Guest column | ​Clinical validation denials 101

CDI Journal - Volume 17, Issue 6

by Denise Wilson, MS, RN, RRT

I first became aware of clinical validation denials 12 years ago. I had the great fortune of working alongside a very astute coder at the time. When the Medicare Recovery Audit Contractors began audits for clinical validation in 2011, she quickly picked up on the difference between coding denials and clinical validation denials. She realized early on that a different appeal strategy would be needed to successfully defend clinical validation denials.

Clinical validation has become one of the hottest targets in payer auditing. For reporting purposes, I believe clinical validation denials belong in their own classification. Clinical validation denials include a component of coding, for sure, but they are more heavily weighted toward proving that clinical support for the diagnosis was sufficiently documented in the record.

Medical necessity

  • Is the hospital status assigned appropriately?
  • Do the procedures and/or services meet medical necessity?
  • What is the readmission rate?

Clinical validation

  • Do the documented clinical indicators support the diagnosis?


  • Are the principal and secondary diagnoses assigned appropriately?
  • Are the procedures coded appropriately?


  • Is this a duplicate claim?
  • Are any of the modifiers assigned incorrectly?  

Due to their mix of clinical and coding knowledge, CDI professionals are a natural fit for managing and preventing clinical validation denials and authoring successful appeal arguments. The following are some best practices in appealing clinical validation denials that have proven to be successful in my experience:

  • Exploit the notion that there is no single gold standard for diagnosing some diseases. For example, Kidney Disease: Improving Global Outcomes (KDIGO) may be the most recent and most widely accepted criteria set for diagnosing acute kidney injury, but does that mean Acute Kidney Injury Network (AKIN) or Risk, Injury, Failure, Loss of kidney function, and End-stage (RIFLE) kidney disease criteria are no longer valid? Payers tend to select one set of criteria to audit against and don’t consider any other alternatives. If your hospital has gone so far as to create agreed-upon policies for matching certain criteria to certain diagnoses, include the relevant policy in your appeal. Some payers may take that into consideration, though others may not.
    • Sample appeal language: There are many different clinical algorithms that purport to define renal diagnoses. It is up to the individual physician to determine which criteria are appropriate for the individual patient and circumstances.
  • Point out that no diagnostic criteria set should be used as a stand-alone tool. Physicians diagnose. Diagnostic criteria assist physicians in their work. Clinical judgment must be considered when assessing the documented support for a diagnosis. Challenge the payer when it’s apparent that their unfavorable audit finding is based purely on comparison with a published diagnostic criteria set.
    • Sample appeal language: Licensed providers including a nephrologist are responsible for the care of the patient documented diagnostic criteria combined with their professional clinical judgment in determining the diagnosis.
  • Clarify for the payer why the diagnosis is still appropriate even if one or more supporting clinical criteria are absent. It’s not uncommon for a patient to present to the emergency department (ED) stating they have been experiencing a fever at home, but no fever is present in the ED. That’s because they took two Tylenol® before coming to the ED. The Tylenol is continued during the admission, and the patient never experiences more than a half-point increase in temperature. If the payer is assessing a diagnosis that typically includes a fever, they might use the lack of said fever as part of the denial rationale.
    • Sample appeal language: Although fever is typically found in patients presenting with pneumonia, this patient did not experience fever during hospitalization because he took two Tylenol before coming to the ED and the Tylenol was continued during his hospitalization. Mr. Jones did experience other symptoms supporting the pneumonia diagnosis such as cough with purulent sputum, dyspnea, chest discomfort, inspiratory crackles, leukocytosis, and consolidation on chest x-ray.
  • Refute any of the payer’s incorrect statements regarding the documentation in the medical record. For example, a denial for acute respiratory failure stated, “The patient’s oxygen saturation on room air was 86% and the patient's oxygen saturations were maintained in the 90s with low flow nasal oxygen.” In fact, the patient was treated with 100% oxygen via a mask. It’s important to point out errors in the denial rationale. Doing so helps document payer issues and trends that can be brought back to the payer for resolution.
    • Sample appeal language: The payer misrepresented the patient’s oxygen needs by stating, “The patient’s oxygen saturation on room air was 86% and the patient's oxygen saturations were maintained in the 90s with low flow nasal oxygen.” In fact, the patient was treated with 100% oxygen via a mask; see ED nursing notes, p. 86 in the medical record.
  • Examine the clinical criteria used by the payer to challenge a diagnosis and employ well-accepted, evidence-based clinical references for support of the diagnosis. A good example is when the payer denies acute respiratory failure (hypoxemic) as a valid diagnosis because there were no arterial blood gas results with carbon dioxide levels greater than 50 or oxygen levels less than 60. Sometimes a payer cites a Coding Clinic as a reference or cites no reference at all.
    • Sample appeal language: Current diagnostic practice is to use pulse oximetry to assess and manage mild to moderate hypoxemia. Arterial blood gases are reserved for the most severe cases of respiratory failure. Clinical information the payer used to refute the well-documented diagnosis of acute respiratory failure came from a Coding Clinic (one from as far back as 1988). Clinical information in Coding Clinic is to be used to assist a coder to understand clinical situations, not to confirm or refute a diagnosis made by a licensed provider. “The gold standard for the diagnosis of acute hypoxemic respiratory failure is an arterial pO2 on room air less than 60 mmHg measured by arterial blood gases (ABG). In the absence of an ABG, SpO2 less than 91% measured by pulse oximetry on room air can serve as a substitute for the pO2 because SpO2 of 91% equals pO2 of 60 mmHg.”

Successfully defending clinical validation denials through the appeal process comes down to a few simple principles. There is rarely a single gold standard for diagnosing some diseases. The diagnoses targeted by payers are not easily diagnosed with one simple blood test, for example. Also, every person is different. Not everyone is going to have all of the expected symptoms for a particular diagnosis, and there may be a simple explanation as to why. Keep the payers honest and accountable by challenging any inaccurate statements in their denial rationale. And, finally, use well-accepted, evidence-based clinical references to support the diagnosis.

Editor’s note: Wilson is the senior vice president for PayerWatch + AppealMasters, and president of AHDAM. Contact her at Opinions expressed do not necessarily reflect those of ACDIS, HCPro, or any of its subsidiaries.

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Denials & Appeals