It's frustrating when a transformative new technology is held back because the infrastructure can't yet support it.
Think of electric vehicles (EVs), which are caught in a Catch-22 of sorts. Many people are reluctant to buy them until there are more public chargers available, and charging networks are not being built until there are more EVs to use them.
Genetic testing faces a similar problem. It has the potential to transform healthcare through precision diagnostics and therapies, but it's being held back by health plans' insufficient programs for managing it. Caught by surprise by the rapid growth in the number and applicability of tests, plans have been struggling to handle them through their routine testing programs.
It's not working. More than 180,000 genetic tests are on the market, with an average of 10 added daily. CPT coding has not kept up. There are about 500 CPT codes for roughly 360 times as many tests. This results in a system that is slow, inefficient, expensive, and susceptible to waste, fraud, and abuse. Health plans need management programs built specifically for genetic testing, which will only grow in volume and complexity.
As health plans work to improve their handling of genetic testing, whether internally or with a lab benefits management firm, they should ensure that the following nine elements are incorporated into their genetic testing benefits framework.
1. Accreditation and regulatory compliance: Utilization management is necessary to ensure patients receive the proper care and required services without overusing resources. Accreditation by respected agencies like the National Committee for Quality Assurance and URAC and good standing with state regulatory agencies help ensure that organizations making these decisions follow evidence-based best practices.
2. Coverage criteria based on science: The volume of genetic tests is exploding, and maintaining a current understanding of the clinical science and the appropriate coverage criteria documented in clinical policies requires frequent review. To ensure the latest science and clinical medicine are codified in medical policies, experienced working laboratorians, pathologists, and geneticists should perform a comprehensive scientific and clinical review of the newest literature annually or as the science warrants. If health plans lack the internal resources to do so, they should partner with a business that specializes in it.
3. Optimized laboratory network and quality testing: Not all labs are created equal. Some perform better than others. Quality evaluations, results, and audits can identify these high-performing labs. Once the trusted labs have been designated, plans can promote these labs to patients, providers, and even tiered networks with increased benefits to those who use higher-tier labs. In return, the labs that benefit from promotion can offer unit price reductions.
Genetic testing must meet appropriate scientific and clinical standards beyond just coverage criteria. Guaranteeing that labs have completed sufficient scientific, technical, and clinical validations is essential to ensure the information provided to the clinician informs patients' healthcare needs. Plans should have systems to evaluate labs beyond Clinical Laboratory Improvement Amendments requirements and the quality of specific mutation analysis tests.
4. Prevention of fraud, waste, and abuse: The looser the operating framework for testing, the more likely fraud, waste, and abuse will occur. Integrating test specificity and enhanced claim-to-authorization matching processes will reduce that and save plans money.
5. Claim-to-authorization match during adjudication: In many cases, the criterion for matching allows broad, non-specific matches, which contributes to inappropriate payments, stopped claims for manual review, delays in claims payment, and the potential for fraud. Increasing the flexibility and specificity of matching criteria alleviates those challenges.
6. Continuing utilization management vs. claims adjudication: Plans should continually evaluate laboratory tests, required coverage criteria, and historical laboratory performance to determine when a specific laboratory or a collection of tests should be adjudicated during the claims process without prior authorization (PA) or continue utilization reviews in a PA process. Additional controls, such as regular auditing of laboratories to ensure compliance, are recommended.
7. Enhanced provider education and experience: In many cases, laboratories perform the same or similar genetic tests while billing with different combinations of CPT codes. While coding tools like MolDX and Concert Genetics help, they must be embedded in comprehensive programs to be effective. Establishing coding requirements for each test at each laboratory allows streamlined operations and more comparative analytics within the plan. The test specificity concepts discussed provide a clean, robust, and efficient means to overcome potential code challenges and clarify provider billing requirements. Health plans adopting a specificity method for test identification will see increased efficiency, improved laboratory and physician satisfaction, and reduced potential fraudulent billing.
8. Expedited review of prior authorizations: PA can be frustrating and time-consuming for all parties. It's why the federal government and states are creating requirements limiting PA requirements. A "gold card" program that eliminates PA for top-performing labs can simplify administration, improve patient outcomes, and increase savings for health plans, labs, and patients. A lab benefits manager identifies and supervises the network of top labs, reducing the burden on payers.
9. Managing demand from biomarker legislation: As more states pass biomarker legislation, plans need a lab benefits management program to ensure patients receive the right tests. Alignment with nationally recognized guidelines and evidence-backed clinical utility is necessary to ensure that these mandates don't inadvertently hinder innovation or inflate healthcare costs.
Genetic testing will become an even more critical—and beneficial—part of healthcare. Plans that establish separate, science-based policies for managing it will realize the maximum benefits for patients, providers, and themselves.
