"Calendar Year (CY) 2025 Clinical Laboratory Fee Schedule (CLFS) Annual Laboratory Meeting Code List1
This worksheet Preliminary Determinations of this Excel workbook contains all of the new CLFS codes and CMS preliminary payment determinations. 

We welcome public comments on our preliminary determinations for the basis of payment.  All comments must be submitted electronically by October 25, 2024 to the following CMS mailbox: CLFS_Annual_Public_Meeting@cms.hhs.gov, and final determinations will be announced in November.  When submitting public comments, please refer to the specific code and its rationale so that we may best respond in the final payment determinations.

1 CPT codes, descriptions and other data only are copyright 2021 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.  
"									
Item #	FACA Mtg Order	Code #	Final Code #	Code Type	Category	Long Code Descriptor	Panel Recommendation	CMS CY 24 Preliminary Recommendation	Rationale
38	1	0445U	0445U	"New
(PLA)"	Immunology	"B-amyloid (abeta42) and phospho tau (181p) (ptau181), electrochemiluminescent immunoassay (eclia), cerebral spinal fluid, ratio reported as positive or negative for amyloid pathology"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                            3. Crosswalk to 0358U: 9"	Crosswalk to 0358U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
45	2	82XX0	82233	New	Immunology	Beta-amyloid;1-40 (Abeta 40)	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                           3. Crosswalk to 0358U x 0.5: 8"	Crosswalk to 83520	"CMS disagrees with the Panel's crosswalk recommendation.  CMS found a similar existing test that uses this code. The descriptor for the new test does not cite any of the analyses in the proposed Crosswalk, nor a risk score. "
46	3	82XX1	82234	New	Immunology	Beta-amyloid;1-42 (Abeta 42)	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                           3. Crosswalk to 0358U x 0.5: 8"	Crosswalk to 83520	"CMS disagrees with the Panel's crosswalk recommendation.  CMS found a similar existing test that uses this code. The descriptor for the new test does not cite any of the analyses in the proposed Crosswalk, nor a risk score. "
77	4	83XX0	83884	New	Immunology	Neurofilament light chain (NfL)	"1. Abstain
2. Gapfill   
3. Crosswalk to 0358Ux0.5: 9"	Crosswalk to 83520	"CMS disagrees with the Panel's crosswalk recommendation.  CMS found a similar existing test that uses this code. The descriptor for the new test does not cite any of the analyses in the proposed Crosswalk, nor a risk score. "
82	5	86XX1	86581	New	Immunology	"Streptococcus pneumoniaeantibody (IgG), serotypes, multiplex immunoassay, quantitative"	"1. Abstain: 1
2. Gapfill: 7                                                                                                                                                                                                                                                                                                                                                                                                                  3. Crosswalk to 87633: 1"	Crosswalk to 87502	"CMS does not agree with the proposed crosswalk, there is no reference to number of targets in the descriptor of 86XX1.  However, CMS also disagrees with gapfilling this code and identified a different crosswalk of 87502."
48	6	8X3XX	84394	New	Immunology	"Tau, total (tTau)"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                     3. Crosswalk to 0358U x 0.5: 8"	Crosswalk to 83520	"CMS disagrees with the Panel's crosswalk recommendation.  CMS found a similar existing test that uses this code. The descriptor for the new test does not cite any of the analyses in the proposed Crosswalk, nor a risk score. "
61	7	XX42U	0462U	"New
(PLA)"	Chemistry	"Melatonin levels test, sleep study, 7 or 9 sample melatonin profile (cortisol optional), enzyme-linked immunosorbent assay (ELISA), saliva, screening/preliminary "	"1. Abstain
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 80307: 8"	crosswalk to 83520	CMS disagrees with the proposed crosswalk and instead is proposing a crosswalk to 83520.  The descriptor for 0462U refers only to ELISA while the proposed crosswalk includes several different immunoassays.  
87	8	XX65U	0480U	New	Microbiology Infectious Disease	"Infectious disease (bacteria, viruses, fungi, and parasites), cerebrospinal fluid (CSF), metagenomic next-generation sequencing (DNA and RNA), bioinformatic analysis, with positive pathogen identification"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 0323U: 8"	Crosswalk to 0323U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
6	9	86041	86041	Reconsidered	Immunology	Acetylcholine receptor (AchR); binding antibody	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                          3. Crosswalk to 86341: 8"	Crosswalk to 83519	CMS does not agree with the panel to change the crosswalk recommended from last year.  CPT 83519 has been used as a billing code for this test prior to this time. CMS continues to believe 83519 is the most appropriate comparable crosswalk. 
7	10	86042	86042	Reconsidered	Immunology	Acetylcholine receptor (AChR); blocking antibody	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                             3.  Crosswalk to 86341: 9"	Crosswalk to 83519	CMS does not agree with the panel to change the crosswalk recommended from last year.  CPT 83519 has been used as a billing code for this test prior to this time. CMS continues to believe 83519 is the most appropriate comparable crosswalk. 
8	11	86043	86043	Reconsidered	Immunology	Acetylcholine receptor (AChR); modulating antibody	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 86053: 8                                                                                                                                                                                                    "	Crosswalk to 86255	CMS does not agree with the panel to change the crosswalk recommended from last year.  CPT 86255 has been used as a billing code for this test prior to this time. CMS continues to believe 83519 is the most appropriate comparable crosswalk. 
9	12	86366	86366	Reconsidered	Immunology	Muscle-specific kinase (MuSK) antibody	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 84586: 8"	Crosswalk to 83519	CMS does not agree with the panel to change the crosswalk recommended from last year.  CPT 83519 has been used as a billing code for this test prior to this time. CMS continues to believe 83519 is the most appropriate comparable crosswalk. 
24	13	0431U	0431U	"New
(PLA)"	Immunology	"Glycine receptor alpha1 IgG, serum or cerebrospinal fluid (CSF), live cell-binding assay (LCBA), qualitative "	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 84238: 8"	Crosswalk to 84238	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
25	14	0432U	0432U	"New
(PLA)"	Immunology	"Kelch-like protein 11 (KLHL11) antibody, serum or cerebrospinal fluid (CSF), cell-binding assay, qualitative "	"1. Abstain: 1
2. Gapfill; 1                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 84238: 7                                                                                                                                                                                                                                                                                                                                                                                 4. Crosswalk to 0345U+ 0419U+ 0411U"	Crosswalk to 84238	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
36	15	0443U	0443U	"New
(PLA)"	Immunology	"Neurofilament light chain (nfl), ultra-sensitive immunoassay, serum or cerebrospinal fluid"	"1. Abstain
2. Gapfill 
3. Crosswalk to 0358U x 0.5: 9"	Crosswalk to 83520	"CMS disagrees with the proposed crosswalk.  We feel that simply dividing 0358U by two is an arbitrary comparison for 0443U, specifically given the 'ultra-sensitive' immunoassay referenced in 0443U.  CMS instead is proposing a crosswalk to 83520 but welcomes more input on any differences in an ultra-sensitive immunoassay.  "
51	16	XX32U	0451U	"New
(PLA)"	Chemistry	"Oncology (multiple myeloma), LCMS/MS, peptide ion quantification, serum, results compared with baseline to determine monoclonal paraprotein abundance"	"1. Abstain
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 0077U: 8"	Crosswalk to 0077U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
12	17	0394U	0394U	Reconsidered (PLA)	Chemistry	"Perfluoroalkyl substances (PFAS) (e.g., perfluorooctanoic acid, perfluorooctane sulfonic
acid), 16 PFAS compounds by liquid chromatography with tandem mass spectrometry (LCMS/MS), plasma or serum, quantitative"	"1. Abstain
2. Gapfill: 9      
3. Crosswalk to 0263U"	Crosswalk to G0482	"CMS continues to believe that G0482 is the most appropriate crosswalk for this code.  The proposed crosswalk to 0263U includes an algorithmic analysis, which is not included in the descriptor for 0394U.  CMS also does not agree with the Panel's recommendation to gapfill this code since there are existing codes with similar methodology on the CLFS."
76	18	8X051	87564	New	Microbiology	"Infectious agent detection by nucleic acid (DNA or RNA); Mycobacterium tuberculosis, rifampin resistance, amplified probe technique"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                3. Crosswalk to 87556+ 87641: 8                                                                                                                                                                                                                                                                                                                                                                               4. Crosswalk to 1/6th of  0008U"	Crosswalk to 87556+87641	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
47	19	8X3X0	84393	New	Immunology	"Tau, phosphorylated (e.g., pTau 181, pTau 217), each"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                         3. Crosswalk to 0358U x 0.5: 8"	Crosswalk to 83520	"CMS disagrees with the panel recommendation, and instead is proposing a crosswalk to CPT 83520.  The descriptor for the 8X3X0 does not cite any of the analyses in the proposed Crosswalk of 0358U, nor a risk score.  CMS feels the descriptor of CPT 83520 is more comparable to that of 8X3X0."
78	20	8XX00	81515	New	Microbiology Infectious Disease & Genome Sequencing Procedure  	"Infectious disease, bacterial vaginosis and vaginitis, real-time PCR amplification of DNA markers for Atopobium vaginae, Atopobium species, and Megasphaera type 1, Bacterial VaginosisAssociated Bacteria 2 (BVAB-2), utilizing vaginal-fluid specimens, algorithm reported as positive or negative for high likelihood of bacterial vaginosis, includes separate detection of Trichomonas vaginalis and Candida species (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata/Candida krusei, when reported"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        3. Crosswalk to:81514: 8"	Crosswalk to 81514	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
28	21	0435U	0435U	"New
(PLA)"	Molecular Pathology	"Oncology, chemotherapeutic drug cytotoxicity assay of cancer stem cells (CSCs), from cultured CSCs and primary tumor cells, categorical drug response reported based on cytotoxicity percentage observed, minimum of 14 drugs or drug combinations "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                 3. Crosswalk to 0248U: 9"	Crosswalk to 0248U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
109	22	XX84U	0502U	New	Genomic Sequencing Procedures; Infectious Disease	"Human papillomavirus (HPV), E6/E7 markers for high-risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), cervical cells, branched-chain capture hybridization, reported as negative or positive for high risk for HPV"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 87624: 9"	Crosswalk to 87624	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
112	23	XX89U	0505U	New	Genomic Sequencing Procedures; Infectious Disease	"Infectious disease (vaginal infection), identification of 32 pathogenic organisms, swab, real-time PCR, reported as positive or negative for each organism"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 87507+87506: 9"	Crosswalk to 87507+87506	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
122	24	XX99U	0515U	New	Immunology	"Gastroenterology (irritable bowel disease [IBD]), immunoassay for the quantitative determination of infliximab (IXL) levels in venous serum in patients undergoing infliximab therapy, results reported as a numerical value as micrograms per milliliter (g/mL)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                        3. Crosswalk to 80230: 9"	Crosswalk to 80230	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
118	25	XX97U	0511U	New	Pharmacogenomics	"Oncology (solid tumor), tumor cell culture in 3D microenvironment, 36 or more drug panel, reported as tumor-response prediction for each drug"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 0248U: 8                                                                                                                                                                                                                                                                                                                                                                       4. Crosswalk to 0248U x 3: 1"	Crosswalk to 0248U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
121	26	XX98U	0514U	New	Immunology	"Gastroenterology (irritable bowel disease [IBD]), immunoassay for the quantitative determination of adalimumab (ADL) levels in venous serum in patients undergoing adalimumab therapy, results reported as a numerical value as micrograms per milliliter (g/mL)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 80145: 9"	Crosswalk to 80145	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
23	27	0430U	0430U	"New
(PLA)"	Chemistry	"Gastroenterology, malabsorption evaluation of alpha-1-antitrypsin, calprotectin, pancreatic elastase and reducing substances, feces, quantitative "	"1. Abstain: 1
2. Gapfill
3. Crosswalk to 82103+83993+82653+84376: 8"	Crosswalk to 82103+83993+82653+84376	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
20	28	0427U	0427U	"New
(PLA)"	Hematology	"Monocyte distribution width, whole blood (List separately in addition to code for primary procedure) 

(Use 0427U in conjunction with 85004, 85025) "	"1. Abstain: 1
2. Gapfill: 7                                                                                                                                                                                                                                                                                                                                                                    3. Crosswalk to 85049: 1"	Crosswalk to 85049	CMS agrees with  minority panel and public's recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
127	29	X102U	0520U	New	Therapeutic Drug Assay	"Therapeutic drug monitoring, 200 or more drugs or substances, LC-MS/MS, plasma, qualitative and quantitative therapeutic minimally effective range of prescribed and non-prescribed medications"	"1. Abstain
2. Gapfill: 3                                                                                                                                                                                                                                                                                                                                                                                    3. Crosswalk to G0483: 6                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  4. Crosswalk to 0063U"	Crosswalk to G0483	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
110	30	XX85U	0503U	New	Immunology	"Neurology (Alzheimer disease), beta amyloid (A?40, A?42, A?42/40 ratio) and tau-protein (p-tau217, np-tau217, p-tau217/np-tau217 ratio), blood, immunoprecipitation with quantitation by liquid chromatography with tandem mass spectrometry (LC-MS/MS), algorithm score reported as the likelihood of positive or negative for amyloid plaques"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 0384U: 8                                                                                                                                                                                                                                                                                                                                                                                                  4. Crosswalk to 0247U"	Crosswalk to 0384U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
111	31	XX88U	0504U	New	Genomic Sequencing Procedures; Infectious Disease	"Infectious disease (urinary tract infection), identification of 17 pathologic organisms, urine, real-time PCR, reported as positive or negative for each organism"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 87507: 9"	Crosswalk to 87507	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
79	32	87XX0	87594	New	Microbiology Infectious Disease	"Infectious agent detection by nucleic acid (DNA or RNA); Pneumocystis jirovecii, amplified probe technique"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                       
3. Crosswalk to 87481: 8                                                                                                                                                                                                                                                                                                                                                                          
4. Crosswalk to 1/6th of code 0008U
5. Crosswalk to 87556"	Crosswalk to 87481	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
81	33	87XX1	87626	New	Microbiology Infectious Disease & Genome Sequencing Procedure  	"Infectious agent detection by nucleic acid (DNA or RNA); Human Papillomavirus (HPV), separately reported high-risk types (e.g., 16, 18, 31,45, 51, 52) and high-risk pooled result(s)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                           
3. Crosswalk to 87624 + (87625 x 2): 4
4. Crosswalk to 87624 +87625: 4"	Crosswalk to 87624	"CMS agrees with part of the crosswalk recommendation, but does not agree with the sums of separate tests.  All of the risk types are listed in new test descriptor.  It is unclear whether there would be redundancies between 87624 and 87625.  "
67	34	XX48U	0468U	"New
(PLA)"	MAAA	"Hepatology (nonalcoholic steatohepatitis [NASH]), miR-34a5p, alpha 2-macroglobulin, YKL40, HbA1c, serum and whole blood, algorithm reported as a single score for NASH activity and fibrosis"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                    3. Crosswalk to 0003M x 0.5: 9"	Crosswalk to 0003M x .5	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
29	35	0436U	0436U	"New
(PLA)"	Molecular Pathology	"Oncology (lung), plasma analysis of 388 proteins, using aptamer based proteomics technology, predictive algorithm reported as clinical benefit from immune checkpoint inhibitor therapy "	"1. Abstain
2. Gapfill: 7                                                                                                                                                                                                                                                                                                                                                                       3. Crosswalk to 0249U: 1"	Gapfill	"CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  In particular, CMS believes the use of aptamer based proteomics is not used by existing tests on the CLFS.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."
39	36	0446U	0446U	"New
(PLA)"	MAAA	"Autoimmune diseases (systemic lupus erythematosus [sle]), analysis of 10 cytokine soluble mediator biomarkers by immunoassay, plasma, individual components reported with an algorithmic risk score for current disease activity"	"1. Abstain: 1
2. Gapfill     
3. Crosswalk to 81490: 8"	Crosswalk to 81490	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
40	37	0447U	0447U	"New
(PLA)"	MAAA	"Autoimmune diseases (systemic lupus erythematosus [sle]), analysis of 11 cytokine soluble mediator biomarkers by immunoassay, plasma, individual components reported with an algorithmic prognostic risk score for developing a clinical flare"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                          3. Crosswalk to 81490: 8"	Crosswalk to 81490	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
125	38	X103U	0518U	New	Therapeutic Drug Assay	"Therapeutic drug monitoring, 90 or more pain and mental health drugs or substances, LC-MS/MS, plasma, qualitative and quantitative therapeutic minimally effective range of prescribed and non-prescribed medications"	"1. Abstain
2. Gapfill: 3                                                                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to G0483: 6                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  4. Crosswalk to 0063U"	Crosswalk to G0483	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
22	39	0429U	0429U	"New
(PLA)"	Microbiology Infectious Disease	"Human papillomavirus (HPV), oropharyngeal swab, 14 high-risk types (i.e., 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                  3. Crosswalk to 87624+87625: 9                                                                                                                                                                                                                                                                                                                                            4. Crosswalk to 87636"	Crosswalk to 87624	"CMS agrees with part of the crosswalk recommendation, but does not agree with the sums of separate tests.  All of the risk types are listed in new test descriptor.  It is unclear whether there would be redundancies between 87624 and 87625.  "
58	40	XX39U	0458U	"New
(PLA)"	Chemistry	"Oncology (breast cancer), S100A8 and S100A9, by enzyme linked immunosorbent assay (ELISA), tear fluid with age, algorithm reported as a risk score "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 81500: 9"	Crosswalk to 81500	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
124	41	X101U	0517U	New	Therapeutic Drug Assay	"Therapeutic drug monitoring, 80 or more psychoactive drugs or substances, LC-MS/MS, plasma, qualitative and quantitative therapeutic minimally and maximally effective dose of prescribed and non-prescribed medications"	"1. Abstain
2. Gapfill: 3                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        3. Crosswalk to G0483: 6                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  4. Crosswalk to 0063U"	Crosswalk to G0483	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
89	42	XX63U	0482U	New	Chemistry	"Obstetrics (preeclampsia), biochemical assay of soluble fms-like tyrosine kinase 1 (sFlT-1) and placental growth factor (PIGF), serum, ratio reported for sFlT-1/PIGF, with risk of progression for preeclampsia with severe features within 2 weeks"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                3. Crosswalk to 0243U x 2: 8"	Crosswalk to 81512	"CMS disagrees with the panel recommendation, and instead is suggesting a crosswalk to 81512.  This is a very similar crosswalk to 0243U, but includes assays of multiple analytes, as does XX63U"
10	43	87593	87593	New* Missed from 2022	Microbiology Infectious Disease	"Infectious agent detection by nucleic acid (DNA or RNA); Orthopoxvirus (e.g., monkeypox virus, cowpox virus, vaccinia virus), amplified probe technique, each"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                  3. Crosswalk to 87635: 9"	Crosswalk to 87635	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
35	44	0442U	0442U	"New
(PLA)"	Microbiology Infectious Disease	"Infectious disease (respiratory infection), myxovirus resistance protein a (mxa) and c-reactive protein (crp), fingerstick whole blood specimen, each biomarker reported as present or absent"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 87811: 9"	Crosswalk to 87811	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
57	45	XX38U	0457U	"New
(PLA)"	Chemistry	"Perfluoroalkyl substances (PFAS) (e.g., perfluorooctanoic acid, perfluorooctane sulfonic acid), 9 PFAS compounds by LC-MS/MS, plasma or serum, quantitative "	"1. Abstain
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 0394U: 8"	Crosswalk to 0394U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
126	46	X104U	0519U	New	Therapeutic Drug Assay	"Therapeutic drug monitoring, medications specific to pain, depression, and anxiety, LC-MS/MS, plasma, 110 or more drugs or substances, qualitative and quantitative therapeutic minimally effective range of prescribed, non-prescribed, and illicit medications in circulation"	"1. Abstain
2. Gapfill: 3                                                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to G0483: 6                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  4. Crosswalk to 0063U"	Crosswalk to G0483	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
50	47	XX31U	0450U	"New
(PLA)"	Chemistry	"Oncology (multiple myeloma), liquid chromatography with tandem mass spectrometry (LCMS/MS), monoclonal paraprotein sequencing analysis, serum, results reported as baseline presence or absence of detectable clonotypic peptides"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                  3. Crosswalk to 0077U: 9"	Crosswalk to 0077U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
55	48	XX36U	0455U	"New
(PLA)"	Microbiology Infectious Disease	"Infectious agents (sexually transmitted infection), Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, multiplex amplified probe technique, vaginal, endocervical, gynecological specimens, oropharyngeal swabs, rectal swabs, female or male urine, each pathogen reported as detected or not detected "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 0402U: 9"	Crosswalk to 0402U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
90	49	XX66U	0483U	New	MAAA; Microbiology	"Carbonic anhydrase VI (CA VI), parotid specific/secretory protein (PSP) and salivary protein (SP1) IgG, IgM, and IgA antibodies, enzyme-linked immunosorbent assay (ELISA), semiqualitative, blood, reported as predictive evidence of early Sjgren syndrome"	"1. Abstain
2. Gapfill: 9 
3. Crosswalk to 87563
4. Crosswalk to 87641"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
62	50	XX43U	0463U	"New
(PLA)"	Microbiology Infectious Disease & Genome Sequencing Procedures; RT-PCR	"Oncology (cervix), mRNA gene expression profiling of 14 biomarkers (E6 and E7 of the highest-risk human papillomavirus [HPV] types 16, 18, 31, 33, 45, 52, 58), by real-time nucleic acid sequence-based amplification (NASBA), exo- or endocervical epithelial cells, algorithm reported as positive or negative for increased risk of cervical dysplasia or cancer for each biomarker "	"1. Abstain
2. Gapfill: 7                                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 0403U: 2"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
75	51	8X050	87513	New	Microbiology	"Infectious agent detection by nucleic acid (DNA or RNA); Helicobacter pylori (H. pylori), clarithromycin resistance, amplified probe technique"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        3. Crosswalk to 87150: 7       
4. Crosswalk to 87541 plus 87641 
5. Crosswalk to 87640 plus CPT 87641: 1     
6. Crosswalk to 1/6 of 0008U"	Crosswalk to 87150	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
71	52	XX52U	0472U	"New
(PLA)"	MAAA	"Carbonic anhydrase VI (CA VI), parotid specific/secretory protein (PSP) and salivary protein (SP1) IgG, IgM, and IgA antibodies, enzyme-linked immunosorbent assay (ELISA), semiqualitative, blood, reported as predictive evidence of early Sjgren syndrome"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
86	53	XX62U	0479U	New	Immunology	"Tau, phosphorylated, pTau217"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                         3. Crosswalk to 0358U 
4. Crosswalk to 0358U x 0.5: 7"	Crosswalk to 83520	"CMS disagrees with the suggested crosswalk and instead is suggesting a crosswalk to CPT 83520.  This is a similar existing test that uses this code for billing purposes. The descriptor for the new test does not cite any of the analyses in the Panel suggested proposed Crosswalk, nor a risk score. "
91	54	XX72U	0484U	New	MAAA: Microbiology	"Infectious disease (Mycoplasma genitalium), macrolide sensitivity (23S rRNA point mutation), oral, rectal, or vaginal swab, algorithm reported as probability of macrolide resistance"	"1. Abstain
2. Gapfill: 7                                                                                                                                                                                                                                                                                                                                                                                          
3. Crosswalk to 87563
4. Crosswalk to 87641: 2"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
34	55	0441U	0441U	"New
(PLA)"	Microbiology Infectious Disease	"Infectious disease (bacterial, fungal, or viral infection), semiquantitative biomechanical assessment (via deformability cytometry), whole blood, with algorithmic analysis and result reported as an index"	"1. Abstain
2. Gapfill: 8                                                                                                                                                                                                                                                                                                                                                                                                                       3. 0305U x 0.5: 1                                                                                                                                                                                 "	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
59	56	XX40U	0459U	"New
(PLA)"	Immunology	"?-amyloid (Abeta42) and total tau (tTau), electrochemiluminescent immunoassay (ECLIA), cerebral spinal fluid, ratio reported as positive or negative for amyloid pathology "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 0358U: 9"	Crosswalk to 0358U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
13	57	0420U	0420U	"New
(PLA)"	Genomic Sequencing Procedures; RT-PCR	"Oncology (urothelial), mRNA expression profiling by real-time quantitative PCR of MDK, HOXA13, CDC2, IGFBP5, and CXCR2 in combination with droplet digital PCR  ddPCR) analysis of 6 single-nucleotide polymorphisms (SNPs) genes TERT and FGFR3, urine, algorithm reported as a risk score for urothelial carcinoma "	"1. Abstain
2. Gapfill: 6       
3. Crosswalk to 0012M: 2          
4. Crosswalk to 0012M+ 0356U"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
119	58	XX95U	0512U	New	TBD	"Oncology (prostate), augmentative algorithmic analysis of digitized whole-slide imaging of histologic features for microsatellite instability (MSI) status, formalin-fixed paraffin-embedded (FFPE) tissue, reported as increased or decreased probability of MSI-High (MSI-H)"	"1. Abstain
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                                                                                                   3. Crosswalk to 0220U: 8"	Crosswalk to 0220U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
120	59	XX96U	0513U	New	TBD	"Oncology (prostate), augmentative algorithmic analysis of digitized whole-slide imaging of histologic features for microsatellite instability (MSI) and homologous recombination deficiency (HRD) status, formalin-fixed paraffin-embedded (FFPE) tissue, reported as increased or decreased probability of each biomarker
"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                3. Crosswalk to 0220U: 9"	Crosswalk to 0220U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
32	60	0439U	0439U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Cardiology (coronary heart disease [chd]), dna, analysis of 5 single-nucleotide polymorphisms (snps) (rs11716050 [loc105376934], rs6560711 [wdr37], rs3735222 [scin/loc107986769], rs6820447 [intergenic], and rs9638144 [esyt2]) and 3 dna methylation markers (cg00300879 [transcription start site {tss200} of cnksr1], cg09552548 [intergenic], and cg14789911 [body of spatc1l]), qpcr and digital pcr, whole blood, algorithm reported as a 4-tiered risk score for a 3-year risk of symptomatic chd"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                 3. Crosswalk to 81493: 9"	Gapfill	"CMS disagrees with the panel recommendation to crosswalk this code.  In past decisions The descriptor for 0439U cites several test methods not referenced in 81493.  Therefore, by gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."
33	61	0440U	0440U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Cardiology (coronary heart disease [chd]), dna, analysis of 10 single-nucleotide polymorphisms (snps) (rs710987 [linc010019], rs1333048 [cdkn2b-as1], rs12129789 [kcnd3], rs942317 [ktn1-as1], rs1441433 [ppp3ca], rs2869675 [prex1], rs4639796 [zbtb41], rs4376434 [linc00972], rs12714414 [tmem18], and rs7585056 [tmem18]) and 6 dna methylation markers (cg03725309 [sars1], cg12586707 [cxcl1, cg04988978 [mpo], cg17901584 [dhcr24-dt], cg21161138 [ahrr], and cg12655112 [ehd4]), qpcr and digital pcr, whole blood, algorithm reported as detected or not detected for chd"	"1. Abstain
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                                3. Crosswalk to 81493: 8"	Gapfill	"CMS agrees with the minority panel recommendation to gapfill this code.  The descriptor for 0439U cites several test methods not referenced in 81493.  Therefore, by gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."
65	62	XX46U	0466U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Cardiology (coronary artery disease [CAD]), DNA, genome wide association studies (564856 single-nucleotide polymorphisms [SNPs], targeted variant genotyping), patient lifestyle and clinical data, buccal swab, algorithm reported as polygenic risk to acquired heart disease "	"1. Abstain
2. Gapfill: 9                                                                                                                                                                                                                                                                                                                                                                                   3. Crosswalk to 0078U"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
97	63	XX73U	0490U	New	Genomic Sequencing Procedures	"Oncology (cutaneous or uveal melanoma), circulating tumor cell selection, morphological characterization and enumeration based on differential CD146, high molecularweight melanoma-associated antigen, CD34 and CD45 protein biomarkers, peripheral blood"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                     3. Crosswalk to 0337U: 9"	Crosswalk to 0337U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
98	64	XX75U	0491U	New	Genomic Sequencing Procedures	"Oncology (solid tumor), circulating tumor cell selection, morphological characterization and enumeration based on differential epithelial cell adhesion molecule (EpCAM), cytokeratins 8, 18, and 19, CD45 protein biomarkers, and quantification of estrogen receptor (ER) protein biomarkerexpressing cells, peripheral blood"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 0338U: 9"	Crosswalk to 0338U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
99	65	XX74U	0492U	New	Genomic Sequencing Procedures	"Oncology (solid tumor), circulating tumor cell selection, morphological characterization and enumeration based on differential epithelial cell adhesion molecule (EpCAM), cytokeratins 8, 18, and 19, CD45 protein biomarkers, and quantification of PD-L1 protein biomarkerexpressing cells, peripheral blood"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                         3. Crosswalk to 0338U: 9"	Crosswalk to 0338U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
11	66	0355U	0355U	Reconsidered (PLA)	Genomic Sequencing Procedures; targeted variant analysis	"APOL1 (apolipoprotein L1) (e.g., chronic kidney disease), risk variants (G1, G2)"	"1. Abstain
2. Gapfill: 9"	Crosswalk to 81401	CMS does not agree with the panel recommendation to gapfill this test code.  CMS still maintains a crosswalk to 81401 is a comparable code to 0355U.
107	67	XX83U	0500U	New	Genomic Sequencing Procedures	"Autoinflammatory disease (VEXAS syndrome), DNA, UBA1 gene mutations, targeted variant analysis (M41T, M41V, M41L, c.118-2A>C, c.118-1G>C, c.118-9_118-2del, S56F, S621C)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                     3. Crosswalk to 81233: 9"	Crosswalk to 81233	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
30	68	0437U	0437U	"New
(PLA)"	Molecular Pathology	"Psychiatry (anxiety disorders), mRNA, gene expression profiling by RNA sequencing of 15 biomarkers, whole blood, algorithm reported as predictive risk score "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                   3. Crosswalk to 0293U: 9"	Crosswalk to 0293U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
56	69	XX37U	0456U	"New
(PLA)"	MAAA	"Autoimmune (rheumatoid arthritis), next-generation sequencing (NGS), gene expression testing of 19 genes, whole blood, with analysis of anticyclic citrullinated peptides (CCP) levels, combined with sex, patient global assessment, and body mass index (BMI), algorithm reported as a score that predicts nonresponse to tumor necrosis factor inhibitor (TNFi) therapy"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 0203U: 9"	Crosswalk to 0203U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
21	70	0428U	0428U	"New
(PLA)"	Genomic Sequencing Procedures; cell free DNA	"Oncology (breast), targeted hybrid-capture genomic sequence analysis panel, circulating tumor DNA (ctDNA) analysis of 56 or more genes, interrogation for sequence variants, gene copy number amplifications, gene rearrangements, microsatellite instability, and tumor mutation burden "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                  3. Crosswalk to 81464: 9"	Gapfill	"CMS is recommending to gapfill this code as the proposed crosswalk, 81464, is currently being gapfilled and cannot be used as a crosswalk.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC)."
53	71	XX34U	0453U	"New
(PLA)"	Genomic Sequencing Procedures; cell free DNA & Genomic Sequencing Procedures; methylation analysis	"Oncology (colorectal cancer), cell free DNA (cfDNA), methylation based quantitative PCR assay (SEPTIN9, IKZF1, BCAT1, Septin9-2, VAV3, BCAN), plasma, reported as presence or absence
of circulating tumor DNA (ctDNA)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                            3. Crosswalk to 81327: 9"	Crosswalk to 81327	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
103	72	XX87U	0496U	New	Genomic Sequencing Procedures	"Oncology (colorectal), cell-free DNA, 8 genes for mutations, 7 genes for methylation by real-time RT-PCR, and 4 proteins by enzyme-linked immunosorbent assay, blood, reported positive or negative for colorectal cancer or advanced adenoma risk"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
108	73	XX80U	00501U	New	Genomic Sequencing Procedures	"Oncology (colorectal), blood, quantitative measurement of cell-free DNA (cfDNA)"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
95	74	XX70U	0488U	New	Genomic Sequencing Procedures	"Obstetrics (fetal antigen noninvasive prenatal test), cell-free DNA sequence analysis for the detection of the fetal presence or absence of 1 or more of the Rh, C, c, D, E, Duffy (Fya), or Kell (K) antigen in alloimmunized pregnancies, reported as selected antigen(s) detected or not detected"	"1. Abstain: 2
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                           3. Crosswalk to 81422: 7"	Crosswalk to 81422	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
96	75	XX76U	0489U	New	Genomic Sequencing Procedures	"Obstetrics (single-gene noninvasive prenatal test), cell-free DNA sequence analysis of 1 or more targets (e.g., CFTR, SMN1, HBB, HBA1, HBA2) to identify paternally inherited pathogenic variants, and relative mutation-dosage analysis based on molecular counts to determine the fetal inheritance of the maternal mutation, algorithm reported as a fetal risk score for the condition (e.g., cystic fibrosis, spinal muscular atrophy, beta hemoglobinopathies [including sickle cell disease], alpha thalassemia)"	"1. Abstain: 2
2. Gapfill: 7                                                                                                                                                                                                                                       "	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
101	76	XX82U	0494U	New	Genomic Sequencing Procedures	"Red blood cell antigen (fetal RhD gene analysis), next-generation sequencing of circulating cell-free DNA (cfDNA) of blood in pregnant individuals known to be RhD negative, reported as positive or negative"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 81422: 8"	Crosswalk to 81422	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
69	77	XX50U	0470U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Oncology (oropharyngeal), detection of minimal residual disease by next-generation sequencing (NGS) based quantitative evaluation of 8 DNA targets, cell-free HPV 16 and 18 DNA from plasma "	"1. Abstain
2. Gapfill: 7                                                                                                                                                                                                                                                                                                                                                                                                                                          3. Crosswalk to 0356U +87625: 2"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
4	78	81462	81462	Reconsidered	Genomic Sequencing Procedures; cell free DNA	"Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (e.g., plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants and rearrangements"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 81445 x 2: 9 "	Gapfill	CMS does not agree with the panel's recommendation to crosswalk this reconsidered code.  CMS did not receive any public input on this code and has decided to maintain the gapfill decision made last year. 
5	79	81464	81464	Reconsidered	Genomic Sequencing Procedures; cell free DNA	"Solid organ neoplasm, genomic sequence analysis panel, cell-free nucleic acid (e.g., plasma), interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
15	80	0422U	0422U	"New
(PLA)"	Genomic Sequencing Procedures; cell free DNA	"Oncology (pan-solid tumor), analysis of DNA biomarker response to anti-cancer therapy using cell-free circulating DNA, biomarker comparison to a previous  baseline pre-treatment cell-free circulating DNA analysis using next-generation sequencing, algorithm reported as a quantitative change from baseline, including  specific alterations, if appropriate "	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
60	81	XX41U	0460U	"New
(PLA)"	Genomic Sequencing Procedures; targeted variant analysis	"Oncology, whole blood or buccal, DNA single-nucleotide polymorphism (SNP) genotyping by real-time PCR of 24 genes, with variant analysis and reported phenotypes "	"1. Abstain
2. Gapfill: 3                                                                                                                                                                                                                                                                                                                                                                                       3. Crosswalk to 0055U: 6"	Gapfill	"CMS agrees with the minority of the panel to gapfill this code.  We do not agree with the proposed crosswalk to 0055U, this is specifically for cfDNA.  However, other RT-PCR codes on the CLFS involve algorithms, which 0460U does not cite.  Therefore we recommend to gapfill this test.  "
92	82	XX69U	0485U	New	Genomic Sequencing Procedures	"Oncology (solid tumor), cell-free DNA and RNA by next-generation sequencing, interpretative report for germline mutations, clonal hematopoiesis of indeterminate potential, and tumor-derived single-nucleotide variants, small insertions/deletions, copy number alterations, fusions, microsatellite instability, and tumor mutational burden"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                            3. Crosswalk to 0211U: 9"	Gapfill	CMS does not agree with the panel's recommendation; the proposed crosswalk does not analyze cell-free DNA.   By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
93	83	XX77U	0486U	New	Genomic Sequencing Procedures	"Oncology (pan-solid tumor), next-generation sequencing analysis of tumor methylation markers present in cell-free circulating tumor DNA, algorithm reported as quantitative measurement of methylation as a correlate of tumor fraction"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                          3. Crosswalk to 0405U x 2.0: 8"	Gapfill	CMS does not agree with the panel's recommendation; the proposed crosswalk does not analyze cell-free DNA.   By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
44	84	8156X	81558	New	Genomic Sequencing Procedures; RT-PCR	"Transplantation medicine (allograft rejection, kidney), mRNA, gene expression profiling by quantitative polymerase chain reaction (qPCR) of 139 genes, utilizing whole blood, algorithm reported as a binary categorization as transplant excellence, which indicates immune quiescence, or not transplant excellence, indicating subclinical rejection"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 81595: 9"	Crosswalk to 81595 	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
100	85	XX78U	0493U	New	Genomic Sequencing Procedures	"Transplantation medicine, quantification of donor-derived cell-free DNA using next-generation sequencing, plasma, reported as percentage of donor-derived cell-free DNA (cfDNA)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 0331U: 8      
4. Crosswalk to 0118U: 1"	Crosswalk to 0118U	"CMS agrees with the minority of the CDLT panel, and with the public to crosswalk XX78U to 0118U.  "
115	86	XX93U	0508U	New	Molecular Pathology	"Transplantation medicine, quantification of donor-derived cell-free DNA using 40 single-nucleotide polymorphism (SNPs), plasma, and urine, initial evaluation reported as percentage of donor-derived cell-free DNA with risk for active rejection"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
116	87	XX94U	0509U	New	Molecular Pathology	"Transplantation medicine, quantification of donor-derived cell-free DNA using up to 12 single-nucleotide polymorphism (SNPs) previously identified, plasma, reported as percentage of donor-derived cell-free DNA with risk for active rejection"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
18	88	0425U	0425U	"New
(PLA)"	Genomic Sequencing Procedures	"Genome (e.g., unexplained constitutional or heritable disorder or syndrome), rapid sequence analysis, each comparator genome (e.g., parents, siblings) "	"1. Abstain
2. Gapfill: 7  
3. Crosswalk to 81426 x 1.51: 2
"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
19	89	0426U	0426U	"New
(PLA)"	Genomic Sequencing Procedures	"Genome (e.g., unexplained constitutional or heritable disorder or syndrome), ultra-rapid sequence analysis "	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
42	90	0449U	0449U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Carrier screening for severe inherited conditions (e.g., cystic fibrosis, spinal muscular atrophy, beta hemoglobinopathies [including sickle cell disease], alpha thalassemia), regardless of race or self-identified ancestry, genomic sequence analysis panel, must include analysis of 5 genes (cftr, smn1, hbb, hba1, hba2)"	"1. Abstain: 1
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                              
3. Crosswalk to: 81222+81329+81269+81363+81223+81259+81364: 4                                                                                                                                                                                                                                                                  
4. Crosswalk to: 81412: 2
5. Crosswalk to: 81162                                                                                                                                                                                                       "	Gapfill 	"CMS agrees with the minority panel recommendation to gapfill this code.    CMS does not agree with the proposed crosswalk to add individual tests when 0449U is a panel assay.  By gapfilling this code the resources, and efficiencies of combining several tests into one panel, can be better estimated by a Medicare Administrative Contractor (MAC)."
68	91	XX49U	0469U	"New
(PLA)"	Genomic Sequencing Procedures	"Rare diseases (constitutional/heritable disorders), whole genome sequence analysis for chromosomal abnormalities, copy number variants, duplications/deletions, inversions, unbalanced translocations, regions of homozygosity (ROH), inheritance pattern that indicate uniparental disomy (UPD), and aneuploidy, fetal sample (amniotic fluid, chorionic villus sample, or products of conception), identification and categorization of genetic variants, diagnostic report of fetal results based on phenotype with maternal sample and paternal sample, if performed, as comparators and/or maternal cell contamination"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                        3. Crosswalk to 81349+81265+88235: 9  "	Crosswalk to 81349	"CMS agrees with part of the crosswalk, though disagrees with the sum of three separate tests.  The additional crosswalks suggested by the lab are not  included in the descriptor of the new test code (0469U), and it is unclear to CMS why the additional 2 tests should be included in the crosswalk.  Also the descriptor states comparator genome is not always performed. "
132	92	0417U	0417U	Reconsidered	Genomic Sequencing Procedures; mitochondrial	"Rare diseases (constitutional/heritable disorders), whole mitochondrial genome sequence with heteroplasmy detection and deletion analysis, nuclear-encoded mitochondrial gene analysis of 335 nuclear genes, including sequence changes, deletions, insertions, and copy number variants analysis, blood or saliva, identification and categorization of mitochondrial disorder-associated genetic variants"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                         
3. Crosswalk to 81460+81465+81440: 9"	Gapfill	CMS disagrees with the panel recommendation and is maintaining the recommendation to gapfill this test.  CMS believes there is too much redundancy across the suggested Crosswalk to codes to simply be able to add them up.  Gapfilling the code allows the MACs to look at the resources for this specific test. 
43	93	0X00M	0020M	New	Genomic Sequencing Procedures; methylation analysis	"Oncology (central nervous system), analysis of 30000 DNA methylation loci by methylation array, utilizing DNA extracted from tumor tissue, diagnostic algorithm reported as probability of matching a reference tumor subclass"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                 3. Crosswalk to 0016M: 9"	Gapfill	CMS disagrees with the panel recommendation to crosswalk this code.  In past decisions CMS has crosswalked tests involving DNA methylation differently from  mRNA analysis.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
88	94	XX67U	0481U	New	Genomic Sequencing Procedures	"Isocitrate dehydrogenase 1 (IDH1), isocitrate dehydrogenase 2 (IDH2), and telomerase reverse transcriptase (TERT) promoter (e.g., central nervous system [CNS] tumors), next-generation sequencing (single-nucleotide variants [SNV], deletions, and insertions)"	"1. Abstain: 1
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                           3. Crosswalk to 81120+81121+81345: 8                                                                                                                                                                                                                                                                                                                                            4. Crosswalk to 81120"	Crosswalk to 81120+81121+81345	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
14	95	0421U	0421U	"New
(PLA)"	Genomic Sequencing Procedures; RT-PCR	"Oncology (colorectal) screening, quantitative real-time target and signal amplification of 8 RNA markers (GAPDH, SMAD4, ACY1, AREG, CDH1, KRAS, TNFRSF10B,  GLN2) and fecal hemoglobin, algorithm reported as a positive or negative for colorectal cancer risk "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                       3. Crosswalk to 81528: 9"	Crosswalk to 81528	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
63	96	XX44U	0464U	"New
(PLA)"	Genomic Sequencing Procedures; methylation analysis	"Oncology (colorectal) screening, quantitative real-time target and signal amplification, methylated DNA markers, including LASS4, LRRC4 and PPP2R5C, a reference marker ZDHHC1, and a protein marker (fecal hemoglobin), utilizing stool, algorithm reported as a positive or negative result "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         3. Crosswalk to 81528: 5                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          4. Crosswalk to 81528 x 1.25: 4"	Crosswalk to 81528	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
70	97	XX51U	0471U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Oncology (colorectal cancer), qualitative real-time PCR of 35 variants of KRAS and NRAS genes (exons 2, 3, 4), formalin fixed paraffin-embedded (FFPE), predictive, identification of detected mutations "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                         3. Crosswalk to 81275+81276+81311: 9"	Crosswalk to 0005U	CMS disagrees with the panel recommendation and instead is suggesting a crosswalk to 0005U.  CMS believes that 0005U is more comparable to 0471U than adding three individual tests as a comparison.  0005U better accounts for efficiencies in combining several analyses into one test.
105	98	XX68U	0498U	New	Genomic Sequencing Procedures	"Oncology (colorectal), next-generation sequencing for mutation detection in 43 genes and methylation pattern in 45 genes, blood, and formalin-fixed paraffin-embedded (FFPE) tissue, report of variants and methylation pattern with interpretation"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
106	99	XX86U	0499U	New	Genomic Sequencing Procedures	"Oncology (colorectal and lung), DNA from formalin-fixed paraffin-embedded (FFPE) tissue, next-generation sequencing of 8 genes (NRAS, EGFR, CTNNB1, PIK3CA, APC, BRAF, KRAS, and TP53), mutation detection"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                   3. Crosswalk to 81445: 9"	Crosswalk to 81445	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
113	100	XX90U	0506U	New	Genomic Sequencing Procedures	"Gastroenterology (Barretts esophagus), esophageal cells, DNA methylation analysis by next-generation sequencing of at least 89 differentially methylated genomic regions, algorithm reported as likelihood for Barretts esophagus"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                           3. Crosswalk to 0114U: 9"	Crosswalk to 0114U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
73	101	XX54U	0475U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Hereditary prostate cancer related disorders, genomic sequence analysis panel using next-generation sequencing (NGS), Sanger sequencing, multiplex ligation-dependent probe amplification (MLPA), and array comparative genomic hybridization (CGH), evaluation of 23 genes and duplications/deletions when indicated, pathologic mutations reported with a genetic risk score for prostate cancer "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                              
3. Crosswalk to 81435+ (81436 x 0.25): 8                                                                                                                                                                                                                                                                                                                                                                                        
4. Crosswalk to 0101U                                                                                                                                                                                                                                                                                                                                                                         
5. Crosswalk to 0103U: 1"	Crosswalk to 0129U	"CMS disagrees with the Panel recommendation and instead is suggesting a crosswalk to 0129U.  CMS believes this is a more comparable crosswalk to 0475U in terms of methods and resources. This test is similar to other new tests on this list that we also recommended 0129U as a crosswalk.  For consistency, we believe 0129U is the best crosswalk based on methodology and resources. "
74	102	XX55U	0474U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Hereditary pan-cancer (e.g., hereditary sarcomas, hereditary endocrine tumors, hereditary neuroendocrine tumors, hereditary cutaneous melanoma), genomic sequence analysis panel of 88 genes with 20 duplications/deletions using next generation sequencing (NGS), Sanger sequencing, blood or saliva, reported as positive or negative for germline variants, each gene "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                              
3. Crosswalk to 81435+ (81436 x 0.25): 7                                                                                                                                                                                                                                                                                                                                                                                        
4. Crosswalk to 0101U                                                                                                                                                                                                                                                                                                                                                                         
5. Crosswalk to 0103U: 2"	Crosswalk to 0129U	"CMS disagrees with the Panel recommendation and instead is suggesting a crosswalk to 0129U.  CMS believes this is a more comparable crosswalk to 0474U in terms of methods and resources. This test is similar to other new tests on this list that we also recommended 0129U as a crosswalk.  For consistency, we believe 0129U is the best crosswalk based on methodology and resources. "
128	103	81432	81432	REVISE	TBD	"Hereditary breast cancer-related disorders (e.g., hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer, hereditary pancreatic cancer, hereditary prostate cancer);, genomic sequence analysis panel, 5 or more genes, interrogation for sequence variants and copy number variants must include sequencing of at least 10 genes, always including BRCA1, BRCA2, CDH1, MLH1, MSH2, MSH6, PALB2, PTEN, STK11, andTP53"	"1. Abstain
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                                                       
3. 81432+ (81433 x 0.25): 6                                                                                                                                                                                                                                                                                                                                                                                                               
4. 81432 + 81433: 2"	Crosswalk to 0129U	CMS disagrees with the Panel recommendation and instead is suggesting a crosswalk to 0129U.  CMS does not agree with adding two existing tests together to approximate the resources of a new panel test; this does not take into account any efficiencies of the new panel test.  
129	104	81435	81435	REVISE	TBD	"Hereditary colon cancer-related disorders (e.g., Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familial adenomatosis polyposis);, genomic sequence analysis panel, 5 or more genes, interrogation for sequence variants and copy number variants must include sequencing of at least 10 genes, including APC, BMPR1A, CDH1, MLH1, MSH2, MSH6, MUTYH, PTEN, SMAD4, and STK11"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                      
3. Crosswalk to 81435+(81436 x 0.25): 7                                                                                                                                                                                                                                                                                                                                     
4. Crosswalk to 81435 + 81436: 2"	Crosswalk to 0129U	CMS disagrees with the Panel recommendation and instead is suggesting a crosswalk to 0129U.  CMS does not agree with adding two existing tests together to approximate the resources of a new panel test; this does not take into account any efficiencies of the new panel test.  
130	105	81437	81437	REVISE	TBD	"Hereditary neuroendocrine tumor-related disorders (e.g., medullary thyroid carcinoma, parathyroid carcinoma, malignant pheochromocytoma or paraganglioma);, genomic sequence analysis panel, 5 or more genes, interrogation for sequence variants and copy number variants must include sequencing of at least 6 genes, including MAX, SDHB, SDHC, SDHD, TMEM127, and VHL"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                   3. Crosswalk to 81437+(81438 x 0.25): 7                                                                                                                                                                                                                                                                                                                               4. Crosswalk to 81437+81438: 2"	Crosswalk to 0129U	CMS disagrees with the Panel recommendation and instead is suggesting a crosswalk to 0129U.  CMS does not agree with adding two existing tests together to approximate the resources of a new panel test; this does not take into account any efficiencies of the new panel test.  
41	106	0448U	0448U	"New
(PLA)"	Genomic Sequencing Procedures; targeted variant analysis	"Oncology (lung and colon cancer), dna, qualitative, next generation sequencing detection of single-nucleotide variants and deletions in egfr and kras genes, formalin-fixed paraffin embedded (ffpe) solid tumor samples, reported as presence or absence of targeted mutation(s), with recommended therapeutic options"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        3. Crosswalk to 0111U: 1                                                                                                                                                                                                                                                                                                                                                                   4. Crosswalk to 81235 + 81275: 8                                                                                                                                                                                                                                        "	Crosswalk to 81235+81275	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
85	107	XX61U	0478U	New	Molecular Pathology	"Oncology (non-small cell lung cancer), DNA and RNA, digital PCR analysis of 9 genes (EGFR, KRAS, BRAF, ALK, ROS1, RET, NTRK 1/2/3, ERBB2, and MET) in formalin-fixed paraffin-embedded (FFPE) tissue, interrogation for single nucleotide variants, insertions/deletions, gene rearrangements, and reported as actionable detected variants for therapy selection"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
114	108	XX91U	0507U	New	Genomic Sequencing Procedures	"Oncology (ovarian), DNA, whole-genome sequencing with 5-hydroxymethylcytosine (5hmC) enrichment, using whole blood or plasma, algorithm reported as cancer detected or not detected"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                
3. Crosswalk to 0410U: 8"	Crosswalk to 0410U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
117	109	XX92U	0510U	New	TBD	"Oncology (pancreatic cancer), augmentative algorithmic analysis of 16 genes from previously sequenced RNA whole-transcriptome data, reported as probability of predicted molecular subtype"	"1. Abstain
2. Gapfill: 9"	Gapfill	CMS agrees with the CDLT Panel majority recommendation to Gapfill because there are no existing codes on the CLFS with similar methods or resources.  By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
1	110	81457	81457	Reconsidered	Genomic Sequencing Procedures	"Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, microsatellite instability"	"1. Abstain
2. Gapfill
3. Crosswalk to 81445 x 1.5: 9"	Gapfill	CMS does not agree with the panel's recommendation to crosswalk this reconsidered code.  CMS did not receive any public input on this code and has decided to maintain the gapfill decision made last year. 
2	111	81458	81458	Reconsidered	Genomic Sequencing Procedures	"Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis, copy number variants and microsatellite instability"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 81445 x 2: 9      "	Gapfill	CMS does not agree with the panel's recommendation to crosswalk this reconsidered code.  CMS did not receive any public input on this code and has decided to maintain the gapfill decision made last year. 
3	112	81459	81459	Reconsidered	Genomic Sequencing Procedures	"Solid organ neoplasm, genomic sequence analysis panel, interrogation for sequence variants; DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements"	"1. Abstain
2. Gapfill: 3                                                                                                                                                                                                                                                                                                                                                                 3. Crosswalk to 81445
4. Crosswalk to 81445 x 2.5: 5                                                                                                                                                                                                                                            "	Gapfill	CMS agrees with the minority Panel recommendation.  CMS did not receive any public input on this code and has decided to maintain the gapfill decision made last year. 
37	113	0444U	0444U	"New
(PLA)"	Genomic Sequencing Procedures; targeted variant analysis	"Oncology (solid organ neoplasia), targeted genomic sequence analysis panel of 361 genes, interrogation for gene fusions, translocations, or other rearrangements, using dna from formalin-fixed paraffin-embedded (ffpe) tumor tissue, report of clinically significant variant(s)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 81455: 9"	Crosswalk to 81455 	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
72	114	XX53U	0473U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Oncology (solid tumor), next generation sequencing (NGS) of DNA from formalin-fixed paraffin embedded (FFPE) tissue with comparative sequence analysis from a matched normal specimen (blood or saliva), 648 genes, interrogation for sequence variants, insertion and deletion alterations, copy number variants, rearrangements, microsatellite instability, and tumor-mutation burden "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                    3. 0037U"	NA	Test is an ADLT
94	115	XX71U	0487U	New	Genomic Sequencing Procedures	"Oncology (solid tumor), cell-free circulating DNA, targeted genomic sequence analysis panel of 84 genes, interrogation for sequence variants, aneuploidy-corrected gene copy number amplifications and losses, gene rearrangements, and microsatellite instability"	"1. Abstain: 2
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 0326U: 6                                                                                                                                                                                                                                                                                                                                                                        "	Gapfill	CMS does not agree with the panel's recommendation; the proposed crosswalk does not analyze cell-free DNA.   By gapfilling this code the resources used in this code can be better estimated by a Medicare Administrative Contractor (MAC).
17	116	0424U	0424U	"New
(PLA)"	Genomic Sequencing Procedures; RT-PCR	"Oncology (prostate), exosome based analysis of 53 small noncoding RNAs (sncRNAs) by quantitative reverse transcription polymerase chain reaction (RTqPCR), urine, reported as no molecular evidence, low-, moderate- or elevated-risk of prostate cancer "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                               3. Crosswalk to 0343U: 9"	Crosswalk to 0343U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
26	117	0433U	0433U	"New
(PLA)"	Genomic Sequencing Procedures; RT-PCR	"Oncology (prostate), 5 DNA regulatory markers by quantitative PCR, whole blood, algorithm, including prostate-specific antigen, reported as likelihood of cancer "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                   3. Crosswalk to 0012M: 9"	Crosswalk to 0012M	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
52	118	XX33U	0452U	"New
(PLA)"	Genomic Sequencing Procedures; methylation analysis	"Oncology (bladder), methylated PENK DNA detection by linear target enrichment-quantitative methylation-specific real-time PCR (LTE-qMSP), urine, reported as likelihood of bladder cancer"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 81327: 9"	Crosswalk to 81327	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
64	119	XX45U	0465U	"New
(PLA)"	Genomic Sequencing Procedures; methylation analysis	"Oncology (urothelial carcinoma), DNA, quantitative methylation specific PCR of 2 genes (ONECUT2, VIM), algorithmic analysis reported as positive or negative "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 81551: 9                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        4. Crosswalk to 0012M"	Crosswalk to 0114U	"CMS disagrees with the panel recommendation and instead is suggesting a crosswalk to 0114U.  CMS believes this is a more comparable crosswalk (81551 specifically cites RT-PCR as a method, which 0465U does not).  CMS believes 0114U is a more comparable crosswalk. "
66	120	XX47U	0467U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Oncology (bladder), DNA, next generation sequencing (NGS) of 60 genes and whole genome aneuploidy, urine, algorithms reported as minimal residual disease (MRD) status positive or negative and quantitative disease burden "	"1. Abstain
2. Gapfill: 4                                                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 81455: 5"	Gapfill	"CMS agrees with the minority of the panel to gapfill this code.  We do not agree with the proposed crosswalk to 0055U, this is specifically for cfDNA.  However, other RT-PCR codes on the CLFS involve algorithms, which 0460U does not cite.  Therefore we recommend gapfilling this code so that the Medicare Administrative Contractors (MACs) can better estimate the resources for this test. "
102	121	XX79U	0495U	New	Genomic Sequencing Procedures	"Oncology (prostate), analysis of circulating plasma proteins (tPSA, fPSA, KLK2, PSP94, and GDF15), germline polygenic risk score (60 variants), clinical information (age, family history of prostate cancer, prior negative prostate biopsy), algorithm reported as risk of likelihood of detecting clinically significant prostate cancer"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                             3. Crosswalk to 81539: 8                                                                                                                                                                                                                                                                                                                                                              4. Crosswalk to 0359U"	Crosswalk to 81539 	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
104	122	XX81U	0497U	New	Genomic Sequencing Procedures	"Oncology (prostate), mRNA gene-expression profiling by real-time RT-PCR of 6 genes (FOXM1, MCM3, MTUS1, TTC21B, ALAS1, and PPP2CA), utilizing formalin-fixed paraffin-embedded (FFPE) tissue, algorithm reported as a risk score for prostate cancer"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                  3. Crosswalk to 0047U: 8"	Crosswalk to 0005U 	"CMS disagrees with the panel recommendation and instead is suggesting a crosswalk to 0005U.  Although both potential crosswalks are similar, 0005U describes a similar scale of analysis to XX81U.  "
80	123	88XX0	81195	New	Molecular Pathology; Optical Genome Mapping	"Cytogenomic genome-wide analysis, hematologic malignancy, structural variations and copy number variations, optical genome mapping (OGM)"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 0331U: 8"	Crosswalk to 0260U	CMS disagrees with the proposed crosswalk and instead is recommending a crosswalk to 0260U.  CMS believes this crosswalk is more comparable to 88XX0 as it is consistent with other optical genome analyses.
131	124	0413U	0413U	Reconsidered	Genomic Sequencing Procedures; optical genome mapping	"Oncology (hematolymphoid neoplasm), optical genome mapping for copy number alterations, aneuploidy, and balanced/complex structural rearrangements, dna from blood or bone marrow, report of clinically significant alterations"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 0331U: 8"	Crosswalk to 0260U	" CMS disagrees with the panel's recommendation and instead is suggesting a crosswalk to 0260U.  Although both 0260U and 0331U have similarities to 0413U, CMS believes the descriptor of what is analyzed in 0413U is better reflected in 0260U"
54	125	XX35U	0454U	"New
(PLA)"	Genomic Sequencing Procedures; dup/del analysis	"Rare diseases (constitutional/heritable disorders), identification of copy number variations, inversions, insertions, translocations, and other structural variants by optical genome mapping "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                              3. Crosswalk to 0260U: 8"	Crosswalk to 0260U	CMS agrees with the majority CDLT Panel recommendation to crosswalk the code.  The crosswalked code(s) appear to use similar methods and resource utilization.
16	126	0423U	0423U	"New
(PLA)"	Genomic Sequencing Procedures; targeted variant analysis	"Psychiatry (e.g., depression, anxiety), genomic analysis panel, including variant analysis of 26 genes, buccal swab, report including metabolizer status and risk of drug toxicity by condition "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                     3. Crosswalk to 0349U: 8                                                                                                                                                                                                                                                                                                                                                                                            4. Crosswalk to 0345U + 0419U+ 0411U                          "	Crosswalk to 0380U	CMS disagrees with the recommendation of the panel and instead is suggesting a crosswalk to 0380U.  CMS believes this is a more comparable crosswalk and highlights similar types of variant analysis.
27	127	0434U	0434U	"New
(PLA)"	Genomic Sequencing Procedures; targeted variant analysis	"Drug metabolism (adverse drug reactions and drug response), genomic analysis panel, variant analysis of 25 genes with reported phenotypes "	"1. Abstain
2. Gapfill: 1                                                                                                                                                                                                                                                                                                                                                                3. Crosswalk to 0348U: 7"	Crosswalk to 0380U	CMS disagrees with the recommendation of the panel and instead is suggesting a crosswalk to 0380U.  CMS believes this is a more comparable crosswalk and highlights similar types of variant analysis.
31	128	0438U	0438U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Drug metabolism (adverse drug reactions and drug response), buccal specimen, gene-drug interactions, variant analysis of 33 genes, including deletion/duplication analysis of CYP2D6, including reported phenotypes and impacted gene drug interactions "	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                      3. Crosswalk to 0350U: 8"	Crosswalk to 0380U	"CMS disagrees with the recommendation of the panel and instead is suggesting a crosswalk to 0380U.  CMS believes this is a more comparable crosswalk and highlights similar types of variant analysis.  0438U test code specifies type of analysis, 0350U simply refers to variant analysis.  "
49	129	XX30U	0461U	"New
(PLA)"	Genomic Sequencing Procedures; targeted sequence analysis	"Oncology, pharmacogenomic analysis of single-nucleotide polymorphism (SNP) genotyping by real-time PCR of 24 genes, whole blood or buccal swab, with variant analysis, including impacted gene-drug interactions and reported phenotypes "	"1. Abstain
2. Gapfill: 5                                                                                                                                                                                                                                                                                                                                                                   3. Crosswalk to 0055U: 3"	Gapfill	"CMS agrees with the majority of the panel to gapfill this code.  We do not agree with the proposed crosswalk to 0055U, this is specifically for cfDNA.  However, other RT-PCR codes on the CLFS involve algorithms, which 0460U does not cite.  Therefore we recommend to gapfill this test.  "
83	130	XX64U	0476U	New	"Molecular Pathology, Pharmacogenomics"	"Drug metabolism, psychiatry (e.g., major depressive disorder, general anxiety disorder,?attention deficit hyperactivity disorder [ADHD], schizophrenia), whole blood, buccal swab, pharmacogenomic genotyping of 14 genes and CYP2D6 copy number variant analysis, and reported phenotypes
"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                           3. Crosswalk to 81418: 8"	Crosswalk to 0380U	CMS disagrees with the recommendation of the panel and instead is suggesting a crosswalk to 0380U.  CMS believes this is a more comparable crosswalk and highlights similar types of variant analysis.
84	131	XX60U	0477U	New	"Molecular Pathology, Pharmacogenomics"	"Drug metabolism, psychiatry (e.g., major depressive disorder, general anxiety disorder,?attention deficit hyperactivity disorder [ADHD], schizophrenia), whole blood, buccal swab, pharmacogenomic genotyping of 14 genes and CYP2D6 copy number variant analysis, including impacted gene-drug interactions and reported phenotypes"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                       3. Crosswalk to 81418: 8"	Crosswalk to 0380U	CMS disagrees with the recommendation of the panel and instead is suggesting a crosswalk to 0380U.  CMS believes this is a more comparable crosswalk and highlights similar types of variant analysis.
123	132	X100U	0516U	New	Immunology	"Drug metabolism, whole blood, pharmacogenomic genotyping of 40 genes and CYP2D6 copy number variant analysis, reported as metabolizer status"	"1. Abstain
2. Gapfill                                                                                                                                                                                                                                                                                                                                                                                                                                 3. Crosswalk to 0349U: 8"	Crosswalk to 0380U	CMS disagrees with the recommendation of the panel and instead is suggesting a crosswalk to 0380U.  CMS believes this is a more comparable crosswalk and highlights similar types of variant analysis.
