Clinical Validation: The Physician Advisor’s Role

Ritu Prasad, MD

There are billions of reasons why denials are generated ($). The level of care/medical necessity physician advisor (PA) may be more versed in the medical necessity/status denial, whereas the clinical documentation integrity (CDI) PA is tasked with clinical validation. Originally, coding denials were Diagnosis Related Group (DRG) validation audits. The auditor was evaluating whether the correct codes had been assigned and whether the sequencing of diagnoses was accurate. The question being considered was, “Was the encounter coded correctly?”

The clinical validation (CV) denial has become much more prevalent and has been requiring enormous expenditure of time, effort, and resources to combat. CV is the determination of whether conditions documented in the medical record were actually present. The question asked is, “Are the diagnoses claimed supported by the clinical evidence?”

Clinical validation is a bit of a misnomer. Adjudicating whether a condition is present, i.e., valid, can really only be done by a clinician caring for the patient. They are familiar with all the additional observations, discussions, and thoughts that never made it into the chart. For our purposes, however, the clinical validation process is the act of someone reading the documentation and questioning whether the diagnosis seems legitimate.

The Recovery Audit Contractor Statement of Work (2011, p. 23) is oft quoted as saying, “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.” (Draft Statement of Work for the Recovery Audit Contractors (cms.gov)) This is the rule for the RAC, not for your organization. Anyone whom you deem competent to perform CV may do so, and this may include a knowledgeable coder.

CV is an ongoing process. The PA participates in multiple steps.

A CV issue may be picked up by a CDI specialist or coder. Let’s just call that individual a CDIS for the purposes of this article. The CDIS recognizes a potential issue and must determine a plan of action.

• The CDIS must understand the clinical conditions, especially ones which often result in CV questions (e.g., sepsis, pneumonia, respiratory failure, encephalopathy). The PA may be instrumental in educating them on the clinical aspects.
• The PA may be exposed to CV queries in the course of chart reviews and have an opinion as to the CDIS’ understanding of the issues and the effectiveness of their queries. The PA can work with the CDI manager/supervisor/director to improve the CDIS knowledge base and queries.

The PA may be recruited to assist with CV as another set of eyes and a second opinion. There are two points of entry – concurrently regarding necessity for a CV query and retrospectively to fight CV denials.

• Does the PA think the condition being questioned concurrently is clinically valid?
• Yes…could it be that the CDIS needs education?
• Yes, the condition is valid, but the documentation is substandard. The PA can assist by educating the provider as to best documentation practices.
• No, it doesn’t seem valid. Again, the provider may need feedback and education. A CV query may be indicated.
• Indeterminate…this merits a CV query.

Most organizations do not have the PA composing CDI queries. I agree with the philosophy that it is better to separate educational duties from querying. Have PAs educate their peers; delegate querying to the CDIS. If the PA’s organization endorses them querying, it should be ensured that the queries are done in a compliant fashion (see CDI Querying on the CDI Resource page on ACPAdvisors.org website). The PA can help design compliant, effective CV query templates. However, under no circumstances should a PA who has not taken care of the patient clinically document in the record to shore up support for a diagnosis, even if the condition is clinically valid.

PAs are well positioned to fight CV denials, either primarily or secondarily. Some facilities have someone from the CDI team offer the first appeal and then escalate further appeals to the PA. The PA must assess whether the CV denial is well-founded, which is the converse of whether the condition is clinically valid.

• Yes, the denial is valid. If the condition wasn’t present, the claim should be allowed to be adjusted.
• No, the condition was clearly present (whether documented well or not). This denial should be fought tooth and nail using current literature and up-to-date references.
• It is unclear whether the condition was present, so it is understandable that a denial was generated. The encounter will be out of the window to query for definitive clarification (CV denials often come long after the encounter), but the PA could discuss with the clinician, if desired. If the condition was present but suboptimally documented, at least try a pass at overturning the denial. You may have to weigh the time/effort/aggravation investment against the likelihood of success at some point in the denial appeal process. Choose your battles wisely.

The final action is always to close the loop with feedback and education. Feedback is informing the provider that a denial occurred, explaining why and how to avoid another one in the future. Education can be anticipatory and prospective or reactive targeting a topic according to a provider’s or service line’s needs. Issues which elicit frequent CV queries or denials can be the game plan for education, templates, and internal clinical guidelines.

Internal clinical guidelines are meant to standardize and hopefully optimize diagnosis and treatment of medical conditions where there may be some controversary or variability in clinical practice. The CDI PA should have a seat at that table, advocating for CDI needs as well as ensuring current best-practice clinical care. Organizations cannot just make up their own definitions and clinical criteria, however, and expect that the payers will accede.

Denials management is likely to continue to constitute a significant expenditure of the PA’s time. Having a concrete plan in place may minimize the work effort required. And an ounce of prevention on the front end (education, CV queries) is worth a pound of cure on the back end (fighting CV denials)!