pharmacy benefits; prescribing; exemption
What changed between versions
PBMs cannot limit or exclude coverage for prescription drugs that were previously approved for a covered individual, as long as the individual remains enrolled with the same health care insurer.
PBMs must provide at least 60 days' notice before making formulary changes that affect covered individuals, including information about how to request continued use of nonformulary drugs.
PBMs must respond to formulary exception requests within 72 hours, or 24 hours for expedited reviews in exigent circumstances.
New criteria for automatic approval of formulary exceptions when a patient has been previously approved for the same nonformulary drug under the same plan.
Written denials of formulary exceptions must include medical or pharmacological reasons and be sent to the patient's treating health care provider.
New definition of 'limit or exclude coverage' to include increasing cost sharing and requiring additional prior authorization based solely on formulary tier changes.
Expanded definition of when a drug can be removed from a formulary to include situations where the manufacturer notifies the FDA of discontinuation.
