Reimbursement
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Pear Therapeutics Obtains First Medicaid Coverage For PDTs
Massachusetts’ Medicaid program will cover reSET and reSET-O prescription digital therapeutics for the treatment of substance abuse disorder and opioid use disorder.
Medicare To Cover At-Home Test To Detect Organ Rejection After Kidney Transplant Surgery
US Medicare has issued a local coverage determination (LCD) for NephroSant’s QSant test, which uses artificial intelligence to score a patient’s likelihood of experiencing organ rejection after transplant. Early detection of rejection could be a game-changer for organ recipients.
Legislation Introduced In US Congress Addresses Rare Cancers
The Cancer Patient Equity Act seeks to expand coverage for cancer molecular analysis and testing and encourage education and awareness of rare cancers.
Device Week, 1 October 2020 – MDUFA And MCIT In Spotlight At AdvaMed's MedTech Conference
In this week’s podcast, reporters discuss the high points of the recent AdvaMed MedTech Conference. Ferdous Al-Faruque goes in-depth on FDA comments about user fees, while Brian Bossetta discusses varying points of view on Medicare coverage of breakthrough devices – including the crucial role of real-world evidence.
QUOTED. Aparna Higgins.
A panel of experts discussed the fate of the Medicare Coverage for Innovative Technology (MCIT) rule during AdvaMed’s annual Medtech Conference. Aparna Higgins, a senior policy fellow at the Duke-Margolis Center for Health Policy, stressed that FDA and CMS criteria are not the same.
Real-World Evidence Deemed Essential For Breakthrough Designations
A panel of experts in the health care and medical device industries discussed the fate of the Medicare Coverage for Innovative Technology (MCIT) rule during AdvaMed’s annual Medtech Conference.
New FDA Guidance Offers Additional Info On eStar Submissions
The US Food and Drug Administration says its guidance for manufacturers seeking premarket clearance is part of the agency’s overall commitment to improve e-submission consistency and enhance the review process.
Lawmakers Urge Medicare To Not Cut Reimbursement For Some Specialty Procedures
A bipartisan group of legislators in the US House of Representatives wants to stop the Centers for Medicare & Medicaid Services (CMS) from finalizing proposed cuts to treatments for cancer, kidney failure, artery disease and other conditions.
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