{"abstract":"As required by an order issued by the U.S. District Court for the District of Columbia, this action provides notice of the delay of the effective date of certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (\"Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals And Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees\") published on November 30, 2020. The new effective date for these certain amendments is January 1, 2023.","action":"Final rule; notification of court-ordered delay of effective date.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Office of Inspector General"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2021/03/22/2021-05903.html","cfr_references":[{"chapter":null,"citation_url":null,"part":"1001","title":42}],"citation":"86 FR 15132","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"As of March 18, 2021, the January 29, 2021 effective date of the amendments to 42 CFR 1001.952(h)(6) through (9), (cc), and (dd) published at 85 FR 76666, November 30, 2020, which was delayed to March 22, 2021, pursuant to the rule published at 86 FR 7815, February 2, 2021, is further delayed until January 1, 2023. In addition, the effective date of the corrections published at 86 FR 7815, February 2, 2021, is delayed from March 22, 2021, to January 1, 2023.","disposition_notes":null,"docket_ids":[],"dockets":[],"document_number":"2021-05903","effective_on":"2023-01-01","end_page":15133,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2021/03/22/2021-05903.xml","html_url":"https://www.federalregister.gov/documents/2021/03/22/2021-05903/fraud-and-abuse-removal-of-safe-harbor-protection-for-rebates-involving-prescription-pharmaceuticals","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2021-05903?publication_date=2021-03-22","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2021-03-22/2021-05903/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":1019,"last_updated":"2026-10-22 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2021-03-22/pdf/2021-05903.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2021-05903.pdf?1616098524","publication_date":"2021-03-22","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2021/03/22/2021-05903.txt","regulation_id_number_info":{"0936-AA08":{"issue":"202010","html_url":"https://www.federalregister.gov/regulations/0936-AA08/removal-of-safe-harbor-protection-for-rebates-to-plans-or-pbms-involving-prescription-pharmaceutical","title":"Removal of Safe Harbor Protection for Rebates to Plans or PBMs Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202010&RIN=0936-AA08&operation=OPERATION_EXPORT_XML","priority_category":"Economically Significant"}},"regulation_id_numbers":["0936-AA08"],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Medicare and State Health Care Programs: Fraud and Abuse; Procedures Regarding the Submission of Advisory Opinion Requests to, and the Issuance of Advisory Opinions by, Office of Inspector General","document_id":"HHSIG_FRDOC_0001-0450"},{"title":"Fraud and Abuse: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Delayed Effective Date","document_id":"HHSIG_FRDOC_0001-0444"},{"title":"Requirements and Registrations: The Simple Extensible Sampling Tool Challenge","document_id":"HHSIG_FRDOC_0001-0423"},{"title":"Medicare And State Health Care Programs: Fraud And Abuse; Revisions to the Office Of Inspector General's Civil Monetary Penalty Rules","document_id":"HHSIG_FRDOC_0001-0422"},{"title":"Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements","document_id":"HHSIG_FRDOC_0001-0421"},{"title":"The Simple Extensible Sampling Tool Challenge Requirements and Registration","document_id":"HHSIG_FRDOC_0001-0420"},{"title":"Civil Monetary Penalties","document_id":"HHSIG_FRDOC_0001-0418"},{"title":"Statements of Organization, Functions, and Delegations of Authority","document_id":"HHSIG_FRDOC_0001-0417"},{"title":"Medicare Program: Final Waivers in Connection with the Shared Savings Program","document_id":"HHSIG_FRDOC_0001-0415"},{"title":"Solicitation of New Safe Harbors and Special Fraud Alerts","document_id":"HHSIG_FRDOC_0001-0402"}],"comments_count":0,"agency_id":"HHSIG","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=HHSIG_FRDOC_0001","supporting_documents_count":0,"docket_id":"HHSIG_FRDOC_0001","document_id":"HHSIG_FRDOC_0001-0444","regulation_id_number":null,"title":"Recently Posted HHSIG Rules and Notices.","checked_regulationsdotgov_at":"2021-03-23T03:30:07Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":15132,"subtype":null,"title":"Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Additional Delayed Effective Date","toc_doc":"Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees; Delayed Effective Date","toc_subject":"Fraud and Abuse:\n","topics":[],"type":"Rule","volume":86}