New Final Rules were recently released on the Stark Law and the Federal Anti-Kickback Statute that go into effect in January 2021. A summary overview article from the American Health Law Association can be found here.
At a very high level, these rules create a new value-based arrangement safe harbor for health care providers pursuing joint ventures and also tweak existing safe harbors and exceptions, with the stated intentions of easing the regulatory burden on health care providers and further incentivizing the transition from volume to value for health care reimbursement.
There is a lot to digest but the American Health Lawyers Association (“AHLA”) has come out with a thorough resource hub here. This includes helpful redlines to current safe harbors and exceptions.
Again, while the stated purpose from the government is to ease regulatory burden, it remains to be seen the impact these changes will have on pre-existing arrangements and we have yet to locate a grandfathering or grace period provision. In some situations where an existing “change in law” provision in a contract might not be sufficient, amendments or other measures may be needed.
In terms of practical advice and to narrow the scope of inquiry, if you have arrangements you know rely heavily on a particular Stark exception or AKS safe harbor, it would be prudent to consult the redlines at the AHLA resource hub above to confirm that any new elements will be met going forward. If that is too burdensome, at a minimum and with some assumed risk, the next time such contracts come up for renewal, they should be run through the new safe harbors and exceptions to confirm compliance moving forward.
AHLA will continue to update the public resource hub above as more analysis and commentary comes is available.
Please contact the Gordon & Rees Health Care Regulatory & Transactional Group should you have any questions.