Editorial

Appropriateness

RiChaRD h. DaFFneR, mD, FaCR

Sharon Taylor’s recent perspective piece on prior authorization (PA)1 inspired me to “dust off” my plans to comment on a subject that I was intimately involved with for many years – appropriateness of diagnostic imaging. In the early ‘90’s, Medicare, looking for ways to reduce costs, began requiring providers to obtain approval before ordering a diagnostic procedure or implementing certain treatments. The goal was to eliminate unwarranted or inappropriate care. The private insurance carriers (the “Blues”, Aetna, United, et al) quickly followed suit and began their own systems for PA.

The use of imaging in medical practice has exploded over the past eighty years. In the 1940’s imaging impacted the diagnosis in one of twelve patients; in the 1950’s, one in six; in the 1960’s, one in three; and in the 1970’s, one in two. By the 1980’s, virtually all patients had some form of imaging performed. With the development of CT and MRI, the costs skyrocketed. Prior to 1970, a fluoroscopy unit was the most expensive piece of equipment in a radiology department. In the 1970s, a CT scanner cost $200,000 on average. As CT evolved and MRI entered the picture, the costs of those pieces of equipment rose dramatically. Today, MRI or PET CT machines can cost upwards of $3,500,000.

In 1993, the American College of Radiology (ACR) recognized the need to develop national guidelines for the appropriate use of imaging technologies. These guidelines became the ACR Appropriateness Criteria® 2 (ACR AC®) as a guide for radiologists and, more importantly, for non-radiologists who ordered imaging studies on their patients. The concept was formally presented to the US House Ways and Means Committee by the former chair of the ACR Board of Chancellors, Dr. K. K. Wallace, who stated that the ACR was ready to create these guidelines to help eliminate the inappropriate utilization of diagnostic imaging.

In 1994, the ACR formed a task force to begin developing scientifically based guidelines that would be nationally accepted, to assist referring physicians in making appropriate imaging decisions depending on their patient’s clinical conditions. The charge of the task force was to follow acceptable medical practice guidelines used by the federal Agency for Healthcare Research and Quality that had been designed by the Institute of Medicine. The methodology relied on evidence from the scientific literature. In those instances where the data from the literature was insufficient or were inconclusive, the recommendations were based on expert consensus.

Expert panels were selected for each of the eleven areas in diagnostic radiology (Breast, Chest, Cardiac, Gastrointestinal, Interventional, Musculoskeletal, Neurologic, Pediatric, Urologic, Vascular, and Women’s). Members of each panel are nationally recognized experts and leaders in their subspecialty. In addition to radiologists, each panel has physicians from other medical specialties to provide important clinical perspectives. I was a member of the Expert Panel on Musculoskeletal Diseases (MSK) from 1994 - 2011 and chaired the panel from 2006 - 2011. The MSK panel has an orthopedic surgeon, an emergency medicine physician, and a neurosurgeon as our clinical consultants.

The goal, as mentioned above, is to produce evidence-based guidelines to assist referring physicians and other providers in making the most appropriate imaging or treatment decisions for a specific clinical condition. An additional goal is to maximize the benefits of performing medical imaging and invasive radiologic procedures as well as to minimize risk to patients.

Each member of an expert panel submits a list of topics to the ACR staff for them to conduct a search of the literature in Pub Med. The author then assesses the literature and determines

which articles to retain and which to reject. After reviewing the literature, the author produces an evidence table of the articles reviewed to determine the validity of the conclusions of each article. The Evidence Table considers four categories of study quality. In Category 1, the study is clearly welldesigned and accounted for common biases. In Category 2, the study is moderately well-designed and accounted for most common biases. In Category 3 there are important study design limitations. Category 4 studies are deemed not useful as primary evidence because of flawed design or conclusions (“bad science”).

Once the literature review by the author is completed, the author will create a list of variants for each category. (S)he will then list the procedures to be evaluated. This document is sent to the other members of the expert panel in tabular form for evaluation and voting. The panel is asked to rate each procedure for that variant based on the benefits of performing a specific procedure for a specific clinical scenario balanced against the risks. The ratings given by each panel member are based on the evidence in the literature. On rare occasion, the rating may be based on the reviewer’s own experience. If the evidence is incomplete or unavailable, expert opinion by consensus will determine the rating. Ratings do not consider availability, contradictions, or costs. The rating system ranges from 1 - 9. Ratings of 1, 2, or 3 indicate that the procedure is usually not appropriate. In addition, the imaging procedure or treatment is not only unlikely to be indicated or the risk-benefit ratio for patients is likely to be unfavorable. Ratings of 4, 5, or 6 indicate that the procedure may be appropriate. Ratings of 7, 8, or 9 indicate that the procedure is usually appropriate. In this category, the imaging procedure or treatment is indicated in the specific clinical scenario at a favorable risk- benefit ratio for patients.

Following the initial voting round, the results are sent back to each panel member for a second vote. This second vote may result in a change of how an individual member initially voted once they can now see how their colleagues have voted. (“Gee, I thought that was appropriate, but I guess I’m wrong.”) A third vote then occurs. After the third vote, there is a conference call for reconciliation. When 80% of the panel agrees, consensus is achieved, and the author writes the final document. If consensus is not reached, comments explaining the reason(s) are made in the narrative portion of the final document.

The final document begins with a tabular listing of each variant. A scholarly narrative summary of the literature review follows, beginning with the title of the clinical condition (e.g. Suspected Spine Trauma) followed by a background discussion on the topic and the conclusions reached by the expert panel in the summary and recommendations for each variant. This is followed by a supporting documents section that gives an Internet link if the reader wants to see the Evidence Table from which the conclusions are based. The document also includes a table defining appropriateness category names and definitions as well as a table defining relative radiation level for each study. The references used in arriving at the conclusions are listed at the end, as is a separate patient-friendly summary (in layman’s terms).

Figure 1 shows an excerpt from the current (2018 revision) ACR AC® on Suspected Spine Trauma. I authored the original document in 2008.

Each topic is reviewed annually and is updated as necessary. In 2021, there were 216 diagnostic imaging and interventional radiology topics with over 1,030 variants as well as 2,400 clinical scenarios in the diagnostic imaging topics. In June 2016, the Centers for Medicare and Medicaid Services (CMS), named the ACR as a “Qualified Provider” approved to provide appropriate use criteria (AUC) under the Medicare Appropriate Use Criteria program for advanced diagnostic imaging. ACR AC® are available online for anyone at: www.acr.org/ac. The ACR, cognizant of their duty to the next generations of physicians also has resources available for instructing medical students on using the appropriateness criteria.

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From Page 9

Figure 1. Sample table from ACR AC® on Suspected Spine Trauma2

References

1. Taylor SL. Let’s talk about prior auth!

ACMS Bulletin, November 2021, pp 319 – 321.

2. ACR Appropriateness Criteria®.

American College of Radiology.,

Reston VA, 2021.

Dr. Daffner is a retired radiologist, who practiced at Allegheny General Hospital for over 30 years. He is Emeritus Clinical Professor of Radiology at Temple University School of Medicine.

The opinion expressed in this column is that of the writer and does not necessarily reflect the opinion of the Editorial Board, the Bulletin, or the Allegheny County Medical Society.