Editor’s Note: In a recent Health Affairs blog post, Ian Spatz analyzes the widespread pushback against the Medicare Part D proposed rule. Highlights are summarized below. Click here to read the full post.

On January 10, the Centers for Medicare and Medicaid Services (CMS) published a Medicare Part D proposed rule that set off a firestorm of dissent. Fundamentally, CMS has suggested some major changes to the decade-old Medicare prescription drug program that further inserts itself into directing the terms of competition in Part D.

The CMS proposed rule has united a disparate group of interests who, while not agreeing on much else, do agree they want the proposal to go away. For example, on February 28, 277 organizations (with more continuing to join)—including patient advocates, insurance companies, health plans, employers and both brand and generic drug companies—signed a letter slamming the proposed rule. Following that, 20 of the 24 members of the Senate Finance Committee wrote CMS Administrator Marilyn Tavenner, urging her to scrap the plan.

What’s Causing the Controversy?

While some may like parts of the proposed rule, as a whole, many believe the status quo is better than the Part D future Medicaid has presented. Some key areas of controversy include:

  • Introducing new criteria for protected drug classes. From the start of Part D, CMS believed there were certain conditions for which patients and physicians needed immediate access to a broad choice of medicines that might not be available if a Part D plan excluded them from its formulary. CMS is now suggesting criteria for whether a class of drug would need this protection. The result is that two of the six protected classes, antidepressants and immunosuppressants, would lose their protection immediately, and antipsychotics might lose it in a year. While Part D plans support this result because of potential cost savings, drug companies and some beneficiary groups are concerned that patients and caregivers won’t know how to navigate the process of appealing a drug coverage denial.
  • Expanding medication therapy management. Part D requires plans to provide extra medication counseling and coordination to beneficiaries with multiple chronic conditions and high drug costs. CMS is planning to expand that requirement significantly. Pharmacy groups are cheering the move, but plans question the value of the added costs.
  • Limiting plan offerings. CMS has proposed a series of changes that would limit the number and kind of plans offered under Part D. One change would limit of the use of preferred pharmacy networks. Plan sponsors oppose the change, claiming limited networks lower premiums and cost sharing for beneficiaries, while CMS is concerned they actually increase costs. Another change limits the number of plans offered in a region, with CMS asserting that too many choices with too little differentiation causes confusion. Opponents don’t understand why CMS would take choices away, asserting that beneficiaries are able to pick the plan that’s right for them.
  • Breaching the principle of noninterference in drug pricing. In its proposed rule, CMS surprised everyone by stating that it needed to define the limits of its powers related to drug pricing. Its proposed language has alarmed Part D plans and provided little comfort to drug companies.


Each of these issues and more have inflamed groups with strong interest in Part D. While not all agree on every issue, the powerful pushback indicates that now may not be the right time to rock the Part D boat.