SUBJECT:

In re CMS LCD Complaint:

Breast Prosthesis

This Local Coverage Determination (LCD) appeal was docketed and assigned to me for review. Pursuant to the applicable regulations, I must determine if the complaint is acceptable. 42 C.F.R. � 426.410(b). In so doing, I must determine if the complaint meets the requirements for a valid complaint as set forth in 42 C.F.R. � 426.400.

I reviewed the complaint and found it was unacceptable because I had some questions concerning whether it constituted a LCD denial pursuant to the Medicare statute and applicable regulations. However, so that I had all the relevant information, and pursuant to the relevant regulation at 42 C.F.R. � 426.410(c)(1), I provided the aggrieved party, in an Order dated June 23, 2004, one opportunity to amend her complaint. I further informed the aggrieved party that if she failed to submit an acceptable amended compliant by the deadline imposed, I must issue a decision dismissing the unacceptable complaint.

I asked that within 30 days of the date of my Order she submit the following:

�Treating physician written statement (42 C.F.R. � 426.400(c)(3))-The regulations require a copy of a written statement from the treating physician that the beneficiary needs the service that is the subject of the LCD. The report submitted by the aggrieved party from Dr. Cynthia W. Su is for a cosmetic consultation and indicates that the patient presented for a consultation regarding breast reconstruction as a result of significant weight loss. There is no indication from this report that the treating physician, Dr. Su, states that the aggrieved party/beneficiary needs such surgery or that such surgery is "medically necessary." Moreover, the LCD cited by the aggrieved party/beneficiary is "Medicare covers breast prosthesis (including a surgical brassiere ) after a mastectomy." There is no indication from Dr. Su's report that the aggrieved party/beneficiary has had a mastectomy and is requesting reconstructive surgery. I also note that there is a National Coverage Determination (NCD), effective May 15, 1980, which provides for Medicare Coverage for "reconstruction of the affected and the contralateral unaffected breast following a medically necessary mastectomy" and that "program payment may be made for breast reconstruction surgery following removal of a breast for any medical reason." NCD Section 35-47. That Manual section specifically provides, however, that "program payment may not be made for breast reconstruction for cosmetic reasons. (Cosmetic surgery is excluded from coverage under section 1862(a)(10) of the Social Security Act.)." NCD 35-47.

I also requested that the aggrieved party identify in her amended complaint more specifically-

� the title of the LCD the aggrieved party is challenging;

� why that provision applies to the service the aggrieved party alleges she needs;

� the particular provision of the LCD which the aggrieved party alleges affects her; and

� why this service is "needed" or "medically necessary" and why the LCD is incorrect.

To date, no such submission has been received. Thus, the aggrieved party has not filed an acceptable complaint within the reasonable time frame set in my Order. Therefore, I must dismiss the unacceptable complaint pursuant to 42 C.F.R. � 426.410(c)(2).

Alfonso J. Montano

Administrative Law Judge