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