By Ruth Carol, contributing writer, May 01, 2013
The appropriate use criteria (AUC) for Mohs micrographic surgery (MMS) published this past fall may mean many things to many people. For dermatologists who refer Mohs cases, they are an aid in clinical decision making. For Mohs surgeons, they may mean getting the most appropriate cases for referral. For researchers, they may serve as a call for more definitive research. For those in the quality arena, they may serve as a basis for quality measures and quality improvement (QI) efforts. For insurers, they should demonstrate that Mohs is not only an appropriate, cost-effective modality, but that dermatologists are using evidence-based medicine, whenever possible, to make the call.
The AUC were developed by a task force established by the American Academy of Dermatology (AAD) in collaboration with the American College of Mohs Surgery (ACMS), the American Society for Dermatologic Surgery Association, and the American Society for Mohs Surgery. The task force used the Appropriateness Method developed in the 1980s by RAND/University of California Los Angeles to create AUC for 270 clinical scenarios for which MMS is frequently considered based on tumor and patient characteristics. For 200 of those scenarios, MMS was considered appropriate. It was deemed uncertain for 24 scenarios and inappropriate for 46 of them.
Clinical decision-making aid
“When all of the available data has been reviewed and vetted by 17 independent dermatologists, the majority of whom were not Mohs surgeons, and they say Mohs surgery is indicated for a certain location and tumor type, you can feel pretty secure when you send a patient for Mohs,” said former ACMS President and current AAD President-elect Brett Coldiron, MD, a Mohs surgeon who served on the AAD task force. [pagebreak]
Former AAD President Diane Baker, MD, another task force member, agreed that the AUC serve as a useful guide and reference. “Most of us who refer to Mohs surgeons know the types of tumors that need to be referred either because they are complicated, large or in a certain location, and the AUC support that,” she said. The AUC are even more helpful when it comes to borderline tumors, Dr. Baker added. “I don’t have to do an extensive literature review, I can just go to the document and see that the literature has been thoroughly reviewed and is based on either evidence or expert opinion. That holds a lot of credibility.”
The task force considered 85 percent of clinical scenarios, she pointed out. “We couldn’t include every conceivable scenario, but we looked at the most common ones.” Consequently, there might be scenarios that seem similar to one of those given an “inappropriate” classification where clinician judgment still indicates a referral for MMS. Additionally, “uncertain” means there is not currently enough evidence to be more definitive about appropriateness for that scenario, she said — it is an appraisal of the evidence, not a recommendation for action. In those cases, Dr. Baker recommended taking into consideration the tumor’s characteristics and the individual patient’s situation and using one’s best clinical judgment and expertise to determine the best treatment option. Good communication with the Mohs surgeon is essential, she said, as is good documentation.
The AUC also provide helpful feedback to referring dermatologists, Dr. Coldiron noted. For example, sometimes a dermatologist refers a patient to a Mohs surgeon who performs MMS on three skin lesions and excises two lesions. The referring dermatologist may not understand why the Mohs surgeon chose the different treatments; a decision that is clarified in the AUC. [pagebreak]
Additionally, the AUC can be useful when speaking with patients. “It is very useful to help explain that not all skin cancers are the same,” Dr. Baker said. Some patients who have had MMS previously think they need it for every subsequent non-melanoma skin cancer (NMSC). One patient, who Dr. Baker diagnosed with a small superficial basal cell carcinoma (BCC) on the back, insisted on MMS as soon as the diagnosis was made. She ended up referring the patient for a second opinion. Another patient had two similar-looking BCCs on her leg. One was a superficial BCC, for which MMS is inappropriate, and the other one was an infiltrative BCC on the lower leg, for which MMS was appropriate. Dr. Baker used the AUC to explain the difference between the tumors and treatment options. “Before we had the AUC, it was more difficult to explain,” she said.
When a referral for MMS is inappropriate, the AUC will support the Mohs surgeon’s decision to use another modality, said Oliver Wisco, DO, who served on the AAD task force. “The Mohs surgeon doesn’t have to feel bad about declining a consult or recommending an alternate way to treat the tumor,” he said. While the AUC might decrease referrals a little, they will decrease it for tumors that don’t need true margin control, Dr. Wisco said. Subsequently, the referrals the Mohs surgeons receive will be better ones. “It will ultimately strengthen the relationship with the referring physician,” he added.
In some cases where MMS is deemed “uncertain” or “inappropriate,” the Mohs surgeon will have to use the literature to substantiate the decision to use MMS, Dr. Wisco said. For example, the AUC says that MMS is inappropriate for superficial BCCs on the trunk in healthy patients. “Overall, that is true, but there are exceptions. For example, for a 10-centimeter large superficial, recurrent BCC on the back on a non-immunocompromised patient, margin control with Mohs surgery is useful,” he continued. Substantial data demonstrate that MMS is the best treatment for clearance and can be the most cost-effective treatment taking specific patients into account, Dr. Wisco noted. That data will most likely be necessary to provide the insurance company when seeking an appeal for an exception to the AUC. “We’ll have to fight for Mohs in certain areas, but overall the document will protect us when we’re trying to advocate for the appropriate use of it on the head and neck,” he said. [pagebreak]
Dr. Coldiron doesn’t think that the AUC will change the number of referrals substantially because, he said, MMS was being used appropriately prior to its publication. Last year, approximately one in four NMSCs was treated with MMS. “Many more patients are being cured and avoiding recurrences, repeated excisions, and mutilating procedures.” Between 1995 and 2009, the use of MMS increased 400 percent; approximately one in 15 skin cancers was being treated with MMS in 1995.
The increase in utilization of MMS has slowed somewhat, particularly on the trunk and extremities, according to preliminary data from 2012, Dr. Coldiron noted. For example, utilization of MMS on the trunk and extremities increased only 2 percent and only 5-6 percent for tumors on the head and neck. Previously, utilization had been increasing approximately 10 percent per year. But the impact of the AUC on use of Mohs is yet to be fully determined. “It’s good that the rise in utilization is slowing down,” he said. “But I don’t know if it’s because of the AUC or policies imposed by local carriers.”
“You have to realize that we have an epidemic of skin cancer,” Dr. Coldiron continued. There are nearly four million new cases of NMSCs in the U.S. each year. “That number is expected to double every 15 to 20 years at the rate it is going,” he said.
More research needed
Whenever possible, published clinical information was used to determine the appropriateness of MMS. However, when evidence-based information was lacking, clinical expertise played a significant role in determining the appropriateness of scenarios.
For clinical scenarios that were deemed “uncertain,” there was little or no data to make a determination, Dr. Coldiron said. Those areas, he said, are where the dermatology community must concentrate its research efforts.
Dr. Wisco hopes that the AUC will not only spur cost-effectiveness research, but also gap data analysis. One of the problems with conducting such research is deciding how to do prospective studies, he said. Do the studies have two arms, one in which standard excision is performed and one in which MMS is performed on a tumor in the same location? Is the end point histological or clinical? Is it recurrence or clearance? [pagebreak]
Basis for quality measures
The AUC could serve as a basis for developing quality measures for Medicare and other quality reporting programs, according to task force members. For practicing dermatologists who don’t perform Mohs, the measure could look at the percentage of patients with NMSCs who were referred for MMS.
Similarly, dermatologists could use that measure to determine if their referral patterns conform to best practices, Dr. Baker said. It could, perhaps, qualify as a QI activity that would fulfill part of component 4 of Maintenance of Certification, she added.
The AUC are a good base on which to start building metrics that prevent overuse, said Dr. Wisco, who also serves as chair of the AAD’s Performance Measurement Task Force. “But we have to be careful that the metrics are not misconstrued,” he said. “The AUC demonstrate our participation in health care reform. They will also streamline what we do, with the understanding that there are limitations in the data we had.”
Speaking of health care reform, Dr. Coldiron is optimistic that the AUC will help preserve the ability to use MMS for patients where the benefit is most widely accepted. However, the AUC have not been widely adopted yet. The Centers for Medicare and Medicaid and Medicare local carriers move at a slow pace, as do the private insurers, he said. “When they decide to review their policies, they will hopefully look to the appropriate use criteria in their decision making process to determine which NMSCs need to be treated with Mohs and which ones don’t. In some cases, they’ll become stricter, and in some cases, they will become more liberal in line with what the AUC recommends.”
The AUC ratings
The appropriate use criteria rate the use of Mohs micrographic surgery as appropriate, uncertain, or inappropriate for 270 clinical scenarios. An appropriate rating means that Mohs is generally considered acceptable for the specific clinical scenario; that is, the expected benefits of the procedure outweigh the possible negative consequences/risk. An uncertain rating means that it is unclear whether the procedure is appropriate for a specific clinical scenario. This does not mean that Mohs should not be performed or that there is no evidence of benefit, but rather that more information or research is needed. As such, an uncertain designation could be determined to be appropriate with the input of additional clinical judgment. An inappropriate rating indicates that Mohs is generally not considered acceptable for the specific clinical scenario, that is, the expected benefits of the procedure do not outweigh the possible negative consequences/risk.