In March 2017, CMS announced new rules regarding continuous glucose monitoring (CGM) coverage for Medicare beneficiaries with diabetes, but after years of advocacy, what was supposed to be a moment of celebration turned into a collective It turned into a scream.
The notice states that those seeking a CGM refund can only use the receiver that came with the system, not the smartphone app that can display blood glucose data on a user's phone or share it with a caregiver. It had been. In addition to disabling technology for key features, the rule forced Dexcom to disable app compatibility on all CGMs shipped to Medicare enrollees.
For beneficiaries, the smartphone episode became emblematic of everything that's wrong with CMS's approach to technology. But it opens new paths that allow Medicare to adopt new tools and pay for them while gathering the evidence needed to ensure the technology is safe and appropriate for older adults. It may have helped make your point.
Transition Coverage for Emerging Technologies (TCET) Pathway. Proposed in June 2023 and discussed in a Viewpoint article published in June 2023 JAMA Health Forum,1 , a panel discussion held at ISPOR on Tuesday, “Revolutionizing Regulatory Pathways: Unleashing the Power of Real-World Evidence, Adaptive Trials, and Synergistic Collaboration to Speed FDA Device Approval, Breakthrough Designation, and CMS Reimbursement It was featured in “Achieving the Realization of the Future”. Health Economics and Outcomes Research Group, Atlanta, Georgia.
This discussion, moderated by Lenny Arnold, Ph.D., RPh, of the National Institutes of Health, discussed reforms to improve technology success rates at the FDA, the use of real-world evidence in fit-for-purpose trials, and CMS emergencies were also highlighted. Medical technology evaluation organization.
Further adjustments at FDA
In 2020, panelist Douglas Kelly, M.D., became Deputy Director and Chief Scientist of the FDA's Division of Devices, Diagnostics, and Digital Health, after spending 30 years trying to bring devices to market and seeing the struggle from the other side. I came to the FDA as a person.
Douglas Kelly, Maryland | Image credit: LinkedIn
Kelly said his agency for decades failed to recognize a key difference between biotechnology and medical technology: drugs reach the public relatively quickly and with much lower risk than medical devices. He explained that it was possible. Therefore, the failure rate of medical equipment is 90%. As many noted during the meeting, Kelly said the FDA's “safe and effective” standard and Medicare's “reasonable, necessary and appropriate” standard are not necessarily the same.
When it comes to medical devices, “no single stakeholder owns the process,” he said, and even if the FDA approves a product, coverage is not guaranteed. Therefore, raising funds for medical device ventures is extremely difficult. At the same time, throughout my time at the FDA, I've been shocked by how many potential applicants come forward with ideas they've never talked to patients outside of their own practice.
The solution is TAP (Total Product Life Cycle (TPLC) Advisory Program).
“We believe that if we bring everyone together early, we can eliminate a lot of failures in the later stages,” Kelly said. The group of TAP advisors is based on the principle that “We don't teach doctors how to practice medicine; We are coordinating discussions among stakeholders. We listen to doctors' opinions about how they practice medicine and use that to help determine where the real risks are with devices and their use. ”
TAP has two phases. The diagnostic phase assesses the project status and missing elements. The second phase is a process and policy phase that presents options to the entire FDA. TAP team members come from a variety of backgrounds, Kelly said. “If you have a problem, you can find someone who has solved it or has dealt with it before.”
The goal is to avoid pitfalls and reduce failure rates. “We want to help innovators plan for stakeholder risk early.” “It makes no sense to start clinical studies before we really understand what's going on.”
Of course, patient concerns are top of mind for the FDA. “It is ethically questionable to subject large numbers of patients to clinical studies when the chances of commercialization are very low,” he said.
TCET takes time to gather evidence.
When CMS issued the infamous rule banning CGM coverage when seniors used CGM technology on smartphones, their reasoning was that smartphones did not meet the definition of a durable medical device. was. A lawyer who successfully sued Medicare to force CGM coverage called the restriction “nonsense.”
Stephen Farmer, MD | Image credit: CMS
However, as Stephen Farmer, M.D., chief strategy officer for coverage at CMS, explained, it is the very nature of innovation that makes it difficult to fit technological advances into Medicare benefit categories; was founded decades ago before some of it was even imagined. Seems like a legitimate candidate for today's coverage.
Medicare will need to show evidence that the technology is “reasonable, necessary and appropriate” for that particular population, but studies may exclude older patients or those with comorbidities. It can be difficult due to the nature of “We believe that setting high standards of evidence is essential to ensure that we provide the highest quality care to our patients,” Farmer said. “CMS may expand the coverage of a product or service if it meets reasonable and necessary standards.”
Medicare also considers current standards of care when evaluating emerging technologies, but in some cases “an established standard may not exist.”
Mr Farmer said the TCET pathway aims to address these challenges. The idea is to allow coverage for a limited time to create an opportunity to gather evidence. He explained the guidance document:
- Review of evidence: Farmer describes how CMS reviews a body of evidence when determining whether a product or service is “reasonable” or “necessary.” said.
- Coverage by Evidence Development (CED): This outlines the standards that apply to coverage determination (CD) studies.
- Clinical Endpoint Guidance Series: These aim to define what endpoints are available within a therapeutic area. What are the relevant endpoints in the Medicare population? How can clinically meaningful differences be defined? How long is follow-up required?
“The idea is that by providing more clarity about what our expectations are, upstream manufacturers can more effectively incorporate that information into their own important clinical studies.” By the time it is launched, it will be ready to meet CMS expectations. said the farmer.
The next step is learning guidance tailored to your goals. “At the near-market stage, the TCET pathway aims to accelerate coverage reviews by engaging with manufacturers well in advance of FDA market clearance,” he said. “The proposed notice sets an expectation to work with manufacturers approximately one year in advance of FDA market approval.”
Similar to FDA's TAP initiative, the idea is to consider details such as coding issues through CED studies in a collaborative way that proactively uncovers evidence gaps and plans to address them in the postmarket period. is. The transition period is time-limited and comes with clear expectations to monitor safety signals and complete all studies.
He referred to the need for 'fit for purpose' research, which is the theme of the ISPOR 2024 conference. This approach uses data to ensure that a system or program operates in a way that meets patient needs in a particular setting or situation.
“Whether something is fit for purpose really depends on the question and the context in which that question is asked,” Farmer says. “However, we strongly encourage manufacturers to thoroughly consider which development methods are appropriate for their research objectives and what data sources are available.”
Evolution of CMS as an HTA organization?
Dr. Peter Newman of Tufts Medical Center presented ideas from a paper he co-authored with Sean Tunis, MD, a former FDA and CMS official and current principal of Rubix Health. Paper “Transforming CMS into a medical technology assessment agency”2 Newman said CMS is required to evaluate drugs and devices in an increasingly complex world. He said this was especially true as there was no central health technology assessment (HTA) in the federal government.
Dr. Peter Neumann | Image credit: Tufts Medicine
To be sure, CMS has evolved from its origins in insurance payments and explicitly does not interfere with how care is delivered. Of course, there was an interest in ensuring that public money paid for things that worked and that things evolved, Newman said. In 2001 he said changes occurred with the words CMS evaluating new technologies, and in 2006 reporting with evidence development was created.
Once the FDA begins granting breakthrough status to certain technologies, Newman said, people should consider covering devices under Medicare “in the face of significant uncertainty about benefits and risks.” .
“The growing number of promising but expensive devices, and by extension, drugs, is raising new questions about how Medicare evaluates and pays for them,” he said.
The 2022 controversy over whether to cover aducanumab after FDA approval raises new questions, and now the Inflation Control Act moves CMS' evaluation role into entirely new territory. “Price negotiation necessarily means evaluating the underlying clinical evidence of a drug,” he said.
“Again, we are seeing CMS stepping into this role more and more for agencies like HTA, which is very different from what we see elsewhere overseas. We evaluate the evidence when we launch a drug, and this is about evaluating the evidence.'' rear The drug has been on the market for some time. However, that's the idea. ”
Newman said there are workforce challenges, a continued need for increased collaboration with the FDA, and a need for new legislative authorities to improve the coverage process. “Ideally, this would not be easy to do, and would be difficult in any environment, but certainly difficult in this kind of polarized political environment. It needs to be clarified that the idea of strengthening the ability to perform has sometimes been questioned.
“We argue that whether we like it or not, CMS is becoming a kind of HTA agency. In our view, they should embrace that role and do an equally good job. [they] can. “
References
- Farmer SA, Fleischer LA, Bloom JD. Emerging Technology Pathway Transition Coverage – Enhance innovation while establishing patient safety nets. JAMA Health Forum. 2023;4(8):e232780. doi:10.1001/jamahealthforum.2023.2780.
- Neumann PJ, Tunis SR. Transform CMS into a health technology assessment agency. N English J Medicine. 2023;389(8):682-684. doi:10.1056/NEJMp2305280
