PDAC Code Review - E0740 Non-Implantable Pelvic Floor Electrical Stimulator - JD DME

DME MAC Joint Publication

The Pricing, Data, Analysis and Coding Contractor (PDAC) recently evaluated HCPCS code E0740 (INCONTINENCE TREATMENT SYSTEM, PELVIC FLOOR STIMULATOR, MONITOR, SENSOR AND/OR TRAINER) and discovered two differing product types on the Product List: (1) pelvic floor muscle electrical stimulators, and (2) pelvic floor muscle monitoring devices. The PDAC reviewed the history of the code to determine which product type E0740 was intended to describe.

Code E0740 History
During the 1980's E0740 was used to describe a battery used in a TENS device. In 1988 the code was discontinued. In 1995, the CMS HCPCS Workgroup reassigned the code as:

E0740 (INCONTINENCE TREATMENT SYSTEM, PELVIC FLOOR STIMULATOR, MONITOR, SENSOR AND/OR TRAINER).

This reassigned code narrative was effective for use January 1, 1995.

CMS concurrently published a National Coverage Determination (NCD 230.8) for pelvic floor electrical stimulators. The NCD says:

230.8 - Non-Implantable Pelvic Floor Electrical Stimulator
Non-implantable pelvic floor electrical stimulators provide neuromuscular electrical stimulation through the pelvic floor with the intent of strengthening and exercising pelvic floor musculature. Stimulation is generally delivered by vaginal or anal probes connected to an external pulse generator.

The methods of pelvic floor electrical stimulation vary in location, stimulus frequency (Hz), stimulus intensity or amplitude (mA), pulse duration (duty cycle), treatments per day, number of treatment days per week, length of time for each treatment session, overall time period for device use and between clinic and home settings. In general, the stimulus frequency and other parameters are chosen based on the patient's clinical diagnosis.

Pelvic floor electrical stimulation with a non-implantable stimulator is covered for the treatment of stress and/or urge urinary incontinence in cognitively intact patients who have failed a documented trial of pelvic muscle exercise (PME) training.

A failed trial of PME training is defined as no clinically significant improvement in urinary continence after completing 4 weeks of an ordered plan of pelvic muscle exercises designed to increase periurethral muscle strength.

Part of the code history assessment is to identify what product were initially included in E0740 when the revised code narrative was assigned in 1995. CMS Alpha-Numeric Workgroup applications from 1995 were reviewed to determine the predicate product(s) used to establish HCPCS code E0740. A predicate product is the item(s) used as the index product in the establishment of the original HCPCS code and is the exemplar to which other products are compared when assessing code assignment. The three predicate products used for code E0740 in 1995 were:

• Perry Vaginal (Self-Regulation Systems, Inc.)
• Perry Anal (Self-Regulation Systems, Inc.)
• Innova ™ Feminine Incontinence Treatment System (Empi, Inc.)

All of these products are non-implantable pelvic floor electrical stimulation devices with muscle contraction monitoring capability included.

Coding Determination
Based upon the code narrative, code history including the predicate products, and creation of National Coverage Determination 230.8, the PDAC concluded that HCPCS code E0740 is intended to describe non-implantable pelvic floor electrical stimulators with integrated monitoring capabilities. Devices limited to only muscle monitoring capability (i.e., without electrical muscle stimulation capability) were not intended to be included in E0740.

Product Review
Products that only have monitoring capabilities but do not include electrical stimulation of the pelvic floor muscles have been assigned to E0740. All products currently listed on the PDAC Product Classification List with HCPCS code E0740 will undergo a code re-review. Manufacturers of affected products will be notified to submit product information to the PDAC to take into consideration along with the product information already on file.

Coding for Monitoring Devices
In general, Medicare does not provide reimbursement for devices used to provide monitoring functions. There may be some Part B coverage for devices used as part of biofeedback therapy. Biofeedback therapy does not fall within DME contractor jurisdiction. Consult the appropriate A/B MAC for information regarding coverage and coding for devices used for biofeedback therapy. Coding for products that fall within DME contractor jurisdiction will be assigned as part of the coding review process.

For questions about correct coding, contact the PDAC Contact Center at (877) 735-1326 during the hours of 8:30 a.m. to 4 p.m. CT, Monday through Friday, or email the PDAC by completing the DME PDAC Contact Form.