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October 17, 2014 01:00 AM

HHS extends Stark, anti-kickback waiver for ACOs

Lisa Schencker
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    HHS will allow Medicare accountable care organizations to continue operating outside of federal kickback and physician self-referral laws for at least another year.

    Experts say it’s just the latest move toward more flexibility as healthcare shifts from the traditional fee-for-service model to one focused more on quality and efficiency.

    Waivers to the federal anti-kickback statute and the federal physician self-referral law, also known as the Stark law, for ACOs participating in the Patient Protection and Affordable Care Act’s Shared Savings Program will be extended through Nov. 2, 2015, HHS’ Office of the Inspector General and the CMS said in the interim final rule. The waivers, which have been in place for nearly three years, were otherwise set to expire in November.

    Without the action, the waivers would have expired, the agencies said, “creating legal uncertainty for ACOs participating in the Shared Savings Program and potentially disrupting ongoing business plans or operations of some ACOs.”

    The Shared Savings Program was one of the first initiatives implemented under the ACA and was designed to help boost quality and lower costs for individual Medicare beneficiaries and the Medicare program. Under the program, ACOs may share in the savings they generate within Medicare.

    Experts said they weren’t surprised Friday to see the waivers extended. “In a nutshell, if the waivers had not been extended, the entire Medicare Shared Savings Program would have immediately collapsed,” said Joe Lynch, a partner at King & Spalding in Washington.

    The waivers allow ACOs the flexibility they need to coordinate care for patients across providers. Charles Buck, a healthcare attorney with McDermott Will & Emery in Boston, said the anti-kickback and Stark laws are designed to prevent abuse in a fee-for-service context but “otherwise can act as a barrier to hospitals and health systems working closely with physicians and physician groups and other providers.”

    He said it’s a matter of balancing the need to continue to prevent abuses in traditional systems while also making sure new models have the flexibility they need to be successful.

    “All of this sort of reflects the underlying tension between a recognition that these laws were originally designed to protect the program or the beneficiary,” Buck said, “(but) because of the different structure and incentives in the Medicare Shared Savings Program, again, the laws are not, on the one hand, as important in protecting the program and beneficiaries, and, on the other hand, actually can act as barriers to incentivizing the kind of performance and behavior that CMS is trying to get out of ACOs.”

    Lynch said he believes more state and federal waivers will become necessary in coming years as healthcare continues to evolve.

    Harold Miller, president and CEO of the Center for Healthcare Quality and Payment Reform in Pittsburgh, said, if anything, he found Friday’s announcement “troubling” because it didn’t go far enough. He said he’d like to see the waiver regulations finalized, not merely extended for another year. He also said the current waivers are too narrow and “do not go nearly as far as they need to in order to enable providers to redesign care effectively.”

    Miller said the extension “introduces additional uncertainty into the ACO program at a time when there are serious concerns about its ability to succeed.” He said he worries that uncertainty could deter additional providers from entering the ACO program.

    The rule announced Friday explains that the agencies decided to extend the waivers for a number of reasons. For one, the CMS is now developing its own rule regarding the Shared Savings Program. Also, the CMS and OIG want time for input from stakeholders on the effectiveness of the waivers.

    “We believe that an extension of the (waivers) will avoid impediments to the development of innovative care models envisioned by the Shared Savings Program and new approaches to the delivery of healthcare for beneficiaries,” according to the new rule.

    The decision to issue another interim final rule rather than a final rule, the agencies said, “should not be viewed as a diminution of the department’s commitment to establish waivers” that foster the success of the ACO program and its goals.

    Follow Lisa Schencker on Twitter: @lschencker

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