2017 -- H 5676

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LC001624

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2017

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A N   A C T

RELATING TO HEALTH AND SAFETY - TREATMENT FOR PATIENTS WITH

TERMINAL ILLNESS--THE RHODE ISLAND TERMINALLY ILL PATIENTS' RIGHT TO

TRY ACT OF 2017

     Introduced By: Representatives McNamara, Vella-Wilkinson, Giarrusso, Solomon, and
Tobon

     Date Introduced: March 01, 2017

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

     SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby

amended by adding thereto the following chapter:

CHAPTER 94

TREATMENTS FOR PATIENTS WITH TERMINAL ILLNESS – THE RHODE ISLAND

TERMINALLY ILL PATIENTS' RIGHT TO TRY ACT OF 2017

     23-94-1. Short title - Treatments for patients with terminal illness.

     This chapter shall be known and may be cited as the "Rhode Island terminally ill patients'

right to try act of 2017".

     23-94-2. Purpose.

     The legislature finds that access to and the use of experimental treatments for patients

with terminal illness will provide persons with the fundamental right to control the decisions

relating to their own medical care. In order to respect these rights the legislature declares that the

laws of the state shall recognize experimental treatments for patients with terminal illness and

establish conditions for the use of experimental treatments.

     23-94-3. Definitions.

     (a) As used in this chapter, and unless the context otherwise requires:

     (1) "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 Food and Drug

Administration;

     (iii) Has received a recommendation from their 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; and

     (v) Has documentation from their physician that they meet the requirements of this

section.

     (2) "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 Food and Drug Administration and remains under investigation in a Food

and Drug Administration approved clinical trial.

     (3) "Terminal illness," 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 Food and Drug Administration approved and

available treatments, and that, without life-sustaining procedures, will soon result in death.

     (4) "Written informed consent" means a written document that is signed by:

     (i) The patient;

     (ii) The parent or legal guardian, if the patient is a minor;

     (iii) Legal guardian; or

     (iv) Patient advocate designated by the patient under the provisions of this title.

     (b) Provided that, for purposes of this chapter, written informed consent must be attested

to by the patient's physician and a witness and, at a minimum, includes all of the following:

     (1) An explanation of the currently approved products and treatments for the disease or

condition from which the patient suffers;

     (2) An attestation that the patient concurs with their physician in believing that all

currently approved and conventionally recognized treatments are unlikely to prolong the patient's

life;

     (3) Clear identification of the specific proposed investigational drug, biological product,

or device that the patient is seeking to use;

     (4) 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

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based on the physician's knowledge of the proposed treatment in conjunction with an awareness

of the patient's condition;

     (5) 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;

     (6) 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; and

     (7) A statement that the patient understands that they are liable for all expenses

consequent to the use of the investigational drug, biological product, or device, but that this

liability does not extend to the patient's estate.

     23-94-4. Procedures.

     (a) 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 chapter. This chapter does not require that a manufacturer make

available an investigational drug, biological product, or device to an eligible patient.

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

     (1) Provide an investigational drug, biological product, or device to an eligible patient

without receiving compensation; and

     (2) Require an eligible patient to pay the costs of, or the costs associated with, the

manufacture of the investigational drug, biological product, or device.

     23-94-5. Cost of services.

     (a) This chapter does not expand the coverage required of an insurer pursuant to chapters

18, 19, 20, 20.1, or 41 of title 27.

     (b) 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 chapter.

     (c) This chapter 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.

     (d) This chapter does not require a hospital or facility licensed pursuant to chapter 17 of

this title to provide new or additional services, unless approved by the hospital or facility.

     23-94-6. Treatment expenses liability.

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     Regardless of whether a patient dies while being treated by an investigational drug,

biological product, or device, the patient's heirs and/or the patient's estate shall not be liable for

any outstanding debt related to the treatment or lack of insurance due to the treatment.

     23-94-7. Health care provider immunity.

     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 this title, 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.

     23-94-8. Patient access.

     (a) 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.

     (b) A patient with a terminal diagnosis and condition within the ambits of this chapter has

the right to try the use of an unconventional treatment that has demonstrated more safety and

efficacy, through either trial research-based or anecdotal evidence, than standard conventional

treatment.

     23-94-9. Right to continue treatment.

     A clinical trial patient has a right to continue the experimental treatment in a hospital

setting, provided the patient or guardian signs a waiver of liability in favor of the hospital and its

staff.

     (1) Hospitals and nursing homes, or any other medical facility shall not suspend the

treatment with medications associated with any clinical trial or experimental drug a patient was

using before hospitalization or placement in another medical facility or nursing home.

     (2) A patient's status as participating in a clinical trial or undergoing experimental

treatment shall not be cited as the reason to prohibit access to any medical facility.

     (3) The facility shall have the right to receive all information pertaining to the clinical

trial/experimental treatment drug and may also require some training to administer that treatment.

It shall be the responsibility of the provider of that treatment to provide the training on its

administration.

     (4) The facility shall be immune from any liability for any negative outcomes associated

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with continuing treatment.

     (5) Notwithstanding the foregoing, a facility may withhold the experimental treatment

when necessary for surgical procedures or when inquiring into potential negative interactions

with other drugs to be administered in the course of addressing the patient's other medical needs.

In either instance, the experimental drug provider and/or physician shall be consulted in a timely

fashion for their recommendations.

     (6) A facility may advise discontinuation of experimental treatment when negative drug

interactions are observed, and constitute a grave threat to the patient's life;

     (i) In any conflict of opinion under this subsection, the provider of the experimental

treatment shall determine when or if to discontinue treatment, except that;

     (ii) The patient or the patient's guardian shall have the final decision on whether or not to

continue treatment.

     23-94-10. Cause of action immunity.

     (a) This chapter 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 chapter and has exercised reasonable care.

     (b) This chapter does not affect any mandatory health care coverage for participation in

clinical trials under the insurance provisions contained in this title or title 27.

     23-94-11. Severability.

     If any provisions of this chapter are declared unconstitutional, or the applicability of any

provisions to any person or circumstance is held invalid, the constitutionality of the remainder of

this chapter and its applicability to other persons and circumstances shall not be affected thereby.

     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO HEALTH AND SAFETY - TREATMENT FOR PATIENTS WITH

TERMINAL ILLNESS--THE RHODE ISLAND TERMINALLY ILL PATIENTS' RIGHT TO

TRY ACT OF 2017

***

     This act would create the "Rhode Island terminally ill patient's right to try act of 2017,"

which establishes the conditions for the use of experimental treatments for terminally ill patients.

     This act would take effect upon passage.

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