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

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