Most of the better-known targets of prosecution under the U.S. False Claims Act (FCA) are drug and device manufacturers, but the Department of Justice (DOJ) seems to have opened a new front in the war on Medicare fraud.
The U.S. CMS has expanded the population of Medicare beneficiaries who are eligible for lung cancer screening via low-dose CT (LDCT) imaging. The news drew raves from stakeholders who also lauded the expansion of the facilities that can conduct the procedure, constituting a set of changes that advocates say will save thousands of additional lives.
The U.K. National Institute of Health and Care Excellence has endorsed the use of stereotactic radiosurgery as a treatment of trigeminal neuralgia (TN) after hearing from a patient group, promising more clinical bandwidth for these systems.
Developers of apps for digital health have struggled to obtain Medicare coverage in the U.S. for their products, an impasse that seems unlikely to resolve anytime soon. Jason Bennett of CMS said on a Feb. 9 webinar that while the durable medical equipment (DME) benefit category seems like a natural fit for digital health products, there are some statutory and definitional roadblocks, including that digital health products might not be durable enough to qualify.
In one of its familiar U-turns, the U.K. National Institute for Health and Care Excellence (NICE) has recommended NHS England should fund a rare disease gene therapy from Orchard Therapeutics plc, considered to be the world’s most expensive drug. The list price for Libmeldy (atidarsagene autotemcel) in England and Wales is £2,875,000 (US$3.9 million), making it the most expensive drug that NICE has ever evaluated.
The COVID-19 pandemic shone a bright light on the need for and utility of telehealth, which in turn prompted the U.S. Centers for Medicare & Medicaid Services (CMS) to temporarily expand telehealth coverage. Some of those coverage policies are set to expire when the public health emergency ends, and a group of stakeholders, including the American College of Cardiology, are urging Congress to pass legislation that would make some of these benefits permanent, a potential boon for many telehealth entities.
The U.K. National Institute for Health and Care Excellence (NICE) has endorsed the use of selective laser therapy treatment (SLT) instead of eyedrops as treatment of chronic open-angle glaucoma (COAG) and ocular hypertension. The shift would seem to drive spending in the U.K. away from drugs and toward devices for a condition afflicting nearly 10% of citizens over the age of 75.
While comments continue to pour in, both in opposition and support, regarding the U.S. Centers for Medicare & Medicaid Services’ (CMS) proposed national coverage decision that would restrict Medicare coverage of monoclonal antibodies intended to treat Alzheimer’s to those used in CMS- or NIH-approved clinical trials, some groups also are appealing to Health and Human Services (HHS) Secretary Xavier Becerra to step into an HHS agency turf war.
LONDON – The industry is expressing divergent views of changes to how the U.K. health technology assessment agency, the National Institute for Health and Care Excellence (NICE), will in the future select what products to assess and the methods and processes it will use to carry out its evaluations.
LONDON – The industry is expressing divergent views of changes to how the U.K. health technology assessment agency, the National Institute for Health and Care Excellence (NICE), will in the future select what products to assess and the methods and processes it will use to carry out its evaluations.
