January 31, 2019

Public Response to CMS Proposal to Reduce Number of “Protected Classes” Medicines

First of all, MANY THANKS to all the Academy members who submitted public comments on this issue, as suggested in the previous issues of this column. The deadline for submission was 1/25/2019. According to federal records, a total of 7878 public comments were submitted.

The “Protected Classes” controversy was triggered last November when the Center of Medicare and Medicaid Services (CMS) proposed to “modernize” a regulation approved by Congress in 2008 ensuring that particularly vulnerable Medicare recipients would have ongoing access to the drugs they need without potentially life-threatening delays or the replacement of prescribed drugs by Medicare with less expensive medicines. The new CMS proposal, which seeks to undo this protection, had generated outrage among health care providers and consumers across the country.

In the coming weeks, we are likely to see highly visible condemnation of the CMS proposal in the media as stakeholders work to persuade Congress to reject this proposal to change or reduce Medicare’s six protected classes of essential medicines. STAT reports that a coalition led by the American Medical Association, the American Cancer Society/Cancer Action Network, and the Susan Komen for the Cure Foundation – along with about 50 other well-known health advocacy groups – will soon launch a highly visible campaign headlined, “When you limit drug therapies, you threaten lives.” It’s focus is to urge Senators and Congressmembers to reject the proposal.

As Law 360 observed last week, the Trump Administration (via CMS) proposes to allow Medicare Part D to “restrict access to certain expensive drugs” despite the fact that – as with several of its other proposals – there is a no real indication that this step can “be accomplished without legislation, and litigation is virtually guaranteed at least to delay, if not defeat, their implementation”.

CMS’ proposed assault on the six Protected Classes, if not withdrawn, may or may not withstand legal challenges against it. All that is clear now is that it is generating outrage among medical care providers and people living with medical conditions that require continuous access to drugs in the Protected Classes.

First Op-Ed by Academy Member on Protected Classes Controversy Published

As noted in the in previous issues, we are encouraging members to write op-eds to their local newspapers on the risks associated with the CMS proposal to limit medications in the six Protected Classes. Wesley Thompson is now the first Academy member to complete that challenge. A physician assistant and Medical Director of HIV Care at Amity Medical Group in Charlotte, North CarolinaThompson submitted his column to the Charlotte Observer where it appeared on January 31.

Columns from other members are in process and should see print soon. Anyone interested in developing an op-ed on this is welcome to contact our Communications Director, Amber McCracken at We will be happy to connect you with communications professionals who can discuss your ideas, draft op-ed language for you, and get your opinion on this subject into a local newspaper paper likely to print it.

View the latest Policy Update here.