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.

Benefit Category and other statutory requirements are discussed in the related
Policy Article NONMEDICAL NECESSITY AND COVERAGE RULES section. Refer to the
Policy article for information on these criteria.

The purpose of a Local Coverage Determination (LCD) is to provide information
regarding "reasonable and necessary" criteria based on Social Security Act
1862(a)(1)(A) provisions.

In addition to the "reasonable and necessary" criteria contained in this LCD
there are other payment rules, which are discussed in the following documents,
that must also be met prior to Medicare reimbursement:

  * The LCD-related Standard Documentation Requirements Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  * The LCD-related Policy Article, located at the bottom of this policy under the Related Local Coverage Documents section.

  * Refer to the Supplier Manual for additional information on documentation requirements.

  * Refer to the DME MAC web sites for additional bulletin articles and other publications related to this LCD.

For the items addressed in this LCD, the "reasonable and necessary" criteria,
based on Social Security Act 1862(a)(1)(A) provisions, are defined by the
following coverage indications, limitations and/or medical necessity.

Bed Pans (E0275, E0276) are covered for beneficiaries who are bed-confined
(see NCD 280.1).

Rectal inserts and related accessories (A4337) will be denied as not
reasonable and necessary because they do not meet the medical evidence
requirements outlined in the Centers for Medicare & Medicaid Services (CMS)
Program Integrity Manual (Internet-only Manual 100-08), Chapter 13, 13.7.1.

Electrical continence aids are in the experimental stage of development and
there is no valid scientific documentation of their effectiveness and safety;
therefore, they are denied as not reasonable and necessary (see NCD 230.15).

Rectal catheters/tubes and related collection systems will be denied as
statutorily non-covered (no benefit - see related Policy Article).

Enema systems (gravity and manual pump), codes A4458 and A4459 respectively,
will be denied as statutorily non-covered (no benefit - see related Policy
Article).

Pulsed irrigation and evacuation systems (E0350, E0352) will be denied as
statutorily non-covered (no benefit - see related Policy Article).

Incontinence garments (e.g., briefs, diapers) coded A4520 will be denied as
statutorily non-covered (no benefit - see related Policy Article).

Disposable underpads (A4554) and non-disposable (A4553) underpads will be
denied as statutorily non-covered (no benefit - see related Policy Article).

Toilet seats, raised toilet seats, toilet seat lift mechanisms, bidets and
bidet toilet seats are discussed in the Commodes Local Coverage Determination
and related Policy Article.

  
GENERAL

A Standard Written Order (SWO) must be communicated to the supplier before a
claim is submitted. If the supplier bills for an item addressed in this policy
without first receiving a completed SWO, the claim shall be denied as not
reasonable and necessary.

For Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS)
base items that require a Written Order Prior to Delivery (WOPD), the supplier
must have received a signed SWO before the DMEPOS item is delivered to a
beneficiary. If a supplier delivers a DMEPOS item without first receiving a
WOPD, the claim shall be denied as not reasonable and necessary. Refer to the
LCD-related Policy Article, located at the bottom of this policy under the
Related Local Coverage Documents section.

For DMEPOS base items that require a WOPD, and also require separately billed
associated options, accessories, and/or supplies, the supplier must have
received a WOPD which lists the base item and which may list all the
associated options, accessories, and/or supplies that are separately billed
prior to the delivery of the items. In this scenario, if the supplier
separately bills for associated options, accessories, and/or supplies without
first receiving a completed and signed WOPD of the base item prior to
delivery, the claim(s) shall be denied as not reasonable and necessary.

An item/service is correctly coded when it meets all the coding guidelines
listed in CMS HCPCS guidelines, LCDs, LCD-related Policy Articles, or DME MAC
articles. Claims that do not meet coding guidelines shall be denied as not
reasonable and necessary/incorrectly coded.

Proof of delivery (POD) is a Supplier Standard and DMEPOS suppliers are
required to maintain POD documentation in their files. Proof of delivery
documentation must be made available to the Medicare contractor upon request.
All services that do not have appropriate proof of delivery from the supplier
shall be denied as not reasonable and necessary.