ACOs: Understand, comply with ACO waivers

A. ACOs were created to coordinate care for patients, improve outcomes and reduce medical costs. ACOs achieve those goals through financial incentives, referrals and information sharing—all actions that would generally violate federal fraud and abuse laws if not for waivers authorized by CMS. The five waivers do not require filing or submitting applications.

The five waivers are:

• A pre-participation waiver, which applies to ACOs that are preparing an application to participate in the Shared Savings Program;

• A participation waiver, which applies during the time the ACO has a shared savings contract with CMS;

• A distribution waiver, which applies to distributions of shared savings during and after termination of the shared savings

contract;

• A waiver to protect Stark compliant financial relationships from liability under the anti-kickback statute and under civil monetary penalty rules; and

• A beneficiary inducements waiver that permits ACOs to provide certain items or services to Medicare beneficiaries.

There are some compliance requirements for the waivers. First, the protected arrangements must be “reasonably related to the purposes of the Shared Savings Program.” Under the federal rule the purposes of the Shared Savings Program consist of promoting accountability for the quality, cost and overall care of a Medicare population; managing and coordinating care for Medicare fee-for-service beneficiaries through an ACO; and encouraging investment in infrastructure and redesigned care processes for high-quality and efficient service delivery for patients. Second, both the pre-participation and participation waivers require that the governing body of the ACO make a bona fide determination that the arrangement is reasonably related to the purposes of the Shared Savings Program and expressly authorize the arrangement. Third, both aforementioned waivers require contemporaneous documentation of the arrangement. Fourth, arrangements for which waiver protection is sought must be publicly disclosed.

Carla Hogan is an attorney with Greenberg Traurig. She can be reached at 518.689.141 or hoganc@gtlaw.com.