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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations continue to work with their patients to choose the best treatment. For small rural hospitals that provide breakthrough devices to their patients, this proposed rule is a means for the device to be covered through the Medicare program.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995
dollars, updated annually for inflation.
In 2020, that threshold was approximately $156 million. This final rule would have no consequential effect on State, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule and subsequent final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications.
Since this final rule does not impose any costs on State or local governments, the requirements of Executive Order 13132 are not applicable.
Executive Order 13771 E.O. 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. The proposed rule, is being finalized as proposed, and is expected to impose no more than de minimis costs and thus be neither an E.O. 13771 regulatory action nor an E.O. 13771 deregulatory action.
In accordance with the provisions of Executive Order 12866, this final rule was reviewed by the Office of Management and Budget.
List of Subjects in 42 CFR Part 405
Administrative practice and procedure, Diseases, Health facilities, Health professions, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
For the reasons set forth in the preamble, the Centers for Medicare &
Medicaid Services amends 42 CFR
chapter IV as set forth below:
PART 405FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
1. The authority for part 405
continues to read as follows:

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Authority: 42 U.S.C. 263a, 405a, 1302, 1320b12, 1395x, 1395ya, 1395ff, 1395hh, 1395kk, 1395rr, and 1395wwk.

2. Section 405.201 is amended in paragraph b by adding a definition for Reasonable and necessary in alphabetical order to read as follows:

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405.201 Scope of subpart and definitions.

b
Reasonable and necessary means that an item or service is considered i Safe and effective;
ii Except as set forth in 411.15o of this chapter, not experimental or investigational; and iii Appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it meets all of the following criteria:
A Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patients condition or to improve the function of a malformed body member;
B Furnished in a setting appropriate to the patients medical needs and condition;
C Ordered and furnished by qualified personnel;
D Meets, but does not exceed, the patients medical need; and E Is at least as beneficial as an existing and available medically appropriate alternative; or F Not later than March 15, 2022, CMS will issue draft subregulatory guidance on the methodology of which commercial insurers are relevant based on the measurement of majority of covered lives. For national and local coverage determinations, which have insufficient evidence to meet paragraphs b3i through v of this section, CMS
will consider coverage to the extent the items or services are covered by a majority of commercial insurers. As part of CMS consideration, CMS will include in the national or local coverage determination its reasoning for its decision if coverage is different than the majority of commercial insurers.

3. Subpart F, consisting of 405.601
405.607, is added to read as follows:
Subpart FMedicare Coverage of Innovative Technology Sec.
405.601 Medicare coverage of innovative technology.
405.603 Medical device eligibility.
405.605 Coverage of items and services.
405.607 Coverage period.

Subpart FMedicare Coverage of Innovative Technology 405.601 Medicare coverage of innovative technology.

a Basis and scope. Medicare coverage of innovative technology MCIT is a program that provides national, time-limited coverage under
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section 1862a1A of the Act for certain breakthrough medical devices.
Manufacturer participation in the pathway for breakthrough device coverage is voluntary.
b Definitions. For the purposes of this subpart, the following definitions are applicable:
Breakthrough device means a device that receives such designation by the Food and Drug Administration FDA
section 515Bd1 of the FD&C Act 21
U.S.C. 360e3d1.
MCIT stands for Medicare coverage of innovative technology.
405.603

Medical device eligibility.

The MCIT pathway is available only to medical devices that meet all of the following:
a That are FDA-designated breakthrough devices.
b That were FDA market authorized on Enter date 2 years prior to effective date of final rule and thereafter.
c That are used according to their FDA approved or cleared indication for use.
d That are within a Medicare benefit category.
e That are not the subject of a Medicare national coverage determination.
f That are not otherwise excluded from coverage through law or regulation.
405.605

Coverage of items and services.

Covered items and services furnished within the MCIT pathway may include any of the following, if not otherwise excluded from coverage and according to existing coverage and/or payment policies as applicable:
a The breakthrough device.
b Any reasonable and necessary procedures to implant and/or use the breakthrough device.
c Reasonable and necessary items and services to maintain the breakthrough device.
d Related care and services for the breakthrough device.
e Reasonable and necessary services to treat complications arising from use of the breakthrough device.
405.607

Coverage period.

a Start of the period. The MCIT
pathway begins on the date requested by the manufacturer in an email to CMS at any time opting in to the MCIT pathway provided the requested start date is no earlier than 1 The date the breakthrough device receives FDA market authorization; or 2 The date requested by the manufacturer, provided that such a date is not later than 2 years after the date
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