NON-MEDICAL NECESSITY COVERAGE AND PAYMENT RULES:
For any item to be covered by Medicare, it must 1) be eligible for a defined Medicare benefit category, 2) be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and 3) meet all other applicable Medicare statutory and regulatory requirements. Information provided in this policy article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e. “reasonable and necessary”).
In order for any item to be eligible for coverage under Medicare, the item must be eligible for inclusion into one of the existing coverage Benefit Categories. Rectal inserts and electrical incontinence aids are covered under the Prosthetic Devices benefit (Social Security Act §1861(s)(9)). Bed pans are covered under the Durable Medical Equipment benefit (Social Security Act §1861(s)(6)). In order for a beneficiary’s equipment to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination must be met. In addition, there are specific statutory payment policy requirements, discussed below, that also must be met.
Many bowel management devices (see bulleted list below, not all inclusive) fail one or more of the relevant requirements in §1861(n) of the Act and are thus statutorily excluded from coverage (see the CMS Nation Coverage Determinations Manual (Internet-only Manual 100-03) Chapter 1, Part 4, §280.1):
Disposable Sheets and Bags (A4335) – Deny – Non-reusable disposable supplies
Incontinence Pads (A4553 and A4554) – Deny – Non-reusable supply; Hygienic item
Diapers (A4520) - Deny – Non-reusable supply; Hygienic item
Manual pump enema systems (e.g., Peristeen - Coloplast, Minneapolis, MN) or gravity-administered enema systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability. In addition, these devices do not meet the Prosthetic Benefit because they do not replace a non-functioning internal body organ.
Rectal catheters/tubes and related collection systems do not meet the Durable Medical Equipment (DME) benefit because these devices do not meet the requirement of durability. In addition, these devices do not meet the Prosthetic Benefit because they do not replace a non-functioning internal body organ.
Pulsed irrigation and evacuation devices (PIE – P.I.E. Medical Inc., Buford, GA) do not meet the DME benefit because they are considered institutional equipment.
Vaginal inserts and related accessories (Eclipse Vaginal Insert system - Pelvalon, Inc) for the treatment of fecal incontinence are not DME MAC jurisdiction. Claims for vaginal inserts and related accessories (A4563 - RECTAL CONTROL SYSTEM FOR VAGINAL INSERTION, FOR LONG TERM USE, INCLUDES PUMP AND ALL SUPPLIES AND ACCESSORIES, ANY TYPE EACH) submitted to the DME MACs will be rejected as wrong jurisdiction.
REQUIREMENTS FOR SPECIFIC DMEPOS ITEMS PURSUANT TO Final Rule 1713 (84 Fed. Reg Vol 217)
Final Rule 1713 (84 Fed. Reg Vol 217) requires a face-to-face encounter and a Written Order Prior to Delivery (WOPD) for specified HCPCS codes. CMS and the DME MACs provide a list of the specified codes, which is periodically updated. The required Face-to-Face Encounter and Written Order Prior to Delivery List is available here.
Claims for the specified items subject to Final Rule 1713 (84 Fed. Reg Vol 217) that do not meet the face-to-face encounter and WOPD requirements specified in the LCD-related Standard Documentation Requirements Article (A55426) will be denied as not reasonable and necessary.
If a supplier delivers an item prior to receipt of a WOPD, it will be denied as not reasonable and necessary. If the WOPD is not obtained prior to delivery, payment will not be made for that item even if a WOPD is subsequently obtained by the supplier. If a similar item is subsequently provided by an unrelated supplier who has obtained a WOPD prior to delivery, it will be eligible for coverage.
POLICY SPECIFIC DOCUMENTATION REQUIREMENTS
In addition to policy specific documentation requirements, there are general documentation requirements that are applicable to all DMEPOS policies. These general requirements are located in the DOCUMENTATION REQUIREMENTS section of the LCD.
Refer to the LCD-related Standard Documentation Requirements article, located at the bottom of this Policy Article under the Related Local Coverage Documents section for additional information regarding GENERAL DOCUMENTATION REQUIREMENTS and the POLICY SPECIFIC DOCUMENTATION REQUIREMENTS discussed below.
Rectal inserts are prosthetic devices constructed of rubber, latex, silicone or other similar material and act as a barrier to the passage of fecal matter through the rectum. Use code A4337 (INCONTINENCE SUPPLY, RECTAL INSERT, ANY TYPE, EACH) for this item. Code A4337 includes the insert and any associated supplies or accessories for insertion and maintenance of the device.
Rectal catheters/tubes and related collection systems are products designed to be inserted into the rectum to collect fecal material. They also serve to assist in protection of perianal skin integrity in the patient with fluid and semi-fluid waste.
An electrical continence aid is a prosthetic device consisting of a plastic plug, molded into the shape of the patient's anal canal, which contains two implanted electrodes that are connected by a wire to a small portable generator. An electrical current is produced which stimulates the anal musculature to cause a contraction sufficient to hold the plug in while allowing the patient to ambulate without incontinence.
HCPCS codes A4458 (ENEMA BAG WITH TUBING, REUSABLE) and code A4459 (MANUAL PUMP ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE) describe devices used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. An enema system consists of an irrigation fluid holding chamber and a rectal catheter (with or without an inflatable balloon). Fluid is instilled either via gravity or a manual pump.
The Peristeen transanal irrigation system is a device used to empty the lower bowel and to prevent chronic constipation and fecal incontinence or simply as a method of bowel management. The system consists of an enema bag, a rectal catheter with an inflatable balloon and a pump. Effective for claims with dates of service on or after January 1, 2015, the correct code to bill is A4459 (MANUAL PUMP ENEMA SYSTEM, INCLUDES BALLOON, CATHETER AND ALL ACCESSORIES, REUSABLE, ANY TYPE).
HCPCS code A4459 is an all-inclusive code at initial issue. Separate billing of any of the individual components is not allowed at initial issue. For billing refills of the disposable rectal catheter, HCPCS code A4453 (RECTAL CATHETER FOR USE WITH THE MANUAL PUMP-OPERATED ENEMA SYSTEM, REPLACEMENT ONLY) must be used.
HCPCS code E0350 describes a colorectal irrigation system that consists of an irrigation fluid holding chamber, a rectal catheter with an inflatable balloon and an electric pump. Irrigation fluid is administered in a pulsatile manner to hydrate stool to a semi-liquid form and allow the liquefied stool to evacuate. Code E0352 describes all disposable supplies and accessories used with code E0350 including, but not limited to, a water reservoir, speculum, valve mechanism and collection bag or box.
HCPCS codes E0275 (BED PAN, STANDARD, METAL OR PLASTIC) and E0276 (BED PAN, FRACTURE, METAL OR PLASTIC) describe a shallow vessel placed under a bedridden patient to collect feces and urine. To meet Medicare coverage and DME benefit requirements, they must be durable. Disposable bed pans must be billed using code A9270 (NONCOVERED ITEM OR SERVICE).
Suppliers should contact the Pricing, Data Analysis and Coding (PDAC) Contractor for guidance on the correct coding of these items.