SAN DIEGO(BUSINESS WIRE)
Critical Diagnostics reported today that the U.S. Center for Medicare
and Medicaid Services (CMS) has confirmed that the 2015 Medicare
reimbursement for performing a ST2 test will be $29.931. This
took effect January 1, 2015. At the same time, a new Current Procedural
Terminology (CPT) code2 (83006) was issued by the American
Medical Association through the CPT Editorial Panel, to allow for the
communication of uniform information about ST2 testing.
These favorable decisions follow notice of acceptance by The American
Journal of Cardiology of a comprehensive consensus paper on ST2 that
will appear as a print supplement. The paper grew out of a meeting of
prominent leaders in the field of cardiology gathered earlier in 2014 to
discuss the evidence base behind the evolving role of the cardiac
biomarker ST2 in the management of patients with heart failure and
related cardiac diseases.
Authors on the paper include (in alphabetical order) Ednan Bajwa, MD,
Massachusetts General Hospital, Boston, MA; Antoni Bayes-Genis, MD, PhD,
Hospital Universitari Germans Trias I Pujol, Barcelona, Spain; Lori
Daniels, MD, MPH, University of California, San Diego, CA; Christopher
deFilippi, MD, University of Maryland, Baltimore, MD; Salvatore Di
Somma, MD, PhD, SantAndrea Hospital, Rome, Italy; Jennifer Ho, MD,
Boston Medical Center, Boston, MA; Allan Jaffe, MD, PhD Mayo, Rochester,
MN; James L. Januzzi, Jr, MD, Massachusetts General Hospital, Boston,
MA; Bonnie Ky, MD, MSCE, Assistant Professor of Medicine at the Hospital
of the University of Pennsylvania; Alan S. Maisel, MD, University of
California, San Diego, CA; Alexandre Mebazaa, MD, PhD, Hospital
Lariboisiere, Paris, France; Thomas Mueller, MD, Konventhospital
Bamherzige Bruder Linz, Linz, Austria; Prof. Christian Mller,
Department of Cardiology Head of Outcome Research, University Hospital
Basel; Domingo Pascual-Figal, MD, PhD, University Hospital Virgen de la
Arrixaca, Murcia, Spain; A. Mark Richards, MD, PhD, Christchurch School
of Medicine, Christchurch, New Zealand; Piyamitr Sritara, MD,
Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Thomas
Wang, MD, MPH; Vanderbilt University, Nashville, TN; and Yuhui Zhang,
MD, Fuwai Hospital, Beijing, China.
The recent decisions by CMS, the AMA and the soon-to-be-published ST2
consensus paper are all testament to the ever-expanded body of evidence
supporting ST2's clinical utility in helping physicians better manage
heart failure patients, comments David Geliebter, CEO, Critical
About Heart Failure
Heart failure is a condition in which the heart can't pump enough blood
to meet the body's needs. As noted by Professor Eugene Braunwald in The
War Against Heart Failure, in The Lancet3, Heart
failure is a global problem with an estimated prevalence of 38 million
patients worldwide, and a number that is increasing with the aging of
the population. Heart failure is the most common diagnosis in patients
aged 65 years or older admitted to hospital. Despite some progress, the
prognosis of heart failure is worse than that of most cancers.
ST2 is a soluble protein expressed by the heart in response to disease
or injury. It is reflective of ventricular remodeling and cardiac
fibrosis associated with heart failure. ST2 is not adversely affected by
confounding factors such as age, body mass index and impaired renal
function. Unlike many other cardiac biomarkers, ST2 levels change
quickly in response to changes in the patient's conditionthus helping
physicians make informed decisions on an appropriate course of action to
take and, if needed, to quickly adjust care.
The Presage ST2 Assay from Critical Diagnostics is the only
commercially available ST2 biomarker test in the world. The Presage ST2
Assay has been CE Marked and cleared by the U.S. FDA for use in the risk
stratification of chronic heart failure patients.
About Critical Diagnostics
Founded in 2004, Critical Diagnostics (www.criticaldiagnostics.com)
develops novel biomarkers to help physicians optimize patient care in
cardiovascular diseases, while containing healthcare costs. Critical
Diagnostics has distribution partners for its Presage ST2 Assay in some
50 countries, covering two-thirds of the world's population.
1 This reflects reductions in the Clinical Laboratory Fee
Schedule of -0.25%, as required by law. This rate is the National
Limitation Amount. Local rates may vary.
2 CPT Code is a
copyright of the AMA.
3 Published online November 16,
Dennis Dalangin, VP Marketing, +1 877-700-1250
Source: Critical Diagnostics