Sera Prognostics Announces Pricing for PreTRM® Test, the Only Broadly Validated Blood Test to Assess Risk of Preterm Birth
New Assigned Rate Further Validates the Commercial Value of the PreTRM® Test
Salt Lake City – Dec 2, 2021 – Sera Prognostics Inc., The Pregnancy Company® (NASDAQ: SERA), focused on improving maternal and neonatal health by providing innovative pregnancy biomarker information to doctors and patients, today announced the Centers for Medicare & Medicaid Services (CMS) has set a Medicare payment rate for the existing unique Proprietary Laboratory Analysis (PLA) code, 0247U, for the PreTRM® Test, the company’s proprietary proteomic blood test for measuring a woman’s risk of spontaneous preterm birth to allow more timely intervention. This payment rate for the 0247U code is scheduled to go into effect on January 1, 2022 and is expected to apply for CY 2022, at a rate of $750.00. The establishment of a price, while reinforcing the value of the PreTRM® test, does not necessarily mean the test will be covered by Medicare or any other payer. Medicare coverage of a test requires either a local or national coverage decision.
PLA codes are an addition to the CPT code set approved by the American Medical Association (AMA) CPT Editorial Panel. The codes are alpha-numeric CPT codes with corresponding descriptors for labs wishing to identify their respective tests more specifically. Additional information surrounding the billing and coding article related to the Clinical Laboratory Fee Schedule (CLFS) test codes final pricing determination for the PreTRM® test for CY 2022 is available on the CMS website under ‘Final Payment Determinations.’
“Even though Medicare beneficiaries are not expected to be a large portion of the market for PreTRM® test, the Medicare-determined price is additional evidence of the value of PreTRM® testing and is an important step in our commercial strategy to continue to establish the PreTRM® reimbursement framework,” said Gregory C. Critchfield, MD, MS, chairman and chief executive officer of Sera Prognostics. “Building on Medicare’s pricing determination, we will continue negotiations with commercial, self-insured and governmental insurance programs, including Medicaid, as we work to provide patients with broader access to this important test. The PreTRM® test improves identification of pregnancies at higher risk of prematurity to enable earlier proactive interventions to decrease adverse outcomes in Sera’s quest to improve the well-being of mothers and babies and to decrease healthcare costs.”