National Coverage Determination (NCD)

Laboratory Tests - CRD Patients


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Tracking Information

Publication Number
Manual Section Number
Manual Section Title
Laboratory Tests - CRD Patients
Version Number
Effective Date of this Version
Ending Effective Date of this Version
Implementation Date
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Laboratory Tests

Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description
Indications and Limitations of Coverage

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
  • Serum Creatinine

Per Week or Thirteen Per Quarter

  • BUN


  • CBC
  • Serum Calcium
  • Serum Potassium
  • Serum Chloride
  • Serum Bicarbonate
  • Serum Phosphorous
  • Total Protein
  • Serum Albumin
  • Alkaline Phospatase
  • LDH

Guidelines for tests other than those routinely performed include:

  • Serum Aluminum - one every 3 months
  • 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), 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 Serologic Status HBsAg Patients Anti-HBs Patients
Unvaccinated Susceptible Monthly Semiannually
Unvaccinated HBsAg Carrier Annually None
Unvaccinated Anti-HBs-Positive 1 None Annually
Vaccinated Anti-HBs-Positive 1 None Annually
Vaccinted 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, be sure it meets the conditions of coverage for independent laboratories.

Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
Revision History

06/1997 - Clarified existing policy that Medicare will only pay separately for tests in excess of number included in computation of composit payment rate. Effective date 10/01/1997. (TN 101)

02/1997 - Eliminated certain tests from list of separately billable lab tests that are covered routinely without documentation of medial necessity. Effective date 07/01/1997. (TN 91)

10/1991 - Included hemoglobin as routinely covered test for CRD patient. Effective date 11/12/1991. (TN 53)


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Laboratory Tests - CRD Patients 1 10/01/1997 - N/A You are here
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.