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Food and Drug Administration’s Operation Quack Hack

In a continuing effort by various federal and state agencies to stop COVID-19 related frauds, the FDA has implemented “Operation Quack Hack.” As such, the FDA has issued close to 50 warning letters, and estimates that it will issue hundreds more to a variety of companies. The warning letters allege fraudulent COVID-19 treatments and tests. FDA is working with online marketplaces, social media websites, domain name registers, and consumer reports...

DEA Exceptions and Quota Increase During the COVID-19 Pandemic

To facilitate patient care during the public health emergency, the Drug Enforcement Administration (DEA) has issued four exceptions to regulations for DEA-registered pharmacies, hospitals and clinics. The first exception pertains to satellite hospital/clinics.[1] DEA is permitting registrants to utilize alternate satellite hospital/clinic locations and to accept controlled substances (CS) from distributors at these non-registered locations.[2] The second exception allows narcotic treatment programs to accept CS deliveries and waives the delivery...

HHS Provider Relief Funds Assist Healthcare Providers During the COVID-19 Crisis

$50 Billion in Total Funding Available, But Significant Compliance Requirements Must be Satisfied In mid-April, you may have seen a significant payment from the Federal government mysteriously land in your provider bank account. With little notice or explanation, the U.S. Department Health and Human Services (“DHHS”) at that time sent a total of $30 Billion in Provider Relief Fund payments to all providers who billed Medicare for services in 2019....

Provider Alert: Exercise Caution When Operating Under Blanket Waivers of Stark Sanctions

In response to the COVIDI9 crisis, the Secretary of the Department of Health and Human Services invoked his authority to issue blanket waivers of Section 1877(g) of the Social Security Act (also known as the physician self-referral law or “Stark” law). The waivers were issued to ensure, to the maximum extent feasible, in any emergency area and during an emergency period that: (1) sufficient health care items and services are...

FDA Relaxes Track and Trace Requirements for COVID-19 Related Products

On April 30, 2020, the Food and Drug Administration (FDA) issued new guidance relaxing certain requirements under the Drug Supply Chain Security Act (DSCSA) for COVID-19 related drug products.  In the guidance, FDA explained that under the DSCSA “specific activities are automatically excluded from certain DSCSA requirements upon the declaration of a public health emergency.” This is in an effort to facilitate the efficient distribution of prescription drug products needed to respond...