Bill Text: NY S02044 | 2017-2018 | General Assembly | Introduced
Bill Title: Enacts the "right to try act" which grants access to terminally ill patients to investigational drugs, biological products and devices which may help the patients' conditions.
Spectrum: Partisan Bill (Republican 2-0)
Status: (Introduced - Dead) 2018-01-03 - REFERRED TO HEALTH [S02044 Detail]
Download: New_York-2017-S02044-Introduced.html
STATE OF NEW YORK ________________________________________________________________________ 2044 2017-2018 Regular Sessions IN SENATE January 11, 2017 ___________ Introduced by Sen. HANNON -- read twice and ordered printed, and when printed to be committed to the Committee on Health AN ACT to amend the public health law, in relation to enacting the "right to try act" The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. The public health law is amended by adding a new article 2 40-A to read as follows: 3 ARTICLE 40-A 4 ACCESS TO TREATMENTS FOR 5 TERMINALLY ILL PATIENTS 6 Section 4050. Short title. 7 4051. Legislative intent. 8 4052. Definitions. 9 4053. Availability of investigational drugs, biological products 10 and devices. 11 4054. Action against health care provider. 12 4055. Access to investigational drugs, biological products and 13 devices. 14 4056. No cause of action created. 15 § 4050. Short title. This article shall be known and may be cited as 16 the "right to try act". 17 § 4051. Legislative intent. It is the intent of the legislature to 18 allow for terminally ill patients to use potentially life-saving inves- 19 tigational drugs, biological products and devices. 20 § 4052. Definitions. As used in this article, the following words and 21 phrases shall have the following meanings: 22 1. (a) "Eligible patient" means a person who has: 23 (i) a terminal illness, attested to by the patient's treating physi- 24 cian; EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD00553-01-7S. 2044 2 1 (ii) considered all other treatment options currently approved by the 2 United States food and drug administration; 3 (iii) been unable to participate in a clinical trial for the terminal 4 illness within one hundred miles of the patient's home address for the 5 terminal illness, or not been accepted to the clinical trial within one 6 week of completion of the clinical trial application process; 7 (iv) received a recommendation from his or her physician for an inves- 8 tigational drug, biological product or device; 9 (v) given written, informed consent for the use of the investigational 10 drug, biological product or device or, if the patient is a minor or 11 lacks the mental capacity to provide informed consent, a parent or legal 12 guardian has given written, informed consent on the patient's behalf; 13 and 14 (vi) documentation from his or her physician that he or she meets the 15 requirements of this paragraph. 16 (b) "Eligible patient" shall not include a person being treated as an 17 inpatient in a hospital operated pursuant to article twenty-eight of 18 this chapter. 19 2. "Investigational drug, biological product or device" means a drug, 20 biological product or device that has successfully completed phase one 21 of a clinical trial but has not yet been approved for general use by the 22 United States food and drug administration and remains under investi- 23 gation in a United States food and drug administration-approved clinical 24 trial. 25 3. "Terminal illness" means a condition, illness or injury from which 26 there is no recovery and which reasonably can be expected to cause death 27 within one year. 28 4. "Written, informed consent" means a written document signed by the 29 patient, and attested to by the patient's physician and a witness that, 30 at a minimum: 31 (a) explains the currently approved products and treatments for the 32 disease or condition from which the patient suffers; 33 (b) attests to the fact that the patient concurs with his or her 34 physician in believing that all currently approved and conventionally 35 recognized treatments are unlikely to prolong the patient's life; 36 (c) clearly identifies the specific proposed investigational drug, 37 biological product or device that the patient is seeking to use; 38 (d) describes the potentially best and worst outcomes of using the 39 investigational drug, biological product or device with a realistic 40 description of the most likely outcome, including the possibility that 41 new, unanticipated, different or worse symptoms might result, and that 42 death could be hastened by the proposed treatment, based on the physi- 43 cian's knowledge of the proposed treatment in conjunction with an aware- 44 ness of the patient's condition; 45 (e) makes clear that the patient's health insurer and provider are not 46 obligated to pay for any care or treatments consequent to the use of the 47 investigational drug, biological product or device; 48 (f) makes clear that the patient's eligibility for hospice care may be 49 withdrawn if the patient begins curative treatment and care may be rein- 50 stated if the curative treatment ends and the patient meets hospice 51 eligibility requirements; 52 (g) makes clear that in-home health care may be denied if treatment 53 begins; and 54 (h) states that the patient understands that he or she is liable for 55 all expenses consequent to the use of the investigational drug, biolog- 56 ical product or device, and that this liability extends to the patient'sS. 2044 3 1 estate, unless a contract between the patient and the manufacturer of 2 the drug, biological product or device states otherwise. 3 § 4053. Availability of investigational drugs, biological products and 4 devices. 1. A manufacturer of an investigational drug, biological prod- 5 uct or device may make available the manufacturer's investigational 6 drug, biological product or device to eligible patients pursuant to this 7 article. This article shall not be deemed to require that a manufacturer 8 make available an investigational drug, biological product or device to 9 an eligible patient. 10 2. A manufacturer may: 11 (a) provide an investigational drug, biological product or device to 12 an eligible patient without receiving compensation; or 13 (b) require an eligible patient to pay the costs of or the costs asso- 14 ciated with the manufacture of the investigational drug, biological 15 product or device. 16 3. (a) Nothing in this article shall be deemed to expand the coverage 17 provided in article forty-four of this chapter, articles thirty-two and 18 forty-three of the insurance law, and title eleven of article five of 19 the social services law. 20 (b) A health insurance carrier may, but is not required to, provide 21 coverage for the cost of an investigational drug, biological product or 22 device. 23 (c) An insurer may deny coverage to an eligible patient from the time 24 the eligible patient begins use of an investigational drug, biological 25 product or device through a period not to exceed six months from the 26 time the investigational drug, biological product or device is no longer 27 used by the eligible patient; except that coverage shall not be denied 28 for a preexisting condition and for coverage for benefits which 29 commenced prior to the time the eligible patient begins use of such 30 drug, biological product or device. 31 4. If an eligible patient dies while being treated by an investiga- 32 tional drug, biological product or device, the patient's heirs shall not 33 be liable for any outstanding debt related to the treatment or lack of 34 insurance due to the treatment. 35 § 4054. Action against health care provider. Notwithstanding any 36 provision of law to the contrary, neither the education department nor 37 the state board for professional medical conduct shall revoke, fail to 38 renew, suspend or take any action against a health care provider's 39 license, based solely on the health care provider's recommendations to 40 an eligible patient regarding access to or treatment with an investiga- 41 tional drug, biological product or device, so long as the recommenda- 42 tions are consistent with medical standards of care. Acting against a 43 health care provider's medicare certification based solely on the health 44 care provider's recommendation that a patient have access to an investi- 45 gational drug, biological product or device is prohibited. 46 § 4055. Access to investigational drugs, biological products and 47 devices. An official, employee or agent of this state shall not block or 48 attempt to block an eligible patient's access to an investigational 49 drug, biological product or device. Counseling, advice or a recommenda- 50 tion consistent with medical standards of care from a licensed health 51 care provider is not a violation of this section. 52 § 4056. No cause of action created. This article shall not be deemed 53 to create a private cause of action against a manufacturer of an inves- 54 tigational drug, biological product or device or against any other 55 person or entity involved in the care of an eligible patient using the 56 investigational drug, biological product or device, for any harm done toS. 2044 4 1 the eligible patient resulting from the investigational drug, biological 2 product, or device so long as the manufacturer or other person or entity 3 is complying in good faith with the terms of this article; unless there 4 was a failure to exercise reasonable care. 5 § 2. This act shall take effect immediately.