Clinical Validation – Where do we Stand?

As everyone probably knows by now that the 2017 Official Guidelines for Coding and Reporting, effective October 1, 2016, contains a new, perplexing and problematic section I.A.19 titled “Code assignment and Clinical Criteria” regarding clinical diagnostic criteria that creates a dilemma for all providers:

“The assignment of a diagnosis code is based on the provider’s diagnostic statement that the condition exists.  The provider’s statement that the patient has a particular condition is sufficient. Code assignment is not based on clinical criteria used by the provider to establish the diagnosis.”

This has been incorrectly interpreted by some to mean that clinical validation of documented conditions is no longer required for code assignment on claims.

In fact, CMS requires that claims submitted for payment must not include diagnoses that cannot be “clinically validated”.  Clinical validation involves clinical review of a case to see whether or not the patient truly had the conditions that were documented in the medical record, applying diagnostic standards (clinical criteria) widely-accepted by the medical community.

What is widely-accepted may be debatable, but CMS expects that at the very least a reasonable physician would agree with the diagnosis based on the findings and treatment documented in the medical record.  Many professional organizations and societies have published consensus diagnostic criteria or guidelines which are authoritative widely-accepted sources.  If a provider makes a diagnosis which is not supported by such an authoritative source, he/she will need to explain the basis of that diagnosis; if not the diagnosis should not be considered clinically valid.

An example of an authoritative diagnostic standard is the National Kidney Foundation’s KDIGO guideline for acute kidney injury and another one for chronic kidney disease.  The Surviving Sepsis Campaign together with the Third International Sepsis Definition Conference of 2016 have established the current diagnostic standards for sepsis, severe sepsis and septic shock (Sepsis-3).  The authoritative source for the diagnostic criteria of acute pancreatitis is the American College of Gastroenterology.

The main reason for the confusion and controversy over clinical validation is the fact that the coding function and the process of claims submission are actually governed by different sets of statutory and regulatory law.  Coding is now governed primarily by the ICD-10-CM and ICD-10-PCS classifications, the official coding guidelines for both of the classifications, and the Affordable Care Act.  Coding Clinic does not have statutory or regulatory authority but is designated by CMS as the official source of interpretation, clarification and application of the classifications and guidelines.  The classifications and guidelines always take precedence over Coding Clinic advice.

On the other hand, clinical validation is a statutory and regulatory necessity.  Claim submission and reimbursement are governed by CMS regulations and policy manuals including the RAC Statement of Work which require clinical validation of diagnoses submitted on claims.  Everyone is aware that clinical validity is a primary focus of the Medicare RAC and commercial recovery contractors, and clinical validation is a frequent reason for payment reductions.

Finally, the False Claims Act of 1863 imposes penalties (potentially “triple damages”) for the submission of claims to the United States government for goods or services not actually rendered.  Today, the law is applied to healthcare claims, including cases where codes for conditions patients actually did not have (i.e., unsubstantiated by accepted clinical criteria) are assigned by any provider with actual knowledge (including deliberate ignorance or reckless disregard) that the claim was false, if doing so increases reimbursement or has a positive impact on quality analytics that now also affect reimbursement.

At the 2017 ACDIS Annual Conference held in May, Nelly LeonChisen, RHIA provided clarification on this new coding guideline since Coding Clinic had received a large volume of questions from facilities.  Nellie is the American Hospital Association’s (AHA) Director of Coding and Classification, the Executive Editor of the AHA’s Coding Clinic, and serves as the AHA representative to the ICD-10 Maintenance and Coordination Committee.

At the meeting, Nelly explained that the guideline was intended to reaffirm long-standing advice that coding must be based on provider documentation:

She also confirmed that this new guideline addressed coding, not clinical validation which is a separate function.

Coding Clinic, Fourth Quarter 2016, pages 147–149 also states that “coders should not be disregarding physician documentation and deciding on their own, based on clinical criteria, abnormal test results, etc., whether or not a condition should be coded.”

In other words, coders should not be accountable for clinical validation because they would not be expected to make such clinically complicated judgements by themselves.  Organizations must establish clear, compliant policies and processes for dealing with this clinical validation dilemma.  Coders must be involved because they are responsible, as employees of the hospital, for ensuring that codes are assigned in compliance with the law, regulations and coding guidelines.

Therefore, organizations must continue clinical validation to ensure that documentation is complete and accurate, and that it appropriately reflects the patient’s clinical conditions, abiding by the statutes, regulations and policies that govern claims submission and reimbursement.

CDI programs that allow and encourage clinical documentation specialists and coders to collaborate and conduct clinical validation are the ideal institutional venue for ensuring compliant coding and claims submission that fully and accurately reflects the patient’s clinical condition and the circumstances of the admission.

Surviving Sepsis Campaign Embraces Sepsis-3 Definition

The 2017 Surviving Sepsis Campaign (SSC) guidelines to be published in the March 2017 issue of Critical Care Medicine* have adopted the 2016 Sepsis-3 definition of sepsis as “life-threatening organ dysfunction caused by a dysregulated host response to infection” discarding the Sepsis-2 definition of sepsis as SIRS due to infection.  It now makes no distinction between sepsis and severe sepsis.  The SSC guidelines are the recognized clinical authority for the diagnosis and management of sepsis, severe sepsis and septic shock since 2002.

Sepsis-3 defines organ dysfunction as an increase in the total SOFA score by 2 points or more from baseline. SOFA classifies 6 organ systems on a scale from 0 to 4 points using objective measures:

1 Respiratory pO2/FIO2 ratio
2 Coagulation Platelet count
3 Liver Bilirubin
4 Cardiovascular Mean arterial pressure or vasopressors
5 CNS Glasgow Coma Scale
6 Renal Creatinine or urine output


Unfortunately, the CMS Hospital Inpatient Quality Reporting (IQR) severe sepsis management measure (called SEP-1), which is abstracted by the hospital’s Quality Department, defines severe sepsis as SIRS due to infection with acute organ dysfunction.  SIRS is defined as 2 or more of 4 criteria: temperature, leukocytosis, tachycardia, and tachypnea. The SEP-1 measure definition of organ dysfunction definition is much different than SOFA. 

If providers do not follow the SEP-1 treatment requirements when the SEP-1 organ dysfunction criteria are met, a deficiency in the quality of care for severe sepsis management will be reported.  Following only the Sepsis-3 definition may allow many cases to “fall through the cracks” for SEP-1 reporting. 

It remains to be seen how CMS will now react to the new SSC guidelines including the adoption of the Sepsis-3 definition which conflicts with the IQR SEP-1 standards.  In the meantime, hospitals should make sure medical staff leadership is engaged with this complex challenge of reconciling authoritative clinical guidelines with the CMS quality reporting imperative. 

What Should We Do?


References:  Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. 

Coding of Pneumonia with COPD

In its 2016 Third Quarter edition, Coding Clinic clarified the use of the following two ICD-10 codes:


COPD and Pneumonia:   Code J44.0 requires that the lower respiratory infection be sequenced after it, meaning the lower respiratory infection cannot be assigned as principal diagnosis in patients with COPD whether an acute exacerbation is present or not.


Controversy has swirled over whether pneumonia and influenza are classified as lower respiratory infections because Tabular entries seem to conflict.  Includes notes at category J44 list only infections of the bronchial tree and not pneumonia or influenza.

However, the titles of ICD-10-CM acute respiratory infection categories suggest that pneumonia and influenza are lower respiratory infections since they are not “upper” respiratory infections and category J20-J22 is titled “other”:

J00-J06 = Acute Upper Respiratory Infections (includes tracheitis)

J09-J18 = Influenza and Pneumonia

J20-J22 = Other Acute Lower Respiratory Infections (bronchitis, bronchiolitis, and other)

Coding Clinic has settled the controversy by stating that acute bronchitis and pneumonia are included in code J44.0 (lower respiratory infections), but influenza is not since it involves both upper and lower respiratory infections. 

Therefore, when a patient is admitted with pneumonia and has COPD, code J44.0 is coded first, followed by the code for pneumonia, and assigned to DRG 190 COPD with MCC. 

AECOPD and Pneumonia:   When a patient has both pneumonia and acute exacerbation of COPD, it is appropriate to assign both codes J44.0 [COPD with acute lower respiratory infection] and J44.1 [COPD with (acute) exacerbation].  Either of these codes may be sequenced first, based on the reason for the admission.

Aspiration pneumonia and COPD:  Based on ICD-10-CM, aspiration pneumonia / pneumonitis is not an acute lower respiratory infection but rather classified as a lung disease due to external agents.  Therefore, if the patient has aspiration pneumonia and COPD, aspiration pneumonia (J69.0) would be coded as principal diagnosis if it is the reason for admission, not J44.0. 


Summary: Like it or not, Coding Clinic advice in this case is definitive since it provides official coding clarification when ICD-10-CM is ambiguous or conflicting.  Even though pneumonia and influenza are classified together in ICD-10-CM, the issue is ambiguous and this Coding Clinic advice has a reasonable basis. 

To enshrine this Coding Clinic advice about J44.0 in ICD-10-CM, it would seem prudent for the ICD-10 Coordination and Maintenance Committee to add an Includes note at J44.0 for the pneumonia code categories J12-J18 and for “other” lower respiratory infection categories J20-J22.

Keep in mind that ICD-10-CM clearly does not classify aspiration pneumonia (J69) as a lower respiratory infection and to do so would require adding it as an Includes note at J44.0.  ICD-10-CM is not ambiguous or conflicting on this.