[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]]

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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.

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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.

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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

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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