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| HHS/OS | RIN: 0991-AB81 | Publication ID: Spring 2011 |
| Title: ●Medicare and State Health Care Programs: Fraud and Abuse; Revisions to the Office of Inspector General's Safe Harbors Under the Antikickback Status, Exclusion Authorities, and Civil Monetary Penalty | |
| Abstract: This rule would: 1) Safe Harbor Provisions: Add safe harbors under the anti-kickback statute addressing arrangements in the following areas (subject to certain conditions): waivers of Federal health care program beneficiary cost-sharing amounts in the context of certain government sponsored clinical trials and in the context of certain emergency medical services furnished by suppliers owned or operated by States or municipalities; certain local transportation provided to Federal health care program beneficiaries; certain waived or reduced cost-sharing amounts under Medicare Part D (codifying in regulations section 101(e) of the Medicare Prescription Drug Improvement and Modernization Act of 2003); and certain discounts in the price of "applicable drugs" of manufacturers furnished to "applicable beneficiaries" under the Medicare Coverage Gap Discount Program (pursuant to section 3301 of the Affordable Care Act of 2010). In addition, this rule would re-propose expanding the existing safe harbor for certain waivers of beneficiary co-insurance and deductible amounts for Part A or Part B services for Medicare SELECT policyholders in accordance with an agreement between the Medicare SELECT issuer and a provider or supplier, in certain contexts. 2) OIG's Authority To Impose Civil Money Penalties and Assessments (610 Review): Revise 42 CFR part 1003, addressing the Office of Inspector General's authority to propose the imposition of civil money penalties and assessments by reorganizing and simplifying existing regulatory text and eliminating obsolete references contained in the current regulations. Among the proposed revisions, this rule would establish separate subparts within part 1003 for various categories of violations; clarify the availability of exclusion for certain violations in addition to civil money penalties and assessments; date various references to managed care organization authorities; and clarify the application of section 1140 of the Social Security Act with respect to the misuse of certain Departmental symbols, emblems, or names through Internet and e mail communications. 3) OIG's Exclusion Authority: In accordance with section 949 of the Medicare Prescription Drug Improvement and Modernization Act of 2003, and section 6402 of the Affordable care Act 0f 2010, this rule would revise the OIG's exclusion authority to permit any Federal health care program to request a waiver of an OIG exclusion imposed under sections 1128(a)(1), 1128(a)(3), or 1128(a)(4) of the Social Security Act if the exclusion would impose a hardship on beneficiaries. In addition, in accordance with sections 6406 and 6408 of the Affordable Care Act, the proposed rule would revise the OIG's exclusion authority to grant testimonial subpoena authority in exclusion cases; to add a new permissive exclusion authority for making false statements or misrepresentation of materials facts, and; to broaden the scope of certain permissive exclusion authorities. Finally, the proposed rule would revise current exclusion authorities in 42 CFR parts 1001, 1002, and 1005, to further clarify OIG's existing exclusion authorities. 4) Exceptions to the Beneficiary Inducement Prohibition for Certain Arrangements This proposed rule will codify section 6402(d)(2)(B) of the Affordable Care Act of 2010, entitled "Clarification of Treatment of Certain Charitable and Other Innocuous Programs." Section 1128A(a)(5) of the Social Security Act provides for a civil monetary penalty for certain inducements offered to Medicare and Medicaid beneficiaries. Section 6402(d)(2)(B) of the ACA adds four exceptions to the definition of remuneration at section 1128A(i)(6) of the Social Security Act for purposes of section 1128A(a)(5): certain remuneration which promotes access to care and poses a low risk of harm to patients and Federal health care programs (as defined in section 1128(f) of the Social Security Act and designated by the Secretary under regulations); certain offers or transfers in connection with retail rewards programs; certain unadvertised transfers of items or services to beneficiaries experiencing financial need; and certain waivers by PDP sponsors of Part D plans or MA organizations offering MA-PD plans of copayments otherwise owed by their enrollees for the first fill of a covered Part D drug that is a generic drug. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
| RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: Undetermined | Unfunded Mandates: No |
| CFR Citation: 42 CFR 1001.952 42 CFR 1001 and 1002 42 CFR 1005 42 CFR 1003.101 42 CFR 1003 ... (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: PL 100-93, sec 14(a), sec OL 111-148, sec 3301, sec 6402 PL 108-173, sec 101(eaaa0, sec 949 PL 105-33, sec 4331, PL 99-660 PL 107-188 42 USC 1320a-7a 42 USC 1395mm 42 USC 1395w-27 42 USC 1396b | |
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Federalism: No | |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Patrice S. Drew Regulations Analyst Department of Health and Human Services 330 Independence Avenue SW, Washington, DC 20201 Phone:202 619-1368 Email: patrice.drew@hhs.gov |
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