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Gives Me Defintion

Coverage and Fair Reimbursement for Customized
Breast Prostheses

Issue. Breast cancer survivors who cannot or are not candidates for, or choose not to have, painful reconstructive surgery should not be denied an aesthetically and functionally adequate
post-mastectomy option.

Background. The American Cancer Society estimates that more than 192,370 women will be diagnosed with breast cancer in 2008, making breast cancer the most common cancer among women in the United States other than skin cancer. A woman has about a 1 in 8 chance of having invasive breast cancer during her life. The good news is that there are approximately 2.5 million breast cancer survivors in the United States today, and the disease has become treatable and beatable. However, breast cancer can leave women with the devastating loss of breasts as a result of a mastectomy. Some women cannot or choose not to have reconstructive surgery and are left without meaningful options.

Medicare Denies Women a Choice. There is currently no requirement for health plans (including Medicare) to pay for external, non-surgical breast reconstruction options. Therefore, while Medicare pays for expensive and invasive reconstructive surgery, women are denied the choice for breast prostheses that are an aesthetically and functionally adequate post-mastectomy option. Medicare has designated a valid Healthcare Common Procedure Coding System (HCPCS) code for custom breast prostheses; however, carriers continue to deny claims for the medically necessary customized features that differentiate this product from non-customized, off-the-shelf products. Medicare covers only off-the-shelf, generic breast forms. Moreover, since private carriers often follow Medicare coverage policy, this policy has sweeping negative consequences by denying coverage for women of all ages who need breast prostheses.

Medicare coverage for custom fitted breast prostheses is not only medically necessary, but is the recognized Standard of Care for treatment of women post-mastectomy. Currently, Medicare only pays for either expensive and invasive breast reconstructive surgery or an off-the-shelf, non-customized (one-size-fits-all) breast form. The non-customized generic forms do not look or function like a breast, and are medically inadequate for many women post-mastectomy, Custom breast prostheses, similar to all other lost or malformed body parts are the STANDARD OF CARE in the treatment of women post-mastectomy. The American Society of Breast Surgeons, the national organization of surgeons who perform mastectomies and surgical breast reconstructions has issued a letter to Medicare supporting the need for Medicare Coverage of custom-fitted breast prostheses.
Medicare provides payment for a custom-fitted prostheses to replace every other amputated or malformed body part, except breast. Not only is there a compelling medical necessity for coverage, and hence access to a custom breast prosthesis as an option to expensive breast reconstructive surgery, it is also pointedly inequitable for the breast to be singled out as the only missing or malformed body part for which a custom prostheses is not covered by Medicare.

The denial of coverage is not only inequitable, but has a disparate impact on both older and minority women in particular. The adverse impact of this inequity is felt only by women at a time when they are most vulnerable and being forced to make decisions that have life saving and life-long consequences. Further, this inequity has a particularly adverse impact on older women and non-white women given that they are less likely to be candidates for surgical breast reconstruction, and hence have no real option for
breast reconstruction.

Custom fabricated breast prostheses are specially fitted to match the anatomical uniqueness of a woman following a mastectomy, providing RESTORATION just like the individualized fit of a custom fabricated external limb or any other amputated or malformed body part. They are custom weighted and and contour precisely to the healed chest wall permitting magnetic and other attachment capabilities. The fit, comfort and confidence a custom fitted prostheses provides facilitates a return to a healthy and
functional lifestyle.

Off-the-shelf forms are heavy, hot to wear, and frequently do not provide symmetry. They often are ill-fitting and insecure. They do not provide restoration of the lost breast, but only assist women in looking normal in clothes. They do not attach or conform to the healed chest wall thereby requiring women to wear a pocketed bra. Further, they do not look or function like the lost breast.
Custom fabricated breast prostheses are offered in different skin tones, and matching nipple areolar complexes providing needed choices to the many minority women who have mastectomies.
Medicare’s Denial of Reimbursement for Medically Necessary Custom fitted Breast Prostheses Leaves Women with No Option for Reconstruction other than Surgery. Given the lack of access to and payment for non-surgical external custom breast prostheses, the surgical reconstruction route is the one increasingly chosen by women to restore their lost breast (40-50+ %). A strong motivating factor for choosing surgical breast reconstruction is to avoid or “get rid of” the external generic prefabricated “off the shelf” breast form which does not conform or fit the chest wall, does not permit attachment in a meaningful way, may not be an appropriate size or weight, does not have an areolar-nipple complex, and does not look or function like the lost breast. An unintended consequence of the lack of a meaningful option to surgery is an increased rate of surgical breast reconstructions.
Providing women with the option of a custom fitted breast prosthesis is less costly than surgery and similar to the cost of prefabricated breast forms and the required pocket bras. Surgical breast reconstruction is not a panacea. Surgical restoration is associated with significant complication rates, and frequent reoperations due to complications or to replace implants. Costs of surgical reconstruction are multiples higher than the cost of a custom fitted breast prostheses.

Further, the costs over time of prefabricated forms and the required pocketed mastectomy bras are similar to the costs of a custom fitted breast prostheses.

Providing women with the option of non-surgical external breast reconstruction is consistent with WHRCA, and provides women who are not surgical candidates an option for breast reconstruction. Women who undergo breast amputation for breast cancer, similar to the individual undergoing limb or other body part amputation for cancer, need and deserve the same option for non-surgical anatomical reconstruction of their breast or their limb.

Provision of a choice for custom fitted breast prostheses will provide women with an alternative to expensive, invasive, and the risks of reconstructive surgery. Further, it would serve not only to ensure women receive the appropriate medical treatment, but likely result in significant cost savings to both Medicare and private insurers over the currently covered and increasingly utilized choice of surgical reconstruction.

Requested Action: Amend Section 1861 of the Social Security Act (42 U.S.C. 1395x) to include coverage for customized fabricated external breast prostheses following surgical removal of the breast. This will provide an aesthetically and functionally adequate post-mastectomy option to expensive and invasive reconstructive surgery and provide medically necessary care for women who are not candidates for surgical breast reconstruction.

Section 1. Short Title

This Act may be cited as the ‘[insert title….of 2009]’.

Section 2. Medicare Coverage of Customized Fabricated External Breast Prosthesis (a) Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended--
(1) in subsection (s)(8)--
(A) by inserting ‘ and customized fabricated external breast prosthesis following the surgical removal of the breast’ after ‘colostomy care)’; and (B) by inserting ‘ and customized fabricated external breast prostheses’ after ‘such devices’.

Here is how the above insert would modify current law:

1861(s) The term "medical and other health services" means any of the following items or services: 1861(s)(8) prosthetic devices (other than dental) which replace all or part of an internal body organ (including colostomy bags and supplies directly related to colostomy care) and customized fabricated external breast prosthesis following the surgical removal of the breast, including replacement of such devices and customized fabricated external breast prostheses, and including one pair of conventional eyeglasses or contact lenses furnished subsequent to each cataract surgery with insertion of an intraocular lens;

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Reimbursement of Breast Replacement Prostheses
Can Save Medicare Millions Final.pdf


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