The U.S. CMS has released the draft Medicare physician fee schedule for calendar year 2024, inviting rebuttal from physician groups thanks to a proposed cut in rates of 1.25%. However, the draft’s proposed cut of roughly 2% for radiation oncology services has also provoked stakeholders who blasted the proposal as a detriment to cancer care, a particularly ironic move given the emphasis on the Biden administration’s Cancer Moonshot.
The U.S. FDA’s recent final guidance for clinical decision support (CDS) software has drawn a second citizen’s petition for withdrawal, this time from a law professor at the University of Florida (UF). Barbara Evans of the UF School of Law asserted that the CDS final “raises constitutional issues” that are of sufficient importance to warrant an investigation led by the FDA commissioner’s office because of what she argues is a disregard for the First Amendment encoded in the guidance.
Rockwell Medical Inc. has acquired the hemodialysis concentrates business of Evoqua Water Technologies LLC for $11 million up front in cash plus two $2.5 million milestone payments at 12- and 24-months following the close of the deal.
Inovedis GmbH received clearance from the U.S. FDA for its Sinefix implant system, which can be used to repair rotator cuff tears. Sinefix allows surgeons to refix the rotator cuff tendon to the bone using a simplified surgical technique that aims to significantly reduce the time and cost of the procedure.
Showing that much lower brand prices are possible, even in the U.S., Theracosbio Inc. announced July 13 that its diabetes drug, Brenzavvy (bexagliflozin), is coming to the U.S. market through the Mark Cuban Cost Plus Drug Co. at a monthly price that’s less than the copay most patients have to pay for other drugs in the class. A new molecular entity approved in January to improve glycemic control in adults with type 2 diabetes, Brenzavvy is an oral, once-daily sodium-glucose cotransporter 2 (SGLT2) inhibitor that will be available through Cost Plus Drugs with a monthly price tag of $47.85, plus shipping and handling. A 30-day supply of other SGLT2 inhibitors costs hundreds of dollars, with some approaching $600 a month.
Cresilon Inc. obtained U.S. FDA clearance for a hemostatic gel that staunches the flow of blood from minor external wounds. The Cresilon hemostatic gel (CHG) is the first technology to blend polymers from the algae plant to instantaneously create a mechanical barrier against bleeding.
The U.S. CMS is proposing to expand coverage of angioplasty and stenting for the carotid arteries to include patients who currently cannot receive this treatment for carotid artery stenosis outside of a clinical trial, generally a cause for celebration among device makers. However, Silk Road Medical Inc. is one possible exception to the overall picture as utilization of its transcarotid artery revascularization (TCAR) system may suffer as a result.
Nuclidium AG, an early stage radiopharmaceuticals and radiodiagnostics developer, aims to bypass the production constraints that have hampered other firms in the field by employing copper radioisotopes for both therapeutic and imaging purposes.
Much of U.S. patent law jurisprudence still revolves around subject matter eligibility, but a new decision by the Court of Appeals for the Federal Circuit revisits the question of what constitutes obviousness in patent applications. The court remanded the case between Irvine, Calif.-based Axonics Inc. and Dublin-based Medtronic plc to the Patent Trial and Appeal Board (PTAB) after determining that the PTAB judge’s understanding of obviousness is “doubly infected by error” in a decision that seems to offer some much-needed clarity where obviousness is concerned.
The tension of clashing politics, policies and prescription drug pricing is coming to a head as U.S. Sen. Bernie Sanders (I-Vt.) acts on his threat to hold presidential appointments in the health arena hostage until President Joe Biden commits to do more to bring down drug prices.
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