AMP offers clinical testing recommendations for public health emergencies
May 2022— The Department of Health and Human Services and the Centers for Medicare and Medicaid Services should engage laboratory stakeholders early and across the spectrum of care delivery environments before laboratory policies are implemented in public health emergencies, the Association for Molecular Pathology says in a report released April 19 titled “Economics of Testing During a Public Health Emergency: Lessons Learned from Two Years of COVID-19.”
That recommendation, the AMP says, will ensure that reactionary policies do not have unintended and negative consequences for laboratories and impede their ability to respond.
In the report, AMP Economic Affairs Committee members reflect on the first two years of the pandemic and examine policies on coding, coverage, and pricing for SARS-CoV-2 molecular diagnostic tests. They make 14 additional recommendations for how the challenges laboratories faced can be mitigated or avoided in future emergencies.
A sampling of the other recommendations follows:
- The AMP encourages the CMS to coordinate early and broadly with the lab community, the AMA CPT editorial panel, and others on diagnostic coding.
- The AMP encourages the CMS to develop a process for rapidly developing interim codes and coding guidance using input from relevant stakeholders.
- In the future, the CMS should work with stakeholders to gain reliable data on the real-world costs of running a test during an emergency situation.
- In the future, the CMS must ensure that test prices align with the resources required to develop and facilitate the tests and other costs associated with supply chain issues.
- In the face of high demand for testing and myriad external pressures on labs to respond quickly during a pandemic, the CMS must ensure that Medicare local coverage policies support the full range of tests available to diagnose and guide treatment and do not contribute to significant burden on labs.
- To ensure that a wide range of clinical samples are sequenced for public health surveillance, federal guidance and funding for these activities should be developed and accessible to all clinical laboratory types.
The full report is at https://tinyurl.com/mpdu7w35.
Accelerate launches Arc Module and BC Kit
Accelerate Diagnostics launched its Accelerate Arc system, an automated path to rapid and accurate microbial identification for positive blood cultures.
The system is composed of the Arc Module and BC Kit and is designed for labs with MALDI. The module is a novel application of inline centrifugal and sample preparation techniques, providing a suspension of cleaned and concentrated microbial cells, which, together with the blood culture kit, allows for direct transfer to a MALDI spotting plate.
The load-and-go workflow eliminates the need for batching multiple specimen tests. The Arc module requires two to three minutes of hands-on time to run and is simple enough to be used on all shifts, by any laboratory technician, the company said in a March 28 release.
In addition, the Accelerate Arc system is designed to eliminate the need for overnight culture incubation for current MALDI users, while reducing the likelihood of cross-reactivity and potential false-positive results. It is intended for research use only and is not for use in diagnostic procedures.
BioMérieux to acquire Specific Diagnostics
BioMérieux has entered into an agreement to acquire Specific Diagnostics, a privately held U.S.-based company that has developed a rapid antimicrobial susceptibility test system that delivers phenotypic AST directly from positive blood cultures.
BioMérieux has held a minority stake in Specific Diagnostics since 2019, and the two companies had signed a co-distribution agreement covering the European market in 2021.
The deal is expected to close this year by the end of the second quarter.
With the addition of the Specific Reveal Rapid AST, the BioMérieux Sepsis Solution allows same-day AST results for Gram-negative bacteria, BioMérieux said in an April 12 release. The Reveal Rapid AST system is an instrument with a targeted menu, small footprint, and modular design for adaptable throughput.
Under the terms of the agreement, BioMérieux will acquire 100 percent ownership of Specific Diagnostics for an acquisition price equivalent to 3.3 percent of BioMérieux market capitalization as of April 11.