The COVID-19 pandemic and the public health emergency (PHE) continue to make waves as its tsunami of impacts sweeps deeply into the whole of healthcare. The multitude of implications includes a new policy draft discussion about preparing for future pandemics. The emerging legislation called the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics (PREVENT) Act (“the Discussion Draft”) will have significant implications for labs with the future of resources at stake in the pandemic response. The aim of the draft is to bolster the coordination and public health infrastructure for a more robust response against a future pandemic or public health emergency. The American Clinical Laboratory Association (ACLA) provided key feedback on provisions of the policy that had direct impacts for labs noting “The ACLA has advocated for legislation that establishes and funds public-private preparedness collaborations, whereby private-sector clinical laboratories with appropriate expertise are a critical element of pandemic response planning, preparedness training, proactive data monitoring, and the early testing response, both for emerging pathogen threats and larger epidemics and pandemics.”
The first point that the ACLA wants to emphasize is the unique value of private-sector clinical laboratories. These labs have the capacity to create, validate, and perform the quality tests needed for testing and identification of diseases. However, the country’s present system emphasizes government laboratories and government-controlled supplies, with private sector laboratories “tapped for assistance on an as needed basis” generally past the point where such a move would be most useful “and dependent on distribution of federally stockpiled materials to meet increased demand in short order.” According to the ACLA:
“Federal, state, and local governments should instead leverage clinical laboratory expertise at every stage of the preparation and response process, and ensure that laboratories are well positioned to rapidly respond to surges that create sharp increases in demand for clinical testing services. This requires earlier and sustained engagement with clinical laboratories to support their ability to maintain on-site testing capacity.”
All the essentials including personnel, equipment, and adequate supply reserves must be swiftly available for meeting the demands of a surge in increased testing. Engagement with clinical laboratories must begin in advance of a full-fledged outbreak that grows into a pandemic. According to the ACLA, proposed policies should create a partnership between private laboratory entities and the government and provide resources for sustaining the necessary laboratory capacity “in a near-ready state” in order to properly facilitate any need for increased testing. The ACLA expressed appreciation that a Discussion Draft of the policy advocates for such collaboration along with recommendations to safeguard laboratory supply capacity.
Among its chief criticisms, ACLA and other stakeholders condemned the federal government’s early response to the pandemic stating that their approach failed to include the necessary collaboration with private-sector clinical laboratories. Specifically, the federal government held early discussions with laboratories communicating the progress of the virus, but the CDC expended too much focus on a single CDC-developed test and it wasn’t until three weeks following the CDC’s authorization of the test, and almost a month after the public health emergency (PHE) was declared, that the FDA acted to provide the first COVID-19 testing policy to speed up the creation of further clinical laboratory diagnostic tests for COVID-19. Furthermore, “Even once private laboratories were called upon to expand their capacity in short order given the emergency, the process was clouded by unclear communication channels with key federal agencies. The ‘one test approach,’ combined with uncoordinated communication, squandered precious weeks of the nation’s first wave response to the virus which could have otherwise been utilized to rapidly validate, scale, and deploy multiple tests within multiple clinical laboratories in parallel partnership with the federal government.”
Based on this history, private-sector labs must be considered significant early strategic partners with the federal government when tackling future PHEs. While the ACLA agrees with provisions found in the PREVENT Pandemic Act Discussion Draft with several key areas that the association gave specific feedback on.
Section 102–Strategic Plan for Public Health Preparedness: Section 102 intends to include a new section to the Public Health Service Act (PHSA) correlating to CDC Director authority. Under this proposal, part of the policy mandates the CDC director to create a “Strategic Plan” “that sets forth strategic priorities and objectives for, among other things, ‘enhancing global and domestic public health capacity, capabilities, and preparedness, including public health data, surveillance, and laboratory capacity and safety.’ Importantly, the provision requires the Director to describe how the plan will incorporate ‘partnerships with private sector entities’ to achieve these objectives.” The ACLA applauds the fact that provisions highlight laboratory capacity as an attribute of the national public health readiness strategy while the policy acknowledges the significance of utilizing the private sector laboratories during
Section 211–Strategic Plan for Situational Awareness System: In this section, the ACLA is pleased that policies are seeking to alter the PHSA § 319D in ways that foster further public private collaborations, which includes clinical laboratories. Part of the goal of this provision is “to modernize the interoperable network of systems for nationwide public health situational awareness.”
Section 211–State Grant Program Situational Awareness System: Under this provision, an amendment is applied to the current grant program for state health situational awareness systems. This amendment seeks to mandate that states include “public-private partnerships” in their grant applications. According to the ACLA, “the health situational awareness systems created by the states are already expected to be developed ‘in collaboration with clinical laboratories,’ but this provision appropriately encourages state governments to consider clinical laboratories and the private sector in the earliest planning stages.”
These are not all the policy impacts of the PREVENT Act. To explore more coding and compliance topics subscribe to our Laboratory Compliance Manager Newsletter. The Laboratory Compliance Manager Newsletter is your monthly gateway to the latest laboratory-specific compliance, coding, and reimbursement news including topics like the clinical laboratory fee schedule, coding changes, the final rules, CLIA-waived tests, PLA code releases, and more. Subscribe today!
Information Source:
https://www.acla.com/wp-content/uploads/2022/02/PREVENT-Pandemics-Act-Discussion-Draft-ACLA-Comment-Letter.pdf
Let me start with some follow-up on a topic I have written about before: the widening of the use of “against medical advice” (AMA) to
The 30th Annual Compliance Institute for the Health Care Compliance Association (HCCA) is scheduled to take place in Orlando next week. If you are there,
Please log in to your account to comment on this article.
Breast biopsy procedures may be clinically straightforward but accurately translating them into compliant billing can be anything but. In this focused webcast, Shawn Blackburn, CPC, CPMA, CIC, CRC, CCS-P breaks down how imaging guidance, lesion count, laterality, and payer expectations all impact how these procedures should be reported. Through clear explanations and real-world scenarios, you’ll gain practical insight into aligning clinical workflows with billing requirements, avoiding common pitfalls, and ensuring your documentation supports accurate reimbursement and compliance.
Gain clarity and confidence in OB‑GYN coding with this expert‑led webcast featuring Sherri L. Clayton, RHIT, CSS. You’ll learn how to apply global maternity package rules accurately, select the right CPT codes for procedures and visits, and identify documentation gaps that lead to denials. With practical guidance and real examples, this session helps you strengthen compliance, reduce audit risk, and ensure accurate reimbursement for women’s health services.
Uncover essential coding insights with nationally recognized coding authority Kay Piper, RHIA, CDIP, CCS. Through ICD10monitor’s interactive, on‑demand webcast series, Kay walks you through the AHA’s 2026 ICD‑10‑CM/PCS Quarterly Coding Clinics, translating each update into practical, easy‑to‑apply guidance designed to sharpen precision, ensure compliance, and strengthen day‑to‑day decision‑making. Available shortly after each official release.
Uncover critical guidance on the ICD-10-CM/PCS code updates. Kay Piper reviews and explains ICD-10-CM/PCS coding guidelines in the AHA’s fourth quarter 2026 ICD-10-CM/PCS Coding Clinic in an easy to access on-demand webcast.
Traditional utilization management models can no longer keep pace with regulatory shifts, payer scrutiny, and operational pressures. In this webcast, Tiffany Ferguson, LMSW, CMAC, ACM, ACPA-C, introduces an Adaptive Model strategy that modernizes UM through role specialization, technology-driven workflows, and proactive, team-based processes. Attendees will learn how to restructure programs to improve efficiency, strengthen clinical collaboration, and enhance financial performance in a rapidly changing healthcare environment.
Federal auditors are intensifying their focus on inpatient psychiatric facilities, using advanced data analytics to spotlight outliers and pursue high‑dollar repayments. In this high‑impact webcast, Michael Calahan, PA, MBA, Compliance Officer and V.P., Hospital & Physician Compliance, breaks down what regulators are really targeting in IPF-PPS admissions, documentation, treatment and discharge planning. Attendees will learn practical steps to tighten processes, avoid common audit triggers and protect reimbursement and reduce the risk of multimillion-dollar repayment demands.
In this timely session, Stacey Shillito, CDIP, CPMA, CCS, CCS-P, CPEDC, COPC, breaks down the complexities of Medical Decision Making (MDM) documentation so providers can confidently capture the true complexity of their care. Attendees will learn practical, efficient strategies to ensure documentation aligns with current E/M guidelines, supports accurate coding, and reduces audit risk, all without adding to charting time.
Join Ronald Hirsch, MD, FACP, CHCQM for The PEPPER Returns – Risk and Opportunity at Your Fingertips, a practical webcast that demystifies the PEPPER and shows you how to turn complex claims data into actionable insights. Dr. Hirsch will explain how to interpret key measures, identify compliance risks, uncover missed revenue opportunities, and understand new updates in the PEPPER, all to help your organization stay ahead of audits and use this powerful data proactively.
Celebrate Lab Week with MedLearn! Sign up to win one year of our Laboratory All Access Pass! Click here to learn more →
CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 1 with code CYBER25
CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 2 with code CYBER24
