Details on October Meeting About Legal Issues For ACOs Provided by Federal Enforcement Agencies

Federal enforcement agencies have released a preliminary agenda of an Oct. 5 workshop to gather industry-wide comments on possibly changing federal laws and regulations to protect accountable care organizations from prosecution, according to a notice in the Federal Register.

The day-long workshop will be held by the Federal Trade Commission, HHS Office of Inspector General and CMS at CMS offices in Baltimore and available by teleconference. It will address antitrust, physician self-referral, anti-kickback and civil monetary penalty issues.

Space for both the meeting and the teleconference is limited and attendees will need to register in advance for both. The deadline to register for attending the workshop is 5 p.m. Eastern Time on Sept. 27. The agencies are also inviting written comments in advance, which have the same deadline as registration. No deadline has been issued for the teleconference. See contact information for registration and providing information at the end of this article.

Preliminary workshop Agenda. The workshop will be divided into three moderated panel discussions and one listening session. A specific agenda for the panel discussions will be released at a later time.

First morning session. Panelists representing providers, insurers and healthcare policy experts will discuss FTC issues for ACOs. Specifically, they will discuss circumstances when collaboration among independent providers in an ACO permits them to engage in joint price negotiations with private payers without the risk of violating antitrust laws. The panel will then discuss what kind of clinical integration would be necessary to help providers improve the quality and whether joint price negotiation is reasonably necessary to achieve these efficiencies.

Second morning session.
In a second FTC discussion, panelists will explore ways to encourage formation of multiple ACOs among otherwise independent providers to improve competition among ACOs and thus improve quality and affordability of healthcare. Panelists will explore:

1. Arrangements where providers or facilities are exclusive, or non-exclusive, to an ACO.
2. Any impact of risk-based contracting, such as global payments or capitated rates, would have on market power assessments.
3. How to assess whether formation of an ACO among independent providers might allow it to increase price and reduce the quality of care.
4. What data on finances, utilization, outcome and patient experience would be necessary to monitor and measure the ACO's impact on prices and quality in relevant markets.

First afternoon session.
A panel representing providers, suppliers and health policy experts will discuss how ACOs would interact with the physician self-referral prohibition, the anti-kickback statute, and the Civil Money Penalties Law. HHS agencies are interested in the types of contractual and financial relationships under existing or planned ACOs that might trigger antitrust laws, the physician self-referral prohibition or the anti-kickback statute (such as compensation and ownership relationships) and payment arrangements that might implicate the Civil Money Penalties Law (such as gainsharing structures).

The agencies also want to know whether a waiver or a full-blown exception to the physician self-referral prohibition is needed.

1. In regards to a waiver, they want to know whether it should apply only to the incentive payments distributed to the ACOs and participating physicians and other participating suppliers and ACO professionals, or whether a broader waiver is necessary.
2. In regards to an exception, the agencies seek recommendations for how a meaningful exception and safe harbor for the incentive payments related to ACOs could be crafted. In particular, they want to know how a physician self-referral exception could be designed to present no risk of program or patient abuse.

Second afternoon session. This is a listening session, in which other attendees will have an opportunity to provide brief comments on the same topics as the first afternoon session, either in person or via the teleconference.

Details and contact information

The workshop begins at 9 a.m. and ends at 4:30 p.m. Eastern Daylight Time. A full  agenda will be posted at www.cms.gov/center/physician.asp at an unspecified date.

Those who wish to attend the event in person should complete on-line registration at www.cms.hhs.gov/apps/events/event.asp?id=607. The workshop will be held in the main auditorium of the CMS Central Building at 7500 Security Boulevard in Baltimore.

Those who wish to make written comments should send them to ACOlegalissues@cms.hhs.gov.

Information on attending via teleconference and Web conference will be posted at an unspecified date on the CMS Web site at http://www.cms.gov/center/physician.asp.  

Read the full Federal Register notice.

Read more about ACOs.

- 4 Best Practices for Successful ACO Homecare Nurses

- 11 Things to Know About Accountable Care Organizations

- Blue Shield of California, CHW and Hill Physicians Create ACO for Retired California State Employees



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