In a March 10, 2014 letter to Congress, CMS Administrator Marilyn Tavenner indicated that—based on concerns from Congress and the public—CMS shall not finalize the Proposed Rules’ proposals that would have:
- Removed the protected class definition for immunosuppressant drugs used in transplant patients, antidepressants, and antipsychotic medicines used to treat schizophrenia and certain related disorders (79 Fed. Reg. 1942 – 44);
- Imposed a minimum level of savings over the costs available at retail cost-sharing rates and limitations on how broadly cost sharing should be applied to a Part D sponsor’s formulary Part D plans’ participation in preferred pharmacy networks (79 Fed. Reg. 1974 – 77);
- Reduced the number of Part D plans a single PDP sponsor in the same region may offer (79 Fed. Reg. 1961 – 64); and
- “Clarified” the non-interference provisions of § 1860D-11(i), which provides that: “In order to promote competition under this part and in carrying out this part, the Secretary: (1) may not interfere with the negotiations between drug manufacturers and pharmacies and PDP sponsors; and (2) may not require a particular formulary or institute a price structure for the reimbursement of covered [MA-PD] drugs.” (79 Fed. Reg. 1969 – 72).
CMS’s forbearance on these issues was announced shortly before a House vote to block the proposed changes to the definition of protected drug classes and amidst significant concern from industry and the public alike over both that and the other proposed changes. The letter goes on to state that CMS shall, “engage in further stakeholder input before advancing some or all of the changes in future years.”