CMS will propose new medical insurance “breakthrough” equipment rules in 2022


According to the Ministry of Health and Human Services, the Biden government intends to release its version of the rules on rapid medical insurance coverage for breakthrough medical technologies in October next year. Regulatory agenda.

Tom Bulleit said that the rule may be different from the Trump administration’s policy version because it requires the collection of more evidence about the effectiveness of the device for Medicare beneficiaries, and may make Medicare and Medicaid Service Centers insured. Have more say in the determination process, partner of Ropes & Gray.

Content management system abolition A rule last month would allow medical insurance to cover medical devices designated as “breakthrough technology” by the U.S. Food and Drug Administration for four years immediately after obtaining market authorization.

When CMS officials repealed the rule, they said that they plan to re-examine and improve access to breakthrough technologies by formulating rules or existing channels. The inclusion of proposed rules on this subject on the regulatory agenda indicates that CMS believes that new rules are necessary to support Medicare’s access to these technologies.

Morgan Lewis partner Susan Feigin Harris said that the notice of the proposed rule is a welcome addition to the regulatory plan next year.

“If you think about all the types of innovation we can pursue, there will be huge changes that push us forward,” Harris said. “I looked at it, it was great, you know, these are the continuations we need.”

The rule never really took effect and was finalized in the last few days of the Trump administration. Medical device manufacturers appreciate the policy, but many suppliers and beneficiary advocacy associations worry that the rule will lead to coverage of equipment without evidence that can adequately meet the needs of medical insurance beneficiaries.

Bulleit believes that CMS may consider these opinions. Bulleit said that CMS seems to believe that the previous policy removed the agency from the coverage determination process because approval will be automatic. He can see that future proposals try to solve this problem. The new rules may require breakthrough devices to have evidence that they are effective for Medicare beneficiaries before approval, or require additional data to be collected after approval.

“In my opinion, this is a reasonable approach. If the data shows bad things that can keep it going, they can always withdraw and report back if it shows good things,” he said.

The Association of American Medical Colleges also hopes to see additional protections for medical insurance beneficiaries in the Biden administration’s policy version, said Ivey Bell, senior director and supervisor of AAMC.

Since CMS abolished the rule, support for accelerated coverage of breakthrough technologies has sprung up.A group of bipartisan parliamentarians Sent a letter to the agency Last month, CMS was urged to promptly introduce a replacement policy.

However, CMS predicts that the newly proposed rules will not be introduced until October next year. Harris said that considering how long the regulatory process takes, this is not surprising. However, Bulleit said the timetable may also be due to a competition of priorities.

Bulleit said: “They have made all this progress, which really surprised me. They said it really takes a year to get back to this point.” “But I guess that means, you know, we have not made enough progress. Close to what CMS wants to see.”

Baer stated that she has not received any indication that CMS intends to include a provision that defines what items or services are considered “reasonable and necessary” for diagnosis or treatment under medical insurance. This is the repealed Trump administration rule. Another component of the.



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