2021 -- H 5077

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LC000160

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2021

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A N   A C T

RELATING TO HEALTH AND SAFETY -- TREATMENT FOR PATIENTS WITH

TERMINAL ILLNESS -- THE NEIL FACHON TERMINALLY ILL PATIENTS' RIGHT TO

TRY ACT OF 2021

     

     Introduced By: Representatives McNamara, and Ackerman

     Date Introduced: January 22, 2021

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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

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amended by adding thereto the following chapter:

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CHAPTER 95

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TREATMENTS FOR PATIENTS WITH TERMINAL ILLNESS -- THE NEIL FACHON

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TERMINALLY ILL PATIENTS' RIGHT TO TRY ACT OF 2021

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     23-95-1. Short title - Treatments for patients with terminal illness.

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     This chapter shall be known and may be cited as the "Neil Fachon Terminally Ill Patients'

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Right To Try Act of 2021".

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     23-95-2. Purpose.

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

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

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

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state shall recognize experimental treatments for patients with terminal illness and establish

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conditions for the use of experimental treatments.

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     23-95-3. Definitions.

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

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     (1) "Eligible patient" means an individual who meets all of the following conditions:

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     (i) Has a terminal illness, attested to by the patient's treating physician;

 

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     (ii) Has considered all other treatment options currently approved by the Food and Drug

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Administration;

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     (iii) Has received a recommendation from their physician for an investigational drug,

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biological product, or device;

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

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product, or device; and

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

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     (2) "Investigational drug, biological product, or device" means a drug, biological product,

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or device that has successfully completed phase 1 of a clinical trial but has not yet been approved

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for general use by the Food and Drug Administration and remains under investigation in a Food

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and Drug Administration approved clinical trial.

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     (3) "Terminal illness," means a progressive disease or medical or surgical condition that

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entails significant functional impairment, that is not considered by a treating physician to be

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reversible even with administration of current Food and Drug Administration approved and

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

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

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     (i) The patient;

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

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     (iii) Legal guardian; or

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

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

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

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

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condition from which the patient suffers;

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

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

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

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device that the patient is seeking to use;

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     (4) A description of the potentially best and worst outcomes of using the investigational

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drug, biological product, or device and a realistic description of the most likely outcome. The

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description shall include the possibility that new, unanticipated, different, or worse symptoms

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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

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the patient's condition;

 

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     (5) A statement that the patient's health plan or third-party administrator and provider are

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not obligated to pay for any care or treatments consequent to the use of the investigational drug,

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biological product, or device, unless they are specifically required to do so by law or contract;

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     (6) A statement that the patient's eligibility for hospice care may be withdrawn if the patient

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begins curative treatment with the investigational drug, biological product, or device and that care

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may be reinstated if this treatment ends and the patient meets hospice eligibility requirements; and

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

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to the use of the investigational drug, biological product, or device, but that this liability does not

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extend to the patient's estate.

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     23-95-4. Procedures.

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     (a) A manufacturer of an investigational drug, biological product, or device may make

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available and an eligible patient may request the manufacturer's investigational drug, biological

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product, or device under this chapter. This chapter does not require that a manufacturer make

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

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

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

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without receiving compensation; and

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

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

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     23-95-5. Cost of services.

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

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

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     (b) A health plan, third-party administrator, or governmental agency may, but is not

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required to, provide coverage for the cost of an investigational drug, biological product, or device,

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or the cost of services related to the use of an investigational drug, biological product, or device

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under this chapter.

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     (c) This chapter does not require any governmental agency to pay costs associated with the

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use, care, or treatment of a patient with an investigational drug, biological product, or device.

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

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

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     23-95-6. Treatment expenses liability.

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

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

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

 

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     23-95-7. Health care provider immunity.

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     A licensing board or disciplinary subcommittee shall not revoke, fail to renew, suspend, or

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take any action against a health care provider's license issued under this title, based solely on the

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health care provider's recommendations to an eligible patient regarding access to or treatment with

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an investigational drug, biological product, or device. An entity responsible for Medicare

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certification shall not take action against a health care provider's Medicare certification based solely

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on the health care provider's recommendation that a patient have access to an investigational drug,

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biological product, or device.

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     23-95-8. Patient access.

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     (a) An official, employee, or agent of this state shall not block or attempt to block an

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eligible patient's access to an investigational drug, biological product, or device. Counseling,

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advice, or a recommendation consistent with medical standards of care from a licensed health care

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provider is not a violation of this section.

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

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

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

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treatment.

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     23-95-9. Right to continue treatment.

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

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

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staff.

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

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

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

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

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

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

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

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

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administration.

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

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with continuing treatment.

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

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

 

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

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

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fashion for their recommendations.

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

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

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

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

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

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continue treatment.

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     23-95-10. Cause of action immunity.

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     (a) This chapter does not create a private cause of action against a manufacturer of an

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investigational drug, biological product, or device, or against any other person or entity involved

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in the care of an eligible patient using the investigational drug, biological product, or device for

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any harm done to the eligible patient resulting from the investigational drug, biological product, or

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device, if the manufacturer or other person or entity is complying in good faith with the terms of

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this chapter and has exercised reasonable care.

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

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

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     23-95-11. Severability.

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

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

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

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     SECTION 2. This act shall take effect upon passage.

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LC000160

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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 NEIL FACHON TERMINALLY ILL PATIENTS' RIGHT TO

TRY ACT OF 2021

***

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     This act would create the "Neil Fachon Terminally Ill Patients' Right To Try Act of 2021,"

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

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     This act would take effect upon passage.

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LC000160

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