Under pressure from the industry and Congress, the Centers for Medicare & Medicaid Services is withdrawing several proposed changes to the Medicare drug program, but still charging ahead with others that could prove disruptive.
In a large batch of Medicare Part D proposed regulations first published in January, CMS announced plans to end three protected classes of drugs, standardize preferred pharmacy networks, extend negotiated drug pricing across the program and limit the number of plans available in a region, among other things the agency argued would collectively help save $1 billion over five years.
Those proposals and others drew criticism from various corners of Congress and the health, insurance and pharmaceutical industries, especially the elimination of the protected classes of antidepressants, antipsychotics and immunosuppressants and a new interpretation of the Part D "non-interference" clause that would give every pharmacy the ability to contract with plans under preferred terms and conditions.
"In particular," CMS Administrator Marilyn Tavenner wrote to members of Congress, "we heard concerns about the proposals to lift the protected class definition on three drug classes, to set standards on Medicare Part D plans' requirements to participate in preferred pharmacy networks, to reduce the number of Part D plans a sponsor may offer, and clarifications to the non-interference provisions."
"Given the complexities of these issues and stakeholder input, we do not plan to finalize these proposals at this time. We will engage in further stakeholder input before advancing some or all of the changes in these areas in future years," Tavenner wrote.
However, she added, "we plan to finalize proposals related to consumer protections (e.g., ensuring access to care during natural disasters), anti-fraud provisions that have bipartisan support (e.g., strengthening standards for prescribers of prescription drugs), and transparency (e.g., broadening the release of privacy-protected Part D data) after taking into consideration the comments received during the public comment period."
The agency is proposing to start requiring providers writing Part D-covered prescriptions to enroll in Medicare, to combat fraud and perceived or actual over-prescribing of painkillers (that idea has received its own set of criticisms from palliative care advocates).
The proposed rules also included changes to broker compensation, aimed at simplifying what regulators argue is too complex a system. Medicare Advantage organizations and Part D sponsors would continue to have the discretion to decide whether to pay initial or renewal compensation to independent agents, but it would have to be at or less than 35 percent of "fair market value."
And in an effort to support more transparency and research in Part D and prescribing effectiveness, CMS is proposing increase access to a range Part D data with prescriber, pharmacy and plan identifiers intact, although information identifying beneficiaries and Part D sponsor costs would still be off-limits.
The move to open up Part D data and Medicare data in general comes as regulators say they are trying to evolve to more data-driven decision-making, in tandem with the U.S. healthcare system.
"CMS itself is transforming from a passive payer of claims towards a value-based purchaser of health care, while at the same time, other health care payer and provider incentives have shifted toward broader coverage and coordinated care," regulators wrote in the proposed rules.