ARTICLE SUMMARY:
In this week’s roundup: CMS reconsiders coverage of PET scans for dementia assessment and advances payment proposals for dialysis and home health; key documents for implementing the EU IVD Regulation released; FDA plans remote assessment guide, pulse oximetry panel, and new electronic template pilot; and more medtech guidance from the US and China.
Reimbursement Picks
Imaging, dialysis, and home health updates:
CMS relooks at PET dementia policy. The Medicare agency is considering whether to tweak its limited national coverage policy for use of positron emission tomography (PET) in dementia and neurodegenerative disease. CMS opened up an analysis June 16, primarily to decide whether it can lift its coverage limit of one PET amyloid-beta scan per patient in CMS-approved studies. The agency said it received feedback during its recent analysis for monoclonal antibodies for Alzheimer’s (where it restricted coverage to clinical studies) that study protocols sometimes require more than one PET scan per patient. There is no sign at the moment that CMS is considering lifting the clinical study coverage-with-evidence-development requirement for amyloid-beta PET scans.
Dialysis devices seek bonus. Total Medicare payments to dialysis facilities would increase by 3.1% next year under CMS’ proposed End Stage Renal Disease 2023 payment rule, issued June 21. This covers reimbursements for facility-based and home-based dialysis, including adjustments based on an array of quality and performance metrics. As part of the annual payment-setting process, three dialysis devices are pursuing bonus payments next year from CMS to help support market access, but they all have long odds based on the agency’s track record and comments in the proposed rule. The Transitional Add-on Payment Adjustment for New and Innovative Equipment and Supplies (TPNIES) for dialysis devices was launched in 2020, but so far only one device has qualified for the 65% bonus—Outset Medical’s Tablo home hemodialysis system. CMS won’t make any official rulings until the final rule this fall, but the agency underscored concerns with each of the three applicants for 2023 TPNIES add-ons:
