Is it a Clinical Validation Denial?

Posted on June 17, 2020
By Karla Hiravi

It is easy to confuse a clinical validation (CV) denial with a DRG denial. To appeal a CV denial, one must first be sure it is, indeed, a clinical validation denial.  

DRG Denials: CMS tells us that a DRG validation is the process of reviewing physician documentation, and determining whether the correct codes and sequencing were applied to the billing of the claim. Certified coders shall ensure they are not looking beyond what is documented by the physician and are not making determinations that are not consistent with the guidance in Coding Clinic.

Medicare Program Integrity Manual Chapter 6.5.3 -DRG Validation Review (Rev. 608,

Issued: 08-14-15, Effective: 01-01-12, Implementation: 09-14-15)  

Clinical Validation Denials:  A CV denial questions the clinical validity of a diagnosis or multiple diagnoses. In its most basic form, the auditor is essentially saying, “Doctor, you misdiagnosed your patient. On a clinical basis, diagnosis X did not exist.”

Why is it important to know the difference?

DRG denials are coding denials and are generally best appealed using coding guidelines, Coding Clinics, and coding conventions. An appeal using clinical rationale for a coding denial will likely be unsuccessful.

CV denials are clinical denials and generally best appealed using clinical criteria from evidence-based medical sources. Coding guidance will likely not be effective in the argument for the clinical validity of a diagnosis. 

 Examples of DRG (coding) denial rationale:

  • “ATN is denied because a query was warranted in the situation, but not found.”
    • Coding rules and regulations dictate when a query should be posed.
  • “AKI is denied because it does not meet the criteria for a reportable diagnosis.”
    • Whether or not a diagnosis is reportable is not something a provider considers when making the diagnosis. A coder decides when a diagnosis is reportable based on coding rules and regulations, making this is a coding denial.
  • “Acute blood loss anemia was sequenced as the principal diagnosis; dehydration should be the principal diagnosis.”
    • Coding rules and regulations govern sequencing.

Examples of CV denial rationale:

  • “Sepsis is removed because SOFA criteria were not met.”
    • SOFA criteria are medical criteria used by providers to diagnose.
  • “Acute blood loss anemia is not validated because the EBL was only 100cc.”
    • EBL is only one clinical factor to consider when making the diagnosis of acute blood loss anemia. Coding rules and regulations do not govern the clinical factors used to make a diagnosis.
  • Encephalopathy is denied because the patient was described as being alert and neurologically intact.
    • The above is clinical rationale that a provider considers when making the diagnosis. Coding rules and regulations do not govern clinical rationale.