Archive
Wade Emmert
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…
Data Breaches Can Result in Federal and State Liability
Regulatory bodies continue to impose severe penalties on covered entities who fail to protect patient data from unauthorized disclosure. Community Health Systems, Inc. recently settled claims…
Two charged in prescription and kickback scheme
An 11-count indictment unsealed on Friday charges former Kindred Home Health employee Amber Price, 37, and Christopher Cruz, 46, owner of a medical marketing business, CP…
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…
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…
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.
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…
VIDEO: Bad Batch of Miracle Cure: Texas Response to Stem Cell Therapies
https://youtu.be/70S8A7meICI A presentation I gave to the Dallas Bar Association, Health Law Section on stem cell regulation in Texas.
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…
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…