Summer is the time when device makers press their cases for add-on and pass-through payments from the Medicare program, and this year’s draft hospital outpatient prospective payment system for calendar year 2024 is no exception. Both Cook Medical and Philips North America are pushing CMS for new technology pass-through (NTPT) payments for their offerings, but these two larger firms have a lot of company in the NTPT sweepstakes.
U.S. FDA warning letters to device makers seemed to be on pause for a couple of years, but the agency is picking up the pace with two warnings posted July 18. Outset Medical Inc., of San Jose, Calif., was previously known to be the recipient of a warning letter, but Edge Biologicals Inc. of Memphis, Tenn., took in a warning letter that is replete with repeat violations disclosed in 2015 and 2018, as well as a warning letter issued 11 years ago.
The U.S. Federal Trade Commission and the Department of Justice have floated a new set of guidelines that would govern their reviews of mergers in a variety of markets, including the drug and device industries. While many of these guidelines are vaguely worded and open to interpretation, one of the more ambiguously worded passages states that a merger may be rejected if it could create “a clog on competition,” a phrase that appears in a Supreme Court decision handed down more than 60 years ago.
Recalls are a fact of life in the medical technology space, and Medtronic plc and Quidel Cardiovascular Inc., have both been forced to report class I recalls. Dublin-based Medtronic announced a recall of more than 348,000 cardiac electrophysiology devices due to issues that could prevent high-voltage therapy while San Diego-based Quidel is recalling nearly 7,800 Triage cardiac panels because of a risk of false negatives for patients being assessed for an infarct.
A committee of the U.S. House of Representatives met to review the Medicare coverage procedure for innovative drugs and devices, an event that seemed to gin up support for legislation that would help to streamline those processes. The problem for drug and device makers, however, may be that the Centers for Medicare & Medicaid Services
continues to labor under a flat appropriations picture that is eroding daily thanks to inflation.
The False Claims Act (FCA) has generated billions of dollars in fines each year in the U.S., and Atlanta-based Nextgen Healthcare Inc., is the latest to find itself on the wrong end of a whistleblower lawsuit based on the FCA. The U.S. Department of Justice reported that Nextgen will hand over $31 million to settle allegations that the vendor of electronic health records (EHR) not only misrepresented the capabilities of its software, but also paid kickbacks to physician providers to use its software, a pair of violations that have dinged the company’s finances and its reputation.
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.
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.
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.
