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Clinical Laboratory Tests: National Coverage Determinations
Effective January 1, 2003, the Centers for Medicare & Medicaid Services (CMS) implemented National Coverage Determinations (NCDs) for various clinical laboratory tests. NCDs apply to all Medicare Fee for Service contractors and provide a uniform set of instructions for processing claims for these services. NCDs for these tests specify:
- Indications - in what circumstances is the test considered 'medically necessary'?
- Limitations - in what circumstances is the test contraindicated? Are there frequency parameters for Medicare coverage?
- CPT or HCPCS codes included in the NCD
- ICD-9-CM codes covered by the Medicare program
Coverage Alert
Among claims submitted to Palmetto GBA in July and August 2008, denials due to NCDs are the 10th most common reason for denial. The top five CPT codes denied for this reason are:
- 84153: Prostate specific antigen (PSA); total
- 80061: Lipid panel
- 83036: Hemoglobin; glycosylated (A1C)
- 85610: Prothrombin time
- 84443: Thyroid stimulating hormone (TSH)
Other Facts about Clinical Laboratory Tests
- Be aware of coverage restrictions before you submit a claim. If Medicare will not cover the test based on the patient's condition, you may ask the patient to sign an Advance Beneficiary Notice (ABN).
- The covered ICD-9-CM code list changes as often as quarterly for these NCDs. The list may differ depending upon the date of service.
- The ICD-9-CM code reported on the claim must be the most specific code available that accurately reflects the primary reason the test was ordered/performed
- The patient's medical record must support the use of the ICD-9-CM code(s) reported on the claim
- Certain ICD-9-CM codes are designated as 'never covered' by Medicare
- NCDs exist for other clinical laboratory tests
Ordering Physicians and Providers
If you are ordering a clinical laboratory test from an independent laboratory, supply the laboratory with:
- The specific ICD-9-CM code that reflects the reason you are ordering the test. If a diagnosis has not been established, code the signs and/or symptoms.
- Information about the patient's insurance coverage, including his or her Medicare Health Insurance Claim number and any insurance that is primary to Medicare
- The National Provider Identifier (NPI) of the referring physician or provider
- A copy of the Advance Beneficiary Notice, if you obtained a signed copy from the patient prior to sending the specimen to the laboratory
NCDs for Clinical Laboratory Tests
23 NCDs were implemented as part of the final rule, published in the Federal Register on November 23, 2001 (66 FR 58788):
- Alpha-fetoprotein
- Blood Counts
- Blood Glucose Testing
- Carcinoembryonic Antigen
- Collagen Crosslinks, Any Method
- Digoxin Therapeutic Drug Assay
- Fecal Occult Blood Test
- Gamma Glutamyl Transferase
- Glycated Hemoglobin/Glycated Protein
- Hepatitis Panel/Acute Hepatitis Panel
- Human Chorionic Gonadotropin
- Human Immunodeficiency Virus (HIV) Testing (Prognosis Including Monitoring)
- Human Immunodeficiency Virus (HIV) Testing (Diagnosis)
- Lipid Testing
- Partial Thromboplastin Time (PTT)
- Prostate Specific Antigen
- Prothrombin Time (PT)
- Serum Iron Studies
- Thyroid Testing
- Tumor Antigen by Immunoassay CA125
- Tumor Antigen by Immunoassay CA 15-3/CA 27.29
- Tumor Antigen by Immunoassay CA 19-9
- Urine Culture, Bacterial
Resources
- The complete NCD for each of these clinical laboratory tests is available on the CMS Web site at www.cms.hhs.gov/mcd and in the CMS Internet Only manuals (www.cms.hhs.gov/manuals), Pub. 100-03.
- Refer to the 'Medicare National Coverage Determinations Coding Policy Manual and Change Report' for information regarding:
- Specific CPT and HCPCS codes included in the NCD
- Covered ICD-9-CM codes (part of the 'laboratory edit module')
- ICD-9-CM codes that are 'never covered' for any laboratory NCD
- You may also download the entire Lab Code List from this Web page
- For more information on ABNs, refer to the Beneficiary Notices Initiative page on the CMS Web site at www.cms.hhs.gov/BNI/01_overview.asp
- MLN Matters articles will be published as changes are made to the laboratory edit module. Palmetto GBA will publish this information on our Web site as it becomes available.