[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