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Federal Register / Vol. 86, No. 94 / Tuesday, May 18, 2021 / Rules and Regulations and effectiveness requirements for its approved or cleared indications for use may not be able to answer questions such as the following:
Does the benefit differ for older and/or frailer patients with specific comorbidities?
Are clinician experience or facility requirements needed to ensure good health outcomes or to prevent certain harms in those patients?
These guidelines and recommendations have often been part of NCDs, but were not included in the MCIT policy. When making NCDs, CMS
sometimes develops clinician and institutional requirements after careful review of expert physicians specialty society guidelines and clinical study results. Additional rulemaking may provide a further opportunity for the public to opine on whether these types of restrictions are needed when covering breakthrough devices.
Comment: Manufacturers acknowledged the need to develop evidence to achieve long-term coverage, and many indicated their intent to develop real world evidence RWE.
Some stated that MCIT would incentivize manufacturers to develop RWE following market authorization and sought guidance from CMS on desired elements.
Response: Whether evidence development is voluntary or required for coverage, we value manufacturer, CMS, and FDA coordination on RWE
development for coverage and/or postmarket studies. Establishing the RWE
guidance sought by manufacturers and some physicians would be beneficial and that further stakeholder engagement would best inform the guidance. CMS
has multiple pathways to facilitate engagement such as the Medicare Evidence Development and Coverage Advisory Committee MEDCAC and the public input process through the Federal Register. We are also receptive to informal engagement with stakeholders, including with manufacturers who pursue this evidence development approach. We are aware that best practices for RWE
generation are in development by some stakeholders. However, when a device receives breakthrough designation by the FDA, there is currently no clinical study requirement for marketauthorization that Medicare patients must be included. Without relevant Medicare data, including RWE, under the MCIT/R&N final rule, CMS may be covering devices with no data demonstrating that Medicare patients will not be harmed or will benefit from the device. Currently, when CMS sees a trend indicative of a potentially harmful
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device, we are sometimes able to deny coverage through Medicare Administrative Contractors. Under the MCIT/R&N final rule, this authority has been removed as we may only remove a breakthrough device from the MCIT
coverage pathway for limited reasons, including if FDA issues a safety communication, warning letter, or removes the device from the market.
Further, under the current final rule, if CMS is seeing a trend of higher risk specifically in the Medicare population, CMS authority with respect to coverage for Medicare determinations is limited without an FDA action, which would not just take the Medicare population experience into account. That is, the FDAs review of devices is for the entirety of the intended patient population rather than within the narrower Medicare population.
Comment: Some stakeholders continued to express concern that reliance on breakthrough designation ceded decision-making authority on what is reasonable and necessary for Medicare patients to an FDA decision very early in the product lifecycle. A
number of physician commenters with experience in clinical evidence noted a number of compelling evidentiary concerns, including their assertion that the MCIT policy is flawed because of a lack of evidence that breakthroughs benefit Medicare beneficiaries. One manufacturer suggested that pivotal studies should have to demonstrate patient benefit in the Medicare population in order to obtain MCIT
coverage.
Response: The FDA criteria to determine whether a device is designated as a breakthrough is different from the criteria and evidence CMS
reviews to determine appropriateness for the Medicare population. The FDA
does not routinely require data on Medicare patients. The relevant data is key for Medicare national coverage decision-making to ensure that Medicare is paying for devices that are beneficial to Medicare patients. While the goal of the MCIT/R&N final rule was to expedite coverage to speed access to innovative treatments, the immediacy of coverage must be balanced with ensuring that the Medicare program is covering appropriate devices for the Medicare population. Without any data or minimal clinical data to make this determination, it is challenging to ensure that breakthrough devices are beneficial to the Medicare population.
We will further consider public comments seeking modifications to MCIT that might allow for expedited coverage while seeking to ensure devices are safe for Medicare patients
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even when those breakthrough devices do not have an evidence base that is generalizable to Medicare beneficiaries.
Comment: Medical specialty societies also sought modifications to the MCIT/
R&N final rule regarding evidence development, specifically the addition of RWE requirements and a clarification of CMS CED authorities. Commenters specifically recommended post market studies, data collection, and recommended CED as a potential pathway to address uncertainty in health outcomes. In lieu of MCIT, commenters recommended using the Parallel Review program for devices with a broad evidence base and a CED
for devices with a developing evidence base.
Response: We appreciate these comments and refer to our earlier responses addressing similar issues regarding evidence development and RWE-related comments. CED has been utilized for many years to allow beneficiary access while simultaneously fostering evidence development. The public comments suggest there is an interest in additional guidance on CED.
Knowing where there are gaps in clinical evidence for a device or type of devices is a preliminary question asked and researched by CMS and FDA. This gap analysis with respect to the Medicare reasonable and necessary criteria is a precursor to CED parameters for a given item or service. We are aware that manufacturers are interested in more input from CMS on what evidence needs to be developed for coverage, including a discussion of the gap analysis. Based on the comments from manufacturers that indicated they were already developing or would develop evidence following market authorization, we believe there is also interest in coordination with CMS to create an evidence development plan that is fit-for-purpose in line with manufacturer coverage goals to ensure that Medicare patients are protected.
Comment: Several health plans participating in Medicare Advantage MA and their advocacy associations submitted comments that raised concerns with the MCIT/R&N final rule.
Associations specifically indicated that the final rule should be rescinded and not implemented. In general, they recommend post market data collection and use of existing coverage pathways.
One health plan noted several concerns for the MA plans if the MCIT/R&N final rule is implemented specific to bids and plan payment rates and related downstream effects for beneficiaries such as increased out of pocket costs, fewer benefits, and perhaps even fewer plan offerings.

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