BILL NUMBER: SB 37 CHAPTERED
BILL TEXT
CHAPTER 172
FILED WITH SECRETARY OF STATE AUGUST 10, 2001
APPROVED BY GOVERNOR AUGUST 9, 2001
PASSED THE SENATE JULY 21, 2001
PASSED THE ASSEMBLY JULY 20, 2001
AMENDED IN ASSEMBLY JULY 16, 2001
AMENDED IN ASSEMBLY JUNE 26, 2001
AMENDED IN ASSEMBLY JUNE 11, 2001
AMENDED IN SENATE MAY 2, 2001
AMENDED IN SENATE APRIL 16, 2001
AMENDED IN SENATE MARCH 13, 2001
INTRODUCED BY Senator Speier
(Principal coauthors: Assembly Members Jackson and Wayne)
(Coauthor: Senator Perata)
(Coauthors: Assembly Members Alquist, Aroner, Bates, Cedillo,
Cohn, Goldberg, Koretz, Liu, Maldonado, Migden, Pavley, Thomson, and
Zettel)
DECEMBER 4, 2000
An act to add Section 1370.6 to the Health and Safety Code, to add
Section 10145.4 to the Insurance Code, and to add Sections 14087.11,
14132.98, and 14132.99 to the Welfare and Institutions Code,
relating to health insurance.
LEGISLATIVE COUNSEL'S DIGEST
SB 37, 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 specified health care
services related to the treatment of an enrollee or insured diagnosed
with cancer and accepted in a clinical trial meeting specified
requirements. The bill would require copayments and deductibles for
those services delivered in a clinical trial to be the same as for
the services not delivered in a clinical trial.
Existing law provides for the Medi-Cal program, which is
administered by the State Department of Health Services, pursuant to
which medical benefits are provided to public assistance recipients
and certain other low-income persons. Pursuant to existing law,
County Organized Health Systems are systems that contract with the
State Department of Health Services to provide comprehensive health
care to all eligible Medi-Cal beneficiaries residing in a county, and
that are operated directly by a public entity established by a
county government.
This bill would require the Medi-Cal program and County Organized
Health System plans to provide coverage for specified health care
services related to the treatment of an enrollee or beneficiary
diagnosed with cancer and accepted in a clinical trial meeting
specified requirements. By modifying the eligibility determination
process under the Medi-Cal program, the bill would increase the
responsibilities of counties in the administration of the Medi-Cal
program and would result in a state-mandated local program.
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, including the creation of a State Mandates Claims Fund
to pay the costs of mandates that do not exceed $1,000,000 statewide
and other procedures for claims whose statewide costs exceed
$1,000,000.
This bill would provide that with regard to certain mandates no
reimbursement is required by this act for a specified reason.
With regard to any other mandates, this bill would provide that,
if the Commission on State Mandates determines that the bill contains
costs so mandated by the state, reimbursement for those costs shall
be made pursuant to the statutory provisions noted above.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 1370.6 is added to the Health and Safety Code,
to read:
1370.6. (a) 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 specialized
health care service plan contract, that is issued, amended,
delivered, or renewed in this state, shall provide coverage for all
routine patient care costs related to the clinical trial if the
enrollee's treating physician, who is providing covered health care
services to the enrollee under the enrollee's health benefit plan
contract, recommends participation in the clinical trial after
determining that participation in the clinical trial has a meaningful
potential to benefit the enrollee. For purposes of this section, a
clinical trial's endpoints shall not be defined exclusively to test
toxicity, but shall have a therapeutic intent.
(b) (1) "Routine patient care costs" means the costs associated
with the provision of health care services, including drugs, items,
devices, and services that would otherwise be covered under the plan
or contract if those drugs, items, devices, and services were not
provided in connection with an approved clinical trial program,
including:
(A) Health care services typically provided absent a clinical
trial.
(B) Health care services required solely for the provision of the
investigational drug, item, device, or service.
(C) Health care services required for the clinically appropriate
monitoring of the investigational item or service.
(D) Health care services provided for the prevention of
complications arising from the provision of the investigational drug,
item, device, or service.
(E) Health care services needed for the reasonable and necessary
care arising from the provision of the investigational drug, item,
device, or service, including the diagnosis or treatment of the
complications.
(2) For purposes of this section, "routine patient care costs"
does not include the costs associated with the provision of any of
the following:
(A) Drugs or devices that have not been approved by the federal
Food and Drug Administration and that are associated with the
clinical trial.
(B) Services other than health care services, such as travel,
housing, companion expenses, and other nonclinical expenses, that an
enrollee may require as a result of the treatment being provided for
purposes of the clinical trial.
(C) Any item or service that is provided solely to satisfy data
collection and analysis needs and that is not used in the clinical
management of the patient.
(D) Health care services that, except for the fact that they are
being provided in a clinical trial, are otherwise specifically
excluded from coverage under the enrollee's health plan.
(E) Health care services customarily provided by the research
sponsors free of charge for any enrollee in the trial.
(3) Nothing in this section shall require a health care service
plan contracting with the State Department of Health Services for the
purpose of providing Medi-Cal benefits to enrolled beneficiaries or
contracting with the Managed Risk Medical Insurance Board for the
purposes of providing benefits under the Healthy Families Program,
the Access for Infants and Mothers Program, or the California Major
Risk Medical Insurance Program, to be responsible for reimbursement
of services excluded from their contract because another entity is
responsible by statute or otherwise for reimbursement of the service
provider.
(c) The treatment shall be provided in a clinical trial that
either:
(1) Involves a drug that is exempt under federal regulations from
a new drug application.
(2) Is approved by one of the following:
(A) One of the National Institutes of Health.
(B) The federal Food and Drug Administration, in the form of an
investigational new drug application.
(C) The United States Department of Defense.
(D) 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 shall
be at the negotiated rate the plan would otherwise pay to a
participating provider for the same services, less any applicable
copayments and deductibles.
(e) 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.
(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) Copayments and deductibles applied to services delivered in a
clinical trial shall be the same as those applied to the same
services if not delivered in a clinical trial.
SEC. 2. Section 10145.4 is added to the Insurance Code, to read:
10145.4. (a) 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 routine patient care costs related to the clinical trial if
the insured's treating physician, who is providing covered health
care services to the insured under the insured's health benefit plan
contract recommends participation in the clinical trial after
determining that participation in the clinical trial has a meaningful
potential to benefit the insured. For purposes of this section a
clinical trial's endpoints shall not be defined exclusively to test
toxicity, but shall have a therapeutic intent.
(b) (1) "Routine patient care costs" means the costs associated
with the provision of health care services, including drugs, items,
devices, and services that would otherwise be covered under the plan
or contract if those drugs, items, devices, and services were not
provided in connection with an approved clinical trial program,
including the following:
(A) Health care services typically provided absent a clinical
trial.
(B) Health care services required solely for the provision of the
investigational drug, item, device, or service.
(C) Health care services required for the clinically appropriate
monitoring of the investigational item or service.
(D) Health care services provided for the prevention of
complications arising from the provision of the investigational drug,
item, device, or service.
(E) Health care services needed for the reasonable and necessary
care arising from the provision of the investigational drug, item,
device, or service, including the diagnosis or treatment of the
complications.
(2) For purposes of this section, "routine patient care costs"
does not include the costs associated with the provision of any of
the following:
(A) Drugs or devices that have not been approved by the federal
Food and Drug Administration and that are associated with the
clinical trial.
(B) Services other than health care services, such as travel,
housing, companion expenses, and other nonclinical expenses, that an
insured may require as a result of the treatment being provided for
purposes of the clinical trial.
(C) Any item or service that is provided solely to satisfy data
collection and analysis needs and that is not used in the clinical
management of the patient.
(D) Health care services which, except for the fact that they are
not being provided in a clinical trial, are otherwise specifically
excluded from coverage under the insured's health plan.
(E) Health care services customarily provided by the research
sponsors free of charge for any enrollee in the trial.
(c) The treatment shall be provided in a clinical trial that
either (1) involves a drug that is exempt under federal regulations
from a new drug application or (2) that is approved by one of the
following:
(A) One of the National Institutes of Health.
(B) The federal Food and Drug Administration, in the form of an
investigational new drug application.
(C) The United States Department of Defense.
(D) 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 shall be at the
negotiated rate the insurer would otherwise pay to a contracting
provider for the same services, less applicable copayments and
deductibles. 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) The provision of services when required by this section shall
not, in itself, give rise to liability on the part of the insurer.
(f) 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.
(g) 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).
(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 deductible or copayment
provisions contained in the policy.
(i) Copayments and deductibles applied to services delivered in a
clinical trial shall be the same as those applied to the same
services if not delivered in a clinical trial.
SEC. 3. Section 14087.11 is added to the Welfare and Institutions
Code, to read:
14087.11. (a) The provisions of this section shall be applicable
to any county that seeks to provide or arrange for the provision of
health care services provided under Article 2.8 and to Santa Barbara
County if it seeks to provide or arrange the provision of health care
services pursuant to Section 14499.5.
(b) For an enrollee diagnosed with cancer and accepted into a
phase I, phase II, phase III, or phase IV clinical trial for cancer,
every County Organized Health System contract that is issued,
amended, delivered, or renewed in this state, shall provide coverage
for all routine patient care costs related to the clinical trial if
the enrollee's treating physician, who is providing covered health
care services to the enrollee under the enrollee's County Organized
Health System contract, recommends participation in the clinical
trial after determining that participation in the clinical trial has
a meaningful potential to benefit the enrollee. For purposes of this
section, physicians that are providing care under a subcontract with
an entity under contract with a County Organized Health System shall
be considered to be physicians providing covered health care
services to the enrollee under the County Organized Health System
contract. For purposes of this section, a clinical trial's endpoints
shall not be defined exclusively to test toxicity, but shall have a
therapeutic intent.
(c) (1) "Routine patient care costs" means the costs associated
with the provision of health care services, including drugs, items,
devices, and services that would otherwise be covered by the County
Organized Health System if those drugs, items, devices, and services
were not provided in connection with an approved clinical trial
program, including:
(A) Health care services typically provided absent a clinical
trial.
(B) Health care services required solely for the provision of the
investigational drug, item, device, or service.
(C) Health care services required for the clinically appropriate
monitoring of the investigational item or service.
(D) Health care services provided for the prevention of
complications arising from the provision of the investigational drug,
item, device, or service.
(E) Health care services needed for the reasonable and necessary
care arising from the provision of the investigational drug, item,
device, or service, including the diagnosis or treatment of the
complications.
(2) For purposes of this section, "routine patient care costs"
does not include the costs associated with the provision of any of
the following:
(A) Drugs or devices that have not been approved by the federal
Food and Drug Administration and that are associated with the
clinical trial.
(B) Services other than health care services, such as travel,
housing, companion expenses, and other nonclinical expenses, that an
enrollee may require as a result of the treatment being provided for
purposes of the clinical trial.
(C) Any item or service that is provided solely to satisfy data
collection and analysis needs and that is not used in the clinical
management of the patient.
(D) Health care services that, except for the fact that they are
being provided in a clinical trial, are otherwise specifically
excluded from coverage under the enrollee's County Organized Health
System.
(E) Health care services customarily provided by the research
sponsors free of charge for any enrollee in the trial.
(d) The treatment shall be provided in a clinical trial that
either:
(1) Involves a drug that is exempt under federal regulations from
a new drug application.
(2) Is approved by one of the following:
(A) One of the National Institutes of Health.
(B) The federal Food and Drug Administration, in the form of an
investigational new drug application.
(C) The United States Department of Defense.
(D) The United States Veterans' Administration.
(e) 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 shall
be at the negotiated rate the plan would otherwise pay to a
participating provider for the same services, less any applicable
copayments and deductibles.
(f) Nothing in this section shall be construed to prohibit a
County Organized Health System 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.
(g) The provision of services when required by this section shall
not, in itself, give rise to liability on the part of the County
Organized Health System.
(h) Nothing in this section shall be construed to otherwise limit
or modify any existing requirements under the provisions of this
chapter.
SEC. 4. Section 14132.98 is added to the Welfare and Institutions
Code, to read:
14132.98. (a) For a beneficiary diagnosed with cancer and
accepted into a phase I, phase II, phase III, or phase IV clinical
trial for cancer, the Medi-Cal program shall provide coverage for all
routine patient care costs related to the clinical trial if the
beneficiary's treating physician, who is providing covered health
care services to the beneficiary under the Medi-Cal program,
recommends participation in the clinical trial after determining that
participation in the clinical trial has a meaningful potential to
benefit the beneficiary. For purposes of this section, a clinical
trial's endpoints shall not be defined exclusively to test toxicity,
but shall have a therapeutic intent.
(b) (1) "Routine patient care costs" means the costs associated
with the provision of health care services, including drugs, items,
devices, and services that would otherwise be covered under the
Medi-Cal program if those drugs, items, devices, and services were
not provided in connection with an approved clinical trial program,
including:
(A) Health care services typically provided absent a clinical
trial.
(B) Health care services required solely for the provision of the
investigational drug, item, device, or service.
(C) Health care services required for the clinically appropriate
monitoring of the investigational item or service.
(D) Health care services provided for the prevention of
complications arising from the provision of the investigational drug,
item, device, or service.
(E) Health care services needed for the reasonable and necessary
care arising from the provision of the investigational drug, item,
device, or service, including the diagnosis or treatment of the
complications.
(2) For purposes of this section, "routine patient care costs"
does not include the costs associated with the provision of any of
the following:
(A) Drugs or devices that have not been approved by the federal
Food and Drug Administration and that are associated with the
clinical trial.
(B) Services other than health care services, such as travel,
housing, companion expenses, and other nonclinical expenses, that a
beneficiary may require as a result of the treatment being provided
for purposes of the clinical trial, except as required under the
Medicaid Program (42 U.S.C. Sec. 1396a et seq.).
(C) Any item or service that is provided solely to satisfy data
collection and analysis needs and that is not used in the clinical
management of the patient.
(D) Health care services that, except for the fact that they are
being provided in a clinical trial, are otherwise specifically
excluded from coverage by the Medi-Cal program.
(E) Health care services customarily provided by the research
sponsors free of charge for any beneficiary in the trial.
(c) The treatment shall be provided in a clinical trial that
either:
(1) Involves a drug that is exempt under federal regulations from
a new drug application.
(2) Is approved by one of the following:
(A) One of the National Institutes of Health.
(B) The federal Food and Drug Administration, in the form of an
investigational new drug application.
(C) The United States Department of Defense.
(D) The United States Veterans' Administration.
(d) Nothing in this section shall be construed to prohibit the
Medi-Cal program 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) The provision of services when required by this section shall
not, in itself, give rise to liability on the part of the Medi-Cal
program.
SEC. 5. Section 14132.99 is added to the Welfare and Institutions
Code, to read:
14132.99. For services provided pursuant to Chapter 7 (commencing
with Section 14000) of Division 9 of Part 3, Section 14499.5, or
Chapters 1 to 4, inclusive, (commencing with Section 101525) of Part
4 of Division 101 of the Health and Safety Code, the cost for
services defined in Section 1370.6 of the Health and Safety Code, and
Sections 14132.98 and 14087.11 shall be provided by state only funds
if federal financial participation is not available.
SEC. 6. No reimbursement is required by this act pursuant to
Section 6 of Article XIIIB of the California Constitution for certain
costs that may be incurred by a local agency or school district
because in that regard 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.
However, notwithstanding Section 17610 of the Government Code, if
the Commission on State Mandates determines that this act contains
other costs mandated by the state, reimbursement to local agencies
and school districts for those costs shall be made pursuant to Part 7
(commencing with Section 17500) of Division 4 of Title 2 of the
Government Code. If the statewide cost of the claim for
reimbursement does not exceed one million dollars ($1,000,000),
reimbursement shall be made from the State Mandates Claims Fund.