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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
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After consideration of the public comments we received, we are finalizing this section of the proposed rule with only a minor textual clarification to also include reasonable and necessary procedures to use the breakthrough device. The proposed text stated only reasonable and necessary procedures to implant the device, which would not be representative of the universe of breakthrough devices.
4. MCIT Pathway for Breakthrough Devices: 4 Years of Coverage In 405.607a, we proposed that the MCIT pathway for coverage would begin on the same date the device receives FDA market authorization. We proposed this point in time to ensure there is no gap between Medicare coverage and FDA market authorization. This start date supported the MCIT pathways focus of ensuring beneficiaries have a predictable access to new devices.
Comment: CMS proposed that MCIT
coverage would start on the day of FDA
approval of the breakthrough device and last for 4 years. Several commenters supported the MCIT start date as proposed on the day of FDA approval.
A number of other commenters recommend flexibility in the start date to be determined by the manufacturer since the breakthrough device may not be immediately available in the market on the date of FDA approval.
Commenters noted that flexibility would allow the manufacturer time to be fully prepared for device dissemination with set coding, payment, and evidence development if the manufacturer voluntarily chooses.
Response: We appreciate comments and agree. We recognize that not all breakthrough devices may be immediately available in the market on date of FDA approval due to various factors including production, large scale distribution, and coding. We have modified and, in the final rule, will include flexibility in the start date of MCIT to be determined by the manufacturer within certain parameters.
We note that regardless of the date the manufacturer selects to begin MCIT
coverage, they are eligible only during the four year period beginning on the date of FDA market authorization.
Therefore, if a manufacturer waits one year after receiving FDA approval to request MCIT coverage of an item or service, the relevant item or service will have three years of coverage under MCIT. For implementation purposes, manufacturers must inform CMS of the desired future start date. We believe that the clarity and transparency of MCIT
will assist manufacturers in developing product development and deployment
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plans earlier so the 4 years of MCIT can be used more efficiently.
While we believe it is in the best interest of the manufacturer to invoke MCIT coverage early in the 4-year coverage period there may be breakthrough devices that can achieve the desired level of evidence development in less time. Because the time period for evidence development is dependent on the nature of the device and the disease or clinical condition for which it is intended we are comfortable with manufacturers electing their MCIT
coverage start date within the parameters outlined above. We further believe that it is counterintuitive for a breakthrough device manufacturer to opt-into MCIT coverage toward the end of the 2-year opt-in window. However, manufacturers have expressed interest in this type of flexibility and CMS is not in a position to predict the various reasons a manufacturer may find themselves in a position of needing to wait to opt-in.
Comment: Commenters noted the potential time delays from coverage, coding, and payment.
Response: We appreciate the comments and agree that enhanced coordination of coverage, coding and payment would be useful. While a detailed description of coding and payment is beyond the scope of the MCIT rule and resides in other payment rules, CMS, as directed by E.O. 13890, has worked to streamline coverage, coding, and payment. We have established new collaborations internally to enhance efficiency going forward.
We proposed in 405.607b1 that the MCIT pathway for breakthrough devices ends 4 years from the date the device received FDA market authorization. We proposed this 4 year time period because it could allow manufacturers to develop clinical evidence and data regarding the benefit of the use of their device in a real world setting. For example, we believe 4 years would allow most manufacturers sufficient time to complete FDA
required post-approval or other realworld data collection studies that may have been a condition of FDA market authorization. This assumption is based upon our historical experience with studies conducted through coverage with evidence development CED.
Many of these studies were completed within approximately 4 years. Further, this time period allows Medicare to support manufacturers that, whether required by the FDA or not, have an interest in better understanding the health outcomes of their device in the Medicare population, including impacts
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on patient-reported and longer-term outcomes.
Further, in 405.607b we proposed reasons that the MCIT pathway may end prior to 4 years. This included circumstances whereby the device became subject to an NCD, regulation, statute, or if the device could no longer be lawfully marketed.
Comment: Most commenters were supportive of the four year period. Some commenters suggested longer duration up to 5 years at CMS discretion or if the manufacturer is actively conducting a clinical study.
Response: We appreciate the comments and believe the 4 year duration of MCIT continues to be an adequate time period to foster innovation. We recognize the importance of continuing data collection and evidence development but have not mandated evidence development. We believe, with the transparency of MCIT, that manufacturers will be able to appropriately plan studies that could be completed within 4 years. In general evidence on improvements in health outcomes for Medicare patients not only would help support coverage through other mechanisms after MCIT but also importantly help physicians and patients in choosing the treatment that is best suited for the individual patient.
Comment: A large number of respondents supported voluntary evidence development. Many commenters noted that the FDA already requires post market-authorization data collection in most cases. Many commenters argued that manufacturers should discuss their evidence development plans with CMS soon after FDA market-authorization. CMS, in turn, should be clear and transparent about any evidence gaps and any additional evidence needed to reach the reasonable and necessary threshold required for durable coverage after MCIT coverage ends. Commenters suggested that CMS be more flexible in agreeing to acceptable study designs and outcomes, including use of real world data. Commenters stated that manufacturers already have considerable incentive to meet the reasonable and necessary standard to assure coverage continuity after MCIT.
Some commenters objected to a onesize-fits-all mandate for evidence development noting a diversity of devices come through the FDA
breakthrough program. They argued that a voluntary evidence development regime allows flexibility for manufacturers to manage their own clinical study and evidence
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