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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case. You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.The rules say that The GeneSight report segments and displays these psychotropic medications into three "traffic light" categories or "bins" -green, yellow and red. Based on the patient's genetic make-up and the drug's metabolic and therapeutic pathways, the green bin identifies drugs that will likely be well tolerated and efficacious for the tested patient; the yellow bin identifies drugs with an intermediate effect; and the red bin identifies drugs likely to be poorly tolerated and/or ineffective. The report also identifies common drug-drug interactions that aresimilarly influenced by the patient's genetic composition.Pine Rest StudyThe Pine Rest study was a prospective, patient-and rater-blinded, randomized controlled trial evaluating the clinical impact of GeneSight on antidepressant selection and treatment outcomes in depressed outpatients (GeneSight, N=25 vs treatment as usual (TAU), N=24). Patients were assessed for symptom improvement, remission and response from baseline (week 0) and at 2, 4, and 8 weeks, using the HAM-D17 rating.Subjects in theGeneSight arm had a greater average decrease in the 17-item Hamilton Rating Scale for Depression (HAM-D17) scores from baseline at 8 weeks (p = 0.30) and a higher response rate (p = 0.055) and significantly higher remission rate (p = 0.012) at any time point. Response rates in the GeneSight-guided arm were 73% higher compared to the unguided TAU arm. Retrospective analysis of the TAU subjects at the end of the study after un-blinding and stratifying by GeneSight results proved the clinical validity of GeneSight, with 30% of subjects unknowingly on red bin medications showing a significant worsening of depressive symptoms in contrast to significant improvements in depressive symptoms experienced by 30% of subjects unknowingly on green bin medications (p = 0.07). Additionally, surveys from the treating clinicians revealed that the GeneSight composite report had a significant influence on treatment decisions for 65% of the GeneSight subjects.
Hamm StudyThe Hamm Clinic prospective cohort study with two arms (GeneSight (n = 22) vs. TAU (n = 22)) enrolled adult patients with a primary diagnosis of major depressive disorder utilizing DSM-IV criteria for depression not otherwise specified. GeneSight subjects achieved greater reductions in depression symptoms between the baseline and the week 8 visits compared to TAU subjects using the Quick Inventory of Depressive Symptomatology -Clinician version (QIDS-C16) (p = 0.0024) and HAM-D17 (p = 0.042) ratings. Both the response and remission rate were more than doubled in the GeneSight arm compared to the TAU arm. Upon unblinding the TAU group at the end of 8 weeks, TAU subjects were being prescribed significantly more red and yellow bin medications and less green bin medications compared to the GeneSight guidedsubjects (p = 0.02).La CrosseIn the La Crosse prospective cohort study (GeneSight (n = 72) vs. TAU (n = 93)) at the Franciscan Skemp Hospital in La Crosse, Wisconsin, patients with a primary diagnosis of MDD or depression not otherwise specified with a minimum score of 14 on HAM-D17 were enrolled. Diagnosis was confirmed by checking the diagnosis reported in the physician clinical notes in the electronic medical record (EMR). Samples were collected at baseline in both arms, while only the physicians in the GeneSight arm were provided with test results to inform treatment decisions. In addition to the prospective comparisons, retrospective analysis in the TAU subjects at the end of the study was implemented after un-blinding the GeneSight results to test for clinical validity.A greater reduction in depression scores from baseline to the week 8 visit was observed in the GeneSight arm for all three measures of depression: QIDS-C16 (p < 0.0001), HAM-D17 (p < 0.0001), and PHQ-9 (p < 0.0001). In all measures, a faster reduction of symptoms was observed in the GeneSight arm subjects compared to the TAU arm subjects (QIDS-C16 and HAM-D17 (p < 0.0001), PHQ-9 (p = 0.002)). The GeneSight arm had a significantly higher remission rate based on the QIDS-C16 score (p = 0.03), and significantly higher response rates based on QIDS-C16 (p = 0.005), HAM-D17 (p = 0.03), and PHQ-9 (p = 0.01).Physicians changed medications more often for subjects in the GeneSight-guided group (57.9%) than the unguided group (25.9%) (p = 0.0007). Of the 15 GeneSight-guided subjects classified in the red bin category at baseline, fourteen (93.3%) experienced a medication change or dose adjustment during the eight week study period, compared with 8 out of 18 subjects in the unguided group (44.4%) in the red bin category (p = 0.002). A significant association between bin status and outcome was observed within the unguided group (p = 0.028). Subjects classified in the red bin category had less improvement (11%)  than those classified inthe green or yellow categories (31.9%, p = 0.047), further demonstrating the deleterious effects of red bin medications on patient outcomes.Dayton StudyThis retrospective study, in collaboration with Union Health Services (UHS, a staff model HMO located in Chicago, Illinois), examined healthcare utilization in relation to medication categories (binning) using GeneSight. Ninety-six patients previously diagnosed with a depressive disorder or anxiety disorder and treated with one of the medications included in the GeneSight panel were included in the study. The GeneSight bin assignments of patient psychiatric medications were compared to the medical records for patient medication prescriptions, healthcare utilization, medical absence days, and disability claims for the previous 12 months.
Subjects whose medication regimen included a medication in the GeneSight red bin ("use with caution and more frequent monitoring") had 69% more total healthcare visits (p = 0.005), 67% more general medical visits (p =0.02), greater than 3-fold more medical absence days (p = 0.06), and greater than 4-fold more disability claims (p = 0.004) than subjects taking drugs in the green ("use as directed") or yellow bin ("use with caution"). The mean healthcare utilization cost calculated for red bin subjects during the previous 12 month period was higher at $8,627, compared to $3,453 calculated for green bin subjects (p = 0.024) and $3,426 for yellow bin subjects (p = 0.027), yielding an average annual increase in healthcare cost of $5,188 for subjects on GeneSight red bin medications.Meta-analysis of GeneSight Prospective 2-Armed StudiesIn a meta-analysis of three prospective, 2-armed clinical trials (Pine Rest, Hamm, and La Crosse), use of the test to aid in therapeuticselection has improved patient responses to treatment by 73% on average, which is consistent with the results from each study individually, and is highly significant (p=0.004). These findings support the value of the GeneSight test inimproving patient outcomes. Note: Provider may have primary boards in internal medicine or neurology and also have boards in psychiatry or neuropsychiatry and the provider has a designated specialty in PECOS as IM/neurology. CGS is allowing the GeneSight test to be ordered, when medically necessary, by these providers and they will affix a KX modifier attesting that they have psychiatry or neuropsychiatry boards. Assurex will maintain the certification and make it available upon request.You can find this information inMedicare's RETIRED Local Coverage Determination (LCD): MolDX: GeneSight  Assay for Refractory Depression (L35443).If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.