COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

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Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

CMS Releases Interim Final Rule for COVID-19 Reporting and Outlines Enforcement Mechanisms

CMS maze of rules and regulations
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Interim final rule (CMS-3401-IFC) from CMS mandates daily reporting for broader surveillance of COVID-19 and influenza statistics, and outlines strict enforcement mechanisms

On Oct. 6, 2020, the US Centers for Medicare and Medicaid Services (CMS) published a memorandum of COVID-19 reporting requirements that apply to Medicare and Medicaid hospitals and critical access hospitals. This memorandum outlines 38 data points that must be reported at least once daily to the US Department of Health and Human Services (HHS).

CMS-3401-IFC Requires New Data from Clinical Laboratories

While much of the COVID-19 hospital reporting requirements applied to nonlaboratory related data, there were data points that pertained specifically to clinical laboratories. These include:

  • The ability to maintain a three-day supply of nasal pharyngeal swabs, nasal swabs, and viral transport media;
  • Staffing shortage details; and
  • Anticipated or experienced critical staffing shortages.

These reporting requirements also list multiple subsets of various populations for which laboratory-verified COVID-19 results must be reported.

The memorandum also outlined reporting requirements starting on Oct. 19, 2020, that will be optional—initially—with the intention that this reporting will become mandatory. The latest clinical laboratory data requirements relate to reporting influenza results and statistics, in addition to COVID-19 statistics.

The CMS memorandum states, “failure to report the specified data needed to support broader surveillance of COVID-19 may lead to the imposition of the remedy to terminate a provider’s participation from the Medicare and Medicaid programs.” CMS concurrently released a flowsheet outlining the enforcement mechanisms that will be used to ensure compliance with the reporting requirements.

Clinical laboratory leaders should be familiar with the details of this memorandum, and can review it here.

Related Resources:

Interim Final Rule (IFC), CMS-3401-IFC; Requirements and Enforcement Process for Reporting of COVID-19 Data Elements for Hospitals and Critical Access Hospitals

Hospital Mandatory COVID-19 Reporting Enforcement Workflow


Helping Your Lab Stay Afloat During Challenging Times

Dear Colleague,

Robert L. MichelIn these challenging times for our colleagues in clinical laboratories, pathology practices and hospital administration, The Dark Intelligence Group (TDIG) — through generous grants from our partners — is bringing you the COVID-19 STAT Intelligence Briefings.

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