CMS and the HHS Office of Inspector General have issued a joint notice seeking comments on potential waivers for Medicare accountable care organizations on the physician self-referral law, the anti-kickback statute and the civil monetary penalty law.
The notice said a waiver would not be needed for ACO arrangements that fit within an existing exception or safe harbor or do not otherwise violate the law.
In addition, the agencies proposed waivers to cover three scenarios:
1. Shared savings payments received by an ACO and distributed among ACO participants, providers or suppliers.
2. Distribution of shared savings payments to others for activities that are "necessary for and directly related to" the ACO's participation in the shared savings program.
3. In the case of the anti-kickback and civil monetary penalty laws, financial relationships that are "necessary for and directly related to" the ACO's participation in the program, as long as they fully comply with an exception to the physician self-referral law.
The notice also asks for comments on possible waivers to cover ACO start-up costs, ongoing operating expenses and non-shared savings relationships between ACO members or outside entities.
Comments on the notice are due on June 6. CMS said it expects to issue waiver provisions when final regulations for ACOs are issued.
Read the joint notice of CMS and the HHS OIG on ACOs.
Read a CMS fact sheet on legal issues regarding ACOs.
Read more on the possibility of fraud and abuse waivers for ACOs:
- 5 Key Regulatory Concerns for ACOs
- 13 Legal Issues for Hospitals and Health Systems
- Don't Remove Antitrust, Fraud Laws for ACOs, Insurance Industry Warns
The notice said a waiver would not be needed for ACO arrangements that fit within an existing exception or safe harbor or do not otherwise violate the law.
In addition, the agencies proposed waivers to cover three scenarios:
1. Shared savings payments received by an ACO and distributed among ACO participants, providers or suppliers.
2. Distribution of shared savings payments to others for activities that are "necessary for and directly related to" the ACO's participation in the shared savings program.
3. In the case of the anti-kickback and civil monetary penalty laws, financial relationships that are "necessary for and directly related to" the ACO's participation in the program, as long as they fully comply with an exception to the physician self-referral law.
The notice also asks for comments on possible waivers to cover ACO start-up costs, ongoing operating expenses and non-shared savings relationships between ACO members or outside entities.
Comments on the notice are due on June 6. CMS said it expects to issue waiver provisions when final regulations for ACOs are issued.
Read the joint notice of CMS and the HHS OIG on ACOs.
Read a CMS fact sheet on legal issues regarding ACOs.
Read more on the possibility of fraud and abuse waivers for ACOs:
- 5 Key Regulatory Concerns for ACOs
- 13 Legal Issues for Hospitals and Health Systems
- Don't Remove Antitrust, Fraud Laws for ACOs, Insurance Industry Warns