Final rule on ACOs comes with clarifications

As the Centers for Medicare and Medicaid Services (CMS) released a final rule on implementation of the Medicare Shared Savings Program (MSSP) for accountable care organizations (ACOs), others released their notices regarding legal issues related to ACOs.

The final rule on ACOs can be found online at The national law firm of McGuireWoods offers this summary of the legal notices issued with the ACO final rule:

• CMS and the Office of the Inspector General (OIG) issued an interim final rule addressing waivers for application of Stark, Federal Anti-Kickback, and gainsharing and civil monetary penalty laws for certain arrangements by ACOs. That rule can be found online at

• Federal Trade Commission (FTC) and Department of Justice (DOJ) issued an updated policy statement that discusses how antitrust laws will be applied and enforced for ACOs. The rule can be found online at

• The IRS issued a fact sheet tax exempt status for ACOs.

The CMS final rule includes several key differences from the proposed rule that appear to be addressing some of the chief complaints with CMS's approach to the MSSP. McGuire Woods offers this summary:

1. No requirement to assume risk for shared losses. CMS eliminated "two-sided" risk from Track 1.

2. No retrospective assignment of beneficiaries. CMS adopted a "preliminary prospective-assignment" method that identifies beneficiaries assigned to an ACO quarterly, with an annual reconciliation based on patients actually served by the ACO.

3. Assignment to specialists. CMS allows beneficiaries to be assigned to a specialist when the beneficiary has not received any primary care services from a primary care physician. The beneficiary is assigned to the ACO professional having the plurality of allowed charges for primary care services.

4. Significant reduction in the number of quality measures. CMS adopted 33 measures in four domains, down from 65 measures in five domains in the proposed rule.

5. First dollar savings for all. CMS eliminated the minimum savings rate so Track 1 and Track 2 ACOs will be able to share in all savings up to the maximum savings rate.

6. No electronic health record (EHR) meaningful use requirement. CMS will no longer require as a condition of participation that 50% of primary care physicians be meaningful users of an EHR. Meaningful use is, however, incorporated into the MSSP as a quality measure.

7. FQHC and RHCs eligible to participate in ACOs. CMS expanded the list of eligible entities to include federally qualified health centers (FQHCs) and rural health clinics (RHCs). FQHCs and RHCs can form their own ACO or become a participant in other ACOs.