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 […]
Centers for Medicare and Medicaid Services (CMS)
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 […]
CMS aborts launch of MCIT payment program for breakthrough devices
CMS intends to kill the Medicare Coverage of Innovative Technology (MCIT) program that would have accelerated government payments for medical devices designated by the FDA as breakthroughs. CMS (the U.S. Centers for Medicare & Medicaid Services) disclosed its proposal in the Federal Registrar yesterday — three months before the rule was set to take effect […]
Medtech gets behind breakthrough device law for seniors
Congressional Democrats and Republicans today introduced a bill to provide Medicare coverage for devices granted FDA breakthrough designation. Sponsored by U.S. Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cárdenas (D-Calif.), Gus Bilirakis (R-Fla.), Terri Sewell (D-Ala.) and Fred Upton (R-Mich.), the Ensuring Patient Access to Critical Breakthrough Products Act would codify an effort that […]
Senate confirms new CMS leader
The U.S. Senate today confirmed President Joe Biden’s selection to lead CMS, Chiquita Brooks-LaSure, with a 55-44 vote in favor. Brooks-LaSure will be the first Black woman to hold the position, according to Senate Majority Leader Chuck Schumer (D-N.Y.) on Twitter. She previously served in the U.S. Dept. of Health and Human Services during the […]
Medicrea to pay $2M in alleged Medicare kickback scheme
French medical device manufacturer Medicrea International and its American affiliate Medicrea USA have agreed to pay $2 million to settle alleged kickbacks to physicians and other Medicare Open Payments program violations. The company agreed to pay $1 million to the U.S. and participating states to resolve civil whistleblower allegations that the company violated the Anti-Kickback […]
CMS delays Medicare payments for breakthrough devices until December
Medicare coverage for FDA-designated breakthrough medical devices will have to wait several more months, despite broad support. The Centers for Medicare and Medicaid Services (CMS) issued a final rule on Medicare Coverage of Innovative Technology (MCIT) in January, granting coverage for breakthrough devices the same day as their FDA approvals, for up to four years. Immediately […]
CMS extends joint replacement pricing by 3 years
The Centers for Medicare and Medicaid Services (CMS) has extended bundled pricing for hip and knee replacements for three years. The final rule, published in the Federal Register, extends the “Comprehensive Care for Joint Replacement” cost-bundling program through Dec. 21, 2024. The cost-cutting program began in January 2016, when CMS required all hospitals in 67 geographic […]
Boston Scientific, Stryker may get extension on Medicare payments
CMS has issued a proposal for the 2022 fiscal year that would potentially help big medtech companies like Boston Scientific and Stryker. Released yesterday, the proposal for the Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) offers updated Medicare payment policies and rates for operating and capital-related costs of acute […]