This is the first LCD that has been approved for scalp cooling and is a result of a request made to Palmetto GBA in February 2023 by Dignitana and Paxman. This important Palmetto LCD provides a pathway for successful reimbursement of Medicare scalp cooling claims for patients in the seven-state service area, effective November 12, 2023. Dignitana currently serves 37 locations within the Palmetto GBA jurisdiction.

A MAC is a private healthcare insurer that has been awarded a geographic jurisdiction to process claims for Medicare beneficiaries. The Palmetto GBA services two jurisdictions in the US Medicare system covering seven states in the southern US: Alabama, Georgia, North Carolina, South Carolina, Tennessee, Virginia, and West Virginia.

CMS assigns MACs the task of developing LCDs to describe reasonable and necessary services within the Medicare program. CMS also assigns MACs the task of developing coverage articles that give direction on how to bill or code for a service or to provide education on a specific topic. In the Billing and Coding Guide: Scalp Cooling for the Prevention of Chemotherapy-Induced Alopecia (https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=59371&ver=3&contractorName=2&contractorNumber=all&updatePeriod=1062&sortBy=updated&bc=13), Palmetto GBA reaffirms guidance from CMS, "CMS Internet-Only Manual, Pub. 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 2, §110.6 Scalp Hypothermia During Chemotherapy to Prevent Hair Loss is not a barrier to coverage or to pricing/payment of the Category III Temporary CPT® codes for professional/facility services related to scalp cooling (CPT® Codes 0662T and 0663T)."

This action solidifying localized coverage further advances support for healthcare providers to receive reimbursement from Medicare to administer FDA-cleared scalp cooling therapy, such as The DigniCap Scalp Cooling System. Two separate CPT® Category III Codes for "mechanical scalp cooling," 0662T and 0663T, were issued by the AMA with an effective date of July 1, 2021. The CPT® codes, coupled with coverage determinations such as the approved LCD, will expand patient access to scalp cooling and enable oncology providers to appropriately offer the service and bill for the resources required to administer scalp cooling therapy.

Dignitana will use the approval of this LCD to form the strategy with other MACS around the country.