The American Society of Transplant Surgeons (ASTS) applauds the Centers for Medicare and Medicaid Services (CMS) decision not to finalize the provision of a proposed rule that would have eliminated protected class status for immunosuppressive drugs under Medicare Part D. The decision was announced by CMS Administrator Marilyn Tavenner in a letter to the House Committee on Energy and Commerce on March 10 after ASTS and many other health care organizations objected strongly to the proposal.
“As physicians prescribing, monitoring, and managing these vital prescriptions for fragile patients, we breathed a sigh of relief at CMS’ prudence this week. Immunosuppressants were deemed a 'protected class' of drugs for very good reasons. Formulary restrictions on these critical drugs would result in substantial risk of rejection, organ failure, patient demise, serious side effects of medication, and other adverse drug reactions for Medicare Part D beneficiaries who are transplant recipients,” said David J. Reich, MD, chair of the ASTS Legislative Committee.
In the first year of the Medicare prescription drug benefit, CMS implemented a policy that required all Part D plans to include on their formularies “all or substantially all” Part D drugs within six drug classes—antineoplastics, anticonvulsants, antiretrovirals, antipsychotics, antidepressants, and immunosuppressants. The Affordable Care Act later codified this policy and allowed CMS to specify criteria for identifying protected classes through notice and comment rulemaking.
“We were very disappointed to see the proposed rule when it was released in January. It was frankly shocking to think that Congress and CMS both acted to protect immunosuppressants and antidepressant drug categories, and then proposed a rule to remove that protection by allowing formulary restrictions on these particular classes of drugs. We’re fortunate that CMS agreed not to finalize this rule, but we must remain vigilant that this particularly bad idea does not resurface,” said Peggy Tighe, JD, Counsel at Powers Pyles Sutter & Verville PC.
As ASTS pointed out in its comments submitted March 7, the proposal would have “the potential to result in dire health consequences for individual enrollees; to exacerbate an already critical organ shortage; to result in additional confusion and medication non-adherence; and to establish unjustified distinctions in coverage between Part D beneficiaries and those covered under Part B or private plans. In addition, authorizing such formulary restrictions has the potential to significantly increase, rather than decrease, overall patient and program costs.”
ASTS also submitted testimony for the record to the House Committee on Energy and Commerce Subcommittee on Health hearing on February 26, 2014, objecting to this change in the strongest possible terms. ASTS’ testimony was introduced by Dr. Michael Burgess (R-TX), longtime champion of the transplant community. Dr. Burgess (R-TX) noted the rule's "penny wise and pound foolish approach" for immunosuppressants and its negative effects on transplant recipients. Members of Congress from both parties in the House and Senate opposed this rule.
In her letter to Congressman Henry Waxman, Administrator Tavenner noted that on the parts of the proposed rule not being finalized at this time, CMS plans to “engage in further stakeholder input before advancing some or all of these changes in these areas in future years.” ASTS will, as always, monitor the CMS rulemaking process and engage in public comment periods where indicated.
To learn more about ASTS’ advocacy work and read comments and other documents ASTS has submitted, visit http://asts.org/advocacy.