Concerns Over Sudden Increase in Radiation for Skin Cancer

Alexander M. Castellino, PhD

October 21, 2015

Surgery is the standard of care for nonmelanoma skin cancer, with radiation therapy reserved for select patients. But the use of a new form of radiotherapy, electronic brachytherapy (EBT), has suddenly risen 20-fold, sparking concerns over whether it is being used appropriately and how it is being marketed.

The sudden increase in EBT for nonmelanoma skin cancer was highlighted in a viewpoint published in JAMA Dermatology.

The authors were concerned that the excessive use of EBT might be predicated not on its application to the management of appropriate patients but on "the EBT marketing materials directed toward patients that show photographs of younger adults and emphasize 'painless treatment' with good cosmesis for patients 'with busy schedules' who 'are not interested in having surgery.' "

Corresponding author Jack Resneck Jr, MD, professor and vice-chair of dermatology at the University of California, San Francisco, School of Medicine, told Medscape Medical News: "Patients in my own practice were coming in for second opinions for treatment of their skin cancers. Many of them were quite young (in their 30s, 40s, and 50s) and were being offered EBT as first-line treatment for their skin cancers by one of the small number of practices who had acquired one of these devices.

"Subsequently, my colleagues and I began to receive marketing materials and emails from the device manufacturers trying to sell one these devices, which I found extremely concerning," Dr Resneck told Medscape Medical News. "These materials were suggesting the use of inappropriate billing codes, encouraging fee splitting between dermatologists and radiation oncologists, and focused more on the 'attractive economic profile' of the devices than on quality of care," he added.

Following the publication of the viewpoint, several members of the American Society for Radiation Oncology (ASTRO) endorsed this concern in a letter to JAMA Dermatology. The authors were Bruce G. Haffty, MD, from the Department of Radiation Oncology, Rutgers Cancer Institute of New Jersey, in New Brunswick; David C. Beyer, MD, from the Arizona Oncology Services Physicians, in Phoenix; and Brian D. Kavanagh, MD, MPH, from the Department of Radiation Oncology, University of Colorado School of Medicine, Denver.

"The recent sharp increase in use of EBT for patients with nonmelanoma skin cancer and the possible abuse of the physician self-referral law are indeed troubling developments," the ASTRO members write in their letter. They also say that the situation "is reminiscent of the alarming reports by the Government Accountability Office and Mitchell regarding overutilization of intensity-modulated radiation therapy for prostate cancer," which was reported in detail by Medscape Medical News.

Evidence for EBT From Medicare Claims

In their viewpoint article, Dr Resneck and colleagues examined Medicare claims data to determine the use of EBT codes for skin cancer despite lack of long-term efficacy and safety data.

For the current procedural terminology (CPT) code 0182T, the primary code for high-dose EBT, the authors indicated that there was a 20-fold increase in Medicare claims for all diagnoses in 2 years — from 1214 in 2011 to 24,325 in 2013.

The CPT 0182T code, the primary code for high-dose EBT, is billed per fraction, with patients requiring 8 fractions delivered on eight visits over 4 weeks.

Although the CPT 0182T code is used for breast, gynecologic, and other cancers treated with EBT, a random analysis of 6% of claims in 2012 showed that 98% were billed for the diagnosis of nonmelanoma skin cancer.

In addition, in 2013, 99% of the claims listed physicians' offices as sites of service; 86% were paid to radiation oncologists, and 13% to dermatologists

"These findings show that use of EBT for skin cancer in the Medicare population is increasing rapidly," Dr Resneck and colleagues write.

"These data only cover the period through 2013, but sales of the most common EBT skin devices accelerated in 2013 and early 2014, and the top device maker has succeeded in winning Medicare coverage in more regions, so we expect a further increase in use to be revealed when 2014 data become available," they add.

Inappropriate Use, Marketing Concerns Raised

Although Dr Resneck and colleagues welcome the adoption of new and safer treatment options, they believe that the time is not right for widespread adoption of EBT for nonmelanoma skin cancer.

“[B]ecause of the paucity of safety and efficacy data on skin EBT with long enough follow-up to cover the period during which recurrences and radiation sequelae would be expected, we believe that it is premature to consider widespread adoption especially when several highly effective, safe, and lower cost treatments already exist for almost all tumors," they write.

With respect to long-term safety and efficacy data, Dr Resneck and colleagues write: "Among the published, peer-reviewed studies of EBT touting high cure rates, 1 included 44 skin cancers with only 4.1 median months of follow-up, and another included 171 cancers with a mean follow-up of just 10 months. In light of the fact that a large prospective study showed that basal cell carcinoma and cutaneous squamous cell carcinoma recurrences typically occur 4 years after traditional treatments, these follow-up periods are insufficient."

"Moreover, secondary cancers from traditional radiotherapy have a latency of onset of 10 years or greater after initial treatment," they add.

When asked why they looked into Medicare claims (which cover patients aged 65 years and older) and whether such practice may be prevalent in younger patients, Dr Resneck told Medscape Medical News: "We looked at Medicare claims first because they are publicly available and are released quickly, and they are one measure of rapid changes in the use of these devices for skin cancer."

"Private insurance claims are more difficult to obtain, but it would be very interesting to eventually see those numbers as well," he added.

Dr Resneck also indicated that on the basis of the patients he has seen in his own practice who have come to him for second opinions, and on what he has heard from practicing physicians and from insurance companies, this therapy is increasingly being used on younger patients.

"This is extremely concerning given the lack of long-term data. However, we do not yet have national data since treatment of younger patients is often billed to a variety of private insurers," he told Medscape Medical News.

Dr Resneck also indicated that subsequent to the publication of their viewpoint article in JAMA Dermatology, a clinical EBT study has been published online. This study involved 127 patients with 154 nonmelanoma skin lesions, of which 149 were basal cell carcinoma (BCC) lesions. The median follow-up period was 16.1 months — far less than is necessary to observe risk for recurrences, radiation adverse effects, and new tumors from radiation, he indicated.

Moreover, he pointed to a published case study concerning a male patient in his 60s who experienced recurrence 10 months after using EBT for a BCC near the eye. In addition to the recurrence of BCC, the patient experienced ocular adverse effects, Dr Resneck pointed out.

Indeed, Dr Resneck indicated that marketing material by manufacturers of these devices may have promoted the inappropriate use of EBT. He forwarded some of these marketing materials to Medscape Medical News, including the following:

  • A physician brochure from Esteya that discusses an "attractive economic profile" that "grows patient referrals"

  • A patient brochure from Xoft/iCAD that discusses the ideal candidates as patients who "are not interested in having surgery...with busy schedules"

  • A physician brochure from Xoft/iCAD that refers to "growing your practice"

  • A spreadsheet that shows how lucrative their treatment device can be ($24,583 for one course of treatment) and lists the CPT codes they suggest using, several of which refer to more complex procedures than anything that a physician does with their device in treating skin cancer

Physician and patient brochures (copyrighted in 2014) that iCAD Inc, a manufacturer of one such device, shared with Medscape Medical News provide similar information about patients seeking EBT who are not interested in having surgery, patients with busy schedules, and physicians growing their practice. The materials that Dr Resneck shared were copyrighted in 2013.

"Materials provided by these companies suggest the use of 12 unique CPT codes for a course of therapy for a single lesion, resulting in projected collections of more than $24,000 for treatment of 1 Medicare patient in an outpatient office with facility fees, or $16 000 in professional fees alone. These payments are several-fold higher than those for typical treatments," Dr Resneck and colleagues pointed out in their viewpoint article.

CPT code 0182T reimburses at an extraordinarily high rate, which has drawn a substantial amount of attention, according to Christopher B. Zachary, MBBS, FRCP, from the Department of Dermatology, University of California, Irvine, who authored a guest editorial in Cutis.

"Many jurisdictions limit who can administer EBT, so marketing outreach from the companies suggests contracting with a radiation oncologist to deliver therapy in dermatologist offices. The 2 physicians then share revenue on the basis of in-office ancillary services exceptions to the Stark law, which otherwise limits self referral," Dr Resneck and colleagues write.

Response From iCAD Inc

Medscape Medical News contacted iCAD Inc for a response on marketing practices, including coding. John A. DeLucia, vice president of regulatory affairs, clinical affairs, and quality assurance at iCAD Inc and Xoft Inc, provided an extensive written response.

With respect to targeting patients for EBT, DeLucia wrote: "Xoft acknowledges that the primary treatment option for BCC and SCC [squamous cell carcinoma] is Mohs surgery; however, there are segments of the NMSC [nonmelanoma skin cancer] population for whom nonsurgical treatment options could be desirable and advantageous. All of our materials indicate that decisions regarding the most appropriate option must always be made by the treating physicians in consultation with the patient."

In a communication to Medscape Medical News, Ken Ferry, chief executive officer (CEO) of iCAD Inc, referred to "a research analysis recently completed by Xoft regarding HDR electronic brachytherapy showing that the average age of patients treated from 2009-2014 was 74.9 years. We especially note that claims related to the increased use of eBx [EBT] in younger patients do not appear to be supported by available clinical evidence."

Medscape Medical News inquired into the practice of providing physicians with spreadsheets that suggested billing. DuLucia wrote: "Medical device and drug manufactures routinely provide coding information to assist their clients on reimbursements. Without knowing appropriate coding and reimbursement information, providers and health care facilities would not have a means to plan and prepare for new technology." This is a common practice in the radiation oncology industry, he added.

He further wrote: "Information related to coding and reimbursement for electronic brachytherapy procedures is often requested by physicians. CPT codes are established by the American Medical Association, and appropriate coding guidelines are established by regional Medicare providers. In line with industry practice, we provide coding and reimbursement information to customers. In these communications we clearly outline that procedure coding should be based upon medical necessity and the procedures and supplies provided to the patient. We indicate that coding and reimbursement information is provided for informational purposes only and does not ensure coverage of the specific item or service in a given case their practice."

However, Dr Resneck told Medscape Medical News: "Unfortunately, the fact is that the codes suggested on those spreadsheets were entirely inappropriate.

"In fact, one of the brochures promotes a typical procedure time for skin EBT of 6 minutes with only 15 minutes of setup, so suggesting use of all of the other codes describing complex brachytherapy work related to breast tumors raises significant concerns," he added.

Recent Thinking at iCAD Inc

In a September 30 press release, iCAD Inc announced a multiplatform educational campaign "to raise the awareness of a range of topics associated with the use of electronic brachytherapy" in nonmelanoma skin cancer.

"In recent months there has been a strong focus on the use of eBx [EBT] for the treatment of NMSC in the media; however, some of the information presented has been inaccurate or confusing for both clinicians and patients," said Ken Ferry, CEO of iCAD, in the same press release.

In response to a request for details on the education campaign, DeLucia wrote to Medscape Medical News: "Our program to help clinicians understand the effectiveness of eBx will include a range of communications from Xoft that highlight key issues related to the research supporting the use of eBx for patients meeting specific selection criteria.

"This program will include a series of clinical updates for both dermatologists and radiation oncologists (including both users and nonusers of eBx), information available through Xoft at upcoming medical meetings, and information available through the Xoft website and through medical trade media platforms," he added.

Appropriate Patient for EBT

In his Cutis editorial, Dr Zachary discusses what he considers to be appropriate indications for EBT.

"Speaking as a Mohs surgeon, the majority of patients with skin cancers can be quite easily treated by modalities that are less costly than either EBT (or Mohs) surgery. However, regarding this discussion, EBT is an important treatment option for select patients," he writes.

With respect to appropriate patients for EBT, Dr Zachary indicates that radiation oncologists are inclined to use EBT for patients with stage T1 or T2 skin cancers that are 4 cm or smaller in diameter and 5 mm or less in depth. Others who may be candidates for EBT include those with lesions in cosmetically challenging areas (eg, ears, nose), those who have problems with wound healing because of tumor location or medical conditions, those with medical comorbidities that preclude surgery, and those who are not interested in surgery.

iCAD Inc agrees and adds that it may also be preferable in other patients. A white paper from iCAD Inc, which the company shared with Medscape Medical News, says: "[EBT] may also be preferable in elderly patients with health issues such as peripheral vascular disease, diabetes mellitus or those on anticoagulants, in which case anesthesia and surgery may be contraindicated."

It goes on to add: "For patients with dementia, psychiatric illness, anxiety disorders and for those with personal objections that may interfere with prolonged in-office surgical procedures, HDR electronic brachytherapy [EBT] can be performed as primary radiation therapy or can be used as an adjunct to surgery for higher risk lesions, including features such as positive margins or perineural invasion."

With regard to the elderly, Dr Zachary said: "Those senior individuals who are sick and tired of being cut on after decades of surgery might not be interested in further surgery,” and he noted that these patients might also be appropriate candidates for EBT. For Dr Zachary, the appropriate use of such a controversial therapy is permissible in patients in their 70s and 80s — and he has a plethora of such patients — who have given up on surgery in preference for a painless treatment with EBT.

Dr Resneck told Medscape Medical News: "While there indeed may be a subset of elderly patients for whom EBT will be appropriate once we see more long-term data, the recurrences and secondary malignancies caused by skin radiation typically occur 10 years after therapy, and there are plenty of Medicare patients in their 60s and 70s who will certainly live long enough to have those complications ― and we don't have anything close to 10-year data on these devices yet."

The Future of EBT and EBT Coding

Acknowledging the criticism of a lack of long-term data for EBT use in nonmelanoma skin cancer, Dr Zachary indicated that in the spring of 2016, he will be leading a 5-year, multicenter, prospective, randomized study in 720 patients with BCC and squamous cell carcinoma in which EBT will be compared with Mohs micrographic surgery.

However, he told Medscape Medical News that the study may be in jeopardy because Noridian, one of the Medicare contractors, has cut reimbursement drastically for treatment with the CPT 0182T code. This decision has induced most EBT providers to halt offering this modality of treatment, he said.

Dr Resneck indicated that Noridian stepped in to try to deal with the misuse of CPT codes that were not designed for the treatment of skin cancer.

"Their policy clarified that the high-dose rate brachytherapy code 0182T was priced based on more complex treatment of breast cancer and is not appropriate for treating nonmelanoma skin cancers," Dr Resneck told Medscape Medical News.

“They also clarified that many of the radiation planning, dosimetry, simulation, and other codes being billed, described in the viewpoint article, along with 0182T for skin cancers also were not appropriate for skin cancers," he added.

"Noridian is still reimbursing for skin cancer EBT but is no longer allowing use of the inappropriate codes that were generating payments of $20,000 or more," Dr Resneck told Medscape Medical News.

"The device maker, the government, and other funders also have the opportunity to fund studies to look at long-term efficacy and safety of these devices," he added.

"The appropriate solution is probably to have new CPT codes that will be valued appropriately for skin brachytherapy," Dr Resneck said. In this regard, Dr Zachary and Dr Resneck are on the same page.

Dr Zachary indicated that the American Medical Association has developed new category III CPT codes for the treatment of skin cancer that will be effective January 2016.

"These codes take into consideration the need for a radiation oncologist and a physicist to be present for planning, dosimetry, simulation, and selection of parameters for the appropriate depth," he writes in his editorial.

Neither Dr Zachary nor Dr Resneck know what the reimbursement rates will be for these new codes. They are likely to be substantially less than the current payment for treatment with EBX, Dr Zachary indicated.

In an August 3 webcast, iCAD acknowledged that the uncertainty surrounding the Noridian action, along with the pending transition to a new code, negatively affected its business in the second quarter — "both from a subscription and a new product placement perspective."

In the same webcast, iCAD Inc indicated its intention to communicate with all eight Medicare contractors and to provide them with the clinical data that support EBT for the treatment of nonmelanoma skin cancer and the costs associated with delivering the therapy.

iCAD Inc indicated that the transition to a dedicated code for using EBT in nonmelanoma skin cancer should stabilize reimbursement and "potentially be a catalyst for additional regional Medicare contractors to provide coverage and payment for the procedure in 2016."

Dr Zachary compared the overutilization of EBT for patients with nonmelanoma skin cancer with that of Mohs micrographic surgery. When Mohs micrographic surgery was overused, it led to efforts by dermatologic surgery organizations to agree on the so-called appropriate use criteria (AUC), he told Medscape Medical News. A similar set of AUCs should be prepared for EBT in skin cancer.

Dr Resneck pointed out that the American Academy of Dermatology (AAD) has done a strong job of evaluating the evidence and issuing an honest and balanced statement about these devices.

"The AAD statement identifies the need for further research and specifically calls out the importance of proper CPT coding verified by an authoritative entity other than the device manufacturer, raises concerns about the marketing of these devices, and cautions members to be mindful of Stark laws and federal antikickback statues," Dr Resneck told Medscape Medical News.

Medscape Medical News provided iCAD Inc with a preview of this story. "We are concerned that the article as written presents opinions from select industry contacts that often appear as a sweeping indictment of the community of dermatologists and radiation oncologists involved in the treatment of skin cancer with eBx [EBT], including unsubstantiated claims of widespread unethical and potentially illegal behavior," iCAD Inc CEO Ferry wrote in an email.

 
To be clear, this is a small number of dermatologists and radiation oncologists at the present time, but the number of procedures being done by that small cadre is growing rapidly. Dr Jack Resneck Jr
 

Dr Resneck emphasizes that the concerns he and his colleagues have raised over the use of EBR involve only a minority of clinicians. "The vast majority of dermatologists are not using and are not exploring using these devices. To be clear, this is a small number of dermatologists and radiation oncologists at the present time, but the number of procedures being done by that small cadre is growing rapidly," he added.

What will convince Dr Resneck on the use of EBT for nonmelanoma skin cancer? "I think that it is reasonable to expect to have valid evidence from well-done clinical trials of long-term efficacy and safety before expanding use of a new drug or technology and to avoid widespread and exponentially increased use in patients until those studies are completed ― especially since we have highly safe and effective existing therapies," he told Medscape Medical News.

"It's entirely appropriate to study this new technology for skin cancer with informed consent by patients, and I applaud physicians who are doing those studies on limited patient populations with informed patient consent to generate the needed data," he added.

Dr Resneck reports serving on the board of directors of the American Academy of Dermatology and on the board of trustees of the American Medical Association. Dr Zachary is a principal investigator for a planned 720-patient, prospective, randomized, multicenter study comparing EBT with Mohs micrographic surgery that is sponsored by iCAD Inc.

JAMA Dermatol. 2015;151:699-700. Abstract

Cutis. 2015;96:153-154. Editorial

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