Clinical Validation Queries: Ensuring Compliant Claims Submission

Clinical validation plays a critical role in ensuring compliance with claims submission requirements. According to the CMS Medicare Program Integrity Manual:

"The purpose of DRG validation is to ensure that diagnostic and procedural information…coded and reported by the hospital on its claims matches the attending physician’s description and the information contained in the medical record."

Legal Implications Under the False Claims Act

The False Claims Act imposes civil liability on individuals or organizations that knowingly submit—or cause the submission of—false or fraudulent claims to the Federal government. This includes claims with a higher weighted DRG than is supported by the medical record. Diagnoses that are clinically invalid cannot be submitted for payment and must be removed from the claim.

Clinical Validation vs. Coding Guidelines

The Official Coding Guideline (OCG) I.A.19 specifies that "a diagnosis code is based on the provider’s diagnostic statement that the condition exists." However, this guideline does not override the legal requirement for clinical validation.

Key Point: Clinical validation is a legal mandate, whereas the OCG serves as a guideline.

Clinical Validation Queries: Addressing Documentation Gaps

To ensure compliance, clinical validation queries may be initiated when the information in the medical record does not substantiate a documented diagnosis based on widely accepted diagnostic standards and criteria. These queries should be submitted only when the documented evidence is insufficient, prompting one of the following responses:

1. Confirmation that the diagnosis is not clinically valid.
2. Provision of additional information consistent with diagnostic standards.

If additional supportive documentation is not provided, the diagnosis remains invalid and cannot be included in the claim.

Guidance from AHIMA's Clinical Validation Practice Brief

The AHIMA Clinical Validation Practice Brief (2023 Update) reinforces the importance of clinical validation. It states:

"…the clinical validation query requests additional supportive documentation, which may result in the removal of a documented diagnosis…The provider may be unable to build upon the clinical evidence already documented in the health record."

The Practice Brief further advises:

• Organizations should promote consistency among CDI and coding professionals when identifying diagnoses that lack clinical evidence.
• Clinical validation queries may be used to mitigate inappropriate reporting.
• Establishing internal policies to define the clinical validation process is essential.

A critical question to ask during validation is whether other providers, reviewers, coding professionals, and auditors would reach the same conclusion based on the entirety of the health record.

Summary

Clinical validation is not optional; it is a legal requirement to ensure accurate and compliant claims submission. By aligning with AHIMA guidelines and implementing robust internal policies, healthcare organizations can minimize the risk of inappropriate reporting and maintain compliance with regulatory standards.