Genetic Counseling and Benefit Management: New Partnerships Emerge

Genetic testing has been the fastest growing area of laboratory testing and one of the most complex to manage. New types of industry players have emerged to provide specialized services to health plans and patients.

December 11, 2020

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.

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.

Some Key Players in Precision Medicine

  • Providers: Prescribe tests for patients, collect genetic material– and help patients interpret the results. Genetic testing and treatments are typically ordered by geneticists but can also be ordered and prescribed by primary care providers, oncologists and other specialists.
  • Genetic Counselors: Genetic counselors have advanced training in medical genetics and counseling and guide patients seeking more information about how inherited diseases and conditions might affect them or their families. Genetic counselors can help both patients and providers choose the right tests and interpret test results. There are a little over 4,000 licensed genetic counselors in the U.S., and the field is rapidly growing, largely due to growth in the development of genetic tests has created higher demand for both tests and for counselors.11 Some of the new players within precision medicine include virtual genetic counseling companies.
  • Lab Testing Companies: Process genetic material delivered to them by providers. There are hundreds of labs across the country that run tests and submit claims to health plans.
  • Health Plans: Set medical policy and coverage guidelines and execute prior authorizations for genetic testing and gene therapies.
  • Lab Benefit Managers (LBMs): Manage the laboratory testing benefit for payers. Given the complexity and evolving landscape, even major health plans need outside support to manage genetic testing utilization, prior authorization and lab claims.
  • Genetic Benefit Managers: Offer comprehensive end-to-end programmatic solutions related to genetic testing and management of genetic test and therapy benefits. Their primary goal is to assist patients, but they may also adopt some functions of LBMs
  • Pharmaceutical Companies: Develop gene therapies for administration by expertly trained providers. They also often launch such therapies with companion genetic tests that help determine if the drug will be effective in particular patients based on their genetics.
  • Direct-to-Consumer Testing (DTC) Companies: Sell genetic tests directly to consumers, who can send saliva samples directly to the company for processing. These DTC companies also sell to employers.
  • Patients: They are, of course, the reason for these new treatments and tests. Patients are affected by decisions made by each of these key players, often while navigating diagnosis and treatment journeys of their own, which can be frightening and expensive.

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.

According to Health Affairs, there are five major LBMs in the U.S. as of 2019 (see Table 1):

Table 1: Characteristics of major LBMs in the U.S.a

Company

Date Founded

Ownership

Services Managed

Illustrative Contracted Health Plans

AIM Specialty Health

1989

Anthemb

Multiplec

  • Anthem
  • Misc. regional plans

Avalon Healthcare Solutions

2013

Private

Lab only

  • Multiple Blue Cross
  • Blue Shield Plans

Beacon Lab Benefit Solutions

2010

Labcorp

Lab only

United Healthcare

eviCore

1994d

Cignae

Multipled

  • Multiple Blue Cross Blue Shield plans
  • Highmark
  • Misc. regional plans

Kentmere Lab Benefit Management Program

2000

Private

Lab only

Misc. plansf

Source: Phillips KA, Deverka PA. The Emerging Use By Commercial Payers of Third-Party Lab Benefit Managers for Genetic Testing. Health Affairs Blog. October 23, 2019. https://www.healthaffairs.org/do/10.1377/hblog20191021.563154/full/. Accessed December 5, 2020.

Table Authors’ notes:

a. There is no fixed definition of what constitutes an LBM, so we included the five companies that were most clearly defined as LBMs in multiple sources and had the largest estimated revenues. There are other companies with overlapping functions; for example, Concert Genetics describes itself as a “technology company” and InformedDNA, a partner of AIM, provides genetic counseling services.

b. Acquired 2007 via Wellpoint.

c. Companies may manage other services in addition to lab tests, such as., radiology, oncology, and specialty pharmaceuticals.

d. eviCore was created by a merger of two companies that initially focused on services such as radiology.

e. eviCore was acquired by Express Scripts in 2017, then Express Scripts was acquired by Cigna in 2018.

f. Website notes ”national, regional and local health plans of all sizes: from 16,000 members to 23+ million with experience in every state.”


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 2019 the genetic testing market surpassed $13 billion and is expected to climb as high as $29 billion by 2026.54 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.

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:

Informed DNA. Cost & Delivery Institute Presentation: Genetic Benefits Management: Best Practices. January 22, 2020 
Figure 1: Informed DNA. Cost & Delivery Institute Presentation: Genetic Benefits Management: Best Practices. January 22, 2020
  • 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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TABLE OF CONTENTS

  1. Some Key Players in Precision Medicine
  2. LBMs: The New Addition to the Alphabet Soup of Health Care Industry
  3. The Importance of Genetic Counseling
  4. Genetic Benefit Managers: Bringing Genetic Expertise to the Continuum of Genetic Benefit Management
  5. Conclusion