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FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel backs GRAIL's Galleri on a 6 to 4 effectiveness vote TriSalus clears TriNav Advance, its fourth pressure-enabled infusion device Anaconda Biomed raises $56M to finish a 327-patient stroke trial FDA issues an early alert on Impella controllers that miss purge cassettes HighLife raises 80 million euros for a mitral valve CE marked in January Xenix Medical clears the Riva Anchor for sacroiliac fusion at the base of a lumbar construct Dialybrid raises 15 million euros as its silk polyurethane dialysis graft reaches a first patient CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US

Reimbursement

CMS posts preliminary 2027 lab rates and cuts more than 1,100 test codes

MedDevice Startups Staff · 3 days ago · 2 min read · Via CMS

CMS released preliminary calendar year 2027 Clinical Laboratory Fee Schedule rates on September 21. They come from the second round of private payor data collected under PAMA, and the agency estimates about $1B in annual savings.

Of roughly 1,500 tests with calculated rates, more than 1,100 would be paid less and about 186 more. Chemistry tests drop about 16 percent on average. Molecular pathology and genomic sequencing face the deeper reductions. Proprietary laboratory analyses move just over 2 percent. Statute caps the cut at 15 percent per test per year through the phase in.

Comments are due 30 days from release. Final rates publish in November and take effect January 1, 2027. The American Clinical Laboratory Association said the cuts threaten seniors' access to lab services.

If your revenue model rests on a PLA code, pull the preliminary file and check the number now. The comment window is the only place to argue a crosswalk before the rate is set.

Questions & Answers

What did CMS propose for the 2027 Clinical Laboratory Fee Schedule?

CMS released preliminary calendar year 2027 Clinical Laboratory Fee Schedule rates on September 21, 2026, based on the second round of private payor data collected under PAMA. The agency estimates about $1B in annual savings.

How many lab tests would see Medicare payment cuts in 2027?

Of roughly 1,500 tests with calculated rates in the CMS preliminary 2027 Clinical Laboratory Fee Schedule, more than 1,100 would be paid less and about 186 would be paid more. Chemistry tests fall about 16 percent on average.

When do the 2027 Medicare clinical lab rates take effect?

Comments on the CMS preliminary rates are due 30 days from the September 21, 2026 release. Final rates publish in November 2026 and take effect January 1, 2027.

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