Exceptions Process
The Departments are proposing to codify the requirement that plans and issuers that utilize reasonable medical management techniques regarding preventive services must also provide an “easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other person acting as the individual’s authorized representative) under which the plan or issuer covers without cost-sharing the recommended preventive service according to the frequency, method, treatment, or setting determined to be medically necessary with respect to the individual, as determined by the individual’s attending provider.”[3] Thereby, if a plan or issuer is using medical management techniques on preventive services where a service is not considered medically appropriate, an unduly burdensome exceptions process must be in place, where an alternative “medically necessary” service would be covered without cost sharing.
Another way of saying this is, if medical management is used to provide an individual with a particular service with no cost-sharing. Still, their doctor determines this service is not medically appropriate, a process must allow the individual to receive the medically necessary treatment, as determined by their doctor, even if the alternate service is generally not available or not available with no cost-sharing.
The proposed guidance requests guidance on this process but specifically notes that a provider might consider “severity of side effects, differences in permanence and reversibility of a recommended preventive service, and ability to adhere to the appropriate use of the recommended preventive service, as determined by the attending provider” as considerations about whether a drug is medically appropriate.
Medical management techniques for preventive services are not considered reasonable without an exception process. However, the Departments noted they have received many complaints regarding violations of this guidance. The Oversight Committee survey found that PBMs denied, on average, 40 percent of exception requests, with one PBM denying more than 80 percent of requests in a year.
Comments are also solicited regarding how an exception process would be “easily accessible, transparent, and sufficiently expedient.” Generally, the process should be easily identifiable and understood, not require an appeals process, and have a contact available. It is recommended that a standardized form be considered, and the process should be accessible in writing and electronically.
[3] II. Overview of the Proposed Rules – A. Coverage of Recommended Preventive Services – 1. Reasonable Medical Management of Recommended Preventive Services: Exceptions Process