Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Delayed Effective Date
| Citation | 86 FR 10181 |
| Record Number | 2021-03167 |
| Published date | 19 February 2021 |
| Section | Rules and Regulations |
| Court | Inspector General Office |
10181
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Rules and Regulations
1
The effective date of the amendments to 42 CFR
1001.952 (h)(6) through (9), (cc), and (dd) published
at 85 FR 76666, November 30, 2020, was
subsequently delayed until March 22, 2021. 86 FR
7815 (Feb. 2, 2021).
2
Pharmaceutical Care Management Association
v. United States Department of Health & Human
Services et al., No. 1:21–cv–00095 (D. DC. filed Jan.
12, 2021).
3
Pharmaceutical Care Management Association
v. United States Department of Health & Human
Services et al., No. 1:21–cv–00095 (D. DC Jan. 30,
2021)) (order granting joint stipulation and
postponing effective date), Doc. No. 19.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1001
RIN 0936–AA08
Fraud And Abuse; Removal of Safe
Harbor Protection for Rebates
Involving Prescription
Pharmaceuticals and Creation of New
Safe Harbor Protection for Certain
Point-of-Sale Reductions in Price on
Prescription Pharmaceuticals and
Certain Pharmacy Benefit Manager
Service Fees; Delayed Effective Date
AGENCY
: Office of Inspector General
(OIG), Health and Human Services
(HHS).
ACTION
: Final rule; notification of court-
ordered delay of effective date.
SUMMARY
: As required by an order
issued by the U.S. District Court for the
District of Columbia, this action
provides notice of the delay of the
effective date of certain amendments to
the safe harbors to the Federal anti-
kickback statute that were promulgated
in a final rule (‘‘Fraud And Abuse;
Removal of Safe Harbor Protection for
Rebates Involving Prescription
Pharmaceuticals And Creation of New
Safe Harbor Protection for Certain Point-
of-Sale Reductions in Price on
Prescription Pharmaceuticals and
Certain Pharmacy Benefit Manager
Service Fees’’) published on November
30, 2020. The new effective date for
these certain amendments is January 1,
2023.
DATES
: As of February 19, 2021, this
action delays the published effective
date of the amendments to 42 CFR
1001.952(h)(5) published November 30,
2020, at 85 FR 76666, and corrected at
86 FR 7815, February 2, 2021, until
January 1, 2023.
FOR FURTHER INFORMATION CONTACT
:
Aaron Zajic, (202) 619–0335.
SUPPLEMENTARY INFORMATION
: In the
Federal Register of November 30, 2020,
the Department issued a final rule
establishing four changes to the
regulatory safe harbors to the Federal
anti-kickback statute (Social Security
Act Section 1128B(b)). Specifically, the
final rule (1) amended 42 CFR
1001.952(h)(5) to remove safe harbor
protection for reductions in price for
prescription pharmaceutical products
provided to plan sponsors under Part D;
(2) created a new safe harbor at
§ 1001.952(cc) for certain point-of-sale
reductions in price offered by
manufacturers on prescription
pharmaceutical products that are
payable under Medicare Part D or by
Medicaid managed care organizations
that meet certain criteria; (3) created a
new safe harbor at § 1001.952(dd) for
fixed fees that manufacturers pay to
pharmacy benefit managers (PBMs) for
services rendered to the manufacturers
that meet specified criteria; and (4)
added new paragraphs (6)–(9) to 42 CFR
1001.952(h), defining certain terms. The
final rule was published with an
effective date of January 29, 2021,
except for the amendments to 42 CFR
1001.952(h)(5), which were to be
effective on January 1, 2022.
1
On January 12, 2021, a lawsuit
challenging the final rule was filed in
the U.S. District Court for the District of
Columbia.
2
On January 30, 2021, the
Court issued an order postponing until
January 1, 2023 the effective date of all
provisions of the final rule that were
scheduled to take effect on January 1,
2022.
3
Consistent with that order, the
Department is taking this action to
notify the public that the effective date
of the amendments to paragraph 42 CFR
1001.952 (h)(5) in the final rule is now
January 1, 2023. Pursuant to the court
order, any obligation to comply with a
deadline tied to the effective date of
these amendments is similarly
postponed, and those obligations and
deadlines are now tied to the postponed
effective date.
To the extent that 5 U.S.C. 553 applies
to this action, implementation of this
action without opportunity for public
comment is based on the good cause
exception in 5 U.S.C. 553(b)(B). Seeking
public comment is impracticable,
unnecessary, and contrary to the public
interest. The one-year postponement of
the effective date, until January 1, 2023,
is required by court order in accordance
with the court’s authority to postpone a
rule’s effective date pending judicial
review (5 U.S.C. 705). Seeking prior
public comment on this postponement
would have been impracticable, as well
as contrary to the public interest in the
orderly issue and implementation of
regulations.
Norris Cochran,
Acting Secretary.
[FR Doc. 2021–03167 Filed 2–18–21; 8:45 am]
BILLING CODE P
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Parts 0, 1, 27, 90
[ET Docket No. 18–295; FCC 20–51; WT
Docket No. 17–200; FCC 20–67, FRS 17383]
Unlicensed Use of the 6 GHz Band;
Review of the Commission’s Rules
Governing the 896–901/935–940 MHz
Band
AGENCY
: Federal Communications
Commission.
ACTION
: Final rule; announcement of
compliance date.
SUMMARY
: In this document, the
Commission announces that the Office
of Management and Budget has
approved the information collection
requirements associated with the rules
and policies adopted in the Federal
Communications Commission’s 6 GHz
Report and Order, FCC 20–51, making
1,200 megahertz of spectrum in the 6
GHz band (5.925–7.125 GHz) available
for unlicensed use, and 900 MHz Report
and Order, FCC 20–67, establishing
rules for broadband license operations
in the 897.5–900.5/936.5–939.5 MHz
segment of the 900 MHz band (896–901/
935–940 MHz), and that compliance
with the new requirements is now
required.
DATES
: Compliance date: Compliance
with 47 CFR 27.1503 and 27.1505,
published at 85 FR 43124 on July 16,
2020, is required on February 19, 2021.
FOR FURTHER INFORMATION CONTACT
:
Jaclyn Rosen, Mobility Division,
Wireless Telecommunications Bureau,
at (202) 418–0154 or Jaclyn.Rosen@
fcc.gov.
SUPPLEMENTARY INFORMATION
: This
document announces that the Office of
Management and Budget (OMB)
approved the information collection
requirements in 47 CFR 27.1503(b)(1),
(b)(2), (b)(3), (c)(1) and 47 CFR
27.1505(a), (b), on December 10, 2020.
These rules were adopted in the 6 GHz
Order, FCC 20–51, published at 85 FR
31390 on May 26, 2020, and, 900 MHz
Report and Order, FCC 20–67,
published at 85 FR 43124 on July 16,
2020. Compliance with all new or
amended rules adopted in the 6 GHz
Order that do not require OMB approval
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tkelley on DSKBCP9HB2PROD with RULES
