Implementation and Updates of Negotiated National Coverage

120.2 - Implementation and Updates of Negotiated National Coverage Determinations (NCDs) for Clinical Diagnostic Laboratory Services (Rev. 3014, Issued: 08-06-14, Effective: ICD-10: Upon Implementation of ICD-10 ASC-X12: 01-01-12, Implementation: ICD-10: Upon Implementation of ICD-10 ASC X12: 09-08-14) Under a negotiated rulemaking process, the Center for Medicare & Medicaid Services (CMS) developed 23 NCDs for clinical diagnostic laboratory services. The NCDs are applicable to services billed under Part B regardless of the entity providing the services. Thus, they are binding on A/B MACs (A and B) in processing clinical diagnostic laboratory services on an outpatient basis. In order to ensure uniformity in the implementation of the NCDs, CMS developed the NCDs utilizing three lists of diagnosis codes. Every diagnosis code will fall into one the three lists. The lists included: Codes Covered by Medicare, Codes Denied, and Codes That Do Not Support Medical Necessity. Related software, called the laboratory edit module, is incorporated in the shared systems so that laboratory claims subject to one of the 23 NCDs are processed uniformly throughout the nation. In addition, the NCDs are maintained through the NCD process that was announced in the "Federal Register" on September 26, 2003 (68 FR 55634). This process provides for public participation through a comment period at the beginning of the evaluation of the issue and includes a detailed decision document that outlines the rationale for the decision. These documents may be viewed on the Medicare coverage homepage at cms.hhs.gov/coverage. On a quarterly basis, CMS will update the NCD edit module as necessary for ministerial coding changes and to implement the NCD decisions described above. CMS assures the updated software is communicated to the shared system maintainers. The shared system maintainers install the revised edit module after testing and distribute it to the A/B MACs (A and B) as part of their routine release. A/B MACs (A and B) will conduct provider education to advise the laboratories of changes to the laboratory edit module quarterly. Exhibit 1 - List of Diagnostic Tests that are Considered End Stage Renal Disease (ESRD) (Rev. 1769, Issued: 07-10-09, Effective/Implementation: 07-31-09) Refer to section 40.6.2.3 for guidance on the usage of this list. 71010 Chest x-ray 71015 Chest x-ray 71020 Chest x-ray 71021 Chest x-ray 71022 Chest x-ray 71030 Chest x-ray 71035 Chest x-ray 73120 X-ray hand 75710 Artery x-rays, arm/leg 75716 Artery x-rays, arm/leg 75774 Artery x-rays, arms/legs 75790 Artery x-ray, each vessel 75820 Visualize A-V shunt 75822 Vein x-ray, arm/leg 75893 Vein x-ray, arms/legs 75894 Transcath therapy, embolization 75896 X-rays, transcath therapy 75898 X-rays, transcath therapy 75901 Mechanical removal of pericath obstructive material 75902 Mechanical removal of intraluminal obstructive material 75961 Transcath retrieval of intravascular foreign body 75962 Transcath balloon angioplasty 75964 Transcath balloon angioplasty, each additional 76070 Computed tomography, bone mineral density study, axial 76075 Dual energy DEXA, bone density study, axial 76080 Radiologic exam, abscess, fistual or sinus tract study 76092 Screening mammography bilateral 76778 Ultrasound, transplanted kidney 78070 Parathyroid nuclear imaging 78351 Bone density, dual photon absorptionmetry 80048 Basic metabolic panel 80051 Electrolyte panel 80053 Comprehensive Metabolic Panel ? 80061 Lipid panel 80069 Renal function panel 80074 Acute hepatitis panel 80076 Hepatic function panel 80197 Tacrolimus 80410 Calcitonin stim panel 81000 Urinalysis with microscopy 81001 Urinalysis, auto w/scope 81002 Urinalysis nonauto w/o scope 81003 Urinalysis, auto, w/o scope 81005 Urinalysis, qual or semi-quant 81007 Urine screen for bacteria, except by culture or dipstick 81015 Microscopic exam of urine 82009 Test for acetone/ketones,qual 82010 Acetone assay, quant 82017 Acylcarnitines, quant 82040 serum albumin 82042 albumin, urine quant or other source 82108 Assay of aluminum 82232 Beta2microglobulin (monitor large molecular weigh solute clearance by dial 82247 Bilirubin, total 82248 Bilirubin, direct 82306 Assay of vitamin D-3 (calcifediol) 82307 Assay of vitamin D (calciferol) 82308 Assay of calcitonin 82310 Assay of calcium 82330 Assay of calcium, ionized 82374 Bicarbonate (CO2) 82379 Assay of carnitine 82435 Chloride blood (needed to determine acid/base status) 82465 cholesterol, total serum 82550 CPK, total 82565 Assay of creatinine 82570 Assay of urine creatinine 82575 urine creatinine clearance test 82607 Vit B12 82728 ferritin 82746 serum folate 82747 RBC folate 82800 Blood Ggases, ppH onlyy 82803 Blood gases: pH, pO2 & pCO2 82805 Blood gases W/02 saturation 82810 Blood gases, O2 sat only 82945 Glucose other fluid 82947 Assay, glucose, blood quant 82948 Reagent strip/blood glucose 83540 Assay of iron 83550 Iron binding test 83735 magnesium (monitored to avoid hypermagnesium) 83937 Osteocalcin 83970 parathormone (PTH) 83986 Assay of body fluid acidity 84075 alkaline phosphatase 84100 Assay of phosphorus, inorganic 84105 urine phosphorus 84132 Assay of serum potassium 84133 urine potassium 84134 Assay of prealbumin 84155 Assay of protein 84160 serum protein by refractometry 84295 Assay of serum sodium 84315 Body fluid specific gravity 84450 Transferase (AST) (SGOT) 84460 Alanine amino (ALT) (SGPT) 84466 transferrin 84520 Urea nitrogen, quantitative 84540 Assay of urine/urea-n 84545 Urea-N clearance test 84630 zinc 85002 Bleeding time test 85004 Automated diff wbc count 85007 Bl smear w/diff wbc count 85008 Bl smear w/o diff wbc count 85009 Manual diff wbc count b-coat 85013 Spun microhematocrit 85014 Hematocrit 85018 Hemoglobin 85025 Complete CBC w/auto diff wbc 85027 Complete CBC, automated 85032 Manual cell count, each 85041 Automated RBC count 85044 Manual reticulocyte count 85045 Automated reticulocyte count 85046 Reticyte/hgb concentrate 85048 Automated leukocyte count 85049 Automated platelet count 85345 Coagulation time, Lee-White 85347 Coagulation time, activated 85348 Coagulation time, other methods 85520 Heparin assay 85610 Prothrombin time 85611 Prothrombin test,substitution 85651 sed rate 85652 automates sed rate 85730 thromboplastin time, partial (PTT) 85732 Thromboplastin time, partial, substitution 86590 Streptokinase, antibody 86644 CMV screen 86645 Cytomegalovirus antibody dfa (IgM) 86687 HTLV-I antibody 86688 HTLV-II antibody 86689 HTLV/HIV confirmatory test 86692 Hepatitis, delta agent 86701 HIV-1 86702 HIV-2 86703 HIV-1/HIV2, ,singgle assayy 86704 Hep B core antibody, total 86705 Hep b core antibody, IgM 86706 Hep B surface antibody 86707 Hep Be antibody 86709 Hep A, IgM antibody 86803 Hepatitis C ab test 86804 Hep C ab test, confirm 86812 HLA typing, A, B, or C 86813 HLA typing, A, B, or C, multiple antigens 86816 HLA typing, DR/DQ 86817 HLAy tpypigng, DR/DQ, multiple antigens 86900 Blood typing, ABO 86901 Rh typing 86903 Blood typing, antigen screen 86904 Blood typing, patient serum 86905 Blood typing, RBC antigens 86906 Blood typing, Rh phenotype 87040 culture, blood 87070 Culture, bacteria, other 87071 Culture bacteri aerobic other, quant 87073 Culture bacteria anaerobic, quant 87075 Culture bacteria anaerobic, any source w/ID 87076 Culture anaerobe ident, each 87077 Culture aerobic identify 87081 Culture screen only 87084 Culture w/ colony estimation 87086 Urine culture/quant colony count 87088 Urine bacteria culture, isolation & ID 87181 Microbe susceptible, diffuse 87184 Microbe susceptible, disk 87185 Microbe susceptible, enzyme 87186 Microbe susceptible, mic 87187 Microbe susceptible, mlc 87188 Microbe suscept, macrobroth 87190 Microbe suscept, mycobacteri 87197 Bactericidal level, serum 87205 Smear, gram stain 87271 CMV, DFA 87340 HepB surface antigen 87341 HepatitisB surface, ag, eia, neutralization 87350 HepatitisBe ag, eia 87380 Hepatitis delta ag, eia 87390 HIV-1 ag, eia 87391 HIV-2 ag, eia 87515 Hepatitis B, DNA, dir probe 87516 Hepatitis B, DNA, amp probe 87517 Hepatitis B, DNA, quant 87520 Hepatitis C, RNA, dir probe 87521 Hepatitis C, RNA, amp probe 87522 Hepatitis C, RN A, quant 87525 Hepatitis G, DNA, dir probe 87526 Hepatitis G, DNA, amp probe 87527 Hepatitis G, DNA, quant 89050 cell count, peritoneal fluid (no diff) 89051 cell count, peritoneal fluid with diff 93000 Echo exam of heart 93005 Electrocardiogram, tracing 93010 Electrocardiogram report 93040 Rhythm ECG with report 93041 Rhythm ECG, tracing 93042 Rhythm ECG with report 93307 Echo exam of heart 93308 Echo exam of heart, follow-up 93922 Extremity study 93923 Extremity study, multiple levels 93925 Lower extremity study - arterial 93926 Lower extremity study, limited- arterial 93930 Upper extremity study- arterial 93931 Upper extremity study, limited-arterial 93965 Extremity study-venous 93970 Extremity study-venous 93971 Extremity study, limited-venous G0001 Routine venipuncture G0202 Screening mammography, digital