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; Additional Delayed Effective Date
| Published date | 22 March 2021 |
| Citation | 86 FR 15132 |
| Record Number | 2021-05903 |
| Section | Rules and Regulations |
| Court | Inspector General Office |
15132
Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Rules and Regulations
EPA-A
PPROVED
N
ON
-R
EGULATORY
P
ROVISIONS AND
Q
UASI
-R
EGULATORY
M
EASURES IN THE
A
RKANSAS
SIP—Continued
Name of SIP provision Applicable geographic or
nonattainment area
State
submittal/
effective
date
EPA approval date Explanation
Arkansas 2015 O
3
NAAQS
Interstate Transport SIP
Revision.
Statewide ........................... 10/4/2019 3/22/2021 [Insert Federal
Register citation]. Approval of visibility transport portion of
this interstate transport SIP revision
that addresses CAA section
110(a)(2)(D)(i)(II) for the following
NAAQS: 2006 24-hour PM
2.5
NAAQS;
the 2012 annual PM
2.5
NAAQS; the
2008 and 2015 eight-hour O
3
NAAQS;
the 2010 one-hour NO
2
NAAQS; and
the 2010 one-hour SO
2
NAAQS.
Arkansas Regional Haze
SO
2
and PM SIP Revi-
sion.
Statewide ........................... 8/8/2018 3/22/2021 [Insert Federal
Register citation]. Approval of visibility transport portion of
this regional haze SIP revision, as
supplemented by the Arkansas 2015
O
3
NAAQS Interstate Transport SIP
Revision.
■3. In § 52.173, add paragraphs (h) and
(i) to read as follows:
§ 52.173 Visibility protection.
* * * * *
(h) Arkansas Regional Haze Phase III
SIP Revision. The Arkansas Regional
Haze Phase III SIP Revision submitted
on August 13, 2019, is approved as
follows:
(1) The clear weight of evidence
determination that the BART alternative
for Power Boilers No. 1 and 2 satisfies
all of the applicable regional haze
provisions set forth in 40 CFR
51.308(e)(2)(i) to (iv) for the Domtar
Ashdown Mill with respect to SO
2
,
NO
X
, and PM
10
.
(2) The regional haze program-specific
plantwide conditions 32 to 43 from
section VI of Permit #0287–AOP–R22
are approved for Power Boilers No. 1
and 2 for the Domtar Ashdown Mill,
which contain SO
2
, NO
X
, and PM
10
emission limits and conditions for
implementing the BART alternative.
(3) The approval of the withdrawal of
the current PM
10
BART determination of
0.07 lb/MMBtu for Power Boiler No. 1
in the 2008 Arkansas Regional Haze SIP
and replacement with the PM
10
BART
alternative limit in the Arkansas
Regional Haze Phase III SIP Revision.
(4) The reasonable progress
components under 40 CFR 51.308(d)(1)
pertaining to the Domtar Ashdown Mill
are approved.
(5) The long-term strategy component
pertaining to the Domtar Ashdown Mill
that includes the emission limits and
schedules of compliance component
under 40 CFR 51.308(d)(3)(v)(3) is
approved.
(6) Consultation and coordination in
the development of the SIP revision
with the FLMs and with other states
with Class I areas affected by emissions
from Arkansas sources, as required
under 40 CFR 51.308(i)(2) and 40 CFR
51.308(d)(3)(i), is approved.
(i) Portions of the Arkansas 2015 O
3
NAAQS Interstate Transport SIP
Revision and Arkansas Regional Haze
SO
2
and PM SIP Revision addressing
Visibility Transport. The portion of the
Arkansas 2015 O
3
NAAQS Interstate
Transport SIP revision addressing the
visibility transport requirements of CAA
section 110(a)(2)(D)(i)(II) for Arkansas
for the 2006 24-hour PM
2.5
NAAQS; the
2012 annual PM
2.5
NAAQS; the 2008
and 2015 eight-hour O
3
NAAQS; the
2010 one-hour NO
2
NAAQS; and the
2010 one-hour SO
2
NAAQS are
approved. The visibility transport
portion of the Arkansas Regional Haze
SO
2
and PM SIP revision, as
supplemented by the Arkansas 2015 O
3
NAAQS Interstate Transport SIP
revision, is also approved.
[FR Doc. 2021–05362 Filed 3–19–21; 8:45 am]
BILLING CODE 6560–50–P
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; Additional 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 March 18, 2021, the
January 29, 2021 effective date of the
amendments to 42 CFR 1001.952(h)(6)
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15133
Federal Register / Vol. 86, No. 53 / Monday, March 22, 2021 / Rules and Regulations
1
Pharmaceutical Care Management Association
v. United States Department of Health & Human
Services et al., No. 1:21–cv–00095 (D. D.C. filed Jan.
12, 2021).
2
Pharmaceutical Care Management Association
v. United States Department of Health & Human
Services et al., No. 1:21–cv–00095 (D. D.C. Jan. 30,
2021) (order granting joint stipulation and
postponing effective date), Doc. No. 19.
3
86 FR 10181 (Feb. 19, 2021).
4
86 FR 7815 (Feb. 2, 2021).
5
Pharmaceutical Care Management Association
v. United States Department of Health & Human
Services et al., No. 1:21–cv–00095 (D. D.C .Mar. 15,
2021) (order granting joint stipulation and
postponing effective date), Doc. No. 27.
through (9), (cc), and (dd) published at
85 FR 76666, November 30, 2020, which
was delayed to March 22, 2021,
pursuant to the rule published at 86 FR
7815, February 2, 2021, is further
delayed until January 1, 2023. In
addition, the effective date of the
corrections published at 86 FR 7815,
February 2, 2021, is delayed from March
22, 2021, to 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 (h)(6) through (9)
to 42 CFR 1001.952, 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.
On January 12, 2021, a lawsuit
challenging the final rule was filed in
the U.S. District Court for the District of
Columbia.
1
On January 30, 2021, the
Court issued an order postponing until
January 1, 2023, the effective date of the
provisions of the final rule that were
scheduled to take effect on January 1,
2022.
2
Consistent with that order, the
Department notified the public that the
effective date of the amendments to 42
CFR 1001.952(h)(5) in the final rule is
now January 1, 2023.
3
In the Federal Register of February 2,
2021, the Department announced that it
was undertaking a regulatory review of
the interactions between the final rule’s
various provisions and the overall
regulatory framework.
4
To assure
adequate time to determine what
additional action, if any, would be
appropriate, the Department delayed
until March 22, 2021, 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. In addition, the
Department determined that the
November 2020 final rule contained a
technical error in the amendatory
instructions that would have prevented
the Office of the Federal Register from
properly incorporating the amendments
to § 1001.952 into the CFR. The
Department’s February 2, 2021, Federal
Register publication therefore
announced a technical correction to
those instructions that would likewise
take effect on March 22, 2021.
On March 15, 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 March 22, 2021.
5
Consistent with that order, the
Department is taking this action to
notify the public that the effective date
of the amendments to 42 CFR
1001.952(h)(6) through (9), (cc), and
(dd) in the final rule (inclusive of the
technical correction) 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 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. 2021–05903 Filed 3–18–21; 4:15 pm]
BILLING CODE P
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