Newswise — 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.”

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About ThyroSeq®
ThyroSeq is offered nationwide through a partnership between UPMC and CBLPath, a Sonic Healthcare Company. With a 10-year history of continuous refinement, ThyroSeq incorporates all major scientific discoveries and utilizes advanced technology to provide the most accurate diagnosis of benign or malignant disease in thyroid nodules. For more information, visit ThyroSeq.com.

About UPMC
A $19 billion world-renowned health care provider and insurer, Pittsburgh-based UPMC is inventing new models of patient-centered, cost-effective, accountable care. UPMC provides more than $900 million a year in benefits to its communities, including more care to the region’s most vulnerable citizens than any other health care institution. The largest nongovernmental employer in Pennsylvania, UPMC integrates 85,000 employees, 40 hospitals, 600 doctors’ offices and outpatient sites, and a 3.4 million-member Insurance Services Division, the largest medical insurer in western Pennsylvania. As UPMC works in close collaboration with the University of Pittsburgh Schools of the Health Sciences, U.S. News & World Report consistently ranks UPMC Presbyterian Shadyside on its annual Honor Roll of America’s Best Hospitals. UPMC Enterprises functions as the innovation and commercialization arm of UPMC, and UPMC International provides hands-on health care and management services with partners around the world. For more information, go to UPMC.com.

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CITATIONS

Endocrine Practice