On October 17, 2014, CMS and OIG jointly published a notice extending the effectiveness of a November 2011 interim final rule establishing waivers that protect qualifying accountable care organizations (ACOs) from liability under federal fraud and abuse laws. The interim final rule will remain in effect through November 2, 2015, unless a final rule becomes effective on an earlier date.
The interim final rule sets forth five waivers that provide protection from the Stark law, the federal Anti-Kickback Statute, and certain provisions of the civil monetary penalties law. These waivers apply only to ACOs that have a good-faith intent to participate in, or that actually participate in, the Medicare Shared Savings Program. More information about the scope, terms, and conditions of the waivers is available here.
The extension is necessary because the final rule will not be published within the requisite three year period after the November 2011 publication of the interim final rule. The October 17 notice explains that failure to extend the waivers would create legal uncertainty for ACOs participating in the Shared Savings Program and could disrupt ongoing business plans or operations of some ACOs. CMS and OIG believe that it is prudent to extend the timeline for publication of the final waiver regulations because CMS is currently developing a proposed rule that affects the Shared Savings Program. The extension is needed to ensure that the final waiver regulations align with the Shared Savings Program, including these planned changes.
The notice also contains a request for additional input from stakeholders on the following:
- How and to what extent ACOs are using the waivers;
- Whether the existing waivers serve the needs of ACOs and the Medicare program;
- Whether the waivers adequately protect the Medicare program and beneficiaries from the types of harms associated with referral payments or payments to reduce or limit services; and
- Whether there are new or changed considerations that should inform the development of additional notice and comment rulemaking.
The notice does not contain a deadline for stakeholders to submit comments on these issues. The joint CMS/OIG notice is available here.