FEMSelect, Ltd. Announces CMS Reimbursement for Innovative Minimally Invasive Approach to Pelvic Organ Prolapse Repair Procedure

FEMSelect, Ltd., a medical device company addressing unmet needs in the field of pelvic health, announced today that the Centers for Medicare and Medicaid Services (CMS) has created a new HCPCS code (C9778) to describe the procedure associated with the EnPlace® system – vaginal colpopexy by sacrospinous ligament fixation (minimally invasive extra-peritoneal approach), based on its review of a New Technology APC application submitted by FEMSelect. In the final 2022 OPPS Payment Schedule that was released by CMS last week, the EnPlace procedure is positioned for appropriate payment as a Level 5 GYN procedure as well as designated as device-intensive, enabling broader access to EnPlace for women in the ambulatory surgery center (ASC).

Pelvic organ prolapse is a medical condition in which one or more female pelvic floor organs (i.e., bladder, uterus, rectum) shift and descend – creating an extremely uncomfortable condition. Half of women over the age of 50, 25 million women in the U.S. alone, will suffer from a pelvic floor condition in their lifetimes. Prolapse symptoms include discomfort, embarrassment, and urinary and sexual dysfunction, among others that commonly cause loss of productivity, depression, and decreased quality of life.

A vaginal procedure with the EnPlace System, the only minimally-invasive platform indicated for attaching sutures to ligaments of the pelvic floor, involves an outpatient procedure with no use of pelvic floor mesh. "The establishment of CMS reimbursement for EnPlace is a major milestone for FEMSelect and the clinical community," said Debbie Garner, Co-CEO of FEMSelect. "We are excited about the opportunity this presents for millions of women in the U.S. who suffer from the symptoms of pelvic floor prolapse, which greatly impacts quality of life."

HCPCS code C9778 was granted by CMS to describe the specific EnPlace approach, as a Minimally Invasive Extraperitoneal Colpopexy.




Colpopexy, Minimally Invasive, Extraperitoneal

The EnPlace technology is available nationwide through FEMSelect's exclusive partner in the U.S.—LiNA Medical USA.

About FEMSelect
FEMSelect is a women-led company with a mission to make a lasting impact on women's health by delivering innovative technologies that provide consistent results in a patient-centric manner and dramatically improve outcomes for women. For more information, visit: https://femselect.com.

About LiNA Medical USA
LiNA Medical USA specializes in selling innovative, minimally invasive devices in the fields of gynecology and urology. The company is dedicated to partnering with organizations that offer related products that improve the lives of patients and the healthcare professionals that treat them. For more information, visit: https://linamed.com.


Source: https://www.prnewswire.com/news-releases/femselect-ltd-announces-cms-reimbursement-for-innovative-minimally-invasive-approach-to-pelvic-organ-prolapse-repair-procedure-301420858.html

 November 10, 2021