Assembly Bill A6673

                                BILL NUMBER:A6673A

TITLE OF BILL:  An act to amend the social service 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 consequences. 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 transplanted organs as well as the quality
and length of patients' lives. Any change in the dosing or preparation
of these medicines affects the delicate 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 additional 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, especially for transplant patients. The amendment
further recognizes the balance to be achieved by the public policy of
mandatory generic substitution and the health of all Medicaid
patients, especially those who have been given a new lease on life as
the result of an organ transplant.

PRIOR LEGISLATIVE HISTORY: 2007 and 2008: A.8290 -passed Assembly

FISCAL IMPLICATIONS: To be determined.

EFFECTIVE DATE: Immediately