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"Inside Health Policy: More Than 100 Patient Groups Warn Against Eliminating Protected Drug Classes In Part D"

September 12, 2017

Inside Health Policy: More Than 100 Patient Groups Warn Against Eliminating Protected Drug Classes In Part D

A new article in Inside Health Policy highlights a letter from the Partnership for Part D Access and 112 other patient organizations to HHS Secretary Tom Price warning the agency against making changes to Medicare’s ‘six protected classes’ policy. “More than 100 patient-advocate groups are warning against eliminating coverage protections for drugs in six therapeutic classes in an upcoming Part D proposed rule,” the letter states. “The contents of the proposal are unknown, but lobbyists for industry and patients are on edge because CMS plans to propose the first Part D rule since it pursued aggressive policy changes three years ago, according to the regulatory agenda... ‘These tools give Part D plans considerable flexibility to manage more expensive medications, as well as leverage to negotiate rebates with manufacturers,’ the Partnership for Part D Access wrote in a Sept. 8 letter to HHS Secretary Tom Price. Limiting access to drugs in protected classes would probably lower drug spending, but it would do so at the expense of higher hospital costs, the group says.”

More Than 100 Patient Groups Warn Against Eliminating Protected Drug Classes In Part D

More than 100 patient-advocate groups are warning against eliminating coverage protections for drugs in six therapeutic classes in an upcoming Part D proposed rule. The contents of the proposal are unknown, but lobbyists for industry and patients are on edge because CMS plans to propose the first Part D rule since it pursued aggressive policy changes three years ago, according to the regulatory agenda.

Part D plans currently must cover all drugs in six therapeutic classes: anti-retrovirals; immunosuppressants when used for organ rejection; anti-depressants; anti-psychotics; anti-convulsants; and anti-neoplastics.

One of the Part D proposals from three years ago called for eliminating protections for immunosuppressants, antidepressants and antipsychotics. Drug companies and patient advocates attacked that proposal, which led to strong bipartisan congressional opposition to the proposed rule. CMS received more than 7,500 comments on the proposal, most of them opposed to it. The agency dropped the most controversial measures, including the elimination of protected drug classes, and then-CMS Administrator Marilyn Tavenner told Congress the measures were indefinitely on hold.

However, Tavenner was part of the past administration, and lobbyists don’t know what to expect this time around.

“In light of recent indications from the Office of Management and Budget (OMB) that a rule on the Part D program is expected in September, the Partnership -- alongside its stakeholder allies from the patient community -- sent the letter in order to deliver a strong and clear message to the Administration that the protected classes policy continues to provide essential access to medication for Medicare beneficiaries, enjoys widespread, bipartisan support, and should not be changed,” a press release by the Partnership for Part D Access states.

Except for HIV drugs, Part D plans may use prior authorization, step therapy and tiered formularies to manage drugs in protected classes, according to the Partnership for Part D Access.

“These tools give Part D plans considerable flexibility to manage more expensive medications, as well as leverage to negotiate rebates with manufacturers,” the Partnership for Part D Access wrote in a Sept. 8 letter to HHS Secretary Tom Price.

Limiting access to drugs in protected classes would probably lower drug spending, but it would do so at the expense of higher hospital costs, the group says.


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