[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]


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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]
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