Centers for Medicare & Medicaid Services

Content Section

Publication Number

100-3

Manual Section Number

190.17

Version Number

Effective Date of this Version

11/25/2002

Implementation Date

1/1/2003

Benefit Category

Diagnostic Laboratory Tests

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

Item/Service Description

Basic plasma coagulation function is readily assessed with a few simple laboratory tests: the partial thromboplastin time (PTT), PT, thrombin time (TT), 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 or increased consumption of coagulation factors. The PT/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 ratio (INR). The INR is the PT ratio 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 and Limitations of Coverage

Indications

A PT may be used to assess patients taking warfarin. The prothrombin time is generally not useful in monitoring patients receiving heparin who are not taking warfarin.
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 of thrombocytopenia that could be due to disseminated intravascular coagulation.
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 acquired. For example: dysfibrinogenemia; afibrinogenemia (complete); acute or chronic liver dysfunction or failure, including Wilson's 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.
A PT 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 or a condition associated with coagulopathy prior to the use of thrombolytic medication.

Limitations

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.
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 patient's medical status.
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 prothrombin time.
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/clinic-specific policies, protocols, etc., in and of themselves, cannot alone justify coverage.

Note: Scroll down for links to the quarterly Covered Code Lists (including narrative).

Cross Reference

Also see the Medicare Claims Processing Manual, Chapter 120, Clinical Laboratory Services Based on Negotiated Rulemaking.

Transmittal Number

Transmittal Link

http://www.cms.hhs.gov/transmittals/downloads/R17ncd.pdf

Revision History

07/2002 - Implemented NCD. Effective date 11/25/02. Implementation date 1/01/03. (TN AB-02-110) (CR 2130)

07/2004 - Published NCD in the NCD Manual without change to narrative contained in PM AB-02-110. Coding guidance now published in Medicare Lab NCD Manual. Effective and Implementation dates NA. (TN 17) (CR 2130)

Other

Covered Code Lists (including narrative)

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Changes to Lab NCD Edit Software

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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.