"The announcement today from the AMA is a significant milestone for the company that we have worked toward for several years. Category I codes are the gold standard in reimbursement and provide a clear pathway to coverage and payment for DigniCap providers. This in turn provides greater financial accessibility for patients, increasing overall utilization of scalp cooling," said Dignitana CEO Fredrik Jonsson.

CPT® (Current Procedural Terminology) Codes are standardized codes, essential within the United States Healthcare system to ensure healthcare providers can track, report, and submit for reimbursement medical procedures and services. CPT® Category I codes are permanent and are assigned a Relative Value Unit (RVU) to provide payment guidance to payers.

In July 2021, the AMA issued two CPT® Category III codes for mechanical scalp cooling (0662T and 0663T). However, Category III codes are temporary and do not have an associated RVU, leading to unpredictable and inconsistent reimbursement.

• Has redefined the clinical work associated with scalp cooling by issuing three separate codes. This identifies three distinct aspects of work done by clinical staff to administer scalp cooling treatment and allows for all three components to receive coverage and establish payment by public and private payers.
• Recognizes mechanical scalp cooling as a service with demonstrated clinical efficacy and widespread use across the United States that is performed by physicians and other qualified healthcare personnel.
• Sends a strong message to payers that there is now a path to consistent and predictable reimbursement and payment for scalp cooling for providers in the community and academic setting.

Buy and bill is the standard reimbursement model in the United States, but fair and reasonable payment requires the correct coding and coverage. Many of the providers who were early adopters of the DigniCap buy and bill model have been successful in receiving reimbursement from Medicare and private insurers. However, reimbursement with current Category III coding is inconsistent and may not sufficiently cover all aspects of administering treatment.

Over the next 12 months the three new CPT® Category I codes will be evaluated by the AMA Relative Value Update Committee (RUC),a multispecialty committee that makes recommendations to the Centers for Medicare & Medicaid Services (CMS) to assign an RVU. RVUs are a key component of physician compensation and a standardized method to measure the value of a medical service that considers the amount of work, resources, and expertise required to provide a service.RVUs are used to calculate Medicare reimbursement for physician services and are also used by private payers to determine physician payment.Once CMS reviews the RUC's recommendations and accepts or modifies them, the RVUs are then incorporated into the annual Medicare Physician Fee Schedule (MPFS). The RVU is multiplied by the annual conversion factor in dollars to determine the national average fee for any given CPT® I codes. Rates are adjusted according to geographic indices based on provider locality. Private insurers typically adopt these relative values and may apply a higher or lower conversion factor. The rates will be published in the MPFS Proposed Rule, which will be released in July 2025 and like the new CPT codes, the new rates will also become effective January 1, 2026.

"Dignitana partnered with Paxman in this effort, and we appreciate their collaboration along with expertise provided by Dr. Steven Isakoff of Massachusetts General Hospital who participated in the most recent Category I application, and Dr. Paula Klein of Mount Sinai Hospital who supported a previous Category I application. Support from medical societies is also vital in the process, and we thank ASCO (American Society of Clinical Oncology), ACOG (American College of Obstetricians and Gynecologists), and AAP (American Academy of Pediatrics) for their active support of our application," said Jonsson.

The FDA-cleared DigniCap Delta device uses industry-leading thermoelectric cooling to minimize hair loss that is a side effect of chemotherapy prescribed to treat solid tumors such as those from breast cancer, ovarian cancer and prostate cancer. Since 2019, scalp cooling has been included as a Category 2A treatment recommendation in the National Comprehensive Cancer Network (https://nccn.org/)® (NCCN) Guidelines and Compendium.