Final Rule Addresses MSSP Self-Referral and AKS Waivers

The Office of Inspector General and the Centers for Medicare & Medicaid Services recently issued a final rule finalizing five waivers introduced in 2011 which help Accountable Care Organizations (ACOs) take advantage of the Medicare Shared Savings Program while avoiding violations of the physician self-referral law and the federal antikickback statute. Those waivers are the:

• Pre-Participation Waiver for ACO-related start up activities when there is intent to participate in the Shared Savings program.
• ACO Participation Waiver for ACO's participating in the Shared Savings Program during such participation and for a period afterward.
• Shared Savings Distributions waiver for use of shared savings payments.
• Compliance waiver that protects from kickback liability arrangements that could violate the physician self-referral law but satisfy an exception to that law.
• Patient Incentive Waiver that protects incentives offered to beneficiaries to encourage preventive care and treatment compliance.

CMS stated in the final rule that "[t]hese five waivers provide flexibility for ACOs and their constituent parts to pursue a wide array of activities, including start-up and operating activities that further the purposes of the Shared Savings Program." For more information about these waivers and their conditions and limitations, see the Final Rule published in the Oct. 29, 2015 Federal Register.

Takeaway: CMS finally solidifies waivers designed to make it easier for ACOs to achieve shared savings goals without risking fraud and abuse violations.