Medicare National Coverage Determinations 
Manual 
Chapter 1, Part 3 (Sections 170  190.34) 
Coverage Determinations 
 
 
Table of Contents
(Rev. 12112, Issued; 06-29-23) 
 
Transmittals for Chapter 1, Part 3 
 
170 - Nonphysician Practitioner Services (PT/OT/SLP/Audiologists/CRNA) 
170.1 - Institutional and Home Care Patient Education Programs 
170.2 - Melodic Intonation Therapy 
170.3 - Speech -Language Pathology Services for the Treatment of Dysphagia 
180 - Nutrition 
180.1 - Medical Nutrition Therapy (MNT) 
180.2 - Enteral and Parenteral Nutritional Therapy (RETIRED) 
190 - Pathology and Laboratory 
190.1 - Histocompatibility Testing 
190.2 - Diagnostic Pap Smears 
190.3 - Cytogenetic Studies 
190.4 - Electron Microscope (RETIRED) 
190.5 - Sweat Test 
190.6 - Hair Analysis 
190.7 - Human Tumor Stem Cell Drug Sensitivity Assays 
190.8 - Lymphocyte Mitogen Response Assays 
190.9 - Serologic Testing for Acquired Immunodeficiency Syndrome (AIDS) 
190.10 - Laboratory Tests - CRD Patients 
190.11 - Home Prothrombin Time/International Normalized Ratio (PT/INR) 
Monitoring for Anticoagulation Management  (Effective March 19, 2008) 
190.12 - Urine Culture, Bacterial 
190.13 - Human Immunodeficiency Virus (HIV) Testing (Prognosis Including 
Monitoring) 
190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis) 
190.15 - Blood Counts 
190.16 - Partial Thromboplastin Time (PTT)  190.17 - Prothrombin Time (PT) 
190.18 - Serum Iron Studies 
190.19 - Collagen Crosslinks, Any Method 
190.20 - Blood Glucose Testing 
190.21 - Glycated Hemoglobin/Glycated Protein 
190.22 - Thyroid Testing 
190.23 - Lipid Testing 
190.24 - Digoxin Therapeutic Drug Assay 
190.25 - Alpha-fetoprotein 
190.26 - Carcinoembryonic Antigen 
190.27 - Human Chorionic Gonadotropin 
190.28 - Tumor Antigen by Immunoassay  CA 125 
190.29 - Tumor Antigen by Immunoassay CA 15-3/CA 27.29 
190.30 - Tumor Antigen by Immunoassay CA 19-9 
190.31 - Prostate Specific Antigen 
190.32 - Gamma Glutamyl Transferase 
190.33 - Hepatitis Panel/Acute Hepatitis Panel 
190.34 - Fecal Occult Blood Test  170 - Nonphysician Practitioner Services 
(PT/OT/SLP/Audiologists/CRNA 
(Rev. 1, 10-03-03) 
 
170.1 - Institutional and Home Care Patient Education Programs 
(Rev. 1, 10-03-03) 
CIM 80-1 
 
While the Act does not specifically identify patient education programs as covered 
services, reimbursement may be made under Medicare for such programs furnished by 
providers of services (i.e., hospitals, SNFs, HHAs, and OPT providers) to the extent that 
the programs are appropriate, integral parts in the rendition of covered services which are 
reasonable and necessary for the treatment of the individuals illness or injury.  For 
example, educational activities carried out by nurses such as teaching patients to give 
themselves injections, follow prescribed diets, administer colostomy care, administer 
medical gases, and carry out other inpatient care activities may be reimbursable as a part 
of covered routine nursing care.  Also, the teaching by an occupational therapist of 
compensatory techniques to improve a patients level of independence in the activities of 
daily living may be reimbursed as a part of covered occupational therapy.  Similarly, the 
instruction of a patient in the carrying out of a maintenance program designed for him/her 
by a physical therapist may be reimbursed as part of covered physical therapy. 
 
However, when the educational activities are not closely related to the care and treatment 
of the patient, such as programs directed toward instructing patients or the public 
generally in preventive health care activities, reimbursement cannot be made since the 
Act limits Medicare payment to covered care which is reasonable and necessary for the 
treatment of an illness or injury.  For example, programs designed to prevent illness by 
instructing the general public in the importance of good nutritional habits, exercise 
regimens, and good hygiene are not reimbursable under Medicare. 
 
170.2 - Melodic Intonation Therapy 
(Rev. 1, 10-03-03) 
CIM 35-67 
 
Melodic intonation therapy is a technique used in language rehabilitation.  Its purpose is 
to teach aphasic patients to produce useful phrases by intoning them in a melodic pattern 
with strong rhythmic support.  Limited studies by a few institutions show some benefit 
for a small number of nonfluent aphasic patients otherwise unresponsive to conventional 
therapy. 
 
Melodic intonation therapy is a covered service only for nonfluent aphasic patients 
unresponsive to conventional therapy, and only when the conditions for coverage of 
speech pathology services are met.  Please refer to the Medicare Benefit Policy, Chapter 
15, Covered Medical and Other Health Services, 220; the Medicare Claims 
Processing Manual, Chapter 5, Part B Outpatient Rehabilitation and CORF Services, 
for these conditions of coverage.   
170.3 - Speech -Language Pathology Services for the Treatment of 
Dysphagia 
(Rev. 55, Issued: 05-05-06, Effective: 10-01-06, Implementation: 10-02-06) 
 
Dysphagia is a swallowing disorder that may be due to various neurological, structural, 
and cognitive deficits.  Dysphagia may be the result of head trauma, cerebrovascular 
accident, neuromuscular degenerative diseases, head and neck cancer, or 
encephalopathies.  While dysphagia can afflict any age group, it most often appears 
among the elderly.  Speech-language pathology services are covered under Medicare for 
the treatment of dysphagia, regardless of the presence of a communication disability. 
 
Patients who are motivated, moderately alert, and have some degree of deglutition and 
swallowing functions are appropriate candidates for dysphagia therapy.  Elements of the 
therapy program can include thermal stimulation to heighten the sensitivity of the 
swallowing reflex, exercises to improve oral-motor control, training in laryngeal 
adduction and compensatory swallowing techniques, and positioning and dietary 
modifications.  Design all programs to ensure swallowing safety of the patient during oral 
feedings and maintain adequate nutrition. 
 
Cross-reference: 
 
The Medicare Benefit Policy, Chapter 15, Covered Medical and Other Health Services, 
220 and 230.3. 
 
180 - Nutrition 
(Rev. 1, 10-03-03) 
 
180.1 - Medical Nutrition Therapy (MNT) 
(Rev. 11426; Issued: 05-20-22; Effective: 01-01-22; Implementation: 07-05-22) 
 
A.  General 
 
Section 1861(s)(2)(V) of the Social Security Act authorizes Medicare part B coverage 
of medical nutrition therapy services (MNT) for certain beneficiaries who have 
diabetes or a renal disease. Regulations for MNT were established on January 2, 
2002, at 42 CFR 410.130 - 410.134. This national coverage determination (NCD) 
establishes the duration and frequency limits for the MNT benefit and coordinates 
MNT and diabetes outpatient self-management training (DSMT) as an NCD. 
 
B.  Nationally Covered 
 
Effective January 1, 2022, basic coverage of MNT, for the first year a beneficiary 
receives MNT, with either a diagnosis of renal disease or diabetes as defined at 
42 CFR 410.130 is three hours of administration. Basic coverage in subsequent years 
for renal disease or diabetes is two hours. The dietitian/nutritionist may choose how  many units are administered per day as long as all of the other requirements in this 
NCD and 42 CFR 410.130-410.134 are met. Pursuant to the exception at 42 4CFR 
410.132(b)(5), additional hours are considered to be medically necessary and covered if 
the physician determines that there is a change in medical condition, diagnosis, or 
treatment regimen that requires a change in MNT and orders additional hours during 
that episode of care. 
 
If the physician determines that receipt of both MNT and DSMT is medically necessary 
in the same episode of care, Medicare will cover both DSMT and MNT initial and 
subsequent years without decreasing either benefit as long as DSMT and MNT are not 
provided on the same date of service. The dietitian/nutritionist may choose how many 
units are performed per day as long as all of the other requirements in the NCD and 42 
CFR 410.130-410.134 are met. Pursuant to the exception at 42 CFR 410.132(b)(5), 
additional hours are considered to be medically necessary and covered if the physician 
determines that there is a change in medical condition, diagnosis, or treatment regimen 
that requires a change in MNT and 
orders additional hours during that episode of care. 
 
C.  Nationally Non-Covered 
 
N/A 
 
D.  Other 
 
N/A 
 
(This NCD last reviewed December 2021.) 
 
 
180.2 - Enteral and Parenteral Nutritional Therapy (RETIRED) 
(Rev. 11892; Issued: 03-09-23; Effective: 04-10-23; Implementation:04-10-23)   
Effective January 1, 2022, the Centers for Medicare & Medicaid Services determined  
that no national coverage determination (NCD) is appropriate at this time for Enteral  
and Parenteral Nutritional Therapy. In the absence of an NCD, coverage 
determinations  
will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of the  
Social Security Act. 
 
190 - Pathology and Laboratory 
(Rev. 1, 10-03-03) 
 
190.1 - Histocompatibility Testing 
(Rev. 12112; Issued: 06-29-23; Effective: 07- 31-23; Implementation: 07-31- 23) 
 
 Histocompatibility testing involves the matching or typing of the human leucocyte   antigen (HLA). This testing is safe and effective when it is performed on patients: 
 
A.  In preparation for a kidney transplant; 
 
      B.  In preparation for bone marrow transplantation; 
 
C.  In preparation for blood platelet transfusions (particularly where multiple 
            infusions are involved; or 
 
      D.  Who are suspected of having ankylosing spondylitis. 
    
This testing is covered under Medicare when used for any of the indications listed in A, 
B, and C and if it is reasonable and necessary for the patient. 
 
It is covered for ankylosing spondylitis in cases where other methods of diagnosis would 
not be appropriate or have yielded inconclusive results. Request documentation 
supporting the medical necessity of the test from the physician in all cases where 
ankylosing spondylitis is indicated as the reason for the test.  
 
 
190.2 - Diagnostic Pap Smears 
(Rev. 48, Issued:  03-17-06; Effective/Implementation Dates:  06-19-06) 
CIM 50-20, CIM 50-20.1 
 
A diagnostic pap smear and related medically necessary services are covered under 
Medicare Part B when ordered by a physician under one of the following conditions: 
 
  Previous 4cancer of the cervix, uterus, or vagina that has been or is presently 
being treated; 
 
  Previous abnormal pap smear; 
 
  Any abnormal findings of the vagina, cervix, uterus, ovaries, or adnexa; 
 
  Any significant complaint by the patient referable to the female reproductive 
system; or 
 
  Any signs or symptoms that might in the physicians judgment reasonably be 
related to a gynecologic disorder. 
 
Screening Pap Smears and Pelvic Examinations for Early Detection of Cervical or 
Vaginal Cancer.  (See section 210.2.) 
 
190.3 - Cytogenetic Studies 
(Rev. 1, 10-03-03) 
CIM 50-29   
The term cytogenetic studies is used to describe the microscopic examination of the 
physical appearance of human chromosomes.  Medicare covers these tests when they are 
reasonable and necessary for the diagnosis or treatment of the following conditions: 
 
  Genetic disorders (e.g., mongolism) in a fetus (See the Medicare Benefit Policy 
Manual, Chapter 15, Covered Medical and Other Health Services, 20.1 
 
  Failure of sexual development; or 
 
  Chronic myelogenous leukemia. 
 
  Acute leukemias lymphoid (FAB L1-L3), myeloid (FAB M0-M7), and 
unclassified; or 
 
  Myelodysplasia. 
 
190.4 - Electron Microscope (RETIRED) 
(Rev. 11892; Issued: 03-09-23; Effective: 04-10-23; Implementation:04-10-23)   
 
Effective December 18, 2014, NCD 190.4 is retired. 
 
190.5 - Sweat Test 
CIM 50-35 
 
The sweat test is an important diagnostic tool in cystic fibrosis and may be covered when 
used for that purpose.  Usage of the sweat test as a predictor of efficacy of 
sympathectomy in peripheral vascular disease is unproven and, therefore, is not covered. 
 
190.6 - Hair Analysis 
(Rev. 1, 10-03-03) 
CIM 50-24 
 
Not Covered 
 
Hair analysis to detect mineral traces as an aid in diagnosing human disease is not a 
covered service under Medicare. 
 
The correlation of hair analysis to the chemical state of the whole body is not possible at 
this time, and therefore this diagnostic procedure cannot be considered to be reasonable 
and necessary under 1862(a)(1) of the Act. 
 
190.7 - Human Tumor Stem Cell Drug Sensitivity Assays 
(Rev. 1, 10-03-03) 
CIM 50-41   
Human tumor stem cell drug sensitivity assays involve exposure of human tumor stem 
cell colonies grown in tissue culture to anticancer drugs and observing for cytotoxic 
effects.  Their purpose is to screen potential anticancer drugs and predict the effects of 
these drugs on tumors of individual patients, to allow the selection of the most effective 
drug or drugs for that patient.  Human tumor drug sensitivity assays are considered 
experimental, and therefore, not covered under Medicare at this time. 
 
The Fluorescent Cytoprint Assay, a miniaturized organ culture system for cancer 
chemosensitivity testing, allows for qualitative visual estimation of cell kill using low 
power microscopy and a noncytotoxic fluoresence probe for cell viability.  The clinical 
application of the assay, based on testing in tumor microorgans rather than in clones 
derived from single cells, is considered experimental, and therefore, not covered under 
Medicare at this time. 
 
190.8 - Lymphocyte Mitogen Response Assays 
(Rev. 1, 10-03-03) 
CIM 50-45 
 
For Services Performed On or After May 16, 1983 
 
The lymphocyte mitogen response assay measures the immune response of patient 
peripheral blood lymphocytes.  It is a covered test under Medicare when it is medically 
necessary to assess lymphocytic function in diagnosed in munodeficiency diseases and to 
monitor immunotherapy. 
 
It is not covered when it is used to monitor the treatment of cancer, because its use for 
that purpose is experimental. 
 
190.9 - Serologic Testing for Acquired Immunodeficiency Syndrome 
(AIDS) 
(Rev. 1, 10-03-03) 
CIM 50-52 
 
Serologic testing is employed to detect antibodies to the AIDS virus which is currently 
identified by the term human immunodeficiency virus (HIV).  The virus originally was 
named human T-cell lymphotropic virus, type III (HTLV-III), a term that remains in 
common usage. 
 
Antibodies may be detected by a variety of immunoassay techniques, the most common 
being an enzyme-linked immunosorbent assay (ELISA).  When an assay is reactive on 
initial testing, it should be repeated on the same specimen.  A more specific test, 
(Western blot, immunofluorescent assay) is usually performed following repeatedly 
reactive ELISA results. 
  These tests may be covered when performed to help determine a diagnosis for 
symptomatic patients.  They are not covered when furnished as part of a screening 
program for asymptomatic persons. 
 
NOTE:  Two enzyme-linked immunosorbent assay (ELISA) tests that were conducted on 
the same specimen must both be positive before Medicare will cover the Western blot 
test. 
 
190.10 - Laboratory Tests - CRD Patients 
(Rev. 1, 10-03-03) 
CIM 50-17 
 
Laboratory tests are essential to monitor the progress of CRD patients.  The following list 
and frequencies of tests constitute the level and types of routine laboratory tests that are 
covered.  Bills for other types of tests are considered nonroutine.  Routine tests at greater 
frequencies must include medical justification.  Nonroutine tests generally are justified by 
the diagnosis.  The routinely covered regimen includes the following tests: 
 
Per Dialysis 
 
  All hematocrit or hemoglobin and clotting time tests furnished incident to dialysis 
treatments. 
 
Per Week 
 
  Prothrombin time for patients on anticoagulant therapy, and  
  Serum Creatinine 
 
Per Week or Thirteen Per Quarter 
 
  BUN 
 
Monthly 
 
  CBC, 
  Serum Calcium, 
  Serum Chloride, 
  Serum Potassium, 
  Serum Bicarbonate, 
  Serum Phosphorous, 
  Total Protein, 
  Serum Albumin, 
  Alkaline Phospatase, 
  AST, 
  SGOT, and    LDH. 
 
Guidelines for tests other than those routinely performed include: 
 
  Serum Aluminum - one every 3 months, and  
  Serum Ferritin - one every 3 months 
 
The following tests for hepatitis B are covered when patients first enter a dialysis facility: 
hepatitis B surface antigen (HBsAg) and Anti-HBs.  Coverage of future testing in these 
patients depends on their serologic status and on whether they have been successfully 
immunized against hepatitis B virus.  The following table summarizes the frequency of 
serologic surveillance for hepatitis B.  Tests furnished according to this table do not 
require additional documentation and are paid separately because payment for 
maintenance dialysis treatments does not take them into account. 
 
FREQUENCY OF SCREENING 
 
  Vaccination and  HbsAg Patients  Anti-HBs Patients 
Serologic Status 
Unvaccinated  Susceptible  Monthly  Semiannually 
Unvaccinated  HBsAg Carrier  Annually  None 
Unvaccinated  Anti-HBs-Positive (1)  None  Annually 
Vaccinated  Anti-HBs-Positive (1)  None  Annually 
Vaccinated  Low Level or No Anti-HBs  Monthly  Semiannually 
 
(1) At least 10 sample ration units by radioimmunoassay or positive by enzyme 
immunoassay. 
 
Patients who are in the process of receiving hepatitis B vaccines, but have not received 
the complete series, should continue to be routinely screened as susceptible.  Between 
one and six months after the third dose, all vaccines should be tested for anti-HBs to 
confirm their response to the vaccine.  Patients who have a level of anti-HBs of at least 
10 sample ratio units (SRUs) by radioimmunoassay (RIA) or who are positive by enzyme 
immunoassay (EIA) are considered adequate responders to vaccine and need only be 
tested for anti-HBs annually to verify their immune status.  If anti-HBs drops below 10 
SRUs by RIA or is negative by EIA, a booster dose of hepatitis B vaccine should be 
given. 
 
Laboratory tests are subject to the normal coverage requirements.  If the laboratory 
services are performed by a free-standing facility, the facility must meet the conditions of 
coverage for independent laboratories. 
 
190.11 - Home Prothrombin Time/International Normalized Ratio 
(PT/INR) Monitoring for Anticoagulation Management  Effective 
March 19, 2008  (Rev. 90, Issued: 07-25-08, Effective: 03-19-08, Implementation: 08-25-08) 
 
A.  General 
 
Use of the International Normalized Ratio (INR) or prothrombin time (PT) - standard 
measurement for reporting the bloods clotting time) - allows physicians to determine the 
level of anticoagulation in a patient independent of the laboratory reagents used.  The 
INR is the ratio of the patients PT (extrinsic or tissue-factor dependent coagulation 
pathway) compared to the mean PT for a group of normal individuals.  Maintaining 
patients within his/her prescribed therapeutic range minimizes adverse events associated 
with inadequate or excessive anticoagulation such as serious bleeding or thromboembolic 
events.  Patient self-testing and self-management through the use of a home INR monitor 
may be used to improve the time in therapeutic rate (TTR) for select groups of patients.  
Increased TTR leads to improved clinical outcomes and reductions in thromboembolic 
and hemorrhagic events. 
 
Warfarin (also prescribed under other trade names, e.g., Coumadin) is a self-
administered, oral anticoagulant (blood thinner) medication that affects the vitamin K-
dependent clotting factors II, VII, IX and X.  It is widely used for various medical 
conditions, and has a narrow therapeutic index, meaning it is a drug with less than a 2-
fold difference between median lethal dose and median effective dose.  For this reason, 
since October 4, 2006, it falls under the category of a Food and Drug Administration 
(FDA) black-box drug whose dosage must be closely monitored to avoid serious 
complications.  A PT/INR monitoring system is a portable testing device that includes a 
finger-stick and an FDA-cleared meter that measures the time it takes for a persons 
blood plasma to clot. 
 
B.  Nationally Covered Indications 
 
For services furnished on or after March 19, 2008, Medicare will cover the use of home 
PT/INR monitoring for chronic, oral anticoagulation management for patients with 
mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism 
(inclusive of  deep venous thrombosis and pulmonary embolism) on warfarin.  The 
monitor and the home testing must be prescribed by a treating physician as provided at 42 
CFR 410.32(a), and all of the following requirements must be met:  
 
1.  The patient must have been anticoagulated for at least 3 months prior to use of the 
home INR device; and, 
 
2.  The patient must undergo a face-to-face educational program on anticoagulation 
management and must have demonstrated the correct use of the device prior to its use in 
the home; and,  
 
3.  The patient continues to correctly use the device in the context of the management 
of the anticoagulation therapy following the initiation of home monitoring; and, 
  4.  Self-testing with the device should not occur more frequently than once a week. 
 
C.  Nationally Non-Covered Indications 
 
N/A 
 
D.  Other 
 
1.  All other indications for home PT/INR monitoring not indicated as nationally covered 
above remain at local A/B MACs discretion. 
 
2.  This national coverage determination (NCD) is distinct from, and makes no changes 
to, the PT clinical laboratory NCD at section 190.17 of Publication 100-03 of the NCD 
Manual. 
 
(This NCD last reviewed March 2008.) 
 
190.12 - Urine Culture, Bacterial 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
A bacterial urine culture is a laboratory procedure performed on a urine specimen to 
establish the probable etiology of a presumed urinary tract infection.  It is common 
practice to do a urinalysis prior to a urine culture.  A urine culture may also be used as 
part of the evaluation and management of another related condition.  The procedure 
includes aerobic agar-based isolation of bacteria or other cultivable organisms present, 
and quantitation of types present based on morphologic criteria.  Isolates deemed 
significant may be subjected to additional identification and susceptibility procedures as 
requested by the ordering physician.  The physicians request may be through clearly 
documented and communicated laboratory protocols. 
 
Indications 
 
1.  A patients urinalysis is abnormal suggesting urinary tract infection, for example 
abnormal microscopic (hematuria, pyuria, bacteriuria); abnormal biochemical urinalysis 
(positive leukocyte esterase, nitrite, protein, blood); a Grams stain positive for 
microorganisms; positive bacteriuria screen by a non-culture technique; or other 
significant abnormality of a urinalysis.  While it is not essential to evaluate a urine 
specimen by one of these methods before a urine culture is performed, certain clinical 
presentations with highly suggestive signs and symptoms may lend themselves to an 
antecedent urinalysis procedure where follow-up culture depends upon an initial positive 
or abnormal test result. 
 
2.  A patient has clinical signs and symptoms indicative of a possible urinary tract 
infection (UTI).  Acute lower UTI may present with urgency, frequency, nocturia, 
dysuria, discharge or incontinence.  These findings may also be noted in upper UTI with  additional systemic symptoms (for example, fever, chills, lethargy); or pain in the 
costovertebral, abdominal, or pelvic areas.  Signs and symptoms may overlap 
considerably with other inflammatory conditions of the genitourinary tract (for example, 
prostatitis, urethritis, vaginitis, or cervicitis).  Elderly or immunocompromised patients, 
or patients with neurologic disorders may present atypically (for example, general 
debility, acute mental status changes, declining functional status). 
 
3.  The patient is being evaluated for suspected urosepsis, fever of unknown origin, or 
other systemic manifestations of infection but without a known source.  Signs and 
symptoms used to define sepsis have been well established. 
 
4.  A test-of-cure is generally not indicated in an uncomplicated infection.  However, it 
may be indicated if the patient is being evaluated for response to therapy and there is a 
complicating co-existing urinary abnormality including structural or functional 
abnormalities, calculi, foreign bodies, or ureteral/renal stents or there is clinical or 
laboratory evidence of failure to respond as described in Indications 1 and 2. 
 
5.  In surgical procedures involving major manipulations of the genitourinary tract, 
preoperative examination to detect occult infection may be indicated in selected cases 
(for example, prior to renal transplantation, manipulation or removal of kidney stones, or 
transurethral surgery of the bladder of prostate). 
 
6.  Urine culture may be indicated to detect occult infection in renal transplantation 
recipients on immunosuppressive therapy. 
 
Limitations 
 
1.  CPT 87086 may be used one time per encounter. 
 
2.  Colony count restrictions on coverage of CPT 87088 do not apply as they may be 
highly variable according to syndrome or other clinical circumstances (for example, 
antecedent therapy, collection time, degree of hydration). 
 
3.  CPT 87088, 87184, and 87186 may be used multiple times in association with or 
independent of 87086, as urinary tract infections may be polymicrobial. 
 
4.  Testing for asymptomatic bacteriuria as part of a prenatal evaluation may be 
medically appropriate but is considered screening and therefore not covered by Medicare.  
The U.S. Preventive Services Task Force has concluded that screening for asymptomatic 
bacteriuria outside of the narrow indication for pregnant women is generally not 
indicated.  There are insufficient data to recommend screening in ambulatory elderly 
patients including those with diabetes.  Testing may be clinically indicated on other 
grounds including likelihood of recurrence or potential adverse effects of antibiotics, but 
is considered screening in the absence of clinical or laboratory evidence of infection. 
  190.13 - Human Immunodeficiency Virus (HIV) Testing (Prognosis 
Including Monitoring) 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
HIV quantification is achieved through the use of a number of different assays, which 
measure the amount of circulating viral RNA.  Assays vary both in methods used to 
detect viral RNA as well as in ability to detect viral levels at lower limits.  However, all 
employ some type of nucleic acid amplification technique to enhance sensitivity, and 
results are expressed as the HIV copy number. 
 
Quantification assays of HIV plasma RNA are used prognostically to assess relative risk 
for disease progression and predict time to death, as well as to assess efficacy of 
antiretroviral therapies over time. 
 
The HIV quantification is often performed together with CD4+ T cell counts, which 
provide information on extent of HIV induced immune system damage already incurred. 
 
Indications 
 
1.  A plasma HIV RNA baseline level may be medically necessary in any patient with 
confirmed HIV infection. 
 
2.  Regular periodic measurement of plasma HIV RNA levels may be medically 
necessary to determine risk for disease progression in an HIV-infected individual and to 
determine when to initiate antiretroviral treatment regimens. 
 
3.  In clinical situations where the risk of HIV infection is significant and initiation of 
therapy is anticipated, a baseline HIV quantification may be performed.  These situation 
include: 
 
a.  Persistence of borderline or equivocal serologic reactivity in an at-risk 
individual. 
 
b.  Signs and symptoms of acute retroviral syndrome characterized by fever, 
malaise, lymphadenopathy and rash in an at-risk individual 
 
Limitations 
 
1.  Viral quantification may be appropriate for prognostic use including baseline 
determination, periodic monitoring and monitoring of response to therapy.  Use as a 
diagnostic test method is not indicated. 
 
2.  Measurement of plasma HIV RNA levels should be performed at the time of 
establishment of an HIV infection diagnosis.  For an accurate baseline, 2 specimens in a 
2-week period are appropriate.   
3.  For prognosis including anti-retroviral therapy monitoring, regular, periodic 
measurements are appropriate.  The frequency of viral load testing should be consistent 
with the most current Centers for Disease Control and Prevention guidelines for use of 
antiretroviral agents in adults and adolescents or pediatrics. 
 
4.  Because differences in absolute HIV copy number are known to occur using different 
assays, plasma HIV RNA levels should be measured by the same analytical method.  A 
change in assay method may necessitate re-establishment of a baseline. 
 
5.  Nucleic acid quantification techniques are representative of rapidly emerging and 
evolving new technologies.  As such, users are advised to remain current of FDA-
approved status. 
 
190.14 - Human Immunodeficiency Virus (HIV) Testing (Diagnosis) 
(Rev. 131, Issued: 02-23-11, Effective: 12-08-09, Implementation: 07-06-10) 
 
Diagnosis of HIV infection is primarily made through the use of serologic assays.  These 
assays take one of two forms: antibody detection assays and specific HIV antigen (p24) 
procedures.  The antibody assays are usually enzyme immunoassays (EIA), which are 
used to confirm exposure of an individuals immune system to specific viral antigens.  
These assays may be formatted to detect HIV-1, HIV-2, or HIV-1 and 2 simultaneously, 
and to detect both IgM and IgG.  When the initial EIA test is repeatedly positive or 
indeterminant, an alternative test is used to confirm the specificity of the antibodies to 
individual viral components.  The most commonly used method is the Western Blot. 
 
The HIV-1 core antigen (p24) test detects circulating viral antigen which may be found 
prior to the development of antibodies and may also be present in later stages of illness in 
the form of recurrent or persistent antigenemia. Its prognostic utility in HIV infection has 
been diminished as a result of development of sensitive viral RNA assays, and its primary 
use today is as a routine screening tool in potential blood donors. 
 
In several unique situations, serologic testing alone may not reliably establish an HIV 
infection.  This may occur because the antibody response (particularly the IgG response 
detected by Western Blot) has not yet developed (that is, acute retroviral syndrome) or is 
persistently equivocal because of inherent viral antigen variability.  It is also an issue in 
perinatal HIV infection due to transplacental passage of maternal HIV antibody.  In these 
situations, laboratory evidence of HIV in blood by culture, antigen assays, or proviral 
DNA or viral RNA assays, is required to establish a definitive determination of HIV 
infection. 
 
Indications 
 
Diagnostic testing to establish HIV infection may be indicated when there is a strong 
clinical suspicion supported by one or more of the following clinical findings: 
  1.  The patient has a documented, otherwise unexplained, AIDS-defining or AIDS-
associated opportunistic infection. 
 
2.  The patient has another documented sexually transmitted disease, which identifies 
significant risk of exposure to HIV and the potential for an early or subclinical infection. 
 
3.  The patient has documented acute or chronic hepatitis B or C infection that 
identifies a significant risk of exposure to HIV and the potential for an early or 
subclinical infection. 
 
4.  The patient has a documented AIDS-defining or AIDS-associated neoplasm. 
 
5.  The patient has a documented AIDS-associated neurologic disorder or otherwise 
unexplained dementia. 
 
6.  The patient has another documented AIDS-defining clinical condition, or a history 
of other severe, recurrent, or persistent conditions which suggest an underlying immune 
deficiency (for example, cutaneous or mucosal disorders). 
 
7.  The patient has otherwise unexplained generalized signs and symptoms suggestive 
of a chronic process with an underlying immune deficiency (for example, fever, weight 
loss, malaise, fatigue, chronic diarrhea, failure to thrive, chronic cough, hemoptysis, 
shortness of breath, or lymphadenopathy). 
 
8.  The patient has otherwise unexplained laboratory evidence of a chronic disease 
process with an underlying immune deficiency (for example, anemia, leukopenia, 
pancytopenia, lymphopenia, or low CD4+ lymphocyte count). 
 
9.  The patient has signs and symptoms of acute retroviral syndrome with fever, 
malaise, lymphadenopathy, and skin rash. 
 
10.  The patient has documented exposure to blood or body fluids known to be capable 
of transmitting HIV (for example, needle sticks and other significant blood exposures) 
and antiviral therapy is initiated or anticipated to be initiated. 
 
11.  The patient is undergoing treatment for rape. (HIV testing is part of the rape 
treatment protocol.) 
 
Limitations 
 
1.  HIV antibody testing in the United States is usually performed using HIV-1 or HIV-
1/2 combination tests.  HIV-2 testing is indicated if clinical circumstances suggest HIV-2 
is likely (that is, compatible clinical finding and HIV-1 test negative). HIV-2 testing may 
also be indicated in areas of the country where there is greater prevalence of HIV-2 
infections. 
  2.  The Western Blot test should be performed only after documentation that the initial 
EIA tests are repeatedly positive or equivocal on a single sample. 
 
3.  The HIV antigen tests currently have no defined diagnostic usage. 
 
4.  Direct viral RNA detection may be performed in those situations where serologic 
testing does not establish a diagnosis but strong clinical suspicion persists (for example, 
acute retroviral syndrome, nonspecific serologic evidence of HIV, or perinatal HIV 
infection). 
 
5.  If initial serologic tests confirm an HIV infection, repeat testing is not indicated. 
 
6.  If initial serologic tests are HIV EIA negative and there is no indication for 
confirmation of infection by viral RNA detection, the interval prior to retesting is 3-6 
months. 
 
7.  Testing for evidence of HIV infection using serologic methods may be medically 
appropriate in situations where there is a risk of exposure to HIV. 
 
8.  The CPT Editorial Panel has issued a number of codes for infectious agent detection 
by direct antigen or nucleic acid probe techniques that have not yet been developed or are 
only being used on an investigational basis.  Laboratory providers are advised to remain 
current on FDA-approved status for these tests. 
 
190.15 - Blood Counts 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Blood counts are used to evaluate and diagnose diseases relating to abnormalities of the 
blood or bone marrow.  These include primary disorders such as anemia, leukemia, 
polycythemia, thrombocytosis and thrombocytopenia.  Many other conditions secondarily 
affect the blood or bone marrow, including reaction to inflammation and infections, 
coagulopathies, neoplasms and exposure to toxic substances.  Many treatments and 
therapies affect the blood or bone marrow, and blood counts may be used to monitor 
treatment effects. 
 
The complete blood count (CBC) includes a hemogram and differential white blood 
count (WBC).  The hemogram includes enumeration of red blood cells, white blood cells, 
and platelets, as well as the determination of hemoglobin, hematocrit, and indices. 
 
The symptoms of hematological disorders are often nonspecific, and are commonly 
encountered in patients who may or may not prove to have a disorder of the blood or 
bone marrow.  Furthermore, many medical conditions that are not primarily due to 
abnormalities of blood or bone marrow may have hematological manifestations that 
result from the disease or its treatment.  As a result, the CBC is one of the most 
commonly indicated laboratory tests.   
Inpatients with possible hematological abnormalities, it may be necessary to determine 
the hemoglobin and hematocrit, to calculate the red cell indices, and to measure the 
concentration of white blood cells and platelets.  These measurements are usually 
performed on a multichannel analyzer that measures all of the parameters on every 
sample.  Therefore, laboratory assessments routinely include these measurements. 
 
Indications 
 
Indications for a CBC or hemogram include red cell, platelet, and white cell disorders.  
Examples of these indications are enumerated individually below. 
 
1.  Indications for a CBC generally include the evaluation of bone marrow dysfunction 
as a result of neoplasms, therapeutic agents, exposure to toxic substances, or pregnancy.  
The CBC is also useful in assessing peripheral destruction of blood cells, suspected bone 
marrow failure or bone marrow infiltrate, suspected myeloproliferative, myelodysplastic, 
or lymphoproliferative processes, and immune disorders. 
 
2.  Indications for hemogram or CBC related to red cell (RBC) parameters of the 
hemogram include signs, symptoms, test results, illness, or disease that can be associated 
with anemia or other red blood cell disorder (e.g., pallor, weakness, fatigue, weight loss, 
bleeding, acute injury associated with blood loss or suspected blood loss, abnormal 
menstrual bleeding, hematuria, hematemesis, hematochezia, positive fecal occult blood 
test, malnutrition, vitamin deficiency, malabsorption, neuropathy, known malignancy, 
presence of acute or chronic disease that may have associated anemia, coagulation or 
hemostatic disorders, postural dizziness, syncope, abdominal pain, change in bowel 
habits, chronic marrow hypoplasia or decreased RBC production, tachycardia, systolic 
heart murmur, congestive heart failure dyspnea, angina, nailbed deformities, growth 
retardation, jaundice, hepatomegaly, splenomegaly, lmphadenopathy, ulcers on the lower 
extremities). 
 
3.  Indications for hemogram or CBC related to red cell (RBC) parameters of the 
hemogram include signs, symptoms test results illness, or disease that can be associated 
with polycythemia (for example, fever, chills, ruddy skin, conjunctival redness, cough, 
wheezing, cyanosis, clubbing of the fingers, orthopnea, heart murmur, headache, vague 
cognitive changes including memory changes, sleep apnea, weakness, pruritus, dizziness, 
excessive sweating, visual symptoms, weight loss, massive obesity, gastrointestinal 
bleeding, paresthesias, dyspnea, joint symptoms, epigastric distress, pain and erythema of 
the fingers or toes, venous or arterial thrombosis, thromboembolism, myocardial 
infarction, stroke, transient ischemic attacks, congenital heart disease, chronic obstructive 
pulmonary disease, increased erythropoietin production associated with neoplastic, renal 
or hepatic disorders, androgen or diuretic use, splenomegaly, hepatomegaly, diastolic 
hypertension.) 
 
4.  Specific indication for CBC with differential count related to the WBC include signs, 
symptoms, test results, illness, or disease associated with leukemia, infections or  inflammatory processes, suspected bone marrow failure or bone marrow infiltrate, 
suspected myeloproliferative, myelodysplastic or lymphoproliferative disorder, use of 
drugs that may cause leukopenia, and immune disorders (e.g., fever, chills, sweats, shock, 
fatigue, malaise, tachycardia, tachypnea, heart murmur, seizures, alterations of 
consciousness, meningismus, pain such as headache, abdominal pain, arthralgia, 
odynophagia, or dysuria, redness or swelling of skin, soft tissue bone, or joint, ulcers or 
the skin or mucous membranes, gangrene, mucous membrane discharge, bleeding, 
thrombosis, respiratory failure, pulmonary infiltrate, jaundice, diarrhea, vomiting, 
hepatomegaly, splenomegaly, lymphadenopathy, opportunistic infection such as oral 
candidiasis.) 
 
5.  Specific indication for CBC related to the platelet count include signs, symptoms, test 
results, illness, or disease associated with increased or decreased platelet production and 
destruction, or platelet dysfunction (e.g., gastrointestinal bleeding, genitourinary tract 
bleeding, bilateral epistaxis, thrombosis, ecchymosis, purpura, jaundice, petechiae, fever, 
heparin therapy, suspected DIC, shock, pre-eclampsia, neonate with maternal ITP, 
massive transfusions, recent platelet transfusion, cardiopulmonary bypass, hemolytic 
uremic syndrome, renal diseases, lymphadenopathy, hepatomegaly, splenomegaly, 
hypersplenism, neurologic abnormalities, viral or other infection, myeloproliferative, 
myelodysplastic, or lymphoproliferative disorder, thrombosis, exposure to toxic agents, 
excessive alcohol ingestion, autoimmune disorders (SLE, RA and other). 
 
6.  Indications for hemogram or CBC related to red cell (RBC) parameters of the 
hemogram include, in addition to those already listed, thalassemia, suspected 
hemoglobinopathy, lead poisoning, arsenic poisoning, and spherocytosis.] 
 
7.  Specific indications for CBC related to differential count related to the WBC include, 
in addition to those already listed, storage diseases; mucopolysaccharidoses, and use of 
drugs that case leukocytosis such as G-CSF or CM-CSF. 
 
8.  Specific indications for CBC related to platelet count include, in addition to those 
already listed, May-Hegglin syndrome and Wiskott-Aldrich syndrome. 
 
Limitations 
 
1.  Testing of patients who are asymptomatic, or who do not have a condition that could 
be expected to result in a hematological abnormality, is screening and is not a covered 
service. 
 
2.  In some circumstances it may be appropriate to perform only a hemoglobin or 
hematocrit to assess the oxygen carrying capacity of the blood.  When the ordering 
provider requests only hemoglobin or hematocrit, the remaining components of the CBC 
are not covered. 
  3.  When a blood count is performed for an end-stage renal disease (ESRD) patient, and 
is billed outside the ESRD rate, documentation of the medical necessity for the blood 
count must be submitted with the claim. 
 
4.  In some patients presenting with certain signs, symptoms, or diseases, a single CBC 
may be appropriate.  Repeat testing may not be indicated unless abnormal results are 
found, or unless there is a change in clinical condition.  If repeat testing is performed, a 
more descriptive diagnosis code (e.g., anemia) should be reported to support medical 
necessity.  However, repeat testing may be indicated where results are normal in patients 
with conditions where there is a continued risk for the development of hematologic 
abnormality. 
 
190.16 - Partial Thromboplastin Time (PTT) 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Basic plasma coagulation function is readily assessed with a few simple laboratory tests:  
The PTT, prothrombin time (PT), thrombin time (TT), or a quantitative fibrinogen 
determination.  The PTT test is an in vitro laboratory test used to assess the intrinsic 
coagulation pathway and monitor heparin therapy. 
 
Indications 
 
1.  The PTT is most commonly used to quantitate the effect of therapeutic unfractionated 
heparin and to regulate its dosing.  Except during transitions between heparin and 
warfarin therapy, in general both the PTT and PT are not necessary together to assess the 
effect of anticoagulation therapy.  PT and PTT must be justified separately. 
 
2.  A PTT may be used to assess patients with signs or symptoms of hemorrhage or 
thrombosis.  For example:  Abnormal bleeding, hemorrhage or hematoma petechiae or 
other signs of thrombocytopenia that could be dues to disseminated intravascular 
coagulation; swollen extremity with or without prior trauma. 
 
3.  A PTT may be useful in evaluating patients who have a history of a condition known 
to be associated with the risk of hemorrhage or thrombosis that is related to the intrinsic 
coagulation pathway.  Such abnormalities may be genetic or acquired.  For example: 
dysfibrinogenemia; afibrinogenemia (complete); acute or chronic liver dysfunction or 
failure, including Wilsons disease; hemophilia; liver disease and failure; infectious 
processes; bleeding disorders; disseminated intravascular coagulation; lupus 
erythematosus or other conditions associated with circulating inhibitors e.g., factor VIII 
inhibitor, lupus-like anticoagulant; sepsis; vonWillebrands disease; arterial and venous 
thrombosis, including the evaluation of hypercoagulable states; clinical conditions 
associated with nephrosis or renal failure; other acquired and congenital coagulopathies 
as well as thrombotic states. 
  4.  A PTT may be used to assess the risk of thrombosis or hemorrhage in patients who 
are going to have a medical intervention known to be associated with increased risk of 
bleeding or thrombosis.  An example is as follows: evaluation prior to invasive 
procedures or operations of patients with personal or family history of bleeding or who 
are on heparin therapy. 
 
Limitations 
 
1.  The PTT is not useful in monitoring the effects of warfarin on a patients coagulation 
routinely.  However, a PTT may be ordered on a patient being treated with warfarin as 
heparin therapy is being discontinued.  A PTT may also be indicated when the PT is 
markedly prolonged due to warfarin toxicity. 
 
2.  The need to repeat this test is determined by changes in the underlying medical 
condition and/or dosing of heparin. 
 
3.  Testing prior to any medical intervention associated with a risk of bleeding and 
thrombosis (other than thrombolytic therapy) will generally be considered medically 
necessary only where there are signs or symptoms of a bleeding or thrombotic 
abnormality or a personal history of bleeding, thrombosis or a condition associated with a 
coagulopathy.  Hospital/clinical-specific policies, protocols, etc., in and of themselves, 
cannot alone justify coverage. 
 
190.17 - Prothrombin Time (PT) 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Basic plasma coagulation function is readily assessed with a few simple laboratory tests:  
the partial thromboplastin time (PTT), PT, thrombin time, or a quantitative fibrinogen 
determination.  The PT test is one in-vitro laboratory test used to assess coagulation.  
While the PTT assesses the intrinsic limb of the coagulation system, the PT assesses the 
extrinsic or tissue factor dependent pathway.  Both tests also evaluate the common 
coagulation pathway involving all the reactions that occur after the activation of factor X. 
 
Extrinsic pathway factors are produced in the liver and their production is dependent on 
adequate vitamin K activity.  Deficiencies of factors may be related to decreased 
production of increased consumption of coagulation factors.  The PR/INR is most 
commonly used to measure the effect of warfarin and regulate its dosing.  Warfarin 
blocks the effect of vitamin K on hepatic production of extrinsic pathway factors. 
 
A PT is expressed in seconds and/or as an international normalized ration (INR).  The 
INR is the PT ration that would result if the WHO reference thromboplastin had been 
used in performing the test. 
  Current medical information does not clarify the role of laboratory PT testing in patients 
who are self monitoring.  Therefore, the indications for testing apply regardless of 
whether or not the patient is also PT self-testing. 
 
Indications 
 
1.  A PT may be used to assess patients taking warfarin.  The PT is generally not useful 
in monitoring patients receiving heparin who are not taking warfarin. 
 
2.  A PT may be used to assess patients with signs or symptoms of abnormal bleeding or 
thrombosis.  For example: swollen extremity with or without prior trauma; unexplained 
bruising; abnormal bleeding, hemorrhage, or hematoma; petechiae or other signs or 
thrombocytopenia that could be due to disseminated intravascular coagulation. 
 
3.  A PT may be useful in evaluating patients who have a history of a condition known to 
be associated with the risk of bleeding or thrombosis that is related to the extrinsic 
coagulation pathway.  Such abnormalities may be genetic or acquires.  For example: 
dysfibrinogenemia; afibrinogenemia (complete); acute or chronic liver dysfunction or 
failure, including Wilsons disease and hemochromatosis; disseminated intravascular 
coagulation (DIC); congenital and acquired deficiencies of factors II, V, VII, X; vitamin 
K deficiency; lupus erythematosus; hypercoagulable state; paraproteinemia; lymphoma; 
amyloidosis; acute and chronic leukemias; plasma cell dyscrasia; HIV infection; 
malignant neoplasms; hemorrhagic fever; salicylate poisoning; obstructive jaundice; 
intestinal fistula; malabsorption syndrome; colitis; chronic diarrhea; presence of 
peripheral venous or arterial thrombosis or pulmonary emboli or myocardial infarction; 
patients with bleeding or clotting tendencies; organ transplantation; presence of 
circulating coagulation inhibitors. 
 
4.  APT may be used to assess the risk of hemorrhage or thrombosis in patients who are 
going to have a medical intervention known to be associated with increased risk of 
bleeding or thrombosis.  For example: evaluation prior to invasive procedures or 
operations of patients with personal history of bleeding of a condition associated with 
coagulopathy; prior to the use of thrombolytic medication. 
 
Limitations 
 
1.  When an ESRD patient is tested for PT, testing more frequently than weekly requires 
documentation of medical necessity, e.g., other than chronic renal failure or renal failure 
unspecified. 
 
2.  The need to repeat this test is determined by changes in the underlying medical 
condition and/or the dosing of warfarin.  In a patient on stable warfarin therapy, it is 
ordinarily not necessary to repeat testing more than every two to three weeks.  When 
testing is performed to evaluate a patient with signs or symptoms of abnormal bleeding or 
thrombosis and the initial test result is normal, it is ordinarily not necessary to repeat 
testing unless there is a change in the patients medical status.   
3.  Since the INR is a calculation, it will not be paid in addition to the PT when 
expressed in seconds, and is considered part of the conventional PT test. 
 
4.  Testing prior to any medical intervention associated with a risk of bleeding and 
thrombosis (other that thrombolytic therapy) will generally be considered medically 
necessary only where there are signs or symptoms of a bleeding or thrombotic 
abnormality of a personal history of bleeding, thrombosis or a condition associated with a 
coagulopathy.  Hospital/clinic-specific policies, protocols, etc., in and of themselves, 
cannot alone justify coverage. 
 
190.18 - Serum Iron Studies 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Serum iron studies are useful in the evaluation of disorders of iron metabolism, 
particularly iron deficiency and iron excess.  Iron studies are best performed when the 
patients is fasting in the morning and has abstained form medications that may influence 
iron balance. 
 
Iron deficiency is the most common cause of anemia. In young children on a milk diet, 
iron deficiency is often secondary to dietary deficiency.  In adults, iron deficiency is 
usually the result of blood loss and is only occasionally secondary to dietary deficiency or 
malabsorption. 
 
Following major surgery the patient may have iron deficient erythropoiesis for months or 
years if adequate iron replacement has not been given.  High doses of supplemental iron 
may cause the serum iron to be elevated.  Serum iron may also be altered in acute and 
chronic inflammatory and neoplastic conditions. 
 
Total iron binding capacity (TIBC) is an indirect measure of transferring, a protein that 
binds and transports iron.  TIBC quantifies transferring by the amount of iron that it can 
bind.  TIBC and transferrin are elevated in iron deficiency, and with oral contraceptive 
use, and during pregnancy.  TIBC and transferrin may be decreased in malabsorption 
syndromes or in those affected with chronic diseases.  The percent saturation represents 
the ratio of iron to the TIBC. 
 
Assays for ferritin are also useful in assessing iron balance.  Low concentrations are 
associated with iron deficiency and are highly specific.  High concentrations are found in 
hemosiderosis (iron overload without associated tissue injury) and hemochromatosis 
(iron overload with associated tissue injury).  In these conditions the iron is elevated, the 
TIBC and transferring are within the reference range or low, and the percent saturation is 
elevated.  Serum ferritin can be useful for both initiating and monitoring treatment for 
iron overload. 
  Transferrin and ferritin belong to a group of serum proteins known as acute phase 
reactants, and are increased in response to stressful or inflammatory conditions and also 
can occur with infection and tissue injury due to surgery, trauma or necrosis.  Ferritin and 
iron/TIBC (or transferrin) are affected by acute and chronic inflammatory conditions, and 
in patients with these disorders, tests of iron status may be difficult to interpret. 
 
Indications 
 
1.  Ferritin, iron and either iron binding capacity or transferrin are useful in the 
differential diagnosis or iron deficiency, anemia and for iron overload conditions. 
 
a.  The following presentations are examples that may support the use of these 
studies for elevating iron deficiency:  Certain abnormal blood count values (i.e., 
decreased mean corpuscular volume (MCV), decreased hemoglobin/hematocrit when the 
MCV is low or normal, or increased red cell distribution with width (RDW) and low or 
normal MCV); abnormal appetite (pica); acute or chronic gastrointestinal blood loss; 
hematuria; menorrhagia; malabsorption; status post-gastrectomy; status port-
gastrojejunostomy; malnutrition; preoperative autologous blood collection(s); malignant, 
chronic inflammatory and infectious conditions associated with anemia which may 
present in a similar manner to iron deficiency anemia; following a significant surgical 
procedure where blood loss had occurred and had not been repaired with adequate iron 
replacement. 
 
b.  The following presentations are example that may support the se of these 
studies for evaluating iron overload:  chronic hepatitis; diabetes; hyperpigmentation of 
skin; arthropathy; cirrhosis; hypogonadism; hypopituitarism; impaired porphyrin 
metabolism; heart failure; multiple transfusions; sideroblastic anemia; thalassemia major; 
cardiomyopathy, cardiac dysrhythmias and conduction disturbances. 
 
2.  Follow-up testing may be appropriate to monitor response to therapy, e.g., oral 
or parenteral iron, ascorbic acid, and erythropoietin. 
 
3.  Iron studies may be appropriate in patients after treatment for other nutritional 
deficiency anemia, such as folate and vitamin B12, because iron deficiency may not be 
revealed until such a nutritional deficiency is treated. 
 
4.  Serum ferritin may be appropriate for monitoring iron status in patients with 
chronic renal disease with or without dialysis. 
 
5.  Serum iron may also be indicated for evaluation of toxic effects of iron and 
other metals (e.g., nickel, cadmium, aluminum, lead) whether due to accidental, 
intentional exposure or metabolic causes. 
 
Limitations 
  1.  Iron studies should be used to diagnose and manage iron deficiency or ion overload 
states.  These tests are not to be used solely to assess acute phase reactants where disease 
management will be unchanged.  For example, infections and malignancies are associated 
with elevations in acute phase reactants such as ferritin, and decreases in serum iron 
concentration, but iron studies would only be medically necessary if results or iron 
studies might alter the management of the primary diagnosis or might warrant direct 
treatment of an iron disorder or condition. 
 
2.  If a normal serum ferritin level is documented, repeat testing would not ordinarily be 
medically necessary unless there is a change in the patients condition, and ferritin 
assessment is needed for the ongoing management of the patient.  For example, a patient 
presents with new onset insulin-dependent diabetes mellitus and has a serum ferritin level 
performed for the suspicion of hemochromatosis.  If the ferritin level is normal, the repeat 
ferritin for diabetes mellitus would not be medically necessary. 
 
3.  When an end stage renal disease (ESRD) patient is tested for ferritin, testing more 
frequently than every three months requires documentation of medical necessity (e.g., 
other than chronic renal failure or renal failure, unspecified). 
 
4.  It is ordinarily not necessary to measure both transferring and TIBC at the same time 
because TIBC is an indirect measure of transferrin.  When transferrin is ordered as part of 
the nutritional assessment for evaluating malnutrition, it is not necessary to order other 
iron studies unless iron deficiency or iron overload is suspected as well. 
 
5.  It is not ordinarily necessary to measure both iron/TIBC (or transferrin) and ferritin in 
initial patient testing.  If clinically indicated after evaluation of the initial iron studies, it 
may be appropriate to perform additional iron studies either on the initial specimen of on 
a subsequently obtained specimen.  After a diagnosis of iron deficiency or iron overload 
is established, either iron/TIBC (or transferring) or ferritin may be medically necessary 
for monitoring, but not both. 
 
6.  It would not ordinarily be considered medically necessary to do a ferritin as a 
preoperative test except in the presence of anemia or recent autologous blood collections 
prior to the surgery. 
 
190.19 - Collagen Crosslinks, Any Method 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Collagen crosslinks, part of the matrix of bone upon which bone mineral is deposited, are 
biochemical markers the excretion of which provides a quantitative measurement of bone 
resorption.  Elevated levels of urinary collagen crosslinks indicate elevated bone 
resorption.  Elevated bone resorption contributes to age-related and postmenopausal loss 
of bone leading to osteoporosis and increased risk of fracture.  The collagen crosslinks 
assay can be performed by immunoassay or by high performance liquid chromatography  (HPLC).  Collagen crosslink immunoassays measure the pyridinoline crosslinks and 
associated telopeptides in urine. 
 
Bone is constantly undergoing a metabolic process called turnover or remodeling.  This 
includes a degradation process, bone resorption, mediated by the action of osteoclasts, 
and a building process, bone formation, mediated by the action of osteoblasts.  
Remodeling is required for the maintenance and overall health of bone and is tightly 
coupled; that is, resorption and formation must be in balance.  In abnormal states of bone 
remodeling, when resorption exceeds formation, it results in a net loss of bone.  The 
measurement of specific, bone-derived resorption products provides analytical data about 
the rate of bone resorption. 
 
Osteoporosis is a condition characterized by low bone mass and structural deterioration 
of bone tissue, leading to bone fragility and an increased susceptibility to fractures of the 
hip, spine, and wrist.  The term primary osteoporosis is applied where the causal factor in 
the disease is menopause or aging.  The term secondary osteoporosis is applied where the 
causal factor is something other than menopause or aging, such as long-term 
administration of glucocorticosteroids, endocrine-related disorders (other than loss of 
estrogen due to menopause), and certain bone diseases such as cancer of the bone. 
 
With respect to quantifying bone resorption, collagen crosslink tests can provide adjunct 
diagnostic information in concert with bone mass measurements.  Bone mass 
measurements and biochemical markers may have complementary roles to play in 
assessing effectiveness of osteoporosis treatment.  Proper management of osteoporosis 
patients, who are on long-term therapeutic regimens, may include laboratory testing of 
biochemical markers of bone turnover, such as collagen crosslinks, that provide a profile 
of bone turnover responses within weeks of therapy.  Changes in collagen crosslinks are 
determined following commencement of antiresorptive therapy.  These can be measured 
over a shorter time interval, such as three months, when compared to bone mass density.  
If bone resorption is not elevated, repeat testing is not medically necessary. 
 
Indications 
 
Generally speaking, collagen crosslink testing is useful mostly in fast losers of bone.  
The age when these bone markers can help direct therapy is often pre-Medicare.  By the 
time a fast loser of bone reaches age 65, she will most likely have been stabilized by 
appropriate therapy or have lost so much bone mass that further testing is useless.  
Coverage for bone marker assays may be established, however, for younger Medicare 
beneficiaries and for those men and women who might become fast losers because of 
some other therapy such as glucocorticoids.  Safeguards should be incorporated to 
prevent excessive use of tests in patients for whom they have no clinical relevance. 
 
Collagen crosslinks testing is used to: 
 
1.  Identify individuals with elevated bone resorption, who have osteoporosis in whom 
response to treatment is being monitored.   
2.  Predict response (as assessed by bone mass measurements) to FDA approved 
antiresorptive therapy in postmenopausal women. 
 
3.  Assess response to treatment of patients with osteoporosis, Pagets disease or the 
bone, or risk for osteoporosis where treatment may include FDA approved antiresorptive 
agents, anti-estrogens or selective estrogens receptor moderators. 
 
Limitations 
 
Because of significant specimen to specimen collagen crosslink physiologic variability 
(15-20 percent), current recommendations for appropriate utilization include: one or two 
base-line assays from specified urine collections on separate days; followed by a repeat 
assay about 3 months after starting anti-resorptive therapy; followed by a repeat assay in 
12 months after the 3-month assay; and thereafter not more than annually, unless there is 
a change in therapy in which circumstance an additional test may be indicated 3 months 
after the initiation of new therapy. 
 
Some collagen crosslink assays may not be appropriate for use in some disorders, 
according to FDA labeling restrictions. 
 
190.20 - Blood Glucose Testing 
(Rev. 28, Issued: 02-11-05, Effective:  01-01-05, Implementation:  03-11-05) 
 
This policy is intended to apply to blood samples used to determine glucose levels.  
Blood glucose determination may be done using whole blood, serum or plasma.  It may 
be sampled by capillary puncture, as in the fingerstick method, or by vein puncture or 
arterial sampling.  The method for assay may be by color comparison or an indicator 
stick, by meter assay of whole blood or a filtrate of whole blood, using a device approved 
for home monitoring, or by using a laboratory assay system using serum or plasma.  The 
convenience of the meter or stick color method allows a patient to have access to blood 
glucose values in less than a minute or so and has become a standard of care for control 
of blood glucose, even in the inpatient setting. 
 
Indications 
 
Blood glucose values are often necessary for the management of patients with diabetes 
mellitus, where hyperglycemia and hypoglycemia are often present.  They are also 
critical in the determination of control of blood glucose levels in the patient with 
impaired fasting glucose (FPG 110-125 mg/dL), the patient with insulin resistance 
syndrome and/or carbohydrate intolerance (excessive rise in glucose following ingestion 
of glucose or glucose sources of food), in the patient with a hypoglycemia disorder such 
as nesidioblastosis or insulinoma, and in patients with a catabolic or malnutrition state.  
In addition to those conditions already listed, glucose testing may be medically necessary 
in patients with tuberculosis, unexplained chronic or recurrent infections, alcoholism,  coronary artery disease (especially in women), or unexplained skin conditions (including 
pruritis, local skin infections, ulceration and gangrene without an established cause). 
 
Many medical conditions may be a consequence of a sustained elevated or depressed 
glucose level.  These include comas, seizures or epilepsy, confusion, abnormal hunger, 
abnormal weight loss or gain, and loss of sensation.  Evaluation of glucose may also be 
indicated in patients on medications known to affect carbohydrate metabolism. 
 
Effective January 1, 2005, the Medicare law expanded coverage to diabetic screening 
services.  Some forms of blood glucose testing covered under this national coverage 
determination may be covered for screening purposes subject to specified frequencies.  
See 42 CFR 410.18 and section 90, chapter 18, of the Claims Processing Manual, for a 
full description of this screening benefit. 
 
Limitations 
 
Frequent home blood glucose testing by diabetic patients should be encouraged.  In 
stable, non-hospitalized patients who are unable or unwilling to do home monitoring, it 
may be reasonable and necessary to measure quantitative blood glucose up to four times 
annually. 
 
Depending upon the age of the patient, type of diabetes, degree of control, complications 
of diabetes, and other co-morbid conditions, more frequent testing than four times 
annually may be reasonable and necessary. 
 
In some patients presenting with nonspecific signs, symptoms, or diseases not normally 
associated with disturbances in glucose metabolism, a single blood glucose test may be 
medically necessary.  Repeat testing may not be indicated unless abnormal results are 
found or unless there is a change in clinical condition.  If repeat testing is performed, a 
specific diagnosis code (e.g., diabetes) should be reported to support medical necessity.  
However, repeat testing may be indicated where results are normal in patients with 
conditions where there is a confirmed continuing risk of glucose metabolism abnormality 
(e.g., monitoring glucocorticoid therapy). 
 
190.21 - Glycated Hemoglobin/Glycated Protein 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
The management of diabetes mellitus requires regular determinations of blood glucose 
levels.  Glycated hemoglobin/protein levels are used to assess long-term glucose control 
in diabetes.  Alternative names for these tests include glycated or glycosylated 
hemoglobin or Hgb, hemoglobin glycated or glycosylated protein, and fructosamine. 
 
Glycated hemoglobin (equivalent to hemoglobin A1) refers to total glycosylated 
hemoglobin present in erythrocytes, usually determined by affinity or ion-exchange 
chromatographic methodology.  Hemoglobin A1c refers to the major component of  hemoglobin A1, usually determined by ion-exchange affinity chromatography, 
immunoassay or agar gel electrophoresis.  Fructosamine or glycated protein refers to 
glycosylated protein present in a serum or plasma sample.  Glycated protein refers to 
measurement of the component of the specific protein that is glycated usually by 
colorimetric method or affinity chromatography. 
 
Glycated hemoglobin in whole blood assesses glycemic control over a period of 4-8 
weeks and appears to be the more appropriate test for monitoring a patient who is capable 
of maintaining long-term, stable control.  Measurement may be medically necessary 
every 3 months to determine whether a patients metabolic control has been on average 
within the target range.  More frequent assessment, every 1-2 months, may be appropriate 
in the patient whose diabetes regimen has been altered to improve control or in whom 
evidence is present that intercurrent events may have altered a previously satisfactory 
level of control (for example, post-major surgery or a s a result of glucocorticoid 
therapy).  Glycated protein in serum/plasma assesses glycemic control over a period of 1-
2 weeks.  It may be reasonable and necessary to monitor glycated protein monthly in 
pregnant diabetic women.  Glycated hemoglobin/protein test results may be low, 
indicating significant, persistent hypoglycemia, in nesidioblastosis or insulinoma, 
conditions which are accompanied by inappropriate hyperinsulinemia.  A below normal 
test value is helpful in establishing the patients hypoglycemic state in those conditions. 
 
Indications 
 
Glycated hemoglobin/protein testing is widely accepted as medically necessary for the 
management and control of diabetes.  It is also valuable to assess hyperglycemia, a 
history of hyperglycemia or dangerous hypoglycemia. Glycated protein testing may be 
used in place of glycated hemoglobin in the management of diabetic patients, and is 
particularly useful in patients who have abnormalities of erythrocytes such as hemolytic 
anemia or hemoglobinopathies. 
 
Limitations 
 
It is not considered reasonable and necessary to perform glycated hemoglobin tests more 
often than every 3 months on a controlled diabetic patient to determine whether the 
patients metabolic control has been on average within the target range.  It is not 
considered reasonable and necessary for these tests to be performed more frequently than 
once a month for diabetic pregnant women.  Testing for uncontrolled type one or two 
diabetes mellitus may require testing more than four times a year.  The above section 
provides the clinical basis for those situations in which testing more frequently than four 
times per annum is indicated, and medically necessary documentation must support such 
testing in excess of the above guidelines. 
 
Many methods for the analysis of glycated hemoglobin show significant interference 
from elevated levels of fetal hemoglobin or by variant hemoglobin molecules.  When the 
glycated hemoglobin assay is initially performed in these patients, the laboratory may 
inform the ordering physician of a possible analytical interference.  Alternative testing,  including glycated protein, for example, fructosamine, may be indicated for the 
monitoring of the degree of glycemic control in this situation.  It is therefore conceivable 
that a patient will have both a glycated hemoglobin and glycated protein ordered on the 
same day.  This should be limited to the initial assay of glycated hemoglobin, with 
subsequent exclusive use of glycated protein.  These tests are not considered to be 
medically necessary for the diagnosis of diabetes. 
 
190.22 - Thyroid Testing 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Thyroid function studies are used to delineate the presence of absence of hormonal 
abnormalities of the thyroid and pituitary glands.  These abnormalities may be either 
primary or secondary and often but not always accompany clinically defined signs and 
symptoms indicative of thyroid dysfunction. 
 
Laboratory evaluation of thyroid function has become more scientifically defined.  Tests 
can be done with increased specificity, thereby reducing the number of tests needed to 
diagnose and follow treatment of most thyroid disease.  Measurements of serum sensitive 
thyroid-stimulating hormone (TSH) levels, complemented by determination of thyroid 
hormone levels [free thyroxine (fT-4) or total thyroxine (T4) with Triiodothyronine (T3) 
uptake] are used for diagnosis and follow-up of patients with thyroid disorders. 
 
Additional tests may be necessary to evaluate certain complex diagnostic problems or on 
hospitalized patients, where many circumstances can skew tests results.  When a test for 
total thyroxine (total T4 or T4 radioimmunoassay) or T3 uptake is performed, calculation 
of the free thyroxine index (FTI) is useful to correct for abnormal results for either total 
T4 or T3 uptake due to protein binding effects. 
 
Indications 
 
Thyroid function tests are used to define hyper function, euthyroidism, or hypofunction 
of thyroid disease.  Thyroid testing may be reasonable and necessary to: 
 
  Distinguish between primary and secondary hypothyroidism 
 
  Confirm or rule our primary hypothyroidism 
 
  Monitor thyroid hormone levels (for example, patients with goiter, thyroid 
nodules, or thyroid cancer) 
 
  Monitor dug therapy in patients with primary hypothyroidism 
 
  Confirm or rule out primary hyperthyroidism 
 
  Monitor therapy in patients with hyperthyroidism   
Thyroid function testing may be medically necessary in patients with disease or neoplasm 
of the thyroid and other endocrine glands.  Thyroid function testing may also be 
medically necessary in patients with metabolic disorders; malnutrition; hyperlipidemia; 
certain types of anemia; psychosis and non-psychotic personality disorders; unexplained 
depression; ophthalmologic disorders; various cardiac arrhythmias; disorders of 
menstruation; skin conditions; myalgias; and a wide array of signs and symptoms, 
including alterations in consciousness; malaise; hypothermia; symptoms of the nervous 
and musculoskeletal system; skin and integumentary system; nutrition and metabolism; 
cardiovascular; and gastrointestinal system. 
 
It may be medically necessary to do follow-up thyroid testing in patients with a personal 
history of malignant neoplasm of the endocrine system and in patients on long-term 
thyroid drug therapy. 
 
Limitations 
 
Testing may be covered up to two times a year in clinically stable patients; more frequent 
testing may be reasonable and necessary for patients whose thyroid therapy has been 
altered or in whom symptoms or signs of hyperthyroidism of hypothyroidism are noted. 
 
190.23 - Lipid Testing 
(Rev. 28, Issued: 02-11-05, Effective:  01-01-05, Implementation:  03-11-05) 
 
Lipoproteins are a class of heterogeneous particles of varying sizes and densities 
containing lipid and protein.  These lipoproteins include cholesterol esters and free 
cholesterol, triglycerides, phospholipids and A, C, and E apoproteins.  Total cholesterol 
comprises all the cholesterol found in various lipoproteins. 
 
Factors that affect blood cholesterol levels include age, sex, body weight, diet, alcohol 
and tobacco use, exercise, genetic factors, family history, medications, menopausal 
status, the use of hormone replacement therapy, and chronic disorders such as 
hypothyroidism, obstructive liver disease, pancreatic disease (including diabetes), and 
kidney disease. 
 
In many individuals, an elevated blood cholesterol level constitutes an increased risk of 
developing coronary artery disease.  Blood levels of total cholesterol and various 
fractions of cholesterol, especially low density lipoprotein cholesterol (LDL-C) and high 
density lipoprotein cholesterol (HDL-C), are useful in assessing and monitoring treatment 
for that risk in patients with cardiovascular and related diseases.  Blood levels of the 
above cholesterol components including triglyceride have been separated into desirable, 
borderline and high-risk categories by the National Heart, Lung, and Blood Institute in 
their report in 1993.  These categories form a useful basis for evaluation and treatment of 
patients with hyperlipidemia.  Therapy to reduce these risk parameters includes diet, 
exercise and medications, and fat weight loss, which is particularly powerful when 
combined with diet and exercise.   
Indications 
 
The medical community recognizes lipid testing as appropriate for evaluating 
atherosclerotic cardiovascular disease.  Conditions in which lipid testing may be 
indicated include: 
 
  Assessment of patients with atherosclerotic cardiovascular disease 
 
  Evaluation of primary dyslipidemia 
 
  Any form of atherosclerotic disease, or any disease leading to the formation of 
atherosclerotic disease 
 
  Diagnostic evaluation of diseases associated with altered lipid metabolism, such 
as: nephrotic syndrome, pancreatitis, hepatic disease, and hypo and hyperthyroidism 
 
  Secondary dyslipidemia, including diabetes mellitus, disorders of gastrointestinal 
absorption, chronic renal failure 
 
  Signs or symptoms of dyslipidemias, such as skin lesions 
 
  As follow-up to the initial screen for coronary heart disease (total cholesterol + 
HDL cholesterol) when total cholesterol is determined to be high (>240 mg/dL), or 
borderline-high (200-140 mg/dL) plus two or more coronary heart disease risk factors, or 
an HDL cholesterol, <35 mg/dL. 
 
To monitor the progress of patients on anti-lipid dietary management and pharmacologic 
therapy for the treatment of elevated blood lipid disorders, total cholesterol, HDL 
cholesterol and LDL cholesterol may be used.  Triglycerides may be obtained if the lipid 
fraction is also elevated or if the patient is put on drugs (for example, thiazide diuretics, 
beta blockers, estrogens, glucocorticoids, and tamoxifen) which may raise the triglyceride 
level. 
 
When monitoring long-term anti-lipid dietary or pharmacologic therapy and when 
following patients with borderline high total or LDL cholesterol levels, it may be 
reasonable to perform the lipid panel annually.  A lipid panel at a yearly interval will 
usually be adequate while measurement of the serum total cholesterol or a measured LDL 
should suffice for interim visits if the patient does not have hypertriglyceridemia. 
 
Any one component of the panel or a measured LDL may be reasonable and necessary up 
to six times the first year for monitoring dietary or pharmacologic therapy.  More 
frequent total cholesterol, HDL cholesterol, LDL cholesterol and triglyceride testing may 
be indicated for marked elevations or for changes to anti-lipid therapy due to inadequate 
initial patient response to dietary or pharmacologic therapy.  The LDL cholesterol or total 
cholesterol may be measured three times yearly after treatment goals have been achieved.   
Electrophoretic or other quantitation of lipoproteins may be indicated if the patient has a 
primary disorder of lipoid metabolism. 
 
Effective January 1, 2005, the Medicare law expanded coverage to cardiovascular 
screening services.  Several of the procedures included in this NCD may be covered for 
screening purposes subject to specified frequencies.  See 42 CFR 410.17 and section 100, 
chapter 18, of the Claims Processing Manual, for a full description of this benefit. 
 
Limitations 
 
Lipid panel and hepatic panel testing may be used for patients with severe psoriasis 
which has not responded to conventional therapy and for which the retinoid etretinate has 
been prescribed and who have developed hyperlipidemia or hepatic toxicity.  Specific 
examples include erythrodermia and generalized pustular type and psoriasis associated 
with arthritis. 
 
Routine screening and prophylactic testing for lipid disorder are not covered by 
Medicare.  While lipid screening may be medically appropriate, Medicare by statute does 
not pay for it.  Lipid testing in asymptomatic individuals is considered to be screening 
regardless of the presence of other risk factors such as family history, tobacco use, etc. 
 
Once a diagnosis is established, one or several specific tests are usually adequate for 
monitoring the course of the disease.  Less specific diagnoses (for example, other chest 
pain) alone do not support medical necessity of these tests. 
 
When monitoring long-term anti-lipid dietary of pharmacologic therapy and when 
following patients with borderline high total or LDL cholesterol levels, it is reasonable to 
perform the lipid panel annually.  A lipid panel at a yearly interval will usually be 
adequate while measurement of the serum total cholesterol or a measured LDL should 
suffice for interim visits if the patient does not have hypertriglyceridemia. 
 
Any one component of the panel or a measured LDL may be medically necessary up to 
six times the first year for monitoring dietary or pharmacologic therapy.  More frequent 
total cholesterol, HDL cholesterol, LDL cholesterol and triglyceride testing may be 
indicated for marked elevations or for changes to anti-lipid therapy due to inadequate 
initial patient response to dietary or pharmacologic therapy.  The LDL cholesterol or total 
cholesterol may be measured three times yearly after treatment goals have been achieved. 
 
If no dietary or pharmacologic therapy is advised, monitoring is not necessary. 
 
When evaluating non-specific chronic abnormalities of the liver (for example, elevations 
of transaminase, alkaline phosphatase, abnormal imaging studies, etc.), a lipid panel 
would generally not be indicated more than twice per year. 
 
190.24 - Digoxin Therapeutic Drug Assay  (Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
A digoxin therapeutic drug assay is useful for diagnosis and prevention of digoxin 
toxicity and/or prevention for under dosage of digoxin. 
 
Indications 
 
Digoxin levels may be performed to monitor drugs levels of individuals receiving digoxin 
therapy because the margin of safety between side effects and toxicity is narrow or 
because the blood level may not be high enough to achieve the desired clinical effect. 
 
Clinical indications may include individuals on digoxin: 
 
  With symptoms, signs or electrocardiogram (ECG) suggestive of digoxin toxicity 
 
  Taking medications that influence absorption, bioavailability, distribution, and/or 
elimination of digoxin 
 
  With impaired renal, hepatic, gastrointestinal, or thyroid function 
 
  With pH and/or electrolyte abnormalities 
 
  With unstable cardiovascular status, including myocarditis 
 
  Requiring monitoring of patient compliance 
 
Clinical indication may include individuals: 
 
  Suspected of accidental or intended overdose 
 
  Who have an acceptable cardiac diagnosis and for whom an accurate history of 
use of digoxin is unobtainable 
 
The value of obtaining regular serum digoxin levels is uncertain, but it may be reasonable 
to check levels once yearly after a steady state is achieved.  In addition, it may be 
reasonable to check the level if: 
 
  Heart failure status worsens 
 
  Renal function deteriorates 
 
  Additional medications are added that could affect the digoxin level 
 
  Signs or symptoms of toxicity develop 
  Steady state will be reached in approximately 1 week in patients with normal renal 
function, although 2-3 weeks may be needed in patients with renal impairment.  After 
changes in dosages or the addition of a medication that could affect the digoxin level, it is 
reasonable to check the digoxin level one week after the change or addition.  Based on 
the clinical situation, in cases of digoxin toxicity, testing may need to be done more than 
once a week. 
 
Digoxin is indicated for the treatment of patients with heart failure due to systolic 
dysfunction and for reduction of the ventricular response in patients with atrial fibrillation 
of flutter.  Digoxin may also be indicated for the treatment of other supraventricular 
arrhythmias, particularly in the presence of heart failure. 
 
Limitations 
 
This test is not appropriate for patients on digitoxin or treated with digoxin FAB 
(fragment antigen binding) antibody. 
 
190.25 - Alpha-fetoprotein 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Alpha-fetoprotein (AFP) is a polysaccharide found in some carcinomas.  It is effective as 
a biochemical marker for monitoring the response of certain malignancies to therapy. 
 
Indications 
 
The AFP is useful for the diagnosis of hepatocellular carcinoma in high-risk patients 
(such as alcoholic cirrhosis, cirrhosis of viral etiology, hemochromatosis, and alpha 1-
antitrypsin deficiency) and in separating patients with benign hepatocellular neoplasms or 
metastases from those with hepatocellular carcinoma and, as a non-specific tumor 
associated antigen, serves in marking germ cell neoplasms of the testis, ovary, 
retroperitoneum, and mediastinum. 
 
190.26 - Carcinoembryonic Antigen 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Carcinoembryonic antigen (CEA) is a protein polysaccharide found in some carcinomas.  
It is effective as a biochemical marker for monitoring the response of certain 
malignancies to therapy. 
 
Indications 
 
The CEA may be medically necessary for follow-up of patients with colorectal 
carcinoma.  It would however only be medically necessary at treatment decision-making 
points.  In some clinical situations (e.g., adenocarcinoma of the lung, small cell  carcinoma of the lung, and some gastrointestinal carcinomas) when a more specific 
marker is not expressed by the tumor, CEA may be a medically necessary alternative 
marker for monitoring.  Preoperative CEA may also be helpful in determining the post-
operative adequacy of surgical resection and subsequent medical management.  In 
general, a single tumor marker will suffice in following patients with colorectal 
carcinoma or other malignancies that express such tumor markers. 
 
In following patients who have had treatment for colorectal carcinoma, ASCO guideline 
suggests that if resection of liver metastasis would be indicated, it is recommended that 
post-operative CEA testing be performed every two to three months in patients with 
initial stage II or stage III disease for at least two years after diagnosis. 
 
For patients with metastatic solid tumors, which express CEA, CEA may be measured at 
the start of the treatment and with subsequent treatment cycles to assess the tumors 
response to therapy. 
 
Limitations 
 
Serum CEA determinations are generally not indicated more frequently than once per 
chemotherapy treatment cycle for patients with metastatic solid tumors which express 
CEA or every two months post-surgical treatment for patients who have had colorectal 
carcinoma.  However, it may be proper to order the test more frequently in certain 
situation, for example, when there has been a significant change from prior CEA level or 
a significant change in patient status which could reflect disease progression or 
recurrence. 
 
Testing with a diagnosis of an in situ carcinoma is not reasonably done more frequently 
than once, unless the result is abnormal, in which case the test may be repeated once. 
 
190.27 - Human Chorionic Gonadotropin 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Human Chorionic Gonadotropin (hCG) is useful for monitoring and diagnosis of germ 
cell neoplasms of the ovary, testis, mediastinum, retroperitoneum, and central nervous 
system.  In addition, hCG is useful for monitoring pregnant patients with vaginal 
bleeding, hypertension and/or suspected fetal loss. 
 
It is not reasonable and necessary to perform hCG testing more than once per month for 
diagnostic purposes.  It may be performed as needed for monitoring of patient progress 
and treatment.  Qualitative hCG assays are not appropriate for medically managing 
patients with known or suspected germ cell neoplasms. 
 
190.28 - Tumor Antigen by Immunoassay - CA 125 
(Rev. 47, Issued: 02-24-06, Effective: 01-01-06, Implementation: 01-03-06) 
  Immunoassay determinations of the serum levels of certain proteins or carbohydrates 
serve as tumor markers.  When elevated, serum concentration of these markers may 
reflect tumor size and grade. 
 
This policy specifically addresses tumor antigen CA 125. 
 
Indications 
 
The CA 125 is a high molecular weight serum tumor marker elevated in 80 percent of 
patients who present with epithelial ovarian carcinoma.  It is also elevated in carcinomas 
of the fallopian tube, endometrium, and endocervix.  An elevated level may also be 
associated with the presence of a malignant mesothelioma or primary peritoneal 
carcinoma. 
 
A CA 125 level may be obtained as part of the initial pre-operative work-up for women 
presenting with a suspicious pelvic mass to be used as a baseline for purposes of post-
operative monitoring.  Initial declines in CA 125 after initial surgery and/or 
chemotherapy for ovarian carcinoma are also measured by obtaining three serum levels 
during the first month post treatment to determine the patients CA 125 half-life, which 
has significant prognostic implications. 
 
The CA 125 levels are again obtained at the completion of chemotherapy as an index of 
residual disease.  Surveillance CA 125 measurements are generally obtained every 3 
months for 2 years, every 6 months for the next 3 years, and yearly thereafter.  CA 125 
levels are also an important indicator of a patients response to therapy in the presence of 
advanced or recurrent disease.  In this setting, CA 125 levels may be obtained prior to 
each treatment cycle. 
 
Limitations 
 
These services are not covered for the evaluation of patients with signs or symptoms 
suggestive of malignancy.  The service may be ordered at times necessary to assess either 
the presence of recurrent disease or the patients response to treatment with subsequent 
treatment cycles. 
 
The CA 125 is specifically not covered for aiding in the differential diagnosis of patients 
with a pelvic mass as the sensitivity and specificity of the test is not sufficient.  In 
general, a single tumor marker will suffice in following a patient with one of these 
malignancies. 
 
(This NCD last reviewed November 2005) 
 
190.29 - Tumor Antigen by Immunoassay CA 15-3/CA 27.29 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
  Immunoassay determinations of the serum levels of certain proteins or carbohydrates 
serve as tumor markers.  When elevated, serum concentration of these markers may 
reflect tumor size and grade.  This policy specifically addresses the following tumor 
antigens:  CA 15/3 and CA 27.29 
 
Indications 
 
Multiple tumor markers are available for monitoring the response of certain malignancies 
to therapy and assessing whether residual tumor exists post-surgical therapy. 
 
CA 15-3 is often medically necessary to aid in the management of patients with breast 
cancer.  Serial testing must be used in conjunction with other clinical methods for 
monitoring breast cancer.  For monitoring, if necessary, use consistently either CA 15-3 
or CA 27.29, not both. 
 
CA 27.29 is equivalent to CA 15-3 in its usage in management of patients with breast 
cancer. 
 
Limitations 
 
These services are not covered for the evaluation of patients with signs or symptoms 
suggestive of malignancy.  The service may be ordered at time necessary to assess either 
the presence of recurrent disease or the patients response to treatment with subsequent 
treatment cycles. 
 
190.30 - Tumor Antigen by Immunoassay CA 19-9 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Immunoassay determinations of the serum levels of certain proteins or carbohydrates 
serve as tumor markers.  When elevated, serum concentration of these markers may 
reflect tumor size and grade.  This policy specifically addresses the following tumor 
antigen:  CA 19-9. 
 
Indications 
 
Multiple tumor markers are available for monitoring the response of certain malignancies 
to therapy and assessing whether residual tumor exists post-surgical therapy. 
 
Levels are useful in following the course of patients with established diagnosis of 
pancreatic and biliary ductal carcinoma.  The test is not indicated for diagnosing these 
two diseases. 
 
Limitations 
  These services are not covered for the evaluation of patients with signs or symptoms 
suggestive of malignancy.  The service may be ordered at times necessary to assess either 
the presence of recurrent disease or the patients response to treatment with subsequent 
treatment cycles. 
 
190.31 - Prostate Specific Antigen 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
Prostate Specific Antigen (PSA), a tumor marker for adenocarcinoma of the prostate, can 
predict residual tumor in the post-operative phase of prostate cancer.  Three to six months 
after radical prostatectomy, PSA is reported to provide a sensitive indicator of persistent 
disease.  Six months following introduction of antiandrogen therapy, PSA is reported as 
capable of distinguishing patients with favorable response form those in whom limited 
response is anticipated. 
 
The PSA when used in conjunction with other prostate cancer tests, such as digital rectal 
examination, may assist in the decision making process for diagnosing prostate cancer, 
PSA also, serves as a marker in following the progress of most prostate tumors once a 
diagnosis has been established.  This test is also an aid in the management of prostate 
cancer patients and in detecting metastatic or persistent disease in patients following 
treatment. 
 
Indications 
 
The PSA is of proven value in differentiating benign from malignant disease in men with 
lower urinary tract signs and symptoms (e.g., hematuria, slow urine stream, hesitancy, 
urgency, frequency, nocturia and incontinence) as well as with patients with palpably 
abnormal prostate glands on physician exam, and in patients with other laboratory or 
imaging studies that suggest the possibility of a malignant prostate disorder.  PSA is also 
a marker used to follow the progress of prostate cancer once a diagnosis has been 
established, such as in detecting metastatic or persistent disease in patients who may 
require additional treatment.  PSA testing may also be useful in the differential diagnosis 
of men presenting with as yet undiagnosed disseminated metastatic disease. 
 
Limitations 
 
Generally, for patients with lower urinary tract signs or symptoms, the test is performed 
only once per year unless there is a change in the patients medical condition. 
 
Testing with a diagnosis of in situ carcinoma is not reasonably done more frequently than 
once, unless the result is abnormal, in which case the test may be repeated once. 
 
190.32 - Gamma Glutamyl Transferase 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110   
Gamma glutamyltransferase (GGT) is an intracellular enzyme that appears in blood 
following leakage from cells.  Renal tubules, liver, and pancreas contain high amounts, 
although the measurement of GGT serum is almost always used for assessment of 
hepatobiliary function.  Unlike other enzymes, which are found in heart, skeletal muscle, 
and intestinal mucosa as well as liver, the appearance of an elevated level of GGT is 
serum is almost always the result of liver disease or injury.  It is specifically useful to 
differentiate elevated alkaline phosphatase level when the source of the alkaline 
phosphatase increase (bone, liver, or placenta) is unclear.  The combination of high 
alkaline phosphatase and a normal GGT does not, however, rule out liver disease 
completely. 
 
As well as being a very specific marker of hepatobiliary function, GGT is also a very 
sensitive marker for hepatocellular damage.  Abnormal concentrations typically appear 
before elevations of other liver enzymes or bilirubin are evident.  Obstruction of the 
biliary tract, viral infection (e.g., hepatitis, mononucleosis), metastatic cancer, exposure 
to hepatotoxins (e.g., organic cimetidine, barbiturates, phenytoin, and carbamazepine) all 
can cause a moderate to marked increase in GGT serum concentration.  In addition, some 
drugs can cause or exacerbate liver dysfunction (e.g., atorvastatin, troglitazone, and 
others as noted in FDA Contraindications and Warning.) 
 
The GGT is useful for diagnosis of liver disease or injury, exclusion of hepatobiliary 
involvement related to other disease, and patient management during the resolution of 
existing disease or following injury. 
 
Indications 
 
1.  To provide information about known or suspected hepatobiliary disease, for 
example: 
 
a.  Following chronic alcohol or drug ingestion 
 
b.  Following exposure to hepatotoxins 
 
c.  When using medication known to have a potential for causing liver 
toxicity (e.g., following the drug manufacturers recommendations) 
 
d.  Following infection (e.g., viral hepatitis and other specific infections 
such as amebiasis, tuberculosis, psittacosis, and similar infections) 
 
2.  To assess liver injury/function following diagnosis of primary or secondary 
malignant neoplasms 
 
3.  To assess liver injury/function in a wide variety of disorders and diseases 
known to cause liver involvement (e.g., diabetes mellitus, malnutrition, disorders of 
iron and mineral metabolism, sarcoidosis, amyloidosis, lupus and hypertension)   
4.  To assess liver function related to gastrointestinal disease 
 
5.  To assess liver function related to pancreatic disease 
 
6.  To assess liver function in patients subsequent to liver transplantation 
 
7.  To differentiate between the different sources of elevated alkaline phosphatase 
activity 
 
Limitations 
 
When used to assess liver dysfunction secondary to existing non-hepatobiliary disease 
with no change in signs, symptoms, or treatment, it is generally not necessary to 
repeat a GGT determination after a normal result has been obtained unless new 
indications are present. 
 
If the GGT is the only liver enzyme abnormally high, it is generally not necessary 
to pursue further evaluation for liver disease for this specific indication. 
 
When used to determine if other abnormal enzyme tests reflect liver abnormality 
rather than other tissue, it generally is not necessary to repeat a GGT more than one 
time per week. 
 
Because of the extreme sensitivity of GGT as a marker for cytochrome oxidase 
induction or cell membrane permeability, it is generally not useful in monitoring 
patients with known liver disease. 
 
190.33 - Hepatitis Panel/Acute Hepatitis Panel 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB-02-110 
 
This panel consists of the following tests: 
 
  Hepatitis A antibody (HAAb), IgM antibody; 
 
  Hepatitis B core antibody (HBcAb), IgM antibody; 
 
  Hepatitis B surface antigen (HBsAg) and; 
 
  Hepatitis C antibody; 
 
Hepatitis is an inflammation of the liver resulting from viruses, drugs, toxins, and 
other etiologies.  Viral hepatitis can be due to one of at least five different viruses, 
designated hepatitis A, B, C, and E.  Most cases are caused by hepatitis A virus 
(HAV), hepatitis B virus (HBV), or hepatitis C virus, (HCV).   
The HAV is the most common cause of hepatitis in children and adolescents in the 
United States.  Prior exposure is indicated by a positive IgG anti-HAV.  Acute HAV 
is diagnosed by IgM anti-HAV, which typically appears within four weeks of 
exposure, and which disappears within three months of its appearance.  IgG anti-
HAV is similar in the timing of its appearance, but it persists indefinitely.  Its 
detection indicates prior effective immunization or recovery form infection.  
Although HAV is spread most commonly by fecal-oral exposure, standard immune 
globulin may be effective as a prophylaxis. 
 
The HBV produces three separate antigen (surface, cores and e (envelope) antigens) 
when it infects the liver, although only hepatitis B surface antigen (HBsAg) is 
included as part of this panel.  Following exposure, the body normally responds by 
producing antibodies to each of these antigens; one of which is included in this panel: 
hepatitis B surface antibody (HBsAb)-IgM antibody, HBsAg is the earlier marker, 
appearing in serum four to eight weeks after exposure, and typically disappearing 
within 6 months after its appearance.  If HBsAg remains detectable for greater than 6 
months, this indicates chronic HBV infection.  HBcAb, in the form of both IgG and 
IgM antibodies, are next to appear in serum, typically becoming detectable 2-3 
months following exposure.  The IgM antibody gradually declines or disappears 
entirely 1-2 years following exposure, but the IgG usually remains detectable for life.  
Because HBsAg is present for a relatively short period and usually displays a low 
titer, a negative result does not exclude and HBV diagnosis.  HBcAb, on the other 
hand, rises to a much higher titer and remain elevated for a longer period of time, but 
a positive result is not diagnostic of acute disease, since it may be the result of a prior 
infection.  The last marker to appear in the course of a typical infection is HBsAb, 
which appears in serum 4-6 months following exposure to infected blood or body 
fluids; in the U.S., sexual transmission accounts for 30-60 percent of new cases of 
HBV infection. 
 
The diagnosis of acute HBV infection is best established by documentation of 
positive IgM antibody against the core antigen (HBcAb-IgM) and by identification of 
a positive hepatitis B surface antigen (HBsAg).  The diagnosis of chronic HBV 
infection is established primarily by identifying a positive hepatitis B surface antigen 
(HBsAg) and demonstrating positive IgG antibody directed against the core antigen 
(HBcAb-IgG).  Additional tests such as hepatitis B e antigen (HBeAg) and hepatitis B 
e antibody (HBeAb), the envelope antigen and antibody, are not included in the 
hepatitis panel, but may be of importance in assessing the infectivity of patients with 
HBV.  Following completion of a HBV vaccination series, HBsAB alone may be 
used monthly for up to 6 months, or until a positive result is obtained, to verify an 
adequate antibody response. 
 
HCV is the most common cause of post-transfusion hepatitis; overall HCV is 
responsible for 15-20 percent of all cases of acute hepatitis, and is the most common 
cause of chronic liver disease.  The test most commonly used to identify HCV 
measures HCV antibodies, which appear in blood 2-4 months after infection.  False  positive HCV results can occur.  For example, a patient with a recent yeast infection 
may produce a false positive anti-HCV result.  For this reason, at present positive 
results usually are confirmed by a more specific technique.  Like HBV, HCV is 
spread exclusively through exposure to infected blood or body fluids. 
 
This panel of tests is used for differential diagnosis in a patient with symptoms of 
liver disease or injury.  When the time of exposure or the stage of the disease is not 
known, a patient with continued symptoms of liver disease despite a completely 
negative hepatitis panel may need a repeat panel approximately 2 weeks to 2 months 
later to exclude the possibility of hepatitis.  Once a diagnosis is established, specific 
tests can be used to monitor the course of the disease. 
 
Indications 
 
1.  To detect viral hepatitis infection when there are abnormal liver function test 
results, with or without signs or symptoms of hepatitis. 
 
2.  Prior to and subsequent to liver transplantation. 
 
Limitations 
 
After a hepatitis diagnosis has been established, only individual tests, rather than the 
entire panel, are needed. 
 
190.34 - Fecal Occult Blood Test 
(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable) 
PM AB 02-110 
 
The fecal occult blood test (FOBT) detects the presence of trace amounts of blood in 
stool.  The procedure is performed by testing one or several small samples of one, 
two or three different stool specimens. 
 
This test may be performed with or without evidence of iron deficiency anemia, 
which may be related to gastrointestinal blood loss.  The range of causes for blood 
loss include inflammatory causes, including acid-peptic disease, non-steroidal anti-
inflammatory drug use, hiatal hernia, Crohns disease, ulcerative colitis, 
gastroenteritis, strongyloides, ascariasis, tuberculosis, and enteroamebiasis.  Vascular 
causes included angiodysplasia, hemangiomas, varices, blue rubber bleb nevus 
syndrome, and watermelon stomach.  Tumors and neoplastic causes include 
lymphoma, leiomyosarcoma, lipomas, adenocarcinoma and primary and secondary 
metastases to the GI tract.  Drugs such as nonsteroidal anti-inflammatory drugs also 
cause bleeding.  There are extra gastrointestinal causes such as hemoptysis, epistaxis, 
and oropharyngeal bleeding.  Artifactual causes include hematuria, and menstrual 
bleeding.  In addition, there may be other causes such as coagulopathies, gastrostomy 
tubes or other appliances, factitial causes, and long distance running. 
  Three basic types of fecal hemoglobin assays exist, each directed at a different 
component of the hemoglobin molecule. 
 
1.  Immunoassays recognize antigenic sites on the globin portion and are least 
affected by diet or proximal gut bleeding, but the antigen may be destroyed by fecal 
flora. 
 
2.  The heme-porphyrin assay measures heme-derived porphyrin and is least 
influenced by enterocolic metabolism or fecal storage.  This assay does not 
discriminate dietary from endogenous heme.  The capacity to detect proximal gut 
bleeding reduces its specificity for colorectal cancer screening but makes it more 
useful for evaluating overall GI bleeding in case finding for iron deficiency anemia. 
 
3.  The guaiac-based test is the most widely used.  It requires the peroxidase 
activity of an intact heme moiety to be reactive.  Positivity rates fall with storage.  
Fecal hydration such as adding a drop of water increases the test reactivity but also 
increases false positivity. 
 
Of these three tests, the guaiac-based test is the most sensitive for detecting lower 
bowel bleeding.  Because of this sensitivity, it is advisable, when it is used for 
screening, to defer the guaiac-based test if other studies of the colon are performed 
prior to the test.  Similarly, this tests sensitivity may result in a false positive if the 
patient has recently ingested meat.  Both of these cautions are appropriate when the 
test is used for screening, but when appropriate indications are present, the test should 
be done despite its limitations. 
 
Indications 
 
1.  To evaluate known or suspected alimentary tract conditions that might 
cause bleeding into the intestinal tract. 
 
2.  To evaluate unexpected anemia. 
 
3.  To evaluate abnormal signs, symptoms, or complaints that might be 
associated with loss of blood. 
 
4.  To evaluate patients complaints of black or red-tinged stools. 
 
Limitations 
 
1.  The FOBT is reported once for the testing of up to three separate 
specimens (comprising either one or two tests per specimen). 
 
2.  In patients who are taking non-steroidal anti-inflammatory drugs and have 
a history of gastrointestinal bleeding but no other sign, symptoms, or complaints  associated with gastrointestinal blood loss, testing for occult blood may generally be 
appropriate no more than once every 3 months. 
 
When testing is done for the purpose of screening for colorectal cancer in the absence of 
signs, symptoms, conditions, or complaints associated with gastrointestinal blood loss, 
report he HCPCS code for colorectal cancer screening; fecal-occult blood test, 1-3 
simultaneous determinations) should be used. 
  Transmittals Issued for this Chapter 
 
Rev #  Issue Date  Subject  Impl Date  CR# 
R12112NCD 06/29/2023 Technical Revisions Only to the National  07/31/2023  13220 
Coverage Determination (NCD) Manual, 
Publication (Pub) 100-03 
R11892NCD 03/09/2023 Technical Revisions Only to the National  04/10/2023  13105 
Coverage Determination (NCD) Manual 
R11426NCD 05/20/2022 An Omnibus CR Covering: (1) Removal  07/05/2022  12613 
of Two National Coverage Determination 
(NCDs), (2) Updates to the Medical 
Nutrition Therapy (MNT) Policy, and (3) 
Updates to the Pulmonary Rehabilitation 
(PR), Cardiac Rehabilitation (CR), and 
Intensive Cardiac Rehabilitation (ICR) 
Conditions of Coverage 
R11272NCD 02/18/2022 An Omnibus CR Covering: (1) Removal  07/05/2022  12613 
of Two National Coverage Determination 
(NCDs), (2) Updates to the Medical 
Nutrition Therapy (MNT) Policy, and (3) 
Updates to the Pulmonary Rehabilitation 
(PR), Cardiac Rehabilitation (CR), and 
Intensive Cardiac Rehabilitation (ICR) 
Conditions of Coverage- Rescinded and 
replaced by Transmittal 11426 
R181NCD  03/27/2015 Removal of Multiple National Coverage  04/06/2015  9095 
Determinations Using Expedited Process 
R180NCD  03/06/2015 Removal of Multiple National Coverage  04/06/2015  9095 
Determinations Using Expedited Process 
 Rescinded and replaced by Transmittal 
181 
R173NCD  09/04/2014 Pub 100-03, Chapter 1, Language-only  Upon  8506 
Update  Implementation 
of ICD-10 
R159NCD  02/05/2014 Pub 100-03, Chapter 1, Language-only  10/01/2014  8506 
Update  Rescinded and replaced by 
Transmittal 173 
R131NCD  02/23/2011 Screening for the Human  07/06/2010  6786 
Immunodeficiency Virus (HIV) Infection 
R118NCD  03/23/2010 Screening for the Human  07/06/2010  6786 
Immunodeficiency Virus (HIV) Infection 
 Rescinded and replaced by Transmittal 
131  R113NCD  02/19/2010 Screening for the Human  07/06/2010  6786 
Immunodeficiency Virus (HIV) Infection 
- Rescinded and replaced by Transmittal 
118 
R90NCD  07/25/2008 Prothrombin Time (PT/INR) Monitoring  08/25/2008  6138 
for Home Anticoagulation Management 
R55NCD  05/05/2006 Changes Conforming to CR 3648  10/02/2006  4014 
Instructions for Therapy Services 
R48NCD  03/17/2006 Technical Corrections to the NCD  06/19/2006  4278 
Manual 
R47NCD  02/24/2006 Changes to the Covered Indications for  01/03/2006  4257 
Tumor Antigen by Immunoassay CA 125 
to Add Primary Peritoneal Carcinoma 
R28NCD  02/11/2005 Update of Laboratory NCDs to Reference 03/11/2005  3690 
New Screening Benefits 
R17NCD  07/02/2004 Manualization of the Negotiated Clinical  N/A  2130 
Diagnostic Laboratory National Coverage 
Determinations 
R10NCD  04/06/2004 Re-release of NCD Manual  N/A  N/A 
R01NCD  10/01/2003 Initial Release of Manual  N/A  N/A 
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