NY State Senate Bill 2017-S2044

Senate Bill S2044

2017-2018 Legislative Session

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

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Archive: Last Bill Status - In Senate Committee Health Committee

Introduced
- In Committee Assembly
- In Committee Senate
- On Floor Calendar Assembly
- On Floor Calendar Senate
- Passed Assembly
- Passed Senate
Delivered to Governor
Signed By Governor

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	Assembly Actions - Lowercase Senate Actions - UPPERCASE
Jan 03, 2018	referred to health
Jan 11, 2017	referred to health

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2017-S2044 (ACTIVE) - Details

Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add Art 40-A §§4050 - 4056, Pub Health L
Versions Introduced in 2015-2016 Legislative Session:: S4716

2017-S2044 (ACTIVE) - Summary

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.

2017-S2044 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S2044

 TITLE OF BILL :  An act to amend the public health law, in relation
to enacting the "right to try act"

 PURPOSE :

Enacts the "Right to Try Act" to provide terminally ill patients
access to investigational drugs and products which may help the
patients' condition.

 SUMMARY OF PROVISIONS :

Section one adds a new Article 40-a to the Public Health Law to
provide access to treatments for terminally ill patients. This article
details the legislative intent, defines eligible patients and
investigational drugs, and provides for the availability of
investigational drugs, biological products and devices. The article
authorizes, but does not require, a manufacturer to make available an
investigational drug, biological product or device to an eligible
patient either without compensation or paid for by the eligible
patient. While health plans may provide coverage of investigational
drugs, the act expressly provides that they are not required to do so
and the health plan, with certain exceptions may deny coverage when
the patient begins use of the investigational drug or biological
product or device.

Should the eligible patient die during the course of treatment by an
investigational drug or biological product or device, the patient's
estate is not liable for any outstanding medical debt. The article
also provides health care provider protections from professional
misconduct based solely on the provider's recommendation to an
eligible patient regarding access to or treatment by an
investigational drug, so long as the recommendation is consistent with
medical standards of care. The act also expressly provides that it
shall not be deemed to create a private cause of action against a
manufacturer or any other person involved in the care of the eligible
patient provided the terms of this section where complied with in good
faith with reasonable care.

Section two provides that this act shall take effect immediately.

 JUSTIFICATION :

The federal Food and Drug Administration (FDA) mandates that
medications go through a rigorous three-stage investigation before
doctors can prescribe. While such process can often be critical in
ensuring product safety, this lengthy process has the consequence of
prohibiting terminally ill patients from accessing their last viable
treatment option. The FDA does have a compassionate use program which
permits the FDA to grant access to unapproved therapies to people with
exceptional need; however, this process is similarly criticized as
being bureaucratic and lengthy. For patients suffering from terminal
illness, the length of this process can mean the difference between
life and death.

Congress has recently begun looking at the FDA's process, and ways in
which it may be improved. In the meantime, many states have begun to
take action to ensure patients with no other options available have
access to treatments which may save their lives. This legislation,
modeled after a similar law passed in Colorado, permits terminally ill
patients who have exhausted other treatment options to access drugs,
products and devices that have completed phase one of a clinical trial
but have not yet been approved for general use by the FDA. Laws such
as this have how been enacted in five states and another fifteen
states have similar legislation pending. The law is clear that it
neither requires manufacturers to provide treatment, nor requires
insurer to cover the treatment, it merely provides patients in dire
circumstances another option or avenue to seek treatment by.

 LEGISLATIVE HISTORY :

2015-2016: 5.4716

 FISCAL IMPLICATIONS :

None.

 EFFECTIVE DATE :
Immediately.

2017-S2044 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   2044
 
                        2017-2018 Regular Sessions
 
                             I N  S E N A T E
 
                             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:

   Section 1. The public health law is amended by adding  a  new  article
 40-A to read as follows:
                                ARTICLE 40-A
                         ACCESS TO TREATMENTS FOR
                          TERMINALLY ILL PATIENTS
 SECTION 4050. SHORT TITLE.
         4051. LEGISLATIVE INTENT.
         4052. DEFINITIONS.
         4053. AVAILABILITY OF INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS
                 AND DEVICES.
         4054. ACTION AGAINST HEALTH CARE PROVIDER.
         4055. ACCESS  TO  INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND
                 DEVICES.
         4056. NO CAUSE OF ACTION CREATED.
   § 4050. SHORT TITLE. THIS ARTICLE SHALL BE KNOWN AND MAY BE  CITED  AS
 THE "RIGHT TO TRY ACT".
   §  4051.  LEGISLATIVE INTENT.   IT IS THE INTENT OF THE LEGISLATURE TO
 ALLOW FOR TERMINALLY ILL PATIENTS TO USE POTENTIALLY LIFE-SAVING  INVES-
 TIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND DEVICES.
   §  4052. DEFINITIONS. AS USED IN THIS ARTICLE, THE FOLLOWING WORDS AND
 PHRASES SHALL HAVE THE FOLLOWING MEANINGS:
   1. (A) "ELIGIBLE PATIENT" MEANS A PERSON WHO HAS:
   (I) A TERMINAL ILLNESS, ATTESTED TO BY THE PATIENT'S  TREATING  PHYSI-
 CIAN;
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD00553-01-7

 S. 2044                             2
 
   (II)  CONSIDERED ALL OTHER TREATMENT OPTIONS CURRENTLY APPROVED BY THE
 UNITED STATES FOOD AND DRUG ADMINISTRATION;
   (III)  BEEN UNABLE TO PARTICIPATE IN A CLINICAL TRIAL FOR THE TERMINAL
 ILLNESS WITHIN ONE HUNDRED MILES OF THE PATIENT'S HOME ADDRESS  FOR  THE
 TERMINAL  ILLNESS, OR NOT BEEN ACCEPTED TO THE CLINICAL TRIAL WITHIN ONE
 WEEK OF COMPLETION OF THE CLINICAL TRIAL APPLICATION PROCESS;
   (IV) RECEIVED A RECOMMENDATION FROM HIS OR HER PHYSICIAN FOR AN INVES-
 TIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE;
   (V) GIVEN WRITTEN, INFORMED CONSENT FOR THE USE OF THE INVESTIGATIONAL
 DRUG, BIOLOGICAL PRODUCT OR DEVICE OR, IF THE  PATIENT  IS  A  MINOR  OR
 LACKS THE MENTAL CAPACITY TO PROVIDE INFORMED CONSENT, A PARENT OR LEGAL
 GUARDIAN  HAS  GIVEN  WRITTEN, INFORMED CONSENT ON THE PATIENT'S BEHALF;
 AND
   (VI) DOCUMENTATION FROM HIS OR HER PHYSICIAN THAT HE OR SHE MEETS  THE
 REQUIREMENTS OF THIS PARAGRAPH.
   (B)  "ELIGIBLE PATIENT" SHALL NOT INCLUDE A PERSON BEING TREATED AS AN
 INPATIENT IN A HOSPITAL OPERATED PURSUANT  TO  ARTICLE  TWENTY-EIGHT  OF
 THIS CHAPTER.
   2.  "INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE" MEANS A DRUG,
 BIOLOGICAL PRODUCT OR DEVICE THAT HAS SUCCESSFULLY COMPLETED  PHASE  ONE
 OF A CLINICAL TRIAL BUT HAS NOT YET BEEN APPROVED FOR GENERAL USE BY THE
 UNITED  STATES  FOOD  AND DRUG ADMINISTRATION AND REMAINS UNDER INVESTI-
 GATION IN A UNITED STATES FOOD AND DRUG ADMINISTRATION-APPROVED CLINICAL
 TRIAL.
   3. "TERMINAL ILLNESS" MEANS A CONDITION, ILLNESS OR INJURY FROM  WHICH
 THERE IS NO RECOVERY AND WHICH REASONABLY CAN BE EXPECTED TO CAUSE DEATH
 WITHIN ONE YEAR.
   4.  "WRITTEN, INFORMED CONSENT" MEANS A WRITTEN DOCUMENT SIGNED BY THE
 PATIENT, AND ATTESTED TO BY THE PATIENT'S PHYSICIAN AND A WITNESS  THAT,
 AT A MINIMUM:
   (A)  EXPLAINS  THE  CURRENTLY APPROVED PRODUCTS AND TREATMENTS FOR THE
 DISEASE OR CONDITION FROM WHICH THE PATIENT SUFFERS;
   (B) ATTESTS TO THE FACT THAT THE  PATIENT  CONCURS  WITH  HIS  OR  HER
 PHYSICIAN  IN  BELIEVING  THAT ALL CURRENTLY APPROVED AND CONVENTIONALLY
 RECOGNIZED TREATMENTS ARE UNLIKELY TO PROLONG THE PATIENT'S LIFE;
   (C) CLEARLY IDENTIFIES THE  SPECIFIC  PROPOSED  INVESTIGATIONAL  DRUG,
 BIOLOGICAL PRODUCT OR DEVICE THAT THE PATIENT IS SEEKING TO USE;
   (D)  DESCRIBES  THE  POTENTIALLY  BEST AND WORST OUTCOMES OF USING THE
 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT  OR  DEVICE  WITH  A  REALISTIC
 DESCRIPTION  OF  THE MOST LIKELY OUTCOME, INCLUDING THE POSSIBILITY THAT
 NEW, UNANTICIPATED, DIFFERENT OR WORSE SYMPTOMS MIGHT RESULT,  AND  THAT
 DEATH  COULD  BE HASTENED BY THE PROPOSED TREATMENT, BASED ON THE PHYSI-
 CIAN'S KNOWLEDGE OF THE PROPOSED TREATMENT IN CONJUNCTION WITH AN AWARE-
 NESS OF THE PATIENT'S CONDITION;
   (E) MAKES CLEAR THAT THE PATIENT'S HEALTH INSURER AND PROVIDER ARE NOT
 OBLIGATED TO PAY FOR ANY CARE OR TREATMENTS CONSEQUENT TO THE USE OF THE
 INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE;
   (F) MAKES CLEAR THAT THE PATIENT'S ELIGIBILITY FOR HOSPICE CARE MAY BE
 WITHDRAWN IF THE PATIENT BEGINS CURATIVE TREATMENT AND CARE MAY BE REIN-
 STATED IF THE CURATIVE TREATMENT ENDS  AND  THE  PATIENT  MEETS  HOSPICE
 ELIGIBILITY REQUIREMENTS;
   (G)  MAKES  CLEAR  THAT IN-HOME HEALTH CARE MAY BE DENIED IF TREATMENT
 BEGINS; AND
   (H) STATES THAT THE PATIENT UNDERSTANDS THAT HE OR SHE IS  LIABLE  FOR
 ALL  EXPENSES CONSEQUENT TO THE USE OF THE INVESTIGATIONAL DRUG, BIOLOG-
 ICAL PRODUCT OR DEVICE, AND THAT THIS LIABILITY EXTENDS TO THE PATIENT'S

 S. 2044                             3
 
 ESTATE, UNLESS A CONTRACT BETWEEN THE PATIENT AND  THE  MANUFACTURER  OF
 THE DRUG, BIOLOGICAL PRODUCT OR DEVICE STATES OTHERWISE.
   § 4053. AVAILABILITY OF INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS AND
 DEVICES.  1. A MANUFACTURER OF AN INVESTIGATIONAL DRUG, BIOLOGICAL PROD-
 UCT OR DEVICE MAY  MAKE  AVAILABLE  THE  MANUFACTURER'S  INVESTIGATIONAL
 DRUG, BIOLOGICAL PRODUCT OR DEVICE TO ELIGIBLE PATIENTS PURSUANT TO THIS
 ARTICLE. THIS ARTICLE SHALL NOT BE DEEMED TO REQUIRE THAT A MANUFACTURER
 MAKE  AVAILABLE AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE TO
 AN ELIGIBLE PATIENT.
   2. A MANUFACTURER MAY:
   (A) PROVIDE AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR  DEVICE  TO
 AN ELIGIBLE PATIENT WITHOUT RECEIVING COMPENSATION; OR
   (B) REQUIRE AN ELIGIBLE PATIENT TO PAY THE COSTS OF OR THE COSTS ASSO-
 CIATED  WITH  THE  MANUFACTURE  OF  THE INVESTIGATIONAL DRUG, BIOLOGICAL
 PRODUCT OR DEVICE.
   3. (A) NOTHING IN THIS ARTICLE SHALL BE DEEMED TO EXPAND THE  COVERAGE
 PROVIDED  IN ARTICLE FORTY-FOUR OF THIS CHAPTER, ARTICLES THIRTY-TWO AND
 FORTY-THREE OF THE INSURANCE LAW, AND TITLE ELEVEN OF  ARTICLE  FIVE  OF
 THE SOCIAL SERVICES LAW.
   (B)  A  HEALTH  INSURANCE CARRIER MAY, BUT IS NOT REQUIRED TO, PROVIDE
 COVERAGE FOR THE COST OF AN INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT  OR
 DEVICE.
   (C)  AN INSURER MAY DENY COVERAGE TO AN ELIGIBLE PATIENT FROM THE TIME
 THE ELIGIBLE PATIENT BEGINS USE OF AN INVESTIGATIONAL  DRUG,  BIOLOGICAL
 PRODUCT  OR  DEVICE  THROUGH  A PERIOD NOT TO EXCEED SIX MONTHS FROM THE
 TIME THE INVESTIGATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE IS NO LONGER
 USED BY THE ELIGIBLE PATIENT; EXCEPT THAT COVERAGE SHALL NOT  BE  DENIED
 FOR  A  PREEXISTING  CONDITION  AND  FOR  COVERAGE  FOR  BENEFITS  WHICH
 COMMENCED PRIOR TO THE TIME THE ELIGIBLE  PATIENT  BEGINS  USE  OF  SUCH
 DRUG, BIOLOGICAL PRODUCT OR DEVICE.
   4.  IF  AN  ELIGIBLE PATIENT DIES WHILE BEING TREATED BY AN INVESTIGA-
 TIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE, THE PATIENT'S HEIRS SHALL NOT
 BE LIABLE FOR ANY OUTSTANDING DEBT RELATED TO THE TREATMENT OR  LACK  OF
 INSURANCE DUE TO THE TREATMENT.
   §  4054.  ACTION  AGAINST  HEALTH  CARE  PROVIDER. NOTWITHSTANDING ANY
 PROVISION OF LAW TO THE CONTRARY, NEITHER THE EDUCATION  DEPARTMENT  NOR
 THE  STATE  BOARD FOR PROFESSIONAL MEDICAL CONDUCT SHALL REVOKE, FAIL TO
 RENEW, SUSPEND OR TAKE ANY  ACTION  AGAINST  A  HEALTH  CARE  PROVIDER'S
 LICENSE,  BASED  SOLELY ON THE HEALTH CARE PROVIDER'S RECOMMENDATIONS TO
 AN ELIGIBLE PATIENT REGARDING ACCESS TO OR TREATMENT WITH AN  INVESTIGA-
 TIONAL  DRUG,  BIOLOGICAL  PRODUCT OR DEVICE, SO LONG AS THE RECOMMENDA-
 TIONS ARE CONSISTENT WITH MEDICAL STANDARDS OF CARE.  ACTING  AGAINST  A
 HEALTH CARE PROVIDER'S MEDICARE CERTIFICATION BASED SOLELY ON THE HEALTH
 CARE PROVIDER'S RECOMMENDATION THAT A PATIENT HAVE ACCESS TO AN INVESTI-
 GATIONAL DRUG, BIOLOGICAL PRODUCT OR DEVICE IS PROHIBITED.
   §  4055.  ACCESS  TO  INVESTIGATIONAL  DRUGS,  BIOLOGICAL PRODUCTS AND
 DEVICES. 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 RECOMMENDA-
 TION CONSISTENT WITH MEDICAL STANDARDS OF CARE FROM  A  LICENSED  HEALTH
 CARE PROVIDER IS NOT A VIOLATION OF THIS SECTION.
   §  4056.  NO CAUSE OF ACTION CREATED. THIS ARTICLE SHALL NOT BE DEEMED
 TO CREATE A PRIVATE CAUSE OF ACTION AGAINST A MANUFACTURER OF AN  INVES-
 TIGATIONAL  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

 S. 2044                             4
 
 THE ELIGIBLE PATIENT RESULTING FROM THE INVESTIGATIONAL DRUG, BIOLOGICAL
 PRODUCT, OR DEVICE SO LONG AS THE MANUFACTURER OR OTHER PERSON OR ENTITY
 IS  COMPLYING IN GOOD FAITH WITH THE TERMS OF THIS ARTICLE; UNLESS THERE
 WAS A FAILURE TO EXERCISE REASONABLE CARE.
   § 2. This act shall take effect immediately.

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