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Set Alert for Reimbursement

Bill Covering Breakthrough Products ‘Step In The Wrong Direction,’ Researchers Say

Researchers from the Brigham and Women’s Hospital and Harvard Medical School argue that the Ensuring Patient Access to Critical Breakthrough Products Act is “a step in the wrong direction.”

Medicare Policy

Representatives Press CMS On Coverage Of Innovative Devices

Medicare coverage of innovative and life-saving devices, drugs and diagnostics were the focus of a 19 September Congressional hearing during which representatives pressed for swifter and more predictable paths to reimbursement.

Policy Legislation

AdvaMed Proposes Comprehensive Strategy for CMS To Encourage Access to AI and Software

AdvaMed released a report on tactics CMS could use to improve coverage for AI and software.

Medicare Regulation

Akili Turns Heel, Goes ‘All In’ On OTC Model For ADHD Digital Therapeutics

The Boston, MA-based company says the pivot away from Rx will enable it to pursue a significantly larger market and remove “key friction points” that have prevented patients from accessing its game-based digital ADHD treatment. The company is targeting year-over-year cost savings of $8m-$18m after investments to juice up its direct digital marketing program.

Commercial Business Strategies

China: Value-Based Procurement Reshapes Strategies Of Multinational Medtech Firms

China’s growing market for medtech, estimated at $70bn in 2021, could more than double this decade if the government’s Healthy China 2030 plan stays on track.  

Asia Pacific China

CMS Promises Actions To Support TCET Pathway

CMS has released a list of actions and guidance documents it plans to take to support the TCET pathway.

Medicare Medicaid

Digital Health Roundup: VR, AI Trends In Rehabilitation; Cybersecurity Regulations; Medicare Updates

In this month’s Digital Health Roundup, Medtech Insight’s Marion Webb highlights VR, AI and other high tech trends in rehabilitation and gait training. Hannah Daniel discusses cybersecurity updates such as the new NIST published draft for an updated version of the Cybersecurity Framework, a recent report by Health-ISAC, and an interview with MedCrypt’s Naomi Schwartz about the upcoming FDA cybersecurity regulations for premarket approvals.

Digital Health Artificial Intelligence

News We’re Watching: ICD Trial Success, EOFlow Restraining Order, Hamilton Ventilator Recall

This week, Medtronic presented data from two new real-world trials confirming that ICDs save lives; a restraining order was issued against EOFlow in Insulet’s intellectual property case; and Polarean’s MRI gas XENOVIEW received a new Medicare reimbursement code.  

Commercial Clinical Trials

Expanding Device Eligibility And Other Suggestions For CMS’s TCET Pathway

Comments submitted by industry members about CMS’s TCET notice highlight the need for greater device eligibility and transparency for the pathway.

Reimbursement Policy

RedDress Chronic Wound Treatment Wins Medicare Coverage

The ActiGraft PRO treatment for diabetic ulcers recently procured Medicare coverage nationwide, despite anti-abuse policies that have made reimbursement for new wound care products rare. Company general manager Robert Mueller talked about the process.

Medicare Policy

ATA Publishes Data Principles Aimed At Telehealth Privacy

The American Telemedicine Association has published a new set of data principles to ensure telehealth visits meet standards for patient safety as well privacy of data and information.

Policy Telehealth

Pan-EU Health Data Sharing Platform Takes Shape

Technical teams have laid the cornerstone for the platform that will be developed to link up multiple public and private data sources and make it easier to access, integrate and analyze the vast and diverse range of data they contain.

Europe Digital Health

‘If You Don’t Prove Utility To Me, I Have No Utility For You:’ How To Get IVD Reimbursement

Successful IVD reimbursement requires communication of analytical validity, clinical validity and clinical utility.

Medicare Medicaid

News We’re Watching: Califf Talks ORA Reorg, Contaminants Bring Ventilator Recall, 27-Year Sentence On Medicare Fraud

This week, FDA Commissioner Robert Califf described plans for restructuring the Office of Regulatory Affairs; Studies found chatbots don’t give trustworthy advice to cancer patients; and the owner of an Atlanta genetic testing lab was sentenced to 27 years in prison over a massive Medicare fraud scheme.  

Regulation Approvals

Trade Groups Sign Letter Opposing Physician Payment Cuts

AdvaMed, MITA and MDMA say cuts to Medicare reimbursement rates for office visits would disproportionately harm specialists. 

Medicare Reimbursement
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