Medicare LCD Effective; Pacific Edge Seeks Recoverage

28 April 2025


MEDICARE LCD EFFECTIVE; PACIFIC EDGE SEEKS RECOVERAGE
DUNEDIN, New Zealand – Cancer diagnostics company Pacific Edge (NZX, ASX: PEB) notes
the ‘Genetic Testing in Oncology: Specific Tests’ (L39365) Local Coverage Determination
became effective on 24 April 2025 in the US, halting Medicare coverage of Cxbladder tests.
Pacific Edge filed for a preliminary injunction and undertook political advocacy efforts directed
at the incoming political appointees within CMS
1
, HHS
2
and OGC
3
that included substantial
support from the American Urological Association (AUA). However, on Wednesday 23 April
2025 a Pennsylvania District Court Judge ruled that her court lacks jurisdiction to hear Pacific
Edge’s claim against Medicare Administrative Contractor Novitas and CMS. Meanwhile, the
lobbying efforts have not yielded a change to the effective date or retirement of the LCD.
Pacific Edge, which currently generates ~60% of its US revenue from Medicare, will now focus
on the paths available, which include Medicare appeals for Cxbladder Triage to get paid based
on its inclusion in the AUA microhematuria guideline
4
, despite the non-coverage determination
and reconsideration requests for Triage and Monitor.
Pacific Edge submitted a reconsideration request for Cxbladder Triage under ‘Biomarkers for
Oncology’ LCD (L35396) on 21 March 2025, a request that has already been deemed valid by
Novitas, meaning they will now assess the evidence submitted. It also expects to submit a
reconsideration request for Cxbladder Monitor under ‘Genetic Testing in Oncology: Specific
Tests’ (L39365) as soon as possible and request non-coverage to be removed.
However, Pacific Edge will not seek re-coverage of Cxbladder Detect as no new evidence has
been published that can be submitted for reconsideration. Detect users will be required to move
over to Triage in an acceleration of a plan intended to coincide with the commercial launch of
Triage Plus.
Novitas controls the timeline for these reconsideration requests and is not bound by any
maximum period to complete this work. Industry experts typically estimate the time at 6-9
months for a valid submission of a single product with only a small number of new supporting
publications and not the protracted period of consultation that results from creating a new LCD
as was done with L39365.
Regarding Cxbladder Triage Plus, the company will continue to develop, publish and
subsequently submit a reconsideration request in line with our previously published roadmap
– those activities remain on track. The company will also continue to work with Kaiser

1
Centers for Medicare and Medicaid Services
2
The Department of Health and Human Services
3
Office of the General Counsel (of the Department of Health and Human Services)
4
Under current legislation, MACs are required to consider consensus statements and/or guidelines in determining
coverage.

Permanente on a peer-reviewed publication confirming the real-world utility of Cxbladder
Triage. The preliminary data was presented as a poster at the AUA 2025 annual meeting (April
26–29) in Las Vegas and will be used for future reconsideration requests when published.
While the impact of ‘Genetic Testing for Oncology: Specific Tests’ (L39365) is expected to have
a significant impact on testing volume, Pacific Edge expects to continue to bill and receive
reimbursement from contracted commercial US payers without interruption, notably Kaiser
Permanente, the US Veterans Administration, various Blue Cross Blue Shield plans under the
group purchasing agreement and from non-contracted private payers in line with historic
reimbursement rates. Similarly, Pacific Edge expects collections from our enhanced patient
responsibility and patient assistance programs to continue in line with the rates since the
introduction of that program in July 2023.
Pacific Edge Chief Executive Dr Peter Meintjes said: “This finalization is a poor outcome for
Medicare patients and urologists, as it removes coverage for guideline-recommended testing
and followed a flawed process that failed to review the most-current evidence.
“We are obviously disappointed we have been unable to maintain coverage of our tests in the
short term. However, as we noted when the final LCD was published in mid-January 2025, we
have planned for this possibility. We will update shareholders as these plans are finalized,
though our focus will remain on further evidence generation in parallel with the reconsideration
pathway made available to all providers seeking Medicare coverage of their tests.”
For more information:
Investors: Media:
Dr Peter Meintjes Richard Inder
Chief Executive The Project
Pacific Edge P: +64 21 645 643
P: 022 032 1263
OVERVIEW
Pacific Edge: www.pacificedgedx.com
Pacific Edge Limited (NZX/ ASX: PEB) is a global cancer diagnostics company leading the way
in the development and commercialization of bladder cancer diagnostic and prognostic tests
for patients presenting with hematuria or surveillance of recurrent disease. Headquartered in
Dunedin, New Zealand, the company provides its suite of Cxbladder tests globally through its
wholly owned, and CLIA certified, laboratories in New Zealand and the USA.

Cxbladder: www.cxbladder.com
Cxbladder is a suite of non-invasive genomic urine tests optimized for the risk stratification of
urothelial cancer in patients presenting with microhematuria and those being monitored for
recurrent disease. The tests help improve the overall patient experience, while prioritizing time
and clinical resources to optimize practice workflow and improve efficiency.

Supported by over 20 years of research, Cxbladder’s evidence portfolio extends to more than
25 peer reviewed publications, and Cxbladder Triage is now included in the American
Urological Association’s Microhematuria Guideline. To drive increased adoption and improved
patient health outcomes, Cxbladder is the focal point of numerous ongoing and planned studies
designed to generate further clinical utility evidence.

Cxbladder is available in the US, Australasia, and Israel and in markets throughout Asia and
South America. In the US, the test has been used by over 5,000 urologists who have ordered
more than 130,000 tests. In New Zealand, Cxbladder is accessible to around 70% of the
population via public healthcare and all residents have the option of buying the test online.