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

Results

The Atlantic Information Services' Directory of Health Plans contained 436 private accredited health insurance companies with 206 covering 50,000 or more members (range: 50,000–32,824,278) as of November 2010.[13] Thirty nine companies had a million or more members.

We searched for websites for all 206 moderate-to-large insurers (those having 50,000 members or more). Overall, 66 (32%) had at least one publicly viewable medical coverage policy. Of 39 insurers with a million or more members, 30 had public policies (77%) and nine did not (23%). Of the 167 with less than 1 million members, only 36 had public policies (22%) and 131 did not (78%).

Of the 66 insurers that had publicly viewable medical policies, 65 (98%) included at least one policy addressing genetic testing. These insurers had an average of 13 distinct policy documents related to genetic testing (range: 1–59) and insurers with a million members or more averaged 18 policy documents (range: 1–39). These genetic testing policies adopted a variety of formats and may have been specific to a genetic test or condition, general categorical statements about genetic tests and related procedures, or a combination. Thus, there may be differences in the number of policies that address a test categorically (e.g., pharmacogenetics) versus in a test-specific manner (e.g., CYP2C19).

In searching for genetic testing policies, references to genetic testing outside of policy language were sometimes identified. For example, 13 of the 206 insurer sites we reviewed mentioned genetic testing on their public website but did not have specific genetic testing policies. They either indicated that preauthorization was required for all genetic tests (ten insurers), or generally excluded genetic testing from coverage (three insurers). These insurers are not included in this analysis.

General Genetic Testing Policies

Twelve services of particular interest to genetics were categorically addressed in at least some insurance policies (Table 1). Direct-to-consumer genetic testing (n = 12) and gene therapy (n = 3) were the only two services uniformly not covered. Services that were uniformly covered, for at least some indications, included diagnostic genetic testing (n = 38), genetic counseling (n = 24), prenatal diagnosis in general (n = 15), amniocentesis (n = 12) and chorionic villus sampling (n = 11), specifically recurrent miscarriage evaluation (n = 7) and pharmacogenetic testing (n = 3). Overall, general coverage determinations were concordant among all reviewed policies for nine out of 12 (75%) genetic services, although specific coverage criteria may be different.

Some recurring general coverage themes were identified across multiple genetic services policies and are summarized in Table 2. The most commonly encountered theme was that the test result must affect medical management (51% of insurers with reviewed genetic testing policies). Related to that, in a diagnostic setting, 25% of insurers required that the clinical diagnosis of a genetic disorder must be uncertain (i.e., the test result is required to make the diagnosis). Genetic counseling as part of the pretest decision-making process was discussed in 40% of general genetic testing policies. Approximately one-quarter of policies specified that the genetic test must be scientifically and clinically valid.

Test-specific Policy Review

The 65 insurers with genetic test-specific policies addressed an average of 38 genetic tests (range: 0–155). Five insurers had only general genetic testing policies without addressing any specific genetic tests. Insurers with 1 million or more members addressed an average of 50 genetic tests (range: 0–155) with only one having no test-specific policies, while insurers with less than 1 million members addressed an average of 28 genetic tests (range: 0–82).

Among all insurers studied, there were 272 genetic tests addressed in at least one policy, 87 appeared in ten or more policies and 16 appeared in 30 or more policies (Table 3).

Of all genetic tests addressed by specific policies, half were deemed investigational or were otherwise not covered. A total of 103 of the 272 genetic tests addressed (38%) were uniformly not covered by all insurers. Of tests addressed by at least ten insurers, 31 (36%) were uniformly not covered (Table 4). Often, the various Blue Cross Blue Shield entities adopted similar policies. Since each is counted separately, the number of related policies for some tests is heavily weighted on these Blue Cross Blue Shield policies.

Conversely, 108 of the 272 genetic tests addressed (40%) were uniformly covered (for at least some indications) by all insurers with applicable policies. Of the tests addressed by at least ten insurers, 17 (20%) were uniformly covered (Table 5).

Thus, there were no discrepancies in overall coverage determinations (uniformly covered or not covered) for 211 of the total 272 tests addressed (78%) and 48 of the 87 tests addressed (55%) by at least ten insurers.

Effective Date of Policies

Of the 65 insurers with test-specific policies, only three did not include the most recent revision dates in their policies. Of the remaining 62 insurers, 28 (45%) had at least one policy that had not been reviewed within a year of our review, including 16 insurers with 1 million or more members. Thirteen (21%) had at least one policy that had not been reviewed in over 2 years and the oldest policy had not been revised since 2003 (8 years prior to our study).

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