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 […]
Medicare
iRhythm CEO Mike Coyle steps down for personal reasons, stock slides
iRhythm Technologies (NSDQ:IRTC) announced that president & CEO Mike Coyle has resigned due to personal matters. San Francisco-based iRhythm said in a news release yesterday evening that CFO Douglas Devine will take over as interim CEO while the search for a permanent replacement for Coyle is conducted. The company’s board of directors formed a CEO […]
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 […]
Xavier Becerra confirmed as HHS secretary
The U.S. Senate narrowly voted to confirm Xavier Becerra as the U.S. Dept. of Health & Human Services (HHS) secretary today. Becerra received the nomination for the position from President Joe Biden in December 2020. Today, the Senate voted 50-49 in favor of Becerra, who will have to resign his seat as California’s attorney general. […]
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 […]
