CMS Withdraws Proposal Impacting Part D Psychotropic Protection

The Centers for Medicare and Medicaid Services (CMS) has dropped plans to eliminate protected status for certain psychiatric drugs following vigorous opposition from APA, patient groups, and other medical and mental health groups.

Medicare’s Part D program has six protected drug categories. In a proposed rule issued in January, CMS sought to eliminate two of those categories starting in 2015—antidepressant drugs and those that help suppress the immune system. The agency also said in its draft rule that it was considering dropping protected status for antipsychotic drugs in 2016.

But on March 10, APA learned that its hard work had helped achieve the goal it had sought: CMS Administrator Marilyn Tavenner announced that the proposal was being withdrawn. “We will engage in further stakeholder input before advancing some or all of the changes in these areas in future years,” she said in a statement. “We are committed to continuing to work with Congress to continue to ensure that Parts C and D work best for Medicare beneficiaries.”

APA hailed the decision. “I am delighted to report that APA has been successful in its efforts to help sustain full access to the psychotropic medications for Medicare patients,” said APA President Jeffrey Lieberman, M.D. “[The] decision by CMS corrects what could have been an unwarranted limitation to the quality of mental health care.”

Lieberman also expressed gratitude to Rep. Tim Murphy (R-Pa.) for what Lieberman called “his vigorous actions to support psychiatrists and patients with mental illness.” In a hearing on the proposal, Murphy had quoted from APA’s extensive comments to the administration protesting the proposal and urged the administration to reconsider the proposed rule.

In a March 7 letter to Tavenner, CEO and Medical Director Saul Levin, M.D., M.P.A., outlined a wide range of problems with the administration’s reasoning in its proposal with regard to drug selection and interchangeability of drugs, variability of patient response to drugs, problems related to side effects and adherence, and cost concerns, among many others.

The letter especially protested what it called the administration’s selective reading and misinterpretation of APA’s treatment guidelines on a variety of points, but particularly with regard to what the administration claimed as the “interchangeability” of drugs.

“In the Preamble to the proposed rule, CMS selectively quotes APA’s practice guidelines, arguing they support the concept that antidepressants are interchangeable, when, in reality, the practice guidelines state the opposite conclusion,” Levin wrote.

CMS had quoted the 2010 Practice Guideline for the Treatment of Patients With Major Depressive Disorder as saying that “the effectiveness of antidepressant medications is generally comparable between classes and within classes of medications.”

But Levin pointed out that “this sentence fragment is taken out of context and ignores this practice guideline’s strong recommendation that the evidence for effectiveness is only one factor that must be considered when choosing an antidepressant for an individual patient. If the sentence is cited completely, it clearly indicates that the choice of antidepressant is a complex decision that must take into consideration multiple other factors besides a drug’s effectiveness for symptom control, including its side effects, safety, and tolerability for an individual patient.”

Levin wrote, “It is fundamental to the mission of APA to promote scientific inquiry and evidence-based approaches to the treatment of mental illnesses and to ensure that policy is based upon the scientific evidence available. The proposed rule misrepresents the content of the practice guidelines, is not based upon reliable clinical evidence or data, and is a major public-policy change by the Centers for Medicare and Medicaid Services that will impede access to clinically appropriate pharmaceutical treatments for mental illness. As such, this proposed rule cannot stand.”

Following the withdrawal of the proposal last month, Levin said the administration had done the right thing.

“We are pleased to see that CMS recognized the potential harm inherent in its proposal to remove the protections currently afforded to antidepressant and antipsychotic medications in Medicare Part D,” Levin told Psychiatric News. “This is the right decision for Medicare beneficiaries, who will now retain access to these valuable medications.” ■