July 18, 2005 – Payment Determinations for Calendar Year 2006 for New Clinical Laboratory Tests

The American Society for Microbiology (ASM) appreciates the opportunity to provide comments to the Centers for Medicare and Medicaid Services (CMS) regarding payment methodology to be used for new codes which will be included in the 2006 Medicare Clinical Laboratory Fee Schedule, as announced in the Federal Register on May 27, 2005 [CMS-1293-N]. The ASM is the largest educational, professional, and scientific society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents more than 43,000 microbiologists, professionally employed as scientists and science administrators working in a variety of areas, including biomedical, environmental, and molecular fields as well as in clinical microbiology, clinical immunology, and molecular diagnostics.

Many of our 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 marketing products for use, and researchers involved in developing and evaluating 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 to this statement is a summary table outlining the ASM’s recommendations with respect to payment determinations for select new Current Procedural Terminology (CPT) codes to be included in the 2006 Medicare Clinical Laboratory Fee Schedule. 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 “2006 New Laboratory Tests” document on the CMS web site and provided comment. For each code, the following information is provided, as outlined in the May 27, 2005 Federal Register notice: • New test code and descriptor • Test purpose and method • Test costs and charges (i.e. the National Limitation Amount) • ASM recommendation on payment methodology • Rationale for payment recommendation

ASM appreciates the opportunity to make recommendations on payment levels for 2006 CPT codes. Should additional information or reference materials be required, ASM stands ready to assist in any way possible.
 

Test Code and Descriptor

Recommendation

Method and Purpose

NLA and Relative Costs

Rationale

Code 8019X:

Sirolimus (therapeutic drug assay)

Crosswalk to 80197:

Therapeutic drug assay, Tacrolimus

The method for the new code is a quantitative enzyme immunoassay to monitor therapeutic levels of immunosuppressive therapy.

$19.17

Costs are comparable to other TDM immunoassays.

Methodology to detect Sirolimus is comparable to that for the related agent, Tacrolimus.

Code 8227x: single specimen, (e.g., from digital rectal exam)

No comment

 

 

 

Code 8303x glycosylated (A1C) by device cleared by FDA for home use

No comment

 

 

 

Code 8363x Lactoferrin, fecal; quantitative

Crosswalk to 83520 AND 87015:

Immunoassay, analyte, quantitative; not otherwise specified AND Concentration (any type), infectious agents

The method for the new code is a quantitative enzyme immunoassay to detect fecal lactoferrin; aids in discrimination of inflammatory bowel disease and non-inflammatory bowel syndrome; also used to monitor progression of and therapeutic response to therapy for IBD.

$18.09 + $9.33 = $27.42

Costs include a procedure to process the fecal sample for analysis, followed by costs for the enzyme immunoassay which are comparable to other EIA’s.

Code 87015 for processing specimens for microbial analysis is similar in labor input to the processing required for the fecal sample; the quantitative enzyme immunoassay methodology is comparable to other similar immunoassays for non-infectious analytes.

Code 8369x Lipoprotein (a)

No comment

 

 

 

Code 8370x Liproprotein, blood; electrophoretic separation and quantitation

No comment

 

 

 

Code 8370x high resolution

fractionation and quantitation of lipoproteins including subclasses when performed (e.g., electrophoresis, ultracentrifugation)

No comment

 

 

 

Code 8370x quantification of lipoprotein particle numbers and lipoprotein particle subclasses (e.g., by nuclear magnetic resonance spectroscopy)

No comment

 

 

 

Code 8390x amplification of patient nucleic acid, multiplex, first two nucleic acid sequences each

Crosswalk to 83898 x 2:

Molecular diagnostics, amplification of patient nucleic acid, single primer pair, each primer pair

The method for the new code involves the simultaneous amplification of two specific target sequences in a sample

$23.42 x 2 =

$46.84

The primary cost component is for each specific primer pair

Each amplification should be accounted for in the reimbursement. Economies of the multiplex reaction are realized in sharing of other molecular diagnostic codes.

Code 83901 (revised) amplification of patient nucleic acid, multiplex, each additional nucleic acid sequence (List separately in addition to code for primary procedure)

Crosswalk to 83898:

Molecular diagnostics, amplification of patient nucleic acid, single primer pair, each primer pair

The revised code is intended for use as an add-on code for the previous dual analyte multiplex code.

$23.42

The primary cost component is for each specific primer pair.

Each amplification should be accounted for in the reimbursement. Economies of the multiplex reaction are realized in sharing of other molecular diagnostic codes, e.g. processing codes, interpretation codes.

Code 8390x lysis of cells prior to nucleic acid extraction (e.g., stool specimens, paraffin embedded tissue)

Crosswalk to 87015 AND 87176:

Concentration (any type), for infectious agents AND homogenization, tissue, for culture

The proposed code is for processing of tissues prior to amplification to release nucleic acids, remove inhibitory tissue components, and otherwise optimize the nucleic acid sample for analysis.

$9.33 +  $8.22 =

$17.55

Costs are comparable to general tissue processing costs.

Codes for sample processing for infectious disease agent analysis are roughly equivalent to the processes used in sample cellular lysis and include tissue homogenization (87176) and concentration, i.e. centrifugation (87015), e.g. processing codes, interpretation codes.

Code 8390x signal amplification of patient nucleic acid, each nucleic acid sequence

Crosswalk to 83898:

Molecular diagnostics, amplification of patient nucleic acid, single primer pair, each primer pair

The proposed code is for an alternative amplification method not using other methods covered by 83898.

$23.42

Costs are comparable to PCR based amplification.

The alternative amplification method covered by the new code provides equivalent information and uses comparable resources.

Code 8390x separation and identification by high resolution technique (e.g., capillary electrophoresis

Crosswalk to 83903:  Molecular diagnostics, mutation scanning, by physical properties (e.g. single strand conformational polymorphisms, heteroduplex, denaturing gradient gel eletrophoresis, RNAase A), single segment, each

The proposed code is for an alternative method for post-amplification detection of single segment sequences.

$23.42

Costs are comparable to other segment detection techniques.

The alternative detection method is a physical detection method roughly comparable to code 83903 in resources.

Code 8391x Mutation identification by enzymatic ligation or primer extension, single segment, each segment (e.g., oligonucleotide ligation assay (OLA), single base chain extension (SBCE), or allele-specific primer extension (ASPE))

Crosswalk to 83904:

Molecular diagnostics, mutation identification by sequencing, single segment, each segment

The proposed code is for alternative method for post-amplification mutation identification.

$23.42

Costs are comparable to other mutation identification techniques.

The alternative mutation detection method is a nucleic acid based method roughly comparable to code 83904 in resources.

Code 8620x Cyclic citrullinated peptide (CCP), antibody

No comment

 

 

 

Code 8635x B cells, total count

Crosswalk to 86064:

B cells; total count

The proposed code uses flow cytometric analysis with B cell specific reagent to quantify B cells present in a cell preparation.

$52.70

The proposed code is simply a transfer of the previous code to a new location.

Code 8635x Natural killer (NK) cells, total count

Crosswalk to 86379:

Natural killer (NK) cells, total count

The proposed code uses flow cytometric analysis with NK cell specific reagent to quantify NK cells present in a cell preparation.

$52.70

The proposed code is simply a transfer of the previous code to a new location.

Code 8636x Stem cells, (i.e., CD34), total count

Crosswalk to 86587 AND 86361:

Stem cells (CD34), total count AND T cells, absolute CD4 count

The proposed code uses flow cytometric analysis of stem cells including exact quantitation of numbers present and assessment of viability to identify, quantitate and assess viability of stem cell preparations to be used for transplant.

$52.70 + $37.41 =  $90.11

Costs are a composite of materials and labor costs for both CD34 cell count and viability determination.

The proposed code is intended to be a transfer to a new location. However, the current fee fails to account for the increased complexity of the analysis. Code 86587 accounts for the CD34 assessment and 86361 accounts for the viability determination.

Code 8648x Tuberculosis test, cell mediated immunity measurement of gamma interferon antigen response

Crosswalk to 86353  AND 83520:

Lymphocyte transformation, mitogen (phytomitogen) or antigen induced blastogenesis

AND Immunoassay, analyte, quantitative; not otherwise specified

 

The proposed code is for a two stage assay which includes:

(1) a whole blood lymphocyte stimulation using tuberculosis antigen, and (2) measurement of interferon gamma production by stimulated lymphocytes using a quantitative enzyme immunoassay. Interpretation requires comparison to a control (non-antigen exposed) blood sample.

$68.49 +  $18.09 = $86.58

Costs are a composite of the lymphocyte stimulation process and the gamma interferon measurement using an enzyme immunoassay.

Code 86353 accounts for the lymphocyte stimulation process in the first stage of the assay, and code 83520 accounts for the quantitative enzyme immunoassay performed to detect gamma interferon.

Code 8720x complex special stain (e.g., trichrome, iron hemotoxylin) for ova and parasites

Crosswalk to the national mean for the TC from the PFS for 88104:

Cytopathology, fluids, washings, or brushings, except cervical or vaginal; smears with interpretation.

The proposed code is primarily intended for the special stains (trichrome, iron-hemotoxylin) used for protozoa detection as a component of a complete “O&P” (Ova and Parasite) analysis.

Mean TC = $24.20

The protozoal stains are equivalent in complexity for performance to the stains used for non-gynecologic cytology (e.g. Papanicolaou stain). The training requirements and time required to read a slide are also comparable to those for a non-gynecologic cytologic examination by a cytotechnologist.

Code 8790x Infectious agent drug susceptibility phenotype prediction using regularly updated genotypic bioinformatics

Crosswalk to 87903 AND 87904:

Infectious agent phenotype analysis by nucleic acid (DNA or RNA) with drug resistance tissue culture analysis, HIV 1; first through 10 drugs tested AND Each additional 1 through 5 drugs tested

 

The proposed code is an update of a Category III code to a Category I code. While the method is that described by 87901 (genotyping), the continuous data update allows provision of comprehensive data equivalent to that provided by 87903 and the add-on code 87904 (phenotyping). The method has been referred to as “virtual phenotyping.”

$687.79 + $182.11=

$864.83

The comprehensive and continuously updated data justifies reimbursement greater than 87903 alone. However, whether 87904 should be recommend as a single or as a replicate is unclear.

 

 

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