LCD L35001

Coverage Guidance

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Section 1862(a)(7) excludes routine physical examinations, unless otherwise covered by statute.

CMS Publications:

CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Part 2:

Section 140.2 Breast Reconstruction Following Mastectomy

Indications and Limitations of Coverage

Abstract:

Reduction mammaplasty is the surgical removal of a substantial portion of the breast, including the skin and underlying glandular tissue, until a clinically normal size is obtained. Breasts are pair organs, and breast hypertrophy generally affects both sides, therefore, bilateral surgery is usually performed.

Reduction mammaplasty is performed to reduce the size of the breasts and help ameliorate symptoms caused by the hypertrophy and to reduce the size of a normal breast to bring it into symmetry with a breast reconstructed after cancer surgery.

Indications:

Reduction mammaplasty is considered medically necessary:

• When the patient has significant symptoms that have interfered with normal daily activities, despite conservative management, for at least 6 months, including at least one of the following criteria:

• History of back and/or shoulder pain which adversely affects activities of daily living (ADLs) unrelieved by, e.g.:

• conservative analgesia (e.g., such as NSAID, compresses, massage, etc.)

• supportive measures (e.g., such as garments, back brace, etc.),

• physical therapy

• correction of obesity

• History of significant arthritic changes in the cervical or upper thoracic spine, optimally managed with persistent symptoms and/or significant restriction of activity, e.g.:

• Signs and symptoms of ulnar paresthesias

• Cervicalgia

• Torticollis

• Acquired kyphosis

Signs and symptoms of:

• intertriginous maceration or infection of the inframammary skin (e.g., hyperpigmentation, bleeding, chronic moisture, and evidence of skin breakdown), refractory to dermatologic measures, or

• shoulder grooving with skin irritation (e.g., areas of excoriation and breakdown) by appropriate supporting garment

AND

Considerable attention has been given to the amount of breast tissue removed in differentiating between cosmetic and medically necessary reduction mammoplasty. To be considered a non-cosmetic procedure it is expected that at least a minimal amount of breast tissue will be removed. Yet, arbitrary minimum weight breast tissue removed criteria do not consistently reflect the consequences of mammary hypertrophy in individuals with a unique body habitus. There are wide variations in the range of height, weight, and associated breast size that cause symptoms. The amount of tissue that must be removed in order to relieve symptoms will vary and depend upon these variations.

The following are guidelines (not rules) that address the patient's body surface area (BSA) and the amount of breast tissue removed

BSA 1.35-1.45 199-238

BSA 1.46-1.55 239-284

BSA 1.56-1.69 285-349

Equal to or greater than 350g

Limitations of Coverage:

1. Cosmetic surgery to reshape the breasts to improve appearance is not a Medicare benefit.

2. Indications of Coverage must be met.

Note: Reconstruction of the affected and the contralateral unaffected breast following a medically necessary mastectomy is considered a non-cosmetic procedure. National coverage provides for payment of breast reconstruction surgery following removal of a breast for any medical reason.

Summary of Evidence

N/A

Analysis of Evidence

N/A

Bibliography

Wagner DS, Alfonso DR. The influence of obesity and volume resection on success in reduction mammaplasty: an outcomes study. Plast Reconstr Surg. 2005 Apr;115(4):1034-8