Yesterday, the Centers for Medicare & Medicaid Services (“CMS”) Administrator Marilyn Tavenner responded to several Congressional concerns regarding CMS’ recent proposed rule on the Medicare Part D outpatient prescription drug benefit. We previously reported on that proposed rule here. In a Letter to Representative Sander Levin, Ranking Member of the House Committee on Ways and Means, Tavenner indicated, that, among other things, CMS does not plan to finalize its proposal to alter its current policy requiring Part D plans to cover “all or substantially all” drugs in the antidepressant, immunosuppressant, and antipsychotic classes. Tavenner’s letter follows the March 6 introduction of H.R. 4160, the “Keep the Promise to Seniors Act”, by Rep. Renee Ellmers (R-NC), which was intended to block the implementation of “any provision of the proposed regulation…insofar as such regulation relates to the provisions of part D”.
In her letter, Tavenner stated the following:
“[We] heard concerns about the proposals to lift the protected class definition on three drug classes, to set standards on Medicare Part D plans’ requirements to participate in preferred pharmacy networks, to reduce the number of Part D plans a sponsor may offer, and clarifications to the non-interference provisions. Given the complexities of these issues and stakeholder input, we do not plan to finalize these proposals at this time. We will engage in further stakeholder input before advancing ·some or all of the changes in these areas in future years. That said, we plan to finalize proposals related to consumer protections (e.g., ensuring access to care during natural disasters), anti-fraud provisions that have bipartisan support (e.g., strengthening standards for prescribers of prescription drugs), and transparency (e.g., broadening the release of privacy-protected Part D data) after taking into consideration the comments received during the public comment period.”
And so the “protected classes” would appear to be safe for now (although they may still be managed by plans in other ways such as formulary tiering, subject to CMS requirements). In addition, CMS’ decision to not finalize certain other controversial proposals, such as its proposal to regulate “preferred pharmacy networks”, will provide at least a temporary reprieve to managed care and pharmacy benefit management companies that utilize such networks in their Part D plan design. The final rule itself has not yet been issued.