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Reimbursement

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News We’re Watching: SALSA Reintroduced, FDA Approves Abbott Valve, Metallic Implant Study

A bill aimed at preventing laboratory reimbursement cuts has been reintroduced in the US Congress. Additionally, an Abbott valve landed FDA approval, On Target Labs reported trial results, and the FDA warned that dental palate expanders may pose health risks to adults.

Commercial Regulation

HHS Watchdog Blesses Proposed Gift Card Giveaway To Encourage Test Returns

A proposal that would give some patients gift cards in exchange for returning a screening test sample would not violate anti-kickback law because it doesn’t encourage medically unnecessary services, HHS-OIG says.

Compliance Legal Issues

Podcast Special: J&J's Andrie Leday Addresses ASC Market With Customized Approach

In this special podcast from Medtech Insight, editor Reed Miller talked to Andrie Leday, the US vice president for ambulatory surgery centers (ASCs) at Johnson & Johnson/DePuy Synthes. Leday's group is dedicated to creating a new "ecosystem" around DePuy Synthes' broad range of orthopedic implants and tools to meet the demand of an aging population.

Artificial Intelligence Business Strategies

Breakthrough Device Coverage Legislation Introduced In House

A bipartisan group of representatives introduced the Ensuring Patient Access to Critical Breakthrough Products Act of 2023 to provide seniors access breakthrough devices.

Policy Medicare

How Innovative UTI Diagnostics Can Help Combat Antibiotic Resistance

UTIs are one of the most common reasons for antibiotics to be prescribed, but accurate and timely diagnostic tools are lacking. England’s NICE has identified four innovative IVDs that could be rolled out for NHS patients, but said more research is needed on these products first.

Europe EU

Industry Supports Transparency On Proposed CMS Prior Authorization Rule

Industry trade groups applaud CMS’s proposal to increase transparency for prior authorization approvals but are asking for expedited timeframes to provide care.

Policy Reimbursement

Podcast: German Hospital Reform Ushers In A Reimbursement ‘Revolution’

Germany is introducing a new system of paying for inpatient care, whereby funds will be allocated both to diagnosis related groups and to a provisional pot from which funds will be distributed according to the type of care delivered. In this podcast with Medtech Insight, Gabriel Flemming of Germany Trade & Invest explains what it all means for medtech.

Germany Market Access

Pain Device Firm’s Undoing Over $16K ‘Piece of Plastic’

Neuromodulation company Stimwave has agreed to pay $10M in fines and the ex-CEO is facing health care fraud charges after a whistleblower revealed the company was selling a fraudulent “receiver” component. 

Regulation Enforcement
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