Proposed Rule CMS-4190-P: Appeal Escalation

Today the Centers for Medicare & Medicaid Services (CMS) published their proposed rule CMS-4190-P. This post focuses on the automatic appeal escalation to external review for Medicare Part D drugs under the Drug Management Program, or DMP.

Background: Under DMPs, a plan engages in case management by contacting prescribers to determine whether a beneficiary is at-risk for misuse or abuse of frequently abused drugs. If a determination is made that the beneficiary is at-risk, the beneficiary is notified in writing and the plan may limit their access to coverage of opioids and/or benzodiazepines to a certain prescriber and/or certain pharmacies. (CMS is proposing to make DMPs mandatory effective January 1, 2022, noting the majority of Part D sponsors have already voluntarily implemented DMPs.)

CMS is also proposing to require the automatic forwarding of redeterminations of a DMP appeal to the independent review entity (IRE) responsible for conducting Part D reconsiderations (Part D level 2 appeals). Medicare Advantage plans have been familiar with the auto-forward requirement for years, as affirmed reconsiderations (Part C level 1 appeals) must be forwarded by the expiration of the adjudication timeframe. However, this process would be new for Part D-only plans such as standalone Prescription Drug Plans, or PDPs, as today only untimely decisions are auto-forwarded to the IRE.

What would this finalized provision mean for a beneficiary? For members who receive an affirmed denial of a DMP appeal, this means their appeal will automatically be forwarded to the IRE. Currently, other affirmed Part D redeterminations are not auto-forwarded. The appellant must make an additional request for an independent review. If this proposal moves forward, those who have been denied their medications due to a DMP decision will be guaranteed that “outside look” to either affirm or overturn the plan’s decision. This streamlines the steps the appellant has to take in this special circumstance. 

What would this finalized provision mean for a plan? If this moves forward, the plan will need to ensure procedures are changed and training is conducted, not only for the appeals department, but also for member services and the case management team working on the DMP decisions. It would be anticipated that member notices would change should this proposed rule become final. Plan and delegate parties to the process must understand how the member’s rights will change. 

Is the volume going to be high? CMS thinks not. The agency expects there will be approximately 28,600 appeals per year, of which 0.08 percent (or 23 cases) will be subject to this auto-forward. Based on this estimate, some plans might never process one of these appeals. However, even if one is received and denied, it is going to be important to auto-forward the case correctly and timely. CMS has been reviewing appeals in their program audit protocol for years, and if this provision is finalized, it could be anticipated DMP appeals may be targeted for sample selection to ensure adherence to the new rule.