Category: Alert

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Medical Device Maker to Pay $18 Million to Settle Allegations of Improper Payments to Physicians

This is not a Texas company, but it is a good example of how some manufacturers try to cloak improper payments under the veil of legitimate compensation.

The device manufacturer paid millions of dollars in “advertising assistance, practice development, practice support, and purported unrestricted educational grants” directly to local healthcare providers to induce sales of their products. Moreover, these inducements were only paid to select providers to reward them for past sales. The press release highlights the fact that the manufacturer’s compliance officer warned them of the practice, but those warnings went unheeded.

This matter started as a qui tam (Whistleblower) action under the False Claims Act by the former chief compliance officer of the company.

Source: Medical Device Maker to Pay $18 Million to Settle Allegations of Improper Payments to Physicians

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OCR Settles Eighth Investigation in HIPAA Right of Access Initiative

Since 2019, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) has been prioritizing enforcement actions against covered entities that do not allow patients timely access to their health records at a reasonable cost as required by HIPAA. This month, OCR settled an eighth investigation for $160,000 and corrective action against a hospital who failed to provide a mother full access to her son’s medical records for more than 22 months.

Source: OCR Settles Eighth Investigation in HIPAA Right of Access Initiative

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VIDEO: TBCE Stem Cell Stakeholder meeting

https://youtu.be/8De4ocoV8tY

Stem Cell Stakeholder meeting of the Texas Board of Chiropractic Examiners from Tuesday, October 13, 2020.

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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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Professional Relators Have No Right to Sue for Beneficial Conduct

The Seventh Circuit determined that professional qui tam relators formed as “investment vehicles for financial speculators” should not be allowed to challenge conduct determined by the government likely to be lawful, and definitely beneficial to the government and the public.

The court creates a new standard for dismissal, joining the standards articulated in Sequoia Orange and Swift. Under the new standard, “[t]he Government may dismiss the action without the relator’s consent if the relator receives notice and opportunity to be heard.”

Source: United States ex re. Cimznhca, LLC v. UCB, Inc.

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FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

The FDA proposed updates to clarify the types of evidence it considers when determining the “intended use” of a product. A product’s “intended use” determines whether it is a medical product within the FDA’s jurisdiction. The proposed updates allow any source to be considered, even the subjective knowledge of the manufacturer. The proposed update clarifies, however, that just because a manufacturer has knowledge that health care providers prescribe or use the product for an unapproved use, does not establish a new “intended use” for the product.

Source: FDA Clarifies Types of Evidence Relevant to Determining the “Intended Use” of FDA-Regulated Products

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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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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