The U.K. health technology assessment body has given its approval to the use of nine digital health products for treating mental disorders, enabling them to get conditional reimbursement in the National Health Service (NHS), while real world evidence of their cost effectiveness is collected.
The U.S. Department of Justice announced that a judgment of more than $487 million has been lodged against Cameron-Ehlen Group Inc., of Bloomington, Minn., for alleged violations of the False Claims Act (FCA) in connection with the company’s distribution of products used in cataract surgeries. That final amount is more than 10 times the amount alleged to have been billed illicitly to federal health programs, a clear signal that inducement of this sort will be met with severe penalties.
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
A subcommittee of the U.S. House Ways and Means Committee met to review the status of policies for novel medical devices and drugs, but a partisan rift was immediately evident at the hearing. House Democrats were generally in favor of more drug price negotiation power for the federal government and opposed to immediate Medicare coverage of breakthrough medical devices while Republicans generally steered in the opposite direction, suggesting that drug and device makers should not expect clear legislative sailing over the course of the 118th Congress.
The U.S. Preventive Services Task Force (USPSTF) is proposing to lower the age of onset of regular breast cancer screening to 40 years, a massive jump of 10 years over the current recommended age of 50 years. While this is just a draft proposal, analysts who track the medical device industry say that medical imaging manufacturers, such as Marlborough, Mass.-based Hologic Inc., could see a significant uptick in demand for their systems, a much-needed boost as the drop in demand incurred by the COVID-19 pandemic comes to an end.
For several years, the U.S. CMS has been musing a coverage policy specifically for breakthrough medical devices, and the absence of activity on this front has once again drawn the attention of Congress. Rep. Cathy McMorris Rodgers (R-Wash.), said a representative of CMS had recently appeared before a House subcommittee for the first time in four years, and that the subcommittee is prepared to act on breakthrough devices coverage if CMS doesn’t produce a final rule this year.
The Ministry of Health and Prevention has just published a decree introducing the anticipated coverage by the National Health Insurance Fund of digital medical devices and remote medical monitoring activities.
New York-based Apos Medical Assets Ltd., doing business as Aposhealth, has been developing a shoe that provides some relief from pain and disability in patients who are candidates for total knee arthroplasty (TKA), and the Apos shoe seems to have gained a toehold in the U.K. market. The National Institute for Health and Care Excellence (NICE) has provided a guarded recommendation for the use of the Apos shoe in the U.K., although the agency still has questions as to how long use of the shoe can delay the need for TKA.
Medicare coverage of medical devices in the U.S. sometimes is limited to a coverage with evidence development (CED) study, a process that may soon become more stringent. A recent advisory hearing on the CED process suggests that significant changes may be in the making, including a requirement that CED studies more closely reflect the demographic diversity of Medicare beneficiaries at large, a mandate that may force device makers to apply more resources to ensure that CED study enrollments fulfill that mandate.
Philips RS North America LLC, formerly known as Respironics Inc., has agreed to pay more than $24 million to settle allegations that the company violated the False Claims Act in relation to CPAP equipment, another hit on the company which has been dealing with a stream of FDA recalls for these products. The allegations include that Philips RS provided durable medical equipment suppliers physician prescribing data to help these suppliers market their inventory, an unusual vector for violation of the FCA.
