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Set Alert for Reimbursement

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.

Reimbursement Telehealth

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.

Policy Medicare

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.

Legislation Rare Diseases

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.

Device Week Regulation

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.

Quoted Real-World Evidence

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.

FDA Real-World Evidence

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.

FDA Guidance Documents

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.

Medicare Reimbursement
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