In re LCD Complaint: Vitamin D Assay Testing (L36692), DAB CR6441 (2024)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

On December 18, 2023, the Civil Remedies Division (CRD) of the Departmental Appeals Board, United States Department of Health & Human Services (DHHS), received correspondence from Rosemary T. Flynn (Aggrieved Party).  Based on the contents of the letter, it appeared that the Aggrieved Party was challenging the local coverage determination (LCD) regarding magnesium and vitamin D testing.  CRD docketed the LCD Complaint under C-24-135 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 January 18, 2024.

The Order advised the Aggrieved Party that while her correspondence provided information to identify the LCD being challenged, it was missing other information necessary to constitute a valid LCD complaint.  The Order also 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:

• Treating Physician Written Statement:  A copy of a written statement from the treating physician that the beneficiary needs the service that is the subject of the LCD.  This statement may be in the form of a written order for the service or other documentation from the beneficiary’s medical record (such as progress notes or discharge summary) indicating that the beneficiary needs the service.
• LCD identifying information:  (i) Name of the contractor using the LCD; (ii) Title of the LCD being challenged; (iii) The specific provision (or provisions) of the LCD adversely affecting the aggrieved party.
• Aggrieved party statement:  A statement from the aggrieved party explaining what service is needed and why the aggrieved party thinks that the provision(s) of the LCD is (are) not valid under the reasonableness standard.
• Clinical or scientific evidence:  Copies of clinical or scientific evidence that support the complaint and an explanation for why the aggrieved party thinks that this evidence shows that the LCD is not reasonable.  This can include articles from medical journals or healthcare publications.

To date, the Aggrieved Party has not filed an amended complaint in response to my January 18, 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.