HF 3026

as introduced - 91st Legislature (2019 - 2020) Posted on 03/04/2020 04:29pm

A bill for an act
relating to medical assistance; providing coverage for routine patient costs that
are incurred in the course of a clinical trial if the medical assistance program would
provide coverage for the same routine patient costs not incurred in a clinical trial;
amending Minnesota Statutes 2018, section 256B.0625, by adding a subdivision.

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

Section 1.

Minnesota Statutes 2018, section 256B.0625, is amended by adding a subdivision
to read:

new text begin Subd. 67. new text end

new text begin Qualified clinical trials. new text end

new text begin (a) For purposes of this subdivision, the terms defined
in this paragraph have the meanings given:
new text end

new text begin (1) "approved clinical trial" means a phase I, II, III, or IV research study involving the
prevention, detection, or treatment of cancer or any other life-threatening disease or condition
or severely debilitating disease or condition if one or more of the following conditions apply:
new text end

new text begin (i) the study or investigation is conducted under an investigational new drug application
or an investigational device exemption reviewed by the federal Food and Drug
Administration;
new text end

new text begin (ii) the study or investigation is a drug trial that is exempt from having an investigational
new drug application or an investigational device exemption from the federal Food and
Drug Administration; or
new text end

new text begin (iii) the study or investigation is funded, including funding through in-kind contributions,
or approved by:
new text end

new text begin (A) the National Institutes of Health;
new text end

new text begin (B) the Centers for Disease Control and Prevention;
new text end

new text begin (C) the Agency for Healthcare Research and Quality;
new text end

new text begin (D) the Patient-Centered Outcomes Research Institute;
new text end

new text begin (E) the federal Centers for Medicare and Medicaid Services;
new text end

new text begin (F) a cooperative group or center of any of the entities described in subitems (A) to (E);
new text end

new text begin (G) a cooperative group or center of the United States Department of Defense;
new text end

new text begin (H) a cooperative group or center of the United States Department of Veterans Affairs;
new text end

new text begin (I) a qualified nongovernmental research entity identified in the guidelines issued by
the National Institutes of Health for center support grants; or
new text end

new text begin (J) the United States Department of Veterans Affairs, the United States Department of
Defense, or the United States Department of Energy, provided that review and approval of
the study or investigation occurs through a system of peer review that is comparable to the
peer review of studies performed by the National Institutes of Health, including an unbiased
review of the highest scientific standards by qualified individuals who have no interest in
the outcome of the review;
new text end

new text begin (2) "care method" means the use of a particular drug or device in a particular manner;
new text end

new text begin (3) "life-threatening disease or condition" means a disease or condition from which the
likelihood of death is probable unless the course of the disease or condition is interrupted;
new text end

new text begin (4) "severely debilitating disease or condition" means a disease or condition that causes
major irreversible morbidity;
new text end

new text begin (5) "routine patient costs" means the costs of medically necessary services related to the
care method that is under evaluation in a clinical trial. Routine care costs include the costs
of items and services related to the prevention, detection, and treatment of any adverse
effects and complications arising from the patient's medical care, including any complications
related to participation in the clinical trial. The term does not include the following:
new text end

new text begin (i) the drug or device that is under evaluation in a clinical trial; or
new text end

new text begin (ii) items or services that are:
new text end

new text begin (A) provided solely for data collection and analysis and not in the direct clinical
management of an individual enrolled in a clinical trial;
new text end

new text begin (B) customarily provided at no cost by a research sponsor to an individual enrolled in a
clinical trial; or
new text end

new text begin (C) provided solely to determine eligibility of an individual for participation in a clinical
trial.
new text end

new text begin (b)(1) The medical assistance program must provide coverage for routine patient costs
that are incurred in the course of an approved clinical trial if the medical assistance program
would provide coverage for the same routine care costs not incurred in a clinical trial.
new text end

new text begin (2) The coverage that must be provided under this subdivision is subject to the terms,
conditions, restrictions, exclusions, and limitations that apply generally under the medical
assistance program, including terms, conditions, restrictions, exclusions, or limitations that
apply to health care services rendered by participating and nonparticipating providers.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective August 1, 2020, and applies to medical
assistance coverage as defined in section 256B.02.
new text end