Xoft Response to AAD Position Statement Regarding Superficial Radiation Therapy & Electronic Surface Brachytherapy
On November 9, 2013 the Board of Directors of the American Academy of Dermatology approved a position statement regarding the use of superficial radiation therapy (SRT) and electronic surface brachytherapy (eBx) for the treatment of basal cell (BCC) and squamous cell (SCC) carcinomas. The statement reiterated the Academy’s belief that surgical treatment remains the primary intervention for treating BSC and SCC and that further clinical research is necessary before the AAD will fully accept radiation therapy alternatives as effective treatment options. In addition, the AAD cautioned that electronic brachytherapy should not be administered by dermatologists, nor should it be used as the basis for a business model designed solely for practice financial gain.
As the industry-leader in electronic brachytherapy, Xoft would like to address each of the AAD’s concerns as follows:
• Xoft works with both dermatologists and radiation oncologists to ensure that the Xoft technology is implemented as designed, using sound clinical judgment. At no time has Xoft indicated that the system can be used without a radiation oncologist prescribing the appropriate dose and treatment regimen. Xoft has always expected that the radiation oncologist will collaborate with other specialties in every clinical application of our system. Close collaboration between radiation oncologists and the appropriate specialist ensures proper patient selection, as well as accurate treatment planning and delivery. Any dermatologist interested in providing eBx as a treatment option to his or her patients should have appropriate radiation oncology supervision. In addition, providers and their strategic partners should review and comply with all federal, state and local laws applicable to arrangements for the administration of radiation therapy, including applicable federal and state fraud and abuse laws such as the Stark Law and the federal Anti-Kickback Statute.
• Xoft acknowledges that while the primary treatment option for BCC and SCC is surgery, there are segments of the non-melanoma skin cancer (NMSC) population for whom non-surgical treatment options could be desirable and advantageous. NMSC is considered an epidemic with over 3.6 million cases diagnosed annually. Of those cases, approximately 20-30% have specific diagnoses and lesion criteria that make them potential candidates for electronic brachytherapy. The Xoft System is a viable alternative treatment option for patients with lesions staged as T1 & T2, ≤4 cm in diameter and ≤5 mm in depth. In addition, ideal candidates for non-surgical treatment options such as electronic brachytherapy include patients with lesions in cosmetically challenging locations (ear, nose, scalp, neck), or those with locations and/or medical conditions that experience difficulties in wound healing (lower extremities, diabetes, peripheral vascular disease), patients with medical comorbidities that may preclude them from surgery, patients on anticoagulants or with pacemakers, and patients who are not interested in pursuing surgery . The decision regarding the most appropriate option must always be made by the treating physicians in close consultation with the patient. To date, the Xoft System has been used to treat over 3,000 NMSC patients.
• The Xoft System is the only electronic brachytherapy system with peer reviewed published scientific data in non-melanoma skin cancer. Since July of 2009, Dr. Ajay Bhatnagar, Radiation Oncologist at Cancer Treatment Services Arizona in Casa Grande, Arizona and a medical consultant to iCAD/Xoft, has been conducting a clinical study on NMSC patients treated with the Xoft System: “Nonmelanoma Skin Cancer Treated with Electronic Brachytherapy: Results at 1 Year” was published in Brachytherapy 12 (2013) reporting no recurrences with mean follow up of 10 months. The study included 122 subjects with 171 lesions treated. At ASTRO 2013, Dr. Bhatnagar presented follow up data on this study: “Electronic Brachytherapy for the Treatment of Nonmelanoma Skin Cancer: Results at 3 Years.” This update included 187 subjects with 275 lesions treated. At mean follow up of 11.3 months, Dr. Bhatnagar reported excellent (93%) cosmesis up to 3-years post-treatment, low toxicity, and no recurrences.
• Xoft strongly believes that the primary driver for implementing a skin eBx program should be improved patient care. The availability of innovative skin cancer treatment options enables clinicians to provide their patients with access to an increasingly wider range of alternatives. Xoft believes that physicians in consultation with their patients are best suited to determine the most appropriate specific treatment option.
• Procedure coding should be based on medical necessity and procedures and supplies provided to the patient. All procedures should have a written order and appropriate clinical documentation to support medical necessity. Clinicians should contact their local Medicare Fiscal Intermediary, Carrier, Medicare Administrative Contractor, or CMS for specific information as coverage and payment rates are subject to change and vary by payer and region. Clinicians should be aware of quarterly correct coding initiative (CCI) edits. To the extent that cost information is submitted to Medicare, Medicaid or any other reimbursement program to support claims for services or items, clinicians are obligated to accurately report the actual price paid for such items, including any discounts or subsequent adjustments. Xoft makes no guarantee of coverage, or reimbursement of fees.
It is important to note that while the AAD addresses both SRT and eBx as radiation treatment options for skin cancer in the position statement, there are several important differences between the two technologies. The Xoft eBx System has a low energy (50kV) source and rapid dose fall-off which results in less radiation exposure to underlying tissue, nerves, blood vessels, fat, and adventitia. This also allows Xoft eBx to be used in a minimally shielded environment. Electronic brachytherapy can be administered in fewer fractions than SRT (typically 8 vs. 20) thereby reducing radiation exposure and impact on patient quality of life. SRT and eBx also differ from a reimbursement perspective in that each technology has a specified billing code with distinct rates of reimbursement.
It is Xoft’s position that electronic brachytherapy is, and will continue to be, a viable treatment alternative for certain NMSC patients. As a company, Xoft remains committed to partnering with clinicians to offer their patients successful treatment alternatives that provide the highest standard of care.
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