Mandatory Generic Drug Program

Overview of the Mandatory Generic Drug Program

Introduction

With the exception of drugs subject to the Preferred Drug Program, State statute excludes coverage of brand-name drugs in the Medicaid program when the Federal Food and Drug Administration (FDA) has approved a generic product, unless a prior authorization is received. As of November 17, 2002, all new prescriptions for brand-name drugs, where an A-rated generic equivalent is available, are subject to prior authorization.

Patient-Specific Prior Authorization Process

When prescribers want to order brand-name drugs, and a generic is available, they will need to call and answer a brief set of questions about why the patient requires the brand product. Prescribers may either enter the information by voice or by using the phone keypad. They will be asked to provide identifying information and a clinical reason why the patient requires the brand-name drug instead of the generic. A prior authorization number will be assigned which must be written on the prescription.

The process for approval of the brand-name drug is an abbreviated version of the process used for prior authorization of other drugs under the Medicaid program. The call line 1-877-309-9493 is in operation 24 hours a day, seven days a week. A prior authorization is effective for the original dispensing and all refills of that prescription within the next six months.

Product-Specific Exemption Process

The Commissioner of Health has the authority to exempt specific brand-name drugs from prior authorization. In addition, interested parties can submit a request that the Commissioner exempt additional brand-name drugs that have a generic equivalent from this requirement. Drugs which are exempt from the Mandatory Generic Program will not require prior authorization. A standardized process for interested parties to request an exemption, The New York State Medicaid Mandatory Generic Clinical Exemption Request, has been developed and is available on the Department of Health (DOH) website. The document must be printed, manually completed, and returned by mail to the address shown on the document. The DOH will only accept completed request forms for an exemption to be considered.

The following brand-name drugs, which have a generic available, may be prescribed without prior authorization:

  • Coumadin®
  • Gengraf®
  • Sandimmune®
  • Clozaril®
  • Lanoxin®
  • Tegretol®
  • Dilantin®
  • Neoral®
  • Zarontin®
  • Levothyroxine Sodium (Unithroid®, Synthroid®, Levoxyl®)

These exemptions are not meant to discourage generic prescribing. These drugs have been exempted from new prior authorization requirements based on specific characteristics of the drug and/or disease state generally treated. Their exemption should not be considered an opinion on the bioequivalency of the generic versions.

The Pharmacy & Therapeutics (P&T) Committee consists of experienced physicians, nurse practitioners, and pharmacists who have been appointed by the Commissioner of Health to serve in an advisory capacity. The group provides clinical guidance to the Commissioner regarding pharmacy issues for the Medicaid program. They bring specialized expertise in areas such as mental health, geriatrics, internal medicine, HIV/AIDS and children's health.

The P&T Committee reviews new exemption requests which are submitted by interested parties. After hearing public comments, and reviewing information provided through the exemption requests, the P&T Committee recommends any additional products to be excluded from mandatory generic requirements. The Commissioner of Health makes final determinations after considering the Committee's recommendations.

To assure public input into the process, the agenda for the Committee is posted on the DOH website prior to the meeting. The Committee meeting includes a public comment session, where representatives can provide additional information regarding exemption requests. A summary of the recommendations and the Commissioner's final determinations is also available on the DOH website.

Ongoing Maintenance

The Medicaid program continues to monitor, evaluate and amend the mandatory generic process to assure effectiveness and efficiency. When the FDA approves new generic drugs, the DOH allows the equivalent brand-name drug to be dispensed for a period of six months, without prior authorization, to assure that there is an adequate supply of the new generic readily available. Prior to the addition of new multi-source brand-name drugs to the Mandatory Generic Drug Program, the DOH will post the list of proposed drug additions on the DOH website and publish this information in the Medicaid Update, at least 45 days prior to the effective date. Prescriptions and their refills, which were already written prior to the addition of a brand-name drug to the Mandatory Generic Drug Program will not require prior authorization. When the current prescription expires, however, a prior authorization will be required for that patient to continue to receive the brand-name drug.

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For More Information, Contact: Pharmacy Policy & Operations staff at (518) 486-3209 or E-mail PPNO@health.state.ny.us