Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Home INR/Prothrombin time monitors and all supplies are covered under the DME benefit. 

2)    This benefit is only available to patients who are expected to require life-long INR monitoring because of long-term/permanent use of Warfarin.

1)    ALL of the following requirements must be met:

a)    The monitor and the home testing must be prescribed by a treating network physician, and received from a network DME provider; and

b)    The patient must have a face-to-face educational program on anticoagulation management and must have demonstrated the correct use of the device prior to home use; and

c)     The patient must have been taking warfarin therapy and been stable for at least three months prior to using the home testing device; and

d)    The patient’s medical condition must not require testing more than once a week; and

e)    The patient must have a medical condition that is expected to require lifelong monitoring with diagnosis code Z79.01 (Long-term [current] use of anticoagulants).  A patient expected to be on warfarin for a defined time (for example, after a single episode of DVT due to specific limited risk factors) is not eligible for coverage.

2)    While home INR testing using devices such as CoaguChek has been shown to be as accurate as that provided in a laboratory, it has not been shown to produce better clinical outcomes or decreased complications as opposed to monitoring of INR in a coagulation clinic.

Codes Used In This BI:

1)    Demonstration of use of home INR monitoring is limited to once per lifetime.

2)    Billing for supplies and equipment, and for review of results, is limited to once per 28 days.

Prothrombin time home testing systems are portable, battery-operated instruments for the quantitative determination of prothrombin time from finger-stick whole blood. These products are designed to aid in the management of high-risk patients taking oral anticoagulants. They require considerable patient training and compliance to be useful. Self-testing and/or self-management by the patient using home international normalization ratio (INR) monitors represent another model of care with the potential for improved outcomes as well as greater convenience. Self-testing may provide a convenient opportunity for increased frequency of testing when deemed necessary. The use of the same instrument may increase the degree of consistency in instrumentation, and self-testing provides the potential for greater knowledge and awareness of therapy which may lead to improved compliance. There is, however, insufficient evidence comparing the effectiveness of patient self-testing and self-management using a home INR monitor to care provided by an anticoagulation management service. Ansell, et al. (2001) explained: "Although a growing number of studies indicate the superiority of patient PST [patient self-testing] or PSM [patient self-management of dose adjustments] over UC [usual care, i.e., patients managed by their usual physicians], there is little evidence comparing them to care provided by an AMS [anticoagulation management service (i.e., anticoagulation clinic)]. PST and PSM require special patient training to implement, and therapy should be managed by a knowledgeable provider. A definitive recommendation cannot yet be made as to the overall value of PST or PSM."

In a randomized controlled trial, Gardiner and colleagues (2005) ascertained if patients can achieve accurate INR values through patient self-testing (PST) by means of the CoaguChek S (Roche Diagnostics, Lewes, UK). The main outcome measurements were comparability of INR values obtained by PST and the hospital laboratory, patient acceptability as assessed by a questionnaire and anticoagulant control. A total of 84 subjects (53 men, 31 women; median age of 59 years), receiving long-term oral anticoagulation (warfarin), were recruited. Subjects were randomized to weekly self-testing or continuing 4-weekly hospital laboratory monitoring of INR. Comparison of INRs (n = 234) showed no significant differences between the CoaguChek (median INR 3.02) and laboratory testing (median INR 3.07). There was excellent correlation between the two methods (r = 0.95), with 85% of CoaguChek results within 0.5 INR units of the laboratory method. On four occasions, differences of greater than 1 unit INR were obtained, but in each case the patient`s anticoagulation was unstable (INR greater than 4.5 by both methods) and the differences in INR would not have altered patient management. The results showed that 87% of patients found self-testing straightforward, 87% were confident in the result they obtained and 77% preferred self-testing. These investigators concluded that PST is a reliable alternative to hospital clinic attendance and is acceptable to the majority of suitably trained patients.

Addendum:

1.     Effective 03/01/2017:  Added ICD10 diagnosis code Z79.01, Long-term (current) use of anticoagulants to BI as a requirement for coverage.

This policy applies to all health plans and products administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet.  Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) or Certificate of Coverage (COC) for those plans or products insured by QualChoice.  In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC or COC, the SPD,  EOC, or COC, as applicable, will prevail.  State and federal mandates will be followed as they apply.