The Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector General (OIG) published a final rule that sets forth waivers of fraud and abuse laws applicable to the Medicare Shared Savings Program (MSSP). With this final rule, there are five applicable waivers from the covered fraud and abuse laws for MSSP ACOs: (1) ACO Pre-Participation Waiver); (2) ACO Participation Waiver); (3) Shared Servicing Distribution Waiver; (4) Patient Incentive Waiver; and (5) Compliance with Physician Self-Referral Law Waiver. This comes as CMS introduced other changes to the Stark Law in the 2016 Medicare Physician Fee Schedule.
The Waivers
The waivers provide MSSP ACOs and their participants with broad protection against specified fraud and abuse laws if all the conditions to the waivers are met. The ACO Pre-Participation Waiver, like the other waivers, applies to the Stark Law and the Anti-Kickback Statute, and this in particular applies to start-up arrangements for ACOs that anticipate participating in the MSSP. There are limitations, including on the duration of the waiver and the parties covered. The Participation Waiver applies broadly to ACO arrangements during the term of the ACO’s participation agreement under the MSSP and for a limited period of time afterward. The Shared Service Distribution Waiver applies to distributions and uses of shared savings payments earned under the MSSP.
The Patient Incentive Waiver of the civil monetary penalties law provisions addressing inducements to Medicare beneficiaries and the Anti-Kickback Statute for medically related incentives offered by the ACO or participating providers under the MSSP to Medicare beneficiaries to encourage preventative care and treatment programs. Additionally, the Compliance with Physician Self-Referral Law Waiver applies to the Anti-Kickback Statute for ACO arrangements that would implicate the Stark Law and satisfies the requirements of an existing exception.
Other Aspects of Final Rule
The final rule continues waivers originally proposed but eliminates the waiver of the Gainsharing Civil Monetary Penalty Law and makes it illegal for hospitals to knowingly make payments directly or indirectly, to induce a physician to reduce or limit medically necessary services to Medicare or state program beneficiaries under the physician’s direct care. The final rule also clarifies “home health supplier” are not eligible for waiver protection under the Pre-Participation Waiver, which generally applies to start-up arrangements. In the final rule, CMS states that a home health supplier is an entity that is primarily engaged in furnishing home health care services.
The final rule states that the waivers adequately protect beneficiaries and Federal health care programs, but that CMS and the OIG will continue to monitor ACOs and may consider additional rulemaking if needed. Both CMS and OIG remain committed to the MSSP and accountability measures for the cost and quality of health care. However, it also shows an interest in flexibility within the regulatory schemes created by these programs to promote some arrangements and activities.