HF 1453

as introduced - 87th Legislature (2011 - 2012) Posted on 04/14/2011 10:50am

A bill for an act
relating to insurance; requiring health insurance to cover routine health
care received while participating in a qualified clinical trial under certain
circumstances; proposing coding for new law in Minnesota Statutes, chapter 62Q.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [62Q.526] COVERAGE OF QUALIFIED CLINICAL TRIALS.
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new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the terms described in
this subdivision have the meanings given.
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new text begin (b) "Clinical trial" means a type of research study that tests how well new medical
treatments or other approaches work in human beings, including new methods of
screening, prevention, diagnosis, or treatment of a disease or other condition.
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new text begin (c) "Cooperative group" means a formal network of facilities that collaborate on
research projects and that have an established peer review program approved by the
National Institutes of Health operating within the group.
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new text begin (d) "Health plan" means a health plan, as defined in section 62Q.01, subdivision 3.
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new text begin (e) "Multiple project assurance contract" means a contract between an institution
and the federal Department of Health and Human Services that defines the responsibilities
of the institution and the procedures that will be used by the institution to protect human
subjects.
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new text begin (f) "Nonroutine patient cost" means:
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new text begin (1) the cost of an investigational drug or device that is not approved by the federal
Food and Drug Administration to market for any indication;
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new text begin (2) the cost of a nonhealth care service that an enrollee is required to receive as a
result of the treatment being provided for purposes of the clinical trial;
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new text begin (3) costs associated with managing the research associated with the clinical trial;
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new text begin (4) costs that would not be covered for noninvestigational treatments;
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new text begin (5) any item, service, or cost that is reimbursed, otherwise paid for, or eligible for
payment or reimbursement by, the sponsor of the study;
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new text begin (6) transportation, lodging, food, or other expenses for the enrollee or a family
member or companion of the enrollee that are associated with travel to or from a facility at
which a clinical trial is conducted;
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new text begin (7) the costs of services that are provided primarily to meet the needs of the clinical
trial, including but not limited to tests, measurements, and other services that are typically
covered under the health plan but which are provided under the clinical trial at a greater
frequency, intensity, or duration; and
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new text begin (8) costs of services or items that are not covered under the health plan.
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new text begin (g) "Qualified clinical trial" means a clinical trial approved by one of the following:
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new text begin (1) one of the National Institutes of Health;
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new text begin (2) a National Institutes of Health cooperative group or a National Institutes of
Health center;
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new text begin (3) the federal Food and Drug Administration in the form of an investigational
new drug application;
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new text begin (4) the federal Department of Veterans Affairs;
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new text begin (5) the federal Department of Defense; or
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new text begin (6) an institutional review board of an institution that has a multiple project
assurance contract approved by the Office of Protection from Research Risks of the
National Institutes of Health.
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new text begin (h) "Routine patient care cost" means the cost of any medically necessary health care
service that is incurred as a result of treatment being provided to an enrollee of a health
plan. Routine patient care costs are those for which the health plan regularly covers its
enrollees under the terms of the enrollee's health plan and that would be covered if the
enrollee were not participating in a clinical trial. Routine patient costs do not include
nonroutine patient costs.
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new text begin Subd. 2. new text end

new text begin Coverage requirement. new text end

new text begin A health plan must cover the routine patient care
costs incurred by an enrollee in a qualified clinical trial if:
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new text begin (1) the qualified clinical trial is:
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new text begin (i) a phase I, phase II, phase III, or phase IV investigation of prevention, including
prevention of reoccurrence, early detection, treatment, or palliation of cancer; or
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new text begin (ii) treatment of a life-threatening condition;
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new text begin (2) there is no clearly superior noninvestigational treatment alternative;
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new text begin (3) the available clinical or preclinical data provides a reasonable expectation that
the treatment will be at least as effective as the best noninvestigational alternative; and
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new text begin (4) the enrollee's treating physician, who is providing covered health care services
to the enrollee under the health plan, has stated in a written opinion that it is reasonable
to expect that the treatment will provide a medical benefit that is commensurate with the
risks of participation in the clinical trial.
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new text begin Subd. 3. new text end

new text begin Conforming and other related provisions. new text end

new text begin (a) Coverage of services
required under this section does not create a legal presumption that the health plan
company recommended, directed, or required the enrollee to participate in the clinical trial.
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new text begin (b) A health plan's definitions of "experimental," "investigational," and similar terms
for purposes of coverage exclusion must not include coverage required under this section.
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new text begin (c) If the providers providing health care services under the clinical trial are parties
to a provider agreement that applies to the enrollee's health plan, the payment rates
required for services provided under this section are the rates provided in the provider
agreement, and the provider may not balance-bill the enrollee for the services except as
permitted under the health plan and provider agreement for deductibles, co-payments, and
other normal enrollee cost sharing. If the providers do not have a provider agreement
described in this paragraph, the health plan company may pay the amount, if any, that
it would normally pay for out-of-network care, and the enrollee is responsible for the
balance, unless otherwise agreed.
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new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2011, and applies to
coverage offered, sold, issued, renewed, or continued as defined in Minnesota Statutes,
section 60A.02, subdivision 2a, on or after that date.
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