BlueCross BlueShield of Tennessee Administrative Services

Formulary Exception Policy

 DESCRIPTION

The purpose of this document is to establish a policy for the approval of pharmacy products that are excluded under the pharmacy benefit as non-formulary for a Commercial or Marketplace member. For a determination of the benefits that a member is entitled to receive under his or her health plan, the member's health plan must be reviewed. The express terms of the health plan or government program will govern benefits.

Members and/or providers may seek coverage of non-formulary drugs for indications with traditional FDA approval through the Formulary Exception policy if medically necessity is established. A non-formulary drug may be deemed medically necessary if the health care provider certifies and medical records support that: the indication is approved under the Federal Food, Drug and Cosmetic Act OR state/nationally recognized compendia and have one of the following:

1. All formulary alternatives have been ineffective in the treatment of the member’s disease or condition prior to the requested excluded product; or

2. Formulary alternatives are expected to cause adverse or harmful reactions to the member; or

3. Contraindication to formulary alternatives used to treat the member’s disease or condition; or

4. A drug shortage exists for the formulary alternatives, as documented on the FDA’s Drug Shortage Database.

Medical records or other supporting documentation must be included with the request. Requests may be made verbally or via facsimile along with the following form: : 508C Pharmacy Medication Review Request. All requests will be reviewed and evaluated on a case-by-case basis. Any reauthorization request for a non-formulary product will require documentation of a clinically significant response and/or sustained benefit from therapy.  

ORIGINAL EFFECTIVE DATE:  4/1/2026

MOST RECENT REVIEW DATE:  4/14/2026

ID_Pharmacy

This document has been classified as public information.