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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
are not FDA market authorized or cleared often referred to as premarket devices. Any IDE device FDAdesignated as breakthrough device is eligible for MCIT when it is FDA
authorized for marketing The MCIT
pathway begins no earlier than the date the breakthrough device receives FDA
market authorization, or the date requested by the manufacturer, provided the requested date is within the four year window for MCIT
eligibility.
Comment: CMS should continue working to expand to a wider range of innovative medical devices outside of breakthrough designation.
Response: We appreciate the comment. CMS continues to review its coverage pathways to find appropriate efficiencies.
Comment: CMS should expand MCIT
to include humanitarian use devices.
Commenter asserted they approved through an FDA expedited program to get technology to patients with rare conditions.
Response: At this time, we are not expanding the MCIT pathway beyond the proposed rule. This includes any medical device that receives such designation by the FDA section 515Bd1 of the FD&C Act 21 U.S.C.
360e3d1 and meets the other criteria outlined in this rule is eligible for the MCIT pathway.
Comment: If CMS chooses to retain the fifth criteria proposed in Section 405.603e, then we would ask that the agency clarify that ineligibility is tied to an absolute national non-coverage determination.
Response: Upon receiving notification by a manufacturer of interest in MCIT, CMS will determine if there is an existing NCD on point. While possible, it is unlikely that there is pre-existing, explicit non-coverage NCD given the breakthrough nature of eligible devices.
Comment: Patient preference should be considered when qualifying devices for MCIT. Commenter gave the example of non-invasive medical devices including focused ultrasound that may be strongly preferred by patients.
Response: Any medical device that receives such designation by the FDA
section 515Bd1 of the FD&C Act 21
U.S.C. 360e3d1 and meets the other criteria outlined in this rule is eligible for the MCIT pathway. FDA takes patient preference under consideration as they make market authorization decisions.
After consideration of the public comments we received, we are finalizing our proposed definition of breakthrough devices.

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2. MCIT Pathway Device Eligibility In 405.603a we proposed that the pathway is available to devices that meet the definitions proposed in 405.601. Based on the explicit mention of devices in E.O. 13890 and our interaction and feedback from stakeholders who expressed their concern that there is more uncertainty of coverage for devices than for other items and services for example, diagnostics, drugs and biologics, the proposed policy is for devices only.
We proposed in 405.603b that the breakthrough devices that received FDA
market authorization no more than 2
calendar years prior to the effective date of this subpart the date the final rule is finalized and thereafter will be eligible for coverage for claims submitted on or after the effective date of this rule.
Claims for breakthrough devices with dates of service that occurred before the effective date of this rule will not be covered claims through MCIT.
Breakthrough devices market authorized prior to the effective date of this rule will not be eligible for all 4 years of coverage. For these lookback devices, the 4-year period starts on the date of FDA market authorization. We proposed that if a manufacturer initially chooses to not utilize the MCIT pathway, and then chooses to do so some time after the breakthrough devices market authorization, coverage still only lasts 4
years from the date of FDA market authorization. We sought comment on this eligibility criterion for devices and specifically the 2 year lookback.
Comment: Almost all commenters were supportive of a lookback period.
Many agreed with a two year interval.
A few commenters suggested a four year lookback or unlimited to the start of the Breakthrough Devices Program.
Response: We appreciate the comments. We proposed a two year lookback to try to maximize the benefit of the MCIT rule. We believe this interval includes the recent period that presented the greatest initial confusion and uncertainty for manufacturers of innovative devices before the MCIT
rule. We agree with commenters that the lookback period is important to launch the rule with highest impact.
Considering comments, we believe that a two year lookback remains appropriate and maintains efficiency at start up. For breakthrough devices older than 2 years, it is possible that other coverage pathways such as LCDs or NCDs may have been developed and coverage concerns have been addressed. Potential overlap of coverage policies would hinder implementation. In addition, the majority of breakthrough devices were
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approved in the past 2 years since the program was authorized in 2017 final agency guidance issued in December 2018 available at: https www.fda.gov/
media/108135/download. We note that the lookback period is a one-time occurrence since there will not be a need for a lookback period for breakthrough devices approved going forward once the MCIT rule is effective.
We proposed in 405.603c that to be part of the MCIT pathway, the device must be used according to its FDA
approved or cleared indication for use.
We proposed that the device is only covered for use consistent with its FDA
approved or cleared indication for use because that is the indication and conditions for use that were reviewed by the FDA and authorized for marketing. Data are unlikely to be available to support uses extending beyond the FDA required labeling for breakthrough devices on the date of marketing authorization. Use of the device for a condition or population that is not labeled off-label will not be covered as that use would not be FDA
authorized. We specifically sought comment on whether off-label use of breakthrough devices should be covered and, if so, under what specific circumstances and/or evidentiary support.
Comment: Most commenters agreed with the inclusion of the FDA required indication. A number of commenters noted that off indication or off label uses should be included under MCIT as well.
Some commenters raised concern for on-indication use of breakthrough devices because the devices are so new to market.
Response: We appreciate the comments. Consistent with the breakthrough device designation, we specified the FDA required indication on-indication for MCIT. We did not specifically provide automatic coverage for off-indication or off-label uses in the proposed MCIT rule, but we do not preclude possible coverage under other coverage mechanisms, such as through the claims process. However, we note that in general there is typically little clinical evidence to support off-label uses of new technology. We are aware that concerns for on-indication use of breakthrough devices were reiterated in recent published articles Neumann and Chambers. Health Affairs, 12/02/2020;
Bach. New York Times, 12/01/2020.
Comment: Commenters noted that the FDA label indication only is not sufficient since other factors have important roles in determining positive outcomes from device therapy such as physician training and experience and facility capabilities and experience.

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