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Timestamp: 2016-02-09 03:20:27
Document Index: 677276151

Matched Legal Cases: ['art 1001', '§ 14', '§ 1128', 'art 1001', '§ 205', '§ 1128', 'art 1001']

Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Solicitation of New Safe Harbors and Special Fraud Alerts This Proposed Rule document was issued by the Inspector General Office Health and Human Services Department (HHSIG)For related information, Open Docket Folder Show agency attachment(s) DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 1001
AgencyOffice of Inspector General (OIG), HHS.
ActionNotice of intent to develop regulations.
SummaryIn accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 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.
DatesTo ensure consideration, public comments must be delivered to the address provided below by no later than 5 p.m. on February 26, 2013.
AddressesIn commenting, please refer to file code OIG-121-N. Because of staff and resource limitations, we cannot accept comments by facsimile (fax) transmission.
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, Congressional and Regulatory Affairs, Department of Health and Human Services, Attention: OIG-121-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 ContactPatrice Drew, Congressional and 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-121-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 as soon as possible after they have been received. 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 9:30 a.m. to 5 p.m. To schedule an appointment to view public comments, phone (202) 619-1368.I. BackgroundA. OIG Safe Harbor ProvisionsSection 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. Theoffense 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, section 14 of the Medicare and Medicaid Patient and Program Protection Act of 1987, Public Law 100-93 § 14, the Act, § 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 AlertsOIG 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 1996Section 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 notice in theFederal Registerformally 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 ProposalsIn accordance with the requirements of section 205 of HIPAA, OIG last published aFederal Registersolicitation notice for developing new safe harbors and Special Fraud Alerts on December 29, 2011 (76 FR 89104). As required under section 205, a status report of the public comments received in response to that notice is set forth in Appendix F. (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 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 ProvisionsIn 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 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 AlertsIn 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.
Daniel R. Levinson,
[FR Doc. 2012-31107 Filed 12-27-12; 8:45 am]BILLING CODE 4152-01-PFootnotes
The OIG Semiannual Report to Congress can be accessed through the OIG Web site at http://oig.hhs.gov/publications/semiannual.asp. Attachments View All (0) View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Feb 26 2013, at 11:59 PM ET ID: HHSIG_FRDOC_0001-0031 Tracking Number: View original printed format: Document Information Date Posted: Dec 28, 2012RIN: Not AssignedCFR: 42 CFR Part 1001Federal Register Number: 2012-31107 Show More Details Submitter Information Comments354 Comments Received* If an anesthesiologist working at an Ambulatory Surgical Center (ASC) is told by the owners, who are the physician group doing procedures (e.g., GI doctors... View Comment Re: Solicitation of New Safe Harbors and Special Fraud Alerts, OIG-121-N
As one of the over 50,000 members of the American Society of Anesthesiologists, I... View Comment Re: Solicitation of New Safe Harbors and Special Fraud Alerts, OIG-121-N
Our company, Warren Anesthesia Consultants LLC, had provided anesthesia service at... View Comment Docket Information This document is contained in HHSIG_FRDOC_0001 Related Dockets: NoneRelated RINs: NoneRelated Documents: Solicitation of New Safe Harbors and Special Fraud Alerts,Medicare Program: Final Waivers in Connection with the...Solicitation of New Safe Harbors and Special Fraud Alerts Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!