CMS Bets on Tech as US Healthcare Hits ‘Inflection Point’

Americans are their best when backed into a corner, said Chris Klomp, director of Medicare and deputy administrator of Centers for Medicare & Medicaid Services, and he expects it to lead to “American exceptionalism” in the healthcare industry. Commercial tech solutions are a key enabler of that goal.  

“I’m excited that we’re hitting an inflection point in healthcare where the challenges are plain and obvious. We can’t rationalize our way out of them,” he said at the Chamber of Commerce’s Health Summit Thursday. “I think we’re getting backed into a corner on healthcare right now, and that’s the time where we shine; we do our best work. And I see all of the talent in this sector in that moment, and I think that this could be our greatest moment — with the technology that we couldn’t even fathom five years ago, with the political will, with the national will — to do extraordinary things.”  

Klomp, who also serves as senior advisor to the health secretary, leads Medicare, a $1.1 trillion program that serves nearly 70 million Americans. He said healthcare is the number one cause of personal bankruptcy in the U.S. and one of the leading causes of sovereign insolvency, which means it’s time to “do things differently” and embrace the entrepreneurial mindset.  

He called on the private sector to think about “interesting, creative and novel solutions” to healthcare challenges, but to remember that CMS doesn’t typically procure technology directly on behalf of patients or providers.  

“Our job is to create the conditions in which you can thrive, but you’ve got to actually go sell in the marketplace. You need to actually demonstrate a track record, performance and clinical data,” he said.  “We can create the conditions for you to thrive if the market determines that your product has value, and markets generally are pretty good at doing that.” 

Initiatives to Advance Public Tech in Healthcare 

CMS is currently accepting applications to participate in its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, which will launch in July. The program will use an outcome-aligned payment method that allows Medicare clinicians to offer innovative technology-supported care for chronic conditions like high blood pressure, diabetes, chronic pain and depression. 

Klomp said initially there was pushback that the outcome targets were too lofty or unrealistic. 

“Then quietly in the background were the insurgents who were doing the work that insurgents do, that entrepreneurs do, sitting and thinking, ‘I think I can hit that outcome. I’m going to have to invent some new technology. I think I can do it. I can do it for that price point.’ And then they started to bubble up, and that’s exactly what we want,” he said.  

CMS said last week that 150 healthcare organizations have been approved to participate in the program, which is expected to run for 10 years. The application deadline is May 15.  

Inside the RAPID Coverage Pathway

Last week, the FDA and CMS launched the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway, an initiative meant to expedite access to certain FDA-designated Class II and Class III Breakthrough Devices for people with Medicare. 

“The RAPID coverage pathway allows CMS and the FDA to work together with innovators earlier in the technology development lifecycle so that evidence generated for FDA review can also support Medicare coverage decisions. By aligning regulatory and coverage expectations in advance, the RAPID coverage pathway is designed to significantly reduce delays that have historically occurred between FDA market authorization and Medicare national coverage determinations,” according to the announcement.  

Klomp said it’s possible for product developers to get paid as quickly as 60 days after an FDA approval rather than waiting years for a second approval from CMS.