Rule2022-00313
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 11, 2022
Effective
February 10, 2022
Issuing agencies
Health and Human Services Department
Abstract
OIG is amending the regulations governing the procedures for the submission of advisory opinion requests to, and the issuance of advisory opinions by, OIG.
Full Text
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<title>Federal Register, Volume 87 Issue 7 (Tuesday, January 11, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-00313]
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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.
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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.
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\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.
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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\
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\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).
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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.
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\9\ OIG, OIG Modernization Initiative To Improve Its Publicly
Available Resources--Request for Information, 86 FR 53072 (Sept. 24,
2021).
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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
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</html>Indexed from Federal Register on January 11, 2022.
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