Coverage Determinations, Exceptions, and Appeals
If the preferred drug(s) on a consumer’s prescription drug plan’s (PDP) formulary would not be as effective as the drugs that the consumer is currently taking or would have an adverse effect on the consumer, then the consumer or his or her physician can file for coverage determination or an exception from the prescription drug plan.
Questions Answered
Can consumers get medications that are not on the plan’s drug list?
Yes, consumers can get off-formulary medications. A consumer or his/her physician may file a request for an exception to the formulary. All exception requests must be accompanied by the prescribing physician’s oral or written statement supporting the request. The physician’s request must demonstrate that the drug is medically necessary because all of the covered drugs on any tier of the plan’s formulary used to treat the same condition would not be as effective for the consumer as the non-formulary drug and/or would have adverse effects.
What should the consumer do if the pharmacist says the drug is not on the formulary?
In this case, a provider would have to help a consumer contact their plan to request an exception. If the plan denies an exception, then the consumer can appeal the plan’s decision.
Who can file for a coverage determination?
- The enrollee
- The appointed representative of enrollee (varies by state)
- The physician who prescribed the medication
What are the requirements for filing a coverage determination?
Each prescription drug plan will establish its own contact and documentation requirements. However, all prescription drug plans must have an exception process for enrollees to request that a formulary drug be provided at a lower tier for cost sharing or that a non-formulary drug be provided by the plan.
In order to file an exception, you must:
- Establish the medical necessity of the prescribed drug.
- Prove that other drugs on the formulary will not be as effective and/or will have an adverse effect.
A prescription drug plan has up to 72 hours to make a coverage determination (e.g., coverage of a non-formulary drug). A request for an expedited coverage determination (no more than 24 hours) may be made if the standard timeline would be medically inappropriate for the consumer’s health condition. When a physician requests an expedited coverage determination, it is automatically approved. If the expedited request is approved, the drug plan must make a decision within 24 hours or the request will move to the next level of appeal.
What happens if my exception is rejected? Can I file an appeal?
The consumer may appeal an unfavorable coverage determination with the prescription drug plan that made the first determination.
If that appeal is denied, then a consumer can request a further review known as Reconsideration, which will be performed by an “Independent Review Entity” (IRE). If this review fails to satisfy, the consumer may then appeal to an Administrative Law Judge (ALJ), then to the Medicare Appeals Council (MAC), and finally to federal court. There are rules covering each level of appeal.
The organizations that created this website are very interested in tracking how enrollees are faring with their appeals during the early days of Part D so we can try to rectify any problems that are discovered. If you filed a coverage determination and an appeal and received an unfavorable response, please let us know. You can email us.
Current as of 9-26-2005
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