Medicare and State Health Care Programs: Fraud and Abuse; Procedures Regarding the Submission of Advisory Opinion Requests to, and the Issuance of Advisory Opinions by, OIG, 1367-1369 [2022-00313]
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Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations
submit a report containing this rule and
other required information to the U.S.
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Representatives, and the Comptroller
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publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
determined that Executive Order 13132,
entitled ‘‘Federalism’’ (64 FR 43255,
August 10, 1999) and Executive Order
13175, entitled ‘‘Consultation and
Coordination with Indian Tribal
Governments’’ (65 FR 67249, November
9, 2000) do not apply to this action. In
addition, this action does not impose
any enforceable duty or contain any
unfunded mandate as described under
Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et
seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
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12(d) of the National Technology
Transfer and Advancement Act
(NTTAA) (15 U.S.C. 272 note).
Dated: January 5, 2022.
Marietta Echeverria,
Acting Director, Registration Division, Office
of Pesticide Programs.
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
Therefore, for the reasons stated in the
preamble, EPA is amending 40 CFR
chapter I as follows:
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
PART 180—TOLERANCES AND
EXEMPTIONS FOR PESTICIDE
CHEMICAL RESIDUES IN FOOD
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.555, amend the table in
paragraph (a) by:
■ a. Adding in alphabetical order the
entries for ‘‘Caneberry, subgroup 13–
07A’’; ‘‘Currant’’; ‘‘Pea and bean,
succulent shelled, subgroup 6B’’;
‘‘Tropical and subtropical, small fruit,
edible peel, subgroup 23A’’; and
‘‘Vegetable, legume, edible podded,
subgroup 6A’’.
■ b. Add footnote 4.
The additions read as follows:
■
§ 180.555 Trifloxystrobin; tolerances for
residues.
(a) * * *
Parts per
million
Commodity
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Caneberry, subgroup 13–07A 4 ...........................................................................................................................................................
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Currant 4 ...............................................................................................................................................................................................
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Pea and bean, succulent shelled, subgroup 6B 4 ...............................................................................................................................
*
*
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*
*
*
Tropical and subtropical, small fruit, edible peel, subgroup 23A 4 ......................................................................................................
*
*
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Vegetable, legume, edible podded, subgroup 6A 4 .............................................................................................................................
*
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3
4 There
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are no U.S. registrations on this commodity as of January 11, 2022.
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ACTION:
[FR Doc. 2022–00311 Filed 1–10–22; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of Inspector General
42 CFR Part 1008
Medicare and State Health Care
Programs: Fraud and Abuse;
Procedures Regarding the Submission
of Advisory Opinion Requests to, and
the Issuance of Advisory Opinions by,
OIG
Office of Inspector General
(OIG), Department of Health and Human
Services (HHS).
AGENCY:
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17:25 Jan 10, 2022
Jkt 256001
*
*
Final rule.
OIG is amending the
regulations governing the procedures for
the submission of advisory opinion
requests to, and the issuance of advisory
opinions by, OIG.
DATES: This final rule is effective
February 10, 2022.
FOR FURTHER INFORMATION CONTACT:
Christina Hinkle, Office of Counsel to
the Inspector General, (202) 465–6245.
SUPPLEMENTARY INFORMATION:
SUMMARY:
BILLING CODE 6560–50–P
khammond on DSKJM1Z7X2PROD with RULES
*
I. Background
Pursuant to section 1128D of the
Social Security Act (the Act),1 HHS,
through OIG, publishes advisory
opinions regarding the application of
*
PO 00000
U.S.C. 1320a–7d.
Frm 00051
Fmt 4700
Sfmt 4700
3
0.2
0.3
1.5
*
*
the Federal anti-kickback statute 2 and
the safe harbor provisions, as well as
OIG’s administrative sanction
authorities, to parties’ proposed or
existing arrangements. More
specifically, in consultation with the
Department of Justice (DOJ) OIG issues
written advisory opinions to requesting
parties with regard to: (1) What
constitutes prohibited remuneration
under the Federal anti-kickback statute;
(2) whether an arrangement or proposed
arrangement satisfies the criteria in
section 1128B(b)(3) of the Act, or
established by regulation (i.e., safe
harbors),3 for activities that do not result
in prohibited remuneration; (3) what
constitutes an inducement to reduce or
2 Section
1128B of the Act; 42 U.S.C. 1320a–7b(b).
safe harbor regulations are set forth at 42
CFR 1001.952.
3 The
1 42
2
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11JAR1
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Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations
limit services to Medicare or Medicaid
program beneficiaries under section
1128A(b) of the Act; 4 and (4) whether
an activity or proposed activity
constitutes grounds for the imposition
of sanctions under section 1128,5
1128A, or 1128B of the Act.
Section 1128D(b) required the
issuance of regulations to carry out the
advisory opinion process and specified
that the regulations must provide for
‘‘the procedure to be followed by the
[OIG] in responding to a request for an
advisory opinion.’’ In response to this
requirement, OIG issued an interim final
rule with comment period in 1997.6 In
this interim final rule, OIG established
a new 42 CFR part 1008, which contains
the specific procedures for the
submission of requests by individuals or
entities for advisory opinions to and the
issuance of advisory opinions by OIG, in
consultation with DOJ. We revised and
clarified our regulations in a final rule
issued in 1998.7 In 2008, we revised
certain procedural requirements in 42
CFR part 1008 for submitting payments
for advisory opinion costs.8
In the 1997 interim final rule, OIG
established a procedural regulation—42
CFR 1008.15(c)—that describes the
circumstances in which OIG will not
accept a request or will not issue an
opinion. Specifically, § 1008.15(c)
provides that an advisory opinion
request will not be accepted and/or an
advisory opinion will not be issued
when: (1) The request is not related to
a named individual or entity; (2) the
same or substantially the same course of
action is under investigation, or is or
has been the subject of a proceeding
involving HHS or another governmental
agency; or (3) an informed opinion
cannot be made, or could be made only
after extensive investigation, clinical
study, testing, or collateral inquiry.
Section 1008.15(c) has not been
modified since it was promulgated in
1997.
khammond on DSKJM1Z7X2PROD with RULES
II. Final Rule
This final rule removes the procedural
provision at 42 CFR 1008.15(c)(2),
which precludes the acceptance of an
advisory opinion request and/or
issuance of an advisory opinion when
the same or substantially the same
course of action is under investigation
or has been the subject of a proceeding
involving HHS or another governmental
agency. In addition, this final rule
4 42
U.S.C. 1320a–7a(b).
U.S.C. 1320a–7.
6 62 FR 7350 (Feb. 19, 1997).
7 63 FR 38311 (July 16, 1998).
8 73 FR 15937 (Mar. 26, 2008); 73 FR 40982 (July
17, 2008).
5 42
VerDate Sep<11>2014
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Jkt 256001
corrects a grammatical error in
§ 1008.15(c).
Section 1008.15(c) is a procedural
rule that was promulgated consistent
with our statutory obligation under
section 1128D(b) of the Act. The
purpose of § 1008.15(c)(2) is to prevent
the advisory opinion process from
interfering with the investigatory or
prosecutorial authority of OIG, DOJ, or
any other governmental agency. Under
the current regulation, no advisory
opinion is issued if the same or
substantially the same course of action
is under investigation or is the subject
of a proceeding involving HHS or
another governmental agency.
We are removing § 1008.15(c)(2) for
two reasons. First, removal of this
provision will offer OIG more flexibility
in responding to requests for advisory
opinions. In particular, this final rule
will afford OIG the flexibility to issue a
favorable or unfavorable advisory
opinion when an arrangement presented
in an advisory opinion request involves
conduct that is the same or substantially
the same as conduct that is under
investigation or subject to a proceeding.
When OIG has rejected advisory opinion
requests pursuant to the existing
regulation, some requestors have
expressed frustration with this
regulatory provision because it prevents
OIG from providing its legal opinion
regarding the application of certain
Federal fraud and abuse authorities.
Second, removal of § 1008.15(c)(2) may
provide industry stakeholders with
greater transparency regarding factors
the Government may consider in
evaluating compliance with certain
Federal fraud and abuse laws and
distinguishing between similar
arrangements.
In conjunction with issuing this rule,
OIG is publishing on its website an
enforcement policy statement
announcing that, as of the effective date
of this rule, if the arrangement for which
an advisory opinion is sought is the
same or similar to conduct that is
currently under investigation or is the
subject of a proceeding involving a
governmental agency, that fact will
weigh against the issuance of a favorable
advisory opinion because such
circumstances generally indicate that
the arrangement does not present a
sufficiently low risk of fraud and abuse.
That said, consistent with current
practices, OIG will carefully consider
the facts and circumstances of each
advisory opinion request in our legal
assessment.
This rulemaking is separate and
distinct from the Request for
Information (RFI) entitled ‘‘OIG
Modernization Initiative To Improve Its
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
Publicly Available Resources,’’
published in the Federal Register on
September 24, 2021.9 OIG has not yet
reviewed and considered comments
made in response to the RFI, and this
rulemaking is not connected to any
feedback received in response to the
RFI.
III. Regulatory Impact Statement
As set forth below, we have examined
the impact of this final rule as required
by Executive Order 12866, the
Regulatory Flexibility Act (RFA) of
1980, the Unfunded Mandates Reform
Act of 1995, Executive Order 13132, and
Executive Order 13771.
A. Administrative Procedure Act
The advisory opinion process is an
established OIG program. This final rule
is limited to modifying the internal
governmental procedure for handling
advisory opinion requests involving
conduct that is the same or similar to an
ongoing investigation or proceeding.
The modification likely will result in a
similar outcome for most advisory
opinion requests involving conduct that
is the same or similar to an ongoing
investigation in that those requests
likely would not result in favorable
advisory opinions. This rule does not
modify eligibility of a party to request
an advisory opinion or the process for
requesting an advisory opinion.
OIG expects that this final rule will
further the public’s interest with
minimal burden by fulfilling the
statutory obligations to consult with
DOJ as part of the advisory opinion
process, providing greater flexibility for
OIG in its procedures to be followed in
responding to a request for an advisory
opinion, and potentially promoting
greater transparency regarding factors
the Government may consider in
evaluating compliance with certain
Federal fraud and abuse laws and
distinguishing between similar
arrangements. Because this rule is
procedural, notice and comment
rulemaking is not required under 5
U.S.C. 553(b)(A).
B. Executive Order 12866 and
Regulatory Flexibility Act
Because no notice of proposed
rulemaking is required for this rule, the
provisions of the RFA do not apply.
Furthermore, this document does not
meet the criteria for a significant
regulatory action as specified in
Executive Order 12866.
9 OIG, OIG Modernization Initiative To Improve
Its Publicly Available Resources—Request for
Information, 86 FR 53072 (Sept. 24, 2021).
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Federal Register / Vol. 87, No. 7 / Tuesday, January 11, 2022 / Rules and Regulations
C. Unfunded Mandates Reform Act
Section 202 of the Unfunded
Mandates Reform Act of 1995, Public
Law 104–4, requires that agencies assess
anticipated costs and benefits before
issuing any rule that may result in
expenditures in any one year by State,
local, or tribal governments in the
aggregate, or by the private sector, of
$100 million or more (adjusted annually
for inflation). We believe that this final
rule will not impose any mandates on
State, local, or tribal governments or the
private sector that would result in an
expenditure of $100 million or more
(adjusted for inflation) in any given
year, and that a full analysis under the
Unfunded Mandates Reform Act is not
necessary.
khammond on DSKJM1Z7X2PROD with RULES
D. Executive Order 13132
Executive Order 13132 establishes
certain requirements that an agency
must meet when it promulgates a rule
that imposes substantial direct
requirements or costs on State and local
governments, preempts State law, or
otherwise has federalism implications.
In reviewing this final rule under the
threshold criteria of Executive Order
13132, Federalism, we have determined
that this final rule would not
significantly limit the rights, roles, and
responsibilities of State or local
governments. We have determined,
VerDate Sep<11>2014
17:25 Jan 10, 2022
Jkt 256001
therefore, that a full analysis under
Executive Order 13132 is not necessary.
E. Executive Order 13771
Executive Order 13771 requires that
the costs associated with significant
new regulations ‘‘to the extent permitted
by law, be offset by the elimination of
existing costs associated with at least
two prior regulations.’’ This final rule
imposes no more than de minimis costs
and is neither a regulatory nor a
deregulatory action under Executive
Order 13771.
In accordance with section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995, we are required
to solicit public comments, and receive
final Office of Management and Budget
(OMB) approval, on any information
collection requirements set forth in
rulemaking. This final rule will not
impose any information collection
burden or affect information currently
collected by OIG.
List of Subjects in 42 CFR Part 1008
Administrative practice and
procedure, Medicaid, Medicare,
Reporting and recordkeeping
requirements.
Frm 00053
Fmt 4700
Sfmt 9990
For the reasons set out in the
preamble, 42 CFR part 1008 is amended
as follows:
PART 1008—ADVISORY OPINIONS BY
THE OIG
1. The authority citation for part 1008
continues to read as follows:
■
Authority: 42 U.S.C. 1320a–7d(b).
2. Section 1008.15 is amended by
revising paragraph (c) to read as follows:
■
§ 1008.15 Facts subject to advisory
opinions.
*
IV. Paperwork Reduction Act
PO 00000
1369
*
*
*
*
(c) An advisory opinion request will
not be accepted, and/or an opinion will
not be issued when—
(1) The request is not related to a
named individual or entity; or
(2) An informed opinion cannot be
made, or could be made only after
extensive investigation, clinical study,
testing, or collateral inquiry.
*
*
*
*
*
Dated: January 3, 2022.
Christi A. Grimm,
Principal Deputy Performing Duties of the
Inspector General.
Xavier Becerra,
Secretary.
[FR Doc. 2022–00313 Filed 1–7–22; 8:45 am]
BILLING CODE 4152–01–P
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]]>Agencies
[Federal Register Volume 87, Number 7 (Tuesday, January 11, 2022)]
[Rules and Regulations]
[Pages 1367-1369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00313]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of Inspector General
42 CFR Part 1008
Medicare and State Health Care Programs: Fraud and Abuse;
Procedures Regarding the Submission of Advisory Opinion Requests to,
and the Issuance of Advisory Opinions by, OIG
AGENCY: Office of Inspector General (OIG), Department of Health and
Human Services (HHS).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: OIG is amending the regulations governing the procedures for
the submission of advisory opinion requests to, and the issuance of
advisory opinions by, OIG.
DATES: This final rule is effective February 10, 2022.
FOR FURTHER INFORMATION CONTACT: Christina Hinkle, Office of Counsel to
the Inspector General, (202) 465-6245.
SUPPLEMENTARY INFORMATION:
I. Background
Pursuant to section 1128D of the Social Security Act (the Act),\1\
HHS, through OIG, publishes advisory opinions regarding the application
of the Federal anti-kickback statute \2\ and the safe harbor
provisions, as well as OIG's administrative sanction authorities, to
parties' proposed or existing arrangements. More specifically, in
consultation with the Department of Justice (DOJ) OIG issues written
advisory opinions to requesting parties with regard to: (1) What
constitutes prohibited remuneration under the Federal anti-kickback
statute; (2) whether an arrangement or proposed arrangement satisfies
the criteria in section 1128B(b)(3) of the Act, or established by
regulation (i.e., safe harbors),\3\ for activities that do not result
in prohibited remuneration; (3) what constitutes an inducement to
reduce or
[[Page 1368]]
limit services to Medicare or Medicaid program beneficiaries under
section 1128A(b) of the Act; \4\ and (4) whether an activity or
proposed activity constitutes grounds for the imposition of sanctions
under section 1128,\5\ 1128A, or 1128B of the Act.
---------------------------------------------------------------------------
\1\ 42 U.S.C. 1320a-7d.
\2\ Section 1128B of the Act; 42 U.S.C. 1320a-7b(b).
\3\ The safe harbor regulations are set forth at 42 CFR
1001.952.
\4\ 42 U.S.C. 1320a-7a(b).
\5\ 42 U.S.C. 1320a-7.
---------------------------------------------------------------------------
Section 1128D(b) required the issuance of regulations to carry out
the advisory opinion process and specified that the regulations must
provide for ``the procedure to be followed by the [OIG] in responding
to a request for an advisory opinion.'' In response to this
requirement, OIG issued an interim final rule with comment period in
1997.\6\ In this interim final rule, OIG established a new 42 CFR part
1008, which contains the specific procedures for the submission of
requests by individuals or entities for advisory opinions to and the
issuance of advisory opinions by OIG, in consultation with DOJ. We
revised and clarified our regulations in a final rule issued in
1998.\7\ In 2008, we revised certain procedural requirements in 42 CFR
part 1008 for submitting payments for advisory opinion costs.\8\
---------------------------------------------------------------------------
\6\ 62 FR 7350 (Feb. 19, 1997).
\7\ 63 FR 38311 (July 16, 1998).
\8\ 73 FR 15937 (Mar. 26, 2008); 73 FR 40982 (July 17, 2008).
---------------------------------------------------------------------------
In the 1997 interim final rule, OIG established a procedural
regulation--42 CFR 1008.15(c)--that describes the circumstances in
which OIG will not accept a request or will not issue an opinion.
Specifically, Sec. 1008.15(c) provides that an advisory opinion
request will not be accepted and/or an advisory opinion will not be
issued when: (1) The request is not related to a named individual or
entity; (2) the same or substantially the same course of action is
under investigation, or is or has been the subject of a proceeding
involving HHS or another governmental agency; or (3) an informed
opinion cannot be made, or could be made only after extensive
investigation, clinical study, testing, or collateral inquiry. Section
1008.15(c) has not been modified since it was promulgated in 1997.
II. Final Rule
This final rule removes the procedural provision at 42 CFR
1008.15(c)(2), which precludes the acceptance of an advisory opinion
request and/or issuance of an advisory opinion when the same or
substantially the same course of action is under investigation or has
been the subject of a proceeding involving HHS or another governmental
agency. In addition, this final rule corrects a grammatical error in
Sec. 1008.15(c).
Section 1008.15(c) is a procedural rule that was promulgated
consistent with our statutory obligation under section 1128D(b) of the
Act. The purpose of Sec. 1008.15(c)(2) is to prevent the advisory
opinion process from interfering with the investigatory or
prosecutorial authority of OIG, DOJ, or any other governmental agency.
Under the current regulation, no advisory opinion is issued if the same
or substantially the same course of action is under investigation or is
the subject of a proceeding involving HHS or another governmental
agency.
We are removing Sec. 1008.15(c)(2) for two reasons. First, removal
of this provision will offer OIG more flexibility in responding to
requests for advisory opinions. In particular, this final rule will
afford OIG the flexibility to issue a favorable or unfavorable advisory
opinion when an arrangement presented in an advisory opinion request
involves conduct that is the same or substantially the same as conduct
that is under investigation or subject to a proceeding. When OIG has
rejected advisory opinion requests pursuant to the existing regulation,
some requestors have expressed frustration with this regulatory
provision because it prevents OIG from providing its legal opinion
regarding the application of certain Federal fraud and abuse
authorities. Second, removal of Sec. 1008.15(c)(2) may provide
industry stakeholders with greater transparency regarding factors the
Government may consider in evaluating compliance with certain Federal
fraud and abuse laws and distinguishing between similar arrangements.
In conjunction with issuing this rule, OIG is publishing on its
website an enforcement policy statement announcing that, as of the
effective date of this rule, if the arrangement for which an advisory
opinion is sought is the same or similar to conduct that is currently
under investigation or is the subject of a proceeding involving a
governmental agency, that fact will weigh against the issuance of a
favorable advisory opinion because such circumstances generally
indicate that the arrangement does not present a sufficiently low risk
of fraud and abuse. That said, consistent with current practices, OIG
will carefully consider the facts and circumstances of each advisory
opinion request in our legal assessment.
This rulemaking is separate and distinct from the Request for
Information (RFI) entitled ``OIG Modernization Initiative To Improve
Its Publicly Available Resources,'' published in the Federal Register
on September 24, 2021.\9\ OIG has not yet reviewed and considered
comments made in response to the RFI, and this rulemaking is not
connected to any feedback received in response to the RFI.
---------------------------------------------------------------------------
\9\ OIG, OIG Modernization Initiative To Improve Its Publicly
Available Resources--Request for Information, 86 FR 53072 (Sept. 24,
2021).
---------------------------------------------------------------------------
III. Regulatory Impact Statement
As set forth below, we have examined the impact of this final rule
as required by Executive Order 12866, the Regulatory Flexibility Act
(RFA) of 1980, the Unfunded Mandates Reform Act of 1995, Executive
Order 13132, and Executive Order 13771.
A. Administrative Procedure Act
The advisory opinion process is an established OIG program. This
final rule is limited to modifying the internal governmental procedure
for handling advisory opinion requests involving conduct that is the
same or similar to an ongoing investigation or proceeding. The
modification likely will result in a similar outcome for most advisory
opinion requests involving conduct that is the same or similar to an
ongoing investigation in that those requests likely would not result in
favorable advisory opinions. This rule does not modify eligibility of a
party to request an advisory opinion or the process for requesting an
advisory opinion.
OIG expects that this final rule will further the public's interest
with minimal burden by fulfilling the statutory obligations to consult
with DOJ as part of the advisory opinion process, providing greater
flexibility for OIG in its procedures to be followed in responding to a
request for an advisory opinion, and potentially promoting greater
transparency regarding factors the Government may consider in
evaluating compliance with certain Federal fraud and abuse laws and
distinguishing between similar arrangements. Because this rule is
procedural, notice and comment rulemaking is not required under 5
U.S.C. 553(b)(A).
B. Executive Order 12866 and Regulatory Flexibility Act
Because no notice of proposed rulemaking is required for this rule,
the provisions of the RFA do not apply. Furthermore, this document does
not meet the criteria for a significant regulatory action as specified
in Executive Order 12866.
[[Page 1369]]
C. Unfunded Mandates Reform Act
Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law
104-4, requires that agencies assess anticipated costs and benefits
before issuing any rule that may result in expenditures in any one year
by State, local, or tribal governments in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation). We believe that this final rule will not impose any
mandates on State, local, or tribal governments or the private sector
that would result in an expenditure of $100 million or more (adjusted
for inflation) in any given year, and that a full analysis under the
Unfunded Mandates Reform Act is not necessary.
D. Executive Order 13132
Executive Order 13132 establishes certain requirements that an
agency must meet when it promulgates a rule that imposes substantial
direct requirements or costs on State and local governments, preempts
State law, or otherwise has federalism implications. In reviewing this
final rule under the threshold criteria of Executive Order 13132,
Federalism, we have determined that this final rule would not
significantly limit the rights, roles, and responsibilities of State or
local governments. We have determined, therefore, that a full analysis
under Executive Order 13132 is not necessary.
E. Executive Order 13771
Executive Order 13771 requires that the costs associated with
significant new regulations ``to the extent permitted by law, be offset
by the elimination of existing costs associated with at least two prior
regulations.'' This final rule imposes no more than de minimis costs
and is neither a regulatory nor a deregulatory action under Executive
Order 13771.
IV. Paperwork Reduction Act
In accordance with section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, we are required to solicit public comments, and receive
final Office of Management and Budget (OMB) approval, on any
information collection requirements set forth in rulemaking. This final
rule will not impose any information collection burden or affect
information currently collected by OIG.
List of Subjects in 42 CFR Part 1008
Administrative practice and procedure, Medicaid, Medicare,
Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 42 CFR part 1008 is
amended as follows:
PART 1008--ADVISORY OPINIONS BY THE OIG
0
1. The authority citation for part 1008 continues to read as follows:
Authority: 42 U.S.C. 1320a-7d(b).
0
2. Section 1008.15 is amended by revising paragraph (c) to read as
follows:
Sec. 1008.15 Facts subject to advisory opinions.
* * * * *
(c) An advisory opinion request will not be accepted, and/or an
opinion will not be issued when--
(1) The request is not related to a named individual or entity; or
(2) An informed opinion cannot be made, or could be made only after
extensive investigation, clinical study, testing, or collateral
inquiry.
* * * * *
Dated: January 3, 2022.
Christi A. Grimm,
Principal Deputy Performing Duties of the Inspector General.
Xavier Becerra,
Secretary.
[FR Doc. 2022-00313 Filed 1-7-22; 8:45 am]
BILLING CODE 4152-01-P
