In re LCD Complaint: Rituximab (L33394), DAB CR6220 (2023)

DECISION DISMISSING COMPLAINT

On January 5, 2022, the Civil Remedies Division (CRD) of the Departmental Appeals Board, United States Department of Health & Human Services (DHHS), received correspondence from Dr. Tamara H. W. Schwartz challenging a local coverage determination (LCD) for the use of Rituximab in treating chronic inflammatory demyelinating polyneuropathy (CIDP), on behalf of her patient, Sandra Cort.  On January 18, 2022, I issued an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint. 

Sandra Cort, the Aggrieved Party (AP), filed an amended complaint on February 4, 2022.  The amended complaint incorrectly identified the LCD being challenged as L35026.  In response, an Order was issued on March 4, 2022, requesting a copy of the initial denial notice and clarification regarding the Medicare contractor using the LCD.  On March 16, 2022, the AP responded and provided National Government Services, Inc. (NGS) as the name of the Medicare contractor using the LCD.  An Order Finding Amended Complaint Acceptable, Order to File LCD Record, and Briefing Schedule was issued on March 30, 2022.

On April 1, 2022, NGS filed a Motion for Clarification Regarding Amended Complaint.  On April 4, 2022, I issued an order giving the AP a deadline of April 18, 2022 to respond  and giving NGS a deadline of May 2, 2022 to reply.  On April 18, 2022, Robert Squier, Jr., counsel for NGS, filed a Waiver of Reply and Motion to Correct Caption, moving to amend the case caption to reflect the LCD number being challenged as L33394.  On April 20, 2022, NGS’s motion was granted, and the case caption was amended to reflect the

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correct LCD number.  On April 27, 2022, NGS filed a Notice of Agreement to Stay Proceedings, requesting a stay until November.  The request was granted on May 3, 2022.

On November 1, 2022, NGS filed a document titled “Notice of Revised Local Coverage Determination and Article and Request for Dismissal Under 42 CFR § 426.420(e).”  In the notice, NGS stated that it had issued Local Coverage Determination (LCD) L39297 and the implementing Article A59101, which were filed with the notice as NGS Exhibit 4 and NGS Exhibit 5, respectively.¹  NGS stated that, under LCD L39297, “ICD-10 code G61.81 (chronic inflammatory demyelinating polyneuritis or CIDP) has been added to the list of permitted and covered uses for Rituximab.”²  NGS asserted that “[c]laims by the Aggrieved Party for Rituximab to treat her CIDP will be covered and will not be denied outright under this new LCD.  However, such claims will remain subject to all other applicable Medicare rules and requirements.”  Based on the foregoing, NGS moved that I dismiss the Aggrieved Party’s complaint in accordance with 42 C.F.R. § 426.420(e). 

Pursuant to my order dated November 9, 2022, the AP was directed to file a response to NGS’s filing, indicating the AP’s position on NGS’s request for dismissal. 

In a response filed on November 15, 2022, the AP opposed dismissal of this case, and instead, requested a 120-day extension, stating that this time frame would allow for Medicare to either process or deny claims for the December infusions of Rituximab which the AP was scheduled to receive. 

Pursuant to my Order dated November 23, 2022, the parties were advised that this case was stayed until February 21, 2023.  The AP was directed to submit a status report by February 21, 2023, which addressed the status of the most recent Rituximab claim(s).

On December 14, 2022, the AP filed a letter stating that she “received a claim summary from Medicare and the most recent service for Rituximab was processed and approved.  Based on this information, I agree with the dismissal of this case.”

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I construe the AP’s December 14, 2022 correspondence to be a withdrawal of the complaint.  Pursuant to 42 C.F.R. § 426.423(a), an aggrieved party may withdraw a complaint before an administrative law judge (ALJ) issues a decision regarding the LCD.  

Further, under the regulations, “[i]f the ALJ receives a withdrawal notice regarding an LCD before the date the ALJ issued a decision regarding that LCD, the ALJ issues a decision dismissing the complaint under § 426.444 and informs the aggrieved party that he or she may not file another complaint to the same coverage determination for 6 months.”  42 C.F.R. § 426.423(c)(1); see 42 C.F.R. § 426.444(b)(7). 

Because the AP has withdrawn the complaint prior to the issuance of a decision, I dismiss the complaint.  The AP may not file another complaint challenging the same LCD for six months.  42 C.F.R. § 426.423(c)(1). 

Endnotes

¹  The LCD which is the subject of the Aggrieved Party’s complaint is L33394.  However, the LCD referenced by NGS in its motion is “LCD L39297,” and NGS refers to this LCD as a “new LCD.”  It appears that NGS issued a new LCD to cover the off-label use of Rituximab and Rituximab Biosimilars.  NGS Ex. 4.  It is unclear whether LCD L33394 was actually revised.  However, it is unnecessary for me to address this further inasmuch as I find dismissal appropriate based on the Aggrieved Party’s withdrawal of her complaint.

²  Please note that “CIDP” is also known as “chronic inflammatory demyelinating polyneuropathy.”  See NGS Ex. 4 at 6.