The AHA's "Guidance for Clinical Integration," released in 2007, made the case for more guidance on clinical integration from federal antitrust agencies. The working paper also provided proposed guidance on establishing clinical integration programs and a proposed legal analysis of how clinical integration fits within established analysis (To read the working paper, visit "Highlights" under the "Clinical Integration" section of www.aha.org).
While one size will never fit all in the hospital or health care field, the working paper asserts that legitimate clinical integration programs would not run afoul of antitrust laws and policies.
The paper discusses steps that hospitals will likely need to take to develop a clinical integration arrangement. These include: establishing goals for the program; determining its clinical approach and participants; developing mechanisms to monitor and control use and enhance quality and efficiency; building infrastructure, and deciding when to begin negotiations with payers. The AHA's goal in releasing the working paper was to foster a dialogue with antitrust agencies that could lead to the government providing guidance aimed at providers not just antitrust lawyers guidance that could be understood by those in the field responsible for fashioning clinical integration arrangements and that the agencies clearly endorsed.
Response on Capitol Hill
Following release of the working paper, several lawmakers on Capitol Hill told the U.S. Department of Justice (DOJ) and the Federal Trade Commission (FTC) that they support the AHA's call for greater guidance. They have continued to press the antitrust agencies for action.
In a Nov. 3 letter to the DOJ and the FTC, five senators Judiciary Committee Chairman Patrick Leahy, D-VT, Herb Kohl, D-WI, chairman of Judiciary's antitrust, competition policy and consumer rights subcommittee, Sheldon Whitehouse, D-RI, Dianne Feinstein, D-CA, and Arlen Specter, D-PA called on the antitrust agencies "to work with the hospital and provider communities to develop clear and user-friendly guidance for hospitals, physicians and other health care providers seeking to explore clinical integration."
In response, Assistant Attorney General Ronald Weich on Dec. 14 wrote the senators that DOJ is committed to "providing clear guidance to health care providers and others in the health care industry to help them identify and understand any antitrust issues as they explore new ways to collaborate to increase efficiency and benefit consumers through lower cost, higher quality care." He said the department soon will "launch the beginning of [a guidance] review process with industry, consumers and other interested parties." FTC Chairman Jon Leibowitz on Nov. 18 wrote a similar letter.
On a related note, nine Democratic senators on Dec. 23 wrote the antitrust agencies, reiterating concerns expressed a month earlier by Leahy, Kohl and other Judiciary committee members, and urging them to review legal barriers to collaboration.
"Clear and accessible guidelines on forming collaborative care models are critical to help spur streamlined, quality, low-cost care," wrote the senators, adding that "true delivery system reform needs to move forward."
