[November 15, 2016]

CMS Modifies Permanent P-Code Allowing Outpatient Hospital Billing of the Verax PGD® Test

The Centers for Medicare and Medicaid Services (CMS) issued a permanent Healthcare Common Procedure Coding System (HCPCS) Level II code that allows 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 CMS revised the HCPCS code established in 2016 for pathogen-reduced platelets (P9072) to include the use of pathogen-reduction technology or rapid bacterial testing. The descriptor for this code will be revised to read: P9072 (Platelets, apheresis, pathogen reduced or rapid bacterial tested, each unit).

The revised code and updated payment rate, outlined below, was published by CMS on November 1, 2016 in the Hospital Outpatient Prospective Payment System (OPPS) Final Rule for CY2017 and in the Federal register on November 14, 2016. It will become effective January 1, 2017.¹

"We are extremely pleased the CMS has established a permanent P-Code for rapid bacterial testing, as it signals the importance this testing plays in the safety of our nation's blood supply and provides a path for reimbursement for rapid testing," said James Lousararian, Verax's Chief Executive Officer.

The Verax Platelet PGD® Test is a simple, FDA cleared Safety Measure rapid test for bacterial contamination in platelets. The significance of bacterial contamination risk to patient safety and the PGD® test's ability to mitigate that risk by interdicting highly contaminated platelets before transfusion was demonstrated in a pivotal U.S. multi-center trial. This trial and the tests performance led the FDA's Blood Product Advisory Committee to urge the implementation of rapid testing to address this risk.

"The Verax Platelet PGD® test is unique in that it is the only FDA-cleared method to extend platelet dating from 5 to 7 days. The expiration of 5-day platelets costs the US healthcare system more than $150 million dollars annually. Seven-day platelet dating can largely eliminate this cost and the loss of a voluntarily donated life-giving blood component," Lousararian said.

About Verax Biomedical
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 hospital and blood banking community while preserving a critical life giving resource. For more information, visit www.veraxbiomedical.com.

About the Centers for Medicare and Medicaid Services (CMS)
The Centers for Medicare & Medicaid Services (CMS) is a federal agency within the United States Department of Health and Human Services that administers the Medicare program and works in partnership with state governments to administer Medicaid, the State Children's Health Insurance Program, and health insurance portability standards. Visit https://www.cms.gov/ to learn more.

¹ 81 Fed. Reg. 79562, 79577 (Nov. 14, 2016), available online at: https://www.gpo.gov/fdsys/pkg/FR-2016-11-14/pdf/2016-26515.pdf.

View source version on businesswire.com: http://www.businesswire.com/news/home/20161115006028/en/

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