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Medical Policy

Home Prothrombin Time Monitoring Devices Policy Number: OCA 3.27 Version Number: 12 Version Effective Date: 05/01/16

Product Applicability Well Sense Health Plan New Hampshire Medicaid NH Health Protection Program

All Plan+ Products Boston Medical Center HealthNet Plan MassHealth Qualified Health Plans/ConnectorCare/Employer Choice Direct Senior Care Options ◊

Notes: + Disclaimer and audit information is located at the end of this document. ◊ The guidelines included in this Plan policy are applicable to members enrolled in Senior Care Options only if there are no criteria established for the specified service in a Centers for Medicare & Medicaid Services (CMS) national coverage determination (NCD) or local coverage determination (LCD) on the date of the prior authorization request. Review the member’s product-specific benefit documents at www.SeniorsGetMore.org to determine coverage guidelines for Senior Care Options. Policy Summary Home prothrombin time (PT) monitoring devices are considered medically necessary for members who are receiving long-term oral anticoagulation therapy (OAT) and are suitable candidates for selfmanagement based on the Plan’s medical criteria. Plan prior authorization is required. It will be determined during the Plan’s prior authorization process if the service is considered medically necessary for the requested indication. See the Plan’s policy, Medically Necessary (policy number OCA 3.14), for the product-specific definitions of medically necessary treatment.

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Description of Item or Service Home prothrombin time (PT) monitors are portable, battery-operated, hand-held devices that measure PT using capillary whole blood from a fingerstick. These devices can store 30-40 of the most recent test results that the physician can review to monitor trends in oral anticoagulant therapy. Numerous monitors have been FDA approved through the 510K process. Medical Policy Statement Home prothrombin time (PT) monitoring devices are considered medically necessary as a durable medical equipment item for a member when ALL of the following criteria are met and documented in the member’s medical record, as specified below in item 1, item 2, and item 3: 1. The member is receiving long-term oral anticoagulation therapy (OAT) and has been anticoagulated for a minimum of three (3) months and is on a stable regimen of anticoagulation medications; AND 2. The member is receiving OAT for ONE (1) of the following diagnoses (specified as items a through f below): a. Chronic atrial fibrillation; OR b. Congestive cardiomyopathy; OR c. Mechanical heart valve replacement; OR d. Post myocardial infarction with impaired left ventricular function; OR e. Thrombophilia with a history of deep vein thrombosis; OR f. Venous thromboembolism (a disease that includes both deep vein thrombosis and pulmonary embolism); AND 3. The member is a suitable candidate for self-management and ALL of the following criteria are met, as specified below in items a through e: a. The self-monitoring device must be prescribed by a physician who manages the member’s OAT dosage; AND b. The member has participated in a formal, face-to-face educational program on anticoagulation management and has demonstrates the correct use of the device prior to its use in the home setting; AND Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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c. The member has sufficient capacity to understand how to correctly interpret the international normalized ratio (INR) results and has a history of compliance for self management; AND d. The member continues to correctly use the device in the context of management of the anticoagulation therapy following initiation of home monitoring; AND e. Self-testing with the device is not required and does not occur more frequently than once a week. Limitations Limitations include ANY of the following, as specified below in items 1 through 4: 1. A home prothrombin time (PT) monitoring device for a member who requires self-testing less than an average of once per week is considered NOT medically necessary; OR 2. A home PT monitoring device is considered NOT medically necessary for a member who is unable to competently use the home monitoring device or interpret and record results of testing; OR 3. Replacement or repair of a home PT monitoring device is considered NOT medically necessary in ANY of the following instances, as specified below in items a through c: a. The device is still under manufacturer warranty; OR b. The device is lost, stolen, or damaged due to improper care, misuse, or neglect (and documentation such as a police report and corroborating statements may be requested by the Plan); OR c. The member has a functioning model (even if it is not the most current model); the Plan will not authorize an upgrade of the home PT monitoring device when the current device is functioning properly. 4. Some home PT monitoring devices have additional software and/or hardware to track and download test results to the treating provider. Since the home PT monitoring devices already store test results, the Plan considers the use of additional software and/or hardware a convenience item, and therefore is not considered medically necessary and would not be authorized by the Plan.

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Definitions International Normalized Ratio (INR): The ratio of the patient’s prothrombin time compared to the mean prothrombin time for a group of individuals formulated by the World Health Organization (WHO) and the International Committee on Thrombosis and Hemostasis. Normal INR is 0.8 to 1.1. Full anticoagulant therapy is considered reached when the value is 2.0-3.0, depending upon the level necessary for each individual patient circumstance. Prothrombin Time: The minimum amount of time needed for a small amount of blood to clot. Normal range is 11-13.5 seconds. Venous thromboembolism (VTE): A disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). VTE contributes to significant morbidity and mortality both in the community and in hospital. The mainstay of therapy for DVT is anticoagulation, provided there is no contraindication. Following initial anticoagulation, patients with DVT are anticoagulated further to prevent future recurrences, embolism, and thrombosis-related death. Applicable Coding The Plan uses and adopts up-to-date Current Procedural Terminology (CPT) codes from the American Medical Association (AMA), International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnosis codes developed by the World Health Organization and adapted in the United Stated by the National Center for Health Statistics (NCHS) of the Centers for Disease Control under the U.S. Department of Health and Human Services, and the Health Care Common Procedure Coding System (HCPCS) established and maintained by the Centers for Medicare & Medicaid Services (CMS). Because the AMA, NCHS, and CMS may update codes more frequently or at different intervals than Plan policy updates, the list of applicable codes included in this Plan policy is for informational purposes only, may not be all inclusive, and is subject to change without prior notification. Whether a code is listed in the Applicable Coding section of this Plan policy does not constitute or imply member coverage or provider reimbursement. Providers are responsible for reporting all services using the most up-to-date industry-standard procedure and diagnosis codes as published by the AMA, NCHS, and CMS at the time of the service. Providers are responsible for obtaining prior authorization for the services specified in the Medical Policy Statement section and Limitation section of this Plan policy, even if an applicable code appropriately describing the service that is the subject of this Plan policy is not included in the Applicable Coding section of this Plan policy. Coverage for services is subject to benefit eligibility under the member’s benefit plan. Please refer to the member’s benefits document in effect at the time of the service to determine coverage or non-coverage as it applies to an individual member. See Plan reimbursement policies for Plan billing guidelines.

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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HCPCS Codes G0248

G0249

G0250

Description: Codes Covered When Medically Necessary 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 patient’s ability to perform testing and report results 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 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

Clinical Background Information Indications for oral anticoagulant therapy (OAT) with warfarin (Coumadin) to prevent thromboembolic disease without increasing the risk of hemorrhagic complications have increased in recent years to include a variety of cardiac and vascular diseases. The most common indications for OAT include patients who are at risk for the formation of blood clots because of atrial fibrillation, prosthetic heart valve replacements, inherited or acquired disorders, and to prevent the reoccurrence of heart attacks and transient ischemic attacks (TIAs). Prothrombin times must be monitored frequently in patients who are taking oral anticoagulants to determine the safest dose and minimize the risk for complications by maintaining the INR within the appropriate therapeutic range. Over treatment with Coumadin can result in central nervous system and/or gastrointestinal bleeding, and under treatment or failure to treat can result in thrombotic strokes and other thromboembolic complications. Most patients receiving OAT are managed by their own physician, requiring frequent trips to the laboratory for prothrombin testing and more recently by point-of-care (POC) patient self testing with PT/INR devices. These devices should only be considered for use in patients who are expected to be on long-term oral anticoagulation who have artificial heart valves, chronic atrial fibrillation, thrombophilia after recurrent deep vein thrombosis in the leg, pulmonary embolism, post myocardial infarction with impaired left ventricular function, and/or congestive cardiomyopathy. There are many PT/INR devices that have been FDA approved and are portable and easy to use. One drop of capillary whole blood from a fingerstick is placed on a test strip and inserted into the meter for a quick determination of the patient’s prothrombin time. The patient must be responsible for using the device appropriately, recording and interpreting the results accurately, and compliant with clinic or physician appointments for follow-up OAT management. The patient’s physician is responsible for the Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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selection, training, and continuing management of any patient selected for home testing. The goal of POC patient self-testing with a PT/INR device is to achieve optimum therapeutic anticoagulation control with reduction of the risk of complications that are associated with OAT. References Ansell J et al. American College of Chest Physicians. Pharmacology and management of the vitamin K antagonists: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):160S-198S. Ansell J et al. Descriptive analysis of the process and quality of oral anticoagulation management in real-life practice in patients with chronic non-valvular atrial fibrillation: the international study of anticoagulation management (ISAM). J Thromb 2007 23:83-91. Ansell J et al. Guidelines for implementation of patient self-testing and patient self management of oral anticoagulation. International consensus guidelines prepared by International Self-Monitoring Association for Oral Anticoagulation. IJC. 2005;99:37-45. Ansell J et al. Managing Oral Anticoagulant Therapy. Chest 2001;119:225-388. Bloomfield HE et al. Meta-analysis: effect of patient self-testing and self-management of long-term anticoagulation on major clinical outcomes. 2011 Apr 5;154(7):472-82. Bradbury MJ, Taylor G, Short P, Williams MD. A comparative study of anticoagulant control in patients on long-term warfarin using home and hospital monitoring of the international normalized ratio. Arch Dis Child. 2008;93(4):303-306. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Home Prothrombin Time/International Normalized Ratio (PT/INR) Monitoring for Anticoagulation Management (190.11). Effective March 19, 2008. Accessed at: https://www.cms.gov/medicarecoverage-database/details/ncddetails.aspx?NCDId=269&ncdver=2&DocID=190.11&ncd_id=190.11&ncd_version=2&basket=ncd%252 53A190%25252E11%25253A2%25253AHome+Prothrombin+Time+INR+Monitoring+for+Anticoagulatio n+Management&bc=gAAAAAgAAAAAAA%3D%3D& Federal Register. 42 CFR Parts 405 and 414. Centers for Medicare & Medicaid Services (CMS). Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies; Final Rule. Vol. 80 Wednesday, No. 250. December 30, 2015. Table 5 - Final Master List of DMEPOS Items Subject to Frequent Unnecessary Utilization for Prior Authorization. P. 81685. Accessed at: https://www.gpo.gov/fdsys/pkg/FR-2015-12-30/pdf/2015-32506.pdf

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Federal Register. 79 FR 30511 through 30531. Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies. A Rule by the Centers for Medicare & Medicaid Services on 12/30/2015. Accessed at: https://www.federalregister.gov/articles/2015/12/30/2015-32506/medicare-program-priorauthorization-process-for-certain-durable-medical-equipment-prosthetics Fitzmaurice DA et al. An evidence-based review and guidelines for patient self-testing and management of oral anticoagulation. Br J Haematol. 2005 Oct;131(2):156-65. Fitzmaurice DA et al. Self Management of Oral Anticoagulation: randomized trial. BMJ 2005 Oct;331(7524):1057. Gadisseur A et al. Comparison of the Quality of Oral Anticoagulant Therapy through Patient SelfManagement ND Management by specialized Anticoagulation Clinics in the Netherlands: a randomized clinical trial. Arch Intern Med 2003;163:2639-46. Garcia-Alamino JM, Ward AM, Alonso-Coello P et al. Self-monitoring and self-management of oral anticoagulation. Cochrane Database of Systematic Reviews 2010; Issue 4. Art No: CD003839. Accessed at: http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD003839/frame.html Greenway A, Ignjatovic V, Summerhayes R, et al. Point-of-care monitoring of oral anticoagulation therapy in children. Comparison of the CoaguChek XS system with venous INR and venous INR using an International Reference Thromboplastin preparation (rTF/95). Thromb Haemost. 2009;102(1):159-165. Heneghan C, Ward A, Perera R et al. Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 2012; 379(813):322-34. Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/22137798 Hirsh J et al. American Heart Association/American College of Cardiology Foundation Guide to Warfarin Therapy. Circulation 2003;107:1692:711. Holbrook A, Schulman S, Witt DM et al. 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; 141(2 Suppl):e152S-84S. MedlInePlus. Prothrombin time (PT). U.S. National Library of Medicine. Updated 01/27/15. Accessed at: https://www.nlm.nih.gov/medlineplus/ency/article/003652.htm Menéndez-Jándula B et al.. Comparing self management of oral anticoagulant therapy with clinic management: A randomized trial. Ann Intern Med. 2005;142:1-10.

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Ontario Ministry of Health and Long-term Care, Medical Advisory Secretariat (MAS). Point-of-care international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy: An evidence-based analysis. Ontario Health Technology Assessment Series. 2009; 9(12):1-114. Plesch W, van den Besselaar AM. Validation of the international normalized ratio (INR) in a new pointof-care system designed for home monitoring of oral anticoagulation therapy. Int J Lab Hematol. 2009;31(1):20-25. Regier, R et al. Cost-effectiveness of Self-managed versus Physician-managed Oral Anticoagulation Therapy. CMAJ 2006 June;174(13):1847-1852. Ryan F et al. The reliability of point-of-care prothrombin time testing. A comparison of CoaguChek S and XS INR measurements with hospital laboratory monitoring. Int J Lab Hematol. 2010 Feb;32. Sobieraj-Teague M, Daniel D, Farrelly B, et al. Accuracy and clinical usefulness of the CoaguChek S and XS Point of Care devices when starting warfarin in a hospital outreach setting. Thromb Res. 2009;123(6):909-913. Wittkowsky AK et al. Barriers to Patient Self Testing of Prothrombin Time: National Survey of Anticoagulation Practitioners. Pharm 2005;25(2):265-269. Original Approval Date Regulatory Approval: N/A

Original Effective Date* and Version Number

Policy Owner

Approved by

04/01/08 Version 1

Medical Policy Manager MPCTAC, Utilization as Chair of Medical Policy, Management Committee Internal Approval: Criteria, and Technology (UMC), and QIC 11/13/07: MPCTAC Assessment Committee 11/27/07: UMC (MPCTAC) 12/06/07: QIC and member of Quality Improvement Committee (QIC) *Effective Date for the BMC HealthNet Plan Commercial Product(s): 01/01/12 *Effective Date for the Well Sense Heath Plan New Hampshire Medicaid Product(s): 01/01/13 (Policy number was formerly OCA 3.78.)

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Policy Revisions History

Review Date

Summary of Revisions

Revision Effective Date and Version Number

10/14/08

No changes.

Version 2

10/27/09

No changes to criteria, updated coding to include the following HCPCS codes: G0248 and G0249. No changes to criteria, updated references and coding. No criteria changes, updated references and coding. Revised language in Applicable code section, updated code definitions and references, added language in Limitations section which states the Plan does not consider additional software and/or hardware used with home PT monitoring devices to track and download test results to the treating provider to be medically necessary since it is a convenience item only. Off cycle review for Well Sense Health Plan, reformatted Medical Policy Statement section. Review for effective date 09/01/13. Reformatted Medical Policy Statement section without revising criteria. Updated references. Review for effective date 01/01/14. No revisions. Review for effective date 03/01/15. Updated criterion in the Medical Policy Statement section and added references. Change in review calendar. Review for effective date 01/01/16. Updated template with list of applicable products and notes. Revised language in the Applicable

Version 3

10/01/10 11/01/11 07/01/12

07/30/12:

07/01/13

11/01/13 11/01/14

11/25/15

Version 4 Version 5 Version 6

Approved by 10/14/08: 10/28/08: 11/18/08: 10/27/09: 11/19/09:

MPCTAC UMC QIC MPCTAC QIC

11/23/10: 12/22/10: 11/16/11: 12/20/11: 07/18/12: 08/22/12:

MPCTAC QIC MPCTAC QIC MPCTAC QIC

Version 7

08/03/12: MPCTAC 09/05/12: QIC

09/01/13 Version 8

07/17/13: MPCTAC 08/15/13: QIC

01/01/14 Version 9 03/01/15 Version 10

11/20/13: 12/19/13: 11/19/14: 12/10/14:

01/01/16 Version 11

11/18/15: MPCTAC 11/25/15: MPCTAC (electronic vote) 12/09/15: QIC

MPCTAC QIC MPCTAC QIC

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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Policy Revisions History 01/01/16

Coding section. Updated references. Review for effective date 05/01/16. Revised criteria in the Medical Policy Statement and Limitations sections. Updated Definitions and References section.

05/01/16 Version 12

01/20/16: MPCTAC 02/10/16: QIC

Last Review Date 01/01/16 Next Review Date 01/01/17 Authorizing Entity QIC Other Applicable Policies Medical Policy - Medically Necessary, policy number OCA 3.14 Disclaimer Information: + Medical Policies are the Plan’s guidelines for determining the medical necessity of certain services or supplies for purposes of determining coverage. These Policies may also describe when a service or supply is considered experimental or investigational, or cosmetic. In making coverage decisions, the Plan uses these guidelines and other Plan Policies, as well as the Member’s benefit document, and when appropriate, coordinates with the Member’s health care Providers to consider the individual Member’s health care needs. Plan Policies are developed in accordance with applicable state and federal laws and regulations, and accrediting organization standards (including NCQA). Medical Policies are also developed, as appropriate, with consideration of the medical necessity definitions in various Plan products, review of current literature, consultation with practicing Providers in the Plan’s service area who are medical experts in the particular field, and adherence to FDA and other government agency policies. Applicable state or federal mandates, as well as the Member’s benefit document, take precedence over these guidelines. Policies are reviewed and updated on an annual basis, or more frequently as needed. Treating providers are solely responsible for the medical advice and treatment of Members. The use of this Policy is neither a guarantee of payment nor a final prediction of how a specific claim(s) will be adjudicated. Reimbursement is based on many factors, including member eligibility and benefits on the date of service; medical necessity; utilization management guidelines (when applicable); coordination of benefits; adherence with applicable Plan policies and procedures; clinical coding criteria; claim editing logic; and the applicable Plan – Provider agreement.

Home Prothrombin Time Monitoring Devices +

Plan refers to Boston Medical Center Health Plan, Inc. and its affiliates and subsidiaries offering health coverage plans to enrolled members. The Plan operates in Massachusetts under the trade name Boston Medical Center HealthNet Plan and in other states under the trade name Well Sense Health Plan.

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