Pacific Edge Limited (NZX: PEB), has been notified by Novitas¹ that the LCD: Biomarkers for Oncology (L35396) provides coverage for Cxbladder, CPT codes 0012M (Cxbladder Detect) and 0013M (Cxbladder Monitor), for tests performed on or after July 1, 2020 that are medically necessary.

This includes reimbursement for all Cxbladder tests performed for patients covered by the Centers for Medicare and Medicaid Services (CMS) across the USA, at the already determined national CMS price for Cxbladder of US$760 per test. The CMS provides healthcare coverage for all US citizens over 65 years, as well as assistance for healthcare coverage to people with low incomes.  CMS tests currently make up approximately 40% of Pacific Edge’s current Commercial Tests in the USA. Pacific Edge will also be seeking to negotiate reimbursement for the Cxbladder tests that have previously been completed and invoiced for CMS patients.

CEO of Pacific Edge, David Darling, said: “This is a transformational milestone for Pacific Edge and the result of a number of years of hard work and effort from our teams in New Zealand and the USA. This long awaited outcome results from the generation of substantial clinical evidence, publication of numerous clinical papers demonstrating the compelling clinical utility and outperformance of Cxbladder, and growing commercial use of our tests by urologists in the USA and other markets.

“Coverage under the LCD for our two Cxbladder tests with CPT codes² will unlock access to the CMS revenue which currently represents approximately 40% of Pacific Edge’s commercial sales in the US. The coverage decision is also expected to positively impact on demand and positive reimbursement decisions from other healthcare organisations and payers as well. It signals a new phase in Pacific Edge’s commercial journey and we will be pushing hard on the back of this announcement to gain adoption of Cxbladder by other large scale healthcare organisations.”

The LCD coverage notification comes hot on the heels of the signing of a commercial agreement with Kaiser Permanente, one of the largest non-profit healthcare providers in the USA, which was announced by Pacific Edge on 17 June 2020. Kaiser Permanente is one of the largest non-profit healthcare providers in the US, with over 12 million members and annual operating revenue of $84.5b³. It operates 39 hospitals, 714 medical offices and employs approximately 23,000 physicians.

Cxbladder is already in commercial use by the majority of the public healthcare providers in New Zealand and many have adopted it into their guidelines for both the evaluation of haematuria and in the monitoring for recurrence of urothelial cancer.

Chair of Pacific Edge, Chris Gallaher, said: “The LCD coverage signals a major step change for our company with the successful completion of the major reimbursement milestones in the USA. For a company from New Zealand, this is a huge  achievement and one of which we are very proud. On behalf of the Board, I would like to thank our team who have worked tirelessly to make this happen and shareholders for their patience and support as we have worked to commercialise our Cxbladder technology.”

References

1. NOVITAS is the CMS’s Medicare Administrative Contractor (MAC) for Pacific Edge’s USA commercial reimbursement for CMS patients. MACs regionally manage policy and payment related to reimbursement and act as the fiscal intermediary for Medicare. MACs manage provider claims for payment and establish regional policy guidelines, called Local Coverage Determinations (LCDs).

2. Administrative MAAA CPT Codes are issued by the American Medical Association (AMA) Current Procedural Terminology (CPT®) Editorial Panel  and are a key component of the reimbursement process in the USA.

3. Kaiser Permanente Fast Facts https://about.kaiserpermanente.org/who-we-are/fast-facts