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Patients who are prescribed chronic warfarin anticoagulation need ongoing monitoring which has generally taken place in a physician’s office or anticoagulation clinic. Home prothrombin monitoring with an FDA-approved device is proposed 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 anticoagulated at higher levels than patients anticoagulated 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 >3 results is a higher risk of serious hemorrhage, while an INR of 6 increases the risk of developing a serious bleed nearly 7 times that of someone with an INR below 3. In contrast, an INR below 2 is associated with an increased risk of stroke. Therefore, monitoring of the prothrombin time is recommended to ensure that the dose levels are within the therapeutic range.
There are at least 3 sites/methods of monitoring anticoagulation:
In order for home prothombin time monitoring to be effective, patients need to be appropriately trained and be 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 in the results of the self-monitoring and receive further telephonic instructions on warfarin dose.
In January 2007, the CoaguChek XS System (patient self-testing) (Roche Diagnostics Corporation) was cleared for marketing by the 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 prothombin time in patients who are stabilized on anticoagulation medications.
POLICYAt-home monitoring of chronic warfarin therapy may be considered medically necessary in patients who require continuous anticoagulation for chronic medical conditions. These conditions include, but are not limited to, patients with mechanical heart valves and chronic atrial fibrillation. Before initiation of at-home monitoring, patients must have undergone anticoagulation management for at least 3 months.
For the Federal Employee Program (FEP) only, benefits are considered medically necessary for any FDA-approved oral anticoagulant home monitoring device. Effective for processing date January 1, 1999 and forward, benefits will be provided for services and supplies necessary for the appropriate use of the anticoagulation at-home devices (Document # 00-51IHR) (added 6-23-2000).
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Member, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.
For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
POLICY HISTORY2/1999: Approved by Medical Policy Advisory Committee (MPAC)
2/2000: Reviewed by MPAC; status maintained with POLICY EXCEPTIONS clarified
2/1/2002: Appeal statement removed from Policy Exception section
5/1/2002: Type of Service and Place of Service deleted
8/2002: Reviewed by MPAC; investigational status changed to medically necessary, "Description" and "Policy" content revised to be consistent with BCBSA, Source(s) updated, HCPCS A4649 deleted
12/19/2003: Code Reference section updated
4/1/2004: Code Reference section updated, HCPCS E1399 "Note: Use this code for dates of service through June 30, 2002" added
9/12/2006: Coding updated. CPT4/HCPCS 2006 revisions added to policy
1/2/2007: Policy reviewed, no changes
9/20/2007: Code Reference section updated. ICD-9 2007 revisions added to policy
2/25/2008: Patients with chronic atrial fibrillation or deep venous thrombosis added to policy statement as medically necessary. ICD-9 codes 427.31, 453.40 - 453.42 added
12/31/2008: Code reference section updated per 2009 CPT/HCPCS revisions
3/30/2009: Policy reviewed, no changes
9/28/2009: Code reference section updated. New ICD-9 diagnosis codes 453.50-453.52, 453.6, 453.71-453.77, 453.79, 453.81-453.87, 453.89 added to covered table. Deleted statement added to ICD-9 diagnosis code 453.8. Description revised for ICD-9 diagnosis codes 453.2, 453.40, 453.41, 453.42.
04/26/2010: Policy description updated regarding testing devices. Policy statement unchanged. Deleted outdated references from the Sources section.
04/20/2011: Policy reviewed; no changes.
04/19/2012: Policy reviewed; no changes.
04/19/2013: Policy reviewed; no changes.
09/01/2015: Code Reference section updated for ICD-10. Extended ICD-9 diagnosis code 444.0 to the fifth digit as 444.09. Removed deleted ICD-9 diagnosis code 453.8.
04/26/2016: Policy Guidelines updated to add medically necessary definition.
06/07/2016: Policy number L.1.01.409 added.
SOURCE(S)Blue Cross Blue Shield Association policy # 1.01.14
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.