By Jan Bowers, contributing writer
A plethora of new diagnostic tests are enhancing the ability of dermatopathologists to guide dermatologists and their patients toward timely, effective treatment. But knowing when to use which advanced test can be challenging, and the cost of some tests can prompt insurers to balk at reimbursement. The American Society of Dermatopathology (ASDP) tackled both issues head on by systemically developing a set of appropriate use criteria (AUC) for a dozen ancillary tests. The final AUC have been published in the Journal of the American Academy of Dermatology (available online at doi.org/10.1016/j.jaad.2018.04.033) and the Journal of Cutaneous Pathology (2018;45:563-580). In addition, five recommendations based on the AUC have been published on the American Board of Internal Medicine Foundation’s Choosing Wisely® campaign website (see sidebar).
“The cost of health care continues to increase, partly because of wonderful new technologies that are available. They improve patient outcomes, but they also cost money,” said Dirk M. Elston, MD, professor and chairman of the department of dermatology and dermatologic surgery at the Medical University of South Carolina in Charleston. “Going forward, there have to be criteria regarding what [tests are] appropriate when. Someone must develop them, and payers will do it unless the societies do. Who knows more about the actual practice of medicine? The physicians.” Dr. Elston — a former AAD president who was president of the ASDP in 2015, when an AUC task force was formed — pointed to the Academy’s creation of AUC for Mohs surgery as a “very successful effort. Building on their success, we launched a similar effort for some of the reflex testing that would be done in a dermatopathology lab. We did it on a shoestring budget with volunteer time and the end product is very good.”
Evidence bolsters expertise
From the outset, the ASDP adopted the methodology of RAND/UCLA that combines scientific evidence review and analysis with clinical experience and expertise. The process, as described in both manuscripts, began with the establishment of four subgroups: lymphoproliferative, melanocytic, soft tissue, and other — with ‘other’ meaning tests not included in the other categories. Each group then chose two or three ancillary studies to develop AUCs; created a set of definitions to clearly explain the meaning of assigned terms and histologic diagnoses; and developed clinical scenarios to simulate situations most likely to be encountered in clinical practice. The tests were selected “based on their utilization and the preliminary thought that questions about those tests have alreadyarisen,” said Dr. Elston. For example, “there were questions from payers about the testing available for melanoma and lymphomas.” A total of 211 clinical scenarios were chosen to provide context for the appropriateness of each test; the list was “not intended to be exhaustive, but to represent at least 85% of anticipated scenarios,” according to both manuscripts.
A literature search extending from 1940 to 2016 yielded 239 articles, which were summarized and provided to a rating panel of 17 members. Panel raters, who were screened for financial conflicts of interest, included dermatologists and dermatopathologists. Among the panel raters were two representatives from the AAD (both non-dermatopathologists) and two representatives from the College of American Pathologists. “You don’t want to have an ‘inside baseball’ situation, where everyone is very similar in terms of their training and their views,” said AAD representative Murad Alam, MD, vice chair of the department of dermatology at Northwestern University’s Feinberg School of Medicine. “Since the whole purpose is to guide clinical care by selecting the best diagnostic tests, you want to have some people who are clinicians, not pathologists.”
Armed with literature reviews and clinical scenario booklets, the panel members used a nine-point scale, ranging from “rarely appropriate” to “usually appropriate,” to rate each test in the context of the clinical scenarios assigned to it. They were instructed not to consider the cost of the test. “Tests are rarely always appropriate, or never appropriate. Rather, they’re on a spectrum,” said Dr. Alam. “Even if a test is usually appropriate, that doesn’t mean you have to do it. It just means that it may often be the right course of action, but clinical judgement is essential for evaluating each specific instance to determine if a test, in fact, needs to be done. We want to avoid subjecting patients to multiple tests, and we also want to minimize health care costs. On the other hand, we now have some powerful and informative tests, and when they’re appropriate, we do want to suggest that they be used to guide patient care in the best manner possible.”
Appropriate use criteria 101
Read more about the development process for AUC at staging.aad.org/practicecenter/quality/appropriate-use-criteria.
Among the 211 clinical scenarios, consensus was reached for 188; in 43 scenarios, the consensus was “uncertain appropriateness” (indicated by a score of 4-6 on the 9-point scale). In giving a rating of “uncertain appropriateness,” panel raters often felt that “they did have some literature to guide them, but maybe it was underdeveloped, and new literature needs to be explored before they can make a better recommendation,” said Claudia I. Vidal, MD, PhD, associate professor of dermatology at Saint Louis University. “One of the biggest examples was the qRT-PCR. When the ratings were done, there wasn’t very much literature on the test.”
Putting AUC into practice
Dermatologists, as well as dermatopathologists, can now refer to the AUC as they consider what tests would or would not likely benefit a particular patient. “Because the dermatologists get the report from the dermatopathologists, [the dermatologists] need to be able to sometimes make decisions about whether further testing is appropriate or not,” said M. Yadira Hurley, MD, professor of dermatology and pathology and director of dermatopathology at Saint Louis University School of Medicine, and chair of the AUC task force. “As an example, a lot of the tests we looked at were tests that many dermatopathologists do not do reflexively, such as FISH. We polled dermatopathologists at an ASDP meeting and learned that many were asking the dermatologist before performing the test, in some cases, because they were aware the test was expensive and may not be covered by the patient’s insurance. In other cases, they needed more clinical information.” Another example of the continued dialogue and importance for dermatologists to be aware of the dermatopathology AUC is in cases where testing for human papillomavirus is being considered. “As dermatopathologists, we get a lot of requests from our dermatology colleagues to do the test,” said Dr. Vidal. But “both parties need to be aware of the literature and recommendations. The literature is most robust on the use of in situ hybridization for testing, and on histologic findings that are diagnostic for condyloma. There are also many psychosocial implications related to testing. Hopefully, the AUC will provide guidance so that we can all work together and make the best decision for the patient.”
Cost considerations and impact
Although the panel raters were instructed to disregard cost in their evaluation of individual tests, controlling costs to patients and the health care system overall was a secondary goal underlying the development of the AUC. “It used to be that the patient never thought about the cost of lab tests,” said Rosalie Elenitsas, MD, professor of dermatology at the University of Pennsylvania’s Perelman School of Medicine and current president of the ASDP. “No matter what laboratory tests were ordered, the cost was almost always covered by insurance, and the patient was not faced with paying the bill. Now that is not the case. People have really high deductibles, and if they have not met their deductible, they will be responsible for the cost of their pathology. We obviously don’t want to underuse our tests and miss a diagnosis, and we don’t want overutilization for multiple reasons, cost being a big one. The cost of health care has really come to the forefront in the last few years, and finding a balance of utilizing health care resources can be a challenge.”
On the other side of the cost equation, the ASDP recognized that government and private payers have a stake in the reduction of unnecessary testing and reimbursement for tests that will lead to accurate diagnoses and effective treatment. As the AUC task force began its work, “we took the approach of trying to involve payers as much as they would allow us to involve them,” said Dr. Vidal. “We included a representative from a regional Medicare carrier as part of the panel rater group in the initial round. She ended up recusing herself to avoid a conflict of interest, but she asked that we send her the final manuscript, so she could then distribute it to regional Medicare carriers.” Dr. Elston added that the rep sent the ASDP a note of approval stating, “that we had done this really well, and she anticipated it would be widely adopted by Medicare and other payers, and that any future similar efforts on our part would be very welcome.”
Legally speaking
Standards of care guidelines and appropriate use criteria: What’s the difference? Read more at staging.aad.org/dw/monthly/2015/june/standards-of-care-guidelines-and-appropriate-use-criteria-whats-the-difference.
Dr. Alam noted that payers are already using AUC as a pathway for showing when Mohs surgery should be covered. “Some of the Medicare contractors in some states have incorporated the Mohs AUC into their local coverage determinations [LCD], and the same sort of thing could happen with the dermpath criteria. Now if you have condition X, for which test Y is appropriate, and you submit that test, the carrier pays for it because they can refer to the LCD.” The ASDP has not reached out to private payers, Dr. Vidal said, but “in general, private payers tend to follow some of the trends that Medicare ends up making: A cut here, an increase there, and the private payers will do something similar.”
AUC evolution
As new tests emerge, and the body of scientific evidence around advanced testing grows, the ASDP plans to supplement and adapt its AUC. To that end, the society changed the task force to a standing committee, now chaired by Dr. Vidal. In addition to spearheading efforts to get the word about the current AUC out to physicians (including participating in a Twitter journal club discussion), she said the committee is meeting regularly to consider the next steps. “First, we’ll be looking to see what new literature has been published since 2016 on tests that we’ve already explored, and then we’ll go back and look to see if the clinical indications for testing have changed. We’re also just beginning the process of discussing what new tests we will start developing AUCs for — which will require approval from the executive committee of the ASDP.” One likely candidate for re-evaluation is the qRT-PCR, Dr. Vidal said. “For qRT-PCR, the ratings were uncertain appropriateness for the majority of clinical scenarios, with the exception of those instances where histology shows a nevus or melanoma. These latter cases were ranked as rarely appropriate to perform the test.” The updates will likely occur in phases, Dr. Vidal remarked, with the earliest targeted for publication in 2020.
While AUC can be viewed as a first step in developing quality measures, it’s important to understand the distinction between the two, Dr. Vidal noted. “Appropriate use criteria are really just guides to help us in test selection for individuals. There’s no metric to be met. It’s really an aid, another tool to have in your pocket.” She recommended that physicians using the AUC “keep in mind that they are not exhaustive, and treatment should always be based on the specific clinical scenario and the patient at hand. The wording of the appropriateness ratings nicely allows for this individualization of test selection.”