Developers of medical technology have many concerns about the U.S. Centers for Medicare & Medicaid Services’ (CMS) handling of coverage and reimbursement, but those controversies have typically revolved around process. A new report sponsored by industry steers a somewhat different tack, however, arguing that while there are issues of process, one key issue is that of funding, a problem that only Congress can remedy.
The inter partes review (IPR) process used to adjudicate patent disputes in the U.S. has had its share of critics, but ongoing patent litigation revolving around nerve stimulation technology between Axonics Inc., and Medtronic plc has disclosed another bone of contention in how IPRs are handled. The Court of Appeals for the Federal Circuit has ruled that a patent holder, Dublin-based Medtronic in this instance, can offer a new claim construction for its disputed patent once an IPR has been instituted, but said also that the Patent Trial and Appeal Board (PTAB) had erred in not allowing Axonics to respond to the new claim construction, sending the related IPRs back to the PTAB for another look.
The U.S. FDA’s final guidance for premarket submissions for device software functions serves as a much needed overwrite of a badly outdated policy but includes some significant changes over the legacy guidance. There are also a few changes between the 2021 draft and the 2023 final guidance, however, such as a call for more details about how software anomalies were discovered and what a root cause analysis would suggest about the origin of the anomaly.
The debate in the U.S. over the process by which the Medicare program covers new medical technologies has intensified over the past three years and the debate has now spilled onto the pages of the Journal of the American Medical Association. An article in JAMA asserts that only 44% of a group of 64 novel devices had achieved meaningful coverage and reimbursement milestones within a median of 5.7 years after FDA market authorization, adding yet more pressure on the legislative and executive branches to act to deal with what device makers characterize as the med-tech valley of death.
The proposed $875 million acquisition of Cook Medical Inc.’s reproductive health business by the Coopercompanies Inc. has been scotched, a development lauded by the U.S. Federal Trade Commission in a statement describing the proposed transaction as anticompetitive. However, the FTC statement also pointed to cooperation from authorities in both the U.K. and Australia as critical in forcing the abandonment of the transaction, a signal that such cooperation is likely to grow in the future.
U.S. federal government agency recoveries under the False Claims Act (FCA) are down slightly in the first half of 2023 relative to the first half of 2022, but that doesn’t mean companies in the life sciences can afford to let their guard down. The Senate is examining two pieces of legislation that would significantly amplify the risk for device and drug makers, including a Senate bill that would eviscerate the materiality standard as set by the U.S. Supreme Court in Escobar.
The U.K. National Institute for Health and Care Excellence (NICE) is considering a coverage policy for stenting of the carotid arteries in asymptomatic patients, a change that could give these stents a significantly larger patient population in the U.K.
The U.S. FDA recognized several new standards for sterilization of medical devices as part of an effort to reduce the use of ethylene oxide (EtO) for this purpose. While the recognition may stimulate adoption of alternative methods, Congress is applying yet more pressure on the EPA to act more decisively in regulating EtO, thus amplifying pressure on a system that device makers believe is already under stress.
The European Union and the U.S. have wrapped up a data privacy framework that covers broad swaths of both economies, including the transmission of clinical trial data across the Atlantic Ocean. Drug and device makers that want to make use of this framework and thus jettison the contractual clause to ensure data privacy may find compliance with this new framework much more efficient in the long run, but will have to do a lot of compliance work on the front end to achieve those efficiencies.
The U.S. Centers for Medicare & Medicaid Services (CMS) finalized the Medicare inpatient prospective payment system for fiscal year 2024 with a number of new and renewed new technology add-on payments (NTAPs) for the coming fiscal year. Controversially, however, the agency retained a proposal from the draft that requires that a product have received market authorization from the FDA by no later than May 1 of the prior fiscal year to qualify for NTAP payment, a provision that industry has blasted as exclusionary of products that merit an NTAP payment.
