Revisions to safe harbors proposed by the HHS Office of Inspector General
The Department of Health and Human Services’ Office of Inspector General (OIG) has issued a proposed rule that would amend the safe harbors to the anti-kickback statute and the civil monetary penalty (CMP) rules to protect certain payment practices and business arrangements from criminal prosecution or civil sanctions.
Many of the revisions reflect statutory changes in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Affordable Care Act (ACA), as amended by the Health Care and Education Reconciliation Act of 2010. In addition, the rule would revise the definition of "remuneration" added by the Balanced Budget Act of 1997 and ACA, and it would add a gainsharing CMP provision.
Included in the CMP changes are proposals OIG said are "intended to protect certain arrangements that offer beneficiaries incentives to engage in their wellness or treatment regimens or that improve or increase beneficiary access to care, including better care coordination." The rule states, "As hospitals move towards using objective quality metrics, we recognize that a change in practice does not necessarily constitute a limitation or reduction of services, but may in fact constitute an improvement in patient care or reduction in cost without reducing patient care or diminishing its quality."