(a)All individual and group health insurance policies
providing coverage on an expense incurred basis, individual and
group service or indemnity type contracts issued by any insurer
including any nonprofit corporation and individual and group
service contracts or certificates issued by a health maintenance
organization which provide coverage for treatment of cancer
shall also provide coverage for routine patient care costs which
a policyholder or certificate holder, or his covered dependent,
receives as part of a clinical trial or study if:
(i)The medical treatment is provided in a phase II,
phase III or phase IV study or clinical trial for the treatment
of cancer;
(ii)The clinical trial or study is approved by:
(A)An agency of the national institutes of
health as set forth in 42 U.S.C
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(a) All individual and group health insurance policies
providing coverage on an expense incurred basis, individual and
group service or indemnity type contracts issued by any insurer
including any nonprofit corporation and individual and group
service contracts or certificates issued by a health maintenance
organization which provide coverage for treatment of cancer
shall also provide coverage for routine patient care costs which
a policyholder or certificate holder, or his covered dependent,
receives as part of a clinical trial or study if:
(i) The medical treatment is provided in a phase II,
phase III or phase IV study or clinical trial for the treatment
of cancer;
(ii) The clinical trial or study is approved by:
(A) An agency of the national institutes of
health as set forth in 42 U.S.C. 281(b) or a research entity
that meets the NIH granting criteria;
(B) The United States food and drug
administration as an application for a new investigational drug;
(C) The United States department of veterans
affairs; or
(D) The United States department of defense.
(iii) The medical treatment is provided by a licensed
health care provider practicing within the scope of the
provider's license and the facility and personnel providing the
treatment have the experience and training to provide the
treatment in a competent manner; and
(iv) The participant in the clinical trial or study,
before commencing participation, has signed a statement of
consent indicating that the participant has been informed of:
(A) The procedure to be undertaken;
(B) Alternative methods of treatment; and
(C) The general nature and extent of risks
associated with participation in the clinical trial or study.
(b) Coverage for medical treatment required by this
section shall be limited to routine patient care costs.
(c) The coverage required by this section does not
include:
(i) Any portion of the clinical trial or study that
is customarily paid for by a government or a biotechnical,
pharmaceutical or medical industry;
(ii) Coverage for any drug or device that is paid for
by the manufacturer, distributor or provider of the drug or
device;
(iii) Health care services that are customarily
provided by the sponsors of the clinical trial or study free of
charge to the participants in the trial or study;
(iv) Extraneous expenses related to participation in
the clinical trial or study including, without limitation,
travel, housing and other expenses that a participant or person
accompanying a participant may incur;
(v) Any item or service that is provided solely to
satisfy a need or desire for data collection or analysis that is
not directly related to the clinical management of the patient;
(vi) Any costs for the management of research
relating to the clinical trial or study.
(d) Nothing in this section shall:
(i) Preclude an insurer from excluding coverage for
any claim arising from the practice of medicine or other health
care by a person without an applicable physician or health care
provider license;
(ii) Preclude an insurer from asserting the right to
subrogate for expenses arising from complications caused by a
drug or device that is subsequently approved for usage upon
completion of the clinical trial;
(iii) Provide a private cause of action against any
health insurer described in subsection (a) of this section for
damages arising as a result of compliance with this section.
(e) For purposes of this section:
(i) "Clinical trial" means any experiment in which a
drug is administered to, dispensed to or used by one (1) or more
human subjects. For purposes of this paragraph, an experiment
is any use of a drug except for the use of a marketed drug in
the course of medical practice;
(ii) "Routine patient care cost" means:
(A) 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
(B) 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.
ARTICLE 4
INHERITED ENZYMATIC DISORDER COVERAGE