In re LCD Complaint: Routine Foot Care (L35138) and Debridement of Mycotic Nails (L35013) (2025)

DECISION DISMISSING COMPLAINT

On January 16, 2025, the Civil Remedies Division received a mail submission dated January 15, 2025, from the Aggrieved Party, consisting of a cover letter, a copy of the case file from a previous local coverage determination (LCD) complaint that had been dismissed as unacceptable by another administrative law judge in February 2023, and several photographs taken in 2023 and 2024.  Departmental Appeals Board (DAB) Electronic Filing System (E-File) Docket Entry No. 1.  In her cover letter, the Aggrieved Party reported that “[her] condition has deteriorated since” the dismissal of her previous complaint and she is “filing a new matter.”  In her renewed complaint challenging LCDs L35138 (Routine Foot Care) and L35013 (Debridement of Mycotic Nails) issued by Novitas Solutions, Inc., the Aggrieved Party requests that “Medicare should reduce the amount of time between [toenail debridement] visits from 9 weeks to 6 weeks.”

In an Order dated January 27, 2025, I acknowledged receipt of the Aggrieved Party’s complaint.  I explained that, pursuant to the applicable regulations, I am required to determine if the complaint is acceptable.  See 42 C.F.R. § 426.410(b).  I further explained that I must determine whether the complaint meets the requirements for a valid complaint as set forth in 42 C.F.R. § 426.400.  I informed the Aggrieved Party that she had not filed an acceptable complaint. 

I explained that a complaint must be filed within six months of the issuance of a written statement from an aggrieved party’s treating practitioner, in the case of an aggrieved party who chooses to file an LCD challenge before receiving the service, or else within 120 days of the initial denial notice if the aggrieved party has already received the 

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service.  See 42 C.F.R. § 426.400(b).  I explained that the complaint lacked either a recent treating practitioner’s statement or a copy of a recent initial denial notice, and therefore, I could not ascertain whether the complaint is timely.  See 42 C.F.R. § 426.400(b), (c)(3). 

I discussed how the complaint lacked a statement explaining why “the provision(s) of that LCD are not valid under the reasonableness standard.”  See 42 C.F.R. § 426.400(c)(5).  Because the complaint lacked this information, I ordered the Aggrieved Party to amend her complaint to include this information. 

I also explained that 42 C.F.R. § 426.400(c)(6) requires that the Aggrieved Party submit “[c]opies of clinical or scientific evidence that support the complaint and an explanation for why the aggrieved party believes that this evidence shows that the LCD is not reasonable.”  Because the complaint lacked this evidence and explanation, I directed the Aggrieved Party to amend her complaint accordingly. 

I directed the Aggrieved Party to file a response within 30 days, addressing the missing information outlined above.  42 C.F.R. § 426.410(c)(1). 

The Aggrieved Party filed a response on February 20, 2025, that included a February 19, 2025 statement from her treating podiatrist, Dr. Kreamer.  DAB E-File Docket Entries No. 4 (Response) and 5 (treating podiatrist’s statement).  However, the Aggrieved Party’s response did not amend the complaint, as directed.  In particular, the Aggrieved Party did not submit “[c]opies of clinical or scientific evidence that support the complaint and an explanation for why [she] believes the LCD is not reasonable.”  Although the Aggrieved Party’s response quotes from and cites a website page for a Blue Cross / Blue Shield of Rhode Island medical coverage policy for routine foot care and nail debridement, the policy does not constitute either clinical or scientific evidence.  See https://www.bcbsri.com/sites/default/files/polices/Routine%20Foot%20Car… (last visited March 13, 2025).  In fact, the policy neither references clinical or scientific evidence, nor does it address the basis for the Aggrieved Party’s challenge (e.g., the requested frequency of nail debridement).  Further, the sole “reference” listed in the medical coverage policy is the website for a Medicare administrative contractor’s LCD policy for routine footcare and nail debridement.  See https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads… (last visited March 13, 2025).1   

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Because the Aggrieved Party failed to submit an acceptable complaint, even after being afforded an additional 30 days to amend her complaint, I “must issue a decision dismissing the unacceptable complaint.”  42 C.F.R. § 426.410(c)(2).  Therefore, I dismiss the Aggrieved Party’s complaint.  Because the complaint was unacceptable after one amendment, the Aggrieved Party is precluded from filing another complaint for six months.  42 C.F.R. § 426.410(c)(3).