In re LCD Complaint: Hemoglobin A1C Level, DAB CR5896 (2021)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

J.M. (Aggrieved Party or AP) filed correspondence by mail on February 12, 2021, which the Civil Remedies Division (CRD) received and docketed as a complaint challenging the validity of a local coverage determination (LCD).  CRD assigned the case to me for adjudication.

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, dated May 12, 2021, I informed the Aggrieved Party that she had one opportunity to submit an acceptable complaint.  See 42 C.F.R. § 426.410(c)(1).

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

• Timeliness information: A complete copy of the initial denial notice that includes the date of the notice;
• LCD-identifying information: (i) the name of the contractor using the LCD; (ii) the title of the LCD being challenged; (iii) the specific provision(s) of the LCD adversely affecting the AP;

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• Aggrieved Party statement: A statement from the AP explaining why she thinks that the relevant provision(s) of the LCD is (are) not valid under the reasonableness standard; and
• Clinical or scientific evidence:  Copies of clinical or scientific evidence that support the complaint and an explanation for why the AP thinks that this evidence shows that the LCD is not reasonable.

My Order directed the Aggrieved Party to file the amended complaint within 30 days.  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).

The Aggrieved Party failed to respond to my Order.  Therefore, for the reasons explained in that Order, the 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.