Citations Affected:
IC 5-10-8-7.4
;
IC 27-8-14.3
;
IC 27-13-7-15.5.
Synopsis: Clinical trials. Defines "associated treatment cost" for
purposes of payment for medically necessary treatment and drugs and
devices associated with clinical trial treatments. Requires group health
benefit plans for public employees, individual and group accident and
sickness insurance policies, and individual and group health
maintenance organization contracts to provide coverage for associated
treatment cost. Prohibits dollar limits, deductibles, copayments, or
coinsurance requirements on coverage of associated treatment cost that
are less favorable than those for physical illness generally. Requires
health benefit plan administrators, insurers, and health maintenance
organizations to submit annual reports to the insurance commissioner
describing clinical trials for which associated treatment cost was
covered. Requires the insurance commissioner to compile information
gathered and make an annual report available to the public. Establishes
a work group on health care coverage for associated treatment cost to
study and make recommendations regarding costs and benefits of the
coverage required under this act.
Effective: July 1, 2001.
January 11, 2001, read first time and referred to Committee on Health and Provider
Services.
A BILL FOR AN ACT to amend the Indiana Code concerning
insurance.
clinical trial treatment; or
(4) a cost not covered under the health benefit plan for
noninvestigational treatments.
(c) As used in this section, "clinical trial treatment" means:
(1) treatment provided in a phase II, phase III, or phase IV
clinical trial for a life threatening condition;
(2) prevention studies in a phase I, phase II, phase III, or
phase IV clinical trial for cancer;
(3) early detection studies in a phase I, phase II, phase III, or
phase IV clinical trial for cancer; or
(4) treatment studies in a phase I, phase II, phase III, or phase
IV clinical trial for cancer;
that is approved by the National Institutes of Health or one (1) of
its cooperative groups or centers, the federal Food and Drug
Administration in the form of an investigational new drug
application, the United States Department of Veterans Affairs, or
an institutional review board of an institution in Indiana that has
a multiple project assurance contract approved by the office of
protection from research risks of the National Institutes of Health.
(d) As used in this section, "cooperative group" means a formal
network of facilities that collaborate on research projects and have
an established peer review program operating within the group
that is approved by the National Institutes of Health. The term
includes:
(1) the National Cancer Institute Clinical Cooperative Group;
(2) the National Cancer Institute Community Clinical
Oncology Program;
(3) the AIDS Clinical Trials Group; and
(4) the Community Programs for Clinical Research in AIDS.
(e) As used in this section, "covered individual" means an
individual who is:
(1) covered under a self-insurance program established under
section 7(b) of this chapter to provide group health coverage;
or
(2) entitled to services under a contract for health services
entered into or renewed under section 7(c) of this chapter.
(f) As used in this chapter, "health benefit plan" means:
(1) a self-insurance program established under section 7(b) of
this chapter to provide group health coverage; or
(2) a contract for health services entered into or renewed
under section 7(c) of this chapter.
(g) As used in this section, "multiple project assurance
contract" means a contract between an institution and the United
States Department of Health and Human Services that defines the
relationship between the institution and the United States
Department of Health and Human Services and specifies the
responsibilities of the institution and procedures that will be used
by the institution to protect human research subjects.
(h) A health benefit plan must provide a covered individual with
coverage for associated treatment cost if:
(1) the facility and personnel providing the clinical trial
treatment are approved by the organization sponsoring the
clinical trial protocol and the institutional review board of the
institution providing the clinical trial treatment;
(2) there is no clearly superior, noninvestigational treatment
alternative to the clinical trial treatment; and
(3) the available clinical or preclinical data provide a
reasonable expectation that the clinical trial treatment will be
at least as effective as a noninvestigational alternative.
(i) The coverage required under subsection (h) includes
associated treatment cost for a drug or device approved for sale by
the federal Food and Drug Administration to the extent that the
manufacturer, distributor, or provider of the drug or device does
not pay the cost, regardless of whether the drug or device is
approved for the covered individual's particular condition.
(j) The coverage required under subsections (h) and (i) may not
be subject to dollar limits, deductibles, copayments, or coinsurance
provisions that are less favorable to a covered individual than the
dollar limits, deductibles, copayments, or coinsurance provisions
applying to physical illness generally under the health benefit plan.
(k) On or before June 1 of each year, each administrator shall
submit to the insurance commissioner, on a form approved by the
insurance commissioner, a report describing clinical trials for
which the health benefit plan covered associated treatment cost
during the prior year.
(l) The insurance commissioner shall compile an annual
summary report of the information submitted under subsection (k)
and make copies available to the public.
(m) The insurance commissioner shall adopt rules under
IC 4-22-2
to implement subsections (k) and (l).
States Department of Health and Human Services that defines the
relationship between the institution and the United States
Department of Health and Human Services and specifies the
responsibilities of the institution and procedures that will be used
by the institution to protect human research subjects.
(e) A health maintenance organization issued a certificate of
authority in Indiana shall provide coverage for associated
treatment cost under an individual or group contract that provides
coverage for basic health care services if:
(1) the facility and personnel providing the clinical trial
treatment are approved by the organization sponsoring the
clinical trial protocol and the institutional review board of the
institution providing the clinical trial treatment;
(2) there is no clearly superior, noninvestigational treatment
alternative to the clinical trial treatment; and
(3) the available clinical or preclinical data provide a
reasonable expectation that the clinical trial treatment will be
at least as effective as a noninvestigational alternative.
(f) The coverage required under subsection (e) includes
associated treatment cost for a drug or device approved for sale by
the federal Food and Drug Administration to the extent that the
manufacturer, distributor or provider of the drug or device does
not pay the cost, regardless of whether the drug or device is
approved for the enrollee's particular condition.
(g) The coverage required by subsections (e) and (f) may not be
subject to dollar limits, deductibles, copayments, or coinsurance
provisions that are less favorable to an enrollee than the dollar
limits, deductibles, copayments, or coinsurance provisions applying
to physical illness generally under the health maintenance
organization contract.
(h) On or before June 1 of each year, each health maintenance
organization shall submit to the commissioner, on a form approved
by the commissioner, a report describing clinical trials for which
the health maintenance organization covered associated treatment
cost during the prior year.
(i) The commissioner shall compile an annual summary report
of the information gathered under subsection (h) and make copies
available to the public.
(j) The commissioner shall adopt rules under
IC 4-22-2
to
implement subsections (h) and (i).
assess the costs and benefits of health care coverage by:
(1) state employee health benefit plans under
IC 5-10-8-7.4
, as
added by this act;
(2) insurers under
IC 27-8-14.3
, as added by this act; and
(3) health maintenance organizations under
IC 27-13-7-15.5
,
as added by this act;
for associated treatment cost as defined in IC 5-10-8-7.4,
IC 27-8-14.3-1, and IC 27-13-7-15.5, all as added by this act.
(b) The work group on health care coverage for associated
treatment cost consists of nine (9) members appointed by the
insurance commissioner before January 1, 2002, as follows:
(1) One (1) member from the Indiana University School of
Medicine.
(2) One (1) member from the Indiana State Medical
Association.
(3) Two (2) representatives, including one (1) medical director
licensed to practice medicine in Indiana, from accident and
sickness insurers granted certificates of authority in Indiana.
(4) Two (2) representatives, including one (1) medical director
licensed to practice medicine in Indiana, from health
maintenance organizations granted certificates of authority in
Indiana.
(5) One (1) member from the state personnel department.
(6) One (1) member of the public.
(7) The insurance commissioner, or the commissioner's
designee.
(c) The insurance commissioner, or the commissioner's
designee, shall serve as chairperson.
(d) Members shall serve until the final report is submitted under
subsection (g).
(e) Each member of the work group who is not a state employee
is entitled to the minimum salary per diem provided by
IC 4-10-11-2.1
(b). The member is also entitled to reimbursement
for traveling expenses and other expenses actually incurred in
connection with the member's duties, as provided in the state travel
policies and procedures established by the Indiana department of
administration and approved by the budget agency.
(f) The work group on health care coverage for associated
treatment cost for clinical trials shall:
(1) develop a methodology for assessing the economic and
clinical impact of the health care coverage required under
IC 5-10-8-7.4
, IC 27-8-14.3, and
IC 27-13-7-15.5
, all as added
by this act, for associated treatment cost;
(2) collect from health care providers and payers pertinent
aggregate clinical and financial data on insured treatments to
assess differences in associated treatment cost and clinical
outcomes between insureds treated in clinical trials and
insureds treated outside clinical trials;
(3) review any other issues the workgroup considers
appropriate; and
(4) make recommendations to the insurance commissioner
pertaining to coverage for associated treatment cost.
(g) The work group shall submit a final report, including
findings and recommendations, to the legislative council on or
before June 30, 2003.
(h) This SECTION expires June 30, 2006.