On October 28, 2015, CMS and OIG jointly issued a final rule for the Medicare Shared Savings Program ACO waivers, which is slated for publication in the Federal Register on October 29. The ACO waivers have been in place since an interim final rule with comment period (IFC) was published on November 2, 2011, and the final rule leaves the ACO waivers largely unchanged.  The final rule removes any uncertainty regarding the future of the ACO waivers, and is being published just days before the IFC, and thus the ACO waivers, were due to expire on November 2, 2015.

According to the final rule, HHS Secretary Sylvia Burwell determined that, based on “the consideration of public input, [OIG’s] own analysis, and CMS’s experience over the last four years,” the ACO waivers are necessary to carry out the MSSP, and the ACO waivers are “adequately protecting beneficiaries and Federal health care programs while promoting innovative structures within” the MSSP.

The final rule finalizes the following five ACO waivers from the IFC that waive certain provisions of the physician self-referral law (Stark), the Federal anti-kickback statute and/or the Beneficiary Inducements CMP:

  • “ACO pre-participation” waiver
  • “ACO participation” waiver
  • “shared savings distribution” waiver
  • “compliance with the physician self-referral law” waiver
  • “patient incentive” waiver

While the final rule does leave the ACO waivers and their implementation requirements mostly intact from the IFC, CMS and OIG did make a few changes. Most important among these changes is the removal of the Gainsharing CMP from the scope of the ACO waivers. According to the final rule, Section 512(a) of the Medicare Access and CHIP Reauthorization Act of 2015 revised the Gainsharing CMP to prohibit hospitals from knowingly making payments to induce physicians to reduce or limit “medically necessary” services. As such, “arrangements between hospitals and physicians that incentivize greater efficiency and reduction of waste, which previously may have run afoul of the Gainsharing CMP, would no longer implicate the provision,” and thus, need not be covered by an ACO waiver.

The other changes to the ACO waivers include (1) updating condition 4 of the pre-participation and participation waivers to state that ACO waiver documentation now “must” include the basis for the determination by the ACO’s governing body that the arrangement is reasonably related to the purposes of the MSSP, (2) clarification that “home health supplier” means a provider, supplier or other entity that is primarily engaged in furnishing home health services, and (3) corrections of scrivener’s errors.

If you have any questions related to the ACO waivers or their implementation, please contact Jim Wiehl, Bernie Duco, Chris Kanagawa, or Greg Boyle.

The final rule can be found at: https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-27599.pdf