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Compliance Checkup: Takeaways from the Stark Law and Anti-Kickback Statute Final Rules
on April 13, 2021
The Centers for Medicare and Medicaid Services (CMS) and The Department of Health and Human Services Office of Inspector General (OIG) issued final rules updating and revising the Stark Law and the Anti-Kickback Statute. The Stark Law final rule addresses any undue regulatory impact and burden of the physician self-referral law, whereas the Anti-Kickback final rule amends the safe harbors to the Anti-Kickback Statute by adding new safe harbors and modifying those existing that protect certain payment practices and business arrangements from sanctions under the Anti-Kickback Statute. These final rules became effective in January 2021.
We wanted to take the time to highlight some of these changes to help you get a better understanding of the rules that have been updated and revised:
- New protections exist for value-based arrangements under the final rules, with fewer requirements imposed when more risk is assumed.
- The details of the new value-based rules are now crucial. Pay close attention to the definitions of the defined terms related to value-based arrangements under the Stark Law and Anti-Kickback Statute.
- Changes to the indirect compensation arrangement definition means fewer relationships with physicians will trigger the Stark Law.
- The new objective definition of what it means to “take into account the volume or value of referrals” will make it easier to apply the Stark Law.
- The new exception for Limited Remuneration to Physician combined with the special rule allowing 90 days’ grace for getting an arrangement reduced to writing and the new 90 days’ grace for reconciling payments after the end of an arrangement will result in fewer “technical” and minor, non-abusive Stark violations.
- CMS made clear that an arrangement might still be commercially reasonable under the Stark Law even if it is not profitable for one or both parties.
- The OIG relaxed the Anti-Kickback safe harbor rules regarding the provision of free transportation to patients.
- Watch the effective dates to ensure your organization is applying the correct version of the rules.
These changes have far-reaching implications that will provide better flexibility for providers. If you have any questions about the new guidance or safe harbors, call your attorney at Brouse McDowell or reach out to Laura directly at LFryan@Brouse.com.
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