Medicare coverage for FDA-designated breakthrough medical devices will have to wait, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule in January granting coverage for breakthrough devices the same day as their FDA approvals. The rule was supposed to take effect March 12, but CMS has postponed the Medicare Coverage of […]
Centers for Medicare and Medicaid Services (CMS)
CMS delays shift to new payment model for chronic kidney disease treatments
CMS will now wait until Jan. 1, 2022 to start its Kidney Care Choices model, meant to shift the way the U.S. treats chronic kidney disease. The new payment model was supposed to start on Jan. 1 of this year, but health providers are still grappling with the COVID-19 pandemic. The new model could have […]
CMS consolidates coverage for Intersect ENT’s corticosteroid-eluting implant
Intersect ENT (NSDQ:XENT) announced today that it received consolidated Medicare coverage for its Sinuva sinus implant. Menlo Park, Calif.-based Intersect ENT said in a news release that CMS published an average selling price (ASP) for the Sinuva implant, providing predictability, transparency and confidence of reimbursement for providers and payers in the future. Get the full story […]
Abbott’s MitraClip receives boost as CMS expands coverage for TMVR
Abbott (NYSE:ABT) announced today that CMS revised its coverage for TMVR, opening up new possibilities for its MitraClip device. The CMS National Coverage Determination (NCD) expands coverage for transcatheter mitral valve repair (TMVR) to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure. According to an Abbott news release, the CMS decision […]
Medicare to cover breakthrough devices
FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS). The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices […]
CMS finalizes coverage updates that increase access to VADs
The Centers for Medicare & Medicaid Services (CMS) finalized policies that increase access to artificial hearts and ventricular assist devices (VADs). In August, CMS proposed the coverage policy updates meant to increase access to VADs and artificial hearts, which represented potentially good news for major VAD makers Abbott (NYSE:ABT) and Medtronic (NYSE:MDT) and for people with heart failure who […]
UK regulators recommend iRhythm cardiac arrythmia device
iRhythm Technologies (NSDQ:IRTC) announced that it received a recommendation for adoption from National Institute for Health and Care Excellence (NICE). San Francisco-based iRhythm said in a news release that it is the first technology to pass through a new digital health tech pilot, resulting in the successful recommendation for adoption from NICE. The company’s Zio XT […]
Home dialysis gets a boost from Medicare
Medicare will now provide additional coverage for certain home dialysis equipment for patients with chronic kidney failure. The final rule published today encourages the development of new and innovative home dialysis machines. It follows a September announcement of a new model to shift Medicare payments from traditional fee-for-service payments to payments in which providers are incentivized for encouraging the […]
CVRx secures reimbursement win from CMS
CVRx announced that it received the CMS inpatient new technology add-on payment (NTAP) for its Barostim Neo implantable device. Effective Oct. 1, 2020, and ranging over a three-year duration, Medicare is slated to provide an add-on payment for Barostim Neo worth up to 65% of the device cost (up to a maximum amount allowed of […]
ReWalk gains Medicare coverage
ReWalk Robotics (NSDQ:RWLK) announced today that it received authorization from CMS as a medicare provider. Marlborough, Mass.-based ReWalk is now able to bill Medicare directly for the procurement of its ReWalk personal exoskeleton for Medicare beneficiaries, thanks to the authorization from the Centers for Medicare & Medicaid Services (CMS), according to a news release. In July, […]
Medical Alley Association asks CMS to make it easier for breakthrough devices to win coverage
Medtech receiving a breakthrough device designation from FDA should be able to satisfy all of CMS’s non-cost criteria for transitional pass-through payments, according to the Medical Alley Association. The Minnesota-based trade group’s CEO Shaye Mandle made the proposal in comments submitted Sept. 24 in response to a proposed rule from CMS to revise the Medicare […]