In re LCD Complaint: External Breast Prostheses (not specifically identified), DAB CR6401 (2023)

DECISION DISMSSING COMPLAINT

In an acknowledgment dated October 30, 2023, the Civil Remedies Division of the Departmental Appeals Board acknowledged that it had received correspondence, dated September 20, 2023, from Barbara Koenig, whom I will refer to as Petitioner.  She explained that she is a breast cancer survivor, in need of a custom breast prosthesis; she is unable to wear a standard prosthesis, which does not fit properly and causes her pain.  However, the supplier of custom prostheses advised her that Medicare will not pay for a custom prosthesis.

In the October 30 acknowledgment, I explained that the regulations governing these proceedings do not allow me to accept an incomplete complaint and that I had determined that her complaint did not meet the regulatory requirements.  42 C.F.R. §§ 426.400(a), 426.410(b)(1) and (2).  Pursuant to 42 C.F.R. § 426.410(c)(1), I offered Petitioner Koenig an opportunity to file an acceptable complaint and directed her to do so no later than December 4, 2023.

First, I advised her that, based on her submissions, I could not conclude that she was an aggrieved party within the meaning of the regulation.  42 C.F.R. § 426.110.  She had not established that she was a Medicare beneficiary entitled to benefits that were denied based on a local coverage determination (LCD).  In her response to my order, dated November 15, 2023, Petitioner established that she is a Medicare beneficiary in need of the specialized prosthesis.  She did not cite an LCD that precludes coverage.  I am therefore unable to determine that she is an aggrieved party.

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Second, I advised Petitioner that I could not determine whether her complaint was timely filed because she had not established that the physician, whose letter she submitted, is her treating physician.  In her response to my order, she established that the physician is her treating physician and that her complaint was timely.  42 C.F.R. § 426.400(b)(1).

I also advised Petitioner that her amended complaint should include the following information:

• LCD-identifying information, including the name of the Medicare contractor using the LCD being challenged, the title of the LCD being challenged, and the specific provision(s) of the LCD adversely affecting her.  42 C.F.R. § 426.400(c)(4).  Petitioner's amended complaint includes none of this information.
• An aggrieved party statement explaining why she thinks that the provisions of the LCD are not valid under a reasonableness standard.  42 C.F.R. § 426.400(c)(5).  Petitioner has not provided this statement.
• Clinical or scientific evidence that supports the complaint, along with an explanation as to why this evidence shows that the LCD is not reasonable.  42 C.F.R. § 426.400(c)(6).  Petitioner has not provided the required clinical or scientific evidence.

Because Petitioner has not, within the timeframe established, submitted an acceptable amended complaint, I dismiss this action pursuant to 42 C.F.R. § 426.410(c)(2).