senate Bill S6440

2013-2014 Legislative Session

Provides that the commissioner of health may exempt certain brand name drugs so that they fall under medical assistance umbrella

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Archive: Last Bill Status - In Committee


  • Introduced
  • In Committee
  • On Floor Calendar
    • Passed Senate
    • Passed Assembly
  • Delivered to Governor
  • Signed/Vetoed by Governor

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Jan 24, 2014 referred to health

S6440 - Bill Details

See Assembly Version of this Bill:
A5350
Current Committee:
Senate Health
Law Section:
Social Services Law
Laws Affected:
Amd ยง365-a, Soc Serv L
Versions Introduced in Previous Legislative Sessions:
2011-2012: A5038
2009-2010: A6673A

S6440 - Bill Texts

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Provides that the commissioner of health may exempt certain brand name drugs so that they fall under medical assistance umbrella.

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BILL NUMBER:S6440

TITLE OF BILL: An act to amend the social services law, in relation to
certain medical assistance for needy persons

PURPOSE OR GENERAL IDEA OF BILL:

To authorize the Commissioner of Health to review applications for
exemptions from the mandatory generic substitution law during the twelve
month period prior to the expiration of the patent for the brand name
drug.

SUMMARY OF SPECIFIC PROVISIONS:

Section 1 amends paragraph (a-I) of subdivision 4 of section 365-a of
the Social Services Law, as amended by section I 1 of Part C of Chapter
58 of the laws of 2005, to authorize the Commissioner of Health to
review requests for exemption to the mandatory generic substitution law
during the twelve month period prior to the expiration of the patent of
the brand name drug that is the subject of the exemption application.

JUSTIFICATION:

This amendment would go a long way toward avoiding the potentially life-
threatening confusion created when a therapeutic and generic equivalent
to a brand name drug becomes available while an exemption to the
requirement of generic substitution is sought.

At the present time, the Commissioner of Health will only review
exemption requests after a generic equivalent is available. In order for
the review process to be completed, the Pharmacy and Therapeutics
Committee must meet to consider the request. Often times, the Committee
may not be scheduled to meet and may not, in fact, meet for months after
the exemption request is made.

During this period of time, the law mandates that generic equivalents be
substituted for the brand name drug that had been prescribed. At best,
confusion reigns among the clinician and patient community as to what
the law requires in this regard. In the area of transplant medications,
for example, requiring generic substitution could have grave conse-
quences. Many transplant organizations and physicians, including the
American Society for Transplantation, the National Kidney Foundation,
and NATCO, the organization for transplant professionals, recognize that
immunosuppressive agents have markedly improved the longevity of trans-
planted organs as well as the quality and length of patients' lives. Any
change in the dosing or preparation of these medicines affects the deli-
cate balance between a functioning transplant and one that could have
life-threatening consequences.

The Department of Health seemingly recognizes this fact by exempting
anti-rejection drugs, for example, from the requirement of generic
substitution in every known instance. The problem arises, however,

during the time in which generic substitution Is mandated by law, and a
decision is eventually made to preserve the clinician's and transplant
patient's choice as to the appropriate medication.

This amendment to the mandatory generic substitution law goes a long way
toward clarifying the obligations of prescribers and avoid serious
mistakes involving critical medications. The amendment does not inhibit
the discretion of the Commissioner in any way, will not result in addi-
tional costs to the Medicaid program, or require that an exemption be
granted; it simply expands the review period in an effort to avoid the
kinds of confusion that could have life-threatening consequences, espe-
cially for transplant patients. The amendment further recognizes the
balance to be achieved by the public policy of mandatory generic substi-
tution and the health of all Medicaid patients, especially those who
have been given a new lease on life as the result of an organ trans-
plant.

PRIOR LEGISLATIVE HISTORY:

2007-08: A.8290 -passed Assembly
2009-10: A.6673-A - passed Assembly
2011-12: A.5038 - passed Assembly

FISCAL IMPLICATIONS:

To be determined.

EFFECTIVE DATE:

Immediately

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                    S T A T E   O F   N E W   Y O R K
________________________________________________________________________

                                  6440

                            I N  S E N A T E

                            January 24, 2014
                               ___________

Introduced  by  Sen.  RIVERA -- read twice and ordered printed, and when
  printed to be committed to the Committee on Health

AN ACT to amend the social services law, in relation to certain  medical
  assistance for needy persons

  THE  PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:

  Section 1. Subparagraph (i) of paragraph (a-1)  of  subdivision  4  of
section  365-a  of  the social services law, as amended by section 39 of
part D of chapter 56 of the laws of 2012, is amended to read as follows:
  (i) a brand name drug for which  a  multi-source  therapeutically  and
generically  equivalent drug, as determined by the federal food and drug
administration,  is  available,  unless  previously  authorized  by  the
department  of  health.  The  commissioner  of  health  is authorized to
exempt, for good cause shown, any brand name drug from the  restrictions
imposed by this subparagraph. FURTHERMORE, THE COMMISSIONER OF HEALTH IS
AUTHORIZED  TO  REVIEW  AN  APPLICATION FOR AN EXEMPTION OF A BRAND NAME
DRUG FROM THE RESTRICTIONS OF  THIS  SUBPARAGRAPH,  PROVIDED  THAT  SUCH
APPLICATION  IS  SUBMITTED WITHIN A PERIOD OF TWELVE MONTHS PRIOR TO THE
EXPIRATION OF THE PATENT OF SAID BRAND NAME DRUG;
  S 2. This act shall take effect immediately.





 EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
                      [ ] is old law to be omitted.
                                                           LBD01535-02-3

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