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.

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.

Statutory coverage criteria for refractive lenses are specified in the related Policy Article.

For beneficiaries who are aphakic (i.e., who have had a cataract removed but do not have an implanted intraocular lens (IOL) or who have congenital absence of the lens), the following lenses or combinations of lenses are covered when determined to be medically necessary:

1. Bifocal lenses in frames; or
2. Lenses in frames for far vision and lenses in frames for near vision; or
3. When a contact lens(es) for far vision is prescribed (including cases of binocular and monocular aphakia), payment will be made for the contact lens(es), and lens(es) in frames for near vision to be worn at the same time as the contact lens(es) and lenses in frames to be worn when the contacts have been removed.

For beneficiaries who are pseudophakic (i.e., those who have an IOL), refer to the Policy Article for information about coverage of the initial pair of lenses.

For aphakic beneficiaries (i.e., those who do not have an IOL), replacement lenses are covered when they are medically necessary. Refer to the Policy Article for information about noncoverage of replacement lenses for pseudophakic beneficiaries.

Anti-reflective coating (V2750), tints (V2744, V2745) or oversize lenses (V2780) are covered only when they are medically necessary for the individual beneficiary and the medical necessity is documented by the treating practitioner. When these features are provided as a beneficiary preference item and are billed with an EY modifier (see LCD-related Standard Documentation Requirements Article), they will be denied as not reasonable and necessary.

UV protection is considered reasonable and necessary following cataract extraction; therefore, additional medical necessity justification by the treating practitioner beyond inclusion on the order is not necessary.

The addition of UV coating (V2755) is not reasonable and necessary for polycarbonate lenses (V2784). Claims for code V2755 billed in addition to code V2784 will be denied as not reasonable and necessary. Additional information regarding the coding and billing of UV coating (V2755) on lenses with UV protective properties inherent in the material may be found in the related Policy Article.

Tinted lenses (V2745), including photochromatic lenses (V2744), used as sunglasses, which are prescribed in addition to regular prosthetic lenses to an aphakic beneficiary, will be denied as not reasonable and necessary.

Lenses made of polycarbonate or other impact-resistant materials (V2784) are covered only for beneficiaries with functional vision in only one eye. In this situation, an impact-resistant material is covered for both lenses, if eyeglasses are covered. Claims for code V2784 that do not meet this coverage criterion will be denied as not reasonable and necessary.

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.