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National Coverage Determination (NCD)

Home Prothrombin Time INR Monitoring for Anticoagulation Management

190.11

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Tracking Information

Publication Number
100-3
Manual Section Number
190.11
Manual Section Title
Home Prothrombin Time INR Monitoring for Anticoagulation Management
Version Number
1
Effective Date of this Version
07/01/2002
Ending Effective Date of this Version
03/19/2008
Implementation Date
07/01/2002
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Tests (other)


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

Item/Service Description

Use of the International Normalized Ratio (INR) allows physicians to determine the level of anticoagulation in a patient independent of the laboratory reagents used. The INR is the ratio of the patient's prothrombin time compared to the mean prothrombin time for a group of normal individuals. Maintaining patients within the 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.
Indications and Limitations of Coverage

For services furnished on or after July 1, 2002, Medicare will cover for the use of home prothrombin time INR monitoring for anticoagulation management for patients with mechanical heart valves on Warfarin. Home prothrombin monitoring with the use of INR devices is covered only for patients with mechanical heart valves. The monitor and the home testing must be prescribed by a treating physician as provided at 42 CFR 410.32(a) and the following requirements must be met:

  1. The patient must have been anticoagulated for at least three months prior to use of the home INR device;
  2. The patient must undergo an educational program on anticoagulation management and the use of the device prior to its use in the home; and
  3. Self-testing with the device should not occur more frequently than once a week.
Cross Reference
Claims Processing Instructions

Transmittal Information

Transmittal Number
156
Coverage Transmittal Link
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R156CIM.pdf
Revision History

05/2002 - Provided coverage for patients with mechanical heart valves when certain conditions have been met under the Medicare program. Effective and implementation dates 07/01/2002. (TN 156) (CR 2071)
Other

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
Home Prothrombin Time/International Normalized Ratio (PT/INR) Monitoring for Anticoagulation Management 2 03/19/2008 - N/A View
Home Prothrombin Time INR Monitoring for Anticoagulation Management 1 07/01/2002 - 03/19/2008 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.
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