Clinical validation involves a clinical review of the health record to determine whether a patient truly possesses the conditions that were documented. As defined by CMS in the 2011 Recovery Audit Program Statement of Work: "Clinical validation is a separate process, which involves a clinical review of the case to see whether or not the patient truly possesses the conditions that were documented."

Although the 2021 RAC contract states "clinical validation is prohibited in all RAC reviews," it has become a primary denial tool for many commercial payors. Understanding its scope and application is essential for coding, CDI, and clinical professionals.

The clinical documentation integrity (CDI) professional acts as an intermediary between the provider and coding professional, concurrently obtaining additional documentation needed to support accurate diagnosis and procedure code reporting on claims.

Determining if a diagnosis is reportable is often the domain of the coding professional, guided by the Coding Guidelines. However, a diagnosis may be considered reportable yet not fully supported by clinical evidence within the health record.

Clinical validation should not be confused with the validation process used for risk adjustment. The AHA Coding Clinic® (Second Quarter, 2022, p. 30) clarified that risk adjustment coding is not restricted to codes on a single claim — it is based on conditions collected during the calendar year.

The professional performing clinical validation reviews must possess strong critical thinking skills, especially when using assistive technology. Clinical validation requires understanding the complete clinical picture to validate technology recommendations and identify false positives from inappropriate pattern recognition.

Because clinical validation reviews are not always clear-cut, organizations may need to create a second-level review process. This process collaborates with denials management to identify diagnoses at high risk of denial.

CMS advises: "As with all codes, clinical evidence should be present in the health record to support code assignment." A medical record is considered complete if it contains sufficient information to identify the patient, support the diagnosis, justify care and services, document the course and results of care, and promote continuity of care among providers.

Some diagnoses are frequently validated by their treatment (e.g., sepsis, acute respiratory failure, severe malnutrition), but others may only require monitoring and/or clinical evaluation.

Relying on monitoring and clinical evaluation to justify a diagnosis can lead to denials if documentation does not demonstrate the patient is receiving more than routine care. Acute blood loss anemia is a frequently challenged diagnosis.

Organizations may establish internal clinical definitions based on professional medical guidelines, consensus, and evidence-based sources. These definitions create standardization but are not binding with Medicare or other payers.

The most important coding guideline impacting clinical validation is Section I.A.19 of the Coding Guidelines:

Section III of the Coding Guidelines defines criteria for reporting diagnoses in the inpatient setting. "Other diagnoses" are additional conditions that affect patient care by requiring:

Chronic conditions present unique coding and clinical validation challenges. Lifelong chronic conditions such as COPD, hypertension, and diabetes mellitus should be coded in the inpatient setting even if documented as "a history of" (AHA Coding Clinic, Third Quarter, 2007). Obesity was added as a chronic condition always considered clinically significant (Third Quarter, 2011).

Clinical validation in the outpatient setting differs significantly from the inpatient setting. Most outpatient denials challenge the reportability of a condition and the medical necessity of services — not the clinical validity of the documented condition itself.

The process of abstracting diagnoses for Medicare Advantage and other risk-adjustment models is distinct from traditional clinical validation. CMS publishes Medical Record Reviewer Guidance for RADV organizations, advising that reviewers must apply expertise in documentation and official coding guidelines — not provide specific diagnosis coding advice.

During a clinical validation review, a query may be necessary when:

Clinical validation queries are governed by the Guidelines for Achieving a Compliant Query Practice. The intent is not to question the provider's medical judgment but to ensure the documented diagnosis is clinically valid and accurately reported.

Unlike standard queries that aim to add or specify a reportable diagnosis, the clinical validation query may result in the removal of a documented diagnosis. When using multiple-choice format, only reasonable options should be included, always allowing an alternative response such as "other" or "other explanation of clinical findings."

Dr. Jones, The H&P documents acute on chronic respiratory failure (ACRF). Based on the clinical indicators below, please verify if ACRF is clinically valid:

Sepsis documented in H&P assessment but not carried through to progress notes or discharge summary.