Biofrontera AG

CMS issues new reimbursement codes for Ameluz® and for Photodynamic Therapy

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Leverkusen (pta012/10.11.2017/09:15) - Product-specific J-Code to improve reimbursement coding for prescribing physicians

- New CPT® Codes establish favorable reimbursement for Photodynamic Therapy

Biofrontera AG (ISIN: DE0006046113), the specialist for the treatment of sun-induced skin cancer, today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) have assigned a unique, product-specific billing code, or J-Code (J7345), for Biofrontera's lead product Ameluz® for the photodynamic therapy (PDT) of actinic keratosis, a skin cancer precursor. The J-code, which will become effective on January 2, 2018, provides reimbursement coding clarity for physicians prescribing Ameluz® in the United States. Ameluz® is classified by CMS as buy-and-bill drug, such that reimbursement through CMS requires prior purchase of the drug by the doctor's office. This forces the office to initially accept the cost, and missing security in reimbursement poses a major problem on the distribution of such a drug. Issuing a specific J-code is therefore elementary for the future commercial success of the drug.

In addition to the assignment of the permanent J-code, CMS announced the revision of current procedural terminology (CPT) codes relating to PDT, of which codes 96567, 96573 and 96574 will be relevant for the treatment of actinic keratoses with PDT. New code 96574 provides the highest remuneration for PDT application since it includes a provision for the debridement of premalignant hyperkeratotic lesion(s). Ameluz® is the only PDT drug available in the U.S. that includes debridement in the label.

"We are pleased with these decisions from CMS, which we believe will drive greater access and adoption of Ameluz® in the U.S. The permanent J-code significantly simplifies the reimbursement process for dermatologists in the U.S., lowering the barrier to entry," commented Prof. Dr. Hermann Lübbert, CEO of Biofrontera. "Additionally, as a result of the revised CPT codes, we expect dermatologists will be more easily reimbursed by payers in the U.S., providing further support for our customers and allowing more patients to benefit from our superior treatment."