Glossary

An Advance Beneficiary Notice of Noncoverage (ABN) is required by CMS when a provider believes Medicare is likely to deny coverage for a service. By signing the ABN, the patient acknowledges that they may be billed if Medicare denies the claim and agrees to be financially responsible for that cost.

In genetic testing, ABNs are frequently required when a test is being ordered for an indication that does not clearly meet the applicable LCD criteria, or when the patient's clinical context is borderline for coverage. Issuing an ABN correctly protects the lab's right to bill the patient if Medicare denies. Failure to issue a required ABN means the provider may not bill the patient under any circumstances after a Medicare denial.

Assignment of benefits is the mechanism by which a patient authorizes their insurer to pay the healthcare provider directly. When a provider participates in a payer's network, AOB is typically part of the standard provider agreement. For out-of-network providers such as reference laboratories, AOB is critical — without it, the payer may issue payment to the patient rather than the lab.

In genetic testing and oncology billing, AOB documentation is particularly important for out-of-network laboratory services. Labs that accept assignment must verify AOB is on file for each patient before billing. Some states have laws that affect an insurer's ability to withhold payment from a provider that has a valid AOB on file.

An appeal is the formal mechanism for challenging a payer's denial decision. Most payer processes include multiple levels of internal appeal (first-level, second-level), followed by an external independent review if internal appeals are exhausted. Federal and state laws define minimum appeal rights for most plan types.

Appeal success rates vary significantly by denial reason, payer, and quality of the appeal package. Medical necessity denials that go to external review are overturned at materially higher rates than internal reviews alone. A well-constructed appeal directly addresses the specific denial reason, includes applicable clinical guidelines, provides a detailed letter of medical necessity from the treating physician, and cites the relevant policy criteria the service meets. Time limits for filing appeals are strict and vary by payer — missing the window forfeits the right to appeal.

The American Society of Clinical Oncology publishes clinical practice guidelines, provisional clinical opinions, and technology assessments across oncology. ASCO guidelines and policy statements carry significant evidentiary weight in appeals for oncology services, particularly when the treating oncologist is citing the current standard of care.

ASCO also collaborates with the College of American Pathologists (CAP) and other organizations on biomarker testing guidelines — for example, the ASCO/CAP HER2 testing guidelines for breast cancer and the ASCO guideline on next-generation sequencing in advanced cancers. These guidelines can be cited in PA submissions to establish that a requested test meets standard-of-care criteria.

In oncology, biomarkers include DNA mutations (EGFR, KRAS, BRAF), gene amplifications (HER2), expression levels (PD-L1), microsatellite instability (MSI), tumor mutational burden (TMB), and many others. Biomarker-driven oncology is now the standard of care across many cancer types, with FDA approvals and NCCN guidelines specifying biomarker thresholds as prerequisites for specific therapies.

For prior authorization and claims purposes, biomarker test results are frequently required documentation for drug PA requests. Payers require that the specific biomarker referenced in the drug's FDA label or the payer's medical policy has been tested using an approved methodology, and that the patient's result meets the threshold specified in the coverage criteria. Missing or ambiguous biomarker documentation is a leading cause of avoidable oncology PA denials.

A companion diagnostic (CDx) is a test that is co-developed with a targeted therapy and is part of that therapy's FDA labeling. The drug label specifies that patient selection should be based on the CDx result — meaning the test is not optional for coverage purposes when prescribing the associated therapy.

Examples include the PD-L1 companion diagnostics required for certain pembrolizumab (Keytruda) indications and the KRAS/NRAS/BRAF mutation tests required for colorectal cancer therapies. For PA purposes, a companion diagnostic result is typically required documentation for the drug PA submission — payers will not authorize the drug without evidence that the companion test was performed and the patient's result meets the labeled criteria. This creates a two-step PA workflow: test PA (or test result), then drug PA.

Converus is an AI that tells you in simple english what a payer's policy means and helps you apply it to claims and PAs.

A coverage determination is a policy-level decision about whether a category of service is a covered benefit — as opposed to a PA decision, which is a case-level determination that a specific patient's service meets coverage criteria. Coverage determinations include LCDs, NCDs, and insurer medical policies.

Providers can request coverage determinations from Medicare (through a formal LCD or NCD development process) or from commercial payers (through a coverage decision request). This is relevant when a new molecular test or therapy lacks existing coverage, or when a payer's coverage criteria are inconsistent with clinical guidelines. Participating in public comment periods for new LCDs and NCD proposals is a pathway for labs and oncology practices to influence coverage policy for emerging technologies.

CPT codes are maintained by the American Medical Association and serve as the universal language for identifying what procedure or service is being requested or billed. Every PA request and claim for a laboratory test or medical procedure must include the applicable CPT code.

In molecular diagnostics, CPT coding is complex. Multianalyte Assay with Algorithmic Analysis (MAAA) codes and genomic sequencing procedure (GSP) codes are specific to molecular tests. Some labs bill proprietary multianalyte tests using Tier 2 MAAA codes. Payers review CPT codes during PA review to confirm the requested service is covered, matches the clinical indication, and isn't duplicative of recently performed tests.

A denial is a payer's formal refusal to authorize or pay for a requested or delivered service. Denials at the PA stage prevent service delivery; claim denials occur after service delivery and affect reimbursement. Both types include a reason code that specifies the grounds for denial.

Common denial categories include medical necessity, missing documentation, non-covered service, prior authorization not obtained, and experimental/investigational classification. Each category requires a different escalation strategy, ranging from immediate peer-to-peer review (for medical necessity denials) to coverage determination challenges (for benefit exclusions). Denial tracking — by reason code, payer, and service type — is essential for identifying systemic issues and building an effective appeals program.

EGFR mutations — most commonly exon 19 deletions and exon 21 L858R substitutions — are found in approximately 10–15% of NSCLC patients in the United States (higher in Asian populations and in patients with no smoking history). EGFR-mutant NSCLC is treated with EGFR TKIs including erlotinib, gefitinib, afatinib, and osimertinib (Tagrisso).

For PA purposes, EGFR mutation testing results are required documentation for TKI PA requests. Payers require documentation of the specific mutation identified, the testing methodology (PCR, NGS), the tissue or liquid biopsy source, and the testing date. Resistance mutations (such as EGFR T790M, which drives resistance to first- and second-generation TKIs and guides selection of osimertinib) also have specific testing and PA documentation requirements.

An Explanation of Benefits (EOB) is issued by the insurance company after processing a claim. It is not a bill; it is a summary of the claim adjudication. The EOB includes the billed amount, the payer's allowed amount, adjustments, patient cost-sharing, and — if applicable — denial reason codes.

In prior authorization and revenue cycle management, EOBs serve as the primary source document for denial analysis. The denial reason code and remark code on the EOB determine the appropriate appeal strategy. For coordination of benefits (COB) situations, the primary payer's EOB must be attached to the secondary payer's claim. Retaining and systematically reviewing EOBs is foundational to an effective denial management program.

Payers classify a service as experimental or investigational (E&I) when the available evidence is insufficient to establish safety and efficacy under the payer's coverage criteria. Common E&I criteria require that a service have FDA approval or clearance for the requested indication, be supported by peer-reviewed clinical literature demonstrating clinical utility, and be recognized by established clinical guidelines.

In molecular diagnostics, laboratory-developed tests (LDTs) and novel genomic assays are frequently classified as E&I until sufficient evidence accumulates. Appealing an E&I denial requires building an evidentiary record: FDA documents, peer-reviewed publications demonstrating clinical utility, NCCN guideline entries, and positive coverage determinations from other payers or CMS. When standard treatments have failed and no covered alternative exists, some payers will approve under an E&I exception for clinical necessity.

FHIR (pronounced "fire") is the modern interoperability standard for healthcare data exchange, developed by HL7 International. FHIR defines a set of structured data resources — Patient, Observation, DiagnosticReport, MedicationRequest, and others — that allow disparate healthcare systems to exchange clinical information in a standardized format.

In the prior authorization context, FHIR is central to several initiatives: the Da Vinci Project's Coverage Requirements Discovery (CRD) and Prior Authorization Support (PAS) implementation guides define FHIR-based workflows for automated PA submission directly from EHR systems. CMS has also required payers to support FHIR APIs for PA status notifications under recent regulatory rules. For genetic labs and oncology practices, FHIR-based integrations enable automated clinical data extraction from EHRs — pulling diagnosis codes, lab results, and treatment history needed to populate PA requests without manual chart review.

A formulary defines which drugs are covered under a health plan and at what cost-sharing level. Drugs on lower tiers typically require lower copays; specialty drugs (including most oncology drugs) are placed on high-cost tiers and almost universally require prior authorization. Non-formulary drugs — those not on the covered list — may require coverage exception requests.

For oncology billing, formulary management intersects with PA in two ways: first, the drug must be on the formulary (or a formulary exception must be obtained); second, even formulary drugs typically require PA that documents the specific indication, biomarker results, and line of therapy. When a payer's formulary does not include a newly approved oncology drug, the escalation pathway is a formulary exception request, supported by clinical documentation that the non-formulary drug is medically necessary and that formulary alternatives are inappropriate for this patient.

Gold carding (also called PA exemption or provider exemption) allows qualifying providers to bypass the per-request prior authorization process for covered services. To qualify, providers typically must demonstrate a PA approval rate above a defined threshold (commonly 90%+) over a lookback period, along with sufficient request volume to establish a meaningful track record.

A growing number of states have enacted gold carding laws requiring commercial insurers and managed Medicaid plans to offer exemption programs to providers who meet the qualifying criteria. Gold carding reduces administrative burden on both providers and payers, but does not eliminate documentation requirements — post-payment audits can still occur, and providers must maintain the utilization patterns that earned the exemption.

HCPCS Level I consists of CPT codes. HCPCS Level II is a separate set of alphanumeric codes used to bill items and services not covered by CPT — most notably injectable and infusible drugs (J-codes), which are essential for oncology drug billing. For example, J9999 and specific J-codes identify individual oncology drugs for claims and PA submissions.

DEX Z-codes, used within the MolDX program to identify specific molecular diagnostic tests, are also HCPCS Level II codes. When submitting a prior authorization for a MolDX-managed molecular test, the DEX Z-code must typically be included alongside the CPT code to ensure the payer can identify the specific test and apply the correct coverage criteria.

HER2 overexpression or gene amplification occurs in approximately 15–20% of breast cancers and subsets of gastric, gastroesophageal, and other cancers. HER2 status determines eligibility for HER2-directed therapies including trastuzumab (Herceptin), pertuzumab, trastuzumab deruxtecan (Enhertu), and others.

HER2 testing methodology is defined by ASCO/CAP guidelines and payer medical policies. Testing is performed by immunohistochemistry (IHC) for protein expression and fluorescence in situ hybridization (FISH) for gene amplification. For PA purposes, payers require documentation of HER2 testing methodology, result score (IHC 0, 1+, 2+, 3+ or ISH ratio), and — for IHC 2+ results — reflex FISH testing results. HER2-low status (IHC 1+ or IHC 2+/ISH non-amplified) is now recognized as a distinct category that supports eligibility for trastuzumab deruxtecan in certain settings.

ICD-10-CM (Clinical Modification) codes are the standard system for documenting patient diagnoses in the United States healthcare system. Every prior authorization request and claim must include one or more ICD-10 codes that establish the clinical context for the requested service.

In oncology and genetic testing, ICD-10 code selection is often a critical PA success factor. Payers' LCDs and medical policies define which ICD-10 codes support coverage for specific tests. An imprecise code — for example, using a generic "neoplasm of uncertain behavior" code when the patient has a confirmed malignant diagnosis — can trigger a medical necessity denial even when the clinical documentation clearly supports the request. Code specificity matters.

Local Coverage Determinations are binding coverage policies for Medicare claims processed by the issuing MAC. Each LCD specifies covered diagnoses (ICD-10 codes), clinical criteria, and documentation requirements for a defined service. LCDs may also list non-covered indications.

For molecular diagnostics, LCDs issued by Palmetto GBA (the MAC that administers the MolDX program) are especially important. A lab billing molecular tests to Medicare must confirm that the test and the patient's clinical indication align with the applicable LCD. Violating LCD criteria — even unintentionally — results in claim denial and can trigger audit liability.

A laboratory-developed test (LDT) is a type of in vitro diagnostic that a laboratory designs and uses only within that laboratory. Historically, LDTs were regulated primarily under CLIA (Clinical Laboratory Improvement Amendments) rather than FDA oversight. The FDA finalized a rule in 2024 to phase in oversight of LDTs, significantly changing the regulatory landscape.

For coverage and PA purposes, LDT status affects how payers evaluate a test's evidentiary basis. Payers that require FDA approval for coverage may classify LDTs as experimental/investigational even when the test has been validated and is in widespread clinical use. Labs should document analytical validity, clinical validity, and clinical utility data for LDTs in their PA submissions, and reference any NCCN guideline listings, published peer-reviewed studies, or MolDX coverage determinations that support the test's clinical utility.

Medicare Administrative Contractors are the regional entities responsible for processing Medicare Part A and Part B claims within specific jurisdictions. Each MAC may issue its own LCDs that apply to providers and labs within its jurisdiction. The MAC that a lab or provider falls under is determined by the location of the performing entity.

For molecular diagnostics, Palmetto GBA is the MAC that administers the MolDX program and has jurisdiction over a large portion of the country for molecular test coverage determinations. Noridian Healthcare Solutions is another major MAC that has adopted the MolDX program for its jurisdictions. Knowing which MAC governs a specific lab's billing is essential for identifying the applicable LCDs and completing any required MolDX technical assessments.

Medical necessity is the cornerstone concept of prior authorization review. Most payer policies define medical necessity as services that are (1) appropriate for the patient's symptoms, diagnosis, or treatment; (2) consistent with generally accepted standards of medical practice; (3) not primarily for convenience; and (4) the most appropriate level of service considering potential clinical benefit versus risk.

Medical necessity denials — where the payer determines the submitted information does not establish that a service meets these criteria — are the most common denial type in genetic testing and oncology. The most effective response is a robust upfront submission that directly addresses the payer's specific criteria, cites applicable guidelines (NCCN, ASCO), and includes the treating physician's clinical narrative explaining why the service is necessary for this patient.

Medical policies are published by commercial insurers and supplement LCDs and NCDs by providing payer-specific coverage criteria for services that may not be fully addressed by federal coverage rules. Each major commercial payer — UnitedHealthcare, Cigna, Aetna, Anthem, Humana — publishes its own medical policy library, and policies vary significantly across payers for the same service.

For genetic testing and oncology, payer medical policies define the specific ICD-10 codes, clinical criteria, testing indications, and documentation requirements that must be met for coverage. Policies are updated periodically, and a test or drug that was previously covered may become subject to new restrictions or additional PA requirements. Proactively monitoring medical policy changes for high-volume payers is a critical component of laboratory and oncology RCM.

CPT and HCPCS modifiers communicate circumstances that affect how a service was performed or billed without changing the underlying code's definition. In the context of prior authorization and claims, modifiers can indicate that a service was ordered by a different provider than the performing provider, that a test was reduced in scope, or that specific coverage rules apply.

In molecular diagnostics, modifiers such as -59 (distinct procedural service) are used to demonstrate that separately billed tests are clinically distinct and not duplicative. Incorrect or missing modifiers are a common source of claim denials and billing audits. Ensuring modifiers align with the PA that was obtained is a critical step in the billing workflow.

MolDX (Molecular Diagnostic Services) is administered by Palmetto GBA, a Medicare Administrative Contractor. It serves as the primary coverage determination and billing framework for molecular diagnostic tests across a large portion of Medicare jurisdictions, including most of the South and Mountain West, as well as for the DME MAC jurisdiction.

Labs that want to bill molecular tests to Medicare must complete MolDX's technical assessment process, which evaluates a test's analytical validity, clinical validity, and clinical utility. Upon successful assessment, the test is assigned a DEX Z-code used for billing identification. Many commercial payers reference MolDX coverage criteria and Z-codes when establishing their own policies for molecular tests.

Mismatch repair (MMR) proteins correct DNA replication errors. When MMR proteins are deficient (dMMR), DNA errors accumulate, resulting in microsatellite instability-high (MSI-H) tumors. MSI-H/dMMR status is an FDA-approved biomarker for pembrolizumab (Keytruda) in solid tumors regardless of tumor type — the first tissue-agnostic oncology approval.

For prior authorization purposes, MSI-H or dMMR test results are required documentation for pembrolizumab PA requests under the tumor-agnostic indication. Payers require the specific test methodology, result, and testing date. MSI can be measured by PCR or next-generation sequencing; MMR status is typically assessed by immunohistochemistry (IHC). The testing method should align with the payer's and FDA's accepted methodologies listed in the drug's label.

The National Comprehensive Cancer Network publishes the NCCN Clinical Practice Guidelines in Oncology, which are the most widely referenced clinical guidelines in oncology coverage decisions. Payers frequently cite NCCN category designations when evaluating prior authorization requests for oncology drugs and diagnostics.

NCCN assigns evidence categories to each recommendation: Category 1 (high-level evidence, uniform consensus), Category 2A (lower-level evidence, uniform consensus), Category 2B (lower-level evidence, consensus), and Category 3 (major disagreement). Category 1 and 2A designations carry the most weight in PA submissions and appeals, and many payers explicitly limit coverage to NCCN Category 1 or 2A indications.

National Coverage Determinations represent CMS's formal determination of whether a service, item, or technology is covered under Medicare nationally. Unlike LCDs, which vary by MAC jurisdiction, NCDs apply in every state. When an NCD exists for a service, it takes precedence over any local LCD for that service.

Key NCDs relevant to oncology include the coverage determination for next-generation sequencing (NGS) diagnostic laboratory tests for cancer, which established coverage criteria for FDA-approved NGS tests used to guide treatment decisions. Understanding whether an NCD or LCD governs a specific test is a prerequisite for building a compliant PA submission.

Next-generation sequencing (NGS) enables broad genomic profiling of tumor tissue or liquid biopsy samples. NGS panels range from targeted gene panels (dozens to hundreds of genes) to comprehensive genomic profiling (CGP) tests that assess the entire coding exome or genome. In oncology, NGS is used to identify actionable mutations that guide therapy selection with targeted drugs.

For PA purposes, NGS panels are subject to specific coverage criteria — most notably, the CMS NCD for NGS in cancer (NCD 90.2) which covers FDA-approved NGS tests for advanced cancer patients. Coverage criteria typically require a diagnosis of recurrent, relapsed, refractory, metastatic, or advanced-stage cancer; prior standard treatment; and an intent to use results to guide treatment decisions. Labs must ensure their NGS test has completed the required MolDX technical assessment and has an assigned DEX Z-code for Medicare billing.

Off-label prescribing is common and legal in oncology — the FDA approves drugs for specific indications, but clinical evidence frequently supports use in additional settings before formal label expansion occurs. NCCN guidelines regularly include Category 2A or 2B recommendations for off-label uses of approved oncology drugs.

For prior authorization purposes, off-label use requires more robust clinical documentation. Payers often require evidence that the off-label use is supported by peer-reviewed literature, a recognized clinical guideline, or a compendium listing. The most defensible PA submissions for off-label oncology drugs cite a specific NCCN guideline entry, the patient's biomarker profile, and any published clinical trial data supporting the indication, along with an explanation of why on-label alternatives are inappropriate.

In healthcare billing, a "payer" is any organization that pays for healthcare services. The major payer categories relevant to genetic labs and oncology are: commercial health insurers (UnitedHealthcare, Cigna, Aetna, Anthem, Humana), Medicare Fee-for-Service (administered by CMS through MACs), Medicare Advantage plans (private insurers operating under CMS contracts), and Medicaid and managed Medicaid plans (administered by states and managed care organizations).

PA requirements, coverage policies, billing rules, and appeal procedures differ substantially across payer types. Medicare is governed by LCDs and NCDs; commercial payers use medical policies; Medicaid varies by state. Medicare Advantage plans can impose prior authorization requirements stricter than traditional Medicare, while being subject to CMS oversight. Understanding which payer type a patient has is the prerequisite for every downstream PA and billing decision.

PD-L1 expression is measured by immunohistochemistry and reported as a Tumor Proportion Score (TPS) — the percentage of viable tumor cells with membrane staining — or a Combined Positive Score (CPS), which includes tumor cells, lymphocytes, and macrophages. Different checkpoint inhibitors use different scoring methods and different thresholds; pembrolizumab in NSCLC first-line monotherapy requires TPS ≥50%, while CPS is used in other indications.

For PA purposes, PD-L1 test results are required documentation for checkpoint inhibitor PA requests where PD-L1 is a companion diagnostic criterion. Payers require the specific assay used, the scoring method (TPS or CPS), the numerical result, and the testing date. The PD-L1 assay used must be the companion diagnostic designated for the specific drug-indication combination, as different approved companion diagnostic assays may not be interchangeable for coverage purposes.

A peer-to-peer (P2P) review is a physician-to-physician discussion in which the ordering or treating provider speaks directly with the payer's medical director or physician reviewer to advocate for the clinical appropriateness of a denied service. Most payers permit — and some require — a P2P request to be filed within a defined window after a medical necessity denial (commonly 5–14 business days).

Data consistently shows that peer-to-peer reviews overturn medical necessity denials at a materially higher rate than written appeals alone, particularly when the treating physician can articulate the specific clinical rationale, cite relevant guidelines, and explain why alternative treatments are inappropriate. For oncology PA denials involving biomarker-driven therapies or hereditary testing, initiating a P2P review immediately after denial is typically the single highest-yield action a practice can take.

Prior authorization (PA) is the process by which a health insurance payer reviews and approves — or denies — a requested service before it is delivered. The payer evaluates the request against its coverage criteria and medical policies, including applicable LCDs, NCDs, and formulary rules.

For genetic laboratories and oncology practices, PA applies to a broad range of services including molecular diagnostic panels, hereditary cancer testing, tumor biomarker assays, and specialty oncology drugs. Failure to obtain required PA before service delivery typically results in a non-payable claim.

Revenue cycle management encompasses all administrative functions associated with claims processing and reimbursement: patient eligibility verification, prior authorization, charge capture, coding, claim submission, payment posting, denial management, and appeals. For genetic laboratories and oncology practices, RCM is complex due to the volume of PA-required services, the specificity of coding requirements, and the frequency of medical necessity and experimental/investigational denials.

An effective oncology RCM program includes proactive PA management (submitting before service delivery), real-time policy monitoring to anticipate coverage changes, systematic denial tracking by category and payer, and a structured appeal workflow with defined timelines and escalation criteria. Technology platforms that automate PA submission, monitor payer responses, and generate appeal documentation are increasingly central to high-performing RCM operations.

Somatic mutations arise in individual cells during a person's life and are not inherited. Somatic tumor profiling (e.g., next-generation sequencing of a tumor biopsy) identifies mutations driving tumor growth and guides treatment selection with targeted therapies. Somatic testing is ordered by the oncologist and is covered under oncology-specific LCDs and NCDs.

Germline mutations are inherited, present in every cell, and can be passed to offspring. Germline testing (e.g., BRCA1/2 hereditary cancer panels) is ordered to assess hereditary cancer risk, guide surgical decisions, and inform family member testing. Germline testing is subject to separate coverage criteria under genetic testing-specific policies, often requiring documented family history, prior cancer diagnosis, or other risk criteria.

The distinction matters operationally: somatic and germline tests may use different CPT codes, require different ICD-10 codes, fall under different payer policies, and require different documentation. Mixing up somatic and germline documentation in a PA submission is a common source of denials.

Step therapy (also called "fail first") requires that a patient try and fail a specified first-line treatment before a payer will authorize a preferred second-line or specialty treatment. The payer's rationale is cost management: cheaper alternatives should be exhausted before moving to expensive specialty drugs.

In oncology, step therapy requirements can be clinically inappropriate when patient-specific biomarkers or tumor characteristics make first-line agents ineffective or contraindicated. Many states have enacted step therapy override laws requiring payers to grant exceptions when a patient's clinical history, genetics, or contraindications make the step-therapy requirement inappropriate. For PA submissions involving biomarker-driven targeted therapies, documenting the specific biomarker result that supports the requested drug — and any prior treatments received — is essential to avoiding step therapy denials.

Tumor mutational burden (TMB) is measured as the number of somatic mutations per megabase (mut/Mb) of genomic sequence. High TMB (TMB-H) is associated with increased neoantigen production and greater likelihood of immune recognition, making it a predictive biomarker for checkpoint inhibitor response. Pembrolizumab (Keytruda) has FDA approval for TMB-H (≥10 mut/Mb) solid tumors in adults and children who have progressed on prior treatment.

For PA purposes, TMB results must be generated by an FDA-approved companion diagnostic (the FoundationOne CDx assay is the approved CDx for pembrolizumab's TMB-H indication). PA submissions must include the specific TMB score, the assay used, and the testing date. The ≥10 mut/Mb threshold must be clearly documented; borderline or ambiguously reported results commonly trigger additional information requests.

Utilization management (UM) is the umbrella term for the processes payers use to review and manage healthcare service utilization. UM tools include prior authorization, step therapy requirements, quantity limits, concurrent review (ongoing authorization for continuing services), retrospective review (post-service review for appropriateness), and case management.

In the context of genetic testing and oncology, utilization management is increasingly intensive. Payers' UM programs for molecular diagnostics often involve multiple layers of criteria — test-specific LCDs, companion diagnostic requirements, specific ICD-10 coding requirements, and vendor-specific review (some payers route molecular test PAs through specialty benefit managers). Understanding a payer's UM structure for specific services is the first step in designing an efficient PA workflow.