The U.S. Department of Justice (DOJ) reported that it has arrived at a settlement of $45 million with Boca Raton, Fla.-based Modernizing Medicine Inc., an electronic health record (EHR) vendor that was accused of inducing referrals to a clinical lab for pathology services. The department stated that this settlement was the fourth such action against EHR vendors and is part of a concerted DOJ effort to “root out fraud” in the field, a signal that more enforcement against these companies is in the works.
The U.S. CMS has finalized the physician fee rule for calendar year 2023, a document that imposes an across-the-board pay cut of approximately 4.5% for physician Medicare services. However, the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS) blasted the final rule’s failure to provide what they believe are appropriate rates for cardiac ablation services, a position backed by two med-tech trade associations in their comments to the docket for the draft rule.
Broncus Holding Corp.’s disposable nebulizing microcatheter for an endoscope has been approved by China’s NMPA. The product Mist Fountain is the only nebulizing micro-catheter product available on the Chinese market to treat lung disease, according to the company.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apex, Astrazeneca, Aulos, Brim, Karyopharm, Moderna, Rhythm, Shanghai Henlius, Stealth.
Shortages of medical devices were not particularly topical before the COVID-19 pandemic, but they have dotted the landscape in the past three years despite the U.S. FDA’s best efforts to manage such issues. The agency recently announced that tracheostomy tubes are now among the device types that are in a state of shortage, a problem created by a paucity of the raw materials used to manufacture these items.
The U.S. CMS has peeled back a proposed 4.2% rate cut in the home health payment draft rule for calendar year 2023, replacing it instead with a 0.7% increase in overall payments for home health services, a category that affects sales of durable medical equipment and home infusion therapy items. That change was insufficient to mollify the National Association for Home Care & Hospice (NAHC), which argued that the final rule will nonetheless severely hit home care providers and leaves NAHC with no choice but to take its concerns to Capitol Hill.
Despite a busy September, U.S. FDA approvals and global regulatory news fell in October to the lowest point this year. So far in 2022, the FDA has approved 127 drugs and biologics, including supplemental filings. This is 25% less than each of the last two years, which had 170 approvals in 2021 and 169 approvals in 2020 through the end of October. The last time approvals were lower than this year was 2016 when there were 121.
Reflecting statutory and regulatory requirements added over the past five years, the U.S. FDA is issuing a revised draft question-and-answer (Q&A) guidance on expanded access to investigational drugs. One of several guidances recently issued, the 40-page draft incorporates requirements from the 21st Century Cures Act and the 2017 FDA Reauthorization Act that took effect after the current final Q&A guidance was updated in 2017. It also answers new questions sponsors have raised over the past few years.
Shanghai’s State Medical Products Administration announced that GSK plc has been banned from participating in volume-based procurement tenders until April 29, 2024, after failing a good manufacturing practices (GMP) inspection at a contract manufacturing plant in Poland that makes products for China.
Pfizer Inc.’s bivalent prefusion vaccine for protecting newborns from severe respiratory syncytial virus (RSV) hit one of its two primary endpoints in its phase III study, which was good enough for the company to stop enrollment and plan to submit a BLA to the U.S. FDA by year-end. PF-06928316 is one of six RSV vaccines in active phase III development globally, which includes an Astrazeneca plc-Sanofi SA collaboration plus one from GSK plc. Pfizer’s is the only one developed for infants by way of maternal immunization and for older adults.
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