Summary
The CAP supports the FDA’s proposal to reclassify oncology therapeutic nucleic-acid-based test systems from class III to class II devices with 510(k) requirements. The CAP also recommends changes to the Medicare Advantage program, including revising network adequacy requirements, prohibiting narrow physician networks, and easing the burden of prior authorization.
CAP supports device reclassification proposal, suggests ways to strengthen Medicare Advantage
February 2026—In comments submitted Jan. 26 to the FDA commissioner, the CAP said it supports the FDA’s proposal to reclassify oncology therapeutic nucleic-acid–based test systems from class III to class II (special controls) devices with 510(k) requirements.
“We have advocated for the down classification of these tests because they use longstanding and well-understood technologies,” the CAP told Martin Makary, MD, MPH. Downgrading the classification and stipulating special controls, the CAP said, will help broaden access to these companion diagnostic tests at more clinical laboratories across the U.S.
“We encourage the FDA to work with drug and test developers to include in the device labeling sufficient details of the biological basis for the test and its minimum performance characteristics,” the CAP said, noting it will enable pathologists and clinical laboratories to establish benchmarks to compare these tests with others.
The CAP also encouraged the agency to consider reclassifying immunohistochemistry and in situ hybridization test systems, saying IHC and ISH testing techniques have been in regular use longer than the companion diagnostic assays and noting the peer-reviewed scientific evidence demonstrating the analytical and clinical validity of these techniques for oncology therapeutics and treatment outcomes.
In other comments, sent Jan. 26 to CMS administrator Mehmet Oz, MD, the CAP recommended several changes to the Medicare Advantage program. The CMS had requested information on how to strengthen the program.
The CAP urged the CMS to revise the MA network adequacy requirements by adding hospital-based specialties to the list for which MA plans have a specific standard. It also urged the CMS to develop Star Ratings measures that link bonus payments and capitation rates to whether plans maintain adequate physician networks.
The CAP also urged prohibitions on the use of tiered and narrow physician networks that deny patient access to, or attempt to steer patients toward, certain physicians or facilities based primarily on cost of care factors. Inappropriate in-network steering, the CAP wrote, “prioritizes administrative convenience and short-term cost control over timely, coordinated, and patient-centered medical decision-making.”
The CAP’s recommendations include the following, among others:
- Expand efforts to ease the burden of prior authorization by streamlining and automating, and increasing public reporting of, prior authorization processes; strengthening requirements for decision time frames; and expanding gold-carding programs for prior authorization (to help in targeting prior authorization where it’s needed most).
- Reduce reporting complexity with consistent coding. “Non-standard coding and/or reimbursement practices have serious adverse consequences for pathologists and laboratories trying to comply with conflicting requirements,” the CAP said. It recommended, too, that MA payment rates be required to be at least at the levels in traditional Medicare.
Labcorp to deploy Cobas Mass Spec Solution
Labcorp is implementing Roche’s Cobas Mass Spec Solution, describing it as a collaboration that introduces fully automated mass spectrometry into routine clinical practice.
The Cobas Mass Spec Solution has a fully automated workflow, broad test menu (about 60 assays to be introduced over time), and a platform designed for future integration with clinical chemistry and immunochemistry analyzers.
Sysmex America expands CN-Series with CN-9000
Sysmex America announced Jan. 21 the newest addition to its CN-Series, the CN-9000 Automated Hemostasis Solution.
The CN-9000 has continuous sample loading and automated rerun/reflex testing and a throughput of up to 1,000 samples per hour. Labs can run the CN-9000 solution on its own or connect it to a compatible total laboratory automation line. Features such as closed-tube sampling, Preanalytical Sample Integrity checks, and intelligent tube routing minimize manual handling, reduce error risk, and boost overall productivity.
The modular CN-9000 supports up to three CN-3000 or CN-6000 blood coagulation analyzers as well as the optional Sysmex TS-10 integrated tube sorter and archiver. The line can be configured with up to two turn unit modules, allowing 90-degree turns to the left or right, making it suitable for coagulation departments with space constraints.
CLIA certificates as of March 1
The Centers for Medicare and Medicaid Services will switch to electronic CLIA certificates effective March 1. After that date, paper certificates will no longer be available. CAP-accredited laboratories holding a CLIA certificate of accreditation can contact the CAP at [email protected] to update their CMS email contact.