Who Pays? Coverage Challenges for Cardiovascular Genetic Testing in U.S. Patients

Abstract

Inherited cardiovascular (CV) conditions are common, and comprehensive care of affected families often involves genetic testing. When the clinical presentations of these conditions overlap, genetic testing may clarify diagnoses, etiologies, and treatments in symptomatic individuals and facilitate the identification of asymptomatic, at-risk relatives, allowing for often life-saving preventative care. Although some professional society guidelines on inherited cardiac conditions include genetic testing recommendations, they quickly become outdated owing to the rapid expansion and use of such testing. Currently, these guidelines primarily discuss the benefits of targeted genetic testing for identifying at-risk relatives. Although most insurance policies acknowledge the benefit and the necessity of this testing, many exclude coverage for testing altogether or are vague about coverage for testing in probands, which is imperative if clinicians are to have the best chance of accurately identifying pathogenic variant(s) in a family. In response to uncertainties about coverage, many commercial CV genetic testing laboratories have shouldered the burden of working directly with commercial payers and protecting patients/institutions from out-of-pocket costs. As a result, many clinicians are unaware that payer coverage policies may not match professional recommendations for CV genetic testing. This conundrum has left patients, clinicians, payers, and laboratories at an impasse when determining the best path forward for meaningful and sustainable testing. Herein, we discuss the need for all involved parties to recognize their common goals in this process, which should motivate collaboration in changing existing frameworks and creating more sustainable access to genetic information for families with inherited CV conditions.

Genetic testing in steroid-resistant nephrotic syndrome: why, who, when and how?

“…As part of the genetic counselling process, these issues should be discussed with affected families and informed consent obtained prior to genetic testing. A thorough discussion regarding the barriers to genetic testing in public health is beyond the scope of this review, but readers are directed to several useful articles for further information [100][101][102][103][104].…”

Insurance coverage does not predict outcomes of genetic testing: The search for meaning in payer decisions for germline cancer tests

“…The equitable integration of genetic sequencing into routine clinical care requires patient access to this technology. Health insurer coverage policies do not exist for all types of genetic testing, and those that do may not be consistent across payers (Graf, Needham, Teed, & Brown, ; Kutscher, Joshi, Patel, Hafeez, & Grinspan, ; Wang, Beattie, Ponce, & Phillips, ) or conflict with professional society guidelines (Spoonamore & Johnson, ). A lack of transparency and standardization in health insurer coverage policies for genetic testing may be a barrier for patients who are recommended to have genetic testing.…”

Development of a Streamlined Work Flow for Handling Patients’ Genetic Testing Insurance Authorizations

“…Advances in genetics and the advent of next generation sequencing technologies has resulted in the introduction of many new genetic tests, test options, and an increase in the number of genetic testing laboratories (Genetic Testing Registry 2017, GeneTests 2017. More patients are being offered genetic testing to inform their medical care, but use is limited due to problems with obtaining insurance coverage of these tests (Capasso 2014;Prince 2015; Secretary's Advisory Committee on Genetics, Health and Society 2006; Spoonamore and Johnson 2016). Obtaining insurance coverage is a multi-step, timeinvolved process, which often requires genetic counselor (GC) and physician involvement (Fig.…”

“…Insurance coverage of a genetic test, like other medical tests, generally depends on demonstrated clinical validity and evidence of clinical utility, along with there being documentation of medical necessity (Burke 2014;Capasso 2014;Prince 2015; Secretary's Advisory Committee on Genetics, Health and Society 2006; Spoonamore and Johnson 2016). Generally, insurers have a specific list of criteria that have to be met for genetic testing to be considered medically necessary and some may even require genetic counseling services to make this determination (Capasso 2014;Latchaw et al 2010).…”

“…Ascertaining the cost of genetic testing and determining what the patient will be billed is challenging. The list price of a genetic test may not be readily available at a laboratory's website for proprietary reasons and can vary significantly depending on the specific test, methodology, testing laboratory and whether the institution, insurer, or patient is billed (Spoonamore and Johnson 2016;Uhlmann 2009). Negotiated contracts between institutions and labs and institutions and insurance companies impact institutional billing and contracts between labs and insurance companies impact direct insurance billing (Spoonamore and Johnson 2016).…”