Clinical Trials: What
are States Doing?
February 2009 Update
What
is a Clinical Trial?
A clinical trial is a
research study on human patients to test the safety and effectiveness of new
treatments. These trials offer patients access to new and potentially life
saving drugs and cures.
The dramatic progress
made in treating childhood cancers in recent years, is attributable, in part, to
clinical trials, because 60 percent of all children with cancer are enrolled in
some kind of trial. A ten percent drop in breast cancer mortality for
women under the age of 50 is said to be the result of clinical trials
research conducted in the 1970's.
Who Enrolls in
Clinical Trials?
Only two to three
percent of eligible adult patients enroll in clinical trials. For cancer
patients, clinical trials are often the last resort after exhausting all other
approved means of treatment.
Only a small percentage
(approximately 20%) of cancer patients are eligible to participate in a clinical
trial and very few (approximately 3% of cancer patients and less than 0.5% of
Medicare patients) currently enroll. Even if enrollment was increased to the
full 20 percent, it is unlikely that these numbers will significantly impact
overall costs to health plans;1
Insurance Coverage
for Clinical Trials
Typically, when a
patient enrolls in a clinical trial, the cost of tests, procedures, drugs
and any research activity directly associated with the investigation,
are covered by the group sponsoring the trial, such as a pharmaceutical company
or the National Cancer Institute. However, because some health plans
define clinical trials as "experimental" or "investigational," health insurance
coverage may or may not include some or all of the costs of "routine
patient care," such as the doctor visits, hospital stays, tests and x-rays, that
a patient would normally receive whether or not they were enrolled in a
trial.
A growing number
of states have passed legislation or instituted special agreements requiring
health plans to pay the cost of the routine medical care a patient receives as a
participant in a clinical trial.
Advantages:
For cancer patients,
properly designed and conducted clinical trials represent an important
therapeutic option, as well as a critical means of advancing medical
knowledge. Lack of insurance coverage is a barrier to patients who might
otherwise participate. Sixty percent of patients in one survey cited fear
of insurance denial as a major reason for not participating in clinical
trials. And finally, a recent study found only a slight increase in
treatment costs for adult clinical trial patients compared to
nonparticipants--$35,418 versus $33,248.2
Some large HMOs have
computed costs associated with patients in clinical trials. Kaiser
Permanente discovered the cost of medical care for enrollees in clinical
trials that haven't had bone marrow transplant were no higher than for
patients who were not enrolled in a trial. The Kaiser report further states,
“Kaiser has been participating in cancer clinical trials without substantial
increases in the direct costs of medical care.”3
Researchers at the
Mayo Clinic found that patient care costs for those enrolled in clinical trials
is only slightly more than for patients who received standard therapy
protocols.4
The Institutes of
Medicine has also found the following:
-
The reimbursement costs are limited
to the cost of “standard care” which would be covered if the patient were not
enrolled in the trial;1
-
Only a small
percentage (approximately 20%) of cancer patients are eligible to participate in
a clinical trial and very few (approximately 3% of cancer patients and less than
0.5% of Medicare patients) currently enroll. Even if enrollment was increased to
the full 20 percent, it is unlikely that these numbers will significantly impact
overall costs to health plans;1
-
Through clinical
trials, we will be able to identify ineffective treatments, which could save
health plans money and will benefit the nation as a
whole.1
Disadvantages:
Even though the same
recent study found only a slight increase in treatment costs, the 6.5 percent
increase between participants and nonparticipants in clinical trials translated
into an additional $16 million in 1999 spent on treatment costs for the 19,000
adult patients enrolled in National Cancer Institute-sponsored clinical
trials.2 These additional insurance costs, like other mandated
benefits and services, may result in higher insurance premium rates, which are
often cost-shifted onto workers in the form of higher deductibles and
copayments.
For states without
insurance mandates, it is possible that some physicians may enroll patients in
clinical trials but not inform the patients' insurance companies, bypassing the
reimbursement issue for the patient and potentially the
physician.5
It may also be
possible to encourage participation in clinical trials by working within
networks of health care providers and industry, research facilities, patient
groups, as well as major media outlets, without enacting a state wide insurance
mandate.
Sources:
1. Aaron
HJ, Gelband H, editors. Extending Medicare reimbursement in clinical trials.
Washington
,
DC
:
National
Academy
Press; 2000. p
13.
2. Goldman DP, Berry
SH, McCabe M, et al. Incremental Treatment Costs in National Cancer
Institute–Sponsored Clinical Trials. JAMA. 2003;289(22):2970-2977
(doi:10.1001/jama.289.22.2970) http://jama.ama-assn.org/cgi/reprint/289/22/2970.pdf
3. Fireman BH,
Fehrenbacher L, Gruskin EP, Ray GT. Cost of care for patients in cancer clinical
trials. J Natl Cancer Inst 2000;92:136-42.
4. Wagner JL,
Alberts SR, Sloan JA, et al.
Incremental costs of enrolling cancer patients in clinical trials: a
population-based study. J Natl Cancer Inst 1999;91:847-53.
5. McBride G, More
States Mandate Coverage of Clinical Trial Costs, But Does It Make a Difference?,
JNCI Journal of the National Cancer Institute 2003 95(17):1268-1269;
doi:10.1093/jnci/95.17.1268
Definitions of
Phases:
A clinical trial study
is conducted in four phases.
Phase I:
Research is conducted on a small group of volunteers (20 to 80 people) for the
first time to evaluate its safety, determine a safe dosage range and identify
side effects.
Phase II: The
experimental drug or treatment is given to or a procedure is performed on a
larger group of people (100 to 300 individuals) to further measure its
effectiveness and safety.
Phase III:
Further research is conducted to confirm the effectiveness of the drug,
treatment or procedure, monitor the side effects, compare commonly used
treatments and collect information on safe use. Phase III trials are
typically conducted on 1,000 to 3,000 individuals.
Phase IV: After
the drug, treatment or medical procedure is marketed, investigators continue
testing to determine the effects on various populations and whether there are
side effects associated with long-term use.
Summary of State
Laws as of December 2008
Table One provides
a summary of the 23 states and
District of
Columbia
that have
enacted laws regarding mandated coverage of clinical trials.
Table
One
Clinical Trials Laws
|
State
Year of
Enactment
Bill Number and/or
Citation
|
Who is Required
to Pay?
|
What Services
or Benefits are Covered?
|
Other Key
Criteria:
|
Arizona
(2000)
Senate Bill
1213
20-2328
|
Hospital or medical service
corporations, benefit insurers, health care service organizations,
disability insurers, group disability insurers and accountable health
plans
|
Patient costs associated with
participation in Phase I through IV cancer clinical trials.
|
Trail must be reviewed by an
Institutions Review Board in AZ.
Health professional must agree to
accept reimbursement from insurer as payment in full.
Only covers trial
when no clearly superior nonivestigational treatment exists.
Trail must
be in AZ.
|
California
(2000)
Senate Bill
37
|
All
California
insurers, including Medicaid and other medical assistance
programs
|
Routine patient care costs
associated with Phase I through IV cancer clinical
trials.
|
May restrict coverage to
services in CA.
|
Connecticut
(2001)
Senate Bill
325
Public Act
01-171
|
Private insurers, individual
and group health plans
|
Routine patient care costs
associated with cancer clinical trials.
|
Prevention trials are covered
only in Phase III and only if involve therapeutic intervention.
Insurer
may require documentation of the likelihood of therapeutic benefit,
informed consent, protocol information and/or summary of
costs.
|
Delaware
(2001) Senate Bill
181
|
Every group of blanket policy,
including policies or contracts issued by health service
corporations
|
Routine patient care costs for
covered persons engaging in clinical trials for the treatment of life
threatening diseases under specified
conditions.
|
Trial must have therapeutic
intent and enroll individuals diagnosed with the disease.
Trial must
not be designed exclusively to test toxicity or disease
pathophysiology.
|
District of
Columbia
(2008)
Bill
17-469 (D.C. Law 17-166)
|
All insurers in the
District
|
Routine patient care costs for
people in clinical trials undertaken for prevention, early detection,
treatment, or monitoring of cancer and approved or funded in full or in
part by one of the following:
National Institutes of Health
or one of its cooperative groups or centers, Centers for Disease Control
and Prevention, Agency for Health Care Research and Quality, Centers for
Medicare and Medicaid Services, U.S. Food and Drug Administration (FDA),
U.S. Department of Defense, U.S. Department of Veterans Affairs, U.S.
Department of Energy, nongovernmental research entity that has been
awarded a National Cancer Institute support
grant.
|
Routine patient care costs
shall not include
tests or measurements
conducted primarily for the purpose of the clinical trial involved.
services or products provided
solely for data collection and analysis purposes.
services or products
customarily provided free of charge to trial participants by the research
sponsors.
|
Georgia
*
(1998)
33-24-59.1
|
Insurers and the state health
plan
|
Routine patient costs incurred
in Phase II and III of prescription drug clinical trial programs for the
treatment of children's cancer.
|
For the treatment of cancer
that generally first manifests itself in children under the age of
19.
|
Illinois
(1999)
House Bill
1622
(amended 2004)
Senate Bill 2339
Public Act No.
93-1000
20 ILCS
1405/56.3**
|
HMOs and individual/group
insurance policies to offer coverage to the applicant or
policyholder
(2004 amendment: Plans may not be canceled or non renewed
based on an individual's participation in a qualified clinical
trial)
|
Routine patient care if the
individual participates in an approved Phase II through IV cancer research
trial.
|
Coverage benefit can have
annual limit of $10,000.
Trial must be conducted at multiple sites in
state.
Primary care MD must be involved in coordination of
care.
Researchers must submit results of trial for publication in
nationally recognized scientific
literature.
|
Louisiana
(1999)
RS
22:1044
|
HMOs, PPOs, State Employee
Benefits Program and other specified
insurers
|
Patient costs incurred in
Phase II through IV cancer clinical
trials.
|
Only covers costs when no
clearly superior, noninvestigational approach exists.
Available data
must support reasonable expectation that the treatment will be as
effective as the noninvestigational alternative.
Patient must
sign an Institutional Review Board-approved consent
form.
|
Maine
(2000)
24-A-4310
|
Managed care organizations and
private insurers
|
Routine patient care costs
associated with clinical trial.
|
Participation must offer
meaningful potential for significant clinical benefit.
Referring
physician must conclude that trial participation is
appropriate.
|
Maryland
***
(1998)
Chap
146-15-827
|
Private insurers and other
specified managed care organizations.
|
Patient costs for Phase I
through IV cancer treatment, supportive care, early detection, and
prevention trials. Phase II through IV for other life-threatening
conditions, with Phase I considered on a case-by-case
basis.
|
There is no clearly superior,
nonivestigational alternative.
The data provide a reasonable
expectation that the treatment will be as least as effective as the
alternative.
|
Massachusetts
(2002)
Chap 176A Sec
8X
|
All health plans issued or
renewed after Jan. 1, 2003
|
Patient care services
associated with all phases of qualified cancer clinical
trials.
|
Insurers must provide payment
for services that are consistent with the usual and customary standard of
care provided under the trial's protocol and that would be covered if the
patient did not participate in the
trial.
|
Missouri
(2002)
376.429
(2006)- Phase
II
SB 567 &
792
|
All health benefit plans
operating in the state
|
Routine patient care costs as
the result of Phase II, III or IV clinical trials for the prevention,
early detection, or treatment of cancer.
|
There must be identical or
superior nonivestigational treatment alternatives available before
providing clinical trial treatment, and there must be a reasonable
expectation that the trial will be superior to the
alternatives.
Requires coverage of FDA-approved drugs and devices even
if they have not be approved for use in treatment of patient's
particular condition.
|
New
Hampshire
(2000)
415:18
|
Private insurers and specified
managed care plans
|
Medically necessary routine
patient care costs incurred as a result of a treatment for Phase I through
IV cancer clinical trial or trial for a life-threatening
disease.
|
Coverage for Phases I or II
decided on case-by-case basis.
Coverage is required for services needed
to administer drug or device under evaluation.
Coverage is required for
routine patient care associated with drugs or devices which are not
subject of trial, as long as they have been approved by
FDA.
|
Nevada
(2003)
(amended
2005)SB 29
NRS
695G.173
|
All health insurance insurers,
medical service corporations, HMOs and managed care
organizations
|
Patient costs associated with
Phase I through IV cancer or chronic fatigue clinical
trial
|
Healthcare facility and
personnel must have experience and training to provide the treatment
in a capable manner.
There must be no medical treatment available which
is considered a more appropriate alternative medical treatment than the
medical treatment provided in the clinical trial.
There must be
a reasonable expectation based on clinical data that the medical
treatment provided in the clinical trial or study will be at least as
effective as any other medical treatment.
Amendment revises type of
medical treatment covered.
|
New
Mexico
(2002)
(amended 2004 to delay repeal
until July 1, 2009)
59A-22-43
|
A health insurer; a
nonprofit health service provider; a HMO; a managed care
organization; a provider service organization; or the state's medical
assistance program.
|
Routine patient care costs
incurred as a result of the patient's participation in a phase II, III or
IV cancer clinical trial.
|
Must be undertaken for the
purposes of the prevention of reoccurrence of cancer, early detection or
treatment of cancer for which no equally or more effective standard cancer
treatment exists.
Must not be designed exclusively to test
toxicity or disease pathophysiology and it has a therapeutic
intent.
Must be provided as part of a scientific study of a new
therapy or intervention and is for the prevention of reoccurrence, early
detection, treatment or palliation of cancer in humans and in which
includes specific provisions of scientific
study.
|
New
Mexico
(2001)
59A-22-43
|
Private insurers, specified
managed care plans, and Medicaid and other state medical assistance
programs
|
Routine patient care costs
incurred as result of Phase I through IV cancer clinical
trial.
|
Effective through July 1,
2004.
Trial must have therapeutic intent.
Reasonable expectation
that investigational treatment will be at least as effective as standard
treatment.
|
North
Carolina
(2001)
?
58-3-255
|
All health insurance plans and
teachers' and state employees' comprehensive major medical
plan.
|
Medically necessary costs of
health care services associated with Phase II through IV of covered
clinical trials.
|
Patients suffering from a
life-threatening disease or chronic condition may designate a specialist
who is capable of coordinating their health care
needs.
|
Ohio
(2008)
ORC Ann.
1751.01 (2008)
|
All health benefit plans
including those for public employees.
|
Medically necessary costs of
health care services associated with any stage of clinical
trial.
|
Trial must be approved by NIH
or another group under HHS, FDA, DOD or VA. May exclude coverage for
service or product that is part of the investigative trial, item or
procedure used only for data collection for the trial, item not approved
by FDA, and transportation, lodging and food related to travel
for participation in the trial.
|
Rhode
Island
(1994, 1997)
94-S
2623B
97-S 1A
am
|
Private insurers and specified
managed care plans
|
Coverage for new cancer
therapies if treatment is provided under Phase II through IV cancer
clinical trial.
|
|
Tennessee
(2005)
HB
837
|
All health benefit
plans
|
Routine patient care costs
related to Phase I through IV cancer clinical
trial.
|
Treatment must involve
drug that is exempt under federal regulations from a new drug application,
or approved by: NIH, FDA in form of new drug application, DOD, or
VA.
|
Vermont
(2001)
(amended 2005 to
remove March 1, 2005 sunset provision)
Chap 107
-
4088b
HB
6
|
All health insurance policies
and health benefit plans, including
Medicaid
|
Routine patient care costs
incurred during the participation in a cancer clinical
trial.
|
Providers and insurers
required to participate in a cost analysis to determine impact of the
program on health insurance premiums.
Amended law allows for
participation in trial outside of
Vermont
if patient notifies health benefit plan prior to participation, and no
clinical trial is available at
Vermont
or
New
Hampshire
cancer care
providers.
|
Virginia
(1999)
?
38.2-3418.8
|
Private insurers, specified
managed care plans, and public employee health
plans
|
Patient costs incurred during
the participation in Phase II through IV cancer clinical
trials.
Coverage provided on a case-by-case basis for Phase
I.
|
There must be no clearly
superior, nonivestigational alternative.
Data must provide a reasonable
expectation that the treatment will be at least as effective as the
alternative.
|
West
Virginia
(2003)
9-2-12
|
Individual and group insurers,
health service corporations, health care corporations, HMOs, public
employees insurance agency, Medicaid and the children's health insurance
program
|
Patient costs associated with
the participation in Phase II through IV clinical trial for treatment of
life-threatening condition or the prevention, early detection and
treatment of cancer.
|
Facility and personnel
providing the treatment are capable of doing so by virtue of their
experience, training and volume of patients treated to maintain
expertise.
There must be no clearly superior,
noninvestigational treatment alternative.
Data provide a reasonable
expectation that the treatment will be more effective than the
noninvestigational treatment
alternative.
|
Wisconsin
AB
617
(2006)
Act
194
|
Any health insurance plan
offered by the state, any self-insured
plans
|
Routine patient care costs
incurred during the participation in all phases of a cancer clinical
trial.
No policy, plan, or contract may exclude coverage for the cost
of any routine patient care that is administered to an insured in a cancer
clinical trial satisfying the criteria under par. (c) and that would be
covered under the policy, plan, or contract if the insured were not
enrolled in a cancer clinical trial.
|
Trial must meet all
criteria:
1. The purpose is to test whether the intervention
potentially improves the trial participant’s health outcomes.
2. The
treatment provided as part of the trial is given with the intention of
improving the trial participant’s health outcomes.
3. The trial has
therapeutic intent and is not designed exclusively to test toxicity or
disease pathophysiology.
4. The trial does one of the following:
a.
Tests how to administer a health care service, item, or drug for the
treatment of cancer.
b. Tests responses to a health care service, item,
or drug for the treatment of cancer.
c. Compares the effectiveness of
health care services, items, or drugs for the treatment of cancer with
that of other health care services, items, or drugs for the treatment of
cancer.
d. Studies new uses of health care services, items, or drugs
for the treatment of cancer.
5. The trial is approved by one of the
following:
a. A National Institute of Health, or one of its cooperative
groups or centers, under the federal department of health and human
services; federal food and drug administration; federal department of
defense; federal department of veterans
affairs.
|
Wyoming
SF
024
(2008 budget
session)
|
All health insurance
policies, contracts, and certificates providing coverage to any resident
of this state.
|
Routine patient care for a
person enrolled in a Phases II- IV clinical trial. Includes a
medical service or treatment that is a benefit under a health plan that
would be covered if the patient were receiving standard cancer treatment;
or a drug provided to a patient during a cancer clinical trial, other
than the drug that is the subject of the clinical trial, if the drug has
been approved by the federal food and drug administration for use in
treating the patient's particular
condition.
|
Trial must also be approved by
NIH, FDA, Dept. of Defense, or Dept. of Veterans Affairs. The
medical treatment must be provided by a licensed health care provider
operating within the scope of his/her license in a facility whose
personnel has the experience and training necessary to provide the
treatment in a competent manner.
The clinical trial participant
must have signed an informed consent document prior to starting the trial.
|
*In 2002, all major
insurers in
Georgia
agreed to cover routine
patient care costs associated with Phase I, II, III, or IV cancer clinical
trials. Trials include those that involve a drug that is currently exempt
under federal regulations from a new drug application or those that are approved
by specified federal agencies or a local institutional review board. The
agreement also provides for the coverage of cancer screens and examinations in
accordance with the most recently published guidelines and recommendations
established by any nationally recognized health care organization (see
below).
**Illinois Executive
Branch Administrative Code (20 ILCS 1405/1405-20) required the Department of
Insurance to conduct an analysis and study of costs and benefits derived from
the implementation of the coverage requirements for investigational cancer
treatments. The study covered the years 2000 through 2002 and included an
analysis of the effect of the coverage requirements on the cost of insurance and
health care, the results of the treatments to patients, the mortality rate among
cancer patients, any improvements in care of patients, and any improvements in
the quality of life of patients.
***A 2003
Maryland
law (S 128)
repealed a reporting requirement for insurers, nonprofit health service plans,
and HMOs to submit a report that described the trials covered during the
previous year.
Sources: National
Cancer Institute, Health
Policy Tracking Service.
Summary of Other
Actions
Table Two summarizes
the special agreements some states have arranged with insurance companies
to voluntarily provide coverage for clinical trials.
Table
Two
Special
Agreements
|
State
(Year Agreement Became
Effective)
|
Who is Required
to Pay?
|
What Services or
Benefits are Covered?
|
Other Key
Criteria:
|
Georgia
(2002)
Georgia Cancer
Coalition
|
All major insurers
|
Routine patient care costs
associated with Phase I through IV cancer clinical
trials.
|
Trials include those that
involve a drug that is currently exempt under federal regulations from a
new drug application or those that are approved by specified federal
agencies or a local institutional review board.
Provides for the
coverage of cancer screens and examinations in accordance with the most
recently published guidelines and recommendations established by any
nationally recognized health care organization.
|
Michigan
(2002)
Michigan
Consensus
Agreement
|
Private insurance plans, HMOs
and Medicaid
|
Routine patient care
costs associated with Phase II and III cancer clinical
trials.
|
Coverage for Phase I trials is
under consideration.
|
New
Jersey
(1999)
New Jersey Consensus
Agreement
|
All
insurers
|
Routine patient care costs
associated with all phases of cancer clinical trials.
|
|
Ohio
(1999)
Ohio Med
Plan
|
State employees on Ohio Med
Plan
|
Routine patient care costs
associated with Phase II and III cancer treatment clinical
trials.
|
Preauthorization is required
for clinical trial
participation.
|
Federal
Activity
In 2000, Medicare
began covering beneficiaries patient care costs in clinical
trials. While many state Medicaid programs have no legal
requirements to cover clinical trials costs, many do cover all or some
of the costs.
Additional
Resources
American Cancer
Society, National Government Relations memo on Clinical Trials. http://www.cancer.org/docroot/ETO/ETO_6.asp
National Cancer
Institute, States That Require Health Plans to Cover Patient Care Costs in
Clinical Trials. Information and Overview: http://www.cancer.gov/clinicaltrials/ctlaws-home
To legislators and
legislative staff: For more information please contact Karmen
Hanson at health-info@ncsl.org.
|
