Overcoming Clinical Validation Denials Based on the CTCAE

By Richelle Marting, JD, MHSA, RHIA, CPC, CEMC, CPMA, CPC-I | August 23, 2021 | Audits, Appeal Writing, Appeals, Clinical Validation, Denials

The purpose of a clinical validation review is to “see whether or not the patient truly possesses the conditions that were documented in the medical record”, and eventually coded.[i] Some conditions are subject to consensus diagnostic criteria or guidelines which are authoritative and widely accepted in the medical community. Many others, like acute blood loss anemia, have less standardized definitions to clinically validate the condition occurred. Not surprisingly, references that purport to support restrictive diagnostic criteria may be relied upon by payors in clinical validation determinations. One reference material that is increasingly referenced in clinical validation denials for acute blood loss anemia and hyponatremia is the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE).

What is the Common Terminology Criteria for Adverse Events?

The CTCAE criteria were developed as a standardized terminology and grading system for adverse event (AE) reporting. The use of CTCAE allows investigators, trial sponsors (CTEP), and regulatory agencies (FDA) to assess and evaluate AEs to assure patient safety as it relates to cancer treatments. Also called common toxicity criteria, CTCAE describes the severity of organ toxicity for patients receiving cancer therapy. Importantly, though, the grading scale for cancer therapy adverse event reporting are not diagnostic criteria. CTCAE is often relied upon with the improper suggestion that hemoglobin must fall below the equivalent of 10.0 g/dL in order to clinically validate a diagnosis of anemia:

[i] ICD-10-CM Coding Clinic 2016, Quarter 4, pages 147-149.

How to Respond

Start with your payor agreement. Some agreements may specifically permit clinical validation reviews, and others may remain silent on whether clinical validation reviews are allowed. Most agreements contain language that the provider must comply with the payor’s policies, procedures, and manuals and a separate provision that the payor will notify the provider or otherwise make those policies, procedures, and manuals available. Agreements may contain hold-harmless language that precludes the provider from being held responsible if the payor fails to notify the provider of a policy.

If the agreement at issue contains these types of provisions, and if the CTCAE is the sole basis for a clinical validation denial of acute blood loss anemia or any other condition for that matter, highlight in your appeal that the payor has failed to notify or disclose to the provider any policy, procedure, or manual adopting the CTCAE as diagnostic criteria against widely accepted medical community use of the CTCAE as an event reporting system. Emphasize that when this irrelevant resource is appropriately excluded from consideration, the payor has failed to offer a single authoritative clinical source to support its position. If applicable, also emphasize the patient under review does not even have cancer nor is undergoing cancer treatment to even bring CTCAE into the realm of clinical relevance for the particular patient’s care.

Offer instead other authoritative clinical resources that may support the provider’s diagnosis of the patient’s condition – and the more, the better. In the case of acute blood loss anemia, these may include:

  • World Health Organization (WHO) and National Cancer Institute (NCI) reference normal values for hemoglobin (Hgb) are 12 to 16 g/dL in women and 14 to 18 g/dL in men; the National Comprehensive Cancer Network (NCCN) suggests evaluation of anemia if the hemoglobin is ≤11 g/dL or if there is a decrease of ≥2 g/dL below the individual’s baseline.[i]
  • Pinson, MD, FACP (2012). Bleeding and acute blood loss anemia. ACP Hospitalist. Retrieved from http://www.acphospitalist.org/archives/2012/02/coding.htm. “Blood transfusion is not required to substantiate the diagnosis of acute blood loss anemia”.[ii] “Take, for example, a 72-year-old woman with diabetes, osteoporosis, chronic systolic heart failure, stage 4 chronic kidney disease, and anemia of chronic disease, with a baseline hemoglobin of 10.2 g/dL, who requires open reduction and internal fixation for left femoral neck fracture. Hemoglobin level is 9.0 g/dL on postop day 1 and 8.5 g/dL on day 2; it then remains stable for the next 2 days. She has no anemia symptoms and does not require a transfusion. In this case a diagnosis of acute blood loss anemia would be warranted, based on the drop in hemoglobin of 1.7 g/dL over 2 days postop, requiring monitoring to assess the need for transfusion if anemia progressed. In addition, a hemoglobin of 8.5 g/dL represents a significant risk to this patient, given her age, chronic heart failure, and chronic kidney disease.”[iii]
  • Bross, et al, Anemia in Older Persons American Academy of Family Physicians.[iv] “The World Health Organization (WHO) defines anemia using hemoglobin levels as follows… women < 12.0 g/dL”. “While there are no definitive standards [for acute blood loss anemia], the following criteria may be useful:…a decrease in hemoglobin level of 1.0 to 2.0 g/dL”.
  • Anemia in Clinical Practice.[v] References World Health Organization’s definition of anemia, as cited above and references an emerging, lower threshold of anemia as less than 12 g/dL for both sexes. The patient met this criterion..

Identify the acute event (e.g., surgery). Pull hemoglobin and hematocrit lab values prior to the acute event to illustrate the patient’s baseline and pull as many examples of hemoglobin and hematocrit labs that fall outside the reference ranges above as possible for the current stay. Calculate, and emphasize, the drop in hemoglobin and/or hematocrit. List medical record documentation reflecting symptoms of anemia. List every item of documentation discussing anemia-related symptoms, review of lab values, assessments, and plans related to anemia. Consider listing not just a reference to a note (e.g., progress note postop day 2) but sections within the note (e.g., See Subjective, postop day 2 progress note, “increased fatigue, dizziness”; See Exam, postop day 2 progress note “lab values: Hgb 11.2 g/dL”; See Assessment, postop day 2 progress note “ABLA; monitor”; see orders “transfuse if Hgb < 7”). Conclude with a summary of the deficiencies in the determination, such as:

ABC Insurer must overturn its adverse determination because:

  • our agreement at Section 123 with ABC Insurer requires ABC notify Hospital of material policies, procedures, or manuals and ABC Insurer has failed to disclose any such policy, ABC is precluded from relying upon CTCAE as diagnostic criteria for acute blood loss anemia
  • CTCAE was not designed or intended to be used as diagnostic criteria
  • CTCAE is not widely recognized in the medical community as a standard for diagnostic criteria
  • The World Health Organization and extensive additional peer reviewed literature designed to propose diagnostic criteria for anemia support using hemoglobin and/or hematocrit levels as diagnostic criteria that are consistent with the patient’s condition and documentation in the medical record
  • The physician diagnosed the patient’s acute blood loss anemia based on lab values meeting industry-accepted diagnostic criteria
  • Documentation in the medical record supports the diagnosis of acute blood anemia by a physician responsible for the diagnosis, care and management of the patient

In some instances of repeated inappropriate clinical references, organizations may find physician and managed care conversations with the payor beneficial to highlight concerns with the payor’s review methodology and to initiate effective change on future claims. As with all clinical validation denials, always look critically at the references relied upon by the reviewer, understand how they relate to your payor’s contractual obligations, and the applicability of the reference to the condition and case at issue. You may be surprised with how often and how easily you can spot gaps and weaknesses in the sources being relied upon.

[i] Causes of anemia in patients with cancer, UptoDate.

[ii] Pinson, MD, FACP (2012). Bleeding and acute blood loss anemia. ACP Hospitalist. Retrieved from http://www.acphospitalist.org/archives/2012/02/coding.htm.

[iii] Pinson, MD, FACP (2012). Bleeding and acute blood loss anemia. ACP Hospitalist. Retrieved from http://www.acphospitalist.org/archives/2012/02/coding.htm.

[iv] Am Fam Physician. 2010 Sep 1;82(5):480-487

[v] Cappellini MD, Motta I. Anemia in Clinical Practice-Definition and Classification: Does Hemoglobin Change With Aging? Semin Hematol. 2015 Oct;52(4):261-9. doi: 10.1053/j.seminhematol.2015.07.006. Epub 2015 Jul 17. PMID: 26404438.


Richelle Marting
Attorney | + posts

Richelle Marting is a healthcare attorney with a focus on medical coding, billing and reimbursement. She has helped successfully recover or retain millions of dollars for healthcare organizations and individuals through audits and appeals. Richelle has extensive experience in medical coding and revenue integrity audits and has served as an expert witness and consulting expert in litigation. You can contact Richelle at rmarting@richellemarting.com