Dignitana (http://www.dignitana.com/), world leader in scalp cooling innovation, announces that the U.S. Centers for Medicare & Medicaid Services (CMS) has reassigned payment for scalp cooling for Medicare claims filed using CPT code 0662T. This treatment has been reassigned to New Technology APC 1520 with a National Average Payment of $1,850.50, effective January 1, 2022.

"This decision ensures that thousands of cancer patients will now have access to life-changing scalp cooling therapy that was previously financially out of reach," said William Cronin, Dignitana CEO. "It is a major milestone for Dignitana and for so many in the cancer treatment community who have worked tirelessly to make scalp cooling standard of care."

"When the American Medical Association announced the CPT codes for scalp cooling last fall, we initiated a plan to do our part to help the oncology community establish appropriate reimbursement. Medicare coverage is critical to our overall reimbursement efforts and will undoubtedly increase utilization with existing customers and drive demand for DigniCap at new facilities," Cronin added.

The CMS announcement comes after the agency previously published a National Coverage Determination (NCD) for Scalp Hypothermia During Chemotherapy to Prevent Hair Loss (scalp cooling) in June 2021 for APC 5732 (Level 2 Minor Procedures) with a proposed payment rate of $34.72. At that time Dignitana filed an appeal with the agency and initiated conversations, in conjunction with Paxman Scalp Coolers, to determine an appropriate payment level for Medicare coverage of scalp cooling.

An Ambulatory Payment Classification (APC) is the US government's method of paying facilities for outpatient services covered by Medicare. The new payment assignment enables facility reimbursement under the Medicare Hospital Outpatient Prospective Payment System (OPPS).

According to CMS (https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/CMS-Fast-Facts) more than 62 million people rely on Medicare for their health insurance coverage. A 2018 study (https://pubmed.ncbi.nlm.nih.gov/29398469/) found that 14.8 percent of all Medicare beneficiaries have a cancer diagnosis. Additionally, in 2013 the American Cancer Society (https://www.fightcancer.org/sites/default/files/2013-Medicare-Chartbook-Online-Version.pdf) found that Medicare beneficiaries over the age of 65 account for 54 percent of all new cancer cases.

FDA cleared in 2015, The DigniCap Scalp Cooling System minimizes hair loss from chemotherapy in patients with solid tumors. In the United States the National Comprehensive Cancer Network® (NCCN) added scalp cooling to their annual guidelines as a Class 2A recommendation for patients with breast cancer in 2019 and ovarian cancer in 2020. These guidelines are widely recognized as the benchmark for oncology treatment coverage and reimbursement by clinicians and payors. DigniCap is available (https://dignicap.com/locations-us-list/) at over 250 locations in the United States.

Resources:

1. CMS Final Ruling Nov 2, 2022  - CMS-1753FC (page 232-233, scalp cooling)  (https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientpps/cms-1753-fc)

2. CMS Press Release Nov 2, 2022 "CMS OPPS/ASC Final Rule Increases Price Transparency, Patient Safety and Access to Quality Care" (https://www.cms.gov/newsroom/press-releases/cms-oppsasc-final-rule-increases-price-transparency-patient-safety-and-access-quality-care)

3. CMS Fact Sheet Nov 2, 2022 - CY 2022 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS-1753FC) (https://www.cms.gov/newsroom/fact-sheets/cy-2022-medicare-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center-0)

This disclosure contains information that Dignitana AB is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 03-11-2021 07:55 CET.