Solicitation of New Safe Harbors and Special Fraud Alerts, 79803-79805 [2015-32267]
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Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Proposed Rules
of this section in that business entity’s
tax jurisdiction of residence on the
income derived by the permanent
establishment.
(v) Certain transportation income. If a
constituent entity of a U.S. MNE group
derives income from international
transportation or transportation in
inland waterways that is covered by
income tax convention provisions that
are specific to such income and under
which the taxing rights on such income
are allocated exclusively to one tax
jurisdiction, then the U.S. MNE group
should report the information required
under paragraph (d)(2) of this section
with respect to such income for the tax
jurisdiction to which the relevant
income tax convention provisions
allocate these taxing rights.
(e) Reporting of financial amounts.—
(1) Reporting in U.S. dollars required.
All amounts furnished under paragraph
(d)(2) of this section, other than
paragraph (d)(2)(viii) of this section,
must be expressed in U.S. dollars. If an
exchange rate is used other than in
accordance with U.S. generally accepted
accounting principles for conversion to
U.S. dollars, the exchange rate must be
indicated.
(2) Sources of financial amounts. All
amounts furnished under paragraph
(d)(2) of this section, other than
paragraph (d)(2)(viii) of this section,
should be based on applicable financial
statements, books and records
maintained with respect to the
constituent entity, or records used for
tax reporting purposes.
(f) Time and manner for filing.
Returns on Form XXXX, Country-byCountry Report, required under
paragraph (a) of this section for a taxable
year will be filed with the ultimate
parent entity’s income tax return for the
taxable year on or before the due date
(including extensions) for filing that
person’s income tax return.
(g) Maintenance of records. The U.S.
person filing Form XXXX, Country-byCountry Report, as an ultimate parent
entity of a U.S. MNE group must
maintain records to support the
information provided on Form XXXX,
Country-by-Country Report. However,
the U.S. person is not required to have
or maintain records that reconcile the
amounts provided on Form XXXX,
Country-by-Country Report, with the tax
returns of any tax jurisdiction or
applicable financial statements.
(h) Exceptions to furnishing
information. A U.S. person that is an
ultimate parent entity of a U.S. MNE
group is not required to report
information under this section for an
annual accounting period described in
paragraph (c) of this section if the
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17:28 Dec 22, 2015
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annual revenue of the U.S. MNE group
for the immediately preceding annual
accounting period was less than
$850,000,000.
(j) Effective/applicability dates. The
rules of this section apply to taxable
years of ultimate parent entities of U.S.
MNE groups that begin on or after the
date of publication of the Treasury
decision adopting these rules as final
regulations in the Federal Register and
that include annual accounting periods
determined under section 6038(e)(4) of
all foreign constituent entities and
taxable years of all domestic constituent
entities beginning on or after the date of
publication of the Treasury decision
adopting these rules as final regulations
in the Federal Register.
John Dalrymple,
Deputy Commissioner for Services and
Enforcement.
[FR Doc. 2015–32145 Filed 12–21–15; 4:15 pm]
BILLING CODE 4830–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 171
[EPA–HQ–OPP–2011–0183; FRL–9940–59]
RIN 2070–AJ20
Pesticides; Certification of Pesticide
Applicators; Second Extension of the
Comment Period
Environmental Protection
Agency (EPA).
ACTION: Proposed rule; extension of
comment period.
AGENCY:
EPA issued a proposed rule in
the Federal Register of August 24, 2015,
concerning certification of applicators of
restricted use pesticides. This document
extends the comment period to January
22, 2016. The comment period is being
extended to provide additional time for
commenters to prepare their responses.
DATES: The comment period for the
proposed rule published August 24,
2015, at 80 FR 51356, is extended.
Comments, identified by docket
identification (ID) number EPA–HQ–
OPP–2011–0183, must be received on or
before January 22, 2016.
ADDRESSES: Follow the detailed
instructions provided under ADDRESSES
in the Federal Register document of
August 24, 2015 (80 FR 51356) (FRL–
9931–83).
FOR FURTHER INFORMATION CONTACT:
Michelle Arling, Field and External
Affairs Division (7506P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
SUMMARY:
PO 00000
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79803
Ave. NW., Washington, DC 20460;
telephone number: (703) 308–5891;
email address: arling.michelle@epa.gov.
SUPPLEMENTARY INFORMATION: This
document extends the public comment
period established in the Federal
Register document of November 18,
2015 (80 FR 72029) (FRL–9936–82),
which extended the comment period
originally set in the Federal Register
document of August 24, 2015. In the
November 18, 2015 document,
comments were required to be
submitted by December 23, 2015. EPA is
hereby extending the comment period to
January 22, 2016.
To submit comments, or access the
docket, please follow the detailed
instructions provided under ADDRESSES
in the Federal Register document of
August 24, 2015. If you have questions,
consult the person listed under FOR
FURTHER INFORMATION CONTACT.
List of Subjects in 40 CFR Part 171
Environmental protection,
Administrative practice and procedure,
Certified applicator, Commercial
applicator, Indian Country, Indian
Tribes, Noncertified applicator,
Pesticides and pests, Private applicator,
Reporting and recordkeeping
requirements, Restricted use pesticides.
Dated: December 21, 2015.
Oscar Morales,
Acting Assistant Administrator, Office of
Chemical Safety and Pollution Prevention.
[FR Doc. 2015–32457 Filed 12–22–15; 8:45 am]
BILLING CODE 6560–50–P
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: Notice of intent to develop
regulations.
AGENCY:
In accordance with section
205 of the Health Insurance Portability
and Accountability Act of 1996
(HIPAA), this annual document solicits
proposals and recommendations for
developing new, and modifying
existing, safe harbor provisions under
the Federal anti-kickback statute
(section 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
SUMMARY:
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asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
79804
Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Proposed Rules
address provided below by no later than
5 p.m. on February 22, 2016.
ADDRESSES: In commenting, please refer
to file code OIG–124–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–124–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, by hand or courier,
your written comments 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–124–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 timely will also be available for
public inspection as they are received at
Office of Inspector General, Department
of Health and Human Services, Cohen
Building, 330 Independence Avenue
SW., Washington, DC 20201, Monday
VerDate Sep<11>2014
17:28 Dec 22, 2015
Jkt 238001
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
and willfully offer, pay, solicit, or
receive remuneration to induce or
reward business reimbursable under the
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 the 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 section 14, the Act, section
1128B(b), 42 U.S.C. 1320a–7b(b),
specifically required the development
and promulgation of regulations, the socalled ‘‘safe harbor’’ provisions,
specifying various payment and
business practices that, although
potentially capable of inducing referrals
of business reimbursable under the
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. The OIG safe
harbor regulations are found at 42 CFR
part 1001.
B. OIG Special Fraud Alerts
OIG has also periodically issued
Special Fraud Alerts to give continuing
guidance to health care providers with
respect to practices OIG finds
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potentially fraudulent or abusive. The
Special Fraud Alerts encourage industry
compliance by giving providers
guidance that can be applied to their
own practices. OIG Special Fraud Alerts
are intended for extensive distribution
directly to the health care provider
community, as well as to those charged
with administering the Federal health
care programs.
In developing Special Fraud Alerts,
OIG has relied on a number of sources
and has consulted directly with experts
in the subject field, including those
within OIG, other agencies of 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
section 205, the Act, section 1128D, 42
U.S.C. 1320a–7d, requires the
Department to develop and publish an
annual document 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 is required to
thoroughly review 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
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 the 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 notice for developing new
safe harbors and Special Fraud Alerts on
December 30, 2014 (79 FR 78376). As
required under section 205, a status
report of the public comments received
in response to that document is set forth
in Appendix F of OIG’s Fall 2015
Semiannual Report.1 OIG is not seeking
additional public comment on the
1 The OIG Semiannual Report to Congress can be
accessed through the OIG Web site at https://
oig.hhs.gov/publications/semiannual.asp.
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Federal Register / Vol. 80, No. 246 / Wednesday, December 23, 2015 / Proposed Rules
proposals listed in Appendix F at this
time. Rather, this document 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
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 also 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.
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS
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 16, 2015.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2015–32267 Filed 12–22–15; 8:45 am]
BILLING CODE 4152–01–P
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DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
50 CFR Part 17
[Docket No. FWS–R8–ES–2014–0007;
FXES11130900000–156–FF09E42000]
RIN 1018–AY82
Endangered and Threatened Wildlife
and Plants; Withdrawal of Proposed
Rule To Reclassify the Arroyo Toad as
Threatened
Fish and Wildlife Service,
Interior.
ACTION: Proposed rule; withdrawal.
AGENCY:
We, the U.S. Fish and
Wildlife Service (Service), withdraw the
proposed rule to reclassify the arroyo
toad (Anaxyrus californicus) as
threatened under the Endangered
Species Act of 1973, as amended (Act).
This withdrawal is based on our
conclusion that the types of threats to
the arroyo toad remain the same as at
the time of listing and are ongoing, and
new threats have been identified. Some
conservation efforts are ongoing in most
populations to help manage and reduce
impacts to arroyo toads from many
ongoing threats; however, the species
has not yet responded to an extent that
would allow a change in listing status.
The intent of the reclassification criteria
in the recovery plan (Service 1999) has
not been met. We have therefore
determined that reclassification of this
species is not appropriate at this time.
DATES: The March 27, 2014 (79 FR
17106), proposed rule to reclassify the
arroyo toad as threatened is withdrawn
as of December 23, 2015.
ADDRESSES: This withdrawal, comments
on our March 27, 2014, proposed rule
(79 FR 17106), and supplementary
documents are available on the Internet
at https://www.regulations.gov at Docket
No. FWS–R8–ES–2014–0007. Comments
and materials received, as well as
supporting documentation used in the
preparation of this withdrawal, are also
available for public inspection, by
appointment, during normal business
hours at: U.S. Fish and Wildlife Service,
Ventura Fish and Wildlife Office, 2493
Portola Road, Suite B, Ventura, CA
93003; telephone 805–644–1766; or
facsimile 805–644–3958.
FOR FURTHER INFORMATION CONTACT:
Stephen P. Henry, Field Supervisor,
Ventura Fish and Wildlife Office (see
ADDRESSES). If you use a
telecommunications device for the deaf
(TDD), call the Federal Information
Relay Service (FIRS) at 800–877–8339.
SUPPLEMENTARY INFORMATION:
SUMMARY:
PO 00000
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79805
Previous Federal Actions
Please refer to the proposed
reclassification rule for the arroyo toad
(79 FR 17106; March 27, 2014) for a
detailed description of the Federal
actions concerning this species that
occurred prior to publication of the
proposed reclassification rule. We
accepted submission of new information
and comments on the proposed
reclassification for a 60-day comment
period, ending May 27, 2014. In order
to ensure that the public had an
adequate opportunity to review and
comment on our proposed rule, we
reopened the comment period for an
additional 30 days on October 17, 2014
(79 FR 62408).
Background
A scientific analysis was completed
and presented in detail within the
arroyo toad species report (Service 2014,
entire), which was available on https://
www.regulations.gov at Docket Number
FWS–R8–ES–2014–0007 after the
publication of the proposed
reclassification. The species report was
updated to include the information we
received from public and peer review
comments, and the final species report
(Service 2015, entire) is available at
https://www.regulations.gov at Docket
Number FWS–R8–ES–2014–0007. The
species report was prepared by Service
biologists to provide thorough
discussion of the species’ ecology,
biological needs, and an analysis of the
threats that may be impacting the
species. The species report includes
discussion of the species’ life history,
taxonomy, habitat requirements, range,
distribution, abundance, threats, and
progress towards recovery. This detailed
information is summarized in the
following paragraphs of this Background
section and the Summary of Factors
Affecting the Species section.
Arroyo toads are found in low
gradient, medium-to-large streams and
rivers with intermittent and perennial
flow in coastal and desert drainages in
central and southern California, and
Baja California, Mexico. Arroyo toads
occupy aquatic, riparian, and upland
habitats in the remaining suitable
drainages within its range. Arroyo toads
are breeding habitat specialists that
need slow-moving streams that are
composed of sandy soils with sandy
streamside terraces (Sweet 1992, pp. 23–
28). Reproduction is dependent upon
the availability of very shallow, still, or
low-flow pools in which breeding, egglaying, and tadpole development occur.
Suitable habitat for arroyo toads is
created and maintained by periodic
flooding and scouring that modify
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]]>Agencies
[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Proposed Rules]
[Pages 79803-79805]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32267]
=======================================================================
-----------------------------------------------------------------------
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: Notice of intent to develop regulations.
-----------------------------------------------------------------------
SUMMARY: In accordance with section 205 of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA), this annual
document solicits proposals and recommendations for developing new, and
modifying existing, safe harbor provisions under the Federal anti-
kickback statute (section 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
[[Page 79804]]
address provided below by no later than 5 p.m. on February 22, 2016.
ADDRESSES: In commenting, please refer to file code OIG-124-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-124-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, by hand or
courier, your written comments 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-124-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 timely will also be available
for public inspection as they are received at 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 and willfully offer, pay, solicit, or receive
remuneration to induce or reward business reimbursable under the
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 the 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 section 14, the Act, section 1128B(b), 42 U.S.C. 1320a-7b(b),
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 the 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. The OIG safe harbor regulations are found at 42 CFR part
1001.
B. OIG Special Fraud Alerts
OIG has also periodically issued Special Fraud Alerts to give
continuing guidance to health care providers with respect to practices
OIG finds potentially fraudulent or abusive. The Special Fraud Alerts
encourage industry compliance by giving providers guidance that can be
applied to their own practices. OIG Special Fraud Alerts are intended
for extensive distribution directly to the health care provider
community, as well as to those charged with administering the Federal
health care programs.
In developing Special Fraud Alerts, OIG has relied on a number of
sources and has consulted directly with experts in the subject field,
including those within OIG, other agencies of 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 section 205, the Act, section
1128D, 42 U.S.C. 1320a-7d, requires the Department to develop and
publish an annual document 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 is required
to thoroughly review 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 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 the 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 notice for developing
new safe harbors and Special Fraud Alerts on December 30, 2014 (79 FR
78376). As required under section 205, a status report of the public
comments received in response to that document is set forth in Appendix
F of OIG's Fall 2015 Semiannual Report.\1\ OIG is not seeking
additional public comment on the
[[Page 79805]]
proposals listed in Appendix F at this time. Rather, this document
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 Web site 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 also 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 16, 2015.
Daniel R. Levinson,
Inspector General.
[FR Doc. 2015-32267 Filed 12-22-15; 8:45 am]
BILLING CODE 4152-01-P
