• OIG Informs Providers That ACO Waivers Will Probably Be Consistently Applied To ACOs And Not Issued On A Case-By-Case Basis
  • May 13, 2011 | Author: Catherine S. "Kate" Stern
  • Law Firm: King & Spalding LLP - Atlanta Office
  • During an April 28, 2011, telephone conference sponsored by the Health Care Compliance Association, Vicki L. Robinson, Chief of the Industry Guidance Branch and Senior Advisor for Health Care Reform of the Office of the Inspector General, Department of Health and Human Services (OIG), informed providers that the OIG and the Centers for Medicare and Medicaid Services (CMS) envision that Accountable Care Organization (ACO) waivers will be applied consistently to all ACOs rather than on a case-by-case basis.  Therefore, according to the OIG, ACO waivers will most likely not be granted using an approach similar to the Advisory Opinion process.  This elaborates upon the comments of OIG and the CMS in their recent joint notice soliciting comments on proposed ACO waivers.  In such notice published in the Federal Register on April 7, 2011, CMS and OIG informed providers that the agencies are contemplating promulgating waivers in the publication of the final regulations for the Medicare Shared Savings Program that are to be applied consistently and uniformly to all ACOs.

    As stakeholders expressed concern that implementation of the Medicare Shared Savings Program and the development of ACOs would be impeded by certain fraud and abuse laws, the Patient Protection and Affordable Care Act (PPACA) authorizes the Secretary of the Department of Health and Human Services to waive the Stark Law, Anti-Kickback Statute and certain other laws as necessary to implement the program.  CMS and OIG issued the April 7, 2011 notice under this authority, and the comment period ends on June 6, 2011.

    The notice sets forth proposals for waiving application of the Stark Law, the Anti-Kickback Statute and the civil monetary penalty law that prohibits hospitals from paying physicians to reduce or limit services provided (the CMP Law).  In all proposals, the ACO would be required to enter into an agreement with CMS to participate in the Medicare Shared Savings Program and the ACO participants, providers and suppliers would be required to comply with the agreement and all of the requirements applicable to the program.

    The agencies propose waiving the application of the Stark Law and the Anti-Kickback Statute to distributions of shared savings received by an ACO from CMS under the program “to or among ACO participants, ACO providers/suppliers, and individuals and entities that were ACO participants or ACO providers/suppliers during the year in which the shared savings were earned” that are for activities “necessary for and directly related to” the ACO’s participation in the Medicare Shared Savings Program.  Interestingly, the notice also proposes to waive application of the Anti-Kickback Statute and the CMP Law to any financial relationship between or among the ACO, ACO participants and ACO providers and suppliers that are directly related to the ACO’s participation in and operations under the Medicare Shared Savings Program that implicates the Stark Law but fully complies with one of its exceptions.

    CMS also solicits public input on the application of waivers to other related scenarios, such as arrangements that relate to the establishment of an ACO.