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Safe Harbor Regulations | Compliance | Office of Inspector General | U.S. Department of Health and Human Services
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<div id="nav-mobile"> <div id="looking-box" style="display:none;"> <ul> <li><a class="full-site" href="#" rel="/layout/css/style.css">Switch to the full site</a></li> <li><a href="https://web.archive.org/web/20140705072948/https://forms.oig.hhs.gov/hotlineoperations/">Report Fraud</a></li> <li><a href="/web/20140705072948/https://oig.hhs.gov/index.asp">Home</a></li> <li><a href="/web/20140705072948/https://oig.hhs.gov/newsroom/whats-new/">What's New</a></li> <li><a href="/web/20140705072948/https://oig.hhs.gov/fraud/enforcement/criminal/">Enforcement Actions</a></li> <li><a href="/web/20140705072948/https://oig.hhs.gov/fraud/fugitives/">Most Wanted Fugitives</a></li> <li><a href="/web/20140705072948/https://oig.hhs.gov/newsroom/spotlight/">Spotlight Articles</a></li> <li><a href="/web/20140705072948/https://oig.hhs.gov/newsroom/">Newsroom</a></li> </ul> </div> </div> </div> <!--=============== [ /MOBILE NAVIGATION ] ===============--> <a name="skipNav"></a> <div id="mainBody"> <div id="leftSideInterior"> <div id="breadcrumbs"> <ul> <li> <a href="/web/20140705072948/https://oig.hhs.gov/">Home</a> </li> <li> <a href="/web/20140705072948/https://oig.hhs.gov/compliance/index.asp">Compliance</a> </li> <li> Safe Harbor Regulations </li> </ul> </div> <div id="leftContentInterior"> <h1>Safe Harbor Regulations</h1> <p>The "safe harbor" regulations describe various payment and business practices that, although they potentially implicate the Federal anti-kickback statute, are not treated as offenses under the statute.</p> <p>The safe harbor regulations, in their entirety, can be found <a href="https://web.archive.org/web/20140705072948/http://edocket.access.gpo.gov/cfr_2010/octqtr/pdf/42cfr1001.952.pdf" target="_blank">here</a>.</p> <p>Links to Federal Register notices containing preambles to the safe harbor regulations appear below.</p> <div class="featuredContent"> <div class="archiveYears"> Jump to: <a href="#2013">2013</a>, <a href="#2007">2007</a>, <a href="#2006">2006</a>, <a href="#2005">2005</a>, <a href="#2002">2002</a>, <a href="#2001">2001</a>, <a href="#2000">2000</a>, <a href="#1999">1999</a>, <a href="#1996">1996</a>, <a href="#1994">1994</a>, <a href="#1993">1993</a>, <a href="#1992">1992</a>, <a href="#1991">1991</a>, <a href="#1989">1989</a> </div> <div class="clear"></div> </div> <!-- PDF Notification --> <p class="pdf"> <a class="exit" href="https://web.archive.org/web/20140705072948/http://get.adobe.com/reader/" target="_blank">Adobe® Acrobat®</a> is required to read <acronym title="Portable Document Format">PDF</acronym> files. </p> <div id="2013" class="contentSeparator"></div> <h2>2013</h2> <dl> <dt>12-27-2013</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/authorities/docs/2013/2013-30924.pdf">Final Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute</a></dd> <dd><a href="/web/20140705072948/https://oig.hhs.gov/authorities/docs/2013/2013-30429.pdf">Solicitation of New Safe Harbors and Special Fraud Alerts</a></dd> <dt>04-10-2013</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/authorities/docs/2013/EHR_Safe_Harbor_Proposed_Rule.pdf">Proposed Rule: Medicare and State Health Care Programs: Fraud and Abuse; Electronic Health Records Safe Harbor Under the Anti-Kickback Statute</a> (78 Fed. Reg. 21314; April 10, 2013)</dd> </dl> <p><a class="top" href="#top">Top</a></p> <div id="2007" class="contentSeparator"></div> <h2>2007</h2> <dl> <dt>10-04-2007</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/authorities/docs/07/HealthCenterSafeHarbor.pdf" target="_blank">Final Rule: Safe Harbor for Federally Qualified Health Centers Arrangements Under the Anti-Kickback Statute </a> (72 Fed. Reg. 56632; October 4, 2007)</dd> </dl> <p><a class="top" href="#top">Top</a></p> <div id="2006" class="contentSeparator"></div> <h2>2006</h2> <dl> <dt>08-08-2006</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/authorities/docs/06/OIG%20E-Prescribing%20Final%20Rule%20080806.pdf" target="_blank">Final Rule: Safe Harbors for Certain Electronic Prescribing and Electronic Health Records Arrangements Under the Anti-Kickback Statute</a> (71 Fed. Reg. 45110; August 8, 2006)</dd> <dd><a href="https://web.archive.org/web/20140705072948/http://www.cms.hhs.gov/PhysicianSelfReferral/Downloads/CMS-1303-F.pdf" target="_blank">Final Rule: CMS Physician Self-Referral Electronic Prescribing and Electronic Health Records Exceptions</a> (71 Fed. Reg. 45140; August 8, 2006)</dd> </dl> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="2005"></a> <h2>2005</h2> <dl> <dt>10-11-2005</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/authorities/docs/05/101105e-prescribingPR.pdf">Proposed Rule: Safe Harbor for Certain Electronic Prescribing Arrangements Under the Anti-Kickback Statute</a> (70 Fed. Reg. 59015; October 11, 2005)</dd> <dt>07-01-2005</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/authorities/docs/05/070105NPRM-FQHC.pdf" target="_blank">Proposed Rule: Safe Harbor for Federally Qualified Health Centers Under the Anti-Kickback Statute</a> (70 Fed. Reg. 38081; July 1, 2005)</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="2002"></a> <h2>2002</h2> <dl> <dt>09-25-2002</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/MedicareSELECTNPRMFederalRegister.pdf">Proposed Rule: Safe Harbor Under the Anti-Kickback Statute for the Waiver of Medicare SELECT Beneficiary Coinsurance and Deductible Amounts</a> (67 Fed. Reg. 60202; September 25, 2002)</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="2001"></a> <h2>2001</h2> <dl> <dt>12-04-2001</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/restocking_final_rule.pdf">Final Rule: Ambulance Replenishing Safe Harbor Under the Anti-Kickback Statute</a> (66 Fed. Reg. 62979; December 4, 2001)</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="2000"></a> <h2>2000</h2> <dl> <dt>05-22-2000</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/ambulancepr.pdf">Proposed Rule: Ambulance Restocking Safe Harbor under the Anti-Kickback Statute</a> (65 Fed. Reg. 32060; May 22, 2000)</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="1999"></a> <h2>1999</h2> <dl> <dt>11-19-1999</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/getdoc.pdf">Interim Final Rule: Federal Health Care Programs, Fraud and Abuse, Statutory Exception to the Anti-Kickback Statute for Shared Risk Arrangements</a> (64 Fed. Reg. 63504; November 19, 1999)</dd> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/getdoc1.pdf">Final Rule: Clarification of the Initial <acronym title="Office of Inspector General">OIG</acronym> Safe Harbor Provisions and Establishment of Additional Safe Harbor Provisions under the Anti-Kickback Statute</a> (64 Fed. Reg. 63518; November 19, 1999)</dd> <dt>11-18-1999</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/safefs.htm">Fact Sheet: Federal Anti-kickback Law and Regulatory Safe Harbors</a></dd> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/safenr.htm">Press Release: Inspector General Announces Eight New Anti-kickback Statute Safe Harbors</a></dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="1996"></a> <h2>1996</h2> <dl> <dt>01-25-1996</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/012596.pdf">Final Rule: Safe Harbors for Protecting Health Plans</a> (61 Fed. Reg. 2122; January 25, 1996): Revised final rule addressing the three managed care safe harbors originally promulgated in the 11-05-1992 interim final rule.</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="1994"></a> <h2>1994</h2> <dl> <dt>07-21-1994</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/072194.htm">Proposed Rule: Safe Harbor Anti-Kickback Provisions</a> (59 Fed. Reg. 37202; July 21, 1994): Proposed clarifications to the original safe harbor provisions published on 07-29-1991.</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="1993"></a> <h2>1993</h2> <dl> <dt>09-21-1993</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/092193.htm">Proposed Rule: Additional Safe Harbor Provisions Under the Anti-Kickback Statute</a> (58 Fed. Reg. 49008; September 21, 1993): Proposed rule designed to incorporate seven additional safe harbor provisions.</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="1992"></a> <h2>1992</h2> <dl> <dt>11-05-1992</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/110592.htm">Interim Final Rule: Safe Harbors for Protecting Health Plans</a> (57 Fed. Reg. 52723; November 5, 1992): Sets forth three new safe harbors addressing managed care plans through interim final rulemaking.</dd> </dl> </p> <a class="top" href="#top">Top</a><div class="contentSeparator"></div> <p><a name="1991"></a> <h2>1991</h2> <dl> <dt>07-29-1991</dt> <dd><a href="/web/20140705072948/https://oig.hhs.gov/fraud/docs/safeharborregulations/072991.htm">Final Rule: OIG Anti-Kickback Provisions</a> (56 Fed. 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