QUEST Integration – Drug Formulary Exception

Original Effective Date:

08/01/1996

Current Effective Date:

01/01/2015

I. Description

QUEST Integration members who have tried and failed treatment with formulary agents or for whom available formulary alternatives are contraindicated, may qualify for a non-formulary drug.

II. Criteria/Guidelines

1. Providers should be sure to provide complete and accurate information to HMSA’s pharmacy benefit manager to facilitate reviews and avoid unnecessary appeals being forwarded to HMSA. Effective Jan. 1, 2013, HMSA’s pharmacy benefit manager handles all prior authorization requests for QUEST Integration members. To assist with submitting accurate information, please use HMSA’s Pharmacy Benefit Manager Prior Authorization for information and instructions on how to submit a request. Callers must provide general information about the provider and the patient, including:
   1. HMSA QUEST Integration member name
   2. HMSA QUEST Integration member ID
   3. HMSA QUEST Integration member date of birth
   4. The name of the non formulary drug the caller is requesting to be precertified
   5. Additional information that will assist in the review such as diagnosis, drug history, other conditions, risk factors and labs.
2. A non-formulary drug may be considered medically necessary if at least one of the following criteria is met:
   1. Legible documentation from the patient’s medical record submitted by the provider supports that the patient has tried at least two comparable formulary agents in the same category or class and found them to be ineffective, or the patient exhibited intolerance or an allergic reaction. If only one alternative is available, only that formulary agent must have been ineffective or not tolerated.
      1. Ineffective treatment is defined as symptoms and/or signs that are not resolved after completion of treatment at the recommended therapeutic dose and duration. If there is no recommended treatment time, the member must have had a meaningful trial.
      2. Intolerance is defined as having a recognized and reproducible or repeated adverse reaction that is clearly associated with taking the medication.
      3. Allergy is defined as a state of hypersensitivity produced by exposure to a particular antigen resulting in harmful immunologic reactions on subsequent exposures. The most common symptoms are skin rash or anaphylaxis.
   2. Legible documentation from the patient’s medical record indicates that all comparable formulary agents are contraindicated based on the patient’s diagnosis, other medical conditions, or other medication therapy.

III. Limitations/Exclusions

If HMSA QUEST Integration has a specific policy for a drug, the criteria in that policy take precedence over the criteria listed in this policy. Drug-specific policies must be reviewed prior to applying the criteria listed above.

To view a list of pharmacy benefit drugs requiring precertification, refer to the HMSA’s QUEST Integration Drug Formulary, or review the drugs listed in QUEST Integration – Services that Require Precertification.

1. A drug formulary exception is not approved for the following:
   1. When there is an FDA-approved A-rated generic equivalent.
   2. Specialty drugs.
   3. Controlled substances (i.e., Schedule II, II, IV, V drugs).
2. Coverage is not provided for experimental and Drug Efficacy Study Implementation (DESI) drugs for HMSA QUEST Integration plan members.
   1. Drug Efficacy Study Implementation (DESI) drugs are those drugs first marketed between 1938 and 1962, which were approved as safe but did not require that effectiveness be shown prior to FDA approval. The DESI program subsequently made a determination of fully effective for most of these products and they remain in the marketplace. A few DESI products remain classified as less than fully effective while awaiting final administrative disposition. Also classified as DESI, are many products listed as identical, similar, or related to actual DESI products.

IV. Administrative Guidelines

1. Drug Formulary exception requests are reviewed and decided by a pharmacist, usually within 72 hours. Providers are notified immediately by phone for requests they submitted by phone or within 72 hours by fax for requests they submitted by fax. If the provider’s fax number is not available, a letter will be mailed to the provider within 72 hours of the determination. Members are notified by phone within 24 hours, or if the member’s phone number is not available letters will be mailed out within 72 hours of the determination. Denial letters will include the reasons for the denial and information on appealing the denial decision.
2. Prescription refills are subject to changes in the HMSA QUEST Integration formulary in effect at the time of the refill, including any formulary changes that may have occurred since the original prescription was issued.
3. As of Jan. 1, 2013, precertification requests for self-injectable drugs will be managed by HMSA’s pharmacy benefit manager. Precertification requests for other injectable/infusible drugs will be reviewed by HMSA.
4. If a review is initiated by a member or pharmacist, the provider may be contacted by fax or phone, after which CDU will contact the appropriate physician’s office to complete the request.
5. Coverage review requests are reviewed and decided by a pharmacist or physician, usually within 72 hours. Providers are notified via fax within 24 hours of the determination, or if no fax is available, a letter will be mailed within 72 hours. Members are notified by phone within 24 hours, or if no phone number is available, a letter will be mailed within 72 hours. Denial letters will include the reasons for the denial and information on appealing the denial decision.
6. Renewals are subject to changes in the HMSA QUEST Integration formulary (i.e., as additional formulary equivalents become available).
7. Requests for injectable/infusible drugs that require precertification will continue to be reviewed by HMSA.

Revision History