CMS has finalized standards for a health plan’s exceptions process that includes a process for exigent circumstances.
- Exigent circumstances: defined as when an enrollee is suffering from a health condition that may seriously jeopardize the enrollee’s life, health, or ability to regain maximum function or when an enrollee is undergoing a current course of treatment using a non-formulary drug
- This can include combination drugs considered first-line therapies and new drugs
Under this process, an enrollee (or enrollee’s designee) or the enrollee’s prescribing physician (or other prescriber) can request an expedited exceptions process based on exigent circumstances. As part of the request the prescribing physician or other prescriber should support the request by including an oral or written statement that:
- An exigency exists and the basis for the exigency
- A justification supporting the need for the non-formulary drug to treat the enrollee’s condition, including:
- a statement that all covered formulary drugs on any tier will be or have been ineffective,
- would not be as effective as the non-formulary drug, or
- would have adverse effects
Issuers must provide a decision and notify the enrollee (and the prescribing physician or other prescriber as appropriate) of the determination no later than 24 hours after receiving the request.
- The 24-hour review timeframe begins when the issuer or its designee receives an exception request based on exigent circumstances
Following a favorable decision on the expedited request, the enrollee must be provided access to the prescribed drug without unreasonable delay.
- Issuers need to be prepared to communicate rapidly with pharmacies and pharmacy benefit managers, as applicable
- At a minimum, issuers are expected to update certificates of coverage to reflect the availability of this process and to be able to provide instruction to enrollees or their designees and providers or their designees regarding how to use the process
Issuers are encouraged to provide the drug pending the outcome of the exceptions request, but this is not a requirement under the final rule.
Enrollees who are having difficulty accessing a health plan’s exceptions process should first contact the issuer and then contact the State’s Department of Insurance if necessary.