Bill Text: NY A06889 | 2015-2016 | General Assembly | Introduced
Bill Title: Establishes the Right to Try Act; allows patients with terminal illnesses who meet certain requirements including having informed consent to request to use investigational drugs, biological products or devices; establishes that manufacturers are not obligated to provide such drugs or products; establishes that insurance companies are not required to provide coverage; restricts certain causes of action arising from experimental treatment.
Spectrum: Strong Partisan Bill (Democrat 11-1)
Status: (Introduced - Dead) 2016-01-06 - referred to health [A06889 Detail]
Download: New_York-2015-A06889-Introduced.html
S T A T E O F N E W Y O R K
________________________________________________________________________
6889
2015-2016 Regular Sessions
I N A S S E M B L Y
April 8, 2015
___________
Introduced by M. of A. ROSENTHAL, GUNTHER, GALEF, ZEBROWSKI, BENEDETTO,
BROOK-KRASNY, ARROYO, DUPREY, COLTON, MILLER, COOK -- Multi-Sponsored
by -- M. of A. BLAKE, SIMON -- read once and referred to the Committee
on Health
AN ACT to amend the public health law, in relation to establishing 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. This act shall be known and may be cited as the "right to
2 try act".
3 S 2. The public health law is amended by adding a new article 29-CCCC
4 to read as follows:
5 ARTICLE 29-CCCC
6 RIGHT TO TRY ACT
7 SECTION 2994-AAA. DEFINITIONS.
8 2994-BBB. MANUFACTURERS' OBLIGATIONS.
9 2994-CCC. COVERAGE.
10 2994-DDD. LIABILITY FOR PATIENT DEBT.
11 2994-EEE. ACTIONS AGAINST LICENSE OR CERTIFICATION.
12 2994-FFF. IMMUNITY.
13 2994-GGG. ACCESS TO TREATMENT.
14 2994-HHH. CAUSE OF ACTION.
15 S 2994-AAA. DEFINITIONS. THE FOLLOWING WORDS AND TERMS WITHIN THIS
16 ARTICLE SHALL HAVE THE FOLLOWING MEANINGS, UNLESS THE CONTEXT CLEARLY
17 INDICATES OTHERWISE.
18 1. "TERMINAL ILLNESS", FOR PURPOSES OF THIS ARTICLE ONLY, MEANS A
19 PROGRESSIVE DISEASE OR MEDICAL OR SURGICAL CONDITION THAT ENTAILS
20 SIGNIFICANT FUNCTIONAL IMPAIRMENT, THAT IS NOT CONSIDERED BY A TREATING
21 HEALTH CARE PROVIDER TO BE REVERSIBLE EVEN WITH ADMINISTRATION OF
22 CURRENT UNITED STATES FOOD AND DRUG ADMINISTRATION APPROVED AND AVAIL-
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD09973-03-5
A. 6889 2
1 ABLE TREATMENTS AND THAT, WITHOUT LIFE-SUSTAINING PROCEDURES, WILL SOON
2 RESULT IN DEATH.
3 2. "ELIGIBLE PATIENT" MEANS AN INDIVIDUAL WHO MEETS ALL OF THE FOLLOW-
4 ING CONDITIONS:
5 (A) HAS A TERMINAL ILLNESS, ATTESTED TO BY THE PATIENT'S TREATING
6 HEALTH CARE PROVIDER.
7 (B) HAS CONSIDERED ALL OTHER TREATMENT OPTIONS CURRENTLY APPROVED BY
8 THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
9 (C) HAS RECEIVED A RECOMMENDATION FROM HIS OR HER TREATING HEALTH CARE
10 PROVIDER FOR AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
11 (D) HAS GIVEN WRITTEN, INFORMED CONSENT FOR THE USE OF THE INVESTIGA-
12 TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
13 (E) HAS DOCUMENTATION FROM HIS OR HER TREATING HEALTH CARE PROVIDER
14 THAT HE OR SHE MEETS THE REQUIREMENTS OF THIS SUBDIVISION.
15 3. "INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE" MEANS A DRUG,
16 BIOLOGICAL PRODUCT OR DEVICE THAT HAS SUCCESSFULLY COMPLETED PHASE ONE
17 OF A CLINICAL TRIAL BUT HAS NOT YET BEEN APPROVED FOR GENERAL USE BY THE
18 UNITED STATES FOOD AND DRUG ADMINISTRATION AND REMAINS UNDER INVESTI-
19 GATION IN A UNITED STATES FOOD AND DRUG ADMINISTRATION-APPROVED CLINICAL
20 TRIAL.
21 4. "WRITTEN, INFORMED CONSENT" MEANS A WRITTEN DOCUMENT THAT IS SIGNED
22 BY THE PATIENT; PARENT, IF THE PATIENT IS A MINOR; LEGAL GUARDIAN; OR
23 HEALTH CARE AGENT DESIGNATED BY THE PATIENT UNDER ARTICLE TWENTY-NINE-C
24 OF THIS CHAPTER AND ATTESTED TO BY THE PATIENT'S TREATING HEALTH CARE
25 PROVIDER AND A WITNESS AND THAT, AT A MINIMUM, INCLUDES ALL OF THE
26 FOLLOWING:
27 (A) AN EXPLANATION OF THE CURRENTLY APPROVED PRODUCTS AND TREATMENTS
28 FOR THE DISEASE OR CONDITION FROM WHICH THE PATIENT SUFFERS.
29 (B) AN ATTESTATION THAT THE PATIENT CONCURS WITH HIS OR HER TREATING
30 HEALTH CARE PROVIDER IN BELIEVING THAT ALL CURRENTLY APPROVED AND
31 CONVENTIONALLY RECOGNIZED TREATMENTS ARE UNLIKELY TO PROLONG THE
32 PATIENT'S LIFE.
33 (C) CLEAR IDENTIFICATION OF THE SPECIFIC PROPOSED INVESTIGATIONAL
34 DRUG, BIOLOGICAL PRODUCT OR DEVICE THAT THE PATIENT IS SEEKING TO USE.
35 (D) A DESCRIPTION OF THE POTENTIALLY BEST AND WORST OUTCOMES OF USING
36 THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE AND A REALISTIC
37 DESCRIPTION OF THE MOST LIKELY OUTCOME. THE DESCRIPTION SHALL INCLUDE
38 THE POSSIBILITY THAT NEW, UNANTICIPATED, DIFFERENT OR WORSE SYMPTOMS
39 MIGHT RESULT AND THAT DEATH COULD BE HASTENED BY THE PROPOSED TREATMENT.
40 THE DESCRIPTION SHALL BE BASED ON THE HEALTH CARE PROVIDER'S KNOWLEDGE
41 OF THE PROPOSED TREATMENT IN CONJUNCTION WITH AN AWARENESS OF THE
42 PATIENT'S CONDITION.
43 (E) A STATEMENT THAT THE PATIENT'S HEALTH PLAN OR THIRD PARTY ADMINIS-
44 TRATOR AND PROVIDER ARE NOT OBLIGATED TO PAY FOR ANY CARE OR TREATMENTS
45 CONSEQUENT TO THE USE OF THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR
46 DEVICE, UNLESS THEY ARE SPECIFICALLY REQUIRED TO DO SO BY LAW OR
47 CONTRACT.
48 (F) A STATEMENT THAT THE PATIENT'S ELIGIBILITY FOR HOSPICE CARE MAY BE
49 WITHDRAWN IF THE PATIENT BEGINS CURATIVE TREATMENT WITH THE INVESTIGA-
50 TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE AND THAT CARE MAY BE REIN-
51 STATED IF THIS TREATMENT ENDS AND THE PATIENT MEETS HOSPICE ELIGIBILITY
52 REQUIREMENTS.
53 (G) A STATEMENT THAT THE PATIENT UNDERSTANDS THAT HE OR SHE IS LIABLE
54 FOR ALL EXPENSES CONSEQUENT TO THE USE OF THE INVESTIGATIONAL DRUG,
55 BIOLOGICAL PRODUCT OR DEVICE AND THAT THIS LIABILITY EXTENDS TO THE
A. 6889 3
1 PATIENT'S ESTATE, UNLESS A CONTRACT BETWEEN THE PATIENT AND THE MANUFAC-
2 TURER OF THE DRUG, BIOLOGICAL PRODUCT OR DEVICE STATES OTHERWISE.
3 S 2994-BBB. MANUFACTURERS' OBLIGATIONS. 1. A MANUFACTURER OF AN INVES-
4 TIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE MAY MAKE AVAILABLE AND AN
5 ELIGIBLE PATIENT MAY REQUEST THE MANUFACTURER'S INVESTIGATIONAL DRUG,
6 BIOLOGICAL PRODUCT OR DEVICE UNDER THIS SECTION. THIS SECTION DOES NOT
7 REQUIRE THAT A MANUFACTURER MAKE AVAILABLE AN INVESTIGATIONAL DRUG,
8 BIOLOGICAL PRODUCT OR DEVICE TO AN ELIGIBLE PATIENT.
9 2. A MANUFACTURER MAY:
10 (A) PROVIDE AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE TO
11 AN ELIGIBLE PATIENT WITHOUT RECEIVING COMPENSATION; OR
12 (B) REQUIRE AN ELIGIBLE PATIENT TO PAY THE COSTS OF, OR THE COSTS
13 ASSOCIATED WITH, THE MANUFACTURE OF THE INVESTIGATIONAL DRUG, BIOLOGICAL
14 PRODUCT OR DEVICE.
15 S 2994-CCC. COVERAGE. 1. THIS ARTICLE DOES NOT EXPAND THE COVERAGE
16 REQUIRED OF AN INSURER UNDER THE INSURANCE LAW OR ANY OTHER APPLICABLE
17 LAWS.
18 2. A HEALTH PLAN, THIRD PARTY ADMINISTRATOR, OR GOVERNMENTAL AGENCY
19 MAY, BUT IS NOT REQUIRED TO, PROVIDE COVERAGE FOR THE COST OF AN INVES-
20 TIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE OR THE COST OF SERVICES
21 RELATED TO THE USE OF AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR
22 DEVICE UNDER THIS ARTICLE.
23 3. THIS ARTICLE DOES NOT REQUIRE ANY GOVERNMENTAL AGENCY TO PAY COSTS
24 ASSOCIATED WITH THE USE, CARE OR TREATMENT OF A PATIENT WITH AN INVESTI-
25 GATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE.
26 4. THIS ARTICLE DOES NOT REQUIRE A HOSPITAL OR FACILITY ESTABLISHED
27 UNDER ARTICLE TWENTY-EIGHT OF THIS CHAPTER TO PROVIDE NEW OR ADDITIONAL
28 SERVICES, UNLESS APPROVED BY THE HOSPITAL OR FACILITY.
29 5. THIS ARTICLE DOES NOT AFFECT ANY MANDATORY HEALTH CARE COVERAGE FOR
30 PARTICIPATION IN CLINICAL TRIALS UNDER THE INSURANCE LAW OR OTHER APPLI-
31 CABLE LAWS.
32 S 2994-DDD. LIABILITY FOR PATIENT DEBT. IF A PATIENT DIES WHILE BEING
33 TREATED BY AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE, THE
34 PATIENT'S HEIRS ARE NOT LIABLE FOR ANY OUTSTANDING DEBT RELATED TO THE
35 TREATMENT OR LACK OF INSURANCE DUE TO THE TREATMENT.
36 S 2994-EEE. ACTIONS AGAINST LICENSE OR CERTIFICATION. A LICENSING
37 BOARD OR DISCIPLINARY SUBCOMMITTEE SHALL NOT REVOKE, FAIL TO RENEW,
38 SUSPEND OR TAKE ANY ACTION AGAINST A HEALTH CARE PROVIDER'S LICENSE
39 BASED SOLELY ON THE PROVIDER'S RECOMMENDATIONS TO AN ELIGIBLE PATIENT
40 REGARDING ACCESS TO OR TREATMENT WITH AN INVESTIGATIONAL DRUG, BIOLOG-
41 ICAL PRODUCT OR DEVICE. AN ENTITY RESPONSIBLE FOR MEDICARE CERTIFICATION
42 SHALL NOT TAKE ACTION AGAINST A HEALTH CARE PROVIDER'S MEDICARE CERTIF-
43 ICATION BASED SOLELY ON THE HEALTH CARE PROVIDER'S RECOMMENDATION THAT
44 AN ELIGIBLE PATIENT HAVE ACCESS TO AN INVESTIGATIONAL DRUG, BIOLOGICAL
45 PRODUCT OR DEVICE.
46 S 2994-FFF. IMMUNITY. IF AS A RESULT OF THE INVESTIGATIONAL DRUG,
47 BIOLOGICAL PRODUCT OR DEVICE, A PATIENT'S SYMPTOMS WORSEN OR CHANGE OR A
48 PATIENT DIES, NO HEALTH CARE PROVIDER SHALL BE SUBJECT TO CIVIL LIABIL-
49 ITY PROVIDED THAT SUCH HEALTH CARE PROVIDER PARTICIPATED IN GOOD FAITH
50 COMPLIANCE WITH THE PROVISIONS OF THIS ARTICLE AND OBTAINED WRITTEN,
51 INFORMED CONSENT FROM THE PATIENT.
52 S 2994-GGG. ACCESS TO TREATMENT. AN OFFICIAL, EMPLOYEE OR AGENT OF
53 THIS STATE SHALL NOT BLOCK OR ATTEMPT TO BLOCK AN ELIGIBLE PATIENT'S
54 ACCESS TO AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE. COUN-
55 SELING, ADVICE OR A RECOMMENDATION CONSISTENT WITH MEDICAL STANDARDS OF
A. 6889 4
1 CARE FROM A LICENSED HEALTH CARE PROVIDER IS NOT A VIOLATION OF THIS
2 SECTION.
3 S 2994-HHH. CAUSE OF ACTION. THIS SECTION DOES NOT CREATE A PRIVATE
4 CAUSE OF ACTION AGAINST A MANUFACTURER OF AN INVESTIGATIONAL DRUG,
5 BIOLOGICAL PRODUCT OR DEVICE OR AGAINST ANY OTHER PERSON OR ENTITY
6 INVOLVED IN THE CARE OF AN ELIGIBLE PATIENT USING THE INVESTIGATIONAL
7 DRUG, BIOLOGICAL PRODUCT OR DEVICE FOR ANY HARM DONE TO THE ELIGIBLE
8 PATIENT RESULTING FROM THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR
9 DEVICE, IF THE MANUFACTURER OR OTHER PERSON OR ENTITY IS COMPLYING IN
10 GOOD FAITH WITH THE TERMS OF THIS ARTICLE AND HAS EXERCISED REASONABLE
11 CARE.
12 S 3. This act shall take effect on the ninetieth day after it shall
13 have become a law.
