FDA is investigating fraudulent schemes trafficking counterfeit semaglutide (Ozempic); Moderna plans to begin a late-stage trial of its combined COVID-19 and flu vaccine later this year; CMS will begin restricting predictive software used by insurance companies next year.
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 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.
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.
T-Cell Exhaustion in CLL: Allogeneic CAR T Trial Reaching Patients With Unmet Need
April 30th 2024"Off the shelf" CAR T-cell therapies could offer a solution in chronic lymphocytic leukemia, where T-cell exhaustion creates treatment challenges. This article will appear in the May 2024 issue of Evidence-Based Oncology.
Read More
Navigating Health Policy in an Election Year: Insights From Dr Dennis Scanlon
April 2nd 2024On this episode of Managed Care Cast, we're talking with Dennis Scanlon, PhD, the editor in chief of The American Journal of Accountable Care®, about prior authorization, price transparency, the impact of health policy on the upcoming election, and more.
Listen
Interactive mHealth App Helped Improve Patients’ Lifestyle Habits After Undergoing PCI
April 29th 2024These lifestyle improvements included adherence to the Mediterranean diet, improved frequency of healthy food consumption, increased physical activity, and quitting smoking, among other factors.
Read More
Exploring Medicare Advantage Prior Authorization Variations
March 26th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the March 2024 issue of The American Journal of Managed Care® about their findings on variations in prior authorization use across Medicare Advantage plans.
Listen
UK Study: Most Patients With MG Require Hospitalization, Driving Health Care Resource Use
April 27th 2024Over a median follow-up time of nearly 3 years, three-fourths (72.8%) of patients with myasthenia gravis (MG) were hospitalized and half visited the accident and emergency department.
Read More