While last week’s enforcement actions involving the healthcare industry were light in lab-related cases, they did include a couple of key COVID-19-related ones.
In the first enforcement action involving COVID-19, announced Nov. 3, a Massachusetts-based nursing home reached a $175,000 settlement agreement with that state’s Office of Attorney General (AG) regarding alleged pandemic response failures.
Sea View Retreat, Inc., and its owner Stephen Comley II were accused in a May 2022 lawsuit brought forward by the AG’s office of failing to “implement appropriate infection control procedures at the start of the COVID-19 pandemic in spring 2020,” according to the office, which had launched an investigation into the home following complaints made to the Massachusetts Department of Public Health. According to the AG’s office, Sea View and its owner allegedly failed to:
- Ensure “consistent staffing teams dedicated to COVID-19-positive residents to prevent further infection”
- Provide staff with COVID-19 competency training
- Train its staff on proper personal protective equipment use
- Screen staff entering the facility
- Perform surveillance testing of staff and residents
- Properly cohort residents
These failures led to some COVID-19 infections among residents and at least one death, the AG’s Office alleges. In addition to the settlement agreement, Sea View and Comley also agreed “to no longer own, operate, or manage a long-term care or assisted living facility in Massachusetts,” the office adds.1
In the second COVID-19 related enforcement action, announced by the U.S. Department of Justice (DOJ) on Nov. 4, a data entry specialist for medical and hospital services provider Griffin Health Services Corporation was sentenced for falsifying COVID-19 vaccine records. According to the DOJ, the Griffin employee, Zaya Powell, used her access to the company’s blank COVID-19 vaccination cards and electronic health record system, as well as her access to the Vaccine Administration Management System to create fake COVID-19 vaccination records for 14 different people who hadn’t actually been vaccinated. Four of those people worked at a Connecticut Department of Developmental Services facility, according to the DOJ.
Powell, who pleaded guilty “to one count of making a false statement relating to a health care matter” on Aug. 12, was sentenced to 200 hours of community service and ordered to pay a $5,000 fine.2
In the one lab-related enforcement action from last week:
Nov. 1: Florida-based electronic health record (EHR) technology company Modernizing Medicine Inc., also known as ModMed, settled False Claims Act allegations for $45 million. According to the DOJ, the company allegedly violated the FCA in three different ways by:
- Referring its clients to Miraca Life Sciences Inc. (now called Inform Diagnostics) for pathology lab services in exchange for kickbacks from Miraca.
- Conspiring with Miraca to “improperly donate ModMed’s EHR to health care providers” to both boost its user base and Miraca’s number of lab orders
- Paid kickbacks to key players in the healthcare industry, as well as to its healthcare provider clients “to recommend ModMed’s EHR and refer potential customers to ModMed”
The settlement partly resolves claims brought forth in a whistleblower lawsuit by a former vice president of product management at ModMed, according to the DOJ.3
References:
- https://www.mass.gov/news/ag-healey-reaches-settlement-with-rowley-nursing-home-over-pandemic-response-failures
- https://www.justice.gov/usao-ct/pr/waterbury-woman-who-created-false-covid-19-vaccine-records-sentenced
- https://www.justice.gov/opa/pr/modernizing-medicine-agrees-pay-45-million-resolve-allegations-accepting-and-paying-illegal