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Minnesota Legislature

Office of the Revisor of Statutes

SF 100

3rd Engrossment - 89th Legislature (2015 - 2016) Posted on 08/13/2015 01:36pm

KEY: stricken = removed, old language.
underscored = added, new language.
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A bill for an act
relating to health; permitting the use of investigational drugs, biological products,
or devices by certain eligible patients; specifying medical assistance and early
periodic screening, diagnosis, and treatment program does not cover costs for
investigational drugs, biological products, or devices;amending Minnesota
Statutes 2014, section 256B.0625, by adding a subdivision; proposing coding for
new law in Minnesota Statutes, chapter 151.

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

Section 1.

new text begin [151.375] INVESTIGATIONAL DRUG USE.
new text end

new text begin Subdivision 1. new text end

new text begin Title; citation. new text end

new text begin This section may be cited as the "Right to Try Act."
new text end

new text begin Subd. 2. new text end

new text begin Definitions. new text end

new text begin (a) For the purposes of this section, the following terms
have the meanings given them.
new text end

new text begin (b) "Eligible patient" means a patient who meets the requirements in subdivision 3.
new text end

new text begin (c) "Investigational drug, biological product, or device" means a drug, biological
product, or device that has successfully completed phase 1 of a clinical trial, but has not
been approved for general use by the federal Food and Drug Administration (FDA), and is
currently under investigation in a FDA clinical trial.
new text end

new text begin (d) "Terminal illness" means a condition or illness which, to a reasonable degree
of medical probability, is not considered reversible and even with the administration of
current FDA-approved and available treatments and the administration of life-sustaining
procedures will soon result in death.
new text end

new text begin Subd. 3. new text end

new text begin Eligibility. new text end

new text begin In order for a patient to access an investigational drug, biological
product, or device under this section, a physician must document in writing that the patient:
new text end

new text begin (1) has a terminal illness;
new text end

new text begin (2) has, in consultation with a physician, considered all other treatment options
currently approved by the FDA;
new text end

new text begin (3) has been given a prescription or recommendation by a physician for an
investigational drug, biological product, or device; and
new text end

new text begin (4) has given informed consent, in writing, for the use of the investigational drug,
biological product, or device, or if the patient is under the age of 18, or lacks the mental
capacity to provide informed consent, a parent or legal guardian has given informed
consent, in writing, on behalf of the patient.
new text end

new text begin Subd. 4. new text end

new text begin Availability. new text end

new text begin (a) A manufacturer of an investigational drug, biological
product, or device has the option of making its investigational drug, biological product,
or device available to eligible patients under this section.
new text end

new text begin (b) Nothing in this section shall be construed to require a manufacturer to make an
investigational drug, biological product, or device available.
new text end

new text begin Subd. 5. new text end

new text begin Costs. new text end

new text begin (a) A manufacturer may provide an investigational drug, biological
product, or device without receiving compensation.
new text end

new text begin (b) A manufacturer may require an eligible patient to pay the costs associated with
manufacturing the investigational drug, biological product, or device.
new text end

new text begin Subd. 6. new text end

new text begin Professional licensing. new text end

new text begin No health care provider shall be subject to a civil
penalty or disciplinary action by any business, occupational, or professional licensing
board, solely for providing a prescription or recommendation, or providing treatment to an
eligible patient in accordance with this section. Nothing in this section affects a professional
licensing board from taking action in response to violations of any other section of law.
new text end

new text begin Subd. 7. new text end

new text begin Coverage. new text end

new text begin Nothing in this section shall be construed to require that the
costs associated with an investigational drug, biological product, or device be covered
under private health coverage, a state public health care program, the state employee group
insurance program, or a program administered by a state or local government agency that
provides health care services to inmates residing in a state or county correctional facility.
new text end

new text begin Subd. 8. new text end

new text begin Liability. new text end

new text begin Nothing in this section shall create a separate private cause of
action against any health care provider or entity involved in the care of an eligible patient
using an investigational drug, biological product, or device, for any harm done to the
patient resulting from the investigational drug, biological product, or device, so long as
the health care provider or entity is complying with the requirements of this section.
new text end

new text begin Subd. 9. new text end

new text begin Exception. new text end

new text begin This section does not apply to a person committed to the
custody of the commissioner of corrections unless the department's medical director
approves the investigational drug, biological product, or device.
new text end

new text begin Subd. 10. new text end

new text begin Severability. new text end

new text begin If any provision of this section or its application to any
person or circumstances is held to be invalid, the invalidity of the provision shall not affect
any other provision of this section. The provisions of this section are severable.
new text end

Sec. 2.

Minnesota Statutes 2014, section 256B.0625, is amended by adding a
subdivision to read:


new text begin Subd. 64. new text end

new text begin Investigational drugs, biological products, and devices. new text end

new text begin Medical
assistance and the early periodic screening, diagnosis, and treatment (EPSDT) program do
not cover costs incidental to, associated with, or resulting from the use of investigational
drugs, biological products, or devices as defined in section 151.375.
new text end