CMS Increases Reimbursement on Some COVID-19 Tests

April 27, 2020

April 27, 2020
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244
RE: CMS-2020-01-R; CMS Ruling on COVID-19 Reimbursement
The American Society for Microbiology (ASM) appreciates the opportunity to thank the Centers for Medicare & Medicaid Services (CMS) regarding payment for the new HCPCS codes to be used with pandemic COVID-19-associated molecular tests. Many ASM members have primary involvement in clinical laboratory medicine, including individuals directing clinical microbiology, immunology and molecular diagnostic laboratories, individuals licensed or accredited to perform such testing, industry representatives developing laboratory products for use, and researchers involved in development and evaluation of new technologies. Therefore, the ASM has significant interest in the process of establishing reasonable reimbursement for medically necessary laboratory testing to provide quality patient care for Medicare beneficiaries.
Use of high throughput technologies for the detection of SARS–CoV–2 during the ongoing emergency increases the costs of personnel, quality control, instrument purchase and maintenance, and cost of test kits and reagents, thereby placing burden on the financial resources of clinical laboratories. Therefore, setting reimbursement for these tests at $100 will provide adequate financial support to these laboratories to maintain such testing.
Examples of high throughput technology as of April 14 include:
  • Roche cobas 6800/8800 System,
  • Abbott m2000 System,
  • Hologic Panther Fusion System,
  • Cepheid GeneXpert Infinity System, and
  • NeuMoDx 288 Molecular
  • High Throughput Laboratory Developed Tests (LDTs)
We hope, as other high throughput COVID-19/SARS-CoV-2 tests are developed, that they will also be reimbursed at the $100 rate using the following new HCPCS codes:
  • U0003: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R.
  • U0004: 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R.
We agree that neither U0003 nor U0004 should be used be used for reimbursement of COVID-19 antibody tests, and ASM will be available to provide input on any new CPT codes recently created for antibody-based COVID-19 testing.
Omai Garner, Ph.D., D(ABMM)
Chair, Subcommittee on Coding and Reimbursement
Clinical and Public Health Microbiology Committee  

Author: ASM Advocacy

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