Salt Lake City, UT, Feb. 12, 2014 – Clinical Innovations (CI), a leading global provider of medical devices with special emphasis on labor and delivery, is pleased to announce that the Centers for Medicare and Medicaid Services (CMS) have expanded the existing Current Procedure Terminology (CPT) code 84112 to include the protein markers associated with ROM Plus effective January 2014. ROM Plus is a rapid qualitative test for the in vitro detection of amniotic proteins in vaginal secretions of pregnant women as a possible diagnosis of ruptured membranes. Premature rupture of membranes affects 10% of term pregnancies and is associated with over 60% of preterm births, making an accurate and timely diagnosis imperative.1 ROM Plus uses a monoclonal/polyclonal antibody approach to detect two amniotic proteins, AFP and PP12.
“We all know it can be a challenge to accurately diagnose rupture of membranes,” said Dr. Tovah Buikema, Maternal Fetal Medicine Fellow at St. Joseph Mercy Oakland Hospital. “ROM Plus has proven to be reliable, tolerated by patients, and exceptionally easy to use.” For the last 50 years investigators have recognized the critical importance of accurate and prompt diagnosis of PROM which helps decrease or avoid potentially serious complications for mother and fetus.1
The change to the CPT code gives healthcare providers additional treatment options and potentially removes the economic barrier for using this valuable test. Shacey Petrovic, President and Chief Executive Officer of Clinical Innovations said, “ROM Plus has proven to be more sensitive than conventional methods, and now more patients can benefit from this test. Depending on payer mix, this expanded coverage may provide clinicians and their patients access to the newest technological advancement in detection of amniotic proteins as an indication of ruptured obstetrical membranes.”
The decision to expand the existing CPT code was based on a thorough review of published, peer-reviewed literature and clinical use of ROM Plus in the United States.
About Clinical Innovations
Clinical Innovations develops, manufactures and markets state-of-the-art medical devices that improve healthcare outcomes for clinicians and their patients worldwide. With particular emphasis on healthcare solutions for women and their infants, Clinical Innovations has consistently expanded its worldwide presence, becoming the market leader in several product categories, including the Koala® Intrauterine Pressure System and the Kiwi® Vacuum-Assisted Delivery System. With ISO13485 certification and strong relationships with top worldwide medical distributors, Clinical Innovations has the infrastructure in place to promptly respond to market trends and customer suggestions.
CPT® is a registered trademark of the American Medical Association, which develops and maintains CPT codes.