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.
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.
LBD00553-01-7
S. 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's
S. 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 to
S. 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.
