SB-0991, As Passed House, October 1, 2014

SUBSTITUTE FOR

SENATE BILL NO. 991

A bill to authorize access to and use of experimental

treatments for patients with an advanced illness; to establish

conditions for use of experimental treatment; to prohibit sanctions

of health care providers solely for recommending or providing

experimental treatment; to clarify duties of a health insurer with

regard to experimental treatment authorized under this act; to

prohibit certain actions by state officials, employees, and agents;

and to restrict certain causes of action arising from experimental

treatment.

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

Sec. 1. (1) This act shall be known and may be cited as the

"right to try act".

(2) As used in this act, and unless the context otherwise

requires:

(a) "Advanced illness", for purposes of this section only,

means a progressive disease or medical or surgical condition that

entails significant functional impairment, that is not considered

by a treating physician to be reversible even with administration

of current federal drug administration approved and available

treatments, and that, without life-sustaining procedures, will soon

result in death.

(b) "Eligible patient" means an individual who meets all of

the following conditions:

(i) Has an advanced illness, attested to by the patient's

treating physician.

(ii) Has considered all other treatment options currently

approved by the United States food and drug administration.

(iii) Has received a recommendation from his or her physician

for an investigational drug, biological product, or device.

(iv) Has given written, informed consent for the use of the

investigational drug, biological product, or device.

(v) Has documentation from his or her physician that he or she

meets the requirements of this subdivision.

means a drug, biological product, or device that has successfully

completed phase 1 of a clinical trial but has not yet been approved

for general use by the United States food and drug administration

and remains under investigation in a United States food and drug

administration-approved clinical trial.

(d) "Written, informed consent" means a written document that

is signed by the patient; parent, if the patient is a minor; legal

guardian; or patient advocate designated by the patient under

section 5506 of the estates and protected individuals code, 1998 PA

386, MCL 700.5506, and attested to by the patient's physician and a

witness and that, at a minimum, includes all of the following:

(i) An explanation of the currently approved products and

treatments for the disease or condition from which the patient

suffers.

(ii) An attestation that the patient concurs with his or her

physician in believing that all currently approved and

conventionally recognized treatments are unlikely to prolong the

patient's life.

(iii) Clear identification of the specific proposed

investigational drug, biological product, or device that the

patient is seeking to use.

(iv) A description of the potentially best and worst outcomes

of using the investigational drug, biological product, or device

and a realistic description of the most likely outcome. The

description shall include the possibility that new, unanticipated,

different, or worse symptoms might result and that death could be

hastened by the proposed treatment. The description shall be based

on the physician's knowledge of the proposed treatment in

conjunction with an awareness of the patient's condition.

(v) A statement that the patient's health plan or third party

administrator and provider are not obligated to pay for any care or

treatments consequent to the use of the investigational drug,

biological product, or device, unless they are specifically

required to do so by law or contract.

(vi) A statement that the patient's eligibility for hospice

care may be withdrawn if the patient begins curative treatment with

the investigational drug, biological product, or device and that

care may be reinstated if this treatment ends and the patient meets

hospice eligibility requirements.

(vii) A statement that the patient understands that he or she

is liable for all expenses consequent to the use of the

investigational drug, biological product, or device and that this

liability extends to the patient's estate, unless a contract

between the patient and the manufacturer of the drug, biological

product, or device states otherwise.

Sec. 2. (1) A manufacturer of an investigational drug,

biological product, or device may make available and an eligible

patient may request the manufacturer's investigational drug,

biological product, or device under this act. This act does not

require that a manufacturer make available an investigational drug,

biological product, or device to an eligible patient.

(2) A manufacturer may do all of the following:

(a) Provide an investigational drug, biological product, or

device to an eligible patient without receiving compensation.

(b) Require an eligible patient to pay the costs of, or the

costs associated with, the manufacture of the investigational drug,

biological product, or device.

Sec. 3. (1) This act does not expand the coverage required of

an insurer under the insurance code of 1956, 1956 PA 218, MCL

500.100 to 500.8302.

(2) A health plan, third party administrator, or governmental

agency may, but is not required to, provide coverage for the cost

of an investigational drug, biological product, or device, or the

cost of services related to the use of an investigational drug,

biological product, or device under this act.

(3) This act does not require any governmental agency to pay

costs associated with the use, care, or treatment of a patient with

an investigational drug, biological product, or device.

(4) This act does not require a hospital or facility licensed

under part 215 of the public health code, 1978 PA 368, MCL

333.21501 to 333.21571, to provide new or additional services,

unless approved by the hospital or facility.

Sec. 4. If a patient dies while being treated by an

investigational drug, biological product, or device, the patient's

heirs are not liable for any outstanding debt related to the

treatment or lack of insurance due to the treatment.

Sec. 5. A licensing board or disciplinary subcommittee shall

not revoke, fail to renew, suspend, or take any action against a

health care provider's license issued under article 15 or 17 of the

public health code, 1978 PA 368, MCL 333.16101 to 333.18838 and

333.20101 to 333.22260, based solely on the health care provider's

recommendations to an eligible patient regarding access to or

treatment with an investigational drug, biological product, or

device. An entity responsible for medicare certification shall not

take action against a health care provider's medicare certification

based solely on the health care provider's recommendation that a

patient have access to an investigational drug, biological product,

or device.

Sec. 6. An official, employee, or agent of this state shall

not block or attempt to block an eligible patient's access to an

investigational drug, biological product, or device. Counseling,

advice, or a recommendation consistent with medical standards of

care from a licensed health care provider is not a violation of

this section.

Sec. 7. (1) This act does not create a private cause of action

against a manufacturer of an investigational drug, biological

product, or device or against any other person or entity involved

in the care of an eligible patient using the investigational drug,

biological product, or device for any harm done to the eligible

patient resulting from the investigational drug, biological

product, or device, if the manufacturer or other person or entity

is complying in good faith with the terms of this act and has

exercised reasonable care.

(2) This act does not affect any mandatory health care

coverage for participation in clinical trials under the insurance

code of 1956, 1956 PA 218, MCL 500.100 to 500.8302.