In re CMS LCD Complaint: Custom-Made Breast Prostheses, DAB CR5162 (2018)

Department of Health and Human Services
Civil Remedies Division

Docket No. C-18-1016
Decision No. CR5162


Vivian B. Batts (the Aggrieved Party), submitted correspondence dated June 1, 2018, which the Civil Remedies Division treated as a challenge to a local coverage determination (LCD) and docketed as C-18-1016. I was designated to review the purported LCD challenge.

The applicable regulations require that I first determine whether an aggrieved party filed an "acceptable" and "valid" complaint. 42 C.F.R. § 426.410(b). After reviewing the Aggrieved Party's filing, it was unclear whether her challenge was timely, meaning within six months after her treating practitioner issued a written statement explaining the need for the service. 42 C.F.R. § 426.400(b). But even assuming timely filing I concluded the Aggrieved Party had not filed an otherwise acceptable and valid LCD complaint under the applicable regulations. Therefore, on June 22, 2018, I issued an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order). In that order, I informed the Aggrieved Party that she had one opportunity to submit an acceptable complaint. See 42 C.F.R. § 426.410(c)(1).

My June 22 Order described the elements required to be included in an LCD complaint to make it acceptable. I specifically directed the Aggrieved Party to provide all of the following information:

  • Treating Physician Written Statement: The Aggrieved Party did not provide any documentation from her treating physician explaining that she needs custom breast prostheses. I therefore directed the Aggrieved Party to provide a copy of a written

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statement from her treating physician that she needs custom breast prostheses, which I explained could be in the form of a written order for the service or other documentation from her medical record indicating she needed them.

  • LCD-identifying information: As I observed in my June 22, 2018 Order, it was unclear whether the unacceptable complaint was challenging an LCD because the Aggrieved Party did not identify an LCD that she seeks to challenge. I therefore directed the Aggrieved Party to provide (i) the name of the contractor using the LCD; (ii) the title of the LCD; and (iii) the specific provision of the LCD that adversely affects the Aggrieved Party.
  • Clinical or scientific evidence: The Aggrieved Party did not provide copies of clinical or scientific evidence in support of her complaint. Nor did she explain why she believes that this evidence shows that the LCD is not reasonable. I therefore directed the Aggrieved Party to submit such evidence and argument.

My Order directed the Aggrieved Party to file an amended complaint by July 27, 2018. I advised the Aggrieved Party that if she did not submit an acceptable amended complaint, then I would issue a decision dismissing this action. 42 C.F.R. § 426.410(c)(2).

The Aggrieved Party failed to file a response to my June 22, 2018 Order. Therefore, as I explained in that Order, her June 1, 2018 complaint remains unacceptable under 42 C.F.R. § 426.410(b). I am required to dismiss an unacceptable complaint after giving an aggrieved party the opportunity to amend it. 42 C.F.R. § 426.410(c)(2). Accordingly, I order this complaint dismissed.