PREVENT Pandemics Act Draft Holds Consequential Policies for Labs

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.”

Public-Private Collaboration for Accelerated Response

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.

Consulting With Private-Sector Clinical Laboratories

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!

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