Irvington, NY — MELA Sciences, Inc. (NASDAQ: MELA), announced today that it has taken the first step in the process of seeking insurance reimbursement for its Multi-Spectral Digital Skin Lesion Analysis (MSDSLA) procedure that is performed by dermatologists utilizing the MelaFind system as an aid in the detection of melanoma. The company has submitted an application for a Current Procedural Terminology (CPT) code, which is necessary for Medicare Part B reimbursement by the Centers for Medicare and Medicaid Services (CMS). MSDSLA could be eligible for payment under Part B as early as January 1, 2016. The company will also commence efforts to obtain reimbursement from private insurance companies as the CMS review process proceeds.
CPT codes are determined by the American Medical Association (AMA) under a rigorous review process. Currently, there is no CPT code available for the MelaFind process. The AMA’s CPT Editorial Panel ultimately decides whether to accept a new code, and will refer a new code to the AMA’s Relative Value Scale Update Committee (RUC). The RUC determines the relative value of physician work within the procedure or service and makes a recommendation to CMS. CMS then establishes the appropriate reimbursement level for the service. Obtaining Medicare reimbursement is critical in order to secure reimbursement from other public and private insurers.
Rose Crane, President and CEO of MELA Sciences, commented, "Our CPT application is the first concrete step in achieving our goal of obtaining insurance reimbursement for physician use of the MelaFind system. MelaFind’s ability to improve diagnostic accuracy without increasing the number of biopsies, as demonstrated with the data presented at the 2014 American Dermoscopy Association Meeting is very meaningful to both patients and physicians and ultimately can save costs in the healthcare system. We believe our application makes a compelling argument in favor of receiving the CPT code and for obtaining reimbursement from CMS."
The poster presentation at the meeting measured the impact of the MelaFind information on a dermatologist’s decision to biopsy high risk lesions. The biopsy sensitivity of dermatologists (a measure of the percentage of lesions correctly identified as melanoma) increased from 68% to 89% with the addition of the MelaFind probability information, and specificity (a measure of the percentage of lesions correctly identified as not being melanoma) increased from 39% to 54%. The average percentage of benign lesions selected for biopsy decreased from 61% to 46%. The p-value in all three measurements was statistically significant at p<0.001. There was a non-significant change in the percentage of total lesions selected for biopsy.
About MelaFind www.melafind.com
MelaFind is the first and only medical device with FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union designed to assist dermatologists in the evaluation and diagnosis of melanoma at its most curable stage. The MelaFind system utilizes innovative software driven technology and state-of-the-art 3-D optical imaging to non-invasively extract data 2.5 mm below the skin surface from patient’s pigmented ambiguous moles and objectively analyzes them with proprietary algorithms. MelaFind provides important additional perspective to physicians via 3-D spectral images and 100% objective data analysis to help them better understand the structural disorganization of a patient’s pigmented ambiguous moles (before cutting the skin) during the evaluation and diagnosis process for melanoma.
About MELA Sciences, Inc. www.melasciences.com
MELA Sciences is a medical technology company dedicated to designing and developing innovative software-driven technology for the clinical early detection and prevention of skin cancer. MELA Sciences conducted the largest, positive prospective study ever done on the melanoma disease, and is the first and only medical technology company to receive both FDA Pre-Market Approval (PMA) for the U.S. and CE Marking certification for the European Union for a device of this nature.
Safe Harbor
This press release includes "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995. These statements include but are not limited to our plans, objectives, expectations and intentions and may contain words such as "seeks," "look forward," and "there seems" that suggest future events or trends. These statements, including our expectations regarding our ability to obtain a CPT code and appropriate reimbursement for our MelaFind system, are based on our current expectations and are inherently subject to significant uncertainties and changes in circumstances. Actual results may differ materially from our expectations due to financial, economic, business, competitive, market, regulatory and political factors or conditions affecting the company and the medical device industry in general, as well as more specific risks and uncertainties set forth in the company‘s SEC reports on Forms 10-Q and 10-K. Given such uncertainties, any or all of these forward-looking statements may prove to be incorrect or unreliable. MELA Sciences assumes no duty to update its forward-looking statements and urges investors to carefully review its SEC disclosures available at www.sec.gov and www.melasciences.com.
Media
Diana Garcia Redruello
MELA Sciences, Inc.
212-518-4226
dgarcia@melasciences.com
Investors
Andrew McDonald
LifeSci Advisors, LLC
646-597-6987
Press release via Mela Sciences.
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