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Federal Register :: 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
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Use the PDF linked in the document sidebar for the official electronic format.</p></div></div></div></div><div class="content-block "> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Document: 2021-02132 (86 FR 7815)</span></div></div> </div> </div> </div> </div> <div class="doc-content with-utility-nav wide-utility-nav"> <div id="print-only-document-details"> <ul> <li class="published " id="utility-nav-document-details" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Document Details" role="button" aria-label="Document Details" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Document Details"><svg class="svg-icon svg-icon-book-alt-2 "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#book-alt-2"></use></svg></span><span class="content-nav-label " role="button">Document Details</span><div class="fr-box fr-box-published-alt fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Published Content - Document Details</span></div></div><div class="content-block "> <dl class='metadata_list'> <dt>Agencies</dt> <dd> <a href="https://www.federalregister.gov/agencies/health-and-human-services-department">Department of Health and Human Services</a> </dd> <dd> Office of Inspector General </dd> <dt>CFR</dt> <dd>42 CFR 1001</dd> <dt>Document Citation</dt> <dd id="document-citation" data-citation-vol='86' > 86 FR 7815 <span class="copy-to-clipboard svg-tooltip" data-toggle="tooltip" data-title="Copy to Clipboard" data-title-copied="Copied to Clipboard" data-copy-text="86 FR 7815"><svg class="svg-icon svg-icon-content-copy "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#content-copy"></use></svg></span> </dd> <dt>Document Number</dt> <dd class="doc_number"> 2021-02132 <span class="copy-to-clipboard svg-tooltip" data-toggle="tooltip" data-title="Copy to Clipboard" data-title-copied="Copied to Clipboard" data-copy-text="2021-02132"><svg class="svg-icon svg-icon-content-copy "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#content-copy"></use></svg></span> </dd> <dt>Document Type</dt> <dd>Rule</dd> <dt>Page</dt> <dd> 7815 (1 page) </dd> <dt>Publication Date</dt> <dd> <a href="/documents/2021/02/02">02/02/2021</a> </dd> <dt>RIN</dt> <dd> <a href="https://www.federalregister.gov/regulations/0936-AA08/removal-of-safe-harbor-protection-for-rebates-to-plans-or-pbms-involving-prescription-pharmaceutical">0936-AA08</a> </dd> </dl> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Content - 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Document Details</span></div></div><div class="content-block "> <dl class='metadata_list'> <dt>Agencies</dt> <dd> <a href="https://www.federalregister.gov/agencies/health-and-human-services-department">Department of Health and Human Services</a> </dd> <dd> Office of Inspector General </dd> <dt>CFR</dt> <dd>42 CFR 1001</dd> <dt>Document Citation</dt> <dd id="document-citation" data-citation-vol='86' > 86 FR 7815 <span class="copy-to-clipboard svg-tooltip" data-toggle="tooltip" data-title="Copy to Clipboard" data-title-copied="Copied to Clipboard" data-copy-text="86 FR 7815"><svg class="svg-icon svg-icon-content-copy "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#content-copy"></use></svg></span> </dd> <dt>Document Number</dt> <dd class="doc_number"> 2021-02132 <span class="copy-to-clipboard svg-tooltip" data-toggle="tooltip" data-title="Copy to Clipboard" data-title-copied="Copied to Clipboard" data-copy-text="2021-02132"><svg class="svg-icon svg-icon-content-copy "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#content-copy"></use></svg></span> </dd> <dt>Document Type</dt> <dd>Rule</dd> <dt>Page</dt> <dd> 7815 (1 page) </dd> <dt>Publication Date</dt> <dd> <a href="/documents/2021/02/02">02/02/2021</a> </dd> <dt>RIN</dt> <dd> <a href="https://www.federalregister.gov/regulations/0936-AA08/removal-of-safe-harbor-protection-for-rebates-to-plans-or-pbms-involving-prescription-pharmaceutical">0936-AA08</a> </dd> </dl> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Content - Document Details</span></div></div></li> <li class="published " id="utility-nav-document-dates" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Document Dates" role="button" aria-label="Document Dates" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Document Dates"><svg class="svg-icon svg-icon-calendar-alt "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#calendar-alt"></use></svg></span><span class="content-nav-label " role="button">Document Dates</span><div class="fr-box fr-box-published-alt fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Published Content - Document Dates</span></div></div><div class="content-block "> <dl class='metadata_list'> <dt>Effective Date</dt> <dd>11/30/2020</dd> <dt>Dates Text</dt> <dd>As of January 29, 2021, the effective date of the amendments to <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(h)(6)" class="cfr external" target="_blank" rel="noopener noreferrer">42 CFR 1001.952 (h)(6)</a> through <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(h)(9)" class="cfr external" target="_blank" rel="noopener noreferrer">(9)</a>, <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(cc)" class="cfr external" target="_blank" rel="noopener noreferrer">(cc)</a>, and <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(dd)" class="cfr external" target="_blank" rel="noopener noreferrer">(dd)</a> published at <a href="/citation/85-FR-76666" class="fr-reference" data-reference="85 FR 76666">85 FR 76666</a>, November 30, 2020, is delayed until March 22, 2021.</dd> </dl> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Content - 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This repetition of headings to form internal navigation links has no substantive legal effect. </p> <ul class="table-of-contents fr-list with-bullets"> <li class="level-1"><a href="#agency" data-close-utility-nav="true">AGENCY:</a></li> <li class="level-1"><a href="#action" data-close-utility-nav="true">ACTION:</a></li> <li class="level-1"><a href="#summary" data-close-utility-nav="true">SUMMARY:</a></li> <li class="level-1"><a href="#dates" data-close-utility-nav="true">DATES:</a></li> <li class="level-1"><a href="#for-further-information-contact" data-close-utility-nav="true">FOR FURTHER INFORMATION CONTACT:</a></li> <li class="level-1"><a href="#h-6" data-close-utility-nav="true">SUPPLEMENTARY INFORMATION:</a></li> </ul> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Enhanced Content - Table of Contents</span></div></div></li> <li class="divider"></li> <li class="enhanced utility-nav-comments unavailable" id="utility-nav-comments" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Public Comments" role="button" aria-label="Public Comments" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Public Comments"><svg class="svg-icon svg-icon-chat "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#chat"></use></svg></span><span class="content-nav-label " role="button">Public Comments</span><div class="fr-box fr-box-enhanced fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Enhanced Content - 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Use the PDF linked in the document sidebar for the official electronic format.</p></div></div></div></div><div class="content-block "> <div id="fulltext_content_area" class="doc-content-area" data-short-url="https://www.federalregister.gov/d/2021-02132"> <div class="citation-target-icon cj-fancy-tooltip" data-tooltip="Click to copy a short url for this paragraph" data-short-url="https://www.federalregister.gov/d/2021-02132"> <span class="icon-fr2 icon-fr2-bookmark "></span> </div> <div class="citation-target-background"></div> <div class="preamble"> <div class="document-headings"><div class="fr-box fr-box-published-alt no-footer"> <div class="fr-seal-block fr-seal-block-header with-hover"><div class="fr-seal-content"> <span class="h6">Document Headings</span><div class="fr-seal-meta"><div class="fr-seal-desc"> <p> Document headings vary by document type but may contain the following: </p> <ol class="bullets"> <li> the agency or agencies that issued and signed a document </li> <li> the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to </li> <li> the agency docket number / agency internal file number </li> <li> the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions </li> </ol> <p> See the <a href="https://www.archives.gov/files/federal-register/write/handbook/ddh.pdf#page=9"> Document Drafting Handbook </a> for more details. </p> </div></div> </div></div> <div class="content-block "> <h6 class="agency">Department of Health and Human Services</h6> <h6 class="sub-agency">Office of Inspector General</h6> <ol> <li>42 CFR Part 1001</li> <li>RIN 0936-AA08</li> </ol> </div> </div></div> <div id="agency"> <h1 id="h-1">AGENCY:</h1> <p id="p-1" data-page="7815">Office of Inspector General (OIG), Health and Human Services (HHS).</p> </div> <div id="action"> <h1 id="h-2">ACTION:</h1> <p id="p-2" data-page="7815">Final rule; delay of effective date; correction.</p> </div> <div id="summary"> <h1 id="h-3">SUMMARY:</h1> <p id="p-3" data-page="7815"> In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” and given the pendency of litigation, <em>Pharmaceutical Care Management Association</em> v. <em>U.S. Department of Health and Human Services, et al.,</em> Civil Action No. 21-95 (JDB) (D.D.C.), challenging the final rule, this action temporarily delays for 60 days from the date of the memorandum the effective date of certain amendments as promulgated by the final rule titled “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 in the November 30, 2020, <strong>Federal Register</strong> . This document announces that the effective date for the certain provisions of the final rule is delayed until March 22, 2021, the first business day after 60 days from the date of the memorandum. This document also corrects a technical error in the amendatory instructions. </p> </div> <div id="dates"> <h1 id="h-4">DATES:</h1> <p id="p-4" data-page="7815">As of January 29, 2021, the effective date of the amendments to <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(h)(6)" class="cfr external" target="_blank" rel="noopener noreferrer">42 CFR 1001.952 (h)(6)</a> through <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(h)(9)" class="cfr external" target="_blank" rel="noopener noreferrer">(9)</a>, <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(cc)" class="cfr external" target="_blank" rel="noopener noreferrer">(cc)</a>, and <a href="https://www.ecfr.gov/current/title-42/section-1001.952#p-1001.952(dd)" class="cfr external" target="_blank" rel="noopener noreferrer">(dd)</a> published at <a href="/citation/85-FR-76666" class="fr-reference" data-reference="85 FR 76666">85 FR 76666</a>, November 30, 2020, is delayed until March 22, 2021.</p> <p id="p-5" data-page="7815">This correction is effective as of March 22, 2021. The amendatory instructions in FR 2020-25841 (<a href="/citation/85-FR-76666" class="fr-reference" data-reference="85 FR 76666">85 FR 76666</a>), published on November 30, 2020 is corrected.</p> </div> <div id="for-further-information-contact"> <h1 id="h-5">FOR FURTHER INFORMATION CONTACT:</h1> <p id="p-6" data-page="7815">Aaron Zajic, (202) 619-0335.</p> </div> </div> <div class="supplemental-info"> <h1 id="h-6">SUPPLEMENTARY INFORMATION:</h1> <p id="p-7" data-page="7815"> The January 20, 2021 memorandum from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review,” instructed Federal agencies to consider delaying the effective date of rules published in the <strong>Federal Register</strong> , but which have not yet taken effect, for a period of 60 days from the date of the memorandum to permit review of the rule. This action is consistent with that memorandum insofar as the Department has decided to review the rule at issue, and needs time to determine what additional action, if any, is appropriate. </p> <p id="p-8" data-page="7815">The Department also has good cause to delay this rule's effective date without advance notice and comment under <a href="https://www.govinfo.gov/link/uscode/5/553" class="usc external" target="_blank" rel="noopener noreferrer">5 U.S.C. 553(b)(B)</a> because of the pendency of litigation challenging the final rule, and the Department's interest in evaluating its position in that litigation. The litigation includes both procedural and substantive challenges to the rule and its effective date. Though the provisions of the rule being delayed by this notice do not fully overlap with the provisions at issue in the pending litigation, the intersections between the rule's various provisions and the overall regulatory framework are complex. HHS intends to evaluate those interactions as part of its regulatory review process, but needs additional time to do so beyond the current effective date of January 29, 2021.</p> <p id="p-9" data-page="7815">Accordingly, this final rule delays the effective date of certain portions of the safe harbor regulation concerning discounts for prescription pharmaceutical products at <a href="https://www.ecfr.gov/current/title-42/section-1001.952" class="cfr external" target="_blank" rel="noopener noreferrer">42 CFR 1001.952</a>. The effective date of new paragraphs (h)(6) through (9), (cc), and (dd) of that rule, which would have been January 29, 2021, is now March 22, 2021. The temporary delay in the effective date of this final rule is necessary to give Department officials the opportunity for further review and consideration of the revisions to paragraphs (h)(5)(vi) and (viii), as well as the addition of new paragraphs (h)(5)(iii), (6) through (9), (cc), and (dd) of <a href="https://www.ecfr.gov/current/title-42/section-1001.952" class="cfr external" target="_blank" rel="noopener noreferrer">42 CFR 1001.952</a>, consistent with the memorandum of January 20, 2021.</p> <p id="p-10" data-page="7815">Separately, November 2020 final rule contained a technical error in the amendatory instructions that would have prevented the Office of the Federal Register from properly incorporating the amendments to § 1001.952 into the CFR. This document also corrects that error.</p> <p class="amendment-part" id="p-amd-1">In FR 2020-25841 (<a href="/citation/85-FR-76666" class="fr-reference" data-reference="85 FR 76666">85 FR 76666</a>), published on November 30, 2020, the following corrections are made:</p> <div class="section"> <div class="sectno sectno-reference" id="sectno-reference-1001.952"><a href="#sectno-citation-1001.952">§ 1001.952</a></div> <div class="section-subject"> [Corrected]</div> </div> <p class="amendment-part" id="p-amd-2"><span class="amendment-part-number">1. </span>On page 76730, third column, instruction 2 (including a. and b.) is corrected to read as follows: </p> <p class="amendment-part" id="p-amd-3"><span class="amendment-part-number">2. </span>Section 1001.952 is amended by adding paragraphs (h)(6) through (9), (cc), and (dd) to read as follows: </p> <div class="section"> <div class="sectno sectno-reference" id="sectno-reference-1001.952"><a href="#sectno-citation-1001.952">§ 1001.952</a></div> <div class="section-subject"> [Corrected]</div> </div> <p class="amendment-part" id="p-amd-4"><span class="amendment-part-number">2. </span>On page 76731, first column, § 1001.952 is corrected by removing “(5) * * * ”, and the text of paragraphs (vi) through (viii). </p> <div class="section"> <div class="sectno sectno-reference" id="sectno-reference-1001.952"><a href="#sectno-citation-1001.952">§ 1001.952</a></div> <div class="section-subject"> [Corrected]</div> </div> <p class="amendment-part" id="p-amd-5"><span class="amendment-part-number">3. </span>On page 76731, third column, add amendatory instruction 3 to read as follows: </p> <p id="p-11" data-page="7815">3. Effective January 1, 2022, § 1001.952 is amended by revising paragraphs (h)(5)(vi) and (vii) and adding paragraph (h)(5)(viii) to read as follows:</p> <div class="section"> <div class="sectno sectno-reference" id="sectno-reference-1001.952"><a href="#sectno-citation-1001.952">§ 1001.952</a></div> <div class="section-subject"> Exceptions.</div> <div class="stars cj-fancy-tooltip document-markup" data-tooltip-template="#stars-5-tooltip-template"> <span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">*</span> </div> <p id="p-12" data-page="7815">(h) * * *</p> <p id="p-13" data-page="7815">(5) * * *</p> <p id="p-14" data-page="7815">(vi) Services provided in accordance with a personal or management services contract;</p> <p id="p-15" data-page="7815">(vii) Other remuneration, in cash or in kind, not explicitly described in this paragraph (h)(5); or</p> <p id="p-16" data-page="7815">(viii) A reduction in price or other remuneration in connection with the sale or purchase of a prescription pharmaceutical product from a manufacturer to a plan sponsor under Medicare Part D either directly to the plan sponsor under Medicare Part D, or indirectly through a pharmacy benefit manager acting under contract with a plan sponsor under Medicare Part D, unless it is a price reduction or rebate that is required by law.</p> <div class="stars cj-fancy-tooltip document-markup" data-tooltip-template="#stars-5-tooltip-template"> <span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">* </span><span class="icon-fr2 icon-fr2-star">*</span> </div> </div> <div class="signature"> <p class="signature-name">Norris Cochran,</p> <p class="signature-title">Acting Secretary.</p> </div> </div> <div class="end-matter"> <p class="frdoc">[<a href="/d/2021-02132">FR Doc. 2021-02132</a> Filed 1-29-21; 8:45 am]</p> <p class="billing-code">BILLING CODE 4152-01-P</p> </div> </div> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Document: 2021-02132 (86 FR 7815)</span></div></div> </div> </div> </div> <div class="clearfix" style="height: 100px;"></div> </div> </div> <!-- BOOTSTRAP SCOPE END --> </div> <!-- BOOTSTRAP SCOPE END --> </div> </main> <div class="site-footer" id="footer"> <div class="col-xs-3 col-md-3"> <h2>Home</h2> <ul class="bullets"> <li><a href="/" title="Home">Home</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Sections</h2> <ul class="bullets"> <li><a href="/money">Money</a></li> <li><a href="/environment">Environment</a></li> <li><a href="/world">World</a></li> <li><a href="/science-and-technology">Science & Technology</a></li> <li><a href="/business-and-industry">Business & Industry</a></li> <li><a href="/health-and-public-welfare">Health & Public Welfare</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Browse</h2> <ul class="bullets"> <li><a href="/agencies">Agencies</a></li> <li><a href="/topics">Topics (CFR Indexing Terms)</a></li> <li><a href="/documents/current">Dates</a></li> <li><a href="/public-inspection/current">Public Inspection</a></li> <li><a href="/presidential-documents/executive-orders">Executive Orders</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Search</h2> <ul class="bullets"> <li><a href="/documents/search">Document Search</a></li> <li><a href="/documents/search#advanced">Advanced Document Search</a></li> <li><a href="/public-inspection/search">Public Inspection Search</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Reader Aids</h2> <ul class="bullets"> <li><a href="/reader-aids/office-of-the-federal-register-announcements">Office of the Federal Register Announcements</a></li> <li><a href="/reader-aids/using-federalregister-gov">Using FederalRegister.Gov</a></li> <li><a href="/reader-aids/understanding-the-federal-register">Understanding the Federal Register</a></li> <li><a href="/reader-aids/recent-updates">Recent Site Updates</a></li> <li><a href="/reader-aids/federal-register-statistics">Federal Register & CFR Statistics</a></li> <li><a href="/reader-aids/videos-tutorials">Videos & Tutorials</a></li> <li><a href="/reader-aids/developer-resources">Developer Resources</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures">Government Policy and OFR Procedures</a></li> <li><a href="/reader-aids/congressional-review">Congressional Review</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>My FR</h2> <ul class="bullets"> <li><a href="/my/">My Clipboard</a></li> <li><a href="/my/subscriptions">My Subscriptions</a></li> <li><a href="/my/comments">My Comments</a></li> <li><a href="/auth/sign_in">Sign In</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Information</h2> <ul class="bullets"> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site">About This Site</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site#legal-status">Legal Status</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/contact-us">Contact Us</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/privacy">Privacy</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/accessibility">Accessibility</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/foia">FOIA</a></li> <li><a href="https://www.archives.gov/eeo/policy/no-fear-notice.html">No Fear Act</a></li> <li><a href="https://www.archives.gov/federal-register/write/newsletter/2024-may">Continuity Information</a></li> </ul> </div> <div id="zendesk-link"> <a href="" class="btn site-feedback-button" aria-label="Site Feedback"> <span class="icon-fr2 icon-fr2-Chat "></span> <span class="desktop-only">Site Feedback</span> </a> </div> </div> </body> </html>