coverage issues up front
when deciding to enter a
clinical trial. Along the way, enlist the
help of family members and your doctor or other health professionals. You may
find the following checklist useful:
-
Understand the costs associated with the trial. Ask your doctor or the
trial's contact person about the costs that must be covered by you or your
health plan. Are these costs significantly higher than those associated with
standard therapy? Also, inquire about the
experience of other patients in the trial. Have their plans paid for their
care? Have there been any persistent problems with coverage? How often have the
trial's administrators been successful in getting plans to cover patient care
costs?
-
Understand your health plan. Be sure you know what's in your policy;
request and carefully review the actual contract language. If there's a
specific exclusion for "experimental treatment," look closely at the
policy to see how the plan defines such treatment and under what conditions it
might be covered. If it is not clearly defined, call the plan's customer
service line, consult their Web site, and/or write to them. Ask for specific
information about clinical trials coverage.
-
Work closely with your doctor. Talk with your doctor about the paperwork
he or she submits to your health plan. If there have been problems with
coverage in the past, you might ask your doctor or the hospital to send an
information package to the plan that includes studies supporting the
procedure's safety, benefits, and medical appropriateness. This package might
include:
-
publications from peer-reviewed literature about the proposed therapy that
demonstrate patient benefits;
-
a letter that uses the insurance contract's own language to explain why the
treatment,
screening method, or preventive measure
should be covered;
-
letters from researchers that explain the clinical trial;
-
support letters from
patient advocacy groups.
Be sure to keep your own copy of any materials that the doctor sends to your
health plan for future reference.
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If a claim is denied, read your policy to find out what steps you can follow to
make an appeal. In the book called What Cancer Survivors Need to Know about Health Insurance 6,
the National Coalition for Cancer Survivorship suggests that you and your doctor demonstrate to the
health plan that:
-
the therapy is not just a research study, but also a valid procedure that
benefits patients;
-
your situation is similar to that of other patients who are participating in
clinical trials as part of a covered benefit;
-
possible complications have been anticipated and can be handled effectively.
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It's never easy to deal with financial issues when you or a loved one faces
cancer. Unfortunately, costs can present a significant barrier to clinical
trials participation.
The range of insurance issues and health plan contracts makes it impossible to
deal with all of them here. You may wish to consult this partial list of
publications, organizations, and Web sites for more information:
Publications
- What Cancer Survivors Need to Know about Health Insurance
-
National Coalition for Cancer Survivorship 7
-
http://www. cansearch. org/
-
1010 Wayne Avenue, 5th floor
-
Silver Spring, MD 20910
- (301) 650-8868
- Cancer Treatments Your Insurance Should Cover
-
The Association of Community
Cancer Centers 8
-
http://www.accc-cancer.org/main2001.shtml
-
11600 Nebel Street, Suite 201
-
Rockville, MD 20852
- (301) 984-9496
- The Managed Care Answer Guide
-
Patient Advocate Foundation
-
739 Thimble Shoals Boulevard, Suite 704
-
Newport News, VA 23606
-
(757) 873-6668
-
email: ndepaf@pinn.net
-
Publications about Medicare 9 from the Centers
for Medicare and Medicaid Services 10
-
New Medicare site 11
-
http://www.medicare.gov/
-
Medicare Helpline: 1-800-444-4606
- Facing Forward Series: Life After Cancer Treatment (features a section
on insurance issues)
-
National Cancer Institute
-
Facing Forward 12 or by calling 1-800-4-CANCER
Assistance Programs
- Candlelighters Childhood Cancer Foundation 13
-
http://www.candlelighters.org
-
Ombudsman Program
-
910 Woodmont Avenue, #4607
-
Bethesda, MD 20814
-
(301) 657-8401; 1-800-366-2223 (toll-free)
-
email: info@candlelighters.org
- The Ombudsman Program helps families of
children with cancer and survivors of childhood cancer resolve a range of
problems, including insurance coverage difficulties. Local groups appoint a
Parent Advocate who works with the treatment center on behalf of families.
- Medical Care Management Corporation 14
-
http://www.mcman.com/
-
5272 River Road, Suite 650
-
Bethesda, MD 20816-1405
-
(301) 652-1818
-
email: mcman@mcman.com
- Working for a range of clients, including health
plans, employers, and patients, MCMC conducts independent, objective reviews of
high-technology medical care cases to assist in decision-making. While it does
charge for its services, MCMC also offers a volunteer program for those who
cannot afford to pay.
More Information Resources
- OncoLink 15, a service of the University of
Pennsylvania Cancer Center.
http://www.oncolink.com/
In addition to general cancer information, this Web site features a section on
financial information for patients 16 (http://www.oncolink.com/resources/resources.cfm?c=6).
Among the topics: viatical settlements, life insurance, a glossary of financial
and medical terms, and news about billing and insurance.
- AAHP-HIAA 17
-
http://www.aahp.org/
-
601 Pennsylvania Avenue, NW
-
South Building, Suite 500
-
Washington, DC 20004
-
(202) 778-3200
In October 2003, the American Association of Health Plans merged with the
Health Insurance Association of America to form the AAHP-HIAA, the national
trade association representing the private sector in health care.
- American Academy of Family Physicians (AAFP) 19
-
http://www.aafp.org/
-
P.O. Box 11210
-
Shawnee Mission, KS 66207-1210
The AAFP's mission is to preserve and promote the science and art of family
medicine and to ensure high-quality, cost-effective health care for patients of
all ages.
- National Association of Insurance
Commissioners (NAIC) 21
-
http://www.naic.org/index.htm
-
2301 McGee Street
-
Suite 800
-
Kansas City, MO 64108-2662
-
Initiatives to Expand Coverage
The good news is that there has been a recent nationwide effort to assure
clinical trials coverage, with the National Cancer Institute (NCI) involved in
several new initiatives.
-
NCI's Department of Defense Agreement
-
An innovative 1996 agreement between NCI and the Department of Defense (DoD)
has given thousands of DoD cancer patients more options for care and greater
access to state-of-the-art treatments. Patients who are beneficiaries of
TRICARE/CHAMPUS, the DoD's health program, are covered for NCI-sponsored
phase II and
phase III clinical treatment trials. NCI and DoD are refining a system
that allows physicians and patients to determine quickly what current trials
meet their needs and where they are taking place.
See the
VA/DoD Beneficiaries Digest Page 23 for additional information.
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-
NCI's Department of Veterans Affairs Agreement
-
A 1997 agreement with the Department of
Veterans Affairs 24 provides coverage for eligible veterans of the armed
services to participate in NCI-sponsored prevention, diagnosis, and treatment
studies nationwide.
See the
VA/DoD Beneficiaries Digest Page 23 for additional information.
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Other Developments
-
Pediatric Cancer Care Network:
This network, a cooperative agreement among the Children's Cancer Group,
the Pediatric Oncology Group, and the Blue Cross Blue Shield System Association
(BCBS) nationwide, will ensure that children of BCBS subscribers receive care
at designated centers of cancer care excellence and may promote the enrollment
of children in Cooperative Group clinical trials.
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