May 09, 2016 09:21 AM Eastern Daylight Time
MARLBOROUGH, Mass.–(BUSINESS WIRE)–The Centers for Medicare and Medicaid Services (CMS) issued new preliminary Healthcare Common Procedure Coding System (HCPCS) Level II coding decisions that would allow medical facilities running Verax Biomedical Platelet PGD® tests to code and bill for Medicare hospital outpatient reimbursement of platelet components tested with PGD, the company announced today.
Specifically, the preliminary decisions establish a HCPCS modifier for “Rapid bacterial tested†for use with existing HCPCS codes for platelets for outpatient reimbursement purposes. This modifier could be used across the broad variety of platelets currently produced and transfused in the US.
The Verax PGD® test is an FDA cleared Safety Measure for bacterial contamination in platelets, meaning it can also be used to extend platelet dating to 7 days.
“We are incredibly pleased with this decision. When finalized, this will have a significantly positive impact on the practice of transfusion medicine,” said Jim Lousararian, Verax Chief Executive Officer. “We view this as a major development both in terms of blood safety policy and acknowledging the economic value of testing the nation’s platelet supply.”
On June 1st, the CMS will hold a public meeting to take public comment and discussion on its preliminary decision as the next step towards final adoption.
Verax’s patented Pan Genera Detection (PGD) technology is ideally suited to address the need for rapid and practical tests for bacterial contamination, due to its unique and proven ability to detect a wide variety of possible bacterial contaminants quickly, cost effectively and with minimal labor. The PGD® test only has to be run once on a platelet unit within 24 hours of transfusion. It is the most cost effective method of addressing bacterial risk and is the fastest and least labor intensive way to test for platelet bacterial contamination on the market today.
Verax is the producer of the Platelet PGD Test, the only test for bacterial contamination in platelets granted a Safety Measure claim by the FDA. The test can now also be used to extend the dating of apheresis platelets in plasma, the most common platelet type transfused in the U.S., from 5 to 7 days. This dating extension offers the opportunity for significant cost savings to the blood banking community while preserving a critical life giving resource. For more information, visit www.veraxbiomedical.com
Contacts
Verax Biomedical
Joe Sanders, 508-755-7029
SVP/Marketing & Business Development
JSanders@veraxbiomedical.com
The Company's first product is the Platelet PGD Test – a rapid test for the detection of bacterial contamination in platelets.