Value-Based Safe Harbor, Stark Exception Increasingly Important
The value-based arrangement Anti-Kickback Statute safe harbor and Stark Law exception introduced last year are likely to become important components of healthcare provider methods, says Robert Anthony Wells, JD, shareholder with Baker Donelson in Baltimore. CMS and other third-party payors will continue to focus on promoting care coordination and patient outcomes, making the safe harbor and Stark exception critical tools to avoid legal complications.
These rules provide more flexibility for providers to engage in relationships without violating laws. They were created in response to the shift to value-based care, which encourages providers to find more cost-efficient ways to provide care.
“While these protections were implemented over a year ago, we are now starting to see more activity related to developing specific arrangements. We expect that more proposed arrangements will be forthcoming in part due to emphasis on patient outcomes and care coordination and continuing market consolidation efforts,” Wells says. “Cooperative arrangements may be more attractive than acquiring and operating additional service lines.”
The safe harbor and Stark exception provide healthcare entities more confidence in establishing relationships that can reduce costs and increase value, so there is increased interest in finding innovative arrangements, Wells says. He expects that to continue.
“It wasn’t immediate, with the safe harbors being published and everyone running to make arrangements, but we’re starting to see more people evaluating historical gainsharing arrangements,” Wells says. “Where there were no definitive protections in the past, people are now looking to see if there are ways to structure them into value-based enterprise arrangements.”
There may still be some lag in activity until the healthcare community acclimates to opportunities, Wells says. The 2021 changes were intended to provide regulatory certainty and flexibility in how to set up a value-based enterprise, but providers may remain wary.
“One of the things I’m seeing is that there still is this psychological notion that a value-based enterprise is going to require new entities, structure, and governance. That’s not what the regulations say, and it wasn’t what the regulators intended,” Wells says. “It was actually intended to ease the administrative burden, but it may take some time for people to get educated on that and become more comfortable with the idea.”
SOURCE
- Robert Anthony Wells, JD, Shareholder, Baker Donelson, Baltimore. Phone: (410) 862-1121. Email: [email protected].
The value-based arrangement Anti-Kickback Statute safe harbor and Stark Law exception introduced last year are likely to become important components of healthcare provider methods. CMS and other third-party payors will continue to focus on promoting care coordination and patient outcomes, making the safe harbor and Stark exception critical tools to avoid legal complications.
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