As researchers gain growing insight into the mechanics of what makes diseases tick, more and more genetic tests are coming onto the market to help make sure the right patient gets the right drug at the right time. While these diagnostics can help inform diagnosis and treatment for patients, the sheer volume of these tests may be overwhelming payers in their coverage decisions. Stakeholders should work together to help establish the clinical utility that payers need to make coverage decisions on these diagnostics, industry experts say.
Daryl Pritchard, Ph.D., senior vice president of science policy at the Personalized Medicine Coalition (PMC), describes the landscape of coverage for genetic testing as “uneven. Payers are increasingly considering coverage and reimbursement of genetic testing products and services.” However, he tells AIS Health, a division of MMIT, “there remain significant challenges in establishing coverage policies and payment rates for diagnostic tests that reflect the value of their care. As a result, many newer novel diagnostics are under-reimbursed or not covered at all. Such practices ultimately restrict patient access to some needed tests and to optimal care. Coverage and reimbursement policies vary widely among different payers, and decision-making processes are often inconsistent and not transparent.”
To try to drill down on understanding the landscape, PMC is about to begin a study titled “Payer Perspectives and Policies on Personalized Medicine: A Landscape Analysis,” which is aimed at understanding “the current landscape of payer policies and perspectives on all personalized medicine technologies, especially genetic testing,” he says. “PMC has looked into utilization and coverage trends for genetic and genomic testing for several years, but payer perspectives are evolving as personalized medicine continues to advance, and policies can change quickly.”
Kelly Athman, senior director of medical affairs at InformedDNA, agrees that coverage “does vary quite a bit between payers. Many payers are approaching the coverage of genetic testing pretty similarly to how they approach coverage for other clinical specialties, often by a single test or procedure code.” This lack of consistency among plans adds “a layer of complexity when you’re comparing how genetic testing is being covered today.”
One constant among most payers is that they’ll cover genetic testing “when the results will direct care for the patient. For example, testing for biomarkers or mutations that identify the appropriate patient for a biomarker/mutation-direct therapy are generally covered,” explains Erin Lopata, Pharm.D., M.P.H., vice president of the access experience team at PRECISIONvalue. “Payers are less likely to cover testing when the results are not likely to alter the course of treatment for a patient. For this reason, many payers prefer not to cover testing panels, which assess a large number of mutations — all of which may or may not impact the course of treatment for that patient.”
Carolyn Zele, a solution consultant with MMIT, concurs with that assessment, noting that payers may cover a specific test — for example, a BRCA test — but tend not to cover a broader panel that could identify a genetic abnormality for which there are no present symptoms but may need to be treated with an expensive agent. Most payers assume that they’ll have a member for two years at most before that person changes jobs and insurance, so they’re looking to cover a test that has an immediate impact, she tells AIS Health.
“Some genetic tests with long-standing determination of their value to care, such as HER2 testing in breast cancer, are nearly universally covered, but newer novel tests face inconsistent coverage and reimbursement, governed by policies that are often unclear and rapidly changing,” Pritchard states.
“When it comes to coverage of certain diseases and biomarkers, we know that clinical utility evolves over time. It’s kind of a moving target,” says Athman. “When new tests come out, there’s often a gap between the time a test is clinically available from a commercial laboratory to when that might meet medical necessity [and/or] clinical utility standards for insurance coverage. The basis of that really is in peer-reviewed literature establishing clinical utility, national guidelines and professional societies supporting the use of those newer tests within clinical practice, and then…that allows payers to open up that coverage to a wider swath of people.”
As an example, Athman — who has been a board-certified genetic counselor since 2010 and has more than 15 years of experience in the health care industry, including the health plan space — points to chromosomal microarray testing. When she was in clinical practice, that test “was first being offered clinically by laboratories to look at the chromosomes, and it took a little while for payer policies to adopt that coverage and support that broader use. And once it became more established, and more evidence came out regarding the benefits of that type of testing, it really became the standard when you want to look at chromosomal differences, and [a] look toward those coverage policies [showed] that it was something that payers were adopting more readily as part of their policies.”
According to Lopata, “oncology and rare disease are two areas where targeted therapies are proliferating, and as a result, genetic testing as it relates to eligibility for available treatments is often covered. It’s not difficult to show a return on investment for a test that accurately identifies patients who are most likely to benefit from high-cost specialty drugs, including cell and gene therapies.”
In addition, says Athman, “there are some emerging areas right now in genetics and clinical genetics such as pharmacogenetic testing. That is something that I think we might be seeing on the horizon, a little bit more expansion of coverage, and that’s just because there’s emerging evidence that certain types of pharmacogenomic tests and biomarkers can really make a difference when considering things like chemotherapy regimens for individuals who are undergoing treatment for cancer.”
How Can Payer Barriers Be Overcome?
The main barriers to payers’ coverage of a genetic test are “(1) a lack of evidence of the value a test can bring to clinical care, which a payer will need to make a positive coverage determination, and (2) a lack of transparency on the part of payers in making clear what evidence is necessary for a positive coverage determination,” Pritchard says. “A strategy to help overcome these limitations involves innovators directly talking with payers about evidence development for novel tests and what will be necessary. Working together, payers and test manufacturers may affect positive change, but a wide communication gap must be bridged.”
While drug and diagnostic manufacturers “may have a strong sense about the clinical utility that a certain test may bring to a patient and to the overall health system, a payer evaluates new tests and rightfully looks for proof of the test’s utility before covering,” he continues. While practice-based data may offer evidence of clinical utility, it “also goes beyond just clinical outcomes, also accounting for improvements a test can bring to population-level care, health care spending and health systemwide knowledge improvements. It is hard to understand a test’s clinical utility before having used it in practice, and negative coverage determinations can preclude its use in practice, thereby setting up a chicken-and-egg scenario. It will be incumbent upon all stakeholders to address the clinical utility question: Dx [i.e., diagnostic] and Rx [i.e., drug] manufacturers, laboratories, payers, researchers, data experts and, above all, patients.”
Overcoming the gap between when a test first comes out and when it’s considered clinically useful is critical for providing appropriate health care. “And a lot of what that comes down to is really having a cohesive approach to how payers are thinking about genomics benefit management,” maintains Athman. A genomics benefit management framework “is based on policy and really having that genomics expertise either in-house or with experts out in the field to really inform that policy. And for genetics, it really impacts every organ system, so I think there’s a lot that payers really have to cover when it comes to thinking about just the evidence, even broader, the range and the volume, what they have to think about when it comes to coverage. It goes really way beyond those other medical specialties when it comes to that breadth of information needed to make that policy. So involving genomics experts in that coverage policy development really is something that I think is key because it’s taking that real-world experience and hopefully helping payers cover the right tests, the tests that are clinically useful, clinically impactful for their members.”
More than 77,000 genetic tests are available, and new tests are constantly coming to market. “There are a lot of different players in that space for sure,” acknowledges Athman. “And the genetic testing market today…is rapidly growing in size and complexity; it’s changing daily. When it comes to that sheer breadth of knowledge, for payers that’s a challenge with all those changes and new tests and new evidence coming out.”
Some payer coverage may be deterred by costs. “Some payers may be less likely to cover testing that is either exceedingly expensive and/or not available at their preferred in-network lab providers,” declares Lopata. “However, payers may still see the value in covering a test in those situations if it helps to determine eligibility for a high-cost specialty drug.”
She adds that “it’s critical for payers to understand where and how tests fit into the patient journey for a given condition, particularly if that algorithm is based on clinical evidence and guidelines.”
One potential issue, explains Zele, is that if the FDA requires a test for the use of a drug, and a payer requires that test in its policy for coverage of the drug, that doesn’t necessarily mean that the test is covered. “The payer may have an above-brand policy that sits above all these treatment paradigms and covers genetic testing.”
For most payers, the pharmacy & therapeutics (P&T) committee that decides coverage of a drug is not the same as the policy team that writes the genetic testing policy, says Zele. However, says Lopata, “because companion diagnostics are critical for patient identification for many targeted therapies, there is often increasing integration among these teams for drugs that are approved with a companion diagnostic test that helps to determine patient eligibility.”
In addition, the genetic test policy may be updated much less often than the formulary. “Commercial insurance could take up to a year for policies to catch up,” Zele says. And while a test may be in the policy for particular indications and/or specific drugs, if a new use/medication is not in there, that can be an issue until it’s added. “There is a disconnect there for sure.”
Athman also says that she’s worked with payers that have annual or biannual reviews for coverage guidelines, and “that might make sense for many of the medical specialties out there. For genomics, I would say that we recommend more frequent updates,…even a quarterly update, to make sure that individuals are getting that new information covered or the new evidence [is included] within that policy so that it can expand coverage appropriately.”
Prior Authorization Requirements Vary
The landscape of prior authorization for genetic tests also varies. An AHIP industry survey conducted between September and December 2019 found that genetic testing was the third most common treatment for prior authorization behind specialty drugs and high-tech imaging.
“Some national and regional payers do require prior authorization for genetic testing services,” says Athman. While those requirements differ, “in general I would say prior authorization offers providers an opportunity to submit information about that test that’s being requested, such as the test name, the performing laboratory, the billing codes, their procedure codes for that test and also some medical information about how that test will help someone change their care plan or impact their care plan. So that could be in the form of medical records or some laboratories that have [performed the test] to show the need for this genetic testing or even a letter of medical necessity. Some providers choose to write that very specifically to a health plan.”
Still, says Lopata, “many genetic tests do not require a prior authorization. Medical policies may be created for genetic tests where they are recommended in a specific type of patient, to discourage broad use in patients that are not likely to have a positive result. If guidelines (such as NCCN [i.e., the National Comprehensive Cancer Network]) have recommendations regarding when a certain test is appropriate, the policy will likely anchor to those recommendations.”
In situations where a prior authorization is in place, its requirements “will depend on whether there are specific recommendations for when a test should be used and may include diagnosis and/or patient risk factors,” she says. “Payers could also require genetic counseling before a test is reimbursed.”
“We need more genetic counseling, and genetic counseling services need to be regularly covered by payers,” asserts Pritchard. “As genetic testing increases, a genetic counselor is poised to work with patients to ensure that testing is implemented when needed [and] results are interpreted correctly and put to use appropriately.”
According to Athman, “a lot of national payers are covering the cost of genetic counseling as part of their benefits.” And both pre- and post-testing counseling can be beneficial to patients, she says. “A lot of patients, when faced with that pre-test choice and that information,…can make an informed choice [about] whether that test is really something that they would like to pursue at all or even just at this time.…So genetic counselors, especially in my work, we always want to find the right test for the right patient at the right time to ensure that that patient can make those informed choices about their health and feel empowered to do so. So I say that’s the benefit of pre-test counseling.”
One benefit of post-test counseling, she continues, “would be to understand the nuances of those results. Sometimes results of genetic testing can be quite complex and something that really takes a genomics professional to dive deep into the literature to really understand a little bit more about that result in order to explain it in a way that can make sense for that patient’s care and really develop an intricate care plan and partnership with their care team.” The information also may be relevant to family members who may share a genetic marker, so post-test counseling is important in that regard as well.
“In thinking about what we do from informing that pathway of genomic benefit management, I would say payers are out there really to support their members,” contends Athman. “And I think everyone is very hopeful that as we move forward, really having that holistic approach can benefit patients and ensure that they’re getting value out of the care that they’re seeking or the genetic test or the new treatment. When it comes to value-based care, I think we have a lot of great minds in the genomic space who are creating new advances, but we also have a lot of great people who want to ensure that people have access to that most appropriate genetic testing and coverage for that.”
Ultimately, says Pritchard, “payers want to cover testing that provides clear value to patients. We are starting to see, for instance, more and more payers covering genomic testing for pediatric patients with undiagnosed disease in the NICU [i.e., neonatal intensive care unit]. The value picture there is starting to become clear. However, genomic testing for undiagnosed NICU patients has been available for years. What of all those patients that may have benefited but were on a diagnostic odyssey and did not get a definitive diagnosis because a comprehensive genomic test was not covered by their insurance? We need a better, more defined method for payers to determine the clinical utility of tests rapidly, so that we can optimize care for patients sooner rather than later.”
Contact Athman and the InformedDNA health plan team at firstname.lastname@example.org, Lopata through Leslie Campos at email@example.com, Pritchard via Chris Wells at firstname.lastname@example.org and Zele at email@example.com.