CMS issued a final rule Thursday to clear up issues inherent in shared savings payments that could implicate physicians in fraud and abuse laws.
The rule, issued by CMS and HHS' Office of Inspector General, finalizes waivers of the physician self-referral law known as Stark law, the Federal Anti-Kickback Statute and the civil monetary penalty for beneficiary inducements. The interim final rule has been in place since Nov. 2011.
The final rule outlines the following five waivers.
1. ACO pre-participation waiver.
Stark Law and the Anti-Kickback Statute are waived for parties working to develop an accountable care organization arrangement in the Medicare Shared Savings Program.
2. ACO participation waiver.
Stark Law and the Anti-Kickback Statute are waived for ACOs, ACO participants and their providers and suppliers once the ACO is participating and in good standing in a shared savings program.
3. Shared savings distribution waiver.
Stark Law and the Anti-Kickback Statute are waived in regards to distributing shared savings payments.
4. Compliance with the physician self-referal waiver.
The Anti-Kickback Statute is waived in regards to financial relationships between or within the ACO, its participants and its providers and suppliers.
5. Waiver for patient incentives.
The civil monetary penalty law in relation to beneficiary inducements and the Anti-Kickback Statute are waived for items or services at or below fair market value provided by the ACO, its participants and its providers and suppliers.
Notably, the final rule does not finalize waivers of "gainsharing" arrangements under the civil monetary penalty law.
More articles on accountable care:
What do ACOs need to succeed? Q&A with Medullan's Dutch Dwight on making accountable care feasible
Dartmouth-Hitchcock exits Pioneer ACO program: 10 things to know
Brookings Institute's Mark McClellan on ACOs: 'We're at the end of the beginning'