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Date Printed: October 20, 2017: 11:58 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

01-99000-06

Original Effective Date: 06/15/02

Reviewed: 10/25/12

Revised: 11/01/15

Subject: Home Prothrombin Time Monitoring

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates  
           

DESCRIPTION:

Prothrombin time (PT) is a test to measure blood clotting. Measurement of PT is done for individuals receiving long-term warfarin (Coumadin) therapy for conditions such as artificial heart valves, irregular heartbeat, myocardial infarction, deep vein thrombosis, or cerebrovascular disorders.

Patients who are prescribed chronic warfarin anticoagulation need ongoing monitoring that has generally taken place in a physician’s office or anticoagulation clinic. Home prothrombin monitoring with a U.S. Food and Drug Administration (FDA)-approved device is proposed as an alternative to office or laboratory-based testing.

Warfarin is an effective anticoagulant for the treatment and prevention of venous and arterial thrombosis. Chronic warfarin therapy is recommended in all patients with mechanical heart valves and in some patients with chronic atrial fibrillation (i.e., patients with one high-risk factor or more than one moderate-risk factor). Patients with mechanical heart valves are frequently prescribed anticoagulants at higher levels than patients given anticoagulants for other indications, which puts them at higher risk of complications from warfarin therapy. Appropriate levels of warfarin anticoagulation are monitored with periodic prothrombin time measurements, as measured by the International Normalized Ratio (INR). For example, an INR result greater than 3 indicates a higher risk of serious hemorrhage, while an INR of 6 indicates an increased risk of developing a serious bleed nearly 7 times that of someone with an INR less than 3. In contrast, an INR less than 2 is associated with an increased risk of stroke. Therefore, monitoring of the prothrombin time is recommended to ensure that the prescribed dosing regimens result in INRs within the therapeutic range.

In order for home prothrombin time monitoring to be effective, patients need to be appropriately trained and able to generate INR test results comparable to laboratory measures. Moreover, the clinical impact of home prothrombin time monitoring is related to improved warfarin management. Specifically, home prothrombin time monitoring permits more frequent monitoring and self-management of warfarin therapy with the ultimate goal of 1) increasing the time that the anticoagulation is within a therapeutic INR range (intermediate health outcome); and 2) decreasing the incidence of thromboembolic or hemorrhagic events (final health outcome). Home self-monitoring is typically associated with some form of self-management of warfarin therapy. In some cases, the patient may be supplied with treatment algorithms and instructed to alter the dose based on the results of self-monitoring. In other cases, the patient may be instructed to telephone the results of the self-monitoring and receive further telephonic instructions on warfarin dosage.

There are at least 3 sites/methods of monitoring anticoagulation:

In January 2007, the CoaguChek XS System (patient self-testing) (Roche Diagnostics Corporation) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. The FDA determined that this device was substantially equivalent to existing devices, including the CoaguChek SX System (professional, cleared in 2006). Other than a labeling change, the device is identical to the professional version of the CoaguChek XS System. The patient self-testing system is intended for self-monitoring of prothrombin time in patients who are on a stable regimen of anticoagulation medications.

Previously, the ProTime Microcoagulation System (International Technidyne Corporation) was cleared for marketing by the FDA in 1995 for professional use and in 1997 for home use.

POSITION STATEMENT:

Home prothrombin time INR monitoring for anticoagulation management meets the definition of medical necessity when ALL of the following criteria are met:

Home prothrombin time monitoring is considered experimental or investigational for other indications, as there is insufficient clinical evidence to support safety and efficacy in the use of these devices for applications other than those listed above.

BILLING/CODING INFORMATION:

HCPCS Coding:

99363

Anticoagulant management for an outpatient taking warfarin, physician review and interpretation of International Normalized Ratio (INR) testing, patient instructions, dosage adjustment (as needed), and ordering of additional tests; initial 90 days of therapy (must include a minimum of 8 INR measurements) each subsequent 90 days of therapy (must include a minimum of 3 INR measurements)

G0248

Demonstration, prior to initiation of home INR monitoring, for patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria, under the direction of a physician; includes: face-to-face demonstration of use and care of the INR monitor, obtaining at least one blood sample, provision of instructions for reporting home INR test results, and documentation of a patient’s ability to perform testing and report results

G0249

Provision of test materials and equipment for home INR monitoring of patient with either mechanical valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria, includes: provision of materials for use in the home and reporting of test results to physician; not occurring more frequently than once a week; testing materials, billing units of service include 4 tests

G0250

Physician review; interpretation, and patient management of home INR testing for a patient with either mechanical heart valve(s), chronic atrial fibrillation, or venous thromboembolism who meets Medicare coverage criteria; testing not occurring more frequently than once a week; billing units of service include 4 tests

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

D68.51 – D68.59

Primary thrombophilia

D68.61 – D68.69

Other thrombophilia

I26.01 – I26.09

Pulmonary embolism with acute cor pulmonale

I26.90 – I26.99

Pulmonary embolism without acute cor pulmonale

I48.0

Paroxysmal atrial fibrillation

I48.2

Chronic atrial fibrillation

I48.91

Unspecified atrial fibrillation

I80.00 – I80.9

Phlebitis and Thrombophlebitis

I82.211

Chronic embolism and thrombosis of superior vena cava

I82.221

Chronic embolism and thrombosis of inferior vena cava

I82.291

Chronic embolism and thrombosis of other thoracic veins

I82.401 – I82.5Z9

Embolism and thrombosis of deep veins of lower extremity

I82.701 – I82.729

Chronic embolism and thrombosis of veins of upper extremity

I82.811 – I82.891

Embolism and thrombosis of other specified veins

I82.A21 – I82.A29

Chronic embolism and thrombosis of axillary vein

I82.B21 – I82.B29

Chronic embolism and thrombosis of unspecified vein

I82.C21 – I82.C29

Chronic embolism and thrombosis of internal jugular vein

I84.401 – I82.599

Venous embolism and thrombosis of deep veins of lower extremity

Z95.2

Presence of prosthetic heart valve

REIMBURSEMENT INFORMATION:

For codes G0249 and G0250, billing units of services include 4 tests (1 unit = 4 tests). G0249 and G0250 should not be billed more than once every 4 weeks.

Physician management of a patient self-testing with a home prothrombin time monitor may be billed under CPT codes 99363 and 99364.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: Home Prothrombin.

DEFINITIONS:

No guideline-specific definitions apply.

RELATED GUIDELINES:

None applicable.

OTHER:

Index terms:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

CoaguChek Device
Home Monitoring, Protime
Prothrombin self-monitoring
Prothrombin Time Self-Monitoring
Prothrombin Time, Home Monitoring
ProTime Device

REFERENCES:

  1. AHRQ Agency for Healthcare Research and Quality. NGC:007743. Guideline Summary: Outpatient management of uncomplicated deep venous thrombosis. Michigan Quality Improvement Consortium. 2010 Mar. 1 p.
  2. American College of Chest Physicians (ACCP), The Seventh ACCP Conference on Antithrombotic and Thrombotic Therapy Evidence Based Guidelines. Chest 2004; 126; 172-173, (09/04).
  3. Ansell J, Hirsh J, Hylek E et al. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133(6 Suppl):160S-198S.
  4. Blue Cross Blue Shield Association Medical Policy Reference Manual. 1.01.14 – Home Prothrombin Time Monitoring, (March 2012).
  5. Canadian Agency for Drugs and Technologies in Health (CADTH). Devices for Point-of-Care Monitoring of Long-Term Oral Anticoagulation Therapy: Clinical and Cost Effectiveness. (02/07).
  6. Centers for Medicare and Medicaid Services (CMS) HCPCS Level II coding (current edition).
  7. Centers for Medicare and Medicare Services (CMS) National Coverage Determination for Home Prothrombin Time INR Monitoring for Anticoagulation Management, Publication 100-3, Section 190.11, (03/19/08). Updated 08/25/08. (Accessed 09/19/12).
  8. Centers for Medicare and Medicare Services (CMS) Program Memorandum, Transmittal AB-02-180, Change Request 2323, (12/27/02).
  9. Centers for Medicare and Medicare Services (CMS) Program Memorandum, Transmittal 90, Change Request 6138, (03/19/08).
  10. Centers for Medicare and Medicare Services (CMS), Coverage Issues-Diagnostic Services 50-56 Home Prothrombin Time International Normalized Ratio (INR) Monitoring for Anticoagulation Management, (accessed 08/21/06 at CMS website).
  11. ClinicalTrials.gov. NCT00032591. The Home INR Study (THINRS), Department of Veterans Affairs. Last Updated on 01/25/12. (Accessed 09/24/12).
  12. ClinicalTrials.gov. NCT00978445. Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System (vMetrics-AMS). The Cleveland Clinic and ZIN Technologies, Inc. Last Updated on 05/31/12. (Accessed 09/24/12).
  13. Connock M, Stevens C, Fry-Smith A, Jowett S, Fitzmaurice D, Moore D, Song F. Clinical effectiveness and cost-effectiveness of different models of managing long-term oral anticoagulation therapy: a systematic review and economic modelling. Health Technol Assess. 2007 Oct;11(38):iii-iv, ix-66.
  14. ECRI Target Report: #753, “Portable devices for home monitoring of oral anticoagulation therapy”, (04/03/07).
  15. ECRI Institute Health Technology Trends: Remote patient monitoring industry grows as hospitalization costs rise. 04/01/12.
  16. ECRI Institute Health Technology Trends: CMS supports in-home tests for sleep apnea and anticoagulation therapy; proposes covering CPAP treatment trial. 03/01/08.
  17. Florida Medicare Part B Local Medical Review Policy – Home Prothrombin Time International Normalized Ratio (INR) Monitoring (G0248), 07/01/02 (retired 05/03/05).
  18. Gardiner C, Longair I, Pescott MA et al. Self-monitoring of oral anticoagulation: does it work outside trial conditions? J Clin Pathol 2009; 62(2):168-71.
  19. Hayes, Inc. Medical Technology Directory. Self-Monitoring of Oral Anticoagulant Therapy. (04/02, updated 11/09/07).
  20. HCFA Medicare Coverage Policy Decisions Tracking Sheet – Home Prothrombin Time (INR) Monitor for Anticoagulation Management (#CAG-00087A), 01/29/01.
  21. HCPCS Level II coding (current edition).
  22. Hiratzka LF, Bakris GL, et al. Practice Guideline: ACCF/AHA/AATS/ACR/ASA/ SCA/SCAI/SIR/STS/SVM Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease. J Am Coll Cardiol, 2010; 55:27-129, doi: 10.1016. j.jacc.2010.02.015.
  23. Hirsh J, Fuster V, Ansell J, Halperin J. American Heart Association/American College of Cardiology Foundation Guide to Warfarin Therapy. Circulation. 2003; 107:1692-711. (Accessed 09/28/11).
  24. Holbrook A, Schulman S, Witt DM, Vandvik PO, Fish J, Kovacs MJ, Svensson PJ, Veenstra DL, Crowther M, Guyatt GH. Evidence-based management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012 Feb;141.
  25. Holmes Jr DR, Becker JA, Granger CB, Limacher MC, Page II RL, Sila C. American College of Cardiology Foundation/American Heart Association 2011 Health Policy Statement on Therapeutic Interchange and Substitution: A Report of the American College of Cardiology Foundation Clinical Quality Committee. J Am Coll Cardiol, 2011; 58:1287-1307, doi:10.1016/j.jacc.2011.06.001.
  26. Schwandt A. MetroHealth Medical Center/University Hospitals of Cleveland, Case Western University School of Medicine. Case Study: Personalizing Anticoagulation: Determination of Warfarin Dosing. Copyright ©2011 American Society of Hematology.
  27. St. Anthony’s ICD-9 Coding (current edition).
  28. U.S. Food and Drug Administration, 510(k) – K994006 Avocet AcuSure System (for patient self-testing), 11/22/99.
  29. Warnes CA, Williams RD, et al. Practice Guideline: ACC/AHA 2008 Guidelines for the Management of Adults with Congenital Heart Disease. J Am Coll Cardiol, 2008; 52:143-263, doi:10.1016/j.jacc.2008.10.001.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 10/25/12.

GUIDELINE UPDATE INFORMATION:

05/15/01

New Medical Coverage Guideline.

08/15/02

Coverage criteria and HCPCS codes added for Medicare & More.

11/15/02

Revised description section to include information for patients with mechanical heart valves. Added coverage statement for at home monitoring for anticoagulation management of patients with mechanical heart valves on warfarin.

07/15/04

Scheduled review; no changes.

03/15/05

Revision consisting of change in policy number; typographical corrections.

05/15/06

Revision consisting of the addition of clarification regarding provider type.

10/15/06

Scheduled review; no change in coverage statement; added Medicare as the source for the coding information regarding the G codes.

10/15/07

Reviewed; expanded coverage criteria; added coding notation regarding monitoring devices provided by DME suppliers; reformatted guideline; updated references.

10/15/08

Scheduled review; revise position statement to include requirement for long term anticoagulation (>1 year), and self testing must be performed on a weekly basis. Add Medicare exception. Revise HCPCS code descriptors. Update ICD 9 codes. Update references.

02/15/09

Remove notes referring to code E1399.

04/06/09

HCPCS codes descriptors updated.

10/15/09

Scheduled review; no change in position statement. Update description section. Update reimbursement statement to include CPT codes 99363 and 99364.

10/15/10

Revision; related ICD-10 codes added.

10/15/11

Revision; reimbursement information updated.

11/15/11

Scheduled review. Position statement maintained; updated description section and references.

04/01/12

Revision; updated ICD10 coding with new and revised codes.

11/15/12

Scheduled review. Position statement maintained; revised description, CPT coding, ICD9/ICD10 coding and index terms; updated references and reformatted guideline.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: October 20, 2017: 11:58 AM