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Federal Register / Vol. 86, No. 94 / Tuesday, May 18, 2021 / Rules and Regulations
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seek additional public comments on this topic when considering any proposed changes.
Comment: Some stakeholders supported defining reasonable and necessary in regulation while others do not believe a codified definition is necessary. Commenters expressed concerns about transparency of commercial coverage polices and believed the rule could unnecessarily restrict coverage by relying on commercial insurer policies designed for a different population with different incentives. Furthermore, the majority of public comments from patient advocates, policy think tanks, health insurance advocates and manufacturers did not support including commercial insurer criteria in the definition. Most public comments noted that CMS can and has reviewed commercial policies in recent years as part of a national coverage analysis. Other commenters suggested separating and reissuing separate rules for the definition of reasonable and necessary and MCIT
because they were viewed as too distinct.
Response: We will consider this comment for future rulemaking.
C. Impracticability of Implementation by May 15, 2021
As noted previously, many commenters on the March 2021 IFC
supported delaying the MCIT/R&N final rule. Based upon the public comments expressing significant evidentiary concerns, we do not believe that it is in the best interest of Medicare beneficiaries for the MCIT/R&N final rule to become effective May 15, 2021.
Under the current rule, there no requirement for evidence that MCIT
devices will specifically benefit the Medicare target population.
Additionally, the final rule takes away tools the CMS has to deny coverage when it becomes apparent that a particular device can be harmful to the Medicare population. If the rule goes into effect, and a device is later found to be harmful to Medicare recipients is approved under the MCIT pathway, CMS would be limited in the actions it can take to withdraw or modify coverage to protect beneficiaries.
As was noted by some commenters, early and unrestricted adoption of devices may have consequences that may not be easy to reverse. Commenters referenced publications that highlight the relationship between manufacturers and physicians and claimed that the potential for manufacturers to influence physician behavior will persist if coverage is guaranteed under MCIT.
Guaranteed coverage under MCIT may
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further stimulate providers to adopt these technologies and could potentially lead to these technologies being prematurely viewed as standard of care which could adversely impact beneficiaries if a product does not ultimately receive Medicare coverage.
Additionally, providers may make capital and capacity investments that could pose challenges to withdrawing coverage.
A common theme among some commenters is that, under the MCIT/
R&N final rule as currently written, the evidence used to support FDA clearance or approval of a breakthrough device is not generalizable to the Medicare population since the Medicare population is often not adequately represented in clinical trials.
Commenters noted that existing Medicare coverage paradigms rely on careful consideration of the tradeoffs between benefits and risks for the Medicare population and adequate evidence that demonstrates improved health outcomes. Commenters expressed concerns that devices covered under MCIT would not achieve that standard. Additionally, commenters cited several published studies that noted that approval of many breakthrough devices relied upon intermediate endpoints which do not always translate into real world improved health outcomes. Multiple commenters also pointed out that a major limitation of the MCIT pathway under the MCIT/R&N final rule is that manufacturers are not required or incentivized to conduct clinical trials to generate additional evidence, and contended that it is unlikely that manufacturers will voluntarily choose to do so. Further, the shift of the burden of evidence development entirely to manufacturers undermines CMS ability to support evidence development or establish the coverage criteria for example, provider experience, location of service, availability of supporting services that are central to delivery of high-quality, evidence-based care for devices with insufficient evidence of a health benefit for Medicare patients. An additional delay in the effective date would allow time for CMS to address the evidentiary concerns raised by stakeholders and consider how to better balance the needs of all stakeholders and beneficiaries in particular.
Additionally, there is significant uncertainty surrounding coding and payment for new MCIT devices since these issues were not addressed in the MCIT/R&N final rule. If the MCIT/R&N
final rule goes into effect, we believe there could be confusion and disruption stemming from devices receiving MCIT

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approval without a clear path for appropriate coding and payment. The delay will allow CMS time to ensure the public has a clear understanding of the pathways to coverage, coding, and payment.
Further, the delay gives CMS time to evaluate stakeholders recommendation of whether the reasonable and necessary definition should be a separate rule.
There were a number of stakeholder comments supporting delaying defining reasonable and necessary in regulation. Commenters did not believe a codified definition was necessary or thought the rule could unnecessarily restrict coverage by relying on commercial insurer policies.
Furthermore, the majority of public comments from patient advocates, policy think tanks, health insurance advocates and manufactures did not support including commercial insurer criteria in the definition. Most public comments noted that CMS can and has reviewed commercial policies in recent years as part of a national coverage analysis.
Future rulemaking will provide an opportunity for us to fully consider the significant objections to the rule, and will provide another opportunity for the public to present contrary facts and arguments.
II. Provisions of the Final Rule This final rule would further delay the effective date of the MCIT/R&N final rule until December 15, 2021, to provide CMS an opportunity to address all of the issues raised by stakeholders, especially Medicare patient protections, evidence criteria and lack of coordination between coverage, coding and payment as noted previously. During the delay, we will determine appropriate next steps that are in the best interest of all Medicare stakeholders, and beneficiaries in particular.
This final rule delays the effective date of the January 2021 MCIT/R&N
final rule as specified in the DATES
section of this final rule.
III. Waiver of the 30-Day Delay in Effective Date The Administrative Procedure Act, 5
U.S.C. 553d, and section 1871e1Bi of the Act usually require a 30-day delay in effective date after issuance or publication of a rule, subject to exceptions. The purpose of the 30-day delay is to allow the public to prepare to implement the new final rule. We find good cause to waive the 30-day delay in the effective date because the further extension will maintain the status quo, so the public does not need notice to adjust their
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