CMS has recently proposed revisions to the Medicare Advantage (MA) Program (Part C) and Prescription Drug Benefit Program (Part D) regulations that will significantly impact sponsors of prescription drug plans, pharmacy benefit managers, pharmacies, and other stakeholders.
The proposed rule contains many technical and program changes. One proposed change would reduce the number of protected drug categories from six to three, eliminating the requirement for Part D plan sponsors to include drugs from antipsychotic, antidepressant, and immunosuppressant drug classes in their formularies. Another proposed change would prevent plan sponsors from incentivizing the use of selected pharmacies, including their own, which may charge higher rates than competitors. In order to promote more meaningful plan choices, CMS has proposed that Prescription Drug Plan Sponsors offer no more than two Part D plans in the same area. Additionally, several provisions of the proposed rule endeavor to reduce fraud and abuse by granting more enforcement power to CMS and imposing additional restrictions on providers. Finally, CMS has offered an interpretation of the Outpatient Prescription Drug Benefit Law noninterference provision which would allow CMS to participate in negotiations between Part D plan sponsors and pharmacies.
CMS received an influx of comments expressing concern over some of the rule’s more controversial provisions during the comment period which ended on March 7. Comments included concerns that the proposed rules, if implemented, would reduce beneficiary choices, access, and consumer protections, transform the market-based competitive model in a way that would not incentivize plan innovation, and result in a cost burden to sponsors that would create higher premiums for beneficiaries .
CMS Administrator Tavenner announced that CMS would not move forward with the proposals to lift the protected class definition, set standards on Medicare Part D plan requirements related to participation in preferred pharmacy networks, reduce the number of Part D plans a sponsor may offer, or to clarify the noninterference provisions without further stakeholder input. CMS will, however, move forward with other proposals relating to consumer protection and anti-fraud provisions. Stakeholders will have to wait to see how CMS ultimately structures its final rule.
