BILL NUMBER: SB 37 AMENDED
BILL TEXT
AMENDED IN SENATE MARCH 13, 2001
INTRODUCED BY Senator Speier
(Principal coauthors: Assembly Members Jackson and Wayne)
DECEMBER 4, 2000
An act to add Section 1370.6 to the Health and Safety Code, and to
add Section 10145.4 to the Insurance Code, relating to health
insurance, and declaring the urgency thereof, to take effect
immediately.
LEGISLATIVE COUNSEL'S DIGEST
SB 37, as amended, Speier. Health insurance: coverage for
clinical trials.
Existing law provides for the regulation and licensing of health
care service plans by the Director of the Department of Managed
Health Care and for the regulation of disability insurers by the
Insurance Commissioner. Existing law provides that a willful
violation of provisions governing health care service plans is a
crime.
Existing law requires health care service plans and certain
disability insurers to provide an external review process to examine
coverage decisions regarding experimental or investigational
therapies under certain conditions.
This bill would require health care service plans and certain
disability insurers to provide coverage for all health care services
related to the treatment of an enrollee or insured diagnosed
with cancer and accepted in a clinical trial meeting specified
requirements.
Because a willful violation of the bill's requirements with
respect to health care service plans would be a crime, this bill
would impose a state-mandated local program by creating a new crime.
The California Constitution requires the state to reimburse local
agencies and school districts for certain costs mandated by the
state. Statutory provisions establish procedures for making that
reimbursement.
This bill would provide that no reimbursement is required by this
act for a specified reason.
This bill would declare that its provisions would become
effective it is to take effect immediately as an
urgency statute.
Vote: 2/3. Appropriation: no. Fiscal committee: yes.
State-mandated local program: yes.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. It is the intent of the Legislature in enacting this
act to require health care service plans and disability insurers to
cover the costs of health care services that the patient would
normally receive had the patient not enrolled in a clinical trial to
treat cancer. It is not the intent of the Legislature to require
health care service plans and disability insurers to cover costs that
are above and beyond what would be customary had the patient not
enrolled in a clinical trial to treat cancer.
SEC. 2.
SECTION 1. Section 1370.6 is added to the Health and Safety
Code, to read:
1370.6. (a) For the purposes of this section, "clinical or
principal investigator" means the person managing the clinical trial.
(b) (1) For an enrollee diagnosed with cancer and
accepted into a Phase I, Phase II, Phase III, or Phase IV clinical
trial for cancer, every health care service plan contract, except a
specified specialized health care
service plan contract, that is issued, amended, delivered,
or renewed in this state, shall provide coverage for all health care
services related to the clinical trial if the enrollee's physician,
who is either under contract with or employed by the plan, recommends
participation in the clinical trial.
(2) Nothing in this subdivision shall be construed to require a
health care service plan to provide coverage for any of the
following:
(A) The cost of a drug or device that has not been approved by the
federal Food and Drug Administration and that is associated with the
clinical trial.
(B) The cost related to managing the research associated with the
clinical trial.
(C) The cost of travel and other nonclinical expenses.
(D) Items and services provided free of charge by the research
sponsors to an enrollee in the clinical trial.
(c) The treatment shall be provided in a clinical trial that
either involves a drug that is exempt from the requirement
under federal regulations of from
a new drug application or that is approved by one of the
following:
(1) One of the National Institutes of Health.
(2) The federal Food and Drug Administration, in the form of an
investigational new drug application.
(3) The United States Department of Defense.
(4) The United States Veterans' Administration.
(d) In the case of health care services provided by a
participating provider, the payment rate shall be at the agreed-upon
rate. In the case of a nonparticipating provider, the payment rate
shall be at the rate the plan would pay to a participating provider
for comparable the same services.
Nothing in this section shall be construed to prohibit a health care
service plan from restricting coverage for clinical trials to
participating hospitals and physicians in California unless the
protocol for the clinical trial is not provided for at a California
hospital or by a California physician.
(e) (1) The clinical or principal investigator seeking
providing coverage on behalf of an enrollee for
treatment in a clinical trial approved pursuant to subdivision (c)
shall post electronically on the National Cancer Institute's national
physician data query data base a current list of the clinical trials
for which he or she is seeking providing
coverage and that meets the requirements of paragraph (1)
of subdivision (b). This information shall also be provided
to the enrollee's health care service plan.
(2) The list shall include, for each clinical trial, all of the
following:
(A) The name of the trial.
(B) The phase of the trial.
(C) The condition being treated by the trial.
(D) The method by which further information about the trial may be
obtained.
(f) The provision of services when required by this section shall
not, in itself, give rise to liability on the part of the health care
service plan.
(g) Nothing in this section shall be construed to limit, prohibit,
or modify an enrollee's rights to the independent review process
available under Section 1370.4 or to the Independent Medical Review
System available under Article 5.55 (commencing with Section
1374.30).
(h) Nothing in this section shall be construed to otherwise limit
or modify any existing requirements under the provisions of this
chapter or to prevent application of copayment or deductible
provisions in a plan .
(i) On or before April 1 of each year, each health care service
plan shall submit a report to the director in a form required by the
director that summarizes each of the clinical trials in which an
enrollee has participated, that states the number of enrollees who
have enrolled in a clinical trial, and that indicates whether the
National Institutes of Health, the federal Food and Drug
Administration, the Department of Defense, or the Veterans'
Administration approved the clinical trial that the plan covered.
The director shall compile an annual summary report in cooperation
with the Insurance Commissioner pursuant to subdivision (j) of
Section 10145.4 of the Insurance Code. A copy of the joint annual
summary report shall be provided to the Governor and to appropriate
committees of the Legislature. The director shall also post a copy
of the report on the department's web site.
SEC. 3.
SEC. 2. Section 10145.4 is added to the Insurance Code, to
read:
10145.4. (a) For purposes of this section, "clinical or principal
investigator" means the person managing the clinical trial.
(b) (1) For an insured diagnosed with cancer and
accepted into a Phase I, Phase II, Phase III, or Phase IV clinical
trial for cancer, every policy of disability insurance that provides
hospital, medical, or surgical coverage in this state shall provide
coverage for all health care services related to the clinical trial
if the insured's physician recommends participation in the clinical
trial.
(2) Nothing in this subdivision shall be construed to require a
disability insurer to provide coverage for any of the following:
(A) The cost of a drug or device that has not been
approved by the federal Food and Drug Administration and that is
associated with the clinical trial.
(B) The cost related to managing the research associated with the
clinical trial.
(C) The cost of travel and other nonclinical expenses.
(D) Items and services provided free of charge by the research
sponsors to an insured in the clinical trial.
(c) The treatment shall be provided in a clinical trial that
either involves a drug that is exempt from the requirement
under federal regulations of from
a new drug application or that is approved by one of the
following:
(1) One of the National Institutes of Health.
(2) The federal Food and Drug Administration, in the form of an
investigational new drug application.
(3) The United States Department of Defense.
(4) The United States Veterans' Administration.
(d) In the case of health care services provided by a contracting
provider, the payment rate shall be at the agreed-upon rate. In the
case of a noncontracting provider, the payment rate shall be at the
rate the insurer would pay to a contracting provider for
comparable the same services. Nothing in this
section shall be construed to prohibit a disability insurer from
restricting coverage for clinical trials to hospitals and physicians
in California unless the protocol for the clinical trial is not
provided for at a California hospital or by a California physician.
(e) (1) The clinical or principal investigator seeking
providing coverage on behalf of an insured for
treatment in a clinical trial approved pursuant to subdivision (c)
shall post electronically on the National Cancer Institute's national
physician data query data base a current list of the clinical trials
for which he or she is seeking providing
coverage and that meets the requirements of paragraph (1)
of subdivision (b). This information shall also be provided
to the insured's disability insurer.
(2) The list shall include, for each clinical trial, all of the
following:
(A) The name of the trial.
(B) The phase of the trial.
(C) The condition being treated by the trial.
(D) The method by which further information about the trial may be
obtained.
(f) The provision of services when required by this section shall
not, in itself, give rise to liability on the part of the insurer.
(g) This section shall not apply to vision-only, dental-only,
accident-only, specified disease, hospital indemnity, Medicare
supplement, CHAMPUS supplement, long-term care, or
disability income insurance, except that for specified disease and
hospital indemnity insurance, coverage for benefits under this
section shall apply, but only to the extent that the benefits are
covered under the general terms and conditions that apply to all
other benefits under the policy. Nothing in this section shall be
construed as imposing a new benefit mandate on specified disease or
hospital indemnity insurance.
(h) Nothing in this section shall be construed to prohibit, limit,
or modify an insured's rights to the independent review process
available under Section 10145.3 or to the Independent Medical Review
System available under Article 3.5 (commencing with Section 10169).
(i) Nothing in this section shall be construed to otherwise limit
or modify any existing requirements under the provisions of this
chapter or to prevent application of deductible or copayment
provisions contained in the policy .
(j) On or before April 1 of each year, every disability insurer
shall submit a report to the commissioner in a form required by the
commissioner that summarizes each of the clinical trials in which an
insured has participated, that states the number of insureds who have
enrolled in a clinical trial, and that indicates whether the
National Institutes of Health, the federal Food and Drug
Administration, the Department of Defense, or the Veterans'
Administration approved the clinical trial that the insurer covered.
The commissioner shall compile an annual summary report in
cooperation with the Director of the Department of Managed Health
Care pursuant to subdivision (i) of Section 1370.6 of the Health and
Safety Code. A copy of the joint annual summary report shall be
provided to the Governor and to appropriate committees of the
Legislature. The commissioner shall also post a copy of the report
on the department's web site.
SEC. 4.
SEC. 3. No reimbursement is required by this act pursuant to
Section 6 of Article XIIIB of the California Constitution because
the only costs that may be incurred by a local agency or school
district will be incurred because this act creates a new crime or
infraction, eliminates a crime or infraction, or changes the penalty
for a crime or infraction, within the meaning of Section 17556 of the
Government Code, or changes the definition of a crime within the
meaning of Section 6 of Article XIIIB of the California Constitution.
This
SEC. 4. This act is an urgency statute necessary for the
immediate preservation of the public peace, health, or safety within
the meaning of Article IV of the Constitution and shall go into
immediate effect. The facts constituting the necessity are:
There is abundant evidence that health care service plans and
disability insurers are not providing access to and coverage for
medically necessary health care services related to clinical trials
for cancer patients who may die without this treatment. Given the
urgent circumstances for these individuals to receive this vital
treatment on a timely basis, it is necessary hat
that this act take effect immediately.