In re LCD Complaint: Christine M. Deluca, CR6486 (2024)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

On March 19, 2024, the Civil Remedies Division (CRD) of the Departmental Appeals Board, United States Department of Health & Human Services (DHHS), received correspondence from Christine M. DeLuca (Aggrieved Party).  Based on the contents of the letter, it appeared that the Aggrieved Party was challenging a local coverage determination (LCD) regarding a continuous glucose monitor (CGM).  The Dexcom G7 CGM system was specifically recommended by the Aggrieved Party’s physician.  CRD treated the Aggrieved Party’s correspondence as an LCD complaint, docketed the LCD Complaint under C-24-323, and assigned the case to me for adjudication.

I am required to determine if an LCD complaint is “acceptable,” including whether it is “valid” under 42 C.F.R. § 426.400.  After reviewing the Aggrieved Party’s filing, I concluded that it was not an acceptable and valid LCD complaint.  I notified the Aggrieved Party of this conclusion in an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), dated April 8, 2024.

The Order advised the Aggrieved Party that while her correspondence provided information to determine that an LCD was being challenged, it was missing other information necessary to constitute a valid LCD complaint.  The Order informed the Aggrieved Party that the regulations provide only one opportunity to amend and submit an acceptable complaint.  42 C.F.R. § 426.410(c)(1).  The Aggrieved Party was also advised that if an acceptable amended complaint was not submitted, then I am required to issue a decision dismissing the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).

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The Aggrieved Party was directed to submit a valid amended complaint with the following information, within 30 days of the date of the Order:

A copy of the initial denial notice from Medicare. The Aggrieved Party filed her LCD challenge within 6 months of the written statement from her treating practitioner, dated December 20, 2023, and appears to have filed the LCD challenge before receiving the service.  However, there is not enough information provided for me to determine the timeliness of the complaint  pursuant to 42 C.F.R. § 426.400(b).  

If the Aggrieved Party has a representative, then it is required to provide the representative’s identifying information, which must include the representative’s name, mailing address, telephone number, email address, if any, and a copy of the written authorization to represent the beneficiary.  

The name of the contractor using the LCD, title of the LCD being challenged, and the specific provision (or provisions) of the LCD adversely affecting the Aggrieved Party must also be provided as part of an acceptable complaint.

Finally, the Aggrieved Party was required to submit any clinical or scientific evidence that supports the complaint and an explanation for why the Aggrieved Party thinks that this evidence shows that the LCD is not reasonable.

To date, the Aggrieved Party has not filed an amended complaint in response to my April 8, 2024 Order.  Thus, this complaint remains unacceptable within the terms of 42 C.F.R. § 426.410(b).  Accordingly, this complaint is dismissed.  42 C.F.R. § 426.410(c)(2).  A new complaint cannot be filed again for six months.  42 C.F.R. § 426.410(c)(3).

It is so ordered.