CMS repeals final MCIT / R & N rule due to insufficient security

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Monday 22 November 2021

On November 12, 2021, the Centers for Medicare and Medicaid Services (CMS) announced the cancellation of Medicare coverage for innovative technologies and the definition of the final “Reasonable and Necessary” (MCIT / R & N) rule, which would take effect at December 15, 2021.

The Trump administration’s final MCIT / R & N rule would have granted accelerated Medicare coverage of up to 4 years for some Food and Drug Administration (FDA) designated “revolutionary” devices that have received or cleared market approvals. Coverage would commence immediately on the date of the FDA’s marketing authorization or on a date chosen by the manufacturer within 2 years. CMS intended the final MCIT rule to address delays and uncertainty in Medicare coverage that can slow innovation and hinder access to innovative new technologies.

Accelerating coverage of innovative devices would have substantially increased the availability of new innovative technologies for Medicare beneficiaries. In a press release, CMS said it is canceling the final rule, however, to address “concerns that the provisions of the final rule may not have been sufficient to protect Medicare patients.” According to the document published by the Federal Register repealing the final MCIT / R & N rule, CMS said that because this rule does not require data relating to Medicare beneficiaries, it could “establish insufficient protection of beneficiaries for certain devices.” Therefore, CMS has determined that it would be in the best interest of Medicare patients to repeal the final MCIT / R & N rule and revise the policy.

CMS administrator Chiquita Brooks-LaSure says “[a]While we continue to be in favor of improving access to new technologies, we are aware that they may present unknown or unforeseen risks and we must first ensure that such technologies improve health outcomes for Medicare beneficiaries. ” Note, CMS must “balance access and appropriate guarantees” when implementing policies.

In its proposal to repeal the final rule, CMS outlined the main concerns about streamlining coverage. Following the 4-year accelerated coverage in the final rule, manufacturers would have had to extend coverage through existing coverage pathways, such as claim-by-claim decisions, local coverage determinations (LCD), and national coverage determinations (NCD). ). The LCD and NCD process involves clinical evidence reviews to determine whether items and services provided under Medicare Parts A and B are reasonable and necessary. While the second part of the final R&N rule would have implemented regulatory standards to make these reasonable and necessary determinations, CMS has shown concern over the inhibition of its ability to make case-by-case determinations regarding the reasonableness and necessity of a device based on of clinical trials before beginning coverage. The ability to make case-by-case determinations is of paramount importance to the CMS due to the wide range of FDA-approved medical devices, which can range from surgical implants to blood glucose monitoring software, all involving different determinations, reasonable and necessary considerations. .

Although the FDA’s market authorization includes safety and efficacy standards, CMS remains concerned whether the fact that the FDA has determined that a device is safe and effective automatically justifies insurance coverage. Unlike pharmaceuticals where the CMS is required to cover any FDA-approved drug, medical device companies must require insurance companies to cover their newly approved device. (Social Security Act, Section 1862 (l) (2020)). Congress intended this forked system to create a barrier where medical device manufacturers have yet to prove that a device will be both reasonable and necessary to justify insurance coverage. The final rule of MCIT / R & N would have scratched this forked system, a system that can be frustrating for patients and practitioners who are desperate to try innovative devices. Increasing access to these devices too soon, however, could welcome an influx of expensive devices that are technically secure but not necessarily effective enough to be a reasonable and necessary use of limited resources or in the best interest of the beneficiary. The final MCIT / R & N rule would have increased the FDA’s role in determining insurance coverage and, according to CMS, would have weakened CMS’s ability to make the best coverage decisions for its beneficiaries. Coverage of medical devices will always be a balancing act between these two critical issues: access and security.

How CMS will address issues related to coverage of innovative devices remains uncertain. In repealing the final rule, CMS will now need to determine whether (1) accelerated coverage of innovative devices remains a goal for CMS and (2) whether accelerated coverage should result from future regulation or better use of existing pathways.

In the press release, CMS noted that it intends to work with “the FDA, the Agency for Health Research and Quality (AHRQ), medical device manufacturers and other stakeholders to develop a rapid process to cover innovative devices for benefit. of Medicare patients “. CMS also said it plans to hold at least two public stakeholder meetings in 2022 to inform its future decision-making in this space.

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