Genetic Testing Insurance Coverage Trends

A Review of Publicly Available Policies From the Largest US Payers

Michael D Graf; Denise F Needham; Nicole Teed; Trisha Brown

Disclosures

Personalized Medicine. 2013;10(3):235-243. 

In This Article

Abstract and Introduction

Abstract

Aim: Health plan coverage policies can influence utilization of genetic tests. Our goal was to characterize the current state of test-related policies from US private payers.

Methods: We searched the public websites of 206 insurers for coverage policies. We documented the number of policies, tests mentioned, coverage determination and policy effective dates.

Results: Approximately one-third of insurers had at least one genetic testing policy. Moderate consistency was seen between payers. Tests in oncology and personalized medicine were most frequently addressed. Half of the policies specifically excluded coverage of a particular genetic service. Nearly half of insurers had at least one out-of-date policy.

Conclusion: Genetic services are addressed by many large health plans. Challenges remain in ensuring consistency and currency of payer policy for genetic tests.

Introduction

Genomic testing, and the use of such test results to direct healthcare (i.e., personalized medicine), is among the fastest growing segments of the laboratory market with a US$1.5 billion worldwide market, which is expected to reach US$4 billion by 2015.[101] The NIH Genetic Testing Registry was launched in February 2012 as a voluntary listing of clinically available genetic tests, mostly for single-gene disorders. There are over 17,000 laboratory test entries for more than 2300 conditions.[102] Looking to the future, horizon scanning performed by the CDC Office of Public Health Genomics identified approximately two to three new genomic tests per week that were new to the market or in development during a test surveillance pilot in 2009–2010.[1]

Healthcare payers must make decisions about when and how to pay for these technologies, balancing the need to control increasing healthcare costs while maximizing the potential for improved healthcare quality and outcomes. This influx of genomic testing presents a great challenge for payers trying to keep pace with coverage determinations around these tests.

When developing their policies, payers emphasize evidence-based coverage decisions; however, rigorous evidence is often lacking for genetic tests.[2] Payers may look to a variety of sources for informing coverage decisions, but each has significant limitations related to genetic testing. Sources include health technology assessments performed by public or private organizations that are available for only a limited number of genetic tests and may be expensive.[3] Professional guidelines weigh heavily but are also limited in number.[4] While the US FDA clearance has historically been used as a gold standard for test coverage, many genetic tests are created and validated as laboratory-developed tests, which do not currently fall under FDA oversight.[4] Finally, coverage decisions made by other payers may be influential, particularly Medicare, which is the single largest US insurer. By nature of Medicare's mandate, their coverage decisions may not translate well to genetic tests intended to be preventative and often are most beneficial for those under the age of 65 years.[2]

Private payers insure approximately two-thirds of people in the USA.[5] Since payers have varying coverage philosophies and decision-making strategies, reimbursement of genetic tests – and, therefore, patient access to testing – is expected to vary between plans.[2] However, little has been published about how this group is approaching genetic testing: what general limits they place on the scope of genetic services, what genetic tests they address and when they reimburse for those tests.

Reports on this topic have addressed specific aspects of billing and coverage, such as genetic counseling services,[6,7] BRCA testing,[8] hypothetical genetic testing situations,[9] pharmacogenomics,[10] emerging genomic technology,[11] and genetic services coverage in IL, USA only.[12] While each of these was intentionally limited in scope, they all identified variability in medical coverage policies for genetic testing and genetic services. This is the first known survey of all major US private health insurers with publicly available genetic testing policies. We were interested in describing the scope of general genetics coverage policies, identifying the tests most frequently addressed in policies and analyzing coverage variability among insurers.

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