Designation critical step for Medicare local coverage determinant under the Molecular Diagnostic Services (MolDX) program
One in five Americans struggle with a mental health condition, placing a significant cost and resource burden on patients and the healthcare system;i Genomind’s pharmacogenomic testing service has demonstrated improved patient outcomes and reduced costs.
KING OF PRUSSIA, Pa.–(BUSINESS WIRE)–Genomind®, the leading mental health company bringing precision medicine into mainstream mental health treatment, today announced the assignment of a Z-code for its mental health pharmacogenomic (PGx) testing service – Genomind Professional PGx Express™ – in advance of its review under the Molecular Diagnostic Services (MolDX) Program. Genomind Professional PGx Express is the most advanced and comprehensive genetic testing service available to guide mental health medication management.
Z-code designations are requisites for MolDX clinical utility and clinical validity review. This process identifies and establishes coverage and reimbursement policies for molecular diagnostic tests, which would include Genomind Professional PGx Express, as part of Medicare’s Local Coverage Determination (LCD) process. An LCD is a determination by a Medicare Administrative Contractor (MAC) whether to cover a particular service on a MAC-wide basis.
“There has been a recent groundswell of support for the utility of PGx testing and its applications in mental health, and this is an important milestone as we work to make Genomind Professional PGx Express accessible to as many patients in need as possible,” said Shawn Patrick O’Brien, Chief Executive Officer at Genomind. “Mental health care remains one of the most significant resource drains on our healthcare system. Utilization of our PGx testing services is underscored by data showing that it can help improve the lives of patients with depression, anxiety, and other crippling mental health conditions, while reducing healthcare costs. We are eagerly anticipating next steps in this LCD process.”
Genomind Professional PGx Express – available by prescription only – is the most advanced and comprehensive genetic testing service available to guide mental health medication management. Genomind Professional PGx Express analyzes up to 24 genes, identifying patient-specific genetic markers that can better inform mental health treatment decisions. The PGx results are bundled with a suite of services designed to enable access to care, improve patient outcomes, and reduce healthcare costs, including:
- Consultations with Genomind’s PGx experts to review the report results;
- Access to G-DIG, Genomind’s proprietary tool designed to assist providers in checking gene-drug and drug-drug interactions when prescribing medications; and
- Access to NeuroFlow, a secure mobile app that provides continuity of care outside of the provider’s office.
In a recent study published in the Journal of Depression and Anxiety, patients using Genomind’s test, as compared to similar patients who did not use PGx-guided treatment, demonstrated an estimated $1,948 cost reduction in the first six months following testing, 40% fewer emergency room visits for any reason, and 58% fewer hospitalizations for any cause.ii Additional studies have shown that Genomind-guided treatment resulted in measurable improvements in 87% of patients.iii
The DEX Z-Code™ awarded, ZBAVA, references the test ordered for each patient and encompasses the Current Procedural Terminology (CPT) codes, allowing Medicare to determine the exact test used for Genomind’s PGx panel. This code includes the 24 genes that Genomind uses based on scientific and clinical support for their role in mental health treatment decisions. DEX Z-Code Identifiers are unique five-character alpha-numeric codes assigned to specific molecular diagnostics (MDx) tests. They are used by Medicare as an adjunct to non-specific CPT codes.
About Genomind® Professional PGx Express™ (PGx Express)
Genomind Professional PGx Express is the most advanced and comprehensive mental health pharmacogenomic service available, bundling the results of a patient’s individual genetic profile with a set of services to support the patient and clinician in improving treatment outcomes. With a genetic profile obtained via a safe and painless cheek swab, Genomind offers two versions of its report. The full report analyzes potential variants on 24 pharmacokinetic or pharmacodynamic genes selected for inclusion based on guidelines from expert consortia and review of hundreds of peer-reviewed studies. Results include genetic information relevant for the treatment of conditions including depression, anxiety, autism, schizophrenia, chronic pain, bipolar disorder, obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), post-traumatic stress disorder (PTSD), and substance abuse. The CORE Anxiety and Depression Report focuses on a subset panel of the 15 genes most relevant to anxiety and depression, and is currently covered by UnitedHealthcare for certain patients. For both the full and CORE reports, Genomind provides medication-specific results to the clinician team only.
In addition to the genetic report, PGx Express offers:
- Access for healthcare providers to the Genomind Drug Interaction Guide (G-DIG);
- Industry-leading service with 99.9% laboratory accuracy and results within three days;
- Complimentary consultations with Genomind’s expert medical affairs team of MDs, PhDs, and pharmacists to review patient-specific technical and scientific insights;
- An Rx MetaType™ Card that provides the patient’s genotype and the expected impact (phenotype) for certain genetic variants related to drug metabolism, which significantly impact the effects of drugs on that individual; and
- Access to NeuroFlow, a digital platform of behavioral health smart phone apps to help better track compliance with treatment plans and enable remote monitoring and measurement-based care.
Genomind is the leading mental health care company, delivering the genetic testing tools that empower clinicians to make more informed treatment decisions and create better outcomes for patients with mental illnesses. As the scientific leader in genetic testing, Genomind’s flagship offering is Genomind Professional PGx Express – the most advanced and comprehensive mental health genetic service available. Supported by a world-class genetics lab and unique consultative approach, Genomind is advancing a new paradigm of personalized medicine in mental health care. Learn more at www.genomind.com.
i NIMH Report: Mental Health by the Numbers
ii Perlis R et al. Pharmacogenetic testing among patients with mood and anxiety disorders is associated with decreased utilization and cost: A propensity‐score matched study. Depression and Anxiety, 2018. https://doi.org/10.1002/da.22742
iii Brennan FX, Gardner KR, Lombard J, Perlis RH, Fava M, Harris HW, Scott R. Prim Care Companion CNS Disord. 2015 Apr 16;17(2). https://www.ncbi.nlm.nih.gov/pubmed/26445691
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