In re LCD Complaint: Immune Globulins (LCD No. L34771), DAB CR6782 (2025)

DECISION DISMISSING COMPLAINT

The Aggrieved Party (AP) challenged a provision in local coverage determination (LCD) ID No. L34771 regarding coverage indications to allow intravenous immune globulin (IVIG) for the treatment of autoimmune encephalopathy.  The contractor, Wisconsin Physicians Service Insurance Corporation (WPS), has since revised the LCD Billing and Coding article, which has allowed for the payment of claims submitted by the AP.  For the reasons set forth below, I dismiss the AP’s complaint because the challenged provision of L34771 and A57554 has been addressed due to the addition of two billing codes. 

I. Background and Procedural History

On January 29, 2024, the Civil Remedies Division (CRD) of the Departmental Appeals Board, United States Department of Health & Human Services, received correspondence on behalf of the AP.1   The AP has been diagnosed with Hashimoto’s Encephalopathy.  The AP challenged LCD L34771 regarding coverage indications to allow IVIG for the treatment of autoimmune encephalopathy.  Request for Hearing (RFH) at 1. 

CRD treated the correspondence as an LCD complaint, docketed the LCD complaint under C-24-215, and the case was assigned to me for adjudication. 

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WPS filed the LCD Record on March 22, 2024. 

On April 24, 2024, the AP filed two separate statements in response to WPS’s filings.  The statements argued that LCD No. L34771 is not valid under the reasonableness standard found in the regulations.  

WPS filed a response on May 24, 2024.  

On July 1, 2024, the AP filed several documents including a Refiling of the AP’s Statement Why the LCD is not Valid, AP’s list of exhibits, and six exhibits. 

On July 8, 2024, the AP filed a brief and 31 exhibits (AP Exs. 1-31).  The AP refiled a corrected version of the brief on July 9, 2024 (AP Br.). 

On July 12, 2024, WPS filed 57 exhibits (WPS Exs. 1-57). 

On August 7, 2024, WPS filed a Notice of Revision and a Motion to Dismiss, along with Exs. 58 and 59. 

On September 1, 2024, the AP filed a Motion in Opposition to WPS’s Motion to Dismiss. 

A prehearing conference was held on October 29, 2024.  At the conference, the parties were directed to file briefs addressing whether AP remained an aggrieved party given the addition of the two billing codes which allowed for the payment of IVIG for the treatment of autoimmune encephalopathy. 

The AP filed a Request for a WPS Reopening of the Unpaid IVIG Claims.  WPS filed a response on December 6, 2024.  

On December 6, 2024, the AP filed another brief and Statement on Why the LCD Remains Invalid and why the AP remains an AP along with additional documents.  The AP later emailed the former staff attorney assigned to this case to request additional briefing.  WPS objected to the AP’s request.  I issued an order denying the AP’s request for additional briefing on March 10, 2025.  

Despite the AP’s request for additional briefing being denied, on March 12, 2025, the AP filed a statement on Good Cause Why Additional Briefing is Necessary. 

On July 23, 2025, the AP filed a Motion to Compel.  

On July 29, 2025, I issued an order requesting that the parties provide a status update on whether the AP’s IVIG claims have been paid by Medicare since the filing of this case. 

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In response, the AP provided a status report on August 3, 2025, and WPS responded on August 6, 2025.  The AP provided an additional response on August 19, 2025. 

On August 22, 2025, I issued an order informing the parties that no additional filings would be accepted pending a ruling on the Motion to Dismiss.  

II. Legal Framework

An LCD is a “determination by a fiscal intermediary or a carrier . . . respecting whether or not a particular item or service is covered [under the Medicare program] on an intermediary- or carrier-wide basis . . . .”  42 U.S.C. § 1395ff(f)(2)(B).  A fiscal intermediary or carrier that has jurisdiction for the LCD at issue is known as a contractor.  See 42 C.F.R. § 426.110 (definition of Contractor). 

Each Medicare contractor must, at least 45 days before an LCD becomes effective, make the following information available on its internet website and on the Medicare website:  the entire LCD; where and when the proposed LCD was first made public; hyperlinks to the proposed determination and a response to comments submitted to the contractor concerning the proposed determination; a summary of the evidence that was considered by the contractor during the development of the LCD and a list of the sources of such evidence; and an explanation of the rationale that supports the LCD.  42 U.S.C. § 1395y(l)(5)(D).  The Secretary of Health and Human Services (Secretary) coordinates the LCDs issued by the various contractors and determines when to adopt LCDs nationally.  42 U.S.C. § 1395y(l)(5)(A)-(C). 

When a contractor relies on an LCD to deny a claim, the contractor must disclose such reliance in the determination.  42 U.S.C. § 1395ff(a)(4)(A)(i).  Although contractors follow their own LCDs, LCDs “shall not be binding on the qualified independent contractor in making a decision with respect to a reconsideration” but “the qualified independent contractor shall consider the local coverage determination in making such decision.”  42 U.S.C. § 1395ff(c)(3)(B)(ii)(II).  At the next two stages of the Medicare claims review process, adjudicators “are not bound by LCDs . . . , but will give substantial deference to these policies if they are applicable to a particular case.”  42 C.F.R. § 405.1062(a). 

If an LCD prohibits Medicare coverage for a health care item or service that a beneficiary needs, the beneficiary may file a complaint to challenge the LCD or a provision in the LCD.  In a proceeding that is distinct from a Medicare claims appeal, an administrative law judge (ALJ) evaluates the reasonableness of the challenged LCD or provision of the LCD based on the LCD record and evidence submitted during the proceeding.  In doing so, the ALJ will “defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.”  42 U.S.C. § 1395ff(f)(2)(A)(i)(III).  When challenging an LCD or a provision of an LCD, the

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beneficiary has the burden of proving the allegations in his or her complaint by a preponderance of the evidence.  42 C.F.R. § 426.330.  The standard of proof is the preponderance of the evidence standard.  42 C.F.R. § 426.330.  The ALJ may uphold or invalidate the challenged LCD provision.  42 C.F.R. § 426.450.  However, the ALJ must confine such a decision to “the provision(s) of the LCD raised in the [AP’s] complaint.”  42 C.F.R. § 426.431(a)(1). 

A CMS contractor may retire or revise an LCD under review at any time before an ALJ issues a decision.  42 C.F.R. § 426.420(a)-(b).  When this happens, the CMS contractor must notify the ALJ that it has retired or revised the LCD.  42 C.F.R. § 426.420(c).  When the ALJ receives notice that the contractor has retired or revised the LCD to completely remove the provision in question, an ALJ “must dismiss the complaint and inform the [AP] who sought review that he or she or they receive individual claim review without the retired/withdrawn provision(s)”.  42 C.F.R. § 426.420(e)(1).  When an LCD is retired or revised during the LCD complaint process, it has the same effect as an ALJ decision finding that the challenged LCD provision is invalid.  42 C.F.R. §§ 426.420(a)-(b), 426.460(b).  For claims that have already been denied, this means that “the contractor, an M + C organization or another Medicare managed care organization must reopen the claim of the party who challenged the LCD and adjudicate the claim without using the provision(s) of the LCD that the ALJ found invalid.”  42 C.F.R. § 426.460(b)(1)(i).  If a claim had not yet been submitted to a CMS contractor, then once a claim is filed, “the contractor adjudicates the claim without using the provision(s) of the LCD that the ALJ found invalid.”  42 C.F.R. § 426.460(b)(1)(iii). 

III. Analysis

WPS’s Motion to Dismiss

WPS issued a revised version of LCD No. 34771 article A57554 Billing and Coding:  Immune Globulins, effective July 25, 2024.  WPS Ex. 58 at 56.  WPS Mot. at 1 (DAB E- File Doc. No. 74).  The revised article added ICD-10 codes G04.81 (Other encephalitis and encephalomyelitis) and G93.49 (Other encephalopathy) to the Group 12 code table, which allows access to care and coverage for patients with a diagnosis of autoimmune encephalitis, with supporting documentation.  WPS Ex. 58 at 49-50, 54.  WPS filed a Notice of Issuance of Revision and Request to Dismiss LCD Complaint on August 8, 2024.  WPS acknowledges that LCD L34771 does not contain a non-coverage statement for autoimmune encephalitis, but it argues that the changes allow coverage for the AP’s condition and necessitates that the case be dismissed.  WPS Mot. at 1 (DAB E-File Doc. No. 74).  Additionally, WPS argues that there is not enough scientific evidence “that meets the quality threshold WPS requires to support coverage in the LCD as reasonable and necessary under 1862(a)(1)(A)” of the 21st Century Cures Act but maintains that adding the two codes will allow coverage for the treatment of IVIG.  WPS Status Update at 2 (DAB E-File Doc. No. 100). 

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The AP, through counsel, opposes WPS’s Motion to Dismiss and argues that I should permit discovery and the taking of evidence before reaching a determination about the validity of LCD No. L34771.  AP. Mot. in Opp. (DAB E-File Doc. No. 82); DAB E-File Doc. No. 9.  The AP also argues that a change in LCD coverage requires compliance with Section 13.5.4 of the Medicare Program Integrity Manual (MPIM) which includes a list of requirements for proposed and final LCDs.  See MPIM § 13.5.4; AP. Mot. in Opp. at 2, 3 (DAB E-File Doc. No. 82). 

While the AP correctly notes the requirements for proposed and final LCDs, he seemingly ignores the section of the MPIM which requires that all current procedure terminology (CPT) codes and International Classification of Diseases-Tenth Revision-Clinical Modification (ICD-10-CM) codes, such as the codes at issue in this case, be removed from LCDs and placed in billing and coding articles.  See MPIM Chapter 13, pg. 11.  In this case, adding the codes to the billing and coding articles has the effect of revising the LCD because it allows IVIG treatment for those beneficiaries diagnosed with the AP’s condition, which was not originally permitted by the LCD.  Additionally, I do not have the authority to direct WPS to revise the LCD in a specific manner.  Pursuant to 42 C.F.R. § 426.405(d)(12), an ALJ does not have the authority to deny a contractor the right to reconsider, revise, or retire an LCD.  Nor do I have the authority to enter a decision specifying specific terms to be included in an LCD.  42 C.F.R. § 426.405(d)(14). 

According to the regulations, upon receiving notice that the contractor has revised an LCD under review, an ALJ must: 

If, before the ALJ issues a decision, the ALJ receives notice that the contractor has retired the LCD or revised the LCD to completely remove the provision in question, the ALJ must dismiss the complaint and inform the aggrieved party(ies) who sought the review that he or she or they receive individual claim review without the retired/withdrawn provision(s).

42 C.F.R. § 426.420(e)(1); see 42 C.F.R § 426.444(b)(6). 

In the present case, the contractor revised the LCD by adding the two ICD codes to the article, as required by the MPIM, which allowed an avenue for the AP’s claims to be paid.  WPS Ex. 58.  The LCD was revised to “allow coverage for patients with the [AP’s] diagnosis . . . .”  WPS Mot. at 1 (DAB Doc. No. 74).  Based on this revision, L34771 no longer included the challenged provision, i.e., denial of coverage for the treatment for those diagnosed with autoimmune encephalopathy.  See WPS Exs. 58-59; RFH 1-2.  By adding the ICD codes, WPS removed the denial of coverage, which is implicit in the absence of codes covering AP’s diagnosis.  Furthermore, I did not find, and WPS has

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confirmed, that LCD No. L34771 does not contain any statements that prohibit coverage for autoimmune encephalitis.  WPS Ex. 59; WPS Mot. at 1 (DAB Doc. No. 74) (“LCD L34771 does not contain a non-coverage statement for autoimmune encephalitis . . . .”).  WPS has also provided assurances that “claims submitted by other Medicare beneficiaries for IVIG treatment for AP’s diagnosis” have been paid by WPS.  WPS Status Update at 2 (DAB E-File Doc. No. 100 at 2). 

Lastly, it is important to note that some of AP’s claims have been paid.  On August 19, 2025, the AP provided proof that Medicare has paid claims from various dates in 2023 and April 21, 2025 for several procedures, including “infusions into a vein for therapy” and immune globulin injections.  AP Resp. at 2-3 (DAB E-File Doc. No. 101 at 2-3).  While the parties have differing opinions regarding the scientific evidence necessary to revise the LCD, I find it unnecessary to address these arguments because I am required to dismiss the complaint for the reasons set forth above.  42 C.F.R. § 426.420. 

The AP argues that adding the codes to the articles fails to inform others of the change in WPS coverage policy for autoimmune encephalitis.  AP Mot. at 3 (DAB E-File Doc. No. 81 at 3).  In support of its claim, the AP argues that there are approximately 81,500 beneficiaries with autoimmune encephalitis in 38 states.  Id.  However, the regulations only allow for multiple parties to challenge an LCD in the circumstances where each challenging party meets the regulatory definition of an aggrieved party.  42 C.F.R. § 426.410(b)(1).  To proceed to a hearing, there must be an aggrieved party whose claim for reimbursement has been denied, specifically, based on the terms of an LCD.  Speculation that other individuals’ claims might be denied does not provide grounds to continue with this matter, which is being litigated specifically for the AP who requested the hearing.  

Lastly, the AP argues that while the two added codes may allow for the treatment of immune globulin for autoimmune encephalitis, it will not prevent WPS from eliminating the codes from a future version of the LCD and once again denying coverage.  AP Resp. Br. at 2-3 (DAB E-File Doc. No. 101 at 2-3).  However, I cannot allow this case to proceed simply based on the AP’s speculation of what WPS may do in the future.  Because I am required to dismiss this case pursuant to 42 C.F.R. § 426.420, I am also required to inform the AP that he is to receive individual clam review without the withdrawn provision.  See 42 C.F.R. § 426.420(e)(1).  

AP’s Motion to Compel

The AP filed a Motion to Compel WPS to comply with Medicare’s requirement to publish the explanation for the change in IVIG policy.  AP Mot. to Compel.  In support of this motion, the AP argues that his cognitive abilities have declined due to a prolonged gap in IVIG treatment.  Id. at 2. 

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The AP also argues that this matter should proceed to discovery and hearing because Swedish Health Systems will only administer the IVIG treatment if the AP signs an Advance Beneficiary Notice.  AP Mot. to Compel at 2.  The AP argues that he should not have to sign this form and, without authority, argues that the form request is caused by WPS’s past denials of IVIG claims.  AP Mot. to Compel at 2.  However, I do not have jurisdiction over Swedish Health System, nor is the Swedish Health System’s requirement that the AP sign an advance beneficiary notice indicative of the validity of the LCD.  

While I appreciate the AP’s arguments, the reasons set forth in the Motion to Compel do not provide a legal basis to proceed with this matter.  The AP’s Motion to Compel is denied.  

IV. Conclusion

For the reasons set forth above, the AP’s complaint is dismissed.