NY State Senate Bill 2017-S1216

Senate Bill S1216

2017-2018 Legislative Session

Establishes the clinical trial access and education fund to provide grants for certain services for patients with life-threatening or disabling conditions/diseases

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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 06, 2017	referred to health

co-Sponsors

2017-S1216 (ACTIVE) - Details

See Assembly Version of this Bill:: A2538
Current Committee:: Senate Health
Law Section:: Public Health Law
Laws Affected:: Add §2424, Pub Health L
Versions Introduced in Other Legislative Sessions:: 2009-2010: A1805
2011-2012: A807
2013-2014: S6442, A2688
2015-2016: S777, A1567
2019-2020: S932, A1035
2021-2022: S1169, A180
2023-2024: S4793

2017-S1216 (ACTIVE) - Summary

Establishes the clinical trial access and education fund to provide grants to eligible applicants to provide certain services for patients with life-threatening or disabling conditions or diseases.

2017-S1216 (ACTIVE) - Sponsor Memo

                                 BILL NUMBER:  S1216

 TITLE OF BILL :  An act to amend the public health law, in relation
to establishing the clinical trial access and education fund

 PURPOSE OR GENERAL IDEA OF BILL: :

This bill creates the Clinical Trial Access and Education Fund, a
state grant program within the department to provide funding to
address the major barriers to participation in clinical trials in New
York State.

 SUMMARY OF SPECIFIC PROVISIONS: :

Section 1 amends article 24 of the public health law by adding a new
section 2424, the Clinical Trial Access and Education Fund.

Subdivision 1 of the new section provides definitions of eligible
applicant and clinical trial.

Subdivision 2 establishes the clinical trial access and education fund
within the department to provide grants to eligible applicants on a
competitive request for proposal basis to provide certain services to
patients with life-threatening or disabling conditions or diseases.
Such services would include: transportation and lodging to patients so
they may access a clinical trial or related treatment; patient

outreach and education on the existence of and how to enroll in
clinical trials; and patient navigation services to help patients
determine eligibility for clinical trials.

Subdivision 3 establishes an application process for eligible
applicants and states that the commissioner shall give Preference to
applicants who have experience and expertise providing patient
outreach, education, navigation and other services to patients with
life-threatening or disabling conditions or diseases.

Subdivision 4 requires grantees to file an annual report with the
commissioner summarizing how they utilized the grant funds to increase
patient access to clinical trials.

Subdivision 5 requires the commissioner to make any necessary
regulations to implement the section.

Section 2 establishes the effective date.

 JUSTIFICATION :

New therapies to treat cancer and other life threatening diseases are
being developed at an increasing pace. Clinical trials are the most
effective, scientifically valid method of determining the benefits of
experimental treatments. They are critical to improving health care
and mortality rates for patients with cancer and other
life-threatening diseases.

While fewer than 5% of adult cancer patients participate in clinical
trials, 60% of pediatric cancer patients do. This large number of
pediatric enrollees has led to the discovery of groundbreaking
therapies and a survival rate of over 80% for childhood cancer. To
achieve a similar rate of success for adults with cancer and other
diseases, information and access to clinical trials must be made more
widely available to patients and their treating health care
providers.,

A number of studies have looked at the reasons for low adult patient
participation in clinical trials. One recent study conducted by the
University of California Davis Cancer Center surveyed oncologists
regarding patient and physician decision-making about participation in
clinical trials. Of the 276 patients assessed, oncologists only
recommended that 76 patients participate in clinical trials and only
39 patients or 14% actually enrolled in the trials. The two most
common reasons that patients cited for declining to participate were a
desire for other treatment and the distance from the cancer center.
The study authors made a series of recommendations to overcome these
barriers including the need for greater physician and patient
education on the status, availability and benefits of clinical trials
as well as the need to address geographical issues that serve as
strong deterrents to clinical trial access.

The Clinical Trial Access and Education Fund will address these major
barriers identified by the clinical research and anecdotally from
patients and providers in New York, it will provide grants to
non-for-profit community groups, health care provider associations and
research centers that conduct clinical trials so they may provide and/
or facilitate patient navigation, transportation, lodging and patient
and provider education to achieve greater patient participation in
clinical trials.

 PRIOR LEGISLATIVE HISTORY: :

2014: S6442
2015-2016: S777

 FISCAL IMPLICATIONS: :

None - subject to available appropriations.

 EFFECTIVE DATE: :

This act shall take effect immediately.

2017-S1216 (ACTIVE) - Bill Text download pdf

                            
 
                     S T A T E   O F   N E W   Y O R K
 ________________________________________________________________________
 
                                   1216
 
                        2017-2018 Regular Sessions
 
                             I N  S E N A T E
 
                              January 6, 2017
                                ___________
 
 Introduced by Sens. RIVERA, DILAN -- 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 establishing the
   clinical trial access and education fund
 
   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 section
 2424 to read as follows:
   § 2424. CLINICAL TRIAL ACCESS AND EDUCATION FUND. 1. DEFINITIONS.  FOR
 THE PURPOSES OF THIS SECTION, THE FOLLOWING TERMS SHALL HAVE THE FOLLOW-
 ING MEANINGS:
   A. "ELIGIBLE APPLICANT" MEANS (I) A MEDICAL  SCHOOL  THAT  SPONSORS  A
 CLINICAL  TRIAL,  (II) A NOT-FOR-PROFIT ORGANIZATION WITH EXPERIENCE AND
 EXPERTISE WORKING  WITH  PATIENTS  WITH  LIFE-THREATENING  OR  DISABLING
 CONDITIONS OR DISEASES, (III) A HEALTH CARE PROVIDER ORGANIZATION, ASSO-
 CIATION  OR  SOCIETY, (IV) A GENERAL HOSPITAL DEFINED IN ARTICLE TWENTY-
 EIGHT OF THIS CHAPTER, (V) A COUNTY OR CITY HEALTH DEPARTMENT, OR (VI) A
 MUNICIPALITY.
   B. "CLINICAL TRIAL" SHALL HAVE THE  SAME  MEANING  AS  IN  SUBDIVISION
 TWO-B OF SECTION FORTY-NINE HUNDRED OF THIS CHAPTER.
   2.  ESTABLISHMENT  OF  FUND.  THERE  IS  HEREBY ESTABLISHED WITHIN THE
 DEPARTMENT A CLINICAL TRIAL ACCESS AND EDUCATION FUND. SUBJECT TO APPRO-
 PRIATIONS, THE DEPARTMENT SHALL PROVIDE GRANTS TO ELIGIBLE APPLICANTS ON
 A COMPETITIVE REQUEST FOR PROPOSAL BASIS TO PROVIDE ONE OR MORE  OF  THE
 FOLLOWING SERVICES TO PATIENTS WITH LIFE-THREATENING OR DISABLING CONDI-
 TIONS  OR  DISEASES,  AS  SUCH  TERMS  ARE DEFINED IN SECTION FORTY-NINE
 HUNDRED OF THIS CHAPTER, TO FACILITATE ACCESS TO OR EDUCATION  ON  CLIN-
 ICAL TRIALS OF TREATMENTS FOR THE PATIENT'S CONDITION OR DISEASE:
   A. TRANSPORTATION SERVICES AND LODGING TO PROVIDE PATIENTS WITH ACCESS
 TO CLINICAL TRIALS OR OTHER RELATED TREATMENTS WHILE ENROLLED IN A CLIN-
 
  EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                       [ ] is old law to be omitted.
                                                            LBD02083-01-7

 S. 1216                             2
 
 ICAL  TRIAL OR TO ACCESS TESTING AND OTHER SERVICES TO DETERMINE PATIENT
 ELIGIBILITY FOR A CLINICAL TRIAL;
   B.  PATIENT OUTREACH AND EDUCATION SERVICES TO EDUCATE PATIENTS, THEIR
 FAMILIES AND HEALTH CARE  PROVIDERS  ABOUT  THE  EXISTENCE  OF  AND  HOW
 PATIENTS  MAY ENROLL IN CLINICAL TRIALS, UNDER SECTION TWO HUNDRED SEVEN
 OF THIS CHAPTER; AND
   C. PATIENT NAVIGATION SERVICES TO HELP PATIENTS TO DETERMINE  IF  THEY
 ARE ELIGIBLE FOR CLINICAL TRIALS, TO HELP PATIENTS TO ENROLL IN CLINICAL
 TRIALS  AND TO ASSIST PATIENTS IN DEALING WITH INSURANCE OR OTHER ISSUES
 WHICH SERVE AS BARRIERS TO PATIENT ENROLLMENT IN CLINICAL TRIALS.
   3. APPLICATIONS. THE COMMISSIONER SHALL ESTABLISH AN APPLICATION PROC-
 ESS BY WHICH ELIGIBLE APPLICANTS  MAY  APPLY  FOR  A  GRANT  UNDER  THIS
 SECTION.  THE APPLICATION SHALL INCLUDE:
   A. THE GEOGRAPHIC AREA IN WHICH THE SERVICES SHALL BE PROVIDED;
   B. A DETAILED DESCRIPTION OF THE SERVICES TO BE PROVIDED;
   C.  APPLICANT'S EXPERIENCE WORKING WITH PATIENTS WITH LIFE-THREATENING
 OR DISABLING CONDITIONS OR DISEASES;
   D. APPLICANT'S ABILITY TO PROVIDE PATIENT OUTREACH OR  CLINICAL  TRIAL
 EDUCATION  AND NAVIGATION SERVICES, OR COORDINATE OR PROVIDE TRANSPORTA-
 TION AND LODGING FOR PATIENTS; AND
   E. ANY OTHER INFORMATION THAT  THE  COMMISSIONER  DEEMS  RELEVANT  AND
 APPROPRIATE.
   THE COMMISSIONER SHALL GIVE PREFERENCE TO ELIGIBLE APPLICANTS WHO HAVE
 EXPERIENCE  AND EXPERTISE WORKING WITH PATIENTS WITH LIFE-THREATENING OR
 DISABLING CONDITIONS OR DISEASES AND PROVIDING PATIENT OUTREACH,  EDUCA-
 TION AND HEALTH CARE NAVIGATION SERVICES.
   4.  REPORTS. GRANTEES SHALL FILE AN ANNUAL REPORT WITH THE COMMISSION-
 ER, IN SUCH FORM AND WITH SUCH INFORMATION AND DATA AS THE  COMMISSIONER
 PRESCRIBES  DETAILING THE EXPENDITURE OF GRANT FUNDS AND SUMMARIZING THE
 EFFORTS UNDERTAKEN TO INCREASE PATIENT ACCESS TO CLINICAL TRIALS.
   5. THE COMMISSIONER SHALL MAKE  REGULATIONS  REASONABLY  NECESSARY  TO
 IMPLEMENT THE PROVISIONS OF THIS SECTION.
   § 2. This act shall take effect immediately.

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Senate Bill S1216

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Sponsored By

Gustavo Rivera