The U.S. Centers for Medicare & Medicaid Services (CMS) has released the prospective payment rule for end-stage renal disease (ESRD) for calendar year 2024, and advocates had some luck prompting the agency to boost the base ESRD payment rate. However, Atlanta-based Pain Care Labs Inc. came up short in its transitional add-on payment application for the Buzzy Pro for relief of puncture wound site pain because, according to CMS, the device does not represent a substantial improvement over currently available remedies.
The U.S. CMS has peeled back a proposed 4.2% rate cut in the home health payment draft rule for calendar year 2023, replacing it instead with a 0.7% increase in overall payments for home health services, a category that affects sales of durable medical equipment and home infusion therapy items. That change was insufficient to mollify the National Association for Home Care & Hospice (NAHC), which argued that the final rule will nonetheless severely hit home care providers and leaves NAHC with no choice but to take its concerns to Capitol Hill.
Davita Inc., lost a U.S. Supreme Court ruling regarding limits to the private payer coverage for outpatient dialysis services despite, a development that took a double-digit bite out of Davita’s shares. However, shares of competitor Fresenius also took a hit, suggesting that the market sees the decision as a major setback for both companies.
Fist Assist Devices LLC received a breakthrough device designation from the FDA for its Fist Assist Model FA-1 device for patients with end-stage renal disease (ESRD). The pre-surgical dilation device promotes arteriovenous (AV) fistula creation in renal failure patients with inadequate vein size for creation of an AV fistula for hemodialysis. An AV fistula is a surgical connection between an artery and a vein used as an access point for dialysis.
San Francisco-based startup Cloudcath has raised a $12 million series A round to support commercialization of its first product that enables remote, real-time monitoring for at-home peritoneal dialysis patients. The expectation is that the notifications it offers to health care providers will enable earlier intervention to avoid complications, including infection. The Cloudcath system is pending U.S. FDA clearance.
The U.S. FDA has given Medtronic plc a green light for its In.Pact AV drug-coated balloon, the second application for the Dublin-based company’s In.Pact DCB platform. The paclitaxel-coated balloon is now indicated for the treatment failing arteriovenous (AV) access in patients undergoing dialysis due to end-stage renal disease (ESRD). In.Pact AV leverages technology from Medtronic’s In.Pact Admiral DCB, which first snagged FDA approval in 2015 for treatment of superficial femoral artery (SFA) lesions above the knee.