Fraud and Abuse Waivers for ACOs Rule Extended by CMS
- This week, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) extended the effectiveness of an interim final rule related to waivers from fraud and abuse rules for Accountable Care Organizations participating in the Medicare Shared Savings Program. This means that an official final rule will need to wait until next year as the extension reaches until November 2, 2015.
Typically, a final rule is required within three years of the initial rule. However, a one year extension may be granted by the HHS secretary through a notice of continuation. The initial rule was drafted in November 2011 and centers on the establishment of the Shared Savings Program, which encourages the development of Accountable Care Organizations (ACO). It also allows the Secretary to waive certain specified fraud and abuse laws that are deemed “necessary” and are consistent.
The CMS and OIG joint rule (Waiver IFC), builds off of this and established waivers of the application of the Federal physician self-referral law, anti-kickback statute and certain civil monetary penalties law provisions to specify arrangements involving ACOs participating in the Shared Savings Program.
“Our goal is to ensure that the regulations setting forth waivers of the fraud and abuse laws continue to be closely aligned with the Shared Savings Program regulations,” the waiver reads.
It goes on to say that based on feedback from stakeholders and the CMS’s experience with the Shared Savings Program, CMS determined that specific modifications were required to the program. This would happen through proposed rule changes to the program and it is critical that these regulations all align. This makes the most logical course of action to extend the effectiveness of the Waiver IFC.
“In addition, we believe that an extension of the Waiver IFC will avoid impediments to the development of innovative care models envisioned by the Shared Savings Program and new approaches to the delivery of health care for beneficiaries,” the waiver reads.
The waiver does state that applying for this extension should not be seen as a diminution of the Department’s commitment to establish waivers that foster the success of the Shared Savings Program. The goal remains to effectively balance the need for ACO certainty, innovation and flexibility in the Shared Savings Program with protections for beneficiaries and the Medicare program.
Without the extension, the waiver report states that the rule would expire. This would create legal uncertainty for ACOs participating in the Shared Savings Program and potentially disrupt ongoing business plans or operations of some ACOs. It is also stated that the rule would benefit from additional input by stakeholders that have a better understanding of how ACOs are using the waivers.
