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ThyroSeq Test Approved for Medicare Coverage to Improve Thyroid Nodule Diagnosis

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Allison Hydzik
Director, Science and Research

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PITTSBURGH – A UPMC-developed test for diagnosis of thyroid nodules, ThyroSeq® Genomic Classifier, has been approved for coverage by its Medicare Administrative Contractor, Novitas Solutions. This decision paves the way for the test to be accessible to more than 50 million Medicare patients nationwide.

The thyroid is a butterfly-shaped, two-lobe gland in the front of the neck that produces hormones to regulate metabolic rate, among other things. Most thyroid nodules are benign, and, even when they’re cancerous, they’re usually very slow-growing. According to the American Cancer Society, nearly 54,000 people are diagnosed with thyroid cancer in the U.S. each year. 

“We are excited by this insurance coverage decision," said Marina Nikiforova, M.D., professor of pathology at the University of Pittsburgh School of Medicine and director of the UPMC Molecular & Genomic Pathology Laboratory where the test is performed. “Our test allows patients who don’t actually have cancer to avoid unnecessary surgery and preserve their thyroid function, saving them from a lifetime of synthetic thyroid medications and specialist visits. It is incredibly rewarding to finally offer ThyroSeq to patients nationwide and have it covered by Medicare.”

ThyroSeq is an innovative next-generation sequencing-based test that provides comprehensive genomic profiling of thyroid nodules using a small sample of cells. Its highly accurate performance in diagnosing thyroid cancer or benign disease can help to prevent diagnostic thyroid surgeries performed when physicians are not sure if a nodule is malignant, providing cost-effective patient care and saving health care resources. 

As reported in the journal Health Affairs, among patients with all cancers, thyroid cancer patients have one of the highest incidences of bankruptcy filing. An independent analysis by Mayo Clinic researchers that was recently reported in the scientific journal Endocrine Practice found that ThyroSeq testing saved thousands of dollars compared to when patients were treated with diagnostic thyroid surgery.  

Novitas Solutions determined that ThyroSeq is considered reasonable and medically necessary for patients with indeterminate cytology on fine-needle aspiration biopsy. The Centers for Medicare & Medicaid Services relies on a network of Medicare Administrative Contractors, like Novitas Solutions, to serve as the primary operational contact between the Medicare Fee-For-Service program and the health care providers enrolled in the program.

“This decision by Medicare is very important for clinicians like me who see many patients with thyroid nodules,” said Sally Carty, M.D., professor of surgery in Pitt’s School of Medicine and chief of UPMC’s Endocrine Surgery Program. “In the past, an indeterminate cytology result for a thyroid nodule would lead to a patient undergoing surgery to remove at least half of his or her thyroid. Today, we can rely on the result from ThyroSeq to spare many patients from unnecessary surgery or determine the most informed treatment decisions for patients with cancer.”