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Federal Register / Vol. 86, No. 9 / Thursday, January 14, 2021 / Rules and Regulations 39 U.S.C. 3012dMisleading References to the United States Government; Sweepstakes and Deceptive Mailings Persons may be liable to the United States for a civil penalty under 39 U.S.C.
3012d for sending certain deceptive mail matter described in 39 U.S.C.
3001hk, including:
Solicitations making false claims of Federal Government connection or approval;
Certain solicitations for the purchase of a product or service that may be obtained without cost from the Federal Government;
Solicitations containing improperly prepared facsimile checks; and Certain solicitations for skill contests and sweepstakes sent to individuals who, in accordance with 39
U.S.C. 3017d, have requested that such materials not be mailed to them.
Currently, under the implementing regulations, this penalty is not to exceed $14,791 for each mailing. The new penalty will be $14,966.
39 U.S.C. 3017g2Commercial Use of Lists of Persons Electing Not To Receive Skill Contest or Sweepstakes Mailings Under 39 U.S.C. 3017g2, the Postal Service may impose a civil penalty against a person who provides information for commercial use about individuals who, in accordance with 39
U.S.C. 3017d, have elected not to receive certain sweepstakes and contest information. Currently, this civil penalty may not exceed $2,957,993 per violation, pursuant to the implementing regulations. The new penalty may not exceed $2,992,956 per violation.

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39 U.S.C. 3017h1AReckless Mailing of Skill Contest or Sweepstakes Matter Currently, under 39 U.S.C.
3017h1A and its implementing regulations, any promoter who recklessly mails nonmailable skill contest or sweepstakes matter may be liable to the United States in the amount of $14,791 per violation for each mailing to an individual. The new penalty is $14,966 per violation.
39 U.S.C. 3018c1AHazardous Material Under 39 U.S.C. 3018c1A, the Postal Service may impose a civil penalty payable into the Treasury of the United States on a person who knowingly mails nonmailable hazardous materials or fails to follow postal laws on mailing hazardous materials.
Currently, this civil penalty is at least $320, but not more than $127,525 for
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each violation, pursuant to the implementing regulations. The new penalty is at least $324, but not more than $129,032 for each violation.
List of Subjects in 39 CFR Part 233
Administrative practice and procedure, Banks, Banking, Credit, Crime, Infants and children, Law enforcement, Penalties, Privacy, Seizures and forfeitures.
For the reasons set out in the preamble, the Postal Service amends 39
CFR part 233 as follows:
PART 233INSPECTION SERVICE
AUTHORITY
1. The authority citation for part 233
continues to read as follows:

Authority: 39 U.S.C. 101, 102, 202, 204, 401, 402, 403, 404, 406, 410, 411, 1003, 3005e1, 3012, 3017, 3018; 12 U.S.C. 3401
3422; 18 U.S.C. 981, 983, 1956, 1957, 2254, 3061; 21 U.S.C. 881; Pub. L. 101410, 104
Stat. 890 28 U.S.C. 2461 note; Pub. L. 104
208, 110 Stat. 3009; Secs. 106 and 108, Pub.
L. 106168, 113 Stat. 1806 39 U.S.C. 3012, 3017; Pub. L. 11474, 129 Stat. 584.
233.12

Amended
2. In 233.12:
a. In paragraph a, remove $73,951
and add in its place $74,825, remove $147,899 and add in its place $149,647, remove $14,791 and add in its place $14,966, and remove $2,957,993 and add in its place $2,992,956.
b. In paragraph b, remove $36,975
and add in its place $37,412, remove $73,951 and add in its place $74,825, remove $7,395 and add in its place $7,482, and remove $1,478,996 and add in its place $1,496,478.
c. In paragraph c4, remove $14,791 and add in its place $14,966.
d. In paragraph d, remove $2,957,993 and add in its place $2,992,956.
e. In paragraph e, remove $14,791
and add in its place $14,966.
f. In paragraph f, remove $320 and add in its place $324 and remove $127,525 and add in its place $129,032.

Joshua Hofer, Attorney, Federal Compliance.
FR Doc. 202100447 Filed 11321; 8:45 am BILLING CODE 771012P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid Services 42 CFR Part 405
CMS3372F
RIN 0938AT88

Medicare Program; Medicare Coverage of Innovative Technology MCIT and Definition of Reasonable and Necessary Centers for Medicare &
Medicaid Services CMS, HHS.
ACTION: Final rule.
AGENCY:

This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration FDA. The Medicare Coverage of Innovative Technology MCIT pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2
years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862a1A of the Social Security Act the Act for items and services that are furnished under Part A and Part B.
DATES: This final rule is effective on March 15, 2021.
FOR FURTHER INFORMATION CONTACT:
Tamara Syrek Jensen and JoAnna Baldwin, 410 7862281 or CAGinquiries@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:

I. Background The Department is committed to ensuring Medicare beneficiaries have access to new cures and technologies that improve health outcomes. Section 6
of the October 3, 2019 Executive Order 13890 E.O. 13890 Executive Order on Protecting and Improving Medicare for Our Nations Seniors, 1 directs the Secretary to propose regulatory and sub-regulatory changes to the Medicare program to encourage innovation for patients including by streamlining the approval, coverage, and coding process.2 The E.O. 13890 explicitly 1 Executive Order on Protecting and Improving Medicare for Our Nations Seniors, available at https www.whitehouse.gov/presidential-actions/
executive-order-protecting-improving-medicarenations-seniors/.
2 Id.

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