ASM Comments on Diagnostic Test Prices in 2020 Medicare CLFS

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 2020 Medicare Clinical Laboratory Fee Schedule (CLFS) as outlined in the April 1 Federal Register [CMS–1719–N]. The ASM is the largest single life science association, with over 32,000 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 2020 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 Subcommittee on Coding and Reimbursement, which reviewed the codes to be addressed and provided input. Our comments include the following information:

• New test code(s) and descriptor
• Recommendation (cross-walking or gap-fill) and data on which recommendation is based
• Rationale for recommendation

We greatly appreciate the opportunity to comment. If additional supporting materials are required, we will provide them on request.
Sincerely,
Omai Garner, Ph.D., D(ABMM) Chair
Robert Jerris, Ph.D., D(ABMM), Outgoing Chair,
Clinical and Public Health Microbiology Subcommittee on Coding and Reimbursement

 

Code	Descriptor	Public Comment	Rationale
0062U	Autoimmune (systemic lupus erythematosus), IgG and IgM analysis of 80 biomarkers, utilizing serum, algorithm reported with a risk score	ASM recommends a gapfill.	There is no comparable code for the combination of technology and algorithm.
0064U	Antibody, Treponema pallidum, total and rapid plasma reagin (RPR), immunoassay, qualitative	ASM recommends a crosswalk to codes 86780 and 86592	Code 86780 references antibody testing, Code 86592 most closely matches the syphilis test, non-treponemal antibody descriptor
0065U	Syphilis test, non-treponemal antibody, immunoassay, qualitative (RPR)	Crosswalk to 86592	Code 86592 most closely matches the syphilis test, non-treponemal antibody descriptor
0086U	Infectious disease (bacterial and fungal), organism identification, blood culture, using rRNA FISH, 6 or more organism targets, reported as positive or negative with phenotypic minimum inhibitory concentration (MIC)-based antimicrobial susceptibility	ASM recommends a gapfill.	There is no comparable code that exists for this combination of targets and technologies.
0096U	Human papillomavirus (HPV), high-risk types (ie, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68), male urine	Crosswalk to 87624	Code 87624 closely matches the definition Infectious agent detection by nucleic acid (DNA or RNA) HPV DNA, High Risk, Cervical
0097U	Gastrointestinal pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 22 targets (Campylobacter [C. jejuni/C. coli/C. upsaliensis], Clostridium difficile [C. difficile] toxin A/B, Plesiomonas shigelloides, Salmonella, Vibrio [V. parahaemolyticus/V. vulnificus/V. cholerae], including specific identification of Vibrio cholerae, Yersinia enterocolitica, Enteroaggregative Escherichia coli [EAEC], Enteropathogenic Escherichia coli [EPEC], Enterotoxigenic Escherichia coli [ETEC] lt/st, Shiga-like toxin-producing Escherichia coli [STEC] stx1/stx2 [including specific identification of the E. coli O157 serogroup within STEC], Shigella/Enteroinvasive Escherichia coli [EIEC], Cryptosporidium, Cyclospora cayetanensis, Entamoeba histolytica, Giardia lamblia [also known as G. intestinalis and G. duodenalis], adenovirus F 40/41, astrovirus, norovirus GI/GII, rotavirus A, sapovirus [Genogroups I, II, IV, and V]) (BioFire GI Panel)	Crosswalk to 87507	ASM questions the need for a PLA code since a comparable CPT code (87507) already exists.   Is this a change in methodology or is technologist time changed enough to warrant an additional code?
0098U	Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 14 targets (adenovirus, coronavirus, human metapneumovirus, influenza A, influenza A subtype H1, influenza A subtype H3, influenza A subtype H1-2009, influenza B, parainfluenza virus, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae)	Crosswalk to 87633	Code 87633 closely matches the definition
0099U	Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus, coronavirus OC43, human metapneumovirus, influenza A, influenza A subtype, influenza A subtype H3, influenza A subtype H1-2009, influenza, parainfluenza virus, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, human rhinovirus/enterovirus, respiratory syncytial virus, Bordetella pertussis, Chlamydophila pneumonia, Mycoplasma pneumoniae) BioFire Resp. Panel)	Crosswalk to 87633	ASM questions the need for a PLA code since a comparable CPT already exists.   Is this a change in methodology or is technologist time changed enough to warrant an additional code?
0100U	Respiratory pathogen, multiplex reverse transcription and multiplex amplified probe technique, multiple types or subtypes, 20 targets (adenovirus, coronavirus 229E, coronavirus HKU1, coronavirus NL63, coronavirus OC43, human metapneumovirus, human rhinovirus/enterovirus, influenza A, including subtypes H1, H1-2009, and H3, influenza B, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, respiratory syncytial virus, Bordetella parapertussis [IS1001], Bordetella pertussis [ptxP], Chlamydia pneumoniae, Mycoplasma pneumoniae) BioFire Resp. Panel)	Crosswalk to 87633	ASM questions the need for a PLA code since a comparable CPT already exists.   Is this a change in methodology or is technologist time changed enough to warrant an additional code?
8XXXX	Infectious agent detection by nucleic acid (DNA or RNA); Mycoplasma genitalium, amplified probe technique	Crosswalk to 87491	Code 87491 closely matches the test definition Chlamydia trachomatis, amplified probe technique.
0107U	Clostridium difficile toxin(s) antigen detection by immunoassay technique, stool, qualitative, multiple-step method	Crosswalk to 87803 x 2	Code 87803 closely matches test: Infectious agent antigen detection by immunoassay with direct optical observation x 2 (2 A&B toxin)
0109U	Infectious disease (Aspergillus species), real-time PCR for detection of DNA from 4 species (A. fumigatus, A. terreus, A. niger, and A. flavus), blood, lavage fluid, or tissue, qualitative reporting of presence or absence of each species	ASM recommends a gapfill.	There is no comparable code for the combination of technology and specimen types.
0112U	Infectious agent detection and identification, targeted sequence analysis (16S and 18S rRNA genes) with drug-resistance gene	ASM recommends a gapfill.	There is no comparable CPT code for >55 targets, including both bacterial and fungal.
0115U	Respiratory infectious agent detection by nucleic acid (DNA and RNA), 18 viral types and subtypes and 2 bacterial targets, amplified probe technique, including multiplex reverse transcription for RNA targets, each analyte reported as detected or not detected	Crosswalk to 87633	ASM questions the need for a PLA code since a comparable CPT code (87633) already exists.   Is this a change in methodology or is technologist time changed enough to warrant an additional code?