In re CMS LCD Complaint: Vitamin D Assay Testing, DAB CR6909 (2026)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

The Civil Remedies Division (CRD) of the Departmental Appeals Board (DAB) received correspondence dated January 26, 2026 from S.B.1  CRD treated the correspondence as a challenge to a local coverage determination (LCD) and docketed the case as C-26-368 before me. 

The applicable regulations require me to first determine whether S.B. filed an “acceptable” and “valid” complaint.  42 C.F.R. § 426.410(b).  After reviewing S.B.’s filing, I concluded it was not.  Therefore, on April 20, 2026, I issued an Acknowledgment of Receipt and Order to Amend Unacceptable Complaint (Order) to afford S.B. one opportunity to submit an acceptable complaint, as permitted by 42 C.F.R. § 426.410(c)(1). 

In the Order, I described the elements needed for an acceptable LCD complaint.  I identified the deficiencies in S.B.’s complaint and directed her to resolve those deficiencies if she wished to pursue her challenge: 

• Aggrieved Party Status:  I explained S.B’s complaint was unacceptable because I could not verify she is an “aggrieved party” based on her initial filings.  I therefore directed S.B. to provide evidence the Centers for Medicare & Medicaid Services (CMS) or one of its contractors denied a claim submitted on her behalf for coverage by the Medicare program.  Her initial filing also failed to demonstrate CMS or one of its contractors applied an LCD to deny such a claim.  I therefore directed S.B. to submit such evidence. 

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• Timeliness:  S.B. did not submit an initial notice denying coverage for service by the Medicare program.  Therefore, I could not conclude her complaint was timely.  My direction to S.B. to submit evidence of a claim denied by CMS or one of its contractors would resolve this issue.
• LCD Identifying Information:  I explained there is no LCD with the title listed in S.B.’s initial filing.  The information S.B. did provide suggested she may be seeking to challenge LCD L39391, entitled Vitamin D Assay Testing.  I directed S.B. to identify the LCD she wishes to challenge, whether L39391 or a different LCD.
• Aggrieved Party statement:  S.B. has neither identified a provision or provisions of an LCD policy affecting her nor explained why she believes they are not valid under the reasonableness standard.  I directed S.B. to identify the specific LCD policy and provisions she wishes to challenge and explain why they are not valid under the reasonableness standard.
• Clinical or scientific evidence:  S.B. has not submitted clinical or scientific evidence in support of her complaint or an explanation of why that evidence shows the challenged LCD provision is not reasonable.  I directed S.B. to provide this supporting evidence. 

I also required S.B. to either register for access to the DAB E-file system or request a waiver from its use in writing.  I enclosed instructions for registration and use of the DAB E-file system. 

My Order directed S.B. to file an amended complaint addressing these issues by May 20, 2026.  I advised S.B. that if she did not submit an acceptable amended complaint by that date, I would issue a decision dismissing this action.  42 C.F.R. § 426.410(c)(2). 

S.B. has not filed a response since that time.2   Her initial complaint filed February 11, 2026 remains unacceptable under 42 C.F.R. § 426.410(b).  I am required to dismiss an unacceptable complaint after giving one opportunity to amend it.  42 C.F.R. § 426.410(c)(2).  Accordingly, I order this complaint dismissed.