Solicitation of New Safe Harbors and Special Fraud Alerts, 73186-73187 [05-23624]

Download as PDF 73186 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules procedure by submitting written comments in accordance with the instructions outlined earlier in this notice. V. Statutory and Executive Order Reviews Under Executive Order 12866 (58 FR 51735, October 4, 1993), this proposed action is not a ‘‘significant regulatory action’’ and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’ (66 FR 28355, May 22, 2001). This proposed action merely proposes to approve a redesignation to attainment and imposes no additional requirements beyond those imposed by state law. Redesignation of an area to attainment under section 107 of the Clean Air Act is an action that affects the attainment status of a geographical area and does not impose any new regulatory requirements on sources. Accordingly, the Administrator certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule proposes to approve a redesignation to attainment and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). This proposed rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely proposes to approve a redesignation to attainment and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This proposed rule also is not subject to Executive Order 13045 ‘‘Protection of Children from VerDate Aug<31>2005 17:03 Dec 08, 2005 Jkt 208001 Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997), because it is not economically significant. Section 12(d) of the National Technology Transfer Advancement Act (NTTAA) of 1995, Public Law 104–113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impracticable. VCS are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. This action does not involve technical standards. Therefore, EPA did not consider the use of any VCS. This proposed rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). List of Subjects in 40 CFR Part 81 Air pollution control, National parks, Wilderness areas. Authority: 42 U.S.C. 7401 et seq. Dated: November 28, 2005. Robert E. Roberts, Regional Administrator, Region 8. [FR Doc. 05–23808 Filed 12–8–05; 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: SUMMARY: In accordance with section 205 of the Health Insurance Portability and Accountability Act (HIPAA) of 1996, this annual notice 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 assure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 7, 2006. ADDRESSES: Please mail or deliver your written comments to the following PO 00000 Frm 00020 Fmt 4702 Sfmt 4702 address: Office of Inspector General, Department of Health and Human Services, Attention: OIG–101–N, Room 5246, Cohen Building, 330 Independence Avenue, SW., Washington, DC 20201. We do not accept comments by facsimile (FAX) transmission. In commenting, please refer to file code OIG–101–N. Comments received timely will be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, in Room 5541 of the Office of Inspector General at 330 Independence Avenue, SW., Washington, DC, on Monday through Friday of each week from 8 a.m. to 4:30 p.m. FOR FURTHER INFORMATION CONTACT: Joel Schaer, (202) 619–0089, OIG Regulations Officer. SUPPLEMENTARY INFORMATION: 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 in order 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)). Since 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, the Medicare and Medicaid Patient and Program Protection Act of 1987, section 14 of Public Law 100–93, specifically required the development and promulgation of regulations, the socalled ‘‘safe harbor’’ provisions, specifying various payment and business practices which, 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 E:\FR\FM\09DEP1.SGM 09DEP1 Federal Register / Vol. 70, No. 236 / Friday, December 9, 2005 / Proposed Rules 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 any enforcement action under the anti-kickback statute or related administrative authorities. To date, OIG has developed and codified in 42 CFR 1001.952 a total of 22 final safe harbors that describe practices that are sheltered from liability. 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 these 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. To date, OIG has issued 12 individual Special Fraud Alerts. C. Section 205 of Public Law 104–191 Section 205 of Public Law 104–191 requires the Department to develop and publish an annual notice 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 engage in a thorough review of 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. VerDate Aug<31>2005 17:03 Dec 08, 2005 Jkt 208001 II. Solicitation of Additional New Recommendations and Proposals In accordance with the requirements of section 205 of Public Law 104–191, OIG last published a Federal Register solicitation notice for developing new safe harbors and Special Fraud Alerts on December 10, 2004 (69 FR 71766). As required under section 205, a status report of the public comments received in response to that notice is set forth in Appendix F to the OIG’s Semiannual Report covering the period April 1, 2005, through September 30, 2005.1 OIG is not seeking additional public comment on the proposals listed in Appendix F at this time. Rather, this notice seeks additional recommendations regarding the development of proposed or modified safe harbor regulations and new Special Fraud Alerts beyond those summarized in Appendix F to the OIG Semiannual Report referenced above. 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 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 the 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 take into consideration 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 also consider whether, and to what extent, the practices that would be 1 The OIG Semiannual Report can be accessed through the OIG Web site at http://oig.hhs.gov/ publications/semiannual.html. PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 73187 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. 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. Dated: November 30, 2005. Daniel R. Levinson, Inspector General. [FR Doc. 05–23624 Filed 12–8–05; 8:45 am] BILLING CODE 4150–04–P DEPARTMENT OF DEFENSE 48 CFR Parts 208, 252, and 253 and Appendix B to Chapter 2 [DFARS Case 2003–D072] Defense Federal Acquisition Regulation Supplement; Required Sources of Supply Department of Defense (DoD). Proposed rule with request for comments. AGENCY: ACTION: SUMMARY: DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to update text addressing acquisitions made through Government supply sources. This proposed rule is a result of a transformation initiative undertaken by DoD to dramatically change the purpose and content of the DFARS. DATES: Comments on the proposed rule should be submitted in writing to the address shown below on or before February 7, 2006, to be considered in the formation of the final rule. ADDRESSES: You may submit comments, identified by DFARS Case 2003–D072, using any of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • Defense Acquisition Regulations Web Site: http://emissary.acq.osd.mil/ dar/dfars.nsf/pubcomm. Follow the instructions for submitting comments. • E-mail: dfars@osd.mil. Include DFARS Case 2003–D072 in the subject line of the message. • Fax: (703) 602–0350. • Mail: Defense Acquisition Regulations Council, Attn: Ms. Robin Schulze, OUSD (AT&L) DPAP (DAR), IMD 3C132, 3062 Defense Pentagon, Washington, DC 20301–3062. E:\FR\FM\09DEP1.SGM 09DEP1

Agencies

[Federal Register Volume 70, Number 236 (Friday, December 9, 2005)]
[Proposed Rules]
[Pages 73186-73187]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-23624]


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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: Notice of intent to develop regulations.

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

SUMMARY: In accordance with section 205 of the Health Insurance 
Portability and Accountability Act (HIPAA) of 1996, this annual notice 
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 assure consideration, public comments must be delivered to 
the address provided below by no later than 5 p.m. on February 7, 2006.

ADDRESSES: Please mail or deliver your written comments to the 
following address: Office of Inspector General, Department of Health 
and Human Services, Attention: OIG-101-N, Room 5246, Cohen Building, 
330 Independence Avenue, SW., Washington, DC 20201.
    We do not accept comments by facsimile (FAX) transmission. In 
commenting, please refer to file code OIG-101-N. Comments received 
timely will be available for public inspection as they are received, 
generally beginning approximately 3 weeks after publication of a 
document, in Room 5541 of the Office of Inspector General at 330 
Independence Avenue, SW., Washington, DC, on Monday through Friday of 
each week from 8 a.m. to 4:30 p.m.

FOR FURTHER INFORMATION CONTACT: Joel Schaer, (202) 619-0089, OIG 
Regulations Officer.

SUPPLEMENTARY INFORMATION:

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 in order 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)).
    Since 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, the Medicare and Medicaid 
Patient and Program Protection Act of 1987, section 14 of Public Law 
100-93, specifically required the development and promulgation of 
regulations, the so-called ``safe harbor'' provisions, specifying 
various payment and business practices which, 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

[[Page 73187]]

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 any enforcement action under the anti-
kickback statute or related administrative authorities.
    To date, OIG has developed and codified in 42 CFR 1001.952 a total 
of 22 final safe harbors that describe practices that are sheltered 
from liability.

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 these 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. To date, OIG has issued 12 individual Special Fraud 
Alerts.

C. Section 205 of Public Law 104-191

    Section 205 of Public Law 104-191 requires the Department to 
develop and publish an annual notice 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 engage in a thorough review of 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 Public Law 
104-191, OIG last published a Federal Register solicitation notice for 
developing new safe harbors and Special Fraud Alerts on December 10, 
2004 (69 FR 71766). As required under section 205, a status report of 
the public comments received in response to that notice is set forth in 
Appendix F to the OIG's Semiannual Report covering the period April 1, 
2005, through September 30, 2005.\1\ OIG is not seeking additional 
public comment on the proposals listed in Appendix F at this time. 
Rather, this notice seeks additional recommendations regarding the 
development of proposed or modified safe harbor regulations and new 
Special Fraud Alerts beyond those summarized in Appendix F to the OIG 
Semiannual Report referenced above.
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    \1\ The OIG Semiannual Report can be accessed through the OIG 
Web site at http://oig.hhs.gov/publications/semiannual.html.
---------------------------------------------------------------------------

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 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 the 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 take into consideration 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 also 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.
    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.

    Dated: November 30, 2005.
Daniel R. Levinson,
Inspector General.
[FR Doc. 05-23624 Filed 12-8-05; 8:45 am]
BILLING CODE 4150-04-P