In re LCD Complaint: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATS) (L38229), DAB, CR6894 (2026)

DECISION DISMISSING COMPLAINT FOR WANT OF JURISDICTION AND UNACCEPTABILITY

I. Introduction

On March 13, 2026,1  the Civil Remedies Division received a Medicare Redetermination Request Form filed by Medicare beneficiary S.M.2  DAB E-file Dkt. No. C-26-432, Doc. No. 1 (Putative Complaint).  That form is used to seek redetermination after a first-level denial of a Medicare claim by a contractor for the Centers for Medicare & Medicaid Services (CMS). 

With the redetermination request, S.M. attached an October 30, 2025 notice from CMS contractor Novitas Solutions explaining it had denied coverage for payment by the Medicare program for a nucleic acid detection test identified under CPT code 87507.  DAB E-file Dkt. No. C-26-432, Doc. No. 1a (Denial Notice) at 4.  The contractor cited a denial code indicating it had denied S.M.’s claim applying a Local Coverage Determination (LCD) policy identified as L38229 and entitled Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATS).  Id. 

Because Novitas applied an LCD policy to deny S.M.’s claim, and because challenges to the validity of LCD policies are heard in the Civil Remedies Division, my office interpreted S.M’s filing as a challenge to the validity of L38229, resulting in my designation to hear and decide this case as an LCD challenge.  42 C.F.R. § 426.410(b). 

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When a party files a challenge to the validity of an LCD policy, referred to as a complaint, I must first determine whether that complaint is acceptable, meaning it includes all the elements required by the applicable regulations to be permitted to proceed.  Doing so, I determined S.M. had not provided sufficient evidence to assess the timeliness of his complaint and failed to provide several other required elements. 

I therefore issued an Acknowledgment of Receipt and Order to Amend Unacceptable Complaint (Order to Amend) on March 20, 2026.  In that order, I informed S.M. that I had no jurisdiction over the denial of individual claims by Medicare beneficiaries but instead could only hear challenges to the validity of an LCD policy or provisions thereof.  Order to Amend at 2.  But to preserve S.M.’s hearing right if he wished to proceed, I treated his filing as an LCD challenge and advised him of the deficiencies that made his initial complaint unacceptable as an LCD challenge.  Id. at 4-5.  I also provided him with one opportunity to submit an acceptable complaint.  Id. at 5. 

I explained S.M.’s initial attempt to file a valid complaint failed because:  

(1) he did not provide documentation from a treating physician establishing the medical necessity for the service for which Novitas denied coverage;

(2) he did not provide evidence to support his claim that he did not receive the contractor’s October 30, 2025 notice until March 3, 2026;

(3) he failed to identify the LCD he wished to challenge or the specific provision(s) of the LCD adversely affecting him;

(4) he did not submit a statement explaining why the LCD provision he is challenging is not valid under the reasonableness standard; and

(5) he did not provide copies of clinical or scientific evidence in support of his complaint or explain why he believes such evidence shows the LCD is not reasonable.

Id. at 4-5.  

I directed S.M. to file an amended complaint correcting these deficiencies by April 20, 2026.  Id. at 5.  I advised S.M. that if he did not submit an acceptable amended complaint by that date, I would issue a decision dismissing this action.  Id.; 42 C.F.R. § 426.410(c)(2).  S.M. timely responded to my Order to Amend (Resp.) and submitted documents in support of his challenge.  DAB E-File Dkt. No. C-26-432, Doc. Nos. 3-3a.

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II. Discussion

A. I have no jurisdiction in this matter because S.M. does not challenge the validity of an LCD policy or provision.

S M. makes plain that he wishes to challenge Novitas’s application of L38229 to reject his claim.  Resp. at 1; DAB E-File Dkt. No. C-26-432, Doc. No. 3a at 70-91 (coverage guidance in support of S.M.’s application argument).  He explains at length how he met all the requirements imposed by the LCD policy and argues that properly applying L38229, Novitas should have approved his claim for coverage.  Resp. at 1-3. 

Nowhere in his response does S.M. challenge the validity of the LCD or its provisions.  He instead seeks review of whether Novitas properly applied L38229 to deny coverage for his claim by the Medicare program.  I have no jurisdiction over that issue.  See 42 C.F.R. § 426.325(b)(11).  Judges in the Civil Remedies Division only hear challenges to the validity of LCD policies, not the application of those policies to individual claims.3   See 42 C.F.R. §§ 426.110, 426.300. 

B. S.M. has not provided the necessary elements for a valid complaint to challenge an LCD provision.

Even if I were to construe S.M.’s request for hearing as a challenge to the validity of L38229, S.M. has failed to file an adequate complaint.  42 C.F.R. § 426.405(c)(2).  S.M.’s initial filing did not establish he was an aggrieved party or include documentation from the treating physician establishing the medical necessity of the test at issue.  42 C.F.R. § 426.410.  It also omitted three necessary elements for a valid complaint, namely evidence of timeliness, an Aggrieved Party statement, and clinical or scientific evidence with an explanation how that evidence demonstrates the LCD is not reasonable.  42 C.F.R. § 426.400(c)(3),(5),(6)(i). 

I provided S.M. an opportunity to correct these deficiencies.  However, S.M. corrected only two of the four deficiencies I identified in my Order to Amend; he failed to provide evidence to support his claim that he did not receive the contractor’s October 30, 2025 notice until March 3, 2026 and did not provide copies of clinical or scientific evidence in support of his complaint.  See Resp.  I recognize S.M.’s good-faith effort to amend his

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complaint.  But for these reasons, I must find that for the purpose of challenging the validity of an LCD, S.M.’s complaint is unacceptable. 

C. S.M. may wish to refile his appeal in the proper venue.

As I have explained, S.M.’s amended filing shows he intended to appeal the denial of his individual claim for coverage by the Medicare program.  He does not wish to challenge the validity of the LCD used to deny his claim; he wishes to argue Novitas improperly applied the LCD to do so.  After Novitas denied his claim at the initial level, S.M. should have requested redetermination by Novitas.  See 42 C.F.R. § 405.940.  His initial filing in this case – a Medicare Redetermination Request – is the correct form to make that request.  See Putative Complaint.  But S.M. filed it in the wrong place.  Notivas’s denial notice plainly instructs a redetermination request should be sent to:

Medicare Claims Office
c/o Novitas Solutions
P.O. Box 3413
Mechanicsburg, PA 17055-1852

Denial Notice at 7. 

I note that S.M. appears to be a lawyer.  Putative Complaint at 2.  It is unclear to me why he opted to file his redetermination request as an appeal in the Civil Remedies Division.  See 42 C.F.R. § 405.944(a) (“The request for redetermination must be filed with the contractor indicated on the notice of initial determination.”).  Still, S.M. may wish to pursue appeal of the initial denial of his claim by following the instructions at page 7 of the Denial Notice.  If S.G. does so, his appeal will be untimely.  However, Novitas may accept his untimely appeal if he can show good cause for missing the deadline.  The Secretary’s regulations identify circumstances a contractor may consider to establish good cause, among them, “The party sent the request to a Government agency in good faith within the time limit, and the request did not reach the appropriate contractor until after the time period to file a request expired.”  42 C.F.R. § 405.942(b)(3).  S.M.’s improper filing in the Civil Remedies Division appears to provide a basis for a good cause finding. 

However, if S.G. wishes to pursue appeal of his claim denial, he should file his redetermination request with Novitas immediately.  He must include an explanation for his untimely filing and show good cause for both the untimely filing in the Civil Remedies Division and in sending his request to Novitas.  S.G. may wish to consider attaching this dismissal order to establish the date he filed his appeal in the Civil Remedies Division and to explain his delay in filing arose in part because his redetermination request was interpreted by my office as an LCD challenge and treated as such. 

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III. Conclusion

S.M. seeks to challenge Novitas’s individual claim determination, an issue over which I do not have jurisdiction.  Even if I construed his appeal as a challenge to the validity of the LCD policy Novitas applied to deny his claim, S.M. did not establish he timely filed his complaint, provide copies of scientific or clinical evidence to support his complaint, or articulate how such evidence shows L38229, the LCD at issue here, is unreasonable. 

S.M.’s complaint is unacceptable under 42 C.F.R. § 426.410(b)(2).  I am thus required to dismiss it.  42 C.F.R. § 426.410(c)(2).  S.M. may not file another complaint seeking review of the same LCD policy for six months.  42 C.F.R. § 426.410(c)(3).  He has 30 days from the date of this decision to file an appeal with the Departmental Appeals Board.  42 C.F.R. § 426.465.