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Expanding Clinical Validation: What Is It, and Why Is It Important? 

In the CDI arena, there is an increasing focus on clinical validation – and for good reason. According to the Centers for Medicare and Medicaid Services’ (CMS) 2011 Recovery Audit Contractor (RAC) Statement of Work, “Clinical validation is a separate process [from DRG validation], which involves a clinical review of the case to see whether or not the patient truly possesses the conditions that were documented.” The process generally involves matching clinical indicators to diagnoses, ensuring that the reported condition is accurate. Valid clinical indicators for supporting diagnoses include, among others: 

  • Lab and diagnostic test results 
  • Imaging results 
  • Treatment plans 
  • Vital signs 
  • Physical assessment findings  

 As such, clinical validation is typically beyond the skillset of most certified coders. Only a clinician with approved coding credentials can perform this type of review since it requires deep clinical experience. Still, clinical validation is increasingly a focus in the CDI world because coding has expanded outside basic DRG and analytical reporting. Payers are more focused on ensuring the accuracy of any claims reporting; clinical validation will ideally prevent against RAC and MIC denials, as well as provide a bulwark for legal defense against possible malpractice lawsuits. And given the complexity of provider reimbursement, clinical validation is a necessary component for claims submission. Since reimbursement is governed by CMS regulations and policies, it’s critical that the documentation and diagnosis be clinically supported.  

Thus, the main purpose of clinical validation is preventing claims denials by ensuring the patient’s treatment is aligned with their diagnosis, backed up with quantifiable evidence. But it’s also vitally important for ensuring patients get the right care for their specific situation, as the accuracy in the medical report then reaches across the patient care continuum. Coded data informs patients’ future treatment, as well as larger public health data, provider quality reporting and a host of other metrics. Following suit, hospital-acquired conditions, hierarchical condition categories (HCCs) and patient safety indicators are now an important part of accurate coding, in both the inpatient and outpatient arenas. 

The heightened focus on clinical validation illustrates how the industry is moving toward a more proactive approach to ensuring coding accuracy and away from the reactive processes of the past. The number one goal is to help facilitate clean, accurate reflection and proper documentation of treatments and patient care.  

CDI professionals should educate themselves and become familiar with the concept of clinical validation. Even coding auditors performing DRG validation and coding compliance reviews should have some familiarity with targeted diagnoses and related clinical indicators. Actively working to recognize potential denials, and developing a plan to address them through clarification and teamwork, will go a long way to ensuring the entire system functions smoothly. 


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