Pathways’ Picks July 20: Outpatient Pay, User Fee Disarray, and Global Picks

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In this week’s roundup: CMS’ Medicare outpatient payment rule addresses clinical trial, software, and innovative device reimbursement policies; Sen. Burr throws a wrench into user fee process and more FDA news; new survey lays EU MDR gaps bare; and more global picks.

Outpatient Picks

Clinical trials, AI, and pass-throughs in Medicare outpatient pay proposal:

Blended payments for trial integrity. CMS floated a new coding policy to protect the scientific integrity of double-blinded medical device trials in its 2023 Hospital Outpatient Prospective Payment System proposed rule. The new approach addresses Category B Investigational Device Exemption trials, where CMS pays for the studied device and routine trial costs. Under the proposed policy, which CMS has already applied to one ongoing trial—for the V-Wave Interatrial Shunt System (V-Wave Ltd.)—and now wants to extend more broadly, the agency will assign a single temporary HCPCS code for a trial. The code can be used to bill for both the study and control arms, triggering a blended payment based on the average resources used in the study, accounting for the frequency in which the device is used combined with other routine costs. The goal is to avoid differential coding for the two arms, which undermines trial blinding. Category B IDE trials address so-called “non-experimental” devices, where basic questions of safety and effectiveness have been established. For Category A (experimental) IDE trials, CMS can only pay for routine costs but not the studied device. 

Paying for algorithms. CMS proposed several updates in the outpatient proposal that could improve the reimbursement picture for targeted artificial intelligence (AI)-based imaging analysis software tools. It also opened a broader request for comments on future strategies for “software as a service” payment policies across healthcare settings. For more details see: “CMS Seeks Cost-Effective Way to Pay for Software, AI Services,” Market Pathways, July 20, 2022.


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