Payment Determinations for 2017 for New Clinical Laboratory Tests

July 17, 2017

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare & Medicaid Services (CMS) regarding payment methodology to be used for new codes which will be included in the 2017 Medicare Clinical Laboratory Fee Schedule (CLFS) as outlined in the May 13 Federal Register[CMS–1646–N].The ASM is the largest single life science association, with over 41,000 members worldwide. Its members work in environmental, educational, research, industrial, and government settings on issues such as the prevention and treatment of infectious diseases, laboratory and diagnostic medicine, and food and water safety. The ASM’s mission is to advance the microbial sciences as a vehicle for understanding life processes and to apply and communicate this knowledge for the improvement of health and environmental and economic well-being worldwide.

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 ensure quality patient care for Medicare beneficiaries.

Attached are the ASM’s recommendations for payment determinations for new Current Procedural Terminology (CPT) codes to be included in the 2017 Medicare CLFS. We have limited our comments to those tests that affect our constituency, and our recommendations are based on the consensus of ASM’s Public and Scientific Affairs Board Committee on Professional Affairs and Committee on Laboratory Practices, which reviewed the codes to be addressed and provided input. Our comments include the following information:

  • New test code(s) and descriptor
  • Test purpose and method
  • Costs
  • Charges
  • Recommendation (cross-walking or gap-fill) and data on which recommendation is based

We greatly appreciate the opportunity to comment.  If additional supporting materials are required, we will provide them on request.

Sincerely,

Robert Jerris, PhD, D(ABMM)
Chair, Committee on Professional Affairs
Public and Scientific Affairs Board

Clinical Laboratory Fee Schedule (CLFS) CY 2017 Updates
Annual Laboratory Public Meeting, July 18, 2016 

Code

Descriptor

Test Purpose

Cost

Charge

(NLA)

ASM Recommendation and Rationale

           

 

878XX

Infectious agent detection by nucleic acid (DNA or RNA); central nervous system pathogen (e.g., Neisseria meningitidis, Streptococcus pneumonia, Listeria, Haemophilus influenzae, E. coli, Streptococcus agalactiae, enterovirus, human parechovirus, herpes simplex virus type 1 and 2, human herpes virus 6, cytomegalovirus, varicella zoster virus, Cryptococcus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets

Qualitative multiplexed NA-based in vitro test intended simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and fungi directly from CNS

Costs are similar among cleared multiplex assays for detection of multiple unique agents of infection when the number of targets is equivalent. Total costs include an initial specimen preparation component and incremental additional costs based on number of unique targets detected.

87633

=

$567.75

 

Crosswalk to 87633

Infectious agent detection by nucleic acid (DNA or RNA); respiratory virus (eg, adenovirus, influenza virus, coronavirus, metapneumovirus, parainfluenza virus, respiratory syncytial virus, rhinovirus), includes multiplex reverse transcription, when performed, and multiplex amplified probe technique, multiple types or subtypes, 12-25 targets.

 

         

 

G0475

HIV antigen/antibody, combination assay, screening

Simultaneous detection of HIV-1 antigen(s) and antibodies (Ab) to HIV Type 1 and Type 2 in human serum, plasma, or whole blood.

Total costs are similar to other cleared assays and may include personnel costs, quality control, and instrument maintenance.

87389

=

$32.80

 

Crosswalk to 87389

Infectious agent antigen detection by immunoassay technique, (e.g., enzyme immunoassay [EIA], enzyme-linked immunosorbent assay [ELISA], immunochemiluminometric assay [IMCA]) qualitative or semiquantitative, multiple-step method; HIV-1 antigen(s), with HIV-1 and HIV-2 antibodies, single result.

 

         

 

G0476

Infectious agent detection by nucleic acid (DNA or RNA); human papillomavirus HPV), high-risk types (e.g., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68) for cervical cancer screening, must be performed in addition to pap test

Rapid & accurate

HPV genotyping

macro array for

multiple Human

Papillomavirus

detection concomitant with Pap Test screening

Total costs are similar to other cleared assays and may include personnel costs, quality control, and instrument maintenance.

87624

=

$47.80

 

Crosswalk to 87624

Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), high-risk types (eg, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68).