In re LCD Complaint, DAB CR6601 (2025)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

On October 7, 2024, the Civil Remedies Division (CRD) of the Departmental Appeals Board, United States Department of Health & Human Services (DHHS), received correspondence from Dr. Michael Scott Schieber, on behalf of his patient and the  Aggrieved Party, Viktor Ryskin.  Based on the contents of the letter, it appeared that the Aggrieved Party was challenging a local coverage determination (LCD) regarding two gene analysis tests, “Factor V Leiden (81241-90GA)” and “Prothrombin Factor II (81240-90GA),” for which Medicare had denied payment.  Request for Hearing (RFH) at 1.  According to Dr. Schieber, the tests are necessary to treat the Aggrieved Party’s venous thrombosis because they will test for hypercoagulability and assist in determining the best direction to proceed with the patient.  RFH at 1.  CRD treated the correspondence as an LCD complaint, docketed the LCD complaint under C-25-21, 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 the Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), dated October 23, 2024. 

The Order advised the Aggrieved Party that while the correspondence provided enough information for me to determine that an LCD was being challenged, it was missing 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

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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). 

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

• Representative-identifying Information.  If the Aggrieved Party has a representative, then he 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 Aggrieved Party.  42 C.F.R. § 426.400(c)(2).
• LCD-identifying information.  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.  42 C.F.R. § 426.400(c)(4).
• 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 must be provided.  42 C.F.R. § 426.400(c)(5).
• Clinical or scientific evidence.  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.  42 C.F.R. § 426.400(c)(6).

To date, the Aggrieved Party has not filed an amended complaint in response to my October 23, 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.