In re LCD Complaint: Urological Supplies (L33803), DAB CR5995 (2021)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

Mary Sullivan (Aggrieved Party) submitted undated correspondence which the Civil Remedies Division treated as a challenge to a local coverage determination (LCD); docketed as styled above, C-22-37; and assigned to me for review.

The regulations at 42 C.F.R. § 426.410(b) require that I determine whether an aggrieved party has filed an “acceptable” and “valid” complaint.  After reviewing the Aggrieved Party’s filing, I concluded that it was not an acceptable and valid LCD complaint under the applicable regulations.  Therefore, in an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), dated October 20, 2021, I informed the Aggrieved Party that she had one opportunity to submit an acceptable complaint.1  See 42 C.F.R. § 426.410(c)(1).

My Order listed the information that is required to be included in an LCD complaint to make it acceptable.  I specifically directed the Aggrieved Party to provide the following information:

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• Aggrieved Party statement:  The unacceptable complaint explained what items the Aggrieved Party needed, but it did not explain why the Aggrieved Party believed that the provision(s) of the LCD is (are) not valid under the reasonableness standard.  I therefore directed the Aggrieved Party to submit a statement explaining her position.
• Clinical or scientific evidence:  The Aggrieved Party also 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, using the DAB E‑File system, within 30 days of the date of the Order.  I advised the Aggrieved Party that if she did not submit an acceptable amended complaint, then I must issue a decision dismissing the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).

More than 30 days have passed since I issued the Order, and the Aggrieved Party has not filed a response amending the complaint.  Therefore, for the reasons explained in that Order, the undated complaint submitted by the Aggrieved Party remains unacceptable under 42 C.F.R. § 426.410(b).  I am required to dismiss the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  Accordingly, I order that the complaint be dismissed.

• 1. In the Order, I noted that the Aggrieved Party’s arguments – that she needs additional catheters based on factors that are unique to her medical condition – are more properly addressed in an appeal of specific claims in which the contractor has denied coverage for the additional supplies.  I further noted that the process for appealing denied claims is completely separate and independent of the process for challenging an LCD.