CLN - Focus on Laboratory Stewardship
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Molecular diagnostics have emerged as powerful tools for precise disease detection and personalized treatment. While the science is evolving at a rapid pace, the complexity of billing and coding lag behind.
One of the foremost challenges in molecular billing and coding lies in the accuracy and specificity of codes. Unlike more straightforward medical services, molecular tests require codes that account for a wide range of variables, including type of test, specific genes or analytes analyzed, specimens used, methodology, and the purpose of the test, such as diagnostic, screening, or therapeutic.
With around 20,000 genes in the human genome and 160,000 genetic tests, the availability of unique procedural coding is bleak in comparison (1, 2). Without precise coding, payers are left guessing about what occurred on the bench. Incorrect or vague coding can lead to claim denials, delayed reimbursements, compliance issues — and financial toxicity for patients.
Healthcare professionals across medical, laboratory, and payer industries must stay abreast of constantly evolving code sets, such as Current Procedural Terminology (CPT) codes, Healthcare Common Procedure Coding System (HCPCS) codes, and International Classification of Diseases (ICD) codes, some of which publish new code sets quarterly. Each molecular test may require multiple CPT codes to accurately capture the procedure, while others may be more correctly billed as a single code.
Often tests rely on nonspecific codes, further complicating billing.
Although the testing market continues to expand, available code sets have advanced little (2). Three key areas are ripe for innovation and collaboration: technology, standardization, and administration.
Under technological advances, next-generation sequencing (NGS), for example, has revolutionized the field by allowing the simultaneous analysis of multiple genes. It has also introduced new complexities in coding. Coders must differentiate among types of tests (DNA sequencing, RNA sequencing, copy number analyses, methylation), a task complicated by the continuous emergence of new tests and methodologies.
When a new test materializes, yet no specific coding is available, billers rely on the ambiguous 81479 unlisted procedural code. With so many tests billed as 81479, ambiguity leads to lower or no reimbursement as payers navigate the conundrum of enforcing medical necessity. PLA codes are highly specific, but many are obtained prior to clinical utility studies, leading to a lack of reimbursement (See box). As technology advances, PLA codes lack fluidity for modifications in gene content and methodology, hastening obsolescence.
Types of molecular codesMolecular pathology coding can be broken into subgroups that define the type of molecular testing being performed.
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A lack of standardization compounds the problem. There is often inconsistency in how different payers interpret and implement coding guidelines. This lack of standardization burdens laboratories and healthcare providers, who must navigate a maze of payer-specific rules.
Furthermore, federal and state health programs can differ dramatically from commercial and employer-funded health plans in their enforcement of correct coding. As an adjunct to relying on nonspecific coding, organizations develop CPT identifiers to describe each unique test. These are managed by an independent organization and are only made available to payers or laboratories for whom they contract. Without all the layers of the industry adopting a standard system, the CPT identifiers lack context and challenge consistency.
Once claims for molecular testing are submitted to payers, administrative challenges begin. Coders may rely on laboratory details, test menus, and diagnosis codes to piece together the specifics of a test. The same code may be used for different assays, such as performing sequencing of BRCAl in germline and somatic clinical scenarios. The resultant coding of a claim may be unreliable in providing necessary details for enforcement of medical policy.
The administrative burden extends outward as laboratories and clinics identify documentation within patient charting to justify the service billed as they navigate distinctive payer policies. Claim adjudication is a resource-intensive process for all. Traversing these complexities requires proactive communication, ongoing education, and a keen understanding of regulatory and policy updates.
Consider the journey of Whitney, a 45-year-old patient with breast cancer. Whitney’s genetic counselor orders a multigene panel to identify hereditary cancer risks. The laboratory secures prior authorization for a hereditary breast cancer panel, performs the test, and submits the claim. Despite meeting all preauthorization requirements of medical necessity, the claim is denied due to discrepancies in coding interpretations between the lab (billing 81162) and the payer (policy directs billing 81432).
Resolving such issues involves appeals and resubmissions, consuming time and resources. Without resolution, Whitney may be left financially responsible, or the laboratory may not receive any reimbursement. Effective communication between labs, payers, and clinics is essential to streamline this process and minimize delays in patient care.
To overcome these challenges, stakeholders must continue to collaborate on standardizing coding practices and guidelines, including: