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The NIH IDC – Where Are We Now

On February 7, the National Institutes of Health (“NIH”) issued a Notice (NOT-OD-25-068) entitled “Supplemental Guidance to the 2024 NIH Grants Policy Statement: Indirect Cost Rates” (the “Notice”), though which NIH announced...more

Four Years After EKRA: Reminders for Clinical Laboratories

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and...more

Opioids, Sober Homes and “Telefraud”: an Overview of the DOJ 2020 Healthcare Fraud Takedown

In September 2020, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) announced its annual healthcare-related “takedown.” The takedown,...more

OIG Offers an Alternative to Advisory Opinions for Emergency Arrangements During the Public Health Emergency

In an effort to ensure that health care providers have the regulatory flexibility they need to adequately respond to COVID-19 concerns during the current public health emergency, the U.S. Department of Health and Human...more

In an Unprecedented Move, OIG Expands Access to Telehealth in Response to the COVID-19 Outbreak

On March 17, 2020, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a Policy Statement and a companion Telehealth Factsheet[2] notifying health care providers that they will...more

D.C. District Court Clarifies Standard for Laboratory Determination of Medical Necessity

This past June, a federal district court in the District of Columbia made headlines when it declined to dismiss an action brought by a qui tam plaintiff (“Relator”) against defendant Boston Heart Diagnostics (“Boston Heart”),...more

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