Solicitation of New Safe Harbors and Special Fraud Alerts, 71611-71612 [2021-27314]

Download as PDF Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Proposed Rules § 102–73.335 When will Federal lessees provide information to GSA? identity of interests among family members, shared facilities and equipment, and the common use of employees. Federal lessees will submit the required information on an annual basis. Applicability § 102–73.320 provisions? Who must comply with these Each Federal lessee and covered entity must cooperate and comply with these provisions. Information Collection Sections 3 and 4 of the Secure Federal LEASEs Act require that, before the Government may enter into a lease agreement or novation with an entity for high-security leased space (defined as Facility Security Level III, IV or V), offerors must disclose whether the immediate owner, highest-level owner, or beneficial owner of the leased space, including an entity involved in the financing thereof, is a foreign person or entity, including the country associated with the ownership entity. Other agencies may replicate GSA’s approach to this requirement, by referring to the interim rule General Services Administration Acquisition Regulation Case 2021–G527 (86 FR 34966). jspears on DSK121TN23PROD with PROPOSALS1 § 102–73.330 What information must a Federal lessee provide to GSA? Federal lessees must provide the following information when sharing their Secure Federal LEASEs Act disclosures with GSA: (a) Name of the agency conducting the procurement (b) Date of disclosure (c) Solicitation number or Contract number (for novations) (d) Type of Action (prior to entering a lease or prior to a novation agreement) (e) Total number of affirmative disclosures made (note—in some instances, there may be more than one owner-of-a-type. If more than one affirmative disclosure is made, include all disclosures) (f) As part of the total number of disclosures made, was one of the disclosures an affirmative immediate owner disclosure? If so, how many? (g) As part of the total number of disclosures made, was one of the disclosures an affirmative highest-level owner disclosure? If so, how many? (h) As part of the total number of disclosures made, was one of the disclosures an affirmative beneficial owner disclosure? If so, how many? 17:38 Dec 16, 2021 Federal lessees will submit the required information to GSA via email at SFLA@gsa.gov. [FR Doc. 2021–27333 Filed 12–16–21; 8:45 am] BILLING CODE 6820–14–P § 102–73.325 What information must a covered entity provide to a Federal lessee? VerDate Sep<11>2014 § 102–73.340 How will Federal lessees provide information to GSA? Jkt 256001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General Solicitation of New Safe Harbors and Special Fraud Alerts Office of Inspector General (OIG), Department of Health and Human Services (HHS or the Department). ACTION: Notification of intent to develop regulations. AGENCY: In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute), as well as developing new OIG Special Fraud Alerts. DATES: To ensure consideration, public comments must be received no later than 5 p.m. on February 15, 2022. ADDRESSES: In commenting, please refer to file code OIG–1121–N. Because of staff and resource limitations, we cannot accept comments by fax transmission. You may submit comments in one of two ways (no duplicates, please): 1. Electronically. You may submit comments electronically at https:// www.regulations.gov. Follow the ‘‘Submit a comment’’ instructions and refer to file code OIG–1121–N. 2. By regular, express, or overnight mail. You may send written comments to the following address: OIG, Regulatory Affairs, HHS, Attention: OIG–1121–N, Room 5527, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201. Please allow sufficient time for mailed comments to be received before the close of the comment period. For information on viewing public comments, please see the SUPPLEMENTARY INFORMATION section. PO 00000 Frm 00025 Fmt 4702 Sfmt 4702 FOR FURTHER INFORMATION CONTACT: Samantha Flanzer, Office of Inspector General, (202) 619–0335. SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: https:// www.regulations.gov. Follow the search instructions on that website to view public comments. I. Background 42 CFR Part 1001 SUMMARY: 71611 A. OIG Safe Harbor Provisions Section 1128B(b) of the Act (42 U.S.C. 1320a–7b(b)), the Federal anti-kickback statute, provides for criminal penalties for whoever knowingly and willfully offers, pays, solicits, or receives remuneration to induce or reward, among other things, the referral for or purchase of items or services reimbursable under any of the Federal health care programs, as defined in section 1128B(f) of the Act (42 U.S.C. 1320a–7b(f)). The offense is classified as a felony and is punishable by fines of up to $100,000 and imprisonment for up to 10 years. Violations of the Federal anti-kickback statute also may result in the imposition of civil monetary penalties under section 1128A(a)(7) of the Act (42 U.S.C. 1320a–7a(a)(7)), program exclusion under section 1128(b)(7) of the Act (42 U.S.C. 1320a– 7(b)(7)), and liability under the False Claims Act (31 U.S.C. 3729–33). Because of the broad reach of the statute, stakeholders expressed concern that some relatively innocuous business arrangements were covered by the statute and, therefore, potentially subject to criminal prosecution. In response, Congress enacted section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100–93 (note to section 1128B of the Act; 42 U.S.C. 1320a–7b), which requires the development and promulgation of regulations, the socalled safe harbor provisions, that would specify various payment and business practices that would not be subject to sanctions under the Federal anti-kickback statute, even though they potentially may be capable of inducing referrals of business for which payment may be made under a Federal health care program. Since July 29, 1991, there has been a series of final regulations published in the Federal Register E:\FR\FM\17DEP1.SGM 17DEP1 71612 Federal Register / Vol. 86, No. 240 / Friday, December 17, 2021 / Proposed Rules establishing safe harbors protecting various payment and business practices.1 These safe harbor provisions have been developed ‘‘to limit the reach of the statute somewhat by permitting certain non-abusive arrangements, while encouraging beneficial and innocuous arrangements.’’ 2 Health care providers and others may voluntarily seek to comply with the conditions of an applicable safe harbor so that they have the assurance that their payment or business practice will not be subject to sanctions under the Federal antikickback statute. The safe harbor regulations promulgated by OIG are found at 42 CFR part 1001. B. OIG Special Fraud Alerts OIG periodically issues Special Fraud Alerts to give continuing guidance to health care industry stakeholders regarding practices OIG considers to be suspect or of particular concern.3 Special Fraud Alerts encourage industry compliance by giving stakeholders guidance that can be applied to their own practices. OIG Special Fraud Alerts are published in the Federal Register, on OIG’s website, or both, and are intended for extensive distribution. In developing Special Fraud Alerts, OIG relies on several sources and consults directly with experts in the subject field including those within OIG, other agencies of HHS, other Federal and State agencies, and those in the health care industry. C. Section 205 of the Health Insurance Portability and Accountability Act of 1996 Section 205 of HIPAA, Public Law 104–191, and section 1128D of the Act jspears on DSK121TN23PROD with PROPOSALS1 1 See e.g., Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, 81 FR 88368 (Dec. 7, 2016). 2 Medicare and State Health Care Programs: Fraud and Abuse; OIG Anti-Kickback Provisions, 56 FR 35952, 35958 (July 29, 1991). 3 See e.g., Special Fraud Alert: Speaker Programs (Nov. 16, 2020), available at https://oig.hhs.gov/ fraud/docs/alertsandbulletins/2020/ SpecialFraudAlertSpeakerPrograms.pdf. VerDate Sep<11>2014 17:38 Dec 16, 2021 Jkt 256001 (42 U.S.C. 1320a-7d), requires the Department to develop and publish an annual notification in the Federal Register formally soliciting proposals for developing additional or modifying existing safe harbors to the Federal antikickback statute and Special Fraud Alerts. In developing or modifying safe harbors under the Federal anti-kickback statute, and in consultation with the Department of Justice, OIG thoroughly reviews the range of factual circumstances that may receive protection by the proposed or modified safe harbor. In doing so, OIG seeks to identify and develop safe harbors that protect beneficial and innocuous arrangements and safeguard Federal health care programs and their beneficiaries from the harms caused by fraud and abuse. II. Solicitation of Additional New Recommendations and Proposals OIG seeks recommendations regarding the development of additional or modified safe harbor regulations and new Special Fraud Alerts. A detailed explanation of justifications for, or empirical data supporting, a suggestion for a new or modified safe harbor or Special Fraud Alert would be helpful and should, if possible, be included in any response to this solicitation. While OIG welcomes all relevant comments, this solicitation is separate and distinct from the Request for Information entitled ‘‘OIG Modernization Initiative To Improve Its Publicly Available Resources,’’ published in the Federal Register on September 24, 2021 (RFI).4 Commenters need not duplicate comments submitted in response to OIG’s RFI. A. Criteria for Modifying and Establishing Safe Harbor Provisions In accordance with section 205 of HIPAA, we will consider a number of factors in reviewing proposals for additional or modified safe harbor provisions, such as the extent to which the proposals would affect an increase or decrease in: • Access to health care services, • the quality of health care services, • patient freedom of choice among health care providers, • competition among health care providers, • the cost to Federal health care programs, • the potential overutilization of health care services, and • the ability of health care facilities to provide services in medically underserved areas or to medically underserved populations. In addition, we will consider other factors including, for example, the existence (or nonexistence) of any potential financial benefit to health care professionals or providers that may influence their decision whether to: (1) Order a health care item or service or (2) arrange for a referral of health care items or services to a particular practitioner or provider. B. Criteria for Developing Special Fraud Alerts In determining whether to issue additional Special Fraud Alerts, we will consider whether and to what extent the practices that would be identified in a new Special Fraud Alert may result in any of the consequences set forth above, as well as the volume and frequency of the conduct that would be identified in the Special Fraud Alert. Dated: December 2, 2021. Christi A. Grimm, Principal Deputy Performing Duties of the Inspector General. [FR Doc. 2021–27314 Filed 12–16–21; 8:45 am] BILLING CODE 4152–01–P 4 OIG, OIG Modernization Initiative To Improve Its Publicly Available Resources—Request for Information, 86 FR 53072 (Sept. 24, 2021). PO 00000 Frm 00026 Fmt 4702 Sfmt 9990 E:\FR\FM\17DEP1.SGM 17DEP1

Agencies

[Federal Register Volume 86, Number 240 (Friday, December 17, 2021)]
[Proposed Rules]
[Pages 71611-71612]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27314]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of Inspector General

42 CFR Part 1001


Solicitation of New Safe Harbors and Special Fraud Alerts

AGENCY: Office of Inspector General (OIG), Department of Health and 
Human Services (HHS or the Department).

ACTION: Notification of intent to develop regulations.

-----------------------------------------------------------------------

SUMMARY: In accordance with section 205 of the Health Insurance 
Portability and Accountability Act of 1996 (HIPAA), this annual 
notification solicits proposals and recommendations for developing new, 
or modifying existing, safe harbor provisions under section 1128B(b) of 
the Social Security Act (the Act), the Federal anti-kickback statute), 
as well as developing new OIG Special Fraud Alerts.

DATES: To ensure consideration, public comments must be received no 
later than 5 p.m. on February 15, 2022.

ADDRESSES: In commenting, please refer to file code OIG-1121-N. Because 
of staff and resource limitations, we cannot accept comments by fax 
transmission. You may submit comments in one of two ways (no 
duplicates, please):
    1. Electronically. You may submit comments electronically at 
https://www.regulations.gov. Follow the ``Submit a comment'' 
instructions and refer to file code OIG-1121-N.
    2. By regular, express, or overnight mail. You may send written 
comments to the following address: OIG, Regulatory Affairs, HHS, 
Attention: OIG-1121-N, Room 5527, Cohen Building, 330 Independence 
Avenue SW, Washington, DC 20201. Please allow sufficient time for 
mailed comments to be received before the close of the comment period.
    For information on viewing public comments, please see the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Samantha Flanzer, Office of Inspector 
General, (202) 619-0335.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: https://www.regulations.gov. Follow the search instructions 
on that website to view public comments.

I. Background

A. OIG Safe Harbor Provisions

    Section 1128B(b) of the Act (42 U.S.C. 1320a-7b(b)), the Federal 
anti-kickback statute, provides for criminal penalties for whoever 
knowingly and willfully offers, pays, solicits, or receives 
remuneration to induce or reward, among other things, the referral for 
or purchase of items or services reimbursable under any of the Federal 
health care programs, as defined in section 1128B(f) of the Act (42 
U.S.C. 1320a-7b(f)). The offense is classified as a felony and is 
punishable by fines of up to $100,000 and imprisonment for up to 10 
years. Violations of the Federal anti-kickback statute also may result 
in the imposition of civil monetary penalties under section 1128A(a)(7) 
of the Act (42 U.S.C. 1320a-7a(a)(7)), program exclusion under section 
1128(b)(7) of the Act (42 U.S.C. 1320a-7(b)(7)), and liability under 
the False Claims Act (31 U.S.C. 3729-33).
    Because of the broad reach of the statute, stakeholders expressed 
concern that some relatively innocuous business arrangements were 
covered by the statute and, therefore, potentially subject to criminal 
prosecution. In response, Congress enacted section 14 of the Medicare 
and Medicaid Patient and Program Protection Act of 1987, Public Law 
100-93 (note to section 1128B of the Act; 42 U.S.C. 1320a-7b), which 
requires the development and promulgation of regulations, the so-called 
safe harbor provisions, that would specify various payment and business 
practices that would not be subject to sanctions under the Federal 
anti-kickback statute, even though they potentially may be capable of 
inducing referrals of business for which payment may be made under a 
Federal health care program. Since July 29, 1991, there has been a 
series of final regulations published in the Federal Register

[[Page 71612]]

establishing safe harbors protecting various payment and business 
practices.\1\ These safe harbor provisions have been developed ``to 
limit the reach of the statute somewhat by permitting certain non-
abusive arrangements, while encouraging beneficial and innocuous 
arrangements.'' \2\ Health care providers and others may voluntarily 
seek to comply with the conditions of an applicable safe harbor so that 
they have the assurance that their payment or business practice will 
not be subject to sanctions under the Federal anti-kickback statute. 
The safe harbor regulations promulgated by OIG are found at 42 CFR part 
1001.
---------------------------------------------------------------------------

    \1\ See e.g., Medicare and State Health Care Programs: Fraud and 
Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute 
and Civil Monetary Penalty Rules Regarding Beneficiary Inducements, 
81 FR 88368 (Dec. 7, 2016).
    \2\ Medicare and State Health Care Programs: Fraud and Abuse; 
OIG Anti-Kickback Provisions, 56 FR 35952, 35958 (July 29, 1991).
---------------------------------------------------------------------------

B. OIG Special Fraud Alerts

    OIG periodically issues Special Fraud Alerts to give continuing 
guidance to health care industry stakeholders regarding practices OIG 
considers to be suspect or of particular concern.\3\ Special Fraud 
Alerts encourage industry compliance by giving stakeholders guidance 
that can be applied to their own practices. OIG Special Fraud Alerts 
are published in the Federal Register, on OIG's website, or both, and 
are intended for extensive distribution.
---------------------------------------------------------------------------

    \3\ See e.g., Special Fraud Alert: Speaker Programs (Nov. 16, 
2020), available at https://oig.hhs.gov/fraud/docs/alertsandbulletins/2020/SpecialFraudAlertSpeakerPrograms.pdf.
---------------------------------------------------------------------------

    In developing Special Fraud Alerts, OIG relies on several sources 
and consults directly with experts in the subject field including those 
within OIG, other agencies of HHS, other Federal and State agencies, 
and those in the health care industry.

C. Section 205 of the Health Insurance Portability and Accountability 
Act of 1996

    Section 205 of HIPAA, Public Law 104-191, and section 1128D of the 
Act (42 U.S.C. 1320a-7d), requires the Department to develop and 
publish an annual notification in the Federal Register formally 
soliciting proposals for developing additional or modifying existing 
safe harbors to the Federal anti-kickback statute and Special Fraud 
Alerts.
    In developing or modifying safe harbors under the Federal anti-
kickback statute, and in consultation with the Department of Justice, 
OIG thoroughly reviews the range of factual circumstances that may 
receive protection by the proposed or modified safe harbor. In doing 
so, OIG seeks to identify and develop safe harbors that protect 
beneficial and innocuous arrangements and safeguard Federal health care 
programs and their beneficiaries from the harms caused by fraud and 
abuse.

II. Solicitation of Additional New Recommendations and Proposals

    OIG seeks recommendations regarding the development of additional 
or modified safe harbor regulations and new Special Fraud Alerts. A 
detailed explanation of justifications for, or empirical data 
supporting, a suggestion for a new or modified safe harbor or Special 
Fraud Alert would be helpful and should, if possible, be included in 
any response to this solicitation. While OIG welcomes all relevant 
comments, this solicitation is separate and distinct from the Request 
for Information entitled ``OIG Modernization Initiative To Improve Its 
Publicly Available Resources,'' published in the Federal Register on 
September 24, 2021 (RFI).\4\ Commenters need not duplicate comments 
submitted in response to OIG's RFI.
---------------------------------------------------------------------------

    \4\ OIG, OIG Modernization Initiative To Improve Its Publicly 
Available Resources--Request for Information, 86 FR 53072 (Sept. 24, 
2021).
---------------------------------------------------------------------------

A. Criteria for Modifying and Establishing Safe Harbor Provisions

    In accordance with section 205 of HIPAA, we will consider a number 
of factors in reviewing proposals for additional or modified safe 
harbor provisions, such as the extent to which the proposals would 
affect an increase or decrease in:
     Access to health care services,
     the quality of health care services,
     patient freedom of choice among health care providers,
     competition among health care providers,
     the cost to Federal health care programs,
     the potential overutilization of health care services, and
     the ability of health care facilities to provide services 
in medically underserved areas or to medically underserved populations.
    In addition, we will consider other factors including, for example, 
the existence (or nonexistence) of any potential financial benefit to 
health care professionals or providers that may influence their 
decision whether to: (1) Order a health care item or service or (2) 
arrange for a referral of health care items or services to a particular 
practitioner or provider.

B. Criteria for Developing Special Fraud Alerts

    In determining whether to issue additional Special Fraud Alerts, we 
will consider whether and to what extent the practices that would be 
identified in a new Special Fraud Alert may result in any of the 
consequences set forth above, as well as the volume and frequency of 
the conduct that would be identified in the Special Fraud Alert.

    Dated: December 2, 2021.
Christi A. Grimm,
Principal Deputy Performing Duties of the Inspector General.
[FR Doc. 2021-27314 Filed 12-16-21; 8:45 am]
BILLING CODE 4152-01-P
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