November 27, 2023

Employers’ Guide to Precision Medicine: Genetic Testing, Treatments and Implications for Coverage

Precision medicine has great potential to improve patient care and outcomes. The speed of clinical progress has been unprecedented, most notably benefiting patients at risk for, or affected by, genetic conditions.

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Advancements in genetic testing and therapies have required both health plans and providers to expand their services. They also have resulted in the creation of new types of partners whom employers can engage with for more support in navigating this complex field. The new classes of service providers can also assist doctors, health plans and patients in appropriately utilizing genetic testing, treatments and interpreting the data. Opportunities may arise for employers to engage with these vendors to manage cost and utilization.

LBMs: The New Addition to the Alphabet Soup of Health Care Industry

Similar to how pharmacy benefit managers (PBMs) emerged in the wake of rising pharmacy costs, laboratory benefit managers (LBMs) are a new type of benefit manager being contracted by employers and/or insurers to help lower costs and enhance quality of care through lab utilization management practices.¹² The need is clear, as laboratory tests represent the most common medical procedure. Even before the need for COVID-19 testing arose, labs were vital in assisting health care providers and patients with monitoring, diagnosing and treating disease. Their role is to perform a wide range of services, from routine blood tests to groundbreaking genetic and molecular tests. In 2019, over 7 billion lab tests were performed in the U.S.¹³ In fact, prior to the COVID-19 pandemic, genetic testing, was the fastest growing area of laboratory tests.

The scope of services offered by LBMs may include:

• Developing prior authorization requirements and performing prior authorizations;
• Developing preferred lab and provider networks to manage cost and quality of lab testing;
• Developing test formularies for payers to reduce inappropriate testing;
• Utilization management and assisting payers with medical necessity review;
• Lab claim processing and reviews;
• Developing coverage policies; and
• Monitoring emerging evidence and the new testing landscape for timely updates to coverage policies. Some LBMs may describe their basis for developing coverage policies and make such policies publicly available, making it transparent to patients and payers that such coverage decisions are rooted in clinical evidence.

The Importance of Genetic Counseling

Patients may be referred to a genetic counselor by their doctor (such as an obstetrician, oncologist or medical geneticist) to discuss their family history and genetic risks, or before or after having genetic testing. For some patients, genetic counselors should be an integral part of their health care team.

Their role is to help patients understand:

• Genetic risks based on family history;
• Genetic risks for certain diseases or cancer;
• Whether genetic testing might be right for them; and
• What the results of genetic tests may mean for both patients and their families.

Genetic counselors can also provide emotional support and assist with shared decision making by empowering patients and equipping them with relevant and clinically accurate information.¹¹

Genetic Benefit Managers: Bringing Genetic Expertise to the Continuum of Genetic Benefit Management

In 2022, the genetic testing market surpassed $18 billion and is expected to climb as high as $43 billion by 2032⁵⁴ The complexity associated with the administration and design of genetic test benefits has sparked the creation of companies specializing in genetic benefits management, some of which are contracting with health plans, LBMs or directly with employers.

 

Informed DNA. Cost & Delivery Institute Presentation: Genetic Benefits Management: Best Practices. January 22, 2020

Genetic benefit managers claim to offer end-to-end solutions that assist consumers but may also adopt some functions of LBMs. The scope of their services may include:

• Genetic counseling and risk assessment for patients, often through virtual platforms;
• Engagement of credentialed genetics specialists to assist providers without genetic expertise with test selection and risk assessment, augmenting the ordering providers’ genetic knowledge with real time online clinical review;
• Assisting patients directly with genetic test selection;
• Managing the preauthorization process for genetic testing;
• Assisting patients and providers in interpreting genetic test results;
• Developing genetic test coverage policy; and
• Ensuring claim payment integrity and quality through genetic test claims analytics and audits.

In addition to LBMs and genetic benefit managers, there is a growing class of companies marketing  genetic tests directly to consumers and employers. Such companies serve as intermediaries between consumers and physicians prescribing genetic tests, which can mean that patients never actually meet the physicians. Instead, the company requests a physician’s order after the consumer purchases a test online. Some observers have noted that this practice is an example of the testing landscape outpacing the current regulatory framework by circumventing the involvement of physicians in ordering and interpreting genetic test results.¹⁴

Conclusion

Employers considering engaging with new partners for better management of the genetic benefit should evaluate the landscape of providers of such services, understand their relationships with health plans and PBMs and look for potential synergies in engaging with those already affiliated with existing partners. Reviewing existing genetic claim data may help employers assess the needs of their population. Timely engagement with experts may benefit employers by creating the proper framework for genetic testing coverage and review to prepare them for the inevitable continued expansion of testing costs and utilization.

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