What We’re Reading: Counterfeit Weight Loss Drugs; COVID-19–Flu Vaccine Enters Phase 3 Trial; CMS Limits Predictive Software Use

FDA Investigates Counterfeit Weight Loss Drugs

The FDA is currently investigating several fraudulent schemes appearing to traffic counterfeit versions of semaglutide (Ozempic), according to CBS News. According to an alert sent to Pharmaceutical Cargo Security Coalition industry members, FDA investigators found that fraudsters are acting as medical wholesale employees and effectively taking over accounts of legitimate licensed companies. Then, amid the demand surge, the fraudsters target unsuspecting pharmacies looking for discounts on the drug. The pharmacies that fell victim reportedly either received counterfeit semaglutide pens, versions diverted from other countries, or none. This comes after the discovery earlier this year that a counterfeit semaglutide injector pen was being sold at a US pharmacy.

Moderna Moves to Late-Stage Trial on Covid-19–Flu Combo Vaccine

Moderna announced Wednesday that it plans to begin a phase 3 trial later this year in adults 50 years and older for a combination COVID-19–flu vaccine, according to Axios. The company noted that, in preliminary trials, the mRNA-1083 combination vaccine yielded antibody levels in the blood similar to or greater than a standard dose flu vaccine and COVID-19 vaccine. Also, in comparison to the standalone vaccines, Moderna did not identify any new safety concerns in the preliminary trials of the combination vaccine. Moderna’s COVID-flu vaccine comes after Pfizer and BioNTech launched a trial of their combination vaccine late last year, and Novavax also has an investigational shot. The company looks toward regulatory approval in 2025.

CMS Limits Predictive Software Use Affecting Medicare Advantage Coverage

Next year, CMS will begin restricting how insurance companies use predictive technology tools to make coverage decisions for patients with Medicare Advantage plans, according to KFF Health News. For example, naviHealth’s “nH Predict” tool sifts through millions of medical records to match those with similar diagnoses and characteristics; its algorithm then uses these details to anticipate what kind of care a specific patient will need and for how long. Despite the patient needing further treatment, the tool often predicts a patient’s discharge date, which reportedly often coincides with when the insurer cuts off coverage. Beginning in January, new federal rules will help mitigate algorithm use in coverage decisions. These rules require insurance companies to ensure they are making decisions based on the specific individual’s circumstances instead of an algorithm or software that does not account for them.