Solicitation of New Safe Harbors and Special Fraud Alerts, 61229-61230 [2017-27117]

Download as PDF Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Proposed Rules equal or exceed ten acres, (3) are located outside of the Big River Flood Plain Ecoregion and (4) are not listed as having site-specific criteria in Table M of the State’s WQS. (b) Combined Criterion for Missouri lakes and reservoirs. In all instances, nutrient protection values are maximum ambient concentrations expressed as seasonal (April through September) 61229 geometric mean values on a three-year rolling average basis. TABLE 1—LAKE ECOREGION NUTRIENT PROTECTION VALUES (μG/L) AND EUTROPHICATION IMPACTS * Lake Ecoregion TP Plains ........................................................................................................................................... Ozarks .......................................................................................................................................... TN 44 23 Chl-a 817 500 14 7.1 * Table 1 also applies to tributary arms Grand Glaize, Gravois, and Nianga to the Lake of the Ozarks, and tributary arms James River, Kings River, and Long Creek to Table Rock Lake. (1) Lake and reservoir water quality must not exceed nutrient protection values for chlorophyll a. (2) Lake and reservoir water quality must also not exceed nutrient protection values for total nitrogen and total phosphorus unless each of the following eutrophication impacts are evaluated and none occur within the same threeyear rolling average period: (I) Eutrophication-related mortality or morbidity events for fish and other aquatic organisms, (II) An excursion from the DO or pH criteria in Missouri water quality standards applicable for Clean Water Act purposes, (III) Cyanobacteria counts equal to or greater than 100,000 cells per ml, (IV) Observed shifts in aquatic diversity directly attributable to eutrophication, or (V) Excessive levels of mineral turbidity that consistently limit algal productivity during the period May 1—September 30, or Secchi disk measurements of turbidity equal to or less than EPA’s recommended Level III Ecoregions IX (1.53 m) or IX (2.86 m). daltland on DSKBBV9HB2PROD with PROPOSALS (c) Applicability (1) The combined criterion in paragraph (b) of this section applies to waters discussed in paragraph (a) of this section and applies concurrently with other applicable water quality criteria. (2) The combined criterion established in this section is subject to Missouri’s general rules of applicability in the same way and to the same extent as state-adopted and EPA-approved water quality criteria when applied to the waters discussed in paragraph (a). (d) Effective date. Section 131.47 will be in effect [date 60 days after publication of final rule]. [FR Doc. 2017–27621 Filed 12–26–17; 8:45 am] BILLING CODE 6560–50–P VerDate Sep<11>2014 20:10 Dec 26, 2017 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of Inspector General 42 CFR Part 1001 Solicitation of New Safe Harbors and Special Fraud Alerts Office of Inspector General (OIG), HHS. 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, and modifying existing, safe harbor provisions under the Federal anti-kickback statute (§ 1128B(b) of the Social Security Act), as well as developing new OIG Special Fraud Alerts. DATES: To ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 26, 2018. ADDRESSES: In commenting, please refer to file code OIG–127–N. Because of staff and resource limitations, we cannot accept comments by facsimile (fax) transmission. You may submit comments in one of three ways (no duplicates, please): 1. Electronically. You may submit electronic comments on specific recommendations and proposals through the Federal eRulemaking Portal at http://www.regulations.gov. 2. By regular, express, or overnight mail. You may send written comments to the following address: Patrice Drew, Office of Inspector General, Regulatory Affairs, Department of Health and Human Services, Attention: OIG–127–N, Room 5541C, 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. SUMMARY: PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 3. By hand or courier. If you prefer, you may deliver your written comments by hand or courier before the close of the comment period to Patrice Drew, Office of Inspector General, Department of Health and Human Services, Cohen Building, Room 5541C, 330 Independence Avenue SW, Washington, DC 20201. Because access to the interior of the Cohen Building is not readily available to persons without Federal Government identification, commenters are encouraged to schedule their delivery with one of our staff members at (202) 619–1368. For information on viewing public comments, please see the SUPPLEMENTARY INFORMATION section. FOR FURTHER INFORMATION CONTACT: Patrice Drew, Regulatory Affairs Liaison, Office of Inspector General, (202) 619–1368. SUPPLEMENTARY INFORMATION: Submitting Comments: We welcome comments from the public on recommendations for developing new or revised safe harbors and Special Fraud Alerts. Please assist us by referencing the file code OIG–127–N. Inspection of Public Comments: All comments received before the end of the comment period are available for viewing by the public. All comments will be posted on http:// www.regulations.gov after the closing of the comment period. Comments received in a timely manner will also be available for public inspection as they are received at the Office of Inspector General, Department of Health and Human Services, Cohen Building, 330 Independence Avenue SW, Washington, DC 20201, Monday through Friday, from 10 a.m. to 5 p.m. To schedule an appointment to view public comments, phone (202) 619–1368. I. Background A. OIG Safe Harbor Provisions Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C. 1320a– 7b(b)) provides criminal penalties for individuals or entities that knowingly E:\FR\FM\27DEP1.SGM 27DEP1 61230 Federal Register / Vol. 82, No. 247 / Wednesday, December 27, 2017 / Proposed Rules daltland on DSKBBV9HB2PROD with PROPOSALS and willfully offer, pay, solicit, or receive remuneration to induce or reward business reimbursable under Federal health care programs. The offense is classified as a felony and is punishable by fines of up to $25,000 and imprisonment for up to 5 years. OIG may also impose civil money penalties, in accordance with section 1128A(a)(7) of the Act (42 U.S.C. 1320a–7a(a)(7)), or exclusion from Federal health care programs, in accordance with section 1128(b)(7) of the Act (42 U.S.C. 1320a– 7(b)(7)). Because the statute, on its face, is so broad, concern has been expressed for many years that some relatively innocuous commercial arrangements may be subject to criminal prosecution or administrative sanction. In response to the above concern, section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100–93 § 14, specifically required the development and promulgation of regulations, the so-called ‘‘safe harbor’’ provisions, specifying various payment and business practices that, although potentially capable of inducing referrals of business reimbursable under Federal health care programs, would not be treated as criminal offenses under the anti-kickback statute and would not serve as a basis for administrative sanctions. OIG 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’’ (56 FR 35952, July 29, 1991). Health care providers and others may voluntarily seek to comply with these provisions so that they have the assurance that their business practices will not be subject to liability under the anti-kickback statute or related administrative authorities. OIG safe harbor regulations 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 providers with respect to practices OIG considers to be suspect or of particular concern. The Special Fraud Alerts encourage industry compliance by giving providers guidance that can be applied to their own practices. OIG Special Fraud Alerts are published in the Federal Register and on our website and are intended for extensive distribution. In developing Special Fraud Alerts, OIG relies on a number of sources and consults directly with experts in the subject field, including those within OIG, other agencies of the U.S. Department of Health and Human VerDate Sep<11>2014 20:10 Dec 26, 2017 Jkt 244001 Services (the Department), 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 the Health Insurance Portability and Accountability Act of 1996 (HIPAA), Public Law 104–191 § 205 (the Act), § 1128D, 42 U.S.C. 1320a–7d, requires the Department to develop and publish an annual notification in the Federal Register formally soliciting proposals for modifying existing safe harbors to the anti-kickback statute and for developing new safe harbors and Special Fraud Alerts. In developing safe harbors for a criminal statute, OIG thoroughly reviews the range of factual circumstances that may fall within the proposed safe harbor subject area so as to uncover potential opportunities for fraud and abuse. Only then can OIG determine, in consultation with the U.S. Department of Justice, whether it can effectively develop regulatory limitations and controls that will permit beneficial and innocuous arrangements within a subject area while, at the same time, protecting Federal health care programs and their beneficiaries from abusive practices. II. Solicitation of Additional New Recommendations and Proposals In accordance with the requirements of section 205 of HIPAA, OIG last published a Federal Register solicitation notification for developing new safe harbors and Special Fraud Alerts on December 28, 2016 (81 FR 95551). As required under section 205 of the Act, a status report of the proposals OIG received for new and modified safe harbors in response to that solicitation notification is set forth in Appendix F of OIG’s Fall 2017 Semiannual Report to Congress.1 OIG is not seeking additional public comment on the proposals listed in Appendix F at this time. Rather, this notification seeks additional recommendations regarding the development of new or modified safe harbor regulations and new Special Fraud Alerts beyond those summarized in Appendix F. A detailed explanation of justifications for, or empirical data supporting, a suggestion for a safe harbor or Special Fraud Alert would be helpful and should, if possible, be 1 The OIG Semiannual Report to Congress can be accessed through the OIG website at http:// oig.hhs.gov/publications/semiannual.asp. PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 included in any response to this solicitation. 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 new 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 take into account their decisions 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 12, 2017. Daniel R. Levinson, Inspector General. [FR Doc. 2017–27117 Filed 12–26–17; 8:45 am] BILLING CODE 4152–01–P DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS–HQ–ES–2017–0047; 4500090024] RIN 1018–BC83 Endangered and Threatened Wildlife and Plants; Listing the Yangtze Sturgeon as an Endangered Species AGENCY: Fish and Wildlife Service, Interior. E:\FR\FM\27DEP1.SGM 27DEP1

Agencies

[Federal Register Volume 82, Number 247 (Wednesday, December 27, 2017)]
[Proposed Rules]
[Pages 61229-61230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-27117]


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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), HHS.

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, 
and modifying existing, safe harbor provisions under the Federal anti-
kickback statute (Sec.  1128B(b) of the Social Security Act), as well 
as developing new OIG Special Fraud Alerts.

DATES: To ensure consideration, public comments must be delivered to 
the address provided below by no later than 5 p.m. on February 26, 
2018.

ADDRESSES: In commenting, please refer to file code OIG-127-N. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (fax) transmission.
    You may submit comments in one of three ways (no duplicates, 
please):
    1. Electronically. You may submit electronic comments on specific 
recommendations and proposals through the Federal eRulemaking Portal at 
http://www.regulations.gov.
    2. By regular, express, or overnight mail. You may send written 
comments to the following address: Patrice Drew, Office of Inspector 
General, Regulatory Affairs, Department of Health and Human Services, 
Attention: OIG-127-N, Room 5541C, 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.
    3. By hand or courier. If you prefer, you may deliver your written 
comments by hand or courier before the close of the comment period to 
Patrice Drew, Office of Inspector General, Department of Health and 
Human Services, Cohen Building, Room 5541C, 330 Independence Avenue SW, 
Washington, DC 20201. Because access to the interior of the Cohen 
Building is not readily available to persons without Federal Government 
identification, commenters are encouraged to schedule their delivery 
with one of our staff members at (202) 619-1368.
    For information on viewing public comments, please see the 
SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Patrice Drew, Regulatory Affairs 
Liaison, Office of Inspector General, (202) 619-1368.

SUPPLEMENTARY INFORMATION: 
    Submitting Comments: We welcome comments from the public on 
recommendations for developing new or revised safe harbors and Special 
Fraud Alerts. Please assist us by referencing the file code OIG-127-N.
    Inspection of Public Comments: All comments received before the end 
of the comment period are available for viewing by the public. All 
comments will be posted on http://www.regulations.gov after the closing 
of the comment period. Comments received in a timely manner will also 
be available for public inspection as they are received at the Office 
of Inspector General, Department of Health and Human Services, Cohen 
Building, 330 Independence Avenue SW, Washington, DC 20201, Monday 
through Friday, from 10 a.m. to 5 p.m. To schedule an appointment to 
view public comments, phone (202) 619-1368.

I. Background

A. OIG Safe Harbor Provisions

    Section 1128B(b) of the Social Security Act (the Act) (42 U.S.C. 
1320a-7b(b)) provides criminal penalties for individuals or entities 
that knowingly

[[Page 61230]]

and willfully offer, pay, solicit, or receive remuneration to induce or 
reward business reimbursable under Federal health care programs. The 
offense is classified as a felony and is punishable by fines of up to 
$25,000 and imprisonment for up to 5 years. OIG may also impose civil 
money penalties, in accordance with section 1128A(a)(7) of the Act (42 
U.S.C. 1320a-7a(a)(7)), or exclusion from Federal health care programs, 
in accordance with section 1128(b)(7) of the Act (42 U.S.C. 1320a-
7(b)(7)).
    Because the statute, on its face, is so broad, concern has been 
expressed for many years that some relatively innocuous commercial 
arrangements may be subject to criminal prosecution or administrative 
sanction. In response to the above concern, section 14 of the Medicare 
and Medicaid Patient and Program Protection Act of 1987, Public Law 
100-93 Sec.  14, specifically required the development and promulgation 
of regulations, the so-called ``safe harbor'' provisions, specifying 
various payment and business practices that, although potentially 
capable of inducing referrals of business reimbursable under Federal 
health care programs, would not be treated as criminal offenses under 
the anti-kickback statute and would not serve as a basis for 
administrative sanctions. OIG 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'' (56 FR 35952, July 29, 1991). Health care 
providers and others may voluntarily seek to comply with these 
provisions so that they have the assurance that their business 
practices will not be subject to liability under the anti-kickback 
statute or related administrative authorities. OIG safe harbor 
regulations 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 providers with respect to practices OIG 
considers to be suspect or of particular concern. The Special Fraud 
Alerts encourage industry compliance by giving providers guidance that 
can be applied to their own practices. OIG Special Fraud Alerts are 
published in the Federal Register and on our website and are intended 
for extensive distribution.
    In developing Special Fraud Alerts, OIG relies on a number of 
sources and consults directly with experts in the subject field, 
including those within OIG, other agencies of the U.S. Department of 
Health and Human Services (the Department), 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 the Health Insurance Portability and Accountability 
Act of 1996 (HIPAA), Public Law 104-191 Sec.  205 (the Act), Sec.  
1128D, 42 U.S.C. 1320a-7d, requires the Department to develop and 
publish an annual notification in the Federal Register formally 
soliciting proposals for modifying existing safe harbors to the anti-
kickback statute and for developing new safe harbors and Special Fraud 
Alerts.
    In developing safe harbors for a criminal statute, OIG thoroughly 
reviews the range of factual circumstances that may fall within the 
proposed safe harbor subject area so as to uncover potential 
opportunities for fraud and abuse. Only then can OIG determine, in 
consultation with the U.S. Department of Justice, whether it can 
effectively develop regulatory limitations and controls that will 
permit beneficial and innocuous arrangements within a subject area 
while, at the same time, protecting Federal health care programs and 
their beneficiaries from abusive practices.

II. Solicitation of Additional New Recommendations and Proposals

    In accordance with the requirements of section 205 of HIPAA, OIG 
last published a Federal Register solicitation notification for 
developing new safe harbors and Special Fraud Alerts on December 28, 
2016 (81 FR 95551). As required under section 205 of the Act, a status 
report of the proposals OIG received for new and modified safe harbors 
in response to that solicitation notification is set forth in Appendix 
F of OIG's Fall 2017 Semiannual Report to Congress.\1\ OIG is not 
seeking additional public comment on the proposals listed in Appendix F 
at this time. Rather, this notification seeks additional 
recommendations regarding the development of new or modified safe 
harbor regulations and new Special Fraud Alerts beyond those summarized 
in Appendix F.
---------------------------------------------------------------------------

    \1\ The OIG Semiannual Report to Congress can be accessed 
through the OIG website at http://oig.hhs.gov/publications/semiannual.asp.
---------------------------------------------------------------------------

    A detailed explanation of justifications for, or empirical data 
supporting, a suggestion for a safe harbor or Special Fraud Alert would 
be helpful and should, if possible, be included in any response to this 
solicitation.

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 new 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 take into 
account their decisions 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 12, 2017.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2017-27117 Filed 12-26-17; 8:45 am]
 BILLING CODE 4152-01-P