City government

Federal government investigates COVID testing by Nomi Health

Federal authorities informed Orem-based Nomi Health in mid-March that not only did its COVID-19 testing for the state of Utah fail to meet government standards, but that “deficient practices” identified with the assistance of the Utah Department of Health “pose immediate danger to the health and safety of patients.

A spokesperson for the Centers for Medicare and Medicaid Services who provided a copy of the March 16 letter advising Nomi Health of the agency’s findings along with a 16-page report detailing the shortcomings, confirmed Friday that “CMS is investigating on Nomi Health Lab (CLIA # 46D2199811) and its temporary test sites.

It is unclear whether any sanctions have been proposed. According to the spokesperson, generally, when non-compliance is found, the establishment has the opportunity to respond and correct the shortcomings cited, but if it does not do so, sanctions are proposed but can be challenged.

“CMS makes the ultimate enforcement decision regarding the imposition of sanctions,” the spokesperson said.

The letter sent to Nomi Health states that the company had until March 26 to resolve the identified issues and could face suspension and revocation of its federal certificate, cancellation of Medicare and Medicaid payments and civil penalties of more than $21,600 per day of violation. .

Nomi Health said in a statement that the federal regulatory program, known as the Clinical Laboratory Improvement Amendments, or CLIA, “committed us with specific improvements. Our clinical and quality team responded quickly and with This is a federal process that is still ongoing, and we look forward to working together in this process.

A spokesperson for Nomi Health, which earlier this week said it would begin offering for-profit COVID-19 testing after the state ends free testing for most Utahns on Thursday, said the company was “limited to talking about anything that’s going on with the federal government,” but would discuss issues with the state health department.

Nomi Health’s contract with the state requires the company to “ensure that all collections are conducted in accordance with CLIA,” according to a statement from the Utah Department of Health. “UDOH regularly monitors performance and when issues are raised, we notify Nomi of the issues and implement a resolution process.”

The statement, released Thursday amid reports from the federal investigation, says the state health department has “not seen the CMS report” but has requested a copy. A spokeswoman said Friday there was no update to that statement.

Nomi Health remains under contract to provide COVID-19 testing to the state if needed, as part of Governor Spencer Cox’s “steady state” plan to treat COVID-19 like the flu or other diseases with limited outbreaks that have displaced testing and treatment. for the virus to private providers from Friday.

“As state-sponsored testing is suspended for all providers,” the state health department statement reads, “we will use the time during this pause to review the issues raised in the CLIA report and Nomi’s response once we receive them and determine appropriate actions.”

Testing sites operated by Nomi Health in Bountiful, Millcreek, West Jordan, Park City, West Valley City and West Jordan were inspected and results included testing supplies intended to be kept at room temperature stacked on tape and hand warmers, opened next to “yogurt; a bag of Cheez-Its; and rice cakes,” or left cold.

Other issues related to the way the tests were administered, including not properly timing when to check the results. The tests used were the GenBody brand of rapid antigen tests that the state stopped using in early February due to a much higher false-negative rate than expected.

Nomi Health’s statement, also released Thursday, says the company rejects “any involvement or insinuation from certain individuals within the Utah Department of Health that the lack of efficacy of certain antigen tests is somehow unique. at Nomi Health”. It’s not. Our national findings on the effectiveness of antigen testing were consistent with Utah state findings for some tests, leading the state to discontinue antigen testing.

But the investigation, conducted by the state health department and staff at the CMS Kansas City branch, said that based on observation of testing at all inspected sites “and interviews with supervisors, management and testing personnel, the laboratory did not follow the manufacturer’s instructions”.