Though the OIG can grant waivers to allow these arrangements to take place, the potential to violate several key statutes deterred most healthcare organizations from attempting the use of these agreements and cast a negative cloud around them, explains Addison, Texas–based healthcare attorney Cynthia Marcotte Stamer.
There is a key legal distinction between an accountable care organization shared savings arrangement and a gainsharing one, notes Marcotte Stamer. New shared savings rules outline detailed requirements pursuant to which ACOs can reward providers by providing shared savings. In contrast, if the ACO does not meet the ACO shared savings rules or the party other than an ACO offers gainsharing, "the gainsharing arrangement is presumptively against the law and participating parties are subject to enforcement, unless the parties seek and obtain an advisory opinion in which HHS agrees not to enforce the Stark, Fraud & Abuse, and CMP laws without revoking the ruling based on the gainsharing arrangement and the parties receiving that ruling in fact comply with the assumptions of the advisory opinion so as to qualify to rely upon that agreement not to enforce," she explains.
Moreover, each advisory opinion on gainsharing participation is directed specifically to that organization. "The ability to rely upon the [advisory opinion] remains limited to the requesting parties. The fact that a party has obtained an advisory opinion based on its application does not allow a different party to rely upon or claim any protection against prosecution for its gainsharing arrangement even if the facts are similar or even identical," says Marcotte Stamer.
Some of the elements that the OIG requires of those wishing to obtain the commitment not to enforce are defined, Marcotte Stamer says. In 2005, the Deficit Reduction Act renewed interest in gainsharing agreements, and the OIG has agreed not to prosecute organizations that pursue gainsharing arrangements if following criteria are applied: (1) measures that promote accountability and transparency, (2) adequate quality controls, and (3) controls on payment related to referrals, she explains.
The initial DRA exemptions to gainsharing were intended to allow Medicare to create pilot programs for cost savings in its fee-for-service population. However, with the passage of the Patient Protection and Affordable Care Act, gainsharing evolved into shared saving as part of the accountable care organizations program.
However, Marcotte Stamer notes that the regulations surrounding the Medicare ACO model shouldn't be deemed less complex. "These rules are just coming out and … there's tremendous cost involved and liability risk. You're building a very complex organization and asking providers to sign on and consent to rules that could change." Moreover, as with gainsharing, organizations that participate in the Medicare ACO program will need to demonstrate not only cost savings, but also steady or improved patient outcomes.