The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab). Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval. About a week later, nonprofit watchdog group Public Citizen called for high-profile resignations of […]
Medicare
Medtronic announces recent reimbursement wins for CGMs in a number of geographies
Medtronic (NYSE:MDT) announced today that reimbursement for its CGMs has been expanded or initiated across a number of countries. Earlier this month, the Ontario, Canada provincial government announced a comprehensive reimbursement program for continuous glucose monitoring (CGM) for eligible residents who have type 1 diabetes, adding to a similar program for those with type 1 […]
Pear Therapeutics advances in efforts to get CMS to cover prescription digital therapeutics
Pear Therapeutics (NSDQ:PEAR) announced that the Centers for Medicare & Medicaid Services (CMS) established new coding relevant to its prescription digital therapeutics (PDTs). CMS established a new Level II Healthcare Common Procedure Coding System (HCPCS) code to describe prescription digital behavioral therapy — FDA-cleared — per course of treatment, which extends to PDTs including Pear’s reSET, […]
Relievant Medsystems’ Intracept receives new CPT codes to aid reimbursement efforts
Relievant Medsystems announced today that two new Category I Current Procedural Terminology (CPT) codes are now in effect for Intracept. Minneapolis-based Relievant designed its Intracept device and procedure to treat chronic low back pain (CLBP) from degenerative disc disease with Modic changes. It involves a minimally invasive procedure that targets the basivertebral nerve with radiofrequency-based […]
Zacks says Medtronic will gain from expanded CMS coverage for CGMs
Zacks Equity Research today reported that Medtronic (NYSE:MDT) stands to gain from yesterday’s CMS coverage expansion for diabetes technology. CMS’s expanded coverage, confirmed by Medtronic yesterday, covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs. The coverage includes CGMs that integrate with Medtronic insulin pumps. Get the full story at our sister site, […]
CMS expands Medicare coverage to CGMs that integrate with Medtronic insulin pumps
Medtronic (NYSE:MDT) announced today that the U.S. Centers for Medicare & Medicaid Services (CMS) will expand coverage for CGMs. CMS’ expanded coverage covers all types of CGMs (continuous glucose monitors), including adjunctive and non-adjunctive CGMs, and it notably covers CGMs that integrate with Medtronic insulin pumps. Get the full story at our sister site, Drug Delivery […]
CMS puts final nail in MCIT payment proposal for breakthrough devices
The U.S. Centers for Medicare & Medicaid Services (CMS) rescinded the Medicare Coverage of Innovative Technology (MCIT) and definition of “Reasonable and Necessary” final rule today. CMS said it intends to explore ways to improve the coverage process for better access to innovative and beneficial medical devices, including a process for the Medicare program to […]
Senators urge CMS to create payment program for breakthrough devices
Ten U.S. senators are calling on the U.S. Centers for Medicare & Medicaid Services (CMS) to create a new rule allowing government payments for medical devices designated as breakthroughs by the FDA. CMS said in September that it would not move forward with the Medicare Coverage for Innovative Technologies (MCIT) rule, citing safety concerns for […]
iRhythm ‘disappointed’ with CMS final rule on wearable ECG patches
iRhythm Technologies (NSDQ:IRTC) issued a comment on the CMS Calendar Year 2022 Medicare Physician Fee Schedule (MPFS) Final Rule. In the Final Rule, CMS (Centers for Medicare and Medicaid Services) did not issue national pricing and continued carrier pricing for the 2022 calendar year on Category I CPT codes 93241, 93243, 93245 and 93247 for […]
Outset Medical achieves landmark Medicare approval for home dialysis system
Outset Medical (NSDQ:OM) announced today that it received CMS approval for a payment adjustment on its Tablo hemodialysis system. San Jose, California-based Outset said in a news release that it received the first-ever CMS approval for a Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES). The decision helps encourage healthcare providers […]
Xeris reaches payor coverage milestone for glucagon injection
Xeris Pharmaceuticals (NSDQ:XERS) announced today that it achieved a milestone for the payor coverage of its Gvoke glucagon injection. Approximately 91% of Medicare patients, 88% of commercially insured patients and a growing number of Medicaid lives have unrestricted access to Gvoke, Xeris said in a news release. Get the full story at our sister site, Drug […]