SECTIONS 10140-10145.4 - California Statutes

INSURANCE CODE

SECTION 10140-10145.4

10140. (a) No admitted insurer, licensed to issue life or
disability insurance, shall fail or refuse to accept an application
for that insurance, to issue that insurance to an applicant therefor,
or issue or cancel that insurance, under conditions less favorable
to the insured than in other comparable cases, except for reasons
applicable alike to persons of every race, color, religion, sex,
national origin, ancestry, or sexual orientation. Race, color,
religion, national origin, ancestry, or sexual orientation shall not,
of itself, constitute a condition or risk for which a higher rate,
premium, or charge may be required of the insured for that insurance.
Unless otherwise prohibited by law, premium, price, or charge
differentials because of the sex of any individual when based on
objective, valid, and up-to-date statistical and actuarial data or
sound underwriting practices are not prohibited.
(b) Except as otherwise permitted by law, no admitted insurer,
licensed to issue disability insurance policies for hospital,
medical, and surgical expenses, shall fail or refuse to accept an
application for that insurance, fail or refuse to issue that
insurance to an applicant therefor, cancel that insurance, refuse to
renew that insurance, charge a higher rate or premium for that
insurance, or offer or provide different terms, conditions, or
benefits, or place a limitation on coverage under that insurance, on
the basis of a person's genetic characteristics that may, under some
circumstances, be associated with disability in that person or that
person's offspring.
(c) No admitted insurer, licensed to issue disability insurance
for hospital, medical, and surgical expenses, shall seek information
about a person's genetic characteristics for any nontherapeutic
purpose.
(d) No discrimination shall be made in the fees or commissions of
agents or brokers for writing or renewing a policy of disability
insurance, other than disability income, on the basis of a person's
genetic characteristics that may, under some circumstances, be
associated with disability in that person or that person's offspring.
(e) It shall be deemed a violation of subdivision (a) for any
insurer to consider sexual orientation in its underwriting criteria
or to utilize marital status, living arrangements, occupation, sex,
beneficiary designation, ZIP Codes or other territorial
classification within this state, or any combination thereof for the
purpose of establishing sexual orientation or determining whether to
require a test for the presence of the human immunodeficiency virus
or antibodies to that virus, where that testing is otherwise
permitted by law. Nothing in this section shall be construed to
alter, expand, or limit in any manner the existing law respecting the
authority of insurers to conduct tests for the presence of human
immunodeficiency virus or evidence thereof.
(f) This section shall not be construed to limit the authority of
the commissioner to adopt regulations prohibiting discrimination
because of sex, marital status, or sexual orientation or to enforce
these regulations, whether adopted before or on or after January 1,
1991.
(g) "Genetic characteristics" as used in this section shall have
the same meaning as defined in Section 10123.3.
(h) "Sex" as used in this section shall have the same meaning as
"gender," as defined in Section 422.56 of the Penal Code.

10140.1. (a) This section shall apply to the disclosure of genetic
test results contained in an applicant or enrollee's medical records
by an admitted insurer licensed to issue life or disability
insurance, except life and disability income policies issued or
delivered on or after January 1, 1995, that are contingent upon
review or testing for other diseases or medical conditions.
(b) Any person who negligently discloses results of a test for a
genetic characteristic to any third party in a manner that identifies
or provides identifying characteristics, of the person to whom the
test results apply, except pursuant to a written authorization as
described in subdivision (g), shall be assessed a civil penalty in an
amount not to exceed one thousand dollars ($1,000) plus court costs,
as determined by the court, which penalty and costs shall be paid to
the subject of the test.
(c) Any person who willfully discloses the results of a test for a
genetic characteristic to any third party in a manner that
identifies or provides identifying characteristics of the person to
whom the test results apply, except pursuant to a written
authorization as described in subdivision (g), shall be assessed a
civil penalty in an amount not less than one thousand dollars
($1,000) and no more than five thousand dollars ($5,000) plus court
costs, as determined by the court, which penalty and costs shall be
paid to the subject of the test.
(d) Any person who willfully or negligently discloses the results
of a test for a genetic characteristic to a third party in a manner
that identifies or provides identifying characteristics of the person
to whom the test results apply, except pursuant to a written
authorization as described in subdivision (g), that results in
economic, bodily, or emotional harm to the subject of the test, is
guilty of a misdemeanor punishable by a fine not to exceed ten
thousand dollars ($10,000).
(e) In addition to the penalties listed in subdivisions (b) and
(c), any person who commits any act described in subdivision (b) or
(c) shall be liable to the subject for all actual damages, including
damages for economic, bodily, or emotional harm which is proximately
caused by the act.
(f) Each disclosure made in violation of this section is a
separate and actionable offense.
(g) The applicant's "written authorization," as used in this
section, shall satisfy the following requirements:
(1) Is written in plain language.
(2) Is dated and signed by the individual or a person authorized
to act on behalf of the individual.
(3) Specifies the types of persons authorized to disclose
information about the individual.
(4) Specifies the nature of the information authorized to be
disclosed.
(5) States the name or functions of the persons or entities
authorized to receive the information.
(6) Specifies the purposes for which the information is collected.
(7) Specifies the length of time the authorization shall remain
valid.
(8) Advises the person signing the authorization of the right to
receive a copy of the authorization. Written authorization is
required for each separate disclosure of the test results, and the
authorization shall set forth the person or entity to whom the
disclosure would be made.
(h) This section shall not apply to disclosures required by the
Department of Health Services necessary to monitor compliance with
Chapter 1 (commencing with Section 124975) of Part 5 of Division 106
of the Health and Safety Code, nor to disclosures required by the
Department of Managed Health Care necessary to administer and enforce
compliance with Section 1374.7 of the Health and Safety Code.

10140.2. (a) Notwithstanding Section 10140, a health insurance
policy issued, amended, or renewed on or after January 1, 2011, shall
not be subject to premium, price, or charge differentials because of
the sex of any contracting party, potential contracting party, or
person reasonably expected to benefit from the policy as a
policyholder, insured, or otherwise.
(b) For purposes of this section, "sex" shall have the same
meaning as "gender," as defined in Section 422.56 of the Penal Code.

10140.5. (a) In addition to any other remedy permitted by law, the
commissioner shall have the administrative authority to assess
penalties specified in this section against life or disability
insurers for violations of Section 10140.
(b) Any life or disability insurer that violates Section 10140 is
liable for administrative penalties of not more than two thousand
five hundred dollars ($2,500) for the first violation and not more
than five thousand dollars ($5,000) for each subsequent violation.
(c) Any life or disability insurer that violates Section 10140
with a frequency that indicates a general business practice or
commits a knowing violation of that section, is liable for
administrative penalties of not less than fifteen thousand dollars
($15,000) and not more than one hundred thousand dollars ($100,000)
for each violation.
(d) An act or omission that is inadvertent and that results in
incorrect premium rates being charged to more than one subscriber
shall be a single violation for the purpose of this section.

10141. No application for insurance or insurance investigation
report furnished by such an insurer to its agents or employees for
use in determining the insurability of the applicant shall carry any
identification, or any requirement therefor, of the applicant's race,
color, religion, ancestry, national origin, or sexual orientation.

10142. Nothing in this article shall prohibit use in an application
for life or disability insurance of a question asking for the
birthplace of an applicant if such question is used only to identify
the applicant and not to discriminate against him.

10143. (a) No insurance company licensed in this state shall refuse
to issue or sell or renew any policy of life or disability insurance
after appropriate application solely by reason of the fact that the
person to be insured carries a gene which may, under some
circumstances, be associated with disability in that person's
offspring, but which causes no adverse effects on the carrier. Such
genes shall include, but not be limited to, Tay-Sachs trait, sickle
cell trait, thalassemia trait, and X-linked hemophilia A. No such
policy issued and delivered in this state to any association,
corporation, firm, fund, individual, group, order, organization,
society, or trust subject to the supervision of the commissioner
shall demand or require a higher premium rate or charge by reason of
the fact that the person to be insured carries such traits than is at
that time required of any other association, corporation, firm,
fund, individual, group, order, organization, society, or trust in an
otherwise identical classification, nor shall any association,
corporation, firm, fund, group, individual, order, organization,
society, or trust make or require any rebate, discrimination, or
discount upon the amount to be paid or the service to be rendered on
such policy because the person to be insured carries such traits.
(b) No insurance company licensed in this state shall insert in a
policy of life or disability insurance any condition, nor make any
stipulation, whereby the person insured who carries a gene which may,
under some circumstances, be associated with disability in that
person's offspring, but which causes no adverse effects on the
carrier, including, but not limited to, Tay-Sachs trait, sickle cell
trait, thalassemia trait, and X-linked hemophilia A, shall bind
himself, his heirs, executors, administrators, or assignees to accept
any sum or service less than the full value or amount of the policy
in case of a claim accruing thereon other than such as are imposed
upon other persons in similar cases and any such stipulation or
condition so made or inserted shall be void.
(c) No insurance company licensed in this state shall fix any
lower rate in the fees or commissions of agents or brokers for
writing or renewing a policy of life or disability insurance solely
because the applicant carries a gene which may, under some
circumstances, be associated with disability in that person's
offspring, but which causes no adverse effects on the carrier. Such
genes shall include, but are not limited to, Tay-Sachs trait, sickle
cell trait, or X-linked hemophilia A.

10144. No insurer issuing, providing, or administering any contract
of individual or group insurance providing life, annuity, or
disability benefits applied for and issued on or after January 1,
1984, shall refuse to insure, or refuse to continue to insure, or
limit the amount, extent, or kind of coverage available to an
individual, or charge a different rate for the same coverage solely
because of a physical or mental impairment, except where the refusal,
limitation or rate differential is based on sound actuarial
principles or is related to actual and reasonably anticipated
experience.
"Physical or mental impairment" means any physical, sensory, or
mental impairment which substantially limits one or more of that
person's major life activities.

10144.1. A disability insurer that denies coverage for an
experimental medical procedure or plan of treatment for a claimant
with a terminal illness, which for the purposes of this section
refers to an incurable or irreversible condition that has a high
probability of causing death within one year or less, under a
disability insurance policy that includes hospital, medical, or
surgical coverage issued in this state shall provide written
notification directly to the claimant or representative, which shall
include all of the following:
(a) The specific medical and scientific reasons for the denial and
specific references to pertinent policy provisions upon which the
denial is based.
(b) A description of the alternative medical procedures or
treatments covered by the policy, if any. Compliance with this
subdivision by an insurer shall not be construed to mean that the
insurer is engaging in the unlawful practice of medicine.
(c) A description of the process by which the claimant or
representative may exercise his or her right to appeal the denial and
obtain and participate in a review of the information provided to
the claimant or representative pursuant to subdivisions (a) and (b).
The review shall not be limited to written communication and shall be
provided by the appropriate named fiduciary or his or her designee
rendering the decision. The review shall be provided to the claimant
within 30 calendar days following the receipt of the request for
review. However, the review required by this section shall be held
within five business days if the treating physician determines, in
consultation with the medical director of the insurer, based on
standard medical practice, that the effectiveness of either the
proposed treatment, services, or supplies or any alternative
treatment, services, or supplies covered by the policy, would be
materially reduced if not provided at the earliest possible date.

10144.2. (a) No disability insurer covering hospital, medical, or
surgical expenses shall deny, refuse to insure, refuse to renew,
cancel, restrict, or otherwise terminate, exclude, or limit coverage
or charge a different rate for the same coverage, on the basis that
the applicant or insured person is, has been, or may be a victim of
domestic violence.
(b) Nothing in this section shall prevent a disability insurer
covering hospital, medical, or surgical expenses from underwriting
coverage on the basis of the medical condition of an individual so
long as the consideration of the condition (1) does not take into
account whether such an individual's medical condition was caused by
an act of domestic violence, (2) is the same with respect to an
applicant or insured who is not the subject of domestic violence as
with an applicant or insured who is the subject of domestic violence,
and (3) does not violate any other act, regulation, or rule of law.
The fact that an individual is, has been, or may be the subject of
domestic violence shall not be considered a medical condition.
(c) As used in this section, "domestic violence" means domestic
violence, as defined in Section 6211 of the Family Code.

10144.3. (a) No admitted insurer licensed to issue life insurance
shall refuse to accept an application for insurance, refuse to issue
or renew a policy, cancel a policy, or deny coverage under a policy
because the applicant for insurance or any person who is or would be
insured is, or has been, a victim of domestic violence.
(b) Nothing in this section shall prevent a life insurer from
taking any of the actions set forth in subdivision (a) on the basis
of criteria not otherwise made invalid by this section or any other
act, regulation, or rule of law. If discrimination by a life insurer
is not in violation of this section but is based on any other
criteria that are allowable by law, the fact that the applicant or
insured is, has been, or may be the subject of domestic violence
shall be irrelevant.
(c) Nothing in this section shall require a life insurer to pay
for any loss if that payment is prohibited by Section 533.
(d) As used in this section, "domestic violence" means domestic
violence as defined in Section 6211 of the Family Code.

10144.5. (a) Every policy of disability insurance that covers
hospital, medical, or surgical expenses in this state that is issued,
amended, or renewed on or after July 1, 2000, shall provide coverage
for the diagnosis and medically necessary treatment of severe mental
illnesses of a person of any age, and of serious emotional
disturbances of a child, as specified in subdivisions (d) and (e),
under the same terms and conditions applied to other medical
conditions, as specified in subdivision (c).
(b) These benefits shall include the following:
(1) Outpatient services.
(2) Inpatient hospital services.
(3) Partial hospital services.
(4) Prescription drugs, if the policy or contract includes
coverage for prescription drugs.
(c) The terms and conditions applied to the benefits required by
this section that shall be applied equally to all benefits under the
disability insurance policy shall include, but not be limited to, the
following:
(1) Maximum lifetime benefits.
(2) Copayments and coinsurance.
(3) Individual and family deductibles.
(d) For the purposes of this section, "severe mental illnesses"
shall include:
(1) Schizophrenia.
(2) Schizoaffective disorder.
(3) Bipolar disorder (manic-depressive illness).
(4) Major depressive disorders.
(5) Panic disorder.
(6) Obsessive-compulsive disorder.
(7) Pervasive developmental disorder or autism.
(8) Anorexia nervosa.
(9) Bulimia nervosa.
(e) For the purposes of this section, a child suffering from,
"serious emotional disturbances of a child" shall be defined as a
child who (1) has one or more mental disorders as identified in the
most recent edition of the Diagnostic and Statistical Manual of
Mental Disorders, other than a primary substance use disorder or
developmental disorder, that result in behavior inappropriate to the
child's age according to expected developmental norms, and (2) who
meets the criteria in paragraph (2) of subdivision (a) of Section
5600.3 of the Welfare and Institutions Code.
(f) (1) For the purpose of compliance with this section, a
disability insurer may provide coverage for all or part of the mental
health services required by this section through a separate
specialized health care service plan or mental health plan, and shall
not be required to obtain an additional or specialized license for
this purpose.
(2) A disability insurer shall provide the mental health coverage
required by this section in its entire in-state service area and in
emergency situations as may be required by applicable laws and
regulations. For purposes of this section, disability insurers are
not precluded from requiring insureds who reside or work in
geographic areas served by specialized health care service plans or
mental health plans to secure all or part of their mental health
services within those geographic areas served by specialized health
care service plans or mental health plans.
(3) Notwithstanding any other provision of law, in the provision
of benefits required by this section, a disability insurer may
utilize case management, managed care, or utilization review.
(4) Any action that a disability insurer takes to implement this
section, including, but not limited to, contracting with preferred
provider organizations, shall not be deemed to be an action that
would otherwise require licensure as a health care service plan under
the Knox-Keene Health Care Service Plan Act of 1975 (Chapter 2.2
(commencing with Section 1340) of Division 2 of the Health and Safety
Code.
(g) This section shall not apply to accident-only, specified
disease, hospital indemnity, Medicare supplement, dental-only, or
vision-only insurance policies.

10144.6. No disability insurer may utilize any information
regarding whether a beneficiary's psychiatric inpatient admission was
made on a voluntary or involuntary basis for the purpose of
determining eligibility for claim reimbursement.

10145. No insurer issuing, providing, or administering any contract
of individual or group insurance providing life, annuity, or
disability benefits applied for and issued on or after January 1,
1986, shall refuse to insure, or refuse to continue to insure, or
limit the amount, extent, or kind of coverage available to an
individual, or charge a different rate for the same coverage solely
because of blindness or partial blindness.
"Blindness or partial blindness" means central visual acuity of
not more than 20/200 in the better eye, after correction, or visual
acuity greater than 20/200 but with a limitation in the fields of
vision so that the widest diameter of the visual field subtends an
angle no greater than 20 degrees, certified by a licensed physician
and surgeon who specializes in diseases of the eye or a licensed
optometrist.

10145.2. (a) Every policy of disability insurance that is issued,
amended, or renewed on or after July 1, 2002, that covers hospital,
medical, or surgery expenses shall provide coverage for a vaccine for
acquired immune deficiency syndrome (AIDS) that is approved for
marketing by the federal Food and Drug Administration and that is
recommended by the United States Public Health Service.
(b) This section may not be construed to require a policy to
provide coverage for any clinical trials relating to an AIDS vaccine
or for any AIDS vaccine that has been approved by the federal Food
and Drug Administration in the form of an investigational new drug
application.
(c) 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. For hospital indemnity, accident only, or specified
disease insurance coverage, benefits under this section shall apply
only to the extent that the benefits are covered under the general
terms and conditions that apply to all other benefits under the
policy or certificate. Nothing in this section shall be construed as
imposing a new benefit mandate on accident only, hospital indemnity,
or specified disease insurance.
(d) Nothing in this section is to be construed in any manner to
limit or impede a disability insurer's power or responsibility to
negotiate the most cost-effective price for vaccine purchases.

10145.3. (a) Every disability insurer that covers hospital,
medical, or surgical benefits shall provide an external, independent
review process to examine the insurer's coverage decisions regarding
experimental or investigational therapies for individual insureds who
meet all of the following criteria:
(1) (A) The insured has a life-threatening or seriously
debilitating condition.
(B) For purposes of this section, "life-threatening" means either
or both of the following:
(i) Diseases or conditions where the likelihood of death is high
unless the course of the disease is interrupted.
(ii) Diseases or conditions with potentially fatal outcomes, where
the end point of clinical intervention is survival.
(C) For purposes of this section, "seriously debilitating" means
diseases or conditions that cause major irreversible morbidity.
(2) The insured's physician certifies that the insured has a
condition, as defined in paragraph (1), for which standard therapies
have not been effective in improving the condition of the insured,
for which standard therapies would not be medically appropriate for
the insured, or for which there is no more beneficial standard
therapy covered by the insurer than the therapy proposed pursuant to
paragraph (3).
(3) Either (A) the insured's contracting physician has recommended
a drug, device, procedure, or other therapy that the physician
certifies in writing is likely to be more beneficial to the insured
than any available standard therapies, or (B) the insured, or the
insured's physician who is a licensed, board-certified or
board-eligible physician qualified to practice in the area of
practice appropriate to treat the insured's condition, has requested
a therapy that, based on two documents from the medical and
scientific evidence, as defined in subdivision (d), is likely to be
more beneficial for the insured than any available standard therapy.
The physician certification pursuant to this subdivision shall
include a statement of the evidence relied upon by the physician in
certifying his or her recommendation. Nothing in this subdivision
shall be construed to require the insurer to pay for the services of
a noncontracting physician, provided pursuant to this subdivision,
that are not otherwise covered pursuant to the contract.
(4) The insured has been denied coverage by the insurer for a
drug, device, procedure, or other therapy recommended or requested
pursuant to paragraph (3), unless coverage for the specific therapy
has been excluded by the insurer's contract.
(5) The specific drug, device, procedure, or other therapy
recommended pursuant to paragraph (3) would be a covered service
except for the insurer's determination that the therapy is
experimental or under investigation.
(b) The insurer's decision to deny, delay, or modify experimental
or investigational therapies shall be subject to the independent
medical review process established under Article 3.5 (commencing with
Section 10169) of Chapter 1 of Part 2 of Division 2, except that in
lieu of the information specified in subdivision (b) of Section
10169.3, an independent medical reviewer shall base his or her
determination on relevant medical and scientific evidence, including,
but not limited to, the medical and scientific evidence defined in
subdivision (d).
(c) The independent medical review process shall also meet the
following criteria:
(1) The insurer shall notify eligible insureds in writing of the
opportunity to request the external independent review within five
business days of the decision to deny coverage.
(2) If the insured's physician determines that the proposed
therapy would be significantly less effective if not promptly
initiated, the analyses and recommendations of the experts on the
panel shall be rendered within seven days of the request for
expedited review. At the request of the expert, the deadline shall be
extended by up to three days for a delay in providing the documents
required. The timeframes specified in this paragraph shall be in
addition to any otherwise applicable timeframes contained in
subdivision (c) of Section 10169.3.
(3) Each expert's analysis and recommendation shall be in written
form and state the reasons the requested therapy is or is not likely
to be more beneficial for the insured than any available standard
therapy, and the reasons that the expert recommends that the therapy
should or should not be covered by the insurer, citing the insured's
specific medical condition, the relevant documents, and the relevant
medical and scientific evidence, including, but not limited to, the
medical and scientific evidence as defined in subdivision (d), to
support the expert's recommendation.
(4) Coverage for the services required under this section shall be
provided subject to the terms and conditions generally applicable to
other benefits under the contract.
(d) For the purposes of subdivision (b), "medical and scientific
evidence" means the following sources:
(1) Peer-reviewed scientific studies published in or accepted for
publication by medical journals that meet nationally recognized
requirements for scientific manuscripts and that submit most of their
published articles for review by experts who are not part of the
editorial staff.
(2) Peer-reviewed literature, biomedical compendia and other
medical literature that meet the criteria of the National Institutes
of Health's National Library of Medicine for indexing in Index
Medicus, Excerpta Medicus (EMBASE), Medline and MEDLARS database of
Health Services Technology Assessment Research (HSTAR).
(3) Medical journals recognized by the Secretary of Health and
Human Services, under Section 1861(t)(2) of the Social Security Act.
(4) Either of the following reference compendia:
(A) The American Hospital Formulary Service's Drug Information.
(B) The American Dental Association Accepted Dental Therapeutics.
(5) Any of the following reference compendia, if recognized by the
federal Centers for Medicare and Medicaid Services as part of an
anticancer chemotherapeutic regimen:
(A) The Elsevier Gold Standard's Clinical Pharmacology.
(B) The National Comprehensive Cancer Network Drug and Biologics
Compendium.
(C) The Thomson Micromedex DrugDex.
(6) Findings, studies, or research conducted by or under the
auspices of federal government agencies and nationally recognized
federal research institutes, including the Federal Agency for Health
Care Policy and Research, National Institutes of Health, National
Cancer Institute, National Academy of Sciences, Health Care Financing
Administration, Congressional Office of Technology Assessment, and
any national board recognized by the National Institutes of Health
for the purpose of evaluating the medical value of health services.
(7) Peer-reviewed abstracts accepted for presentation at major
medical association meetings.
(e) The independent review process established by this section
shall be required on and after January 1, 2001.

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.