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 […]
Centers for Medicare and Medicaid Services (CMS)
Analysts say high payor coverage, increased CGM adoption bodes well for Abbott, Dexcom
Analysts have suggested that companies like Abbott (NYSE:ABT) and Dexcom (Nasdaq:DXCM) may benefit from expected reimbursement progress. BTIG hosted a conference call with North Shore Medical Center (Salem, Massachusetts) Medical Director Dr. Gary Cohen and Healthcare Analytics, LLC analyst and consultant Dr. Joshua Cohen. The two experts offered insights into prescriber and patient interest in continuous glucose monitors (CGMs) […]
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, […]
iRhythm scores an important reimbursement win
iRhythm Technologies (NSDQ:IRTC) and other companies pioneering remote external EKG monitoring have scored a significant reimbursement win. The regional Medicare administrative contractor Novitas Solutions has set CPT codes 93243 and 93247 at roughly $223 and $233 respectively — news first reported by analysts this morning. The rates are retroactive to Jan. 1, 2022. “We would […]
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 […]
Inspire Medical Systems says reimbursement questions cleared up at CMS
Inspire Medical Systems (NYSE: INSP) says CMS has answered some questions about how it will reimburse its implantable sleep apnea treatment device. The Golden Valley, Minnesota–based company announced on November 10 that CMS has published updated addendum files for the 2022 ambulatory surgery center payment system. The update included an assigned device offset percentage and […]
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 […]
Massachusetts offers Medicaid coverage for Pear Therapeutics’ digital therapeutics
Pear Therapeutics announced today that MassHealth intends to cover the company’s prescription digital therapeutics (PDTs). MassHealth — Massachusetts’ Medicaid program — notified Pear of its plans to cover the FDA-authorized reSET and reSET-O PDTs for treating substance use disorder and opioid use disorder, respectively. The decision remains subject to certain customary conditions, including federal and […]
