How patient advocates can engage with CMS

On Day 2 of the Biotechnology Innovation Organization (BIO) Patient and Health Advocacy Summit, a panel titled Implementing Legislation—Engaging CMS dug into the importance of connecting to Centers for Medicare and Medicaid Services (CMS), especially in the post-Inflation Reduction Act (IRA) landscape.

“CMS has been very public in its desires to work with the industry and patient groups,” said BIO’s Chief Policy Officer John Murphy, who moderated the panel consisting of:

  • Brian Connell, Executive Director of Federal Affairs at The Leukemia & Lymphoma Society
  • Eric Gascho, Senior Vice President, Policy and Government at the National Health Council
  • Michael Ward, Vice President of Public Policy and Government Relations at the Alliance for Aging Research
  • Jennifer Young, Partner at Tarplin, Downs & Young LLC

Connecting on the Hill is important; connecting to CMS is paramount.

“There is an enormous opportunity for the patient advocacy community to influence all of the CMS decisions by focusing the same degree of attention and advocacy that is applied to the Hill and translating it into the regulatory environment,” said Tarplin, Downs & Young’s Jennifer Young, beginning the conversation. “You have to remain ever vigilant. You might have achieved important victories in the congressional battle, but the ultimate war gets decided by people who can work in their own silos and make their own decisions.”

This year has left patient advocates unequivocal in their understanding of the power CMS can wield.

“As many in this room are aware, CMS denied coverage of the first Alzheimer’s disease-modifying therapy,” reflected Alliance for Aging Research’s Michael Ward. “And not only did they do that for the specific Aduhelm therapy, but they did that for the entire class of therapies, even though they don’t have data on the therapeutics. I think that that is precedent-setting and unfortunately, the CMS is having additional meetings in the coming months to potentially figure out how to apply that same metric of coverage restrictions in the future.”

“I think it’s really important that we bring the patient voice to the table,” continued Ward. “We have to be a partner with the agency, as well as a voice for truth when necessary.”

This understanding has bred the sense of urgency patient advocates feel as they prepare to rally and work with CMS as the Inflation Reduction Act (IRA) goes into effect; the agency is tasked with figuring out specifics related to the law’s drug-pricing provisions.

“As we’re transitioning into new policy phases now that the IRA has been signed into law, it is going to be important to start haranguing congressional staff and explaining what is important for patients as we move forward,” explained the National Health Council’s Brian Connell. “We are already a bit behind the eight-ball, so we will have to work hard in the next few months. But it is possible and important. Congress left a lot of policy on the table, so while it is not off the table, they’re not guaranteed under the statute.”

How to work with CMS

The power of patient advocacy in the congressional and regulatory space is its ability to act as a translator for not just patients, but also science, data, and innovation. “

The CMS has people who are brilliantly smart when it comes to very specific areas, for example, hospital systems, Physician Quality Metrics, and the like,” explained Young. “However, they have less understanding around things like the research pipeline. It is places like those that we can come in and advocate most effectively.”

Driving home the point, Young explained, “CMS wants data—DATA, DATA, DATA! A conversation you may have with CMS right now is probably going to be very focused on, Show me what this looks like in the world. You have to ask yourself, how do you translate qualitative patient journey stories into that kind of data input? I think it’s going to be a challenge for all of us and we should think about it. It is going to be the trick we need for fitting our square peg into the CMS round whole.”

Overall, while the dynamic of working with the CMS may look very different from working on the Hill for most patient advocates, it is an area of understanding and growth that, when developed, could be a game changer for patients in the long run.

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