What's happening
This bill allows the health commissioner to consider exemptions for brand name drugs from restrictions up to one year before their patent expires.
Why it matters
Earlier Exemptions May Improve Access to Certain Drugs. By allowing the health commissioner to consider exemption requests up to a year before a brand-name drug’s patent expires, patients and providers may gain earlier access to these drugs without having to wait for generic alternatives or additional administrative reviews.
Potential for Smoother Transitions to Generics. The new timing could help health officials and manufacturers better plan for the shift from brand-name to generic drugs, potentially reducing disruptions in patient care or confusion around medication switches.
Impacts on Drug Costs and Medicaid Spending. While exemptions might allow continued use of some higher-cost brand drugs, they also offer a structured, review-based approach that could help balance patient needs with cost containment for state-funded programs like Medicaid.
Stakeholder Influence and Transparency. The change gives pharmaceutical manufacturers, healthcare providers, and patient advocates a clearer window to make their case for exemptions, possibly increasing transparency and stakeholder input in the drug approval and coverage process.
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Who cares
Headline styles
Cover Some Brand Name Drugs
Plain English, a few words. Used as the page title.
Sponsors
No co-sponsors yet.
History
- Referred to health
- Referred to health
Full text
1 pageUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
1097
2017-2018 Regular Sessions
IN SENATE
January 6, 2017
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 Assembly, 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;
§ 2. This act shall take effect immediately.
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD02117-01-7
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
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 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
2013-2014: S6440 2015-2016: S2219
Fiscal implications
To be determined.
Effective date
Immediately.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.