As the federal government pushes healthcare providers to deliver seamless care with better outcomes at lower costs, agencies say they are thinking hard about how to knock down a big potential barrier: themselves.
Easing the way for ACOs
Feds aim to create antitrust 'safe harbor' for new healthcare delivery model
Toward that end, the Federal Trade Commission, the CMS and HHS' inspector general's office held a workshop with a variety of providers, payers and their associations. The regulators wanted to know how their enforcement of antitrust and fraud-and-abuse laws might hinder the blossoming of accountable care organizations as nurtured by a Medicare shared-savings program in the Patient Protection and Affordable Care Act, as well as seeds of other integrated-care models planted as demonstrations in the reform law (Sept. 20, p. 36).
FTC Chairman Jon Leibowitz said during the forum that the commission and the U.S. Justice Department, which together are responsible for policing healthcare markets, intend to craft a new “safe harbor” that would define parameters that, if met, would provide ACOs certainty that the government would not accuse them of illegally colluding to fix prices or otherwise dampen competition.
ACOs, in many cases, may be alliances of independent providers rather than integrated systems under common ownership, and antitrust issues could arise if those alliances negotiate with commercial payers in addition to providing coordinated care to Medicare beneficiaries. Problems also may arise with the consolidation that comes with integration.
The antitrust authorities included a number of safety zones in healthcare policy statements issued in the 1990s, but they have long resisted calls from hospitals and physicians for more clarity concerning clinical integration among competing providers that form independent practice associations or physician hospital associations. Many now view those models as antecedents of ACOs or even the same thing under different names.
“We've realized that, particularly for accountable care organizations, physicians in small groups are going to have difficulty participating because of antitrust rulings in the past that set a bar so high,” American Medical Association President Cecil Wilson said in an interview after the workshop. Providers have been in the position of investing a couple million dollars to create the framework for an alliance and then still facing the possibility that the FTC or Justice Department might give it a thumbs down, said Wilson, who was a panelist during the antitrust discussion.
Bill Williams, chairman of Covenant Health Partners in Lubbock, Texas, said during the forum that it was difficult to get physicians onboard when setting up the clinically integrated physician-hospital organization because they feared the effort would get tangled up in an FTC investigation. “That turned out not to be the case,” Williams said. “We were investigated by DOJ. We spent $1 million, and they said we were OK.”
Leibowitz also said a new expedited review process may be established to provide guidance to arrangements that fall outside of its new safe harbor. “We need your input because we need to get this right, and here's why: If ACOs end up stifling rather than unleashing competition, we will really have let one of the great opportunities for healthcare reform slip away.”
The FTC plans to issue proposed guidance this fall in order to fit with in the same general timeline of a proposed rule expected from the CMS erecting the regulatory framework for ACOs, which are described broadly in the reform law Congress passed in March. Providers already are working to form ACOs, including one in Washington, Mo. (See story, p. 14).
The law gives the HHS secretary authority to waive the fraud and abuse laws to ease implementation of Medicare shared savings for ACOs and for demonstrations of other delivery models. The CMS and the inspector general's office also have the authority to create safe harbors insulating providers from the anti-kickback statute and exceptions to the Stark law restricting Medicare referrals. The inspector general also can grant leeway in its authority to impose civil monetary penalties when hospitals reward physicians for withholding or limiting care.
“These fraud-and-abuse laws operate on the general principle that programs and patients can best be protected by prohibiting or limiting financial relationships between referral sources and referral recipients,” said Vicki Robinson, the inspector general's senior adviser for healthcare reform.
Melinda Hatton, American Hospital Association senior vice president and general counsel, who did not participate in the forum but listened over the Web, said the questions the moderators posed during the fraud-and-abuse panel indicated that HHS is taking a narrow approach that would grant breathing room only in the context of demonstrations and the coming ACO shared-savings program.
“If that's what they're thinking about, I think they're putting healthcare reform in jeopardy,” Hatton said. “Virtually all the delivery system reforms are premised on a closer working relationship between providers and facilities for the care a patient receives from the beginning to the end. There's going to be a lot of experimentation out there, and it's not going to be in a narrow category called ACOs.”
Robert Saner, a partner in the law firm Powers Pyles Sutter & Verville, who participated on behalf of the Medical Group Management Association, said afterward that he believes the HHS regulators are likely to grant ACOs a waiver and that they must do so in encourage participation from a broad array of providers, rather than only large systems that already are significantly integrated.
That sentiment was echoed by others on the panel, including representatives of the American Medical Group Association, the Association of American Medical Colleges and the Federation of American Hospitals.
As he set the stage for several hours of discussion at CMS headquarters in Baltimore, CMS Administrator Donald Berwick said, “We want our cake, and we want to eat it, too. We want cooperation without corruption. We want aggregation without hegemony, and we want synergy without collusion.”
Send us a letter
Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.