Summary Of Evidence

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Analysis of Evidence

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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.