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From Health Law Daily, December 7, 2016

HHS’ CMP authority grows alongside anti-kickback safe harbors

By Bryant Storm, J.D.

HHS enlarged the scope of its civil monetary penalty (CMP) authority and provided new safe harbors to the anti-kickback statute (AKS), under two new Final rules. Although the new regulations strengthened the agency’s CMP, assessment, and exclusion authority, the agency also amended the regulatory safe harbors to the anti-kickback statute by adding new safe harbors to protect certain payment practices and business arrangements from sanctions (Final rule, 81 FR 88334,December 7, 2016; Final rule, 81 FR 88368, December 7, 2016).

CMPs. The changes to the CMP regulations at 42 C.F.R. part 1003 were proposed and finalized, in accordance with Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) requirements. The new regulations give HHS CMP, assessment, and exclusion authority for: (1) failure to grant OIG timely access to records; (2) ordering or prescribing while excluded; (3) making false statements, omissions, or misrepresentations in an enrollment application; (4) failure to report and return an overpayment; and (5) making or using a false record or statement that is material to a false or fraudulent claim. The Final rule also reorganizes the regulations in a manner designed to give them more clarity.

Safe harbors. The amendments to the AKS safe harbors were designed to give providers greater flexibility while continuing to protect programs and patients from fraud and abuse. The Final rule amends 42 C.F.R. Sec. 1001.952 with: (1) a technical correction to the existing safe harbor for referral services; (2) protection for certain cost-sharing waivers, including: pharmacy waivers of cost-sharing for financially needy beneficiaries; and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services; (3) protection for certain remuneration between Medicare Advantage (MA) organizations and federally qualified health centers (FQHCs); (4) protection for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program; and (5) protection for free or discounted local transportation services that meet specified criteria.

MainStory: TopStory FinalRules CMPNews CMSNews AntikickbackNews FraudNews ProgramIntegrityNews

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