pills As Prescribed

YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
In what can only be characterized as a necessary but significant proposed departure from current political initiatives focused on lowering pharmaceutical drug prices, the Centers for Medicare & Medicaid Services (CMS) proposes considerably increasing reimbursement for certain qualified diagnostic radiopharmaceuticals.
The Civil Division of the US Department of Justice (DOJ) released its annual fraud statistics for fiscal year 2022 on February 7. Of the $2.2 billion recovered under False Claims Act (FCA) settlements and judgments, more than $1.7 billion related to matters that involved the healthcare industry, including medical device and pharmaceutical manufacturers.
The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway before a clinical benefit has been confirmed by the required confirmatory studies.
As we reported on Health Law Scan, the Centers for Medicare and Medicaid Services (CMS) issued an Open Payments COVID-19 Announcement on March 25, citing its plans to exercise enforcement discretion regarding the late or incomplete submission of Program Year 2019 data in some cases.