<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-29-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0936-AA12</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>202504</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0936</CODE>
            <NAME>Office of the Inspector General</NAME>
            <ACRONYM>OIG</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General&apos;s Exclusion Authorities</RULE_TITLE>
        <ABSTRACT><![CDATA[<!DOCTYPE html>
<html>
<head>
</head>
<body>
<p>The proposed rule modifies several sections in 42 CFR 1001 relating to the exclusions authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or Department).&nbsp; First, the proposed rule would implement in OIG&rsquo;s exclusion regulations a statutory change to HHS&rsquo;s authority found in the Medicaid Services Investment and Accountability Act of 2019 that authorizes exclusion of manufacturers that misclassify outpatient drugs, fail to correct such misclassifications, or provide false information or data related to drug pricing or product information.&nbsp; Second, the proposed rule would update several sections of the exclusion regulations consistent with the corresponding statutory authority, including revising the section governing exclusion based on an individual&rsquo;s default on a health education loan or scholarship obligation.&nbsp; Third, the proposed rule would modify or eliminate various aggravating and mitigating factors used to set the length of an exclusion.&nbsp; Fourth, the proposed rule would modify the exclusion regulations that govern OIG&rsquo;s notice to the public and other agencies regarding exclusions, approval of reinstatement requests, and denial of reinstatement requests.&nbsp; Finally, the proposed rule would include clarifying changes and updates to the exclusion regulations based on OIG&rsquo;s recent experience related to exclusion actions.</p>
</body>
</html>]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <EO_13771_DESIGNATION>Not subject to, not significant</EO_13771_DESIGNATION>
        <CFR_LIST>
            <CFR>42 CFR 1001</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>42 U.S.C. 1302</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 1320a–7</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 1320a–7b</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 1395u(j)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 1395u(k)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 1395y(e)</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 U.S.C. 1395hh</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>12/02/2024</TTBL_DATE>
                <FR_CITATION>89 FR 95143</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>01/31/2025</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>05/00/2026</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>David</FIRST_NAME>
                <LAST_NAME>Fuchs</LAST_NAME>
                <TITLE>Deputy Branch Chief</TITLE>
                <AGENCY>
                    <CODE>0936</CODE>
                    <NAME>Office of the Inspector General</NAME>
                    <ACRONYM>OIG</ACRONYM>
                </AGENCY>
                <PHONE>202 763-4750</PHONE>
                <EMAIL>david.fuchs@oig.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>233 N. Michigan Avenue, Suite 801,</STREET_ADDRESS>
                    <CITY>Chicago</CITY>
                    <STATE>IL</STATE>
                    <ZIP>60601</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
