Medicare is no longer required to cover “breakthrough” devices after they are cleared or approved by the Food and Drug Administration. The Centers for Medicare and Medicaid Services rescinded a final rule on Friday, citing safety concerns.
“Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” CMS Administrator Chiquita Brooks-LaSure said in a news release. “The Medicare program needs to implement policies that balance access and appropriate safeguards.”
The Medicare Coverage of Innovative Technology rule has been in limbo for months, since it was first published in the final days of the previous administration. Medicare would have covered devices for up to four years that had received a breakthrough designation, and subsequently received marketing authorization from the FDA.
The FDA’s breakthrough devices program is intended to speed up the review of devices that provide more effective treatment or diagnosis for life-threatening or debilitating health conditions. It applies to a substantial number of devices: nearly 300 as of last year, according to MedTech Dive.
Medical device companies, especially those with cleared breakthrough devices, were proponents of CMS’ rule. However, physician and insurance groups were more skeptical, noting that patients covered by Medicare are often underrepresented in clinical trials, and the requirement could remove some protections for patients.
After bumping back the implementation date to December, CMS had talked about scrapping the final rule. On Friday, that decision became final.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The agency said that the kinds of clinical studies needed for FDA market authorization might not consider the specific needs of Medicare patients, including the differences in clinical profiles or complex medical conditions.
“Under the rule we are repealing, CMS may have covered devices without adequate evidence to demonstrate that the device would be reasonable and necessary to diagnose or treat the Medicare population for particular medical conditions,” Dr. Lee Fleisher, CMS chief medical officer and director for the Center for Clinical Standards and Quality, said in a news release.
For now, device manufacturers will still need to get local coverage determinations or a national coverage determination to be covered by Medicare. However, CMS is leaving the door open for creating new policies to expedite this process.
The agency said it plans to work with the FDA, the Agency for Healthcare Research and Quality, and medical device manufacturers, to develop a process to more quickly cover innovative devices that benefit Medicare patients. It plans to hold stakeholder meetings next year as it drafts future policies.
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