The U.S. Government Accountability Office has issued a report on stakeholders' perspectives on the adequacy of guidance on antitrust issues for healthcare providers. Six antitrust law experts and four healthcare industry groups provided feedback on guidance offered by the Antitrust Division of the Department of Justice and Federal Trade Commission.
The report includes focuses on key aspects of federal antitrust guidance for healthcare collaboration: clinical integration, exclusive arrangements and safety zones.
Clinical integration
Clinical integration involves integrating clinical activities across providers in a collaborative arrangement. It's one way an arrangement can satisfy the requirement of demonstrating potential to yield significant benefits in order to jointly negotiate prices.
Five of six antitrust experts and one of four industry groups said agency guidance on clinical integration was sufficient, while one expert and two industry groups said it was inadequate. The two industry groups also noted that this "inadequate" guidance may have discouraged provider collaboration.
Two of five experts also said that though the guidance was sufficient, it would be helpful if the agencies updated the 1996 Statements of Antitrust Enforcement Policy in Health Care to reflect clinical integration arrangements that have been established since, and also those that incorporate evidence-based medicine and quality measures.
Exclusive arrangements
If providers are participating in a collaborative arrangement, exclusive arrangements restrict their ability to contract with other arrangements or payors. Officials from the FTC and DOJ have said that although exclusive arrangements have potential benefits, they can have anticompetitive effects.
Four experts said the agencies' guidance on exclusive arrangements was reasonable, while three industry groups said agencies should allow greater use of exclusive arrangements. One industry group said the agencies have not acknowledged the efficiencies that can result from exclusive arrangements, such as the minimization of "free-riding." Free-riding refers a collaborative arrengemnt investing capital in a clinical integration, and the risk of other providers profiting from their investment. One legal expert also said he had advised clients not to use exclusive arrangements due to the greater scrutiny they receive from the agencies.
Safety zones
An arrangement falls under a safety zone when it is exempt from antitrust analysis and presumed to be lawful. The metrics for safety zones are outlined in the 1996 Statements of Antitrust Enforcement Policy in Health Care.
One of four industry groups and one of six experts said the size and scope of the safety zones are appropriate, while three industry groups and three experts said the zones should be expanded to include a wider range of arrangements. These include clinically integrated and multi-provider arrangements. One industry group said providers are reluctant to develop a collaborative care model because of the lack of a safety zone for such arrangements.
Agency officials said even if a collaborative arrangement falls outside a safety zone, it does not necessarily face a challenge if it doesn't reduce competition. Officials also expressed reluctance to expand safety zones, noting that multi-provider arrangements are "highly variable and could include combinations of provider specialties with which the agencies are less familiar."
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The report includes focuses on key aspects of federal antitrust guidance for healthcare collaboration: clinical integration, exclusive arrangements and safety zones.
Clinical integration
Clinical integration involves integrating clinical activities across providers in a collaborative arrangement. It's one way an arrangement can satisfy the requirement of demonstrating potential to yield significant benefits in order to jointly negotiate prices.
Five of six antitrust experts and one of four industry groups said agency guidance on clinical integration was sufficient, while one expert and two industry groups said it was inadequate. The two industry groups also noted that this "inadequate" guidance may have discouraged provider collaboration.
Two of five experts also said that though the guidance was sufficient, it would be helpful if the agencies updated the 1996 Statements of Antitrust Enforcement Policy in Health Care to reflect clinical integration arrangements that have been established since, and also those that incorporate evidence-based medicine and quality measures.
Exclusive arrangements
If providers are participating in a collaborative arrangement, exclusive arrangements restrict their ability to contract with other arrangements or payors. Officials from the FTC and DOJ have said that although exclusive arrangements have potential benefits, they can have anticompetitive effects.
Four experts said the agencies' guidance on exclusive arrangements was reasonable, while three industry groups said agencies should allow greater use of exclusive arrangements. One industry group said the agencies have not acknowledged the efficiencies that can result from exclusive arrangements, such as the minimization of "free-riding." Free-riding refers a collaborative arrengemnt investing capital in a clinical integration, and the risk of other providers profiting from their investment. One legal expert also said he had advised clients not to use exclusive arrangements due to the greater scrutiny they receive from the agencies.
Safety zones
An arrangement falls under a safety zone when it is exempt from antitrust analysis and presumed to be lawful. The metrics for safety zones are outlined in the 1996 Statements of Antitrust Enforcement Policy in Health Care.
One of four industry groups and one of six experts said the size and scope of the safety zones are appropriate, while three industry groups and three experts said the zones should be expanded to include a wider range of arrangements. These include clinically integrated and multi-provider arrangements. One industry group said providers are reluctant to develop a collaborative care model because of the lack of a safety zone for such arrangements.
Agency officials said even if a collaborative arrangement falls outside a safety zone, it does not necessarily face a challenge if it doesn't reduce competition. Officials also expressed reluctance to expand safety zones, noting that multi-provider arrangements are "highly variable and could include combinations of provider specialties with which the agencies are less familiar."
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