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Clinical validation is a bit of a misnomer. However, I am going to consider clinical validation as the act of questioning.

Last week, I participated in the American College of Physician Advisors CDI town hall, and our topic was clinical validation. If you missed it, I recommend you go to the website, https://www.acpadvisors.org/, and watch the recording when it is available. Our next Town Hall is scheduled for December 8, 2022 – put that one in your calendar and register when the time comes.

When we hold these town halls, we encourage attendees to submit questions upon registration, and we try to incorporate as many of them as we can, depending on the topic. I introduced our focus of clinical validation and thought I would bring the message to you.

Historically, coding denials were based on DRG validation and whether the codes and sequencing were accurate. The question for the auditor was, “Was the encounter coded correctly?” This type of denial still crops up, but the denials which cause CDISs and physician advisors more heartburn now are clinical validation (CV) denials. CV denials address whether a condition documented in the record and coded was actually present. The question becomes, “Do the clinical indicators seem to support the diagnosis?”

The Recovery Audit Contractor (RAC) statement of work from 2011 (Draft Statement of Work for the Recovery Audit Contractors (cms.gov)) posits that “Clinical validation is beyond the scope of DRG (coding) validation and the skills of a certified coder. This type of review can only be performed by a clinician or may be performed by a clinician with approved coding credentials.” This statement is often misinterpreted as prohibiting coders from being able to do CV denials. It is for the RACs, not institutions. Your organization can allow anyone they think is competent to handle CV denials, clinician or not.

Clinical validation is a bit of a misnomer. The only one who can adjudicate whether a condition is truly present at the time of the encounter is the clinical practitioner caring for that patient. However, for our purposes, I am going to consider clinical validation as the act of questioning.

There are four basic elements to the process: recognition of potential CV concern, what to do concurrently (e.g., CV querying), what to do retrospectively in response to a CV denial, and how to prevent future CV issues with feedback and education.

A CV issue is identified by a CDI specialist or coder, depending on when the record is reviewed. For the sake of ease, I will call this individual a CDIS. The CDIS notes a potential issue and determines a plan of action.

This demands that the CDIS understand the clinical situation and can interpret the clinical indicators. Examples of common conditions which pose CV risk are sepsis, pneumonia, encephalopathy, and respiratory failure.

  • There should be a mechanism for assessing effectiveness and value of queries as a quality assurance function. This may be formalized like a periodic audit or informal like the physician advisor (PA) giving the CDI manager feedback when they review records (or both).
  • The CDIS should be getting regular training on CV and CDI conditions as a matter of course.
  • There is a slight difference in the skill set when doing CV CDI (Does the offered diagnosis match the clinical indicators?) as opposed to traditional CDI (Where is there the diagnosis for the clinical indicators?). A CV query mustn’t send the message that the CDIS is questioning the provider’s judgement.

A second set of eyes (manager/supervisor/director/auditor/educator or PA) may be recruited to assess whether there is a legitimate CV concern. Whoever is doing the assessment, the question must be answered, “Does the condition seem to be clinically valid?”

  • Yes. Does the CDIS need some education around CV or the clinical condition?
  • Yes. The condition seems valid, but the documentation is substandard. This is an opportunity for concurrent CV querying and/or provider education to improve the documentation.
  • No. The condition does not seem valid. The provider may need education and should be encouraged to remove/rule out the diagnosis either by instruction or query. It is important that the documentation accurately reflect the patient encounter.
  • Unclear. A compliant CV query is warranted for clarification. It is very helpful to have a good CV query template with clear presentation of clinical indicators (or lack thereof) and a non-threatening question to determine if the condition is or is not clinically valid.

If the CV issue was not noted concurrently, or if an auditor is throwing spaghetti on the wall trying to avoid paying appropriately, a CV denial may be issued. Similar to the question above, but conversely, one should ask, “Is the denial valid?”

  • Yes, the denial is valid, and the clinical indicators do not support the diagnosis. Allow them to adjust the claim and think of it as a loan, not a loss.
  • No, the denial is unjust, and I just HATE those payers for trying to cheat us out of money we legitimately are entitled to! Fight this denial fiercely and compose as many appeals as needed.
  • It is unclear whether the condition was present, so the denial is justifiable. You are out of the query window, but the provider can be contacted for assistance in making a determination. If the condition was present but the documentation was suboptimal, you should at least try one appeal. If it is upheld, you will have to make your own decision as to whether it is worth more time and effort to continue to fight. Choose your battles wisely.

The final step is tracking and trending and letting that data guide your educational efforts. Feedback is giving providers specific information about specific cases. If you have the bandwidth to do it, it is quite productive. Providers have no idea that these denials are occurring unless you tell them. They don’t know how to do it better unless someone shows them how. The focus of feedback can be the blueprint for future disseminated education.

Internal clinical guidelines can be helpful for standardizing clinical practice, but they cannot be relied upon to ward off denials if they are not clinically sound. You can’t redefine diagnoses to your own organizational specifications. CDI should have a seat at the table to ensure that the clinical indicators used are not going to be at odds with convention.

Empowerment of CDI to perform CV querying, use of a PA to assist in CV and to combat denials, feedback and education are the tools you need to ensure that diagnoses are clinically valid and are well supported in the documentation. Establish a robust process and maintain it. An ounce of prevention is worth a pound of cure.

Programming note: Listen to Dr. Erica Remer today when she cohosts Talk Ten Tuesdays with Chuck Buck at 10 Eastern.


Erica E. Remer, MD, CCDS

Erica Remer, MD, FACEP, CCDS, has a unique perspective as a practicing emergency physician for 25 years, with extensive coding, CDI, and ICD-10 expertise. As physician advisor for University Hospitals Health System in Cleveland, Ohio for four years, she trained 2,700 providers in ICD-10, closed hundreds of queries, fought numerous DRG clinical determination and medical necessity denials, and educated CDI specialists and healthcare providers with engaging, case-based presentations. She transitioned to independent consulting in July 2016. Dr. Remer is a member of the ICD10monitor editorial board and is the co-host on the popular Talk Ten Tuesdays weekly, live Internet radio broadcasts.

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