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NYS Medicaid Pharmacy Prior Authorization Programs

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Overview of the Mandatory Generic Drug Program

Introduction

With the exception of drugs subject to the Preferred Drug Program, State law excludes Medicaid coverage of brand name drugs when the Federal Food and Drug Administration (FDA) has approved a generic product, unless a prior authorization is received. Prescriptions for brand-name drugs, where an A-rated generic equivalent is available, will require that the prescriber obtain prior authorization for the brand name drug.

Patient-Specific Prior Authorization Process

When prescribers want to order brand name drugs, and a generic is available, they must call and answer a brief set of questions about why the patient requires the brand product. They will be asked to provide identifying information and a clinical reason why the patient requires the brand name drug instead of the generic. The call line 1-877-309-9493 is in operation 24 hours a day, seven days a week.

Product-Specific Exemption Process

The Commissioner of Health has the authority to exempt specific brand name drugs from the Mandatory Generic Drug Program. 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 Drug Program will not require Mandatory Generic 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 are exempt from the Mandatory Generic Drug Program:

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

These exemptions are not meant to discourage generic prescribing. These drugs have been exempted from Mandatory Generic 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.

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. E-mail ppno@health.state.ny.us (please note "Mandatory Generic Drug Program" in the subject area).

Information for Prescribers - Mandatory Generic Drug Program
  • Prescribers, or an agent of the prescriber, must call the prior authorization line at 1-877-309-9493 and respond to a series of questions that identify the prescriber, the patient and the reason for prescribing this drug. An authorized agent is an employee of the prescribing practitioner and has access to the patient's medical records (i.e. nurse, medical assistant). The Mandatory Generic Program Prescriber Worksheet and Instructions provide step-by-step assistance in completing the prior authorization process.
  • The prescriber must write "DAW and Brand Medically Necessary" on the face of the prescription.
Information for Pharmacists - Mandatory Generic Drug Program
  • If a prior authorization has not been obtained by the prescriber and the pharmacist or recipient has attempted but is unable to reach the prescriber, and an emergency exists, the pharmacist may obtain a prior authorization for up to a three-day emergency supply of a brand name drug (subject to other State laws and Medicaid restrictions). The Pharmacy Emergency Supply Worksheet and Instructions assist the pharmacist in completing the prior authorization process. The pharmacist is expected to follow up with the prescriber to determine future needs. Once the pharmacist obtains the prior authorization number, dispenses and bills the emergency three-day supply, the prescription is no longer valid for any remaining quantity.