Voglio sapere a riguardo di…

khammond on DSKJM1Z7X2PROD with RULES

Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations would be unavailable to subsequent market entrants, thereby paradoxically decreasing innovation and market competition. As a modification to the proposed MCIT rule, some commenters suggested that CMS cover iterative refinements of the same breakthrough device for the duration of the original devices MCIT term. Some commenters also suggested coverage under the MCIT
pathway for similar but unrelated breakthrough and non-breakthrough designated devices of the same type and indication for the balance of the first devices MCIT term. Other commenters proposed that new market entrants that are very similar to a breakthrough device should each receive the full four years of MCIT coverage.
Response: CMS agrees that the MCIT
pathway is likely to promote development and refinement of innovative technologies and support medical advancement. CMS also agrees that iterative refinements of devices are common following FDA market authorization. These often represent material improvements, and Medicare beneficiaries should have access to the improved version of the predicate breakthrough device. In practice, many of these device refinements are market authorized through a supplement to the initial FDA PMA submission and would therefore remain eligible for coverage through the MCIT pathway for the duration of the original devices MCIT
coverage period.
CMS disagrees that the MCIT pathway provides an unfair advantage to a single device, or that it impedes market competition. The FDA defines breakthrough technologies in section 515Bb of the FD&C Act 21 U.S.C.
360e3b as those 1 that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and 2A that represent breakthrough technologies; B for which no approved or cleared alternatives exist; C that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients ability to manage their own care such as through self-directed personal assistance, or establish long-term NCD definition, FDA breakthrough-designated devices address an unmet need, and subsequent devices do not enjoy the same prioritized review process or breakthrough designation because there is an existing approved or cleared alternative. CMS similarly would not
VerDate Sep<11>2014

18:22 Jan 13, 2021

Jkt 253001

extend automatic coverage to subsequent similar devices because there would no longer be an unmet need in the market. Subsequent similar FDA
market-authorized devices will benefit from any evidence generated through MCIT coverage of the predicate device.
Please explain that although not automatically covered under the regulation, contractors could make a favorable coverage decision if a claim is submitted.
Comment: Several commenters requested that CMS include devices that meet the spirit of breakthrough regardless of whether the device applied or received the FDA breakthrough designation. Examples commenters gave were second-to-market or subsequent technologies of the same type, even for the same indication or subsequent-tomarket non-breakthrough designated technologies that fall under the same class or category as the breakthrough technology and approved for the same indication. Commenters stated that competing devices from other manufacturers that are not breakthrough devices could be caught in a precarious limbo, at least for a time. At least one commenter, submitted a description of its device and how it meets the spirit of the FDA breakthrough designation.
Response: If the device meets the eligibility criteria as outlined in 405.603, it is eligible for the MCIT
pathway. Outside of that designation, CMS is not expanding the eligibility for MCIT. We will, of course, consider whether the subsequent devices satisfy the reasonable and necessary criteria if a claim is submitted for review.
Comment: We received comments supporting expansion of MCIT to include diagnostic radiopharmaceuticals, combination drug or devices device or drug-led, drugs, biologics and other technologies. At least one commenter wanted CMS to specifically include pain management and antimicrobial therapies. Another commenter stated that certain cellular and tissue-based wound care products CTPs do not require the traditional FDA PMA, BLA and 510k processes, but rather are regulated by the FDA under Section 361 as HCT/Ps.
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. We received mixed public comments on expanding beyond devices and have determined to finalize the proposed rule which only includes devices that meet the criteria proposed. We need to provide a rationale not to extend automatic
PO 00000

Frm 00047

Fmt 4700

Sfmt 4700

2999

coverage further in light of the language in the Executive Order. We dont provide reasons to support the conclusion.
Comment: A few commenters requested that CMS include screening tests and preventive screening tests.
Response: Screening and prevention tests have a unique statutory authorities and are not covered based on 1862a1A. These items and services fall outside the scope of this rule.
Medicare has separate regulations for screening and preventive services that have been codified primarily in 42 CFR
part 410, subpart B.
Comment: We had several commenters request CMS to create new benefit categories or make a determination that an item or service e.g., software, digital technologies falls within a benefit category.
Response: Decisions regarding specific items and services and the relevant benefit categories are outside the scope of this rule. For more information on benefit category determinations see the CMS Innovators Guide to Navigating Medicare https
www.cms.gov/medicare/coverage/
councilontechinnov/downloads/
innovators-guide-master-7-23-15.pdf.
Comment: The Executive Order was interpreted too narrow. The commenter stated that MCIT should not be tied to the FDA breakthrough device definition but should include other CMSrecognized innovative non-breakthrough technologies e.g., technologies eligible for New Technology Add-on Payment or Transitional Pass-through Payment. To aid in operationalizing this, commenter recommend that CMS consider preventing MACs from denying coverage of innovative nonbreakthrough technologies that meet predetermined criteria.
Response: At this time, CMS will finalize its proposed definition of 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. We received mixed public comments on expanding beyond devices and have determined to finalize the proposed rule which only includes devices. At this time, MACs retain the ability to make coverage determinations through current processes of either an LCD or claim by claim adjudication.
Comment: Commenters requested that MCIT include IDEs involving breakthrough devices.
Response: Investigation Device Exemptions IDEs are devices defined at 42 CFR 405 Subpart B. IDE devices
E:FRFM14JAR1.SGM

14JAR1