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Gynesonics Announces Centers for Medicare and Medicaid Services Final Rule Approves Ambulatory Surgery Centers as a Site of Service for Transcervical Uterine Fibroid Ablation with Device Intensive Designation

·4 min read

2021 Ruling Also Increases Hospital Outpatient Payment for the Associated Ambulatory Payment Classification That Covers the Sonata Treatment

Gynesonics®, a women’s healthcare company focused on the development of minimally invasive solutions for symptomatic uterine fibroids, announced today that The Centers for Medicare and Medicaid Services (CMS) has included Ambulatory Surgical Centers (ASC) as an approved site of service for Transcervical Uterine Fibroid Ablation (TFA), which describes the procedure associated with the Sonata® System. CMS also assigned a device intensive status to TFA, using the 31 percent default device offset percentage based on the pricing information provided by Gynesonics.1 Effective immediately, the reimbursement amount for the ASC setting will be $3,632.42 for Transcervical Uterine Fibroid Ablation. For Sonata procedures performed in a hospital outpatient setting, Ambulatory Payment Classification (APC) 5416 has increased to $6,794.31. Commercial insurers set reimbursement based on CMS assigned amounts, studies support that a commercial insurer will reimburse an average of 122-264 percent higher than the CMS assigned payment.2, 3 Physician payment is reimbursed separately.

"The decision by CMS to approve Sonata to be performed in an ASC creates more access to care for women suffering from uterine fibroids," said Kelly Petrucci, Gynesonics’ VP of Health Economics and Market Access. "The advantages of this minimally invasive, incision-free, uterus preserving procedure allows women to have a faster recovery than more invasive options. Creating access in an ASC also helps drive down the overall cost of care, especially compared to alternative procedures."

The Sonata System uses a unique intrauterine ultrasound handpiece to locate and target individual fibroids. Radiofrequency energy is delivered to shrink the fibroid and reduce symptoms. The Sonata Treatment is a breakthrough alternative to hysterectomy and myomectomy, and can treat a wide range of fibroid types, sizes, and locations. As the fibroids are treated from inside the uterus, treatment with Sonata requires no incisions, no tissue is surgically removed, and the uterus is preserved. In the SONATA clinical trial, within three months following their Sonata Treatment, 86 percent of women experienced a reduction in heavy menstrual bleeding and 95 percent of patients experienced a reduction in menstrual bleeding by 12 months. Additionally, 50 percent of women return to normal activities the next day. The overall impact of treatment with Sonata was significant for these women, with 97 percent of women at 12 months indicating they would recommend the procedure, and women in the study experiencing durable symptom relief over at least three years.

"The Sonata procedure is a straightforward technique that does not require general anesthesia. These procedural characteristics allowed CMS to consider and then establish payment for Sonata in the ambulatory surgery center setting," said Christopher Owens, Gynesonics President and Chief Executive Officer. "The impact of this action will be significant, expanding the available market for Sonata to now include those physicians and patients who prefer fibroid treatment in the ASC setting. This development will also provide benefits to payers, given that the ASC is a lower cost of care setting compared to the hospital outpatient setting."

  1. https://www.cms.gov/files/document/12220-opps-final-rule-cms-1736-fc.pdf.

  2. Johnson, B. "Comparing Commercial and Medicare Professional Service Prices." Health Care Cost Institute, August 13, 2020, https://healthcostinstitute.org/hcci-research/comparing-commercial-and-medicare-professional-service-prices.

  3. Lopez, E. "How Much More Than Medicare Do Private Insurers Pay: A Study of the Literature." Henry J. Kaiser Family Foundation, April 15, 2020, kff.org/medicare/issue-brief/how-much-more-than-medicare-do-private-insurers-pay-a-review-of-the-literature/.

About Sonata System

The Sonata System uses radiofrequency energy to ablate fibroids under real time sonography guidance from within the uterine cavity, utilizing the first and only intrauterine ultrasound transducer. The System includes a proprietary graphical user interface (SMART Guide), enabling the operator to target fibroids and optimize treatment. The Sonata system provides incision-free transcervical access for a uterus-preserving fibroid treatment. This intrauterine approach is designed to avoid the peritoneal cavity. The Sonata System is CE marked and is approved for sale in the European Union and the United States.

About Gynesonics

Gynesonics is a women’s healthcare company focused on advancing women’s health, by developing minimally invasive, incision-free, uterus-preserving, transcervical technologies for diagnostic and therapeutic applications. Gynesonics has developed the Sonata System for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids. Gynesonics headquarters is in Redwood City, CA. For more information, go to www.gynesonics.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210309005288/en/


Company Contact:
Kelly Petrucci, Vice President of Healthcare Economics and Market Access, Gynesonics, kpetrucci@gynesonics.com

Media Contact:
David Gutierrez, Dresner Corporate Services, dgutierrez@dresnerco.com, (312) 780-7204