New technologies and patient care models are driving laboratory testing to the patient's side—at the point of care (POC). POC testing is diagnostic testing or therapeutic monitoring carried out at or near the site of the patient. By using whole blood or other bodily specimens, POC testing eliminates the time lag associated with laboratory testing and leads to rapid results for quicker therapeutic action and improved patient outcomes and satisfaction.
While such in-office testing is relatively new to behavioral healthcare, it is not a new approach in general medicine. More than 90,000 medical offices perform POC testing in the United States. Familiar POC tests include those that determine blood glucose, pregnancy, strep throat, substances of abuse, and prothrombin time. In-office testing in behavioral healthcare settings is emerging as a method to monitor effects of medications used to treat conditions such as schizophrenia and bipolar disorder.
Antipsychotics treat signs and symptoms such as hallucinations, delusions, disordered thinking, mania, and depression in people suffering from schizophrenia or bipolar disorder. Both of these conditions are chronic, often beginning in young adulthood. Schizophrenia affects 1% of the general population, and bipolar disorder affects 3%. Because of their chronicity, these two conditions account for a sizeable proportion of overall behavioral healthcare costs.
Clinical studies of the atypical antipsychotics have observed weight gain, abnormal lipid levels, and elevated blood sugar in pa-tients—signs of metabolic syndrome, which leads to heart disease and serious medical consequences. These side effects are serious because patients with schizophrenia and/or bipolar disorder, independent of medications, are at greater risk for cardiovascular disease.1,2
As a result of the concern about metabolic syndrome and cardiovascular disease, behavioral healthcare providers now are focused on screening for these conditions.3 The clinical indicators of interest are:
high blood pressure (i.e., ≥130/85 mmHg)
waist circumference >40" in males and >35" in females
fasting blood sugar >110 mg/dl
fasting HDL cholesterol <40 mg/dl in males and <50 mg/dl in females
fasting triglycerides ≥150 mg/dl
A recent study of patients with schizophrenia or bipolar disorder treated with atypicals found a 29.2% prevalence of metabolic syndrome.4 This study found that when elevated abdominal obesity and fasting blood glucose levels were combined, all patients with metabolic syndrome were accurately identified. The authors concluded that these two measures constituted the most cost-effective way to screen for metabolic syndrome in this patient population.
The availability of POC testing methods for blood glucose levels creates new opportunities for behavioral healthcare providers to monitor drug therapy and screen for complications in patients with diabetes. Instant glucose meters and strips are advertised widely on television and in the print media, and they are now widely used among prediabetic and diabetic patients. Reimbursement is possible since many of these tests are “CLIA-waived” by the FDA. A CLIA-waived (Clinical Laboratory Improvement Amendments) test has been tested in three clinical studies using untrained people who, after reading the instructions, perform the test, and the test performs as described without adverse effects. Once a device is CLIA-waived, it can be used in office environments instead of laboratory environments. Behavioral healthcare providers have reason to perform this measure because, based on my and many others’ observations, patients with schizophrenia or bipolar disorder often avoid primary care contacts.
Since the 1970s, lithium has been a mainstay of bipolar disorder treatment and an effective augmentation strategy for treatment-resistant unipolar depression and schizophrenia. Despite lithium's efficacy, many psychiatrists find regular monitoring of lithium blood levels to be burdensome for their patients and for themselves (table 1).
Lithium is a benchmark drug, but the amount for effectiveness is slightly less than toxic levels, so clinicians must monitor levels to ensure maintenance of therapeutic ranges. Lithium is underused in the United States, yet it has the most extensive evidence base for long-term efficacy for bipolar disorder compared with any other drug.5 Lithium is highly rated in many treatment guidelines including those from the Veterans Administration and American Psychiatric Association, and in the Expert Consensus Guidelines.6 Such underuse is particularly notable given the evidence for lithium's potency for suicide prevention.7–9 Only about 400,000 patients are on lithium in the United States out of a total potential population of more than four million.10
Lithium is underused for at least two reasons: (1) Because lithium is not a brand-name drug, it does not generate high revenues for pharmaceutical companies and is consequently downplayed in educational programs sponsored by industry, and (2) it has the monitoring burden mentioned above. Lithium levels are monitored for three reasons: first, to prevent or recognize side effects, such as tremor, nausea, diarrhea, and confusion, all signs of lithium toxicity; second, to ensure ongoing efficacy and effectiveness, including the prevention of suicidal behavior; and, third, to help ensure patient adherence to the prescribed regimen.
Not only does the burden of lithium monitoring probably contribute to underuse of lithium, it also explains the observed underuse of therapeutic monitoring of patients taking lithium in clinical settings. One study of more than 700 patients from a Medicaid database revealed that a substantial proportion of bipolar patients prescribed lithium (36.5%), valproate (42.4%), and carbamazepine (42.2%) did not receive therapeutic drug-level testing during the 12-month study.11 Product labeling for lithium products indicates that stable patients should have their lithium levels checked every two months.
Recently, the FDA approved an instant POC test for lithium blood levels.12–14 The test requires a finger-stick blood sample, which is placed in a reader that reports the blood level in less than two minutes. This new technology offers a benefit to clinicians and patients—instant feedback. By eliminating the need for laboratory testing, clinicians will be able to balance the patient's therapeutic response with possible toxicity at the time of contact. During the visit, the clinician will be able to manage a patient's response to therapy and make adjustments to the patient's dosage level, according to his/her metabolism. Such an individualized response raises the bar for quality of care.
E&M of established patient
|Collection of capillary blood specimen|
Removing the lag time between blood sampling and test results leads to fewer lost results and, consequently, reduced risk for error. It is worth recalling at this point that the Institute of Medicine reported 98,000 deaths occurring annually in U.S. hospitals as a result of preventable medical errors.15 Moreover, a recent international survey supported by The Commonwealth Fund found that one-third of U.S. patients with health problems reported experiencing medical mistakes, medication errors, or inaccurate or delayed lab results, the highest rate of any of the six nations surveyed.16
With in-office lithium testing clinicians can proactively confirm patient adherence to therapy. Problems with lithium adherence are no different than with any other drug, which means that a substantial number of patients are not following the prescription as written.5 Discussing adherence with patients can be awkward because it can mean confronting them about their choice to not follow the prescribers’ recommendations, but when the numbers are right in front of the clinician and the patient, it is easier to initiate a productive dialogue that empowers the therapeutic alliance. More importantly, with instant feedback, an opportunity exists to offer the patient positive reinforcement—a distinct advance in the practice of behavioral healthcare.
The sale of CLIA-waived devices to the practitioner alters the traditional reimbursement pattern for monitoring blood sugar or lithium levels: That is, it shifts the payment from the laboratory to the practitioner or the consumer. In the case of the lithium test, plans and insurance companies need to understand that behavioral healthcare providers will submit CPT code 80178QW for reimbursement for measuring lithium levels. Note that the “QW” modifier after this CPT code indicates that the test has been CLIA-waived. Practitioners also will be able to bill CPT code 36416 for the collection of capillary blood. This shift in the reimbursement pattern means that certain plans (e.g., in capitated systems) will have to reorganize their reimbursement procedures if they have designated a line of funds to go to laboratories, not prescribers.
In addition to the charge for the lithium level test and the finger-stick procedure, providers will seek reimbursement through other CPT Codes.17Table 2 shows typical codes a psychiatrist could bill for after performing an instant lithium test during a regularly scheduled visit. The existing CPT codes in behavioral healthcare do not consider this new technology, which bridges treatment and testing. In this scenario, the patient was scheduled for a visit, so the provider usually would bill under 90862. Yet the time to perform the in-office lithium test and collaborate with the patient regarding findings is not incrementally reflected in the 90862 code, and the prescriber has no existing option to upgrade the charge.
One solution would be for the behavioral health prescriber to use the Evaluation & Management (E&M) 992 code series, in which it would be possible to upgrade the charge to reflect the additional time associated with the instant lithium test. This option is available for POC testing in general medicine, but many plans are rejecting this code series in an attempt to slot behavioral health reimbursement charges into the 908 CPT code series. The need for a fairer level of reimbursement for POC testing in the behavioral health arena is a new challenge for stakeholders.
Technologic advances are expanding POC testing dramatically. POC tests will raise the bar of quality of care in medicine. Such testing is beginning to occur in behavioral health settings and, as it does, payers will have to rethink current reimbursement strategies if these tests are to be available to patients.William M. Glazer, MD, is President and Chief Medical Officer of ReliaLab, maker of the InstaRead Lithium System, a point-of-care test for blood lithium levels.