Will CMS Really Listen and More Importantly – Respond?

This week begins a series of “Listening Sessions” concerning the 10 drugs selected for “negotiations” under the Inflation Reduction Act (IRA). These sessions, labeled the “Medicare Drug Price Negotiation Program Patient-Focused Listening Sessions”, were put in place to, “provide an opportunity for patients, beneficiaries, caregivers, consumer and patient organizations, and other interested parties to share input relevant to drugs selected for the first round of negotiations”. Sounds like a great opportunity for those  affected by the IRA to have their voices heard. Maybe a chance to actually have an impact on how these changes to the immensely popular Medicare Part D prescription drug program are implemented, but I have reservations. The following, in no particular order, details those concerns.

I’m concerned with the narrow focus of the sessions. Their guidance states that, “CMS is interested in patient-focused input relevant to the selected drugs”, nothing on the impacts of other parts of the IRA that affect Americans, especially seniors. I’ve talked in earlier blogs about the importance of how a piece of legislation that is passed and signed into law can have widely different impacts depending on how the law is implemented. These listening sessions are limited to comments on the 10 drugs chosen for price controls. At the very least, wouldn’t it seem logical to invite comments prior to the selection of the 10 drugs? Let alone the chance to broaden the sessions to allow comments on the  implementation of other parts of the law. For example, the Centers for Medicare & Medicaid Services (CMS) put the 5-star rating system in place after the initial 2006 implementation of the new Part D benefit. CMS decided it was a good way to give seniors information on how the different prescription drug plans were performing. The rating system was not directed by the law; it was a CMS decision on how to implement the program. Over the years, this rating system has had a huge affect on the Part D program (many believe it has had a positive effect, some believe it was detrimental). The point here is that this implementation approach was a CMS decision. I can’t find any documentation where CMS conducted listening sessions before they decided to implement the 5-star rating process. I’m concerned with the power CMS has to decide what rules and regulations the IRA will operate under.

I’m also concerned with the small amount of time allotted for each comment. Three minutes only allows an extremely short time for speakers to present to any depth their concerns or possible solutions. It also bothers me that CMS will have no comment or interaction with the commenters during the sessions. This brings me to another concern.

CMS allowed for written comments, which had to be submitted 28 days prior to the first listening session. The process for submittal was cumbersome, driven by questions and not user friendly. It was especially difficult for people who are not used to submitting documents to CMS. For instance, you have to enter your email address before you could see the questions or start the process. This isn’t conducive to seniors who have been warned about submitting personal information, especially when it is prior to seeing any questions or even deciding whether they want to continue with the process. It was also noted that you couldn’t save a work in process which means you must finish in one sitting. Again, an unnecessary roadblock to submission.

From my point-of-view, requiring the submittal of comments earlier would have allowed CMS to respond to some of these comments before or around the scheduled sessions so that we could have a feel for where CMS stands on some of these comments and questions. There is no announced schedule when or if CMS will respond to any of the written or oral comments. This seems like a decidedly one-way flow of information . . . no interaction or response.

I’m also concerned with which questions or comments that CMS will deem meaningful. We have no idea how the submitted information, either written or oral, will be interpreted and if it will be acted upon. I’ll be really interested on what comes from CMS after the listening sessions are over.

I understand that I’ve been pretty negative about these opportunities to communicate with CMS. I’ve been involved in many meetings, comment opportunities and discussions with CMS people and I’ve found some to be constructive but many that were just CMS checking a box to satisfy in their mind that they have heard from the patients and those that advocate for patients. Having said that, I do hope that there are many written comments submitted and a large participation in the oral listening sessions. The worst outcome is for the participation to be small, giving CMS the chance to conclude that giving patients and the private sector a chance to speak out is a fruitless endeavor. I hope the sessions are informative and those that participate are well prepared and meaningful. I truly hope that CMS takes the time to evaluate closely all of the oral and written communication and shares the written submissions with us. It would be a real breakthrough to see changes to the IRA implementation as a result of the private sector communication.

Finally, I hope these listening sessions result in more chances for patients and the private sector to comment on a broader range of topics concerning implementation of the IRA, even to include changes that might directly help Part D beneficiaries. Changes like eliminating the terrible restrictions on small molecule innovation which I’ll write more about in later blogs.

Look for a follow-up blog in a few weeks that will give my views on how the listening sessions went.

Best, Thair