Beneficiaries in the U.S. Medicare program have access to several technologies and procedures for treatment of glaucoma, but Medicare administrative contractors (MACs) seem to be looking sideways at some of these offerings. Both Wisconsin Physician Services and Palmetto GBA have floated draft local coverage proposals that deem procedures such as goniotomy and the combination of canaloplasty and trabeculectomy to be investigational, suggesting that claims for these and other services and devices will not be paid by these MACs.
Proponents of telehealth have been pressing Congress to statutorily broaden coverage of telehealth since before the COVID-19 pandemic, and the Telehealth Expansion Act of 2023 carries the weight of at least some of these expectations. The House Ways and Means Committee’s health subcommittee recently voted 30-12 to pass along the legislation to the full committee, but the bill operates principally to allow high-deductible health plans to cover telehealth benefits before the enrollee has met the deductible, leaving a substantial amount of telehealth terrain unaddressed.
The U.S. CMS has wrapped up a coverage analysis for seat elevation systems that are accessories for power wheelchairs, but the agency went above and beyond the strict terms laid out in the proposed decision memo.
There is a growing body of evidence showing prescription digital therapeutics (DTx) are effective, but slow progress in agreeing reimbursement and integrating them into care pathways is limiting access for patients and holding back commercial development in Europe.
In a new health technology assessment, the U.K. National Institute for Health and Care Excellence (NICE) has voiced misgivings about the evidence behind the use of MRI/ultrasound fusion systems to perform needle biopsy for suspected prostate cancer. NICE said the evidence for these systems could be bolstered by additional research comparing fusion biopsy to cognitive fusion-directed biopsy, suggesting that companies working in this space have a significant evidentiary lift in front of them.
The U.K. government should speed up the approval process for medical devices and strengthen the Medicines and Healthcare products Regulatory Agency, as there is an opportunity for the country to provide global leadership in life sciences regulation in medical devices and medicines on the back of Brexit, according to a report.
The U.S. Centers for Medicare & Medicaid Services (CMS) is flexing its new authority in a proposed rule intended to clamp down on drug prices by providing more transparency in the Medicaid program.
The French National Authority for Health, known in France as the Haute Autorité de la Santé (HAS), recently published a favorable opinion regarding reimbursement for the first diagnostic test to benefit under an innovation initiative. The test is the Metaglut1 test from Metafora Biosystems SAS, a non-invasive diagnostic test that identifies glucose transporter type 1 deficiency syndrome (Glut1DS).
Although digital health technologies are being developed at breakneck speed, policies to reimburse these new technologies are lacking and are desperately needed if Australia is to be competitive in the digital health space, said speakers during the Andhealth Digital Health Summit in Adelaide on May 23.
As the clock ticks toward the “full,” or traditional, approval date for Biogen Inc./Eisai Co. Inc.’s Alzheimer’s drug, Leqembi (lecanemab), the U.S. Centers for Medicare & Medicaid Services (CMS) is facing increasing pressure to get the structures in place to ensure Medicare beneficiaries have access to the drug when the approval comes.
