REG - LungLife AI, INC - LCD coverage for Indeterminate Lung Nodules

LungLife AIAnnouncement

16/08/2024 07:00

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RNS Number : 6843A  LungLife AI, INC  16 August 2024

LungLife AI, Inc.

(the "Company" or "LungLife")

 

Medicare Finalises Coverage for Molecular Risk-Stratification Testing of
Indeterminate Lung Nodules

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung
cancer, is pleased to note the publication of the finalized Local Coverage
Determination (LCD) titled "Molecular Biomarkers for Risk Stratification of
Indeterminate Pulmonary Nodules Following Bronchoscopy" (L39654), issued by
the Medicare Administrative Contractor (MAC) Noridian Healthcare Solutions,
LLC, which has jurisdiction over LungLife's California laboratory.

 

The Medicare coverage criteria are effective for medical insurance claims with
dates of service on or after September 22, 2024. This enables LungLife to
apply for coverage under the LCD in order to receive payment from Medicare.
This is a key step towards commercialisation for LungLife, having already
received a billing code and established a price of $2,030 per LungLB® test.

 

The new Medicare coverage policy establishes criteria for molecular tests that
aid in the diagnosis of lung cancer in patients with indeterminate pulmonary
(lung) nodules. This is crucial for healthcare providers and patients as
setting out the circumstances under which Medicare will pay for these services
removes a fundamental barrier to adoption by clinicians.

 

Key points from the LCD include:

 

·    Coverage for molecular tests to aid in the diagnosis of lung cancer
in patients with indeterminate pulmonary (lung) nodules who have a
non-diagnostic bronchoscopy, provided the other enumerated coverage criteria
of the LCDs are satisfied.

·    LungLife will be eligible to submit a Technical Assessment for
LungLB® under this LCD for post-bronchoscopy indications. Almost half(1) of
bronchoscopy biopsies performed are not diagnostic and thus result in a need
for follow up activities, accentuating the need for risk stratification
testing like LungLB® in the post-bronchoscopy setting governed by the LCD.

·    MolDX(2) is currently considering additional evidence to expand the
indications for coverage to pre-bronchoscopy risk stratification. This
provides an additional opportunity for LungLife to seek coverage under a
potential foundational LCD if they progress with this. Alternatively, LungLife
would be in a position to seek an individual coverage determination for this
area.

 

Fundamental components for commercialisation:

 

There are three fundamental reimbursement components for commercialisation of
LungLB®: securing a designated billing code, establishing a price, and
obtaining coverage. We have made strong progress across each of these as
follows:

 

·    A unique billing code allows LungLife to accurately bill for and
receive reimbursement from insurance payers, including Medicare and private
insurers. LungLife was assigned CPT code 0317U in January 2022.

·    Medicare established a national price of $2,030 per test for
LungLB®, effective in January 2023.

·    Obtaining coverage from public and private payers is the next crucial
step for LungLife. Following the publication of the LCD, we plan to submit a
Technical Assessment for coverage under the LCD in order to receive payment
from Medicare. This Foundational LCD provides a clear pathway for LungLife to
pursue Medicare coverage with MolDX and is generally less time intensive
than obtaining a new test specific LCD.

 

The full publication of the LCD can be found here. Molecular Biomarkers for
Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy
(https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39654&ver=3&contractorName=all&contractorNumber=all&proposedStatus=all&sortBy=noticeStart&bc=10)
.

 

 

 

Commenting, Paul Pagano, Chief Executive Officer of LungLife, said:

"Having a Local Coverage Determination (LCD) for risk stratification testing
of indeterminate lung nodules represents a key opportunity for our company. It
enables us to progress to the next stage of commercialisation by providing a
clear pathway to make our innovative LungLB® test more accessible and
reimbursable under Medicare. This supports our commitment to enabling 80% of
lung cancer to be detected early."

 

 

For further information please contact:

 

 LungLife AI, Inc.                                   www.lunglifeai.com (https://www.lunglifeai.com/)
 Paul Pagano, CEO                                    via investors@lunglifeai.com
 David Anderson, CFO

 Investec Bank plc (Nominated Adviser & Broker)      Tel: +44 (0)20 7597 5970
 Virginia Bull / Lydia Zychowska/ Sara Wallace

 Goodbody (Joint Broker)                             Tel: +44 (0) 20 3841 6202
 Tom Nicholson / Cameron Duncan

 

Notes

1.     https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7729592/
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7729592/)

2.     The MolDX Program was developed in 2011 to identify and establish
coverage and reimbursement for molecular diagnostic tests.

 

About LungLife

LungLife AI is a developer of clinical diagnostic solutions designed to make a
significant impact in the early detection of lung cancer, the deadliest cancer
globally. Using a minimally invasive blood draw, the Company's LungLB® test
is designed to deliver additional information to clinicians who are evaluating
indeterminate lung nodules. For more information visit www.lunglifeai.com
(http://www.lunglifeai.com)

 

Our Purpose is to be a driving force in the early detection to lung cancer.
And our Vision is to invert the 20:80 ratio such that in years to come at
least 80% of lung cancer is detected early.

 

 

 

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