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California Doctor Pleads Guilty to EKRA Violations

On September 15, 2020, Doctor Akikur R. Mohammad, a California resident and drug treatment facility owner, pled guilty before the U.S. District Court of New Jersey for violating the Eliminating Kickbacks in Recovery Act (“EKRA”), one of the country’s first convictions under this statute targeting opioid kickbacks. Enforcement under EKRA can help shed light on questions remaining concerning the statute’s broad definitions, particularly around laboratory services, and its application in light of other federal laws such as the federal anti-kickback statute (“AKS”). Thus far, known enforcement cases under EKRA have focused on opioid and drug treatment cases.

EKRA was designed to combat the opioid crisis, but in its haste to passage, the definition of “laboratory” was not sufficiently limited to those involved in substance abuse testing. The omission has cased a great amount of speculation about the DOJ’s enforcement intentions.

The full extent of EKRA’s implications still remain uncertain. Most open questions circulate around its application to clinical laboratories, but Dr. Mohammed’s guilty plea, as well as earlier enforcement in other jurisdictions have focused on opioid and drug treatment. Such experiences suggest DOJ is focused on EKRA’s intent and inclusion in the SUPPORT Act, despite potentially broader statutory language. That said, such focus does not ensure that it will not be used more broadly in the future. This plea does signal an increased focus on EKRA enforcement by DOJ moving forward. Future enforcement may provide further certainty around EKRA’s applicability to non-opioid-related lab and other services, as well as answer other questions about how the AKS safe harbors and EKRA interact.

You can read the DOJ Press Release here.

Source: California Doctor Pleads Guilty to EKRA Violations

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Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule

In an effort to provide additional relief to a health care system strained by the COVID-19 pandemic, the Office of the National Coordinator for Health IT (“ONC”) released an Interim Final Rule with Comment Period (“IFC”) on October 29, 2020 that extends the compliance dates under the 21st Century Cures Act Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”) and offers some technical corrections and clarifications.

Of particular interest to health care providers, health IT developers and health information networks and exchanges, the IFC extends for five months (from November 2, 2020 to April 5, 2020) the deadline to comply with the Final Rule’s information blocking provisions. The Final Rule also extends the compliance timeframes to meet the updated 2015 Edition Health IT certification criteria, and the Conditions and Maintenance of Certification requirements under ONC’s Health IT Certification Program.

Source: Office of the National Coordinator for Health IT Extends Compliance Deadlines under Interoperability Final Rule