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L.1.01.409
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:
Physician's office (80%) – usually once a month
Anticoagulation clinics (20%) – usually once every 2-3 weeks
Home prothrombin time monitors (<5%)
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.
At-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.
Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
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 Mental Health Disorders, 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 medical necessity, “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.
2/1999: 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.
05/18/2017: Code Reference section updated to make correction: I18.A21- I18.A29 should be I82.A21 - I82.A29.
09/29/2017: Code Reference section updated to revise code descriptions for ICD-10 diagnosis codes I63.22, I63.211, I63.212, I82.811, I82.812, and I82.819. Effective 10/01/2017.
12/20/2017: Code Reference section updated to add new 2018 CPT code 93792.
09/26/2018: Code Reference section updated to add new ICD-10 diagnosis codes I63.81 and I63.89. Revised descriptions for ICD-10 diagnosis codes I63.239 and I63.219. Effective 10/01/2018.
09/24/2019: Code Reference section updated to add new ICD-10 diagnosis codes I82.451, I82.452, I82.453, I82.459, I82.461, I82.462, I82.463, I82.469, I82.551, I82.552, I82.553, I82.559, I82.561, I82.562, I82.563, and I82.569, effective 10/01/2019.
03/21/2023: Policy reviewed. Policy statement unchanged. Policy Exceptions updated regarding the Federal Employee Program. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Code Reference section updated to remove deleted ICD-10 diagnosis code I63.8.
04/30/2024: Policy reviewed; no changes.
08/01/2025: Policy reviewed; no changes.
Blue Cross Blue Shield Association policy # 1.01.14
This 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.
Code Number | Description | ||
CPT-4 | |||
93792 | Patient/caregiver training for initiation of home international normalized ratio (INR) monitoring under the direction of a physician or other qualified health care professional, face-to-face, including use and care of the INR monitor, obtaining blood sample, instructions for reporting home INR test results, and documentation of patient's/caregiver’s ability to perform testing and report results | ||
HCPCS | |||
E1399 | Durable medical equipment, miscellaneous (code used both for purchase of device and test strips); Typically, a one-month to 6-week supply of test strips is requested, which can vary from 25 test strips to only 6 test strips if the patients only self-monitors once a week. | ||
G0248 | Demonstration, prior to initial use, 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 ability to perform testing | ||
G0249 | 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; not occurring more frequently than once a week | ||
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 other coverage criteria; includes face-to-face verification by the physician at least once a year (e.g., during an evaluation and management service) that the patient used the device in the context of the management of the anticoagulation therapy following initiation of the home INR monitoring; not occurring more frequently than once a week | ||
ICD-9 Procedure | ICD-10 Procedure | ||
ICD-9 Diagnosis | ICD-10 Diagnosis | ||
250.70 | Type II (non-insulin dependent type) or unspecified type diabetes mellitus with peripheral circulatory disorders, not stated as uncontrolled | E11.51 - E11.59 | Type 2 diabetes mellitus with circulatory complications |
E13.51 - E13.59 | Other specified diabetes mellitus with circulatory complications | ||
250.71 | Type I (insulin dependent type) diabetes mellitus with peripheral circulatory disorders, not stated as uncontrolled | E10.51 - E10.59 | Type 1 diabetes mellitus with circulatory complications |
250.72 | Type II (non-insulin dependent type) or unspecified type diabetes mellitus with peripheral circulatory disorders, uncontrolled | E11.51 with E11.65 | Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene and Type 2 diabetes mellitus with hyperglycemia |
250.73 | Type I (insulin dependent type) diabetes mellitus with peripheral circulatory disorders, uncontrolled | E10.51 and E10.65 | Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene and Type 1 diabetes mellitus with hyperglycemia |
E10.52 | Type 1 diabetes mellitus with diabetic peripheral angiopathy with gangrene | ||
414.10414.19 | Aneurysm of heartOther aneurysm of heart | I25.3 | Aneurysm of heart |
414.11 | Aneurysm of coronary vessels | I25.41 | Coronary artery aneurysm |
414.12 | Dissection of coronary artery | I25.42 | Coronary artery dissection |
427.31 | Atrial fibrillation | I48.0 - I48.91 | Atrial fibrillation code range |
433.00 | Occlusion and stenosis of basilar artery without mention of cerebral infarction | I65.1 | Occlusion and stenosis of basilar artery |
433.01 | Occlusion and stenosis of basilar artery with cerebral infarction | I63.02 | Cerebral infarction due to thrombosis of basilar artery |
I63.12 | Cerebral infarction due to embolism of basilar artery | ||
I63.22 | Cerebral infarction due to unspecified occlusion or stenosis of basilar artery | ||
433.10 | Occlusion and stenosis of carotid artery without mention of cerebral infarction | I65.21 - I65.29 | Occlusion and stenosis of carotid artery |
433.11 | Occlusion and stenosis of carotid artery with cerebral infarction | I63.031 - I63.039 | Cerebral infarction due to thrombosis of carotid artery |
I63.131 - I63.139 | Cerebral infarction due to embolism of carotid artery | ||
I63.231 - I63.239 | Cerebral infarction due to unspecified occlusion or stenosis of carotid arteries | ||
433.20 | Occlusion and stenosis of vertebral artery without mention of cerebral infarction | I65.01 - I65.09 | Occlusion and stenosis of vertebral artery |
433.21 | Occlusion and stenosis of vertebral artery with cerebral infarction | I63.011 - I63.019 | Cerebral infarction due to thrombosis of vertebral artery |
I63.111 - I63.119 | Cerebral infarction due to embolism of vertebral artery | ||
I63.211 - I63.219 | Cerebral infarction due to unspecified occlusion or stenosis of vertebral arteries | ||
433.30 | Occlusion and stenosis of multiple and bilateral precerebral arteries without mention of cerebral infarction | I65.8 | Occlusion and stenosis of other precerebral arteries |
433.80 | Occlusion and stenosis of other specified precerebral artery without mention of cerebral infarction | ||
433.31 | Occlusion and stenosis of multiple and bilateral precerebral arteries with cerebral infarction | I63.59 | Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery |
433.81 | Occlusion and stenosis of other specified precerebral artery with cerebral infarction | I63.09 | Cerebral infarction due to thrombosis of other precerebral artery |
I63.19 | Cerebral infarction due to embolism of other precerebral artery | ||
I63.59 | Cerebral infarction due to unspecified occlusion or stenosis of other cerebral artery | ||
433.90 | Occlusion and stenosis of unspecified precerebral artery without mention of cerebral infarction | I65.9 | Occlusion and stenosis of unspecified precerebral artery |
433.91 | Occlusion and stenosis of unspecified precerebral artery with cerebral infarction | I63.00 | Cerebral infarction due to thrombosis of unspecified precerebral artery |
I63.10 | Cerebral infarction due to embolism of unspecified precerebral artery | ||
I63.20 | Cerebral infarction due to unspecified or stenosis of unspecified precerebral arteries | ||
I63.29 | Cerebral infarction due to unspecified or stenosis of other precerebral arteries | ||
434.00 | Cerebral thrombosis without mention of cerebral infarction | I66.01 - I66.3 | Occlusion and stenosis of cerebral arteries, not resulting in infarction |
434.01 | Cerebral thrombosis with cerebral infarction | I63.30 - I63.39 | Cerebral infarction due to thrombosis of cerebral arteries |
I63.6 | Cerebral infarction due to cerebral venous, nonpyogenic | ||
434.10 | Cerebral embolism without mention of cerebral infarction | I66.01 - I66.9 | Occlusion and stenosis of cerebral arteries, not resulting in infarction |
434.90 | Unspecified cerebral artery occlusion without mention of cerebral infarction | ||
434.11 | Cerebral embolism with cerebral infarction | I63.40 - I63.49 | Cerebral infarction due to embolism of cerebral arteries code range |
434.91 | Unspecified cerebral artery occlusion with cerebral infarction | I63.50 - I63.59, I63.81 - I63.9 | Cerebral infarction due to unspecified occlusion or stenosis of cerebral arteries |
435.9 | Unspecified transient cerebral ischemia | G45.9 | Transient cerebral ischemic attack, unspecified |
437.0 | Cerebral atherosclerosis | I67.2 | Cerebral atherosclerosis |
440.0 | Atherosclerosis of aorta | I70.0 | Atherosclerosis of aorta |
440.1 | Atherosclerosis of renal artery | I70.1 | Atherosclerosis of renal artery |
440.20 | Atherosclerosis of native arteries of the extremities, unspecified | I70.201 - I70.209 | Unspecified atherosclerosis of native arteries extremities |
440.21 | Atherosclerosis of native arteries of the extremities with intermittent claudication | I70.211 - I70.219 | Atherosclerosis of native arteries of the extremities with intermittent claudication |
440.22 | Atherosclerosis of native arteries of the extremities with rest pain | I70.221 - I70.229 | Atherosclerosis of native arteries of the extremities with rest pain |
440.23 | Atherosclerosis of native arteries of the extremities with ulceration | I70.231 - I70.25 | Atherosclerosis of native arteries of the extremities with ulceration |
440.24 | Atherosclerosis of native arteries of the extremities with gangrene | I70.261 - I70.269 | Atherosclerosis of native arteries of the extremities with gangrene |
440.29 | Other atherosclerosis of native arteries of the extremities | I70.291 - I70.299 | Other atherosclerosis of native arteries of the extremities |
440.4 | Chronic total occlusion of artery of the extremities | I70.92 | Chronic total occlusion of artery of the extremities |
444.09 | Embolism and thrombosis of abdominal aorta | I74.09 | Other arterial embolism and thrombosis of abdominal aorta |
444.1 | Embolism and thrombosis of thoracic aorta | I74.11 | Embolism and thrombosis of thoracic aorta |
444.21 | Embolism and thrombosis of arteries of upper extremity | I74.2 | Embolism and thrombosis of arteries of the upper extremities |
444.22 | Embolism and thrombosis of arteries of lower extremity | I74.3 | Embolism and thrombosis of arteries of the lower extremities |
I74.4 | Embolism and thrombosis of arteries of extremities, unspecified | ||
444.81 | Embolism and thrombosis of iliac artery | I74.5 | Embolism and thrombosis of iliac artery |
444.89 | Embolism and thrombosis of other specified artery | I74.8 | Embolism and thrombosis of other arteries |
444.9 | Embolism and thrombosis of unspecified artery | I74.9 | Embolism and thrombosis of unspecified artery |
451.0 | Phlebitis and thrombophlebitis of superficial vessels of lower extremities | I80.00 - I80.03 | Phlebitis and thrombophlebitis of superficial vessels of lower extremities |
451.11 | Phlebitis and thrombophlebitis of femoral vein (deep) (superficial) | I80.10 - I80.13 | Phlebitis and thrombophlebitis of superficial vessels of femoral vein |
451.19 | Phlebitis and thrombophlebitis of other deep vessels of lower extremities | I80.201 - I80.209, I80.221 - I80.299 | Phlebitis and thrombophlebitis of other and unspecified deep vessels of lower extremities |
451.2 | Phlebitis and thrombophlebitis of lower extremities, unspecified | I80.3 | Phlebitis and thrombophlebitis of lower extremities, unspecified |
451.81 | Phlebitis and thrombophlebitis of iliac vein | I80.211 - I80.219 | Phlebitis and thrombophlebitis of iliac vein |
451.82 | Phlebitis and thrombophlebitis of superficial veins of upper extremities | I80.8 | Phlebitis and thrombophlebitis of other site |
451.83 | Phlebitis and thrombophlebitis of deep veins of upper extremities | ||
451.84 | Phlebitis and thrombophlebitis of upper extremities, unspecified | ||
451.89 | Phlebitis and thrombophlebitis of other site | ||
451.9 | Phlebitis and thrombophlebitis of unspecified site | I80.9 | Phlebitis and thrombophlebitis of unspecified site |
453.0 | Budd-Chiari syndrome | I82.0 | Budd-Chiari syndrome |
453.1 | Thrombophlebitis migrans | I82.1 | Thrombophlebitis migrans |
453.2 | Other venous embolism and thrombosis of inferior vena cava | I82.220 - I82.221 | Acute or Chronic embolism and thrombosis of inferior vena cava |
453.3 | Embolism and thrombosis of renal vein | I82.3 | Embolism and thrombosis of renal vein |
453.40 | Acute venous embolism and thrombosis of unspecified deep vessels of lower extremity | I82.401 - I82.409 | Acute venous embolism and thrombosis of unspecified deep vessels of lower extremity |
453.41 | Acute venous embolism and thrombosis of deep vessels of proximal lower extremity | I82.411 - I82.439, I82.4Y1 - I82.4Y9 | Acute venous embolism and thrombosis of deep vessels of proximal lower extremity |
453.42 | Acute venous embolism and thrombosis of deep vessels of distal lower extremity | I82.441 - I82.499, I82.4Z1 - I82.4Z9 | Acute venous embolism and thrombosis of deep vessels of distal lower extremity |
453.50 | Chronic venous embolism and thrombosis of unspecified deep vessels of lower extremity | I82.501 - I82.509,I82.551, I82.552, I82.553, I82.559, I82.561, I82.562, I82.563, I82.569,I82.591 - I82.599 | Chronic venous embolism and thrombosis of deep veins of lower extremity |
453.51 | Chronic venous embolism and thrombosis of deep vessels of proximal lower extremity | I82.511 - I82.539, I82.5Y1 - I82.5Y9 | Chronic venous embolism and thrombosis of deep veins of lower extremity |
453.52 | Chronic venous embolism and thrombosis of deep vessels of distal lower extremity | I82.541 - I82.549, I82.5Z1 - I82.5Z9 | Chronic venous embolism and thrombosis of deep veins of lower extremity |
453.6 | Venous embolism and thrombosis of superficial vessels of lower extremity | I82.811 - I82.819 | Embolism and thrombosis of superficial veins of lower extremities |
453.71 | Chronic venous embolism and thrombosis of superficial veins of upper extremity | I82.711 - I82.719 | Chronic embolism and thrombosis of superficial veins of upper extremity |
453.72 | Chronic venous embolism and thrombosis of deep veins of upper extremity | I82.721 - I82.729 | Chronic embolism and thrombosis of deep veins of upper extremity |
453.73 | Chronic venous embolism and thrombosis of upper extremity, unspecified | I82.701 - I82.709 | Chronic embolism and thrombosis of unspecified veins of upper extremity |
453.74 | Chronic venous embolism and thrombosis of axillary veins | I82.A21- I82.A29 | Chronic embolism and thrombosis of axillary vein |
453.75 | Chronic venous embolism and thrombosis of subclavian veins | I82.B21 - I82.B29 | Chronic embolism and thrombosis of subclavian veins |
453.76 | Chronic venous embolism and thrombosis of internal jugular veins | I82.C21 - I82.C29 | Chronic embolism and thrombosis of internal jugular veins |
453.77 | Chronic venous embolism and thrombosis of other thoracic veins | I82.211 | Chronic embolism and thrombosis of superior vena cava |
I82.291 | Chronic embolism and thrombosis of other thoracic veins | ||
453.79 | Chronic venous embolism and thrombosis of other specified veins | I82.891 | Chronic embolism and thrombosis of other specified veins |
I82.91 | Chronic embolism and thrombosis of unspecified veins | ||
453.81 | Acute venous embolism and thrombosis of superficial veins of upper extremity | I82.611 - I82.619 | Acute embolism and thrombosis of superficial veins of upper extremity |
453.82 | Acute venous embolism and thrombosis of deep veins of upper extremity | I82.621 - I82.629 | Acute embolism and thrombosis of deep veins of upper extremity |
453.83 | Acute venous embolism and thrombosis of upper extremity, unspecified | I82.601 - I82.609 | Acute embolism and thrombosis of unspecified veins of upper extremity |
453.84 | Acute venous embolism and thrombosis of axillary veins | I82.A11 - I82.A19 | Acute embolism and thrombosis of axillary veins |
453.85 | Acute venous embolism and thrombosis of subclavian veins | I82.B11 - I82.B19 | Acute embolism and thrombosis of subclavian veins |
453.86 | Acute venous embolism and thrombosis of internal jugular veins | I82.C11 - I82.C19 | Acute embolism and thrombosis of internal jugular veins |
453.87 | Acute venous embolism and thrombosis of other thoracic veins | I82.210 | Acute embolism and thrombosis of superior vena cava |
I82.290 | Acute embolism and thrombosis of other thoracic veins | ||
453.89 | Acute venous embolism and thrombosis of other specified veins | I82.890 | Acute embolism and thrombosis of other specified veins |
I82.90 | Acute embolism and thrombosis of unspecified veins | ||
453.9 | Embolism and thrombosis of unspecified site | I82.91 | Chronic embolism and thrombosis of unspecified vein |
671.30 | Deep phlebothrombosis, antepartum, unspecified as to episode of care | O22.30 | Deep phlebothrombosis, in pregnancy, unspecified trimester |
671.31, 671.33 | Deep phlebothrombosis, antepartum code range | O22.31 - O22.33 | Deep phlebothrombosis, in pregnancy, by trimester |
V43.3 | Heart valve replaced by other means | Z95.2 | Presence of prosthetic heart valve |
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