Tag: COVID

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Health Law Highlights

DOJ Releases 2024 COVID-19 Fraud Enforcement Task Force Report

Summary of article from Morrison Foerster, by Adam Braverman, Kate Driscoll, Kamran Jamil, Brian Kidd, Nathaniel Mendell:

The U.S. Department of Justice (DOJ) has released a comprehensive report on the COVID-19 Fraud Enforcement Task Force, calling for an extension of the statute of limitations for pandemic fraud-related offenses and increased funding for investigations and prosecutions. Since May 2021, the Task Force has charged over 3,500 defendants, recovered more than $1.4 billion in government funds, and filed over 400 civil suits. The report highlights cases involving False Claims Act liability, primarily related to the Small Business Administration’s Paycheck Protection Program (PPP), Economic Injury Disaster Loans (EIDL), and COVID-19 testing claims. The DOJ is seeking to establish a permanent interagency body to combat government benefits fraud. The report also calls for legislation to extend time limits for charging pandemic-related fraud cases and further resource fraud investigations.

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Health Law Highlights

Pandemic Fraud Suits Have Yielded Over $100 Million, Report Says

From Bloomberg Law, by Daniel Seiden:

The Covid-19 Fraud Enforcement Task Force has reported that over $100 million has been reclaimed by the US government through False Claims Act (FCA) cases related to pandemic fraud. These funds have been recovered from more than 400 settlements and judgments, including cases of Paycheck Protection Program fraud, Economic Injury Disaster Loan fraud, health-care fraud, and agricultural program fraud. The report indicates a steady rise in new whistleblower actions under the FCA alleging pandemic relief fraud from 2020 to 2023. In 2023 alone, the Department of Justice (DOJ) recovered a record $2.68 billion from 543 FCA settlements and judgments.

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Improper CBD Product Marketing Lands in FDA’s Crosshairs

green and white labeled bottles
Photo by CRYSTALWEED cannabis on Unsplash

The FDA issued warning letters to five companies for violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of cannabidiol (CBD) products.

CBD is the primary non-psychotropic compound in Cannabis sativa plant. The FDA stated the companies who were served warning letters illegally marketed CBD products for the treatment or prevention of medical conditions, including COVID-19. For instance, one company’s website quoted people who used CBD oil “as treatment” for various medical conditions, claiming positive effects. Another company marketed the use of CBD oil to treat medical conditions on social media, using several hashtags related to serious medical conditions.

The FDA considers these products “new drugs” under section 201(p) of the FD&C Act, and therefore they are not considered safe and effective for treatment of medical conditions as these companies promoted.

Source: Improper CBD Product Marketing Lands in FDA’s Crosshairs

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HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth

On December 3, the U.S. Department of Health and Human Services (HHS) issued a fourth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to critical countermeasures against COVID-19.

Source: HHS Amends PREP Act Declaration, Including to Expand Access to COVID-19 Countermeasures Via Telehealth | Holland & Hart Health Law Blog

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Alert

CMS Encourages Faster COVID-19 Diagnostic Testing

CMS is changing its payment methodology to encourage higher throughput of COVID-19 diagnostic testing. Previously, CMS would reimburse $100 per test

Starting January 1, 2021, Medicare will pay lower the base rate to $75. However, if the laboratory can complete the test within two (2) calendar days from the date the specimens is collected, CMS will reimburse an additional $25 for a total of $100 per test.

To be entitled to this $25 incentive, the laboratory must: a) complete the test in two calendar days or less, and b) complete the majority of their COVID-19 diagnostic tests that use high throughput technology in two calendar days or less for all of their patients (not just their Medicare patients) in the previous month.

Source: Press release: CMS Changes Medicare Payment to Support Faster COVID-19 Diagnostic Testing

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Alert

CMS Issues Cease and Desist Orders to Uncertified Labs Performing COVID-19 Testing

Since August 12, 2020, CMS issued 171 cease and desist letters to entities across the U.S. that were testing for COVID-19 without the appropriate certifications under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Every facility that conducts COVID-19 testing is considered a “laboratory” and must be certified under CLIA, which verifies that labs meet federal performance and quality standards to help ensure they provide reliable results.

According to CMS, 34% of the labs that were ordered to stop testing were operating without a CLIA certificate, while the remaining 66% were performing COVID-19 testing outside the scope of their existing CLIA certification. The letters provided non-certified labs with information on how to become CLIA certified and encouraged certified labs to obtain proper CLIA certification so they could resume COVID-19 testing.

Source: CMS Takes Action to Protect Integrity of COVID-19 Testing

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Alert

HHS Renews Public Health Emergency Declaration through January 20, 2021

On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID‑19 will be renewed for another 90 days, beginning on October 23 (the date the PHE was previously scheduled to expire) and extending through January 20, 2021.

Source: Renewal of Determination That A Public Health Emergency Exists

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Alert

FDA Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests

The Food and Drug Administration (FDA) will no longer require premarket review of laboratory developed tests (LDTs), including COVID-19 tests, decline to review emergency use authorization (EUA) request for LDTs. Instead, the FDA will prioritize review of EUAs for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests.

Source: FAQs on Laboratory Developed Tests (LDT)

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Alert

Unapproved and Misbranded COVID Treatments Get FDA Attention

There is no FDA-approved treatment for COVID-19, but that hasn’t stopped one compounding pharmacy from making bold claims. Marketing products as “COVID PACK” and “COVID ‘POSITIVE’ PACK” for the “treatment and recovery from the Covid-19 virus” apparently crossed the line. These products appear to be nothing more than vitamins. It wasn’t the products that got the FDA’s attention, but rather the claims of treatment, recovery, and cure. The FDA gave the pharmacy 48 hours to correct the misleading claims.

Source: Warning Letter – Pharmacy Plus, Inc. dba Vital Care Compounder