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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations
innovative devices that FDA has found to be safe and effective, and we believe are reasonable and necessary for purposes of Medicare coverage.
In light of E.O. 13890, the Secretary has determined that application of the current standards for making reasonable and necessary determinations may take too long following FDA market authorization of breakthrough devices. More importantly, the existing standard has not always provided Medicare beneficiaries access to certain breakthrough medical devices when needed to improve health outcomes. We proposed that breakthrough devices per se meet the reasonable and necessary standard in order to increase access and to reduce the delay from FDA market authorization to Medicare coverage.
Comment: We received a few comments supporting that FDAdesignated breakthrough devices should meet the reasonable and necessary definition under the MCIT pathway.
Response: We appreciate the comments. Under the Secretarys authority to interpret section 1862a1A of the Act supra section I.A., we are revising our interpretation, we are finalizing this rule as proposed, FDA-designated breakthrough devices are considered reasonable and necessary for purposes of MCIT.
Comment: We received a comment that stated reasonable and necessary should apply to any FDA breakthrough device regardless of entry into MCIT.
Response: We disagree, qualification as a breakthrough device, as defined in section 515Bb of the Food, Drug and Cosmetic Act 21 U.S.C. 360e3b is sufficient to satisfy the elements of the reasonable and necessary standard.
The first breakthrough device designation criterion is that a device must provide for more effective treatment or diagnosis of lifethreatening or irreversibly debilitating human disease or conditions 21 U.S.C.
360e3b1. The second criterion is that the device must satisfy one of the following elements: It represents a breakthrough technology; there are no approved or cleared alternatives; it offers significant advantages over existing approved or cleared alternatives, including additional considerations outlined in the statute; or availability of the device is in the best interest of patients 21 U.S.C. 360e 3b2. Thus, breakthrough devices are those that HHS has determined may provide better health outcomes for patients facing life-threatening or irreversibly debilitating human disease or conditions. We believe that a device meeting these criteria, once also FDA

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market authorized, is reasonable and necessary for purposes of Medicare coverage.
Comment: Commenters expressed concern that MCIT eligibility will be based on commercial payer policies.
Response: MCIT eligibility is not based on commercial payer policies. It is solely based on the eligibility criteria outlined in the rule.
Final Action: After consideration of the public comments we received, we are finalizing this policy as proposed.
C. MCIT Pathway We proposed the MCIT pathway to deliver on the Administrations commitment to provide access to breakthrough devices to Medicare beneficiaries. The MCIT pathway provides up to 4 years of national coverage to newly FDA market authorized breakthrough devices. We are aware that this coverage may also facilitate evidence development on devices for the Medicare population because manufacturers can gather additional data on utilization of the device during the MCIT coverage period.
1. Definitions In 405.601a, we proposed that the MCIT pathway is voluntary.
Operationally, we proposed that manufacturers of breakthrough devices notify CMS of their intention to elect MCIT shortly after receiving notice from the FDA of being granted the breakthrough device designation.
Ideally, this notification would be sent to CMS within 2 weeks of receiving breakthrough designation. However, entities will not be penalized for notifying CMS after that time.
Alternatively, submitting a notification to CMS shortly before or concurrently with the date of the FDA marketing application submission should also afford CMS sufficient time to operationalize MCIT for the device. The CMS Coverage and Analysis Group would establish an email box for these inquiries and notification. This notification alerts CMS to offer guidance to manufacturers about the MCIT
pathway and point to resources for coding and payment, which are key conversations to effectuate coverage upon FDA market authorization. We intend to utilize the existing coverage implementation processes to be prepared to offer coverage immediately upon the FDA market authorization when requested by the manufacturer.
In 405.601b, we proposed the following definitions for the purposes of 42 CFR part 405. We proposed to define breakthrough device as a medical
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device that receives such designation by the FDA section 515Bd1 of the FD&C Act 21 U.S.C. 360e3d1. We also proposed to define, for the sake of clarity in the rule that the acronym MCIT stands for Medicare Coverage of Innovative Technology.
Comment: We received a few comments requesting that we not finalize MCIT and do not include drugs and biologics until there is evidence of a gap in coverage. The commenters suggested including drugs and biologics would require separate rulemaking and need to consider other FDA pathways e.g., accelerated approval, priority review vouchers, orphan drug designation.
Response: The final MCIT rule will not include drugs or biologics. The final rule will only include FDA-designated breakthrough devices as defined by the FDA section 515Bd1 of the FD&C
Act 21 U.S.C. 360e3d1.
Comment: We received several comments that support the definition of breakthrough devices. These comments stated that it allows Medicare to focus resources and seems to be a reasonable filter to prevent overutilization of the pathway.
Response: We appreciate the comment.
Comment: We received several comments requesting clarification of whether FDA-designated breakthrough devices that are clinical diagnostic lab tests or non-implanted devices are considered eligible for the MCIT
pathway.
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. This includes any clinical lab diagnostic test, including in-vitro diagnostics, and devices that are not implanted, as long as it meets the MCIT eligibility criteria as outlined at 405.603.
Comment: Some commenters stated that the greater predictability afforded by the MCIT pathway would decrease reimbursement risk and increase both manufacturer and investor interest in developing new and innovative therapies. Several commenters stated that investors perceive reimbursement risk as a greater threat to innovation than technology, regulatory, or clinical risks. Some commenters asserted that the MCIT pathway would make it easier for innovators to raise funds necessary for development and refinement of new technologies e.g., artificial kidney.
However, some commenters argued that the MCIT pathway could give specific technologies an unfair advantage that
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