US CPT PLA Code Granted for CARDIO inCode-SCORE (CIC-SCORE)
03 April 2023
CPT PLA Code is key component for
reimbursement from private medical insurance and
Medicare
Oxford, UK. GENinCode Plc (AIM: GENI), the genetics company focused on the
prevention of cardiovascular disease (“CVD”), announces the Amercian Medical
Asscoiation (AMA) grant of a Current Procedural Terminology (CPT) Proprietary
Laboratory Analyses (PLA) code for its CARDIO inCode-SCORE (“CIC-SCORE”) polygenic test for the risk assessment of
Coronary Heart Disease. The new code 0401U, has been approved and published by
the AMA CPT Editorial Panel1 and is scheduled to become effective on
July 1st 2023.
A payment rate for the new code will be established for Medicare patients through
the Clinical Lab Fee Schedule (CLFS) Annual Public Meeting process. GENinCode
will commence discussions with Medicare and recommend an appropriate basis for
establishing a national Medicare price for the CIC-SCORE code.
CIC-SCORE is entering Early Access Programs with leading institutions in the
United States over the coming months and the grant of the CPT PLA code is an
important step in preparing CIC-SCORE for insurance coverage and reimbursement.
The CPT Code will enable increased access to the CIC-SCORE test for
patients at genetic risk of Coronary Heart Disease.
The grant of the CPT PLA code follows an extensive program of work to gain
California State Licensing and CLIA approval for the CIC-SCORE test at the
Company's Irvine, CA Laboratory together with the clinical and analytical
validation of the CIC-SCORE lab diagnostic test. CPT coding and terminology is
widely used across the United States providing doctors and health care
professionals with a uniform language for coding medical services and procedures
to streamline reporting, increase accuracy and efficiency.
CIC-SCORE is a in-vitro diagnostic test used to assess an individuals inherited
(DNA) genetic risk of Coronary Heart Disease. The test is based on published
clinical evidence amassed over the past 15 years and combined with traditional
clinical risk provides a comprehensive risk assessment of Cardiovascular Disease
(CVD) for use in primary preventative care. GENinCode processes and delivers the
CARDIO inCode-SCORE test to physicians via its online ‘SITAB' cloud based
reporting system.
CIC-SCORE also addresses the well-recognised need for improvement in the CVD
standard of care. The CIC-SCORE test provides an improved estimation of an
individual's risk of heart attack over their lifetime and particularly within a
10-year period following the test. CIC-SCORE provides a step change in patient
risk assessment for CVD thereby providing a major improvement in preventative
care, patient management, diagnosis, and personalised treatment.
GENinCode specialises in polygenic risk assessment of CVD, the leading cause of
death and disability worldwide.
Matthew Walls, CEO of GENinCode PLC said: “The grant of the CPT PLA
code is an important step as we prepare CARDIO inCode-SCORE to enter Early
Access Programs in the United States. The code is instrumental to
obtaining insurance coverage and reimbursement, and will help increase
access to CARDIO inCode-SCORE testing for patients at genetic risk of
Coronary Heart Disease.”
For more information visit www.genincode.com
Enquiries:
GENinCode Plc | www.genincode.com or via Walbrook PR | ||
Matthew Walls, CEO | |||
Stifel Nicolaus Europe Limited (Nomad and Joint Broker) | Tel: +44 (0)20 7710 7600 | ||
Alex Price / Ben Maddison / Richard Short | |||
Cenkos Securities Plc (Joint Broker) | Tel: +44 (0)20 7397 8900 | ||
Giles Balleny | |||
Dale Bellis / Michael Johnson (Sales) | |||
Walbrook PR Limited Anna Dunphy / Louis Ashe-Jepson / Phillip Marriage |
Tel: 020 7933 8780 or genincode@walbrookpr.com Mob: +44 (0)7876 741 001 / +44 (0)7747 515 393 +44 (0) 7867 984 082 |
||
About GENinCode:
GENinCode Plc is a UK based company specialising in genetic risk assessment of
cardiovascular disease. Cardiovascular disease is the leading cause of death and
disability worldwide.
GENinCode operates business units in the UK, Europe through GENinCode S.L.U, and
in the United States through GENinCode U.S. Inc.
GENinCode predictive technology provides patients and physicians with globally leading preventative care and treatment strategies. GENinCode CE marked invitro-diagnostic molecular tests combine clinical algorithms and bioinformatics to provide advanced patient risk assessment to predict disease onset.
About Cardiovascular Disease (CVD):
Heart and circulatory disease also known as Cardiovascular disease (CVD) is the
leading cause of death globally, taking an estimated 17.9 million lives
each year and accounts for 1 in every 4 deaths in the United States. CVD is a
group of disorders of the heart and blood vessels that include coronary
heart disease, cerebrovascular disease, rheumatic heart disease and other
conditions. More than four out of five CVD deaths are due to heart attacks and
strokes, and one third of these deaths occur prematurely in people under 70
years of age. By 2030 the global cost of CVD is set to rise from
approximately US$863 billion in 2010 to US$1,044 billion and is both a major
health issue and global economic burden.
Cardiovascular disease, causes a quarter of all deaths in the UK and is the
largest cause of premature mortality in deprived areas and is the single biggest
area where the NHS can save lives over the next 10 years. CVD is largely
preventable, through lifestyle changes and a combination of public health and
action on smoking and tobacco addiction, obesity, tackling alcohol misuse and
food reformulation.
The most important behavioural risk factors of heart disease and stroke are
unhealthy diet, physical inactivity, tobacco use and harmful use of alcohol. The
effects of behavioural risk factors may show up in individuals as raised blood
pressure, raised blood glucose, raised blood lipids, and overweight and obesity.
These “intermediate risks factors” can be measured in primary care facilities
and indicate an increased risk of heart attack, stroke, heart failure and other
complications.
Identifying those at highest risk of CVDs and ensuring they receive appropriate
treatment can prevent premature deaths. Access to noncommunicable
disease medicines and basic health technologies in all primary health care
facilities is essential to ensure that those in need receive treatment and
counselling.
The current standard of care for assessing cardiovascular risk is primarily based
on traditional clinical risk factors such as age, sex, smoking, body mass, blood
pressure and cholesterol levels from which individuals are categorised as being
at low, moderate or high risk of a CVD event. This categorisation is imperfect
as CVD events frequently occur in those thought to be at low or moderate risk.
The size of the populations at low or moderate risk are much larger than those
at high or very high risk so whilst the relative risk of a CVD event may be
small, the absolute number of CVD events in low and moderate risk
populations is much greater than the number of events in higher risk categories.
Clinicians have for many years recognised the importance of prior CVD events within the families of their patients because genetic factors contribute to the development of atherosclerosis and a patient's family history has become a surrogate for their inherited genetic risk. In recent years, with the advances of genomics, it has proved possible to add genetic profiling to conventional CVD risk factors, the combination of the two (genetics and conventional clinical risk factors) enhancing the predictive capability of patient risk thereby resulting in a personalised and preventative approach to CVD.