The U.K. National Institute for Health and Care Excellence said in a new health technology assessment that cardiac resynchronization devices using the Enduralife battery by Boston Scientific Corp. (BSX), are ready for prime time in the U.K. national health system.
The U.S. CMS waded into controversy with two final rules calendar year 2022, drawing fire from device makers and doctors who allege that cuts in rates for physicians will hamper beneficiary access. Software developers working in the telehealth space will find much to cheer, however, given that some telehealth services that were covered during the COVID-19 pandemic will be covered after the pandemic has passed.
The U.S. Center for Medicare & Medicaid Services (CMS) has made the first award to a product under an add-on payment for treatment of end-stage renal disease (ESRD) as part of the prospective payment schedule for calendar year 2022. Outset Medical Inc., of San Jose, Calif., snared the first of these novel add-on payments for medical technologies under the ESRD prospective payment system, but device makers working the ESRD space can expect to see many similar such awards in the years ahead.
PARIS – The French National Authority for Health (HAS) is expanding the available range of novel autologous technologies reimbursed in the context of breast reconstruction following ablative surgery. In doing so, the HAS is paving the way towards reimbursement for novel autologous techniques in general.
The U.S. Centers for Medicare & Medicaid Services’ (CMS) withdrawal of a proposal to provide automatic coverage of FDA-designated breakthrough devices has drawn criticism from device makers, but the industrial reaction runs the gamut.
Glaukos Corp., of San Clemente, Calif., has taken another step forward in obtaining global market access for its Istent device for glaucoma with a positive coverage recommendation in Canada. Health Quality Ontario (HQO) has recommended that taxpayer dollars be used to cover the device in conjunction with cataract surgery, although the endorsement is limited to patients with mild to moderate glaucoma that is not well controlled with pressure-lowering medications.
The Scottish government has signed a deal with digital therapeutics company Big Health Inc. to make a cognitive behavior therapy (CBT) platform for anxiety and insomnia available through the NHS. It makes Scotland the first country to provide a digital therapeutic for anxiety and insomnia nationally.
The U.S. Office of Inspector General (OIG) said a review of claims for implant of neurostimulation devices indicates that many of these claims lack the data to ensure that the devices were appropriately implanted.
The Medicare Coverage of Innovative Technology (MCIT) rule is administratively a dead letter, but the U.S. House of Representatives’ Cures 2.0 legislation would statutorily resurrect the MCIT concept. Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), said automatic coverage of breakthrough devices does not constitute a subversion of the Medicare coverage process, but added that AdvaMed is not opposed to other means of cutting the Medicare red tape, such as greater resources at CMS.
The U.K. National Institute of Health and Care Excellence (NICE) has examined the evidence for the use of mitral valve-in-valve procedures and found the evidence for safety is well rounded despite concerns about several complications.
