HOUSE BILL No. 5651

 

June 11, 2014, Introduced by Reps. Haines, Muxlow, Shirkey, Callton, Driskell, Kivela, Dianda, Schor, Segal, Slavens, Hooker, Heise, Kowall, Bumstead, Brown, Lane, Goike, Darany, Durhal, Talabi, Smiley, Brunner, Phelps, Dillon, Brinks, Cochran, Geiss, Knezek, Santana, Banks, Stanley, LaVoy, MacMaster, Genetski, Franz, Lori, O'Brien, Pagel, Victory, Graves, Denby, Kurtz and Rendon and referred to the Committee on Health Policy.

 

     A bill to authorize access to and use of experimental

 

treatments for patients with a terminal 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. This act shall be known and may be cited as the "right

 

to try act".

 

     Sec. 2. As used in this act, and unless the context otherwise

 

requires:


 

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

 

the following conditions:

 

     (i) Has a terminal 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 or, if the

 

patient is a minor or lacks the mental capacity to provide informed

 

consent, a parent or legal guardian has given written, informed

 

consent on the patient's behalf.

 

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

 

meets the requirements of this subdivision.

 

     (b) "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 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.

 

     (c) "Terminal illness" means a disease that, without life-

 

sustaining procedures, will soon result in death or a state of

 

unconsciousness from which recovery is unlikely.

 

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

 

signed by the patient and attested to by the patient's physician

 

and a witness 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 insurer 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 and

 

that care may be reinstated if the curative 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. 3. (1) A manufacturer of an investigational drug,

 

biological product, or device may make available the manufacturer's

 

investigational drug, biological product, or device to an eligible

 

patient 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. 4. (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 insurer may, but is not required to, provide

 

coverage for the cost 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.

 

     Sec. 5. 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. 6. Notwithstanding any other law, a licensing board 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, as long as the recommendations are consistent with medical

 

standards of care. A board 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. 7. 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. 8. (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.