DERMATOETHICS

CONSULTATION

The ethical implications of ‘‘more than one way to skin a cat’’ Increasing use of radiation therapy to treat nonmelanoma skin cancers by dermatologists Jane M. Grant-Kels, MD,a and Marta J. VanBeek, MD, MPHb Farmington, Connecticut, and Iowa City, Iowa

CASE SCENARIO Dr Will B. Rich (Dr R) runs a successful dermatology practice but is intrigued by the possibility of increasing his profits in an environment of declining reimbursements. A representative from a company visits his office and introduces him to a novel way to treat skin cancer with a relatively new Food and Drug Administration (FDA)-approved radiation device. The company representative advises Dr R that this technology will allow him to retain patients rather than refer them to a Mohs surgeon for the treatment of nonmelanoma skin cancers (NMSCs). The actual treatment will be performed by a radiation oncologist whose fee is much less than the code the company suggests Dr R use for reimbursement. Dr R realizes that this procedure has the potential to significantly diversify his practice and to allow him to capture revenue he has been losing by referring patients for Mohs micrographic surgery. Dr R should: A. Arrange for the technology to be purchased immediately so that he can treat NMSCs with this technique in his own office rather than excising the lesions or referring the affected patients to a Mohs surgeon. B. Do more research about the technology to better understand when it should be used therapeutically and contact a billing specialist to see which codes are most appropriate. C. Check whether it could be construed as a violation of the Stark law to self-refer by hiring a radiation oncologist to deliver care to his patients in his office and for him to profit from the efforts of another provider. D. Continue to refer recurrent and facial skin cancers to his preferred Mohs surgeons unless there are circumstances that demand alternative therapies (eg, patient comorbidities and age rendering surgery less desirable) at which time Dr R will either send the patients to a local, well-respected radiation oncologist or perform this procedure in his office. E. All the above except A.

DISCUSSION There are numerous ethical and appropriate ways for a dermatologist to successfully treat NMSC, or as Mark Twain wrote in A Connecticut Yankee in King

From the Departments of Dermatology at University of Connecticut Health Centera and University of Iowa Carver College of Medicine.b Funding sources: None. Conflicts of interest: None declared. The opinions expressed are the personal opinions of the authors and do not necessarily reflect the opinion of the American Academy of Dermatology, University of Connecticut Health Center, or University of Iowa Carver College of Medicine.

Arthur’s Court in 1889: ‘‘(S)he was wise, subtle, and knew more than one way to skin a cat.’’1 Recent review articles have outlined the pros and cons of the various therapeutic options available to treat NMSC.2

Correspondence to: Jane M. Grant-Kels, MD, Department of Dermatology, University of Connecticut Health Center, 21 South Rd, Farmington, CT 06032. E-mail: [email protected]. J Am Acad Dermatol 2014;70:945-7. 0190-9622/$36.00 Ó 2014 by the American Academy of Dermatology, Inc. http://dx.doi.org/10.1016/j.jaad.2014.01.849

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Abbreviations used: CPT: eBT: FDA: NMSC: SRT:

Current Procedural Terminology electronic surface brachytherapy Food and Drug Administration nonmelanoma skin cancer superficial radiation therapy

The type of NMSC, histologic morphology (ie, infiltrative), lesion location, patient age, and comorbidities are all considered when selecting the ideal therapy for a NMSC lesion for a particular patient. Superficial radiation therapy (SRT) has long been a part of the dermatologist’s armamentarium but historically has been reserved for second-line therapy in: (1) patients who cannot tolerate surgery; (2) tumors located in a site not amenable to surgery; or (3) patients who are averse to traditional therapy.3 Radiation therapy has also been used as adjuvant therapy for high-risk lesions after the completion of surgery. Recently, however, SRT and electronic surface brachytherapy (eBT) devices are being marketed to dermatologists as a way to enhance their office technology and ‘‘diversify’’ their revenue stream. eBT devices became FDA approved in 2009. These devices deliver high dose rates with low-energy radiation using a computerized controller and a surface applicator. The high dose rate allows for fewer treatment sessions, making this treatment more convenient for patients over conventional radiotherapy. Because eBT does not use radioactive isotopes, it can be administered in a minimally shielded setting.4 Administration of eBT should be conducted by a radiation oncologist, per the manufacturer’s recommendations.5 SRT differs from eBT in that it delivers low-energy photon x-rays. With recent SRT devices, doses are calculated by the device and the technology can be administered by a dermatologist, depending on state scope of practice regulations. Although both technologies (SRT and eBT) have proved efficacious for many malignancies, published literature on longterm cure rates ($ 5 years) for NMSC with these new technologies is lacking. Therefore, at this time, neither can be considered the standard treatment or first line for most skin cancers. The long-term consequences of these new technologies are still unknown and the long-term complications of using these devices on the face of a young or middle-aged patient who is an otherwise good candidate for alternative therapies needs to be elucidated. Certainly, there is a therapeutic niche for these devices, for select patients and specific clinical circumstances when surgical intervention is

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contraindicated. Nonetheless, some dermatologists have adopted this new therapeutic modality to distinguish their practice from other dermatologic practices in the community and possibly to develop a new source of revenue. According to a recent article in the New England Journal of Medicine,6 use of the Current Procedural Terminology (CPT ) codes associated with both SRT and eBT have increased dramatically since 2005. Not surprisingly, the rapid increase in use has caught the attention of those who evaluate the value of CPT codes. Even more concerning, the manufacturers of some of these devices are advising practitioners to bill these technologies with incorrect codes that do not accurately reflect the work required for treatment of NMSC. In the case of SRT, this has resulted in a dramatic increase in the radiation therapy code CPT 77402 (relative value units = 4.56). More specifically, the use of CPT code 77402 has jumped from 1112 in 2008 to 15,029 in 2011 and most notably, is now being used by dermatologists 47.12% of the time. Coding experts suggest that radiation therapy code 77401 CPT (relative value units = 0.61) more accurately reflects the work required to treat NMSC and therefore should be used when coding for SRT, instead of 77402.7 The Stark law8 prohibits physicians from referring Medicare or Medicaid patients for certain health services to any entity with which the practitioner has a financial arrangement, although certain exceptions apply. Currently radiotherapy remains an exception to the Stark law and is legal. However, the overall patterns of self-referral for SRT and eBT have caught the attention of Centers for Medicare and Medicaid Services and the US Government Accountability Office and therefore a practitioner must be cautious not to flagrantly overuse this technology especially if not medically appropriate. In an analogous scenario, the use of intensitymodulated radiation therapy for prostate cancer by selfereferring urologists in private practice has increased by 19.2% (from 13.1%-32.3%) while the rate of this therapy has remained stable by urologists working at National Comprehensive Cancer Center Network Centers at 8.0%.6 Under the anti-kickback statute,9 it is essentially illegal for physicians to offer or provide anything of value as an inducement to refer business covered by federal health care programs. In the scenario of our case, in which there is an obvious selfereferral within the same practice and the referring dermatologist makes a personal profit secondary to that referral, one should be concerned that this will likely

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attract attention of federal agencies including the Centers for Medicare and Medicaid Services. Such practice arrangements with SRT or eBT may receive scrutiny similar to the recent US

ANALYSIS OF CASE SCENARIO The only correct ethical answer to this case scenario is E. Until peer-reviewed, controlled studies suggest that a new therapeutic technique is better in efficacy, safety, and tolerability than the techniques that are considered standard of care, we should not yet embrace the new treatment as our first-line therapy. Brachytherapy holds a lot of promise for NMSCs that are not amenable to surgery and has the added benefit of not requiring many treatment sessions. SRT also holds promise for benefit in a select population of patients with the potential for excellent

BOTTOM LINE Although there may be more than one way to skin a cat, we are ethically mandated to honor the Hippocratic Oath that many traditionally recite upon graduation from medical school. The most efficacious, safest, and reliable treatment should be chosen for our patients over any financial consideration to the dermatologist. Radiation therapy has historically been an important therapeutic arrow in our quiver. Nonetheless, currently this is not the recommended first-line therapy for a majority of our patients. Beneficence (patient’s best interests come first) and nonmaleficence (do no harm) are 2 major cores of ethical behavior11 in the practice of medicine and both are at risk in the case scenario presented if the dermatologist chooses profits over judicious patient care. The ethical argument demonstrated by this case is that choosing therapy on the basis of how lucrative it is to the treating physician or allowing such factors to influence medical decision-making clearly is not in the patient’s best interest, and in fact violates the physician’s fiduciary obligations to the patient.

REFERENCES 1. Twain M. A Connecticut Yankee in King Arthur’s Court. New York: Harpers and Brothers Publishers; 1889. p. 65.

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Government Accountability Office study that demonstrated that dermatologists who incorporated a dermatopathology laboratory into their practice (so-called switchers) performed more biopsies.10

cosmetic outcomes. However, a specific therapy should not be selected because it will allow one to bill for procedures rather than referring the patient to a subspecialist. As physicians, we must always practice with the best interest of the patient as our primary motivation. If we choose the incorrect code to enhance the amount we are reimbursed, and/or if we hire another physician as a radiation oncologist to work in our practice, self-refer, and then pay that specialist less than what we are collecting for that service, we may very well be abrogating the bounds of ethical, moral, and legal conduct.

2. National Comprehensive Cancer Network. Practice guidelines in oncology: basal cell and squamous cell skin cancers. Version 2.2012. Available from: URL:http://www.nccn.org/ professionals/physician_gls/PDF/nmsc.pdf. Accessed January 29, 2014. 3. Cognetta AB, Howard BM, Heaton HP, Stoddard ER, Hong HG, Green WH. Superficial x-ray in the treatment of basal and squamous cell carcinomas: a viable option in select patients. J Am Acad Dermatol 2012;67:1235-41. 4. Bhatnagar A, Loper A. The initial experience of electronic brachytherapy for the treatment of non-melanoma skin cancer. Radiat Oncol 2010;5:87. 5. Bhatnagar A. Nonmelanoma skin cancer treated with electronic brachytherapy: results at 1 year. Brachytherapy 2013;12: 134-40. 6. Mitchell JM. Urologists’ use of intensity-modulated radiation therapy for prostate cancer. N Engl J Med 2013;369:1629-37. 7. RBRVS Data Manager 2013 on CD-ROM: 1 User [CD-ROM]. Chicago (IL): American Medical Association. 8. Stark Act 2005 CFR Title 42, Volume 2, x 411.350. Available from: URL:http://www.access.gpo.gov/nara/cfr/waisidx_05/ 42cfr411_05.html. Accessed January 29, 2014. 9. Anti-kickback statute safe harbors, 42 CFR sec 1001.952. URL:http://law.justia.com/cfr/title42/42-3.0.2.8.2.3.224.10.html. Accessed January 29, 2014. 10. US Government Accountability Office Report to Congressional Requesters. GAO-13-445 Medicare self-referral of anatomic pathology services. Available from: URL:http://www.gao.gov/ assets/660/655442.pdf. Accessed January 29, 2014. 11. Jonsen AR. Do no harm. In: Beauchamp T, Childress J, editors. Principles of biomedical ethics. Oxford: Oxford University Press; 1989.

The ethical implications of "more than one way to skin a cat": increasing use of radiation therapy to treat nonmelanoma skin cancers by dermatologists.

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