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CMS abolishes final rules for MCIT / R & N due to inadequate protection




Monday, November 22, 2021

On November 12, 2021, the Medicare and Medicaid Service Center (CMS) will have the Medicare coverage of innovative technologies and reasonable and necessary (MCIT / R & N) final rules that will come into force on December 15, 2021. Announced to withdraw the definition. ..

The final MCIT / R & N rule from the Trump administration is the scope of rapid Medicare for up to four years for certain market-approved or cleared Food and Drug Administration (FDA) -designated breakthrough devices. Would have admitted. Coverage begins immediately on the FDA’s market approval date, or on a manufacturer-selected date within two years. The CMS intended that the final rules of the MCIT address the delays and uncertainties in Medicare’s scope that could delay innovation and prevent access to new and innovative technologies.

Accelerating the coverage of breakthrough devices will enable Medicare beneficiaries to take advantage of new breakthrough technologies. In a press release, the CMS stated that it would withdraw the final rule, in order to address concerns that the provisions of the final rule may not have been sufficient to protect Medicare patients. According to a federal register public document that invalidates the final MCIT / R & N rule, the CMS provides inadequate beneficiary protection for certain devices as this rule does not require data on Medicare beneficiaries. Insisted that it could be established. Therefore, the CMS has determined that it is in the best interests of Medicare patients to abolish the final rules of MCIT / R & N and review the policy.

CMS Administrator Chiquita Brooks-La Surestatesthat [a]We continue to support increasing access to new technologies, but keep in mind that they may have unknown or unexpected risks, and such technologies will benefit Medicare first. You need to make sure that it improves your health. She states that the CMS needs to balance access and appropriate safeguards when implementing policies.

In a proposal to revoke the final rule, the CMS outlined key concerns regarding coverage rationalization. Following a quick four-year coverage under the final rule, the manufacturer will be able to provide a claim-by-claim ruling, a regional coverage determination (LCD), a national coverage determination (NCD), and other existing coverage. It was necessary to expand the coverage through the route. The LCD and NCD processes include a review of clinical evidence to determine if the items and services offered at Medicare Apartments A and B are reasonable and necessary. The second part of the R & N Final Rule implemented regulatory criteria to make these rational and necessary decisions, but is the CMS rational and necessary for the device based on previous clinical evidence? He expressed concern that it would impede his ability to make case-by-case decisions. Coverage started. The ability to make case-by-case decisions is due to the wide range of FDA-approved medical devices, from surgical implants to blood glucose monitoring software, all with a variety of rational and necessary decision considerations. , Is an important concern for CMS.

While the FDA’s market authorization includes safety and efficacy standards, the CMS automatically justifies the coverage of insurance by the fact that the FDA has determined that the device is safe and effective. I am concerned about whether or not. Unlike drugs that require CMS to cover FDA-approved drugs, medical device companies must apply to insurance companies to cover newly approved devices (Social Welfare Act, Section 1862 (l) (2020). )). Congress intended that this bifurcated system would create a barrier for medical device manufacturers to prove that the device was rational and necessary to justify insurance coverage. .. The final rules of MCIT / R & N would have stripped away this bifurcated system. This system can be frustrating for patients and providers desperate to try out breakthrough devices. However, accessing these devices too early is technically safe, but reasonably and necessaryly uses finite resources and is effective enough for the best interests of the beneficiaries. May welcome the influx of not limited expensive devices. The final rules of MCIT / R & N would have increased the FDA’s role in determining insurance coverage and, according to the CMS, weakened the CMS’s ability to determine the optimal coverage for beneficiaries. The scope of medical devices is the act of balancing between two key issues: access and safety.

It remains uncertain how CMS will deal with breakthrough device coverage-related issues. When revoking the final rule, the CMS will ask (1) whether accelerated breakthrough device coverage remains the CMS’s goal, and (2) accelerated coverage implementation or existing rule-making in the future. You need to determine if it comes from the better use of your route.

In a press release, CMS will work with the FDA, the Agency for Healthcare Research and Quality (AHRQ), medical device manufacturers, and other stakeholders to provide a rapid process to cover innovative devices that benefit Medicare patients. He said he plans to develop it. The CMS further stated that it plans to hold at least two stakeholder public meetings in 2022 to inform future policy decisions in this area.




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