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July 16, 2007 Cassandra Black Deputy Director Division of Ambulatory Services Centers for Medicare and Medicaid Services Dear Ms. Black: The American Association for Clinical (AACC) appreciates the opportunity to submit recommendations on the assignment of payment levels for new codes to be included in the 2008 Medicare Clinical Laboratory Fee Schedule. Our comments follow: CPT Code: 80047

Description: Basic metabolic panel (Calcium, ionized) Test Purpose: The existing basic metabolic panel (BMP) includes 8 common serum blood chemistries used in diagnosing a wide variety of disorders. Many point of care test panels for metabolic function typically include ionized calcium rather than total calcium and consequently can not be reported using the existing BMP code. The new code for basic metabolic panel (Calcium, ionized) allows point of care basic metabolic panels to be reported using a single code rather than eight individual codes as presently required by coding rules. Test Method: Automated chemistry systems and point-of-care analyzers Charges: Payment Rec: Rationale: Average charge based on 2005 Medicare Part B claims: $36.63

80048 (Basic metabolic panel)

Crosswalk to 80048 is recommended because both 80047 and 80048 describe basic metabolic tests and use similar resources ________________ CPT Code: 82610

Description: Cystatin C

CMS July 16, 2007 Page Two Test Purpose: Cystatin C is a cysteine proteinase inhibitor produced by all nucleated cells. It is formed at a constant rate and freely filtered by the kidneys. Its serum concentration is inversely correlated with the glomerular filtration rate (GFR). Cystatin C measurements are used in the diagnosis and treatment of renal diseases. Since the serum concentration of cystatin C remains unchanged with infections, inflammatory or neoplastic states, and is not affected by body mass, diet, or drugs, it is useful as an index of GFR, especially in obese, elderly, and malnourished patients. Test Method: Nephelometry Charges: Payment Rec: Average charge based on 2005 Medicare Part B claims: $76.24

Crosswalk to CPT code 83883 (Nephelometry, each analyte not elsewhere specified)

Rationale:

Crosswalk to nephelometry method code 83883 is recommended because Cystatin-C is currently reported with this code. ________________ CPT Code: 83993

Description: Calprotectin Test Purpose: Calprotectin is a calcium-binding protein secreted predominantly by neutrophils. Elevated fecal calprotectin levels have been observed in patients with inflammatory bowel disease (IBD) and GI tract infections. Elevated levels often precede clinical relapse in patients with quiescent IBD. Fecal calprotectin is also elevated in patients with non-steroidal antiinflammatory drug (NSAID)-induced enteropathy. Test Method: Immunoassay after extraction from stool specimen Charges: Payment Rec: Average charge based on 2005 Medicare Part B claims:$90.43 plus $31.97

Crosswalk to CPT code 83520 (Immunoassay, not otherwise specified) plus 87015 (Concentration, any type for infectious agents) Crosswalk to immunoassay method code 83520 is recommended because calprotectin is currently reported with this code. CPT code 87015 is also required to account for the specialized extraction from stool specimens.

Rationale:

CMS July 16, 2007 Page Three CPT Code: 84704

Description: Gonadotropin, chorinoic (hCG); free beta chain Test Purpose: Measurement of free Beta hCG is used to screen for Down syndrome in the first trimester of pregnancy. Currently, in the USA most specimens for free Beta hCG analysis are collected and transported to the laboratory as dried blood spots. Test Method: Elution from dried blood and immunoassay Charges: Payment Rec: Average charge based on 2005 Medicare Part B claims: $79.98

Crosswalk to CPT code 82677 (Gonadotropin, chorionic (hCG); qualitative)

Rationale:

The Free beta chain hCG assay is similar in methodology [immunoassay] to estriol, and is used for the same clinical purpose: both free beta hCG and estriol are components of a test battery which is used for assessing risk in a pregnant woman for carrying a fetus with neural tube disorders. ________________ CPT Code: 86356

Description: Mononuclear cell antigen, quantitative (e.g. flow cytometry), not otherwise specified, each antigen Test Purpose: This code describes otherwise unlisted cell surface markers typically determined by flow cytometry. Such markers are frequently used in the diagnosis and treatment of leukemia and other hematological disorders. Test Method: Flow cytometry Charges: Payment Rec: Rationale: Not available

Crosswalk to CPT code 86586 (Unlisted antigen) New CPT 86356 replaces 2007 code 86586 (which is to be deleted in 2008) and, therefore, should have the same reimbursement value as the previous CPT.

CMS July 16, 2007 Page Four CPT Code: 86486

Description: Skin test; unlisted antigen, each Test Purpose: This code is used to identify skin tests for otherwise unlisted antigens Test Method: Skintest Charges: Payment Rec: Average charged based on 2005 Medicare Part B claims: $22.15.

Crosswalk to CPT code 86510 on the Medicare Physician Fee Schedule

Rationale: CPT code 86510 is a similar skin tests. ________________ CPT Code: 87500

Description: Vancomycin resistance (e.g., enterococcus species van A, van B) amplified probe technique Test Purpose: Acquired microbial resistance to vancomycin is a growing problem within health care facilities such as hospitals and nursing homes. Vancomycinresistant enterococci (VRE) emerged in 1987. Vancomycin resistance emerged in more common pathogenic organisms during the 1990s and 2000s, including vancomycin-intermediate Staphylococcus aureus (VISA), vancomycin-resistant Staphylococcus aureus (VRSA), and vancomycin-resistant Clostridium difficile. This code is used to report Vancomycin resistance to any infectious agent using DNA or RNA based amplificed probe techniques. Test Method: Molecular diagnostics; amplified probe technique Charges: Payment Rec: Average charged based on 2005 Medicare Part B claims: $227.34

Crosswalk to CPT code 87471 (infectious agent detection by nucleic acid (DNA or RNA); Bartonella henselae and Bartonella quintana)

Rationale:

87471 is the first CPT code in the existing series of similar tests (i.e. infectious agent detection by nucleic acid (DNA or RNA), amplified probe technique)

CMS July 16, 2007 Page Five CPT Code: 87809

Description: Infectious agent antigen detection by immunoassay with direct optical observation; Adenovirus Test Purpose: A Human adenoviruses (HAdVs) are one of the most commonly isolated viruses and are a significant cause of diseases of the respiratory tract and eye. Pharyngoconjunctival fever (PCF) is a widely known adenoviral disease. HAdVs, particularly types 7 and 3, are also known to cause pneumonia. Furthermore, HAdVs are increasingly being recognized as fatal pathogens in immunocompromised patients. Test Method: Lateral flow plus immunoassay with direct optical observation Charges: Payment Rec: Average charged based on 2005 Medicare Part B claims: $42.33

Crosswalk to CPT code 87802 (infectious agent antigen detection by immunoassay with direct optical observation; Streptococcus, group B)

Rationale:

87802 is the first CPT code in the similar test series (i.e. infectious agent antigen detection by immunoassay with direct optical observation) ________________ CPT Code: Gxxxx

Description: Hemoglobin; glycosylated (A1c) Test Purpose: A1C, also known as glycated hemoglobin or glycosylated hemoglobin, indicates a diabetic patient's blood sugar control over the last 2-3 months. A1C values are directly proportional to the concentration of glucose in the blood over the full life span of the red blood cells. A1C values are not subject to the fluctuations that are seen with daily blood glucose monitoring. Test Method: Immunoassay Charges: Average charged based on 2005 Medicare Part B claims: $54.86

CMS July 16, 2007 Page Six Payment Rec:

Crosswalk to 83036

Rationale: We do not understand the need for a new G-code. However, if CMS is going to create one, we recommend that it be crosswalked to 83036. Hemoglobin, glycosylated (A1c) is currently coded using either 83036 or 83037. 83037 is used for a specific testing method, while 83036 is the default code, used for the majority of glycosylated hemoglobin tests, and not limited to specific methodology. Therefore the new code, which uses a generic description (identical, in fact, to the language for 83036), should be crosswalked to the more generic existing test code (83036). AACC looks forward to working with you on this important matter. By way of background, AACC is the principal association of professional laboratory scientists--including MDs, PhDs and medical technologists. AACC's members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry worldwide. The AACC provides international leadership in advancing the practice and profession of clinical laboratory science and its application to health care. If you have any questions, please call me at (504) 568-4281, or Vince Stine, PhD, Director, Government Affairs, at (202) 835-8721. Sincerely,

Larry Broussard, PhD President-Elect, AACC

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