Bevey Miner: Unpacking the 21st Century Cures Act, the Role of Open Comment Periods

Bevey Miner, Consensus Cloud Solutions

In the final segment of this interview series with Bevey Miner, executive vice president of health care strategy and policy, Consensus Cloud Solutions, and The American Journal of Managed Care® (AJMC®), Miner discusses the 21st Century Cures Act and its associated proposed rules.

The open comment period for the Advancing Interoperability and Prior Authorizations Proposed Rule plays a pivotal role in gathering feedback from diverse stakeholders, including prominent hospital systems and associations, Miner said.

The CMS Interoperability and Prior Authorization Final Rule was released on January 17, 2024.

This transcript has been lightly edited for clarity.

Transcript

AJMC: What are ways that organizations can collaborate with government agencies, health care providers, and other stakeholders to influence and contribute to the development of digital health policies?

Miner: Let’s go back to the 21st Century Cures Act; it was a law. It doesn't prescribe how to deliver everything that is laid out in that Act. From there, there are all these different proposed rules that are going to support the 21st Century Cures Act. In those proposed rules, normally, the process for policy is that there will be a proposed rule and then a final rule. During the proposed rule stage, there is what's called an open comment period. So that open comment can come from a hospital system that writes a letter. You can publish a letter in what's called the Federal Register. The Federal Register will house the content for these proposed rules. In there, they will invite comments. In some of the proposed rules, CMS will specifically say, "We invite comments on this particular section. We're looking for comments on this section." You don't have to comment only on the areas that they're looking for comments; you can comment on any part of that rule.

What we saw with one of the most prescribed rules to help support the 21st Century Cures Act is one called the Advancing Interoperability and Prior Authorizations Proposed Rule. That was proposed, I think, back in August. And it had an open comment period of 6 weeks, maybe 2 months, and then it closed. In that open comment period, CMS received over 1500 comment letters. That is a huge amount, probably twice the amount they would normally get on certain rules. The comment letters came from large hospital systems: Mayo Clinic, Cleveland Clinic, Cedar Sinai hospitals, and associations representing their members, such as CHIME (CIOs of all hospitals), the American Hospital Association, the American Medical Association, almost every association I can think of that their members could be impacted by this wrote a comment letter. Vendors could write comment letters; we wrote a comment letter that we hoped would represent our customers that served the vulnerable populations in those outer circles, like substance abuse clinics and assisted living. Our comments were that this could erode health equity because health equity is not just about treating patients all equally; it's about providing access to reliable and actionable data on that patient. So, health equity equals tech equity. By implementing some of these rules, you are removing the ability for those providers to have the information they need.

Now, it's not for the faint of heart to read proposals. There are hundreds of pages, with a lot of legal language. But you can find summaries on CMS, HHS [The United States Department of Health and Human Services], and ONC [The Office of the National Coordinator for Health Information Technology] websites. You can find summary documents, PowerPoint presentations, and they conduct webinars to ask questions and truncate it all down to the essence of what this proposal is supposed to be about. I would encourage everyone to follow these open comment periods, speak your mind, because CMS can't ignore 1500 comment letters that came in. There would be so much pushback in the industry; they could put a final rule in place. But if nobody is going to comply with it, it's not going to be meaningful. They do want a public-private relationship; they can only do so much if they don't get that kind of feedback. So, to me, that is one of the best ways you can participate in shaping rules. Many of these rules are still going to support the ability to provide valuable care with the highest level of quality while keeping the cost of care down.

So when your readers think about all these rules going into play and they think about it with the lens of how this is going to impact managed care, how this is going to impact those payers that are focused on controlling the cost of care, is that sharing information, sharing meaningful and actionable information, and doing it with the right kind of speed is going to mean that you are not going to have the bad health outcomes that we are seeing today. When a patient shows up at a skilled nursing facility, and all their discharge information follows by 2 days, the skilled nursing facility has no idea what meds they are on, no idea how to treat them. So, I like the fact that I'm talking to a publication that covers managed care, and a lot of these rules are to help support that.