Appeals court strikes down No Surprises Act QPA regulations
September 2026—A federal appeals court struck down portions of the federal regulations governing the calculation of the qualifying payment amount (QPA) under the No Surprises Act.
The U.S. Court of Appeals for the Fifth Circuit, sitting en banc, issued its decision Aug. 11 in Texas Medical Association v. United States Department of Health and Human Services.
The QPA is an insurer-calculated figure that is an important element in independent dispute resolution proceedings in which the amount an insurer owes to an out-of-network provider is adjudicated.
Physician groups argued the method used produced artificially low QPAs by allowing insurers to include rates that were not negotiated and to exclude bonus and incentive payments.
ArentFox Schiff LLP lawyers Jack Bierig and Aphrodite Kokolis filed amicus briefs in the case in support of the Texas Medical Association. The AFS lawyers in their Aug. 17 commentary on the decision (https://bit.ly/4qvxVL2) provided this takeaway, among others, for out-of-network health care providers:
“Remind insurers and independent dispute resolution entities (IDREs) that QPA calculations may not include ‘ghost rates’ and must include bonus payments. When calculating QPAs, insurers can no longer use so-called ‘ghost rates,’ i.e., fees listed by an insurer on a default schedule, even when the provider in question did not negotiate those fees, does not bill for the corresponding codes, and is not even equipped to furnish the corresponding services. Further, insurers can no longer categorically exclude bonus and incentive payments. These payments must be considered if they are connected to the services provided. Each of those prior practices likely led to artificially depressed QPAs. Out-of-network providers can emphasize this flaw in the prior methodology when interacting with both insurers and IDREs during the No Surprises Act’s dispute resolution process. They should insist upon fair reimbursement rates that are higher than the QPAs calculated by the insurers themselves.”
Out-of-network providers should watch for further rulemaking and agency guidance and monitor whether this en banc decision is appealed to the U.S. Supreme Court, the AFS lawyers write.
They conclude that the decision is a favorable one for out-of-network providers but that “implementation will determine whether, when, and to what extent it actually results in changes to the reimbursement practices of insurers.”
FDA authorizes robotic blood draw device
The Food and Drug Administration authorized in August Vitestro’s Aletta robotic blood draw device.
In its Aug. 19 release, the FDA said its marketing authorization granted to Vitestro is based on clinical data demonstrating that the Aletta achieves successful blood draw rates comparable to or better than those of trained human phlebotomists when it proceeds with a stick. “Device-related adverse events were uncommon and mild,” the FDA said.
The device is authorized for use in adults in outpatient settings and must be operated under the oversight of a supervisor trained in phlebotomy. One phlebotomist can oversee up to three Aletta devices at the same time. The device autonomously handles each step of the draw, while a phlebotomist initiates each session and remains available throughout to respond to any issue that may arise.
Roche launches two new cyclospora tests
Roche, in collaboration with subsidiary TIB Molbiol, made available in August two new flexible research PCR testing options for the Cyclospora cayetanensis parasite.
The new research-use-only tests are used with the LightCycler 480 and LightCycler Pro instruments. The LightMix Modular Cyclospora assay is for detecting cyclospora only using hydrolysis probe chemistry. The LightMix OneTube Gastro Para 2 assay includes multiplex, real-time PCR detection of Entamoeba histolytica, Giardia, Dientamoeba fragilis, Cryptosporidium, Blastocystis, and Cyclospora cayetanensis.
Those new assays complement an existing assay, UC-TIB-Gastro-Para-2, a multiplex, real-time PCR test for high-throughput research. It detects Dientamoeba fragilis, Blastocystis hominis, and Cyclospora cayetanensis in a single reaction and is used with the Cobas 5800, 6800, and 8800 systems.
The cyclospora portfolio provides the option of panel size and platform type and the economics of one, three, or six targets.
FDA clears Elecsys pTau217
The Food and Drug Administration cleared the Roche Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, developed in collaboration with Eli Lilly.
The single-biomarker blood test supports rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings.