Guilt by Affiliation? Proposed Rule Would Expand CMS Program Integrity Authority

Guilt by Affiliation? Proposed Rule Would Expand CMS Program Integrity Authority


Last month, CMS issued a proposed rule that would drastically expand the agency’s authority to further its program integrity efforts through the provider and supplier enrollment process. This proposed rule, referred to as CMS-6058-P, (located in the Federal Register at 81 Fed. Reg. 40.10720), is intended to implement a provision of the Affordable Care Act that requires Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) providers and suppliers to disclose any direct or indirect affiliation with an individual or entity that poses a risk to the integrity of these federal programs. Among other things, CMS is proposing to require healthcare providers and suppliers to report any affiliation that it or any of its owners or managing employees or organizations has, or, within the past five years, had with entities and individuals that:

  1. have any uncollected debt, such as unreturned overpayments, to Medicare, Medicaid, or CHIP;
  2. have been or are subject to any payment suspension under a federal health care program;
  3. are subject to an Office of Inspector General (OIG) exclusion; or
  4. have had their Medicare, Medicaid, or CHIP enrollment denied or revoked. 

CMS will be permitted to deny or revoke the provider’s or supplier’s Medicare enrollment if CMS determines that the affiliation poses a risk of fraud, waste, or abuse.

While CMS is signaling an increased emphasis on program integrity and fraud and abuse, it is yet to be seen how much of an impact this proposed rule will have. What is certain, is that this proposed regulation would create additional requirements for providers and may increase the need to track ownership affiliations. CMS is accepting comments on the proposed rule until Monday, April 25.

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