Renalytix AI PLC US CPT® reimbursement code effective (2455O)
October 01 2019 - 1:00AM
UK Regulatory
TIDMRENX
RNS Number : 2455O
Renalytix AI PLC
01 October 2019
Renalytix AI plc
("RenalytixAI", the "Company" or the "Group")
US CPT(R) reimbursement code effective for KidneyIntelX(TM)
Renalytix AI plc (AIM: RENX), a developer of artificial
intelligence enabled clinical diagnostics for kidney disease,
announces that CPT reimbursement code 0105U for its
KidneyIntelX(TM) test has become effective nationally in the United
States as of October 1, 2019. The CPT PLA code for KidneyIntelX(TM)
was issued on July 1, 2019 and became effective one quarter later
to allow insurance payors time to load new test codes into their
systems.
Effective immediately, CPT PLA code 0105U can be used to report
KidneyIntelX(TM) services to private and public payors throughout
the United States for reimbursement. Further details are contained
in the Company's announcement dated July 1, 2019. The Company
intends to pursue coverage determinations from both Medicare and
private insurance payors beginning in 2019 for patients with kidney
disease and Type 2 diabetes.
KidneyIntelX(TM) is designed to predict progression of kidney
disease and ultimately improve outcomes and health care system
economics in patients with Type 2 diabetes and existing kidney
disease. KidneyIntelX(TM) uses machine-learning algorithms to
assess a combination of predictive blood-based biomarkers and
features from a patient's electronic health record to generate a
prognostic risk score for rapid-progression of kidney disease.
One of the greatest drivers of health care cost today is
patients with rapidly-progressing diabetic kidney disease who are
not identified in time and who face progressive kidney failure and
unplanned transition to dialysis. Approximately 12 million people
have diabetic kidney disease in the United States(1) . Each year
kidney disease results in the death of more people than breast and
prostate cancer(2) .
The CPT terminology is the most widely accepted medical
nomenclature used across the US to report medical, surgical,
radiology, laboratory, anaesthesiology, genomic sequencing,
evaluation and management services under public and private health
insurance programmes. The CPT PLA code awarded to KidneyIntelX(TM)
is a recent addition to the CPT Code set known as a CPT Proprietary
Laboratory Analysis (PLA) Code. PLA codes are alpha-numeric CPT
codes with a corresponding descriptor for labs or manufacturers
that want to identify their test more specifically.
CPT PLA codes describe proprietary clinical laboratory analyses
and can be provided either by a single ("solesource") laboratory or
licensed or marketed to multiple providing laboratories for tests
that are cleared or approved by the US Food and Drug
Administration. These codes include advanced diagnostic laboratory
tests (ADLTs) and clinical diagnostic laboratory tests (CDLTs) as
defined under the Protecting Access to Medicare Act (PAMA) of
2014.
Notes
(1) https://cjasn.asnjournals.org/content/12/12/2032
(2) https://www.ncbi.nlm.nih.gov/pubmed/30738630
For further information, please contact:
Renalytix AI plc www.renalytixai.com
James McCullough, CEO Via Walbrook PR
Stifel (Nominated Adviser & Joint Broker) Tel: 020 7710 7600
Alex Price / Jonathan Senior / Ben Maddison
N+1 Singer (Joint Broker) Tel: 020 7496 3000
Aubrey Powell / George Tzimas (Corporate Finance)
Tom Salvesen / Mia Gardner (Corporate Broking)
Walbrook PR Limited Tel: 020 7933 8780 or renalytix@walbrookpr.com
Paul McManus / Lianne Cawthorne Mob: 07980 541 893 / 07584 391
303
About Kidney Disease
Kidney disease is now recognised as a public health epidemic
affecting over 850 million people globally. The Centers for Disease
Control estimates there that 15% of United States adults or 37
million people currently have chronic kidney disease. It is
reported that 9 out of 10 adults with CKD do not know they have it
and 1 out of 2 people with very low kidney function who are not on
dialysis do not know they have CKD*. Kidney disease is referred to
as a "silent killer" because it often has no symptoms and can go
undetected until a very advanced stage. Each year kidney disease
kills more people than breast and prostate cancer. Every day 13
patients die in the United States while waiting for a kidney
transplant.
*
https://www.cdc.gov/kidneydisease/publications-resources/2019-national-facts.html
About RenalytixAI
RenalytixAI is a developer of artificial intelligence-enabled
clinical in vitro diagnostic solutions for kidney disease, one of
the most common and costly chronic medical conditions globally. The
Company's products are being designed to make significant
improvements in kidney disease diagnosis, transplant management,
clinical care, patient stratification for drug clinical trials, and
drug target discovery. For more information, visit
renalytixai.com
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of this information may apply. For further information, please
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