Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Correction, 26578-26580 [2019-11923]
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<![CDATA[
26578
Federal Register / Vol. 84, No. 110 / Friday, June 7, 2019 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. Summary of Errors
Centers for Medicare & Medicaid
Services
On page 15680, in our listing of the
effective dates, we made an error in a
regulatory citation.
On page 15713, in our discussion of
dual eligible special needs plans and
contracts with states, we made a
typographical error.
On page 15736, in our discussion of
integrated grievances, we made an error
in regulatory citation.
A. Summary of Errors in the Preamble
42 CFR Parts 422, 423, 438, and 498
[CMS–4185–CN]
RIN 0938–AT59
Medicare and Medicaid Programs;
Policy and Technical Changes to the
Medicare Advantage, Medicare
Prescription Drug Benefit, Programs of
All-Inclusive Care for the Elderly
(PACE), Medicaid Fee-For-Service, and
Medicaid Managed Care Programs for
Years 2020 and 2021; Correction
Centers for Medicare &
Medicaid Services (CMS), HHS.
AGENCY:
ACTION:
Final rule; correction.
This document corrects
technical and typographical errors that
appeared in the final rule published in
the April 16, 2019 Federal Register
titled ‘‘Medicare and Medicaid
Programs; Policy and Technical Changes
to the Medicare Advantage, Medicare
Prescription Drug Benefit, Programs of
All-Inclusive Care for the Elderly
(PACE), Medicaid Fee-For-Service, and
Medicaid Managed Care Programs for
Years 2020 and 2021’’.
SUMMARY:
Effective Date: The corrections to
the preamble of the final rule published
on April 16, 2019 (84 FR 15680), are
effective June 7, 2019. The correction in
instruction 8 (§ 423.120) is effective
June 17, 2019. The corrections in
instructions 5 (§ 422.561), 6 (§ 422.562),
7 (§ 422.633), and 9 (§ 423.120) are
effective on January 1, 2020. The
correction in instruction 4 (§ 422.107(d))
is effective January 1, 2021.
DATES:
FOR FURTHER INFORMATION CONTACT:
Theresa Wachter, (410) 786–1157. Cali
Diehl, (410) 786–4053.
SUPPLEMENTARY INFORMATION:
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I. Background
In FR Doc. 2019–06822 of April 16,
2019 (84 FR 15680), there were a
number of technical and typographical
errors that are identified and corrected
in the Correction of Errors section of
this correcting document. The
provisions in this correction document
are effective as if they had been
included in the document published
April 16, 2019.
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B. Summary of Errors in the Regulations
Text
On page 15828, in the regulation text
for § 422.107(d), we made a
typographical error.
On page 15834, in the regulation text
for § 422.561, we inadvertently
misspelled the term ‘‘complaint’’ and in
§ 422.562, we made errors in two crossreferences.
On page 15838, in the regulation text
§ 422.633, we made inadvertent
technical errors in language of two
regulatory provisions regarding
integrated reconsideration.
On page 15840, we made errors in the
placement of the regulatory text
revisions for § 423.120(c)(6)(iv) and (v).
We inadvertently included the revisions
for § 423.120(c)(6)(iv) with the
amendments effective June 17, 2019
(instead of January 1, 2020) and the
revisions for § 423.120(c)(6)(v) with the
amendments effective January 1, 2020
(instead of June 17, 2019).
normal rulemaking requirements for
good cause if the agency makes a
finding that the notice and comment
process are impracticable, unnecessary,
or contrary to the public interest. In
addition, both section 553(d)(3) of the
APA and section 1871(e)(1)(B)(ii) of the
Act allow the agency to avoid the 30day delay in effective date where such
delay is contrary to the public interest
and an agency includes a statement of
support.
Section 553(d) of the APA ordinarily
requires a 30-day delay in effective date
of final rules after the date of their
publication in the Federal Register.
This 30-day delay in effective date can
be waived, however, if an agency finds
for good cause that the delay is
impracticable, unnecessary, or contrary
to the public interest, and the agency
incorporates a statement of the findings
and its reasons in the rule issued.
III. Waiver of Proposed Rulemaking
We believe that this correcting
document does not constitute a rule that
would be subject to the notice and
comment or delayed effective date
requirements of the APA or section 1871
of the Act. This correcting document
corrects technical errors in the preamble
and regulation text of the final rule but
does not make substantive changes to
the policies that were adopted in the
final rule. As a result, this correcting
document is intended to ensure that the
information in the final rule accurately
reflects the policies adopted in that final
rule.
Under 5 U.S.C. 553(b) of the
Administrative Procedure Act (APA),
the agency is required to publish a
notice of the proposed rule in the
Federal Register before the provisions
of a rule take effect. Similarly, section
1871(b)(1) of the Act requires the
Secretary to provide for notice of the
proposed rule in the Federal Register
and provide a period of not less than 60
days for public comment. In addition,
section 553(d) of the APA, and section
1871(e)(1)(B)(i) of the Act mandate a 30day delay in effective date after issuance
or publication of a rule. Sections
553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the notice
and comment and delay in effective date
APA requirements; in cases in which
these exceptions apply, sections
1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the
Act provide exceptions from the notice
and 60-day comment period and delay
in effective date requirements of the Act
as well. Section 553(b)(B) of the APA
and section 1871(b)(2)(C) of the Act
authorize an agency to dispense with
In addition, even if this were a rule to
which the notice and comment
procedures and delayed effective date
requirements applied, we find that there
is good cause to waive such
requirements. Undertaking further
notice and comment procedures to
incorporate the corrections in this
document into the final rule or delaying
the effective date would be contrary to
the public interest because it is in the
public’s interest to ensure that final rule
accurately reflects our policies.
Furthermore, such procedures would be
unnecessary, as we are not altering
payment eligibility or benefit
methodologies or policies, but rather,
simply implementing correctly the
policies that we previously proposed,
received comment on, and subsequently
finalized. This correcting document is
intended solely to ensure that the final
rule accurately reflects these policies.
Therefore, we believe we have good
cause to waive the notice and comment
and effective date requirements.
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Federal Register / Vol. 84, No. 110 / Friday, June 7, 2019 / Rules and Regulations
IV. Correction of Errors
In FR Doc. 2019–06822 of April 16,
2019 (84 FR 15680), make the following
corrections:
A. Corrections of Errors in the Preamble
1. On page 15680, first column, fourth
full paragraph (Dates section), line 9, the
reference ‘‘423.120(c)(6)(iv)’’ is
corrected to read ‘‘423.120(c)(6)(v)’’.
2. On page 15713, third column,
second full paragraph, line 29, the
phrase ‘‘arrange for’’ is corrected to read
‘‘arranges for’’.
3. On page 15736, first column, first
partial paragraph, line 6, the reference
‘‘§ 422.630(e)(2)(ii)’’ is corrected to read:
‘‘§ 422.630(e)(2)’’.
B. Corrections of Errors in the
Regulations Text
§ 422.107
[Corrected]
4. Effective January 1, 2021, on page
15828, third column, in § 422.107(d),
the phrase ‘‘or arrange for’’ is corrected
to read ‘‘or arranges for’’.
■
§ 422.561
[Corrected]
5. Effective on January 1, 2020, on
page 15834, first column, in § 422.561,
in the definition of ‘‘Integrated
grievance,’’ the term ‘‘compliant’’ is
corrected to read ‘‘complaint’’.
■
§ 422.562
[Corrected]
6. Effective on January 1, 2020, on
page 15834, in § 422.562—
■ a. In paragraph (b)(2), the reference,
‘‘§ 422.631’’ is corrected to read,
‘‘§ 422.631(c)’’.
■ b. In paragraph (b)(4)(ii), the reference
‘‘§ 422.633(f)’’ is corrected to read
‘‘§ 422.633(e)’’.
■
§ 422.633
[Corrected]
7. Effective on January 1, 2020, on
page 15838, in § 422.633—
■ a. In paragraph (f)(1), the phrase, ‘‘no
longer than’’ is corrected to read ‘‘no
later than’’.
■ b. In paragraph (f)(2), the phrase ‘‘of
receipt for’’ is corrected to read ‘‘of
receipt of’’.
■
§ 423.120
[Corrected]
8. Effective June 17, 2019, on page
15840, in second column, amendatory
instruction 28 for § 423.120 and its
corresponding text is corrected in its
entirety to read as follows:
28. Effective June 17, 2019, § 423.120
is amended by revising paragraph
(c)(6)(v) to read as follows:
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■
§ 423.120
*
Access to covered Part D drugs.
*
*
(c) * * *
(6) * * *
VerDate Sep<11>2014
*
(v)(A) CMS sends written notice to the
prescriber via letter of his or her
inclusion on the preclusion list. The
notice must contain the reason for the
inclusion on the preclusion list and
inform the prescriber of his or her
appeal rights. A prescriber may appeal
his or her inclusion on the preclusion
list under this section in accordance
with part 498 of this chapter.
(B) If the prescriber’s inclusion on the
preclusion list is based on a
contemporaneous Medicare revocation
under § 424.535 of this chapter:
(1) The notice described in paragraph
(c)(6)(v)(A) of this section must also
include notice of the revocation, the
reason(s) for the revocation, and a
description of the prescriber’s appeal
rights concerning the revocation.
(2) The appeals of the prescriber’s
inclusion on the preclusion list and the
prescriber’s revocation must be filed
jointly by the prescriber and, as
applicable, considered jointly under
part 498 of this chapter.
(C)(1) Except as provided in
paragraph (c)(6)(v)(C)(2) of this section,
a prescriber will only be included on
the preclusion list after the expiration of
either of the following:
(i) If the prescriber does not file a
reconsideration request under
§ 498.5(n)(1) of this chapter, the
prescriber will be added to the
preclusion list upon the expiration of
the 60-day period in which the
prescriber may request a
reconsideration.
(ii) If the prescriber files a
reconsideration request under
§ 498.5(n)(1) of this chapter, the
prescriber will be added to the
preclusion list effective on the date on
which CMS, if applicable, denies the
prescriber’s reconsideration.
(2) An OIG excluded prescriber is
added to the preclusion list effective on
the date of the exclusion.
*
*
*
*
*
§ 423.120
§ 423.120
*
*
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[Corrected]
9. Effective on January 1, 2020, on
page 15840, beginning in the second
column, amendatory instruction 29 for
§ 423.120 and its corresponding text is
corrected in its entirety to read as
follows:
29. Section 423.120 is further
amended by—
a. Revising paragraph (c)(6)(iv); and
b. Adding paragraphs (c)(6)(vii) and
(viii).
The revision and additions read as
follows:
■
Access to covered Part D drugs.
*
*
(c) * * *
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*
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*
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26579
(6) * * *
(iv) With respect to Part D prescribers
who have been added to an updated
preclusion list but are not currently
excluded by the OIG, the Part D plan
sponsor must do all of the following:
(A) Subject to all other Part D rules
and plan coverage requirements, and no
later than 30 days after the posting of
this updated preclusion list, must
provide an advance written notice to
any beneficiary who has received a Part
D drug prescribed by an individual
added to the preclusion list in this
update and whom the plan sponsor has
identified during the applicable 30-day
period.
(B)(1) Subject to paragraph
(c)(6)(iv)(B)(2) of this section, must
ensure that reasonable efforts are made
to notify the individual described in
paragraph (c)(6)(iv) of this section of a
beneficiary who was sent a notice under
paragraph (c)(6)(iv)(A) of this section.
(2) Paragraph (c)(6)(iv)(B)(1) of this
section applies only upon a prescriber
writing a prescription in Medicare Part
D when:
(i) The plan sponsor has enough
information on file to either copy the
prescriber on the notification previously
sent to the beneficiary or send a new
notice informing the prescriber that they
may not see plan beneficiaries due to
their preclusion status; and
(ii) The claim is received after the
claim denial or reject date in the
preclusion file.
(C) Must not reject a pharmacy claim
or deny a beneficiary request for
reimbursement for a Part D drug
prescribed by the prescriber, solely on
the ground that they have been included
in the updated preclusion list, in the 60day period after the date it sent the
notice described in paragraph
(c)(6)(iv)(A) of this section.
*
*
*
*
*
(vii)(A) Except as provided in
paragraphs (c)(6)(vii)(C) and (D) of this
section, a prescriber who is revoked
under § 424.535 of this chapter will be
included on the preclusion list for the
same length of time as the prescriber’s
reenrollment bar.
(B) Except as provided in paragraphs
(c)(6)(vii)(C) and (D) of this section, a
prescriber who is not enrolled in
Medicare will be included on the
preclusion list for the same length of
time as the reenrollment bar that CMS
could have imposed on the prescriber
had the prescriber been enrolled and
then revoked.
(C) Except as provided in paragraph
(c)(6)(vii)(D) of this section, an
individual, regardless of whether the
individual is or was enrolled in
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07JNR1
26580
Federal Register / Vol. 84, No. 110 / Friday, June 7, 2019 / Rules and Regulations
Medicare, that is included on the
preclusion list because of a felony
conviction will remain on the
preclusion list for a 10-year period,
beginning on the date of the felony
conviction, unless CMS determines that
a shorter length of time is warranted.
Factors that CMS considers in making
such a determination are—
(1) The severity of the offense;
(2) When the offense occurred; and
(3) Any other information that CMS
deems relevant to its determination.
(D) In cases where an individual is
excluded by the OIG, the individual
must remain on the preclusion list until
the expiration of the CMS-imposed
preclusion list period or reinstatement
by the OIG, whichever occurs later.
(viii) Payment denials under
paragraph (c)(6) of this section that are
based upon the prescriber’s inclusion on
the preclusion list are not appealable by
beneficiaries.
*
*
*
*
*
Dated: June 3, 2019.
Ann C. Agnew,
Executive Secretary to the Department,
Department of Health and Human Services.
[FR Doc. 2019–11923 Filed 6–5–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
45 CFR Part 88
RIN 0945–AA10
Protecting Statutory Conscience
Rights in Health Care; Delegations of
Authority
Correction
In rule document 2019–09667
beginning on page 23170 in the issue of
Tuesday, May 21, 2019 make the
following correction:
On pages 23170 through 23272 the
date at the top of the page should read
‘‘Tuesday, May 21, 2019’’.
[FR Doc. C1–2019–09667 Filed 6–6–19; 8:45 am]
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BILLING CODE 1301–00–D
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
46 CFR Parts 10, 11, and 15
[Docket No. USCG–2018–0100]
RIN 1625–AC46
Amendments to the Marine Radar
Observer Refresher Training
Regulations
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is revising
its merchant mariner credentialing
regulations to remove obsolete portions
of the radar observer requirements and
harmonize the radar observer
endorsement with the merchant mariner
credential. These revisions will reduce
an unnecessary financial burden on
mariners required to hold a radar
observer endorsement. This rule will
affect mariners who have served on
radar-equipped vessels, in a position
that routinely uses radar for 1 year in
the previous 5 years for navigation and
collision avoidance purposes, and
mariners who have taught a Coast
Guard-approved or accepted radar
course at least twice within the past 5
years. These mariners will no longer be
required to complete a Coast Guardapproved or accepted radar refresher or
recertification course in order to renew
their radar observer endorsements. We
are retaining the existing requirements
for mariners seeking an original radar
observer endorsement and for mariners
who do not have 1 year of routine
relevant sea service on board radarequipped vessels in the previous 5 years
or have not taught a Coast Guardapproved or accepted radar course at
least twice within the past 5 years. This
final rule adopts, with modification, the
notice of proposed rulemaking
published on June 11, 2018.
DATES: This final rule is effective July
22, 2019.
ADDRESSES: You may view comments
and related material identified by
docket number USCG–2018–0100 using
the Federal eRulemaking Portal at
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
information about this document call or
email Mr. Davis Breyer, Coast Guard;
telephone 202–372–1445, email
davis.j.breyer@uscg.mil.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Table of Contents for Preamble
I. Abbreviations
II. Basis and Purpose
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16:25 Jun 06, 2019
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III. Background and Regulatory History
IV. Discussion of Comments and Changes
V. Discussion of the Rule
VI. Regulatory Analyses
A. Regulatory Planning and Review
B. Small Entities
C. Assistance for Small Entities
D. Collection of Information
E. Federalism
F. Unfunded Mandates Reform Act
G. Taking of Private Property
H. Civil Justice Reform
I. Protection of Children
J. Indian Tribal Governments
K. Energy Effects
L. Technical Standards
M. Environment
I. Abbreviations
ARPA Automatic Radar Plotting Aids
BLS Bureau of Labor Statistics
CFR Code of Federal Regulations
CGAA 2015 Coast Guard Authorization Act
of 2015
CGAA 2018 Coast Guard Authorization Act
of 2018
DHS Department of Homeland Security
FR Federal Register
MERPAC Merchant Marine Personnel
Advisory Committee
MMC Merchant Mariner Credential
MMLD Merchant Mariner Licensing and
Documentation
NPRM Notice of proposed rulemaking
OMB Office of Management and Budget
RA Regulatory analysis
RFA Regulatory Flexibility Act
§ Section
STCW International Convention on the
Standards of Training, Certification and
Watchkeeping for Seafarers, 1978, as
amended
STCW Code Seafarers’ Training,
Certification and Watchkeeping Code
U.S.C. United States Code
II. Basis and Purpose
This rule amends the radar observer
requirements by removing obsolete
portions and harmonizing the expiration
dates of the radar observer endorsement
and the merchant mariner credential
(MMC). Title 46 of the United States
Code (U.S.C.), Section 7101 authorizes
the Coast Guard to determine and
establish the experience and
professional qualifications required for
the issuance of officer credentials. The
Secretary of the Department of
Homeland Security (DHS) has delegated
46 U.S.C. 7101 authority to the
Commandant of the Coast Guard by
Department of Homeland Security
Delegation No. 0170.1(II)(92)(e). The
specifics of these professional
qualifications and the Coast Guard’s
evaluation process are prescribed by
Title 46 Code of Federal Regulations
(CFR) parts 10 and 11, and the manning
requirements are detailed in 46 CFR part
15. Section 304 of the Coast Guard
Authorization Act of 2015 (CGAA 2015),
Public Law 114–120, February 8, 2016
E:\FR\FM\07JNR1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Rules and Regulations]
[Pages 26578-26580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11923]
[[Page 26578]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 422, 423, 438, and 498
[CMS-4185-CN]
RIN 0938-AT59
Medicare and Medicaid Programs; Policy and Technical Changes to
the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of
All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service,
and Medicaid Managed Care Programs for Years 2020 and 2021; Correction
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects technical and typographical errors that
appeared in the final rule published in the April 16, 2019 Federal
Register titled ``Medicare and Medicaid Programs; Policy and Technical
Changes to the Medicare Advantage, Medicare Prescription Drug Benefit,
Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-
For-Service, and Medicaid Managed Care Programs for Years 2020 and
2021''.
DATES: Effective Date: The corrections to the preamble of the final
rule published on April 16, 2019 (84 FR 15680), are effective June 7,
2019. The correction in instruction 8 (Sec. 423.120) is effective June
17, 2019. The corrections in instructions 5 (Sec. 422.561), 6 (Sec.
422.562), 7 (Sec. 422.633), and 9 (Sec. 423.120) are effective on
January 1, 2020. The correction in instruction 4 (Sec. 422.107(d)) is
effective January 1, 2021.
FOR FURTHER INFORMATION CONTACT: Theresa Wachter, (410) 786-1157. Cali
Diehl, (410) 786-4053.
SUPPLEMENTARY INFORMATION:
I. Background
In FR Doc. 2019-06822 of April 16, 2019 (84 FR 15680), there were a
number of technical and typographical errors that are identified and
corrected in the Correction of Errors section of this correcting
document. The provisions in this correction document are effective as
if they had been included in the document published April 16, 2019.
II. Summary of Errors
A. Summary of Errors in the Preamble
On page 15680, in our listing of the effective dates, we made an
error in a regulatory citation.
On page 15713, in our discussion of dual eligible special needs
plans and contracts with states, we made a typographical error.
On page 15736, in our discussion of integrated grievances, we made
an error in regulatory citation.
B. Summary of Errors in the Regulations Text
On page 15828, in the regulation text for Sec. 422.107(d), we made
a typographical error.
On page 15834, in the regulation text for Sec. 422.561, we
inadvertently misspelled the term ``complaint'' and in Sec. 422.562,
we made errors in two cross-references.
On page 15838, in the regulation text Sec. 422.633, we made
inadvertent technical errors in language of two regulatory provisions
regarding integrated reconsideration.
On page 15840, we made errors in the placement of the regulatory
text revisions for Sec. 423.120(c)(6)(iv) and (v). We inadvertently
included the revisions for Sec. 423.120(c)(6)(iv) with the amendments
effective June 17, 2019 (instead of January 1, 2020) and the revisions
for Sec. 423.120(c)(6)(v) with the amendments effective January 1,
2020 (instead of June 17, 2019).
III. Waiver of Proposed Rulemaking
Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA),
the agency is required to publish a notice of the proposed rule in the
Federal Register before the provisions of a rule take effect.
Similarly, section 1871(b)(1) of the Act requires the Secretary to
provide for notice of the proposed rule in the Federal Register and
provide a period of not less than 60 days for public comment. In
addition, section 553(d) of the APA, and section 1871(e)(1)(B)(i) of
the Act mandate a 30-day delay in effective date after issuance or
publication of a rule. Sections 553(b)(B) and 553(d)(3) of the APA
provide for exceptions from the notice and comment and delay in
effective date APA requirements; in cases in which these exceptions
apply, sections 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Act provide
exceptions from the notice and 60-day comment period and delay in
effective date requirements of the Act as well. Section 553(b)(B) of
the APA and section 1871(b)(2)(C) of the Act authorize an agency to
dispense with normal rulemaking requirements for good cause if the
agency makes a finding that the notice and comment process are
impracticable, unnecessary, or contrary to the public interest. In
addition, both section 553(d)(3) of the APA and section
1871(e)(1)(B)(ii) of the Act allow the agency to avoid the 30-day delay
in effective date where such delay is contrary to the public interest
and an agency includes a statement of support.
Section 553(d) of the APA ordinarily requires a 30-day delay in
effective date of final rules after the date of their publication in
the Federal Register. This 30-day delay in effective date can be
waived, however, if an agency finds for good cause that the delay is
impracticable, unnecessary, or contrary to the public interest, and the
agency incorporates a statement of the findings and its reasons in the
rule issued.
We believe that this correcting document does not constitute a rule
that would be subject to the notice and comment or delayed effective
date requirements of the APA or section 1871 of the Act. This
correcting document corrects technical errors in the preamble and
regulation text of the final rule but does not make substantive changes
to the policies that were adopted in the final rule. As a result, this
correcting document is intended to ensure that the information in the
final rule accurately reflects the policies adopted in that final rule.
In addition, even if this were a rule to which the notice and
comment procedures and delayed effective date requirements applied, we
find that there is good cause to waive such requirements. Undertaking
further notice and comment procedures to incorporate the corrections in
this document into the final rule or delaying the effective date would
be contrary to the public interest because it is in the public's
interest to ensure that final rule accurately reflects our policies.
Furthermore, such procedures would be unnecessary, as we are not
altering payment eligibility or benefit methodologies or policies, but
rather, simply implementing correctly the policies that we previously
proposed, received comment on, and subsequently finalized. This
correcting document is intended solely to ensure that the final rule
accurately reflects these policies. Therefore, we believe we have good
cause to waive the notice and comment and effective date requirements.
[[Page 26579]]
IV. Correction of Errors
In FR Doc. 2019-06822 of April 16, 2019 (84 FR 15680), make the
following corrections:
A. Corrections of Errors in the Preamble
1. On page 15680, first column, fourth full paragraph (Dates
section), line 9, the reference ``423.120(c)(6)(iv)'' is corrected to
read ``423.120(c)(6)(v)''.
2. On page 15713, third column, second full paragraph, line 29, the
phrase ``arrange for'' is corrected to read ``arranges for''.
3. On page 15736, first column, first partial paragraph, line 6,
the reference ``Sec. 422.630(e)(2)(ii)'' is corrected to read: ``Sec.
422.630(e)(2)''.
B. Corrections of Errors in the Regulations Text
Sec. 422.107 [Corrected]
0
4. Effective January 1, 2021, on page 15828, third column, in Sec.
422.107(d), the phrase ``or arrange for'' is corrected to read ``or
arranges for''.
Sec. 422.561 [Corrected]
0
5. Effective on January 1, 2020, on page 15834, first column, in Sec.
422.561, in the definition of ``Integrated grievance,'' the term
``compliant'' is corrected to read ``complaint''.
Sec. 422.562 [Corrected]
0
6. Effective on January 1, 2020, on page 15834, in Sec. 422.562--
0
a. In paragraph (b)(2), the reference, ``Sec. 422.631'' is corrected
to read, ``Sec. 422.631(c)''.
0
b. In paragraph (b)(4)(ii), the reference ``Sec. 422.633(f)'' is
corrected to read ``Sec. 422.633(e)''.
Sec. 422.633 [Corrected]
0
7. Effective on January 1, 2020, on page 15838, in Sec. 422.633--
0
a. In paragraph (f)(1), the phrase, ``no longer than'' is corrected to
read ``no later than''.
0
b. In paragraph (f)(2), the phrase ``of receipt for'' is corrected to
read ``of receipt of''.
Sec. 423.120 [Corrected]
0
8. Effective June 17, 2019, on page 15840, in second column, amendatory
instruction 28 for Sec. 423.120 and its corresponding text is
corrected in its entirety to read as follows:
28. Effective June 17, 2019, Sec. 423.120 is amended by revising
paragraph (c)(6)(v) to read as follows:
Sec. 423.120 Access to covered Part D drugs.
* * * * *
(c) * * *
(6) * * *
(v)(A) CMS sends written notice to the prescriber via letter of his
or her inclusion on the preclusion list. The notice must contain the
reason for the inclusion on the preclusion list and inform the
prescriber of his or her appeal rights. A prescriber may appeal his or
her inclusion on the preclusion list under this section in accordance
with part 498 of this chapter.
(B) If the prescriber's inclusion on the preclusion list is based
on a contemporaneous Medicare revocation under Sec. 424.535 of this
chapter:
(1) The notice described in paragraph (c)(6)(v)(A) of this section
must also include notice of the revocation, the reason(s) for the
revocation, and a description of the prescriber's appeal rights
concerning the revocation.
(2) The appeals of the prescriber's inclusion on the preclusion
list and the prescriber's revocation must be filed jointly by the
prescriber and, as applicable, considered jointly under part 498 of
this chapter.
(C)(1) Except as provided in paragraph (c)(6)(v)(C)(2) of this
section, a prescriber will only be included on the preclusion list
after the expiration of either of the following:
(i) If the prescriber does not file a reconsideration request under
Sec. 498.5(n)(1) of this chapter, the prescriber will be added to the
preclusion list upon the expiration of the 60-day period in which the
prescriber may request a reconsideration.
(ii) If the prescriber files a reconsideration request under Sec.
498.5(n)(1) of this chapter, the prescriber will be added to the
preclusion list effective on the date on which CMS, if applicable,
denies the prescriber's reconsideration.
(2) An OIG excluded prescriber is added to the preclusion list
effective on the date of the exclusion.
* * * * *
Sec. 423.120 [Corrected]
0
9. Effective on January 1, 2020, on page 15840, beginning in the second
column, amendatory instruction 29 for Sec. 423.120 and its
corresponding text is corrected in its entirety to read as follows:
29. Section 423.120 is further amended by--
a. Revising paragraph (c)(6)(iv); and
b. Adding paragraphs (c)(6)(vii) and (viii).
The revision and additions read as follows:
Sec. 423.120 Access to covered Part D drugs.
* * * * *
(c) * * *
(6) * * *
(iv) With respect to Part D prescribers who have been added to an
updated preclusion list but are not currently excluded by the OIG, the
Part D plan sponsor must do all of the following:
(A) Subject to all other Part D rules and plan coverage
requirements, and no later than 30 days after the posting of this
updated preclusion list, must provide an advance written notice to any
beneficiary who has received a Part D drug prescribed by an individual
added to the preclusion list in this update and whom the plan sponsor
has identified during the applicable 30-day period.
(B)(1) Subject to paragraph (c)(6)(iv)(B)(2) of this section, must
ensure that reasonable efforts are made to notify the individual
described in paragraph (c)(6)(iv) of this section of a beneficiary who
was sent a notice under paragraph (c)(6)(iv)(A) of this section.
(2) Paragraph (c)(6)(iv)(B)(1) of this section applies only upon a
prescriber writing a prescription in Medicare Part D when:
(i) The plan sponsor has enough information on file to either copy
the prescriber on the notification previously sent to the beneficiary
or send a new notice informing the prescriber that they may not see
plan beneficiaries due to their preclusion status; and
(ii) The claim is received after the claim denial or reject date in
the preclusion file.
(C) Must not reject a pharmacy claim or deny a beneficiary request
for reimbursement for a Part D drug prescribed by the prescriber,
solely on the ground that they have been included in the updated
preclusion list, in the 60-day period after the date it sent the notice
described in paragraph (c)(6)(iv)(A) of this section.
* * * * *
(vii)(A) Except as provided in paragraphs (c)(6)(vii)(C) and (D) of
this section, a prescriber who is revoked under Sec. 424.535 of this
chapter will be included on the preclusion list for the same length of
time as the prescriber's reenrollment bar.
(B) Except as provided in paragraphs (c)(6)(vii)(C) and (D) of this
section, a prescriber who is not enrolled in Medicare will be included
on the preclusion list for the same length of time as the reenrollment
bar that CMS could have imposed on the prescriber had the prescriber
been enrolled and then revoked.
(C) Except as provided in paragraph (c)(6)(vii)(D) of this section,
an individual, regardless of whether the individual is or was enrolled
in
[[Page 26580]]
Medicare, that is included on the preclusion list because of a felony
conviction will remain on the preclusion list for a 10-year period,
beginning on the date of the felony conviction, unless CMS determines
that a shorter length of time is warranted. Factors that CMS considers
in making such a determination are--
(1) The severity of the offense;
(2) When the offense occurred; and
(3) Any other information that CMS deems relevant to its
determination.
(D) In cases where an individual is excluded by the OIG, the
individual must remain on the preclusion list until the expiration of
the CMS-imposed preclusion list period or reinstatement by the OIG,
whichever occurs later.
(viii) Payment denials under paragraph (c)(6) of this section that
are based upon the prescriber's inclusion on the preclusion list are
not appealable by beneficiaries.
* * * * *
Dated: June 3, 2019.
Ann C. Agnew,
Executive Secretary to the Department, Department of Health and Human
Services.
[FR Doc. 2019-11923 Filed 6-5-19; 8:45 am]
BILLING CODE 4120-01-P
