Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities

DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Office of Inspector General</SUBAGY> <CFR>42 CFR Parts 1000 and 1001</CFR> <RIN>RIN 0936-AA12</RIN> <SUBJECT>Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Exclusion Authorities</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Office of Inspector General (OIG), Department of Health and Human Services (HHS). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> This proposed rule proposes to amend the regulations relating to exclusion authorities under the authority of the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS or the Department). The proposed rule would codify changes made by the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), that added exclusion authorities related to misclassification and false information about outpatient drugs. The proposed rule would also update and clarify OIG's procedures for excluding individuals and entities from participation in the Federal health care programs, including the factors that will be considered in determining the length of exclusions, the provisions governing notices of exclusions, and certain provisions related to reinstatement into the programs. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> To ensure consideration, public comments must be received no later than 5 p.m. eastern time on January 31, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> In commenting, please refer to file code OIG-2401-P. Because of staff and resource limitations, we cannot accept comments by fax transmission. You may submit comments in one of two ways (no duplicates, please): 1. <E T="03">Electronically.</E> You may submit comments electronically at <E T="03">https://www.regulations.gov.</E> Follow the “Submit a comment” instructions and refer to file code OIG-2401-P. 2. <E T="03">By regular, express, or overnight mail.</E> You may send written comments to the following address: OIG, Regulatory Affairs, HHS, Attention: OIG-2401-P, Room 5267, 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. For information on viewing public comments, please see the <E T="02">SUPPLEMENTARY INFORMATION</E> section. <E T="03">Docket:</E> Go to the Federal eRulemaking Portal at <E T="03">https://www.regulations.gov</E> for access to the rulemaking docket, including any background documents and the plain-language summary of the proposed rule of not more than 100 words in length required by the Providing Accountability Through Transparency Act of 2023. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> David Fuchs, Deputy Branch Chief, Office of Counsel to the Inspector General, at (202) 763-4750. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <E T="03">Inspection of Public Comments:</E> All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period as soon as possible after they have been received on the following website: <E T="03">https://www.regulations.gov.</E> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Purpose and Need for Regulatory Action</HD> MSIAA expanded OIG's exclusion authority to protect the Federal health care programs from fraud and abuse by allowing OIG to exclude certain individuals and entities that knowingly misclassify a covered outpatient drug, knowingly fail to correct such misclassification, or knowingly provide false information related to drug pricing, drug product information, or data related to drug pricing or drug product information. OIG proposes to update its regulations to codify the changes made by MSIAA in the regulations. At the same time, OIG proposes to amend other sections of the exclusion regulations to ensure consistency with statutory authority, decrease administrative burdens, enhance transparency, and improve the efficiency and effectiveness of government. The proposed amendments include factors that will be considered in determining the lengths of exclusions, the processes governing notices of exclusions, and certain provisions related to reinstatement into the programs, as well as clarifying changes and updates to the regulations. <HD SOURCE="HD2">B. Legal Authority</HD> The legal authority for this regulatory action is found in: 42 U.S.C. 1302; 1320a-7; 1395u(j); 1395u(k); 1395y(e); and 1395hh. <HD SOURCE="HD1">II. Summary of Major Provisions</HD> We propose changes to the exclusion regulations at 42 CFR parts 1000 and 1001 to codify an authority under MSIAA, update processes, and make clarifying and technical changes to existing regulations. Specifically, section 6(d) of MSIAA amended section 1128(b) of the Social Security Act (the Act) to add an exclusion authority for certain conduct related to the misclassification of outpatient drugs, and knowingly providing false information related to drug pricing, drug product information, or data related to drug pricing or drug product information. We propose clarifying changes to aggravating and mitigating factors that are used to determine periods of exclusion under section 1128 of the Act. We propose to simplify the mitigating factor relating to cooperation and to consolidate certain aggravating factors relating to other criminal, civil, and administrative sanctions into a single factor. We propose to modify the exclusion authority under section 1128(b)(12) of the Act, for failure to grant immediate access, to eliminate a requirement for OIG or a State Medicaid Fraud Control Unit (MFCU) to demonstrate that the requested material is about to be altered or destroyed in order to obtain access to the material at the time the request is made. We propose to modify OIG's obligations with respect to beneficiaries' access to physician services in imposing exclusions under section 1128(b)(14) of the Act in accordance with the Act. We propose to modify the regulatory language to align the regulations with certain, current OIG practices for exclusions imposed under sections 1128(a) and (b) of the Act and for waivers. We propose certain changes to the definitions to remove duplication. We propose to modify the circumstances under which early reinstatement is available for individuals and entities excluded under section 1128(b)(4) of the Act to permit individuals who lost their health care licenses for reasons related to patient abuse and neglect to apply for early reinstatement in limited circumstances. <HD SOURCE="HD1">III. Costs and Benefits</HD> There are no significant costs associated with the proposed regulatory revisions that would impose any mandates on State, local, or Tribal governments or the private sector. <HD SOURCE="HD1">IV. Background</HD> <HD SOURCE="HD2">A. Exclusion Authority</HD> The exclusion authorities found in section 1128 of the Act are intended to protect the Federal health care programs and their beneficiaries from untrustworthy individuals and entities whose behavior has demonstrated that those individuals and entities pose a risk to program beneficiaries or to the integrity of these programs. These authorities encompass both mandatory exclusions (section 1128(a) of the Act) and permissive exclusions (section 1128(b) of the Act). The Secretary's authority under section 1128 of the Act has been delegated to OIG. <E T="03">See</E> 53 FR 12993 (Apr. 20, 1988). The mandatory exclusion authorities require OIG to exclude from program participation any individual or entity convicted of an offense that is: related to items or services delivered under Medicare and Medicaid; related to patient abuse or neglect; or a felony related to health care delivery, governmental health care programs, or controlled substances. Mandatory exclusions must be imposed for a minimum 5-year period. The permissive authorities do not require the imposition of an exclusion and may either be: (1) “derivative” exclusions that are based on actions previously taken by a court, other law enforcement, or regulatory agencies; or (2) “non-derivative” exclusions that are based on OIG-initiated determinations of misconduct, <E T="03">e.g.,</E> poor quality care or submission of false claims for Medicare or Medicaid payment. With certain exceptions, there are no specified minimum periods of exclusion under these permissive authorities. Over the years, several statutory and regulatory provisions have amended or further clarified OIG's exclusion authorities. For example, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) expanded OIG's authorities to add several exclusion authorities (sections 1128(a)(3), (a)(4), and (b)(15)) and increase minimum or benchmark periods of exclusion for certain permissive exclusions. The Balanced Budget Act (BBA) of 1997 further amended OIG's exclusion authorities by: (1) extending the scope of an OIG exclusion beyond Medicare and State health care programs to all Federal health care programs; (2) establishing permanent exclusions for persons convicted of three or more health care-related crimes and 10-year exclusions for persons convicted of two health care-related crimes; and (3) expanding the scope of exclusions under section 1128(b)(8) of the Act. The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) amended OIG's authority to waive mandatory exclusions. In 2010, the Patient Protection and Affordable Care Act, Public Law 111-148, 124 Stat. 119 (2010), as amended by the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, 124 Stat. 1029 (2010) (ACA), broadened OIG's ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 174k characters. 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