CMS Pub. 100-04, ch. 16, § 120.2

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