CMS Must Work Harder to Get New Drugs and Devices Covered Quickly, House Members Say

Medicare needs to up its game when it comes to approving coverage for new drugs and devices, witnesses and members of Congress agreed Tuesday at a House hearing.

“Despite the historic advancements in treatments for Alzheimer’s disease, the Biden administration has decided to limit access to these therapies through onerous coverage policies that require patients and their providers to take great lengths in order to administer and gain access to these drugs,” Rep. Brett Guthrie (R-Ky.), chair of the House Energy & Commerce Health Subcommittee, said at a hearing on evaluating Medicare coverage pathways for innovative drugs. “I remain extremely frustrated by the Biden administration’s restrictive approach to addressing this vicious disease.”

Rep. Anna Eshoo (D-Calif.), the subcommittee’s ranking member, noted that a Stanford University study found that Medicare takes 4 to 6 years, on average, to cover a breakthrough technology once it has been approved by the FDA. And she said that although Medicare’s Coverage with Evidence Development (CED) program — under which Medicare covers a recently approved drug as long as the patient taking it participates in a registry to collect data about its use — “sounds like a reasonable compromise, in practice, however, there’s been a wide variability in the implementation of a CED.”

“Some therapies with a CED [policy] have had no data collection mechanisms; that means no one could actually receive coverage for the treatment,” she said. “So that’s a bust. Other therapies have had registries to collect the patient data, but they were too costly or burdensome for the doctors, leading to inequities in coverage.”

Several subcommittee members were unhappy with other efforts by the Centers for Medicare & Medicaid Services (CMS) to speed up these coverage approvals. Rep. Cathy McMorris Rodgers (R-Wash.), chair of the full Energy & Commerce Committee, said she has been encouraged by bipartisan support for the Medicare Coverage of Innovative Technologies (MCIT) rule issued by CMS in January 2021 during the Trump administration; that rule granted expedited Medicare coverage for up to 4 years for any FDA-designated breakthrough device once the device received or cleared market authorization.

The Biden administration repealed the MCIT rule and replaced it last month with a proposed procedural notice known as Transitional Coverage of Emerging Technologies (TCET). Under the TCET program, which is voluntary, a manufacturer would nominate themselves about 1 year before an anticipated FDA approval decision to use the TCET pathway.

If their device was approved, CMS would begin a National Coverage Determination (NCD) for it and would hopefully finalize the NCD within 6 months. The device would then be covered under the NCD “only as long as needed to facilitate the timely generation of evidence that can inform patient and clinician decision-making,” according to CMS; officials there anticipate that it would take 3 to 5 years before a long-term coverage decision would be made.

“There appears to be some good in the [TCET] notice,” said McMorris Rodgers. “But I remain concerned about the uncertainty for patients and doctors created by CMS’s lack of transparency, accountable timelines, and a predictable coverage pathway for FDA-approved technologies.”

Lishan Aklog, MD, chairman and CEO of PAVmed, a company that produces DNA tests for esophageal cancer, lamented the fact that the TCET pathway excludes diagnostic tests like those his company makes. “There’s really no justification for this,” he said. “Molecular diagnostic testing is at the leading edge of innovation.” In addition, TCET “does not currently provide a viable plan to update the decades-old ‘defined benefit category’ system to keep pace with the horizons of innovation, such as digital health.”

And finally, Aklog said, “CMS anticipates a small, fixed number of TCET slots per year. This will not work; it effectively asks companies to buy a TCET lottery ticket and hope their number hits. This will wipe out any improvements in predictability and lead to new inequities favoring certain groups of patients.”

Subcommittee members on both sides of the aisle mentioned their sponsorship of H.R. 1691, the Ensuring Patient Access to Critical Breakthrough Products Act. It would allow for 4 years of transitional Medicare coverage once a device has been approved by the FDA, and would require CMS to establish a payment code for the device within 3 months. It also would require CMS to develop a process for permanent coverage once the transition period expires.

Rep. Tony Cardenas (D-Calif.), said he was proud to co-sponsor the bill and asked Todd Brinton, MD, advanced technology chief scientific officer at Edwards Lifesciences, what kind of impact such legislation might have. “This is an important component of what drives our innovation, and it actually improves the health of the entire American population,” Brinton said. “So either of these — [this] legislation and weighing in on TCET, is beneficial.”

Any solution to the problem must strike a good compromise between getting coverage for people who need a particular therapy and increasing knowledge about how well the therapy is working, said Thomas MacGillivray, MD, president of the Society of Thoracic Surgeons (STS). He gave the example of transcatheter aortic valve replacement (TAVR) therapy.

“When TAVR was first approved by Medicare for Coverage with Evidence Development in 2012, it was only for extremely high-risk patients,” he said. At that time, the STS, collaborating with the American College of Cardiology, created the TVT [transcatheter valve therapy] registry to monitor patient safety related to this new therapy … Over time, more and more patients were able to receive this new therapy based on the data collected in the TVT registry. It is important that reforms strike a balance between providing access to innovative therapy, while also ensuring that the collection of robust evidence is available to best inform these types of decisions.”