Clinical Medical Policy Department Clinical Affairs Division DESCRIPTION

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1 Prothrombin Time/International Normalized Ratio (PT/INR) Monitor for Home Anticoagulation Management [For the list of services and procedures that need preauthorization, please refer to Go to Comunicados a Proveedores, and click Cartas Circulares.] Medical Policy: MP-ME Original Effective Date: November 20, 2008 Revised : October 31, 2017 Next Revision: October, 2018 This policy applies to products subscribed by the following corporations, MCS Life Insurance Company (Commercial), and MCS Advantage, Inc. (Classicare) and, provider s contract; unless specific contract limitations, exclusions or exceptions apply. Please refer to the member s benefit certification language for benefit availability. Managed care guidelines related to referral authorization, and precertification of inpatient hospitalization, home health, home infusion and hospice services apply subject to the aforementioned exceptions. DESCRIPTION Anticoagulant therapy drugs - (Warfarin) Is a prescription drug that interferes with normal blood clotting (coagulation), it is also called an anticoagulant. Many people refer to these drugs as "blood thinners," although they do not actually cause the blood to become less thick, only less likely to clot. The normal clotting mechanism is a complex process that involves multiple substances (clotting factors). These factors are produced by the liver and act in sequence to form a blood clot. In order for the liver to produce some of the clotting factors, adequate amounts of vitamin K must be available. Warfarin blocks one of the enzymes that uses vitamin K to make some of the clotting factors, and in turn reduces their production. As a result, the clotting mechanism is disrupted and it takes longer for the blood to clot. The goal of warfarin therapy is to decrease the clotting tendency of blood, but not to prevent clotting completely. Therefore, the blood's ability to clot must be carefully monitored while a person takes warfarin. The dose of warfarin is adjusted to maintain the clotting time within a target range, based on the results of periodic blood tests. These tests can be done in a laboratory or using a portable device at home. According to the scientific literature, Prothrombin time (PT) is the most frequently used method of monitoring the therapeutic effectiveness of Warfarin. PT is a test that measures the amount of time it takes for a person s blood to clot. They describe at least 3 methods of monitoring anticoagulation: Physician s office usually once a month. Anticoagulation clinics usually once every 2-3 weeks. Home prothrombin time monitors. A PT/INR Home Monitoring System is a portable testing device that includes a finger-stick and an FDAcleared meter that measures the time it takes for a person s blood plasma to clot. The approach of the 1

2 PT/INR home monitoring system is similar to home blood glucose monitoring for diabetics. Patient selftesting and self-management with 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. COVERAGE Benefits may vary between groups and contracts. Please refer to the appropriate member certificate and subscriber agreement contract for applicable diagnostic imaging, DME, laboratory, machine tests, benefits and coverage. INDICATIONS I., (MCS) will consider medically necessary the use of Home Prothrombin Time Testing to monitor chronic oral anticoagulation for members on Warfarin: 1. With mechanical heart valves; or 2. Chronic atrial fibrillation; or 3. Venous thromboembolism (inclusive of deep venous thrombosis and pulmonary embolism). II. The Monitor and the Home testing must be prescribed by a treating physician and ALL the following requirements must be met: 1. The patient must have been anticoagulated for at least 3 months prior to use of the home INR device and require long term anticoagulation (1 year or longer). 2. The patient must require weekly determinations of PT/INR values to ensure that the patient s PT/INR is in the therapeutic range. 3. The patient or caregiver must undergo a face to face educational program on anticoagulation management and must have demonstrated the correct use of the device prior to its use in the home. 4. The patient continues to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring. 5. Self-testing with the device should not occur more frequently than once a week. CONTRAINDICATIONS / LIMITATIONS 1. Porcine valves are not included in this policy, therefore MCS will not make payment on Home INR Monitoring for patients with porcine valves. 2

3 CODING INFORMATION HCPCS CODES (List may not be all inclusive) HCPCS CODES DESCRIPTION G0248 G0249 G0250 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: faceto-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 patient s ability to perform testing and report. Provision of test materials and equipment for home INR monitoring of patient with either mechanical heart 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; testing not occurring more frequently than once a week; testing materials, billing units of service include 4 tests. 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 HCPCS LEVEL II Professional Edition (American Medical Association). ICD-10 Codes (List may not be all inclusive) ICD-10-Codes DESCRIPTION D68.51 Activated protein C resistance D68.52 Prothrombin gene mutation D68.59 Other primary thrombophilia D68.61 Antiphospholipid syndrome D68.62 Lupus anticoagulant syndrome I26.01 Septic pulmonary embolism with acute cor pulmonale I23.6 Thrombosis of atrium, auricular appendage, and ventricle as current complications following acute myocardial infarction I26.09 Other pulmonary embolism with acute cor pulmonale I26.90 Septic pulmonary embolism without acute cor pulmonale I26.99 Other pulmonary embolism without acute cor pulmonale I27.82 Chronic pulmonary embolism I48.0 Paroxysmal atrial fibrillation I48.1 Persistent atrial fibrillation I48.2 Chronic atrial fibrillation I48.91 Unspecified atrial fibrillation I67.6 Nonpyogenic thrombosis of intracranial venous system I80.00 Phlebitis and thrombophlebitis of superficial vessels of unspecified lower 3

4 I80.01 Phlebitis and thrombophlebitis of superficial vessels of right lower I80.02 Phlebitis and thrombophlebitis of superficial vessels of left lower I80.03 Phlebitis and thrombophlebitis of superficial vessels of lower extremities, I80.10 Phlebitis and thrombophlebitis of unspecified femoral vein I80.11 Phlebitis and thrombophlebitis of right femoral vein I80.12 Phlebitis and thrombophlebitis of left femoral vein I80.13 Phlebitis and thrombophlebitis of femoral vein, I Phlebitis and thrombophlebitis of unspecified deep vessels of right lower I Phlebitis and thrombophlebitis of unspecified deep vessels of left lower I Phlebitis and thrombophlebitis of unspecified deep vessels of lower extremities, I Phlebitis and thrombophlebitis of unspecified deep vessels of unspecified lower I Phlebitis and thrombophlebitis of right iliac vein I Phlebitis and thrombophlebitis of left iliac vein I Phlebitis and thrombophlebitis of iliac vein, I Phlebitis and thrombophlebitis of unspecified iliac vein I Phlebitis and thrombophlebitis of right popliteal vein I Phlebitis and thrombophlebitis of left popliteal vein I Phlebitis and thrombophlebitis of popliteal vein, I Phlebitis and thrombophlebitis of unspecified popliteal vein I Phlebitis and thrombophlebitis of right tibial vein I Phlebitis and thrombophlebitis of left tibial vein I Phlebitis and thrombophlebitis of tibial vein, I Phlebitis and thrombophlebitis of unspecified tibial vein I Phlebitis and thrombophlebitis of other deep vessels of right lower I Phlebitis and thrombophlebitis of other deep vessels of left lower I Phlebitis and thrombophlebitis of other deep vessels of lower, I Phlebitis and thrombophlebitis of other deep vessels of unspecified lower I80.3 Phlebitis and thrombophlebitis of lower extremities, unspecified I80.8 Phlebitis and thrombophlebitis of other sites I80.9 Phlebitis and thrombophlebitis of unspecified site I82.0 Budd-Chiari syndrome I82.1 Thrombophlebitis migrans I Acute embolism and thrombosis of superior vena cava I Chronic embolism and thrombosis of superior vena cava I Acute embolism and thrombosis of inferior vena cava I Chronic embolism and thrombosis of inferior vena cava 4

5 I Acute embolism and thrombosis of other thoracic veins I Chronic embolism and thrombosis of other thoracic veins I82.3 Embolism and thrombosis of renal vein I Acute embolism and thrombosis of unspecified deep veins of right lower I Acute embolism and thrombosis of unspecified deep veins of left lower I Acute embolism and thrombosis of unspecified deep veins of lower, I Acute embolism and thrombosis of unspecified deep veins of unspecified lower I Acute embolism and thrombosis of right femoral vein I Acute embolism and thrombosis of left femoral vein I Acute embolism and thrombosis of femoral vein, I Acute embolism and thrombosis of unspecified femoral vein I Acute embolism and thrombosis of right iliac vein I Acute embolism and thrombosis of left iliac vein I Acute embolism and thrombosis of iliac vein, I Acute embolism and thrombosis of unspecified iliac vein I Acute embolism and thrombosis of right popliteal vein I Acute embolism and thrombosis of left popliteal vein I Acute embolism and thrombosis of popliteal vein, I Acute embolism and thrombosis of unspecified popliteal vein I Acute embolism and thrombosis of right tibial vein I Acute embolism and thrombosis of left tibial vein I Acute embolism and thrombosis of tibial vein, I Acute embolism and thrombosis of unspecified tibial vein I Acute embolism and thrombosis of other specified deep vein of right lower I Acute embolism and thrombosis of other specified deep vein of left lower I Acute embolism and thrombosis of other specified deep vein of lower, I Acute embolism and thrombosis of other specified deep vein of unspecified lower I82.4Y1 Acute embolism and thrombosis of unspecified deep veins of right proximal lower I82.4Y2 Acute embolism and thrombosis of unspecified deep veins of left proximal lower I82.4Y3 Acute embolism and thrombosis of unspecified deep veins of proximal lower, I82.4Y9 Acute embolism and thrombosis of unspecified deep veins of unspecified proximal lower 5

6 I82.4Z1 Acute embolism and thrombosis of unspecified deep veins of right distal lower I82.4Z2 Acute embolism and thrombosis of unspecified deep veins of left distal lower I82.4Z3 Acute embolism and thrombosis of unspecified deep veins of distal lower, I82.4Z9 Acute embolism and thrombosis of unspecified deep veins of unspecified distal lower I Chronic embolism and thrombosis of unspecified deep veins of right lower I Chronic embolism and thrombosis of unspecified deep veins of left lower I Chronic embolism and thrombosis of unspecified deep veins of lower, I Chronic embolism and thrombosis of unspecified deep veins of unspecified lower I Chronic embolism and thrombosis of right femoral vein I Chronic embolism and thrombosis of left femoral vein I Chronic embolism and thrombosis of femoral vein, I Chronic embolism and thrombosis of unspecified femoral vein I Chronic embolism and thrombosis of right iliac vein I Chronic embolism and thrombosis of left iliac vein I Chronic embolism and thrombosis of iliac vein, I Chronic embolism and thrombosis of unspecified iliac vein I Chronic embolism and thrombosis of right popliteal vein I Chronic embolism and thrombosis of left popliteal vein I Chronic embolism and thrombosis of popliteal vein, I Chronic embolism and thrombosis of unspecified popliteal vein I Chronic embolism and thrombosis of right tibial vein I Chronic embolism and thrombosis of left tibial vein I Chronic embolism and thrombosis of tibial vein, I Chronic embolism and thrombosis of unspecified tibial vein I Chronic embolism and thrombosis of other specified deep vein of right lower I Chronic embolism and thrombosis of other specified deep vein of left lower I Chronic embolism and thrombosis of other specified deep vein of lower, I Chronic embolism and thrombosis of other specified deep vein of unspecified lower I82.5Y1 Chronic embolism and thrombosis of unspecified deep veins of right proximal lower 6

7 I82.5Y2 Chronic embolism and thrombosis of unspecified deep veins of left proximal lower I82.5Y3 Chronic embolism and thrombosis of unspecified deep veins of proximal lower, I82.5Y9 Chronic embolism and thrombosis of unspecified deep veins of unspecified proximal lower I82.5Z1 Chronic embolism and thrombosis of unspecified deep veins of right distal lower I82.5Z2 Chronic embolism and thrombosis of unspecified deep veins of left distal lower I82.5Z3 Chronic embolism and thrombosis of unspecified deep veins of distal lower, I82.5Z9 Chronic embolism and thrombosis of unspecified deep veins of unspecified distal lower I Acute embolism and thrombosis of unspecified veins of right upper I Acute embolism and thrombosis of unspecified veins of left upper I Acute embolism and thrombosis of unspecified veins of upper, I Acute embolism and thrombosis of unspecified veins of unspecified upper I Acute embolism and thrombosis of superficial veins of right upper I Acute embolism and thrombosis of superficial veins of left upper I Acute embolism and thrombosis of superficial veins of upper, I Acute embolism and thrombosis of superficial veins of unspecified upper I Acute embolism and thrombosis of deep veins of right upper I Acute embolism and thrombosis of deep veins of left upper I Acute embolism and thrombosis of deep veins of upper, I Acute embolism and thrombosis of deep veins of unspecified upper I Chronic embolism and thrombosis of unspecified veins of right upper I Chronic embolism and thrombosis of unspecified veins of left upper I Chronic embolism and thrombosis of unspecified veins of upper, I Chronic embolism and thrombosis of unspecified veins of unspecified upper I Chronic embolism and thrombosis of superficial veins of right upper I Chronic embolism and thrombosis of superficial veins of left upper I Chronic embolism and thrombosis of superficial veins of upper, I Chronic embolism and thrombosis of superficial veins of unspecified upper I Chronic embolism and thrombosis of deep veins of right upper I Chronic embolism and thrombosis of deep veins of left upper 7

8 I Chronic embolism and thrombosis of deep veins of upper, I Chronic embolism and thrombosis of deep veins of unspecified upper I Embolism and thrombosis of superficial veins of right lower extremities I Embolism and thrombosis of superficial veins of left lower extremities I Embolism and thrombosis of superficial veins of lower extremities, I Embolism and thrombosis of superficial veins of unspecified lower extremities I Acute embolism and thrombosis of other specified veins I Chronic embolism and thrombosis of other specified veins I82.90 Acute embolism and thrombosis of unspecified vein I82.91 Chronic embolism and thrombosis of unspecified vein I82.A11 I82.A12 I82.A13 I82.A19 I82.A21 I82.A22 I82.A23 I82.A29 I82.B11 I82.B12 I82.B13 I82.B19 I82.B21 I82.B22 I82.B23 I82.B29 I82.C11 I82.C12 I82.C13 I82.C19 I82.C21 I82.C22 I82.C23 I82.C29 Acute embolism and thrombosis of right axillary vein Acute embolism and thrombosis of left axillary vein Acute embolism and thrombosis of axillary vein, Acute embolism and thrombosis of unspecified axillary vein Chronic embolism and thrombosis of right axillary vein Chronic embolism and thrombosis of left axillary vein Chronic embolism and thrombosis of axillary vein, Chronic embolism and thrombosis of unspecified axillary vein Acute embolism and thrombosis of right subclavian vein Acute embolism and thrombosis of left subclavian vein Acute embolism and thrombosis of subclavian vein, Acute embolism and thrombosis of unspecified subclavian vein Chronic embolism and thrombosis of right subclavian vein Chronic embolism and thrombosis of left subclavian vein Chronic embolism and thrombosis of subclavian vein, Chronic embolism and thrombosis of unspecified subclavian vein Acute embolism and thrombosis of right internal jugular vein Acute embolism and thrombosis of left internal jugular vein Acute embolism and thrombosis of internal jugular vein, Acute embolism and thrombosis of unspecified internal jugular vein Chronic embolism and thrombosis of right internal jugular vein Chronic embolism and thrombosis of left internal jugular vein Chronic embolism and thrombosis of internal jugular vein, Chronic embolism and thrombosis of unspecified internal jugular vein O22.50 Cerebral venous thrombosis in pregnancy, unspecified trimester O22.51 Cerebral venous thrombosis in pregnancy, first trimester O22.52 Cerebral venous thrombosis in pregnancy, second trimester 8

9 O22.53 Cerebral venous thrombosis in pregnancy, third trimester O87.3 Cerebral venous thrombosis in the puerperium T80.0XXA T81.718A T81.72XA T82.817A T82.818A Air embolism following infusion, transfusion and therapeutic injection, initial encounter Complication of other artery following a procedure, not elsewhere classified, initial encounter Complication of vein following a procedure, not elsewhere classified, initial encounter Embolism of cardiac prosthetic devices, implants and grafts, initial encounter Embolism of vascular prosthetic devices, implants and grafts, initial encounter Z79.01 Long term (current) use of anticoagulants Z Personal history of other venous thrombosis and embolism Z95.2 Presence of prosthetic heart valve Z95.4 Presence of other heart-valve replacement REFERENCES 1. Bereznicki, L.R., Jackson, S.L., Peterson, G.M., Jeffrey, E.C., Marsden, K.A., Jupe, D.M. (2007, March). Accuracy and clinical utility of the CoaguChek XS portable international normalised ratio monitor in a pilot study of warfarin home-monitoring. J. Clin. Pathol., 60(3), Epub 2006, Jun 2. DOI: /jcp Accessed September 18, Available at URL address: 2. Centers for Medicare & Medicaid Services. CMS Manual System. Medicare Claims Processing Manual, PUB Transmittal Change Request Date January 8, Effective Date: March 19, Implementation Date: February 9, Accessed September 18, Available at URL address: Guidance/Guidance/Transmittals/downloads/r1663cp.pdf 3. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Home Prothrombin Time/International Normalized Ratio (PT/INR) Monitoring for Anticoagulation Management (190.11). Effective Date of this Version: 3/19/2008. Accessed September 18, Available at URL address: 4. Centers for Medicare & Medicaid Services. Medicare National Coverage Determinations Manual, Ch. 1, Part 3 (Section ) Coverage Determinations. Rev. 181, 3/27/2015. Accessed September 18, Available at URL address: Guidance/Guidance/Manuals/Downloads/ncd103c1_Part3.pdf 5. Centers for Medicare & Medicaid Services. Medicare Claims Processing Manual. Chapter 32 Billing Requirements for Special Services. Rev. 3848, Section 60 - Coverage and Billing for Home Prothrombin Time (PT/INR) Monitoring for Home Anticoagulation Management. 9

10 Accessed October 26, Available at URL address: Guidance/Guidance/Manuals/downloads/clm104c32.pdf 6. Keeling. D., Baglin, T., Tait, C., Watson, H., Perry, D., Baglin, C., Kitchen, S., et al. (2011, August). Guidelines on oral anticoagulation with warfarin - fourth edition. Br. J. Haematol., 154(3), doi: /j x. Epub 2011 Jun 14. Accessed September 18, Available at URL: 7. NICE.org. Anticoagulation Therapy commissioning guide. Dated: May 13, NICE commissioning guides [CMG49]. Accessed September 18, Available at URL Address: and at URL address: oagulation.pdf 8. Perry, D.J., Fitzmaurice, D.A., Kitchen, S., Mackie, I.J. & Mallett, S. (2010). Point-of-care testing in hemostasis. Br. J. Haematol., 150, Accessed September 18, Available at URL: 9. Ryan, F., Byrne, S. & O Shea, S. (2009). Randomized controlled trial of supervised patient selftesting of warfarin therapy using an internet-based expert system. Journal of Thrombosis and Haemostasis, 7, DOI: /j x. Accessed September 18, Available at URL: UpToDate / Hull, R.D., & Garcia, D.A. (2017) Patient information: Warfarin (Coumadin) (Beyond the Basics). Literature review current through: Sep This topic last updated: Aug 18, Accessed September 18, Available at URL Address: Roche Diagnostics. (2016). CoaguChek - Oral Anticoagulation Therapies. Accessed September 18, Available at URL: ation_therapy.html POLICY HISTORY DATE ACTION COMMENT November 6, 2008 Origination of Policy January 21, 2010 Revised Policy revised to add fragment under indications with Mechanical Heart valves, chronic atrial fibrillation, or venous thromboembolism (inclusive of deep venous thrombosis and pulmonary embolism). References updated, ICD-9 added. January 21, 2011 Yearly Review Limitation added: Porcine valves are not included in this policy; & MCS will not make payment on Home INR Monitoring for patients with porcine valves. March 16, 2012 Yearly Review References updated. May 28, 2013 Revised References updated. New reference added: numbers 3 & 5. To Coding Information Added: New ICD-9 Codes ,

11 August 1, 2013 Reviewed References updated. September 16, 2013 Reviewed References updated. February 21,2014 Revised To the Coding section: A new ICD-10 Codes (Preview Draft) section was added to the policy. May 21, 2014 Revised References updated. Description section was restructured with new information. To the References Section: References (#6, 7, 8, and 9) were added to the Policy. August 14, 2015 Revised References updated. To the Description Section: Information in the First Paragraph was adapted to this new description to read as: Anticoagulant therapy drugs (Warfarin) is a kind of oral anticoagulant prescription drug that is prescribed to prevent harmful blood clots from forming or growing larger. Beneficial blood clots prevent or stop bleeding, but harmful blood clots can cause a heart attack, stroke, deep vein thrombosis or pulmonary embolism. Because warfarin interferes with the formation of blood clots, it is called an anticoagulant. The effect of Warfarin on the bloods ability to clot must be carefully monitored in order to prescribe the appropriate dosage adjustment for patients on this drug. Fifth Paragraph was reviewed and restructured in a new manner according to this new document: NICE.org. 3 Monitoring the safety and quality of anticoagulation therapy. Dated: May NICE commissioning guides [CMG49] to read as: Prothrombin time (PT) is the most frequently used method of monitoring the therapeutic effectiveness of Warfarin. PT is a test that measures the amount of time it takes for a person s blood to clot. There are at least 3 clinical settings where monitoring anticoagulation can take place: Hospital outpatient Primary care; and Community settings To the References Section: New Reference #8 was added to the Policy. November 23, 2015 Revised To the coding section: Eliminate ICD-9 codes since they are no longer valid for diagnosis classification. Add new section of ICD-10 codes which are the valid diagnosis classification system since October 1, June 23, 2015 Revised To the Description Section: Information was restructured. Some paragraphs were fixed. To the Coding Section: To the ICD-10 Codes Section: New ICD-10 Codes were added to the Policy: I23.6, I26.09, I27.82, I67.6, I82.211, I82.291, I82.501, I82.502, I82.503, I82.509, I82.511, I82.512, I82.513, I82.519, I82.521, I82.522, I82.523, I82.529, I82.531, I82.532, I82.533, I82.539, I82.541, I82.542, I82.543, I82.549, I82.591, I82.592, I82.593, I82.599, I82.5Y1, I82.5Y2, I82.5Y3, I82.5Y9, I82.5Z1, I82.5Z2, I82.5Z3, I82.5Z9, I82.701, I82.702, I82.703, I82.709, I82.711, 11

12 I82.712, I82.713, I82.719, I82.721, I82.722, I82.723, I82.729, I82.811, I82.812, I82.813, I82.819, I82.891, I82.A21, I82.A22, I82.A23, I82.A29, I82.B21, I82.B22, I82.B23, I82.B29, I82.C21, I82.C22, I82.C23, I82.C29, O22.50, O22.51, O22.52, O22.53, O87.3 and Z To the References Section: New Reference #10 was added to the Policy. October 31, 2017 Revised References updated. To the Description Section: To 4 th paragraph: Modified 3 rd sentence which now reads: They describe at least 3 methods of monitoring anticoagulation. To the Coding Section: Added new ICD-10-CM codes: Z & Z95.4 This document is for informational purposes only. It is not an authorization, certification, explanation of benefits, or contract. Receipt of benefits is subject to satisfaction of all terms and conditions of coverage. Eligibility and benefit coverage are determined in accordance with the terms of the member s plan in effect as of the date services are rendered., (MCS) medical policies are developed with the assistance of medical professionals and are based upon a review of published and unpublished information including, but not limited to, current medical literature, guidelines published by public health and health research agencies, and community medical practices in the treatment and diagnosis of disease. Because medical practice, information, and technology are constantly changing, Medical Card System, Inc., (MCS) reserves the right to review and update its medical policies at its discretion. ; (MCS) medical policies are intended to serve as a resource to the plan. They are not intended to limit the plan s ability to interpret plan language as deemed appropriate. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment they choose to provide. 12