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                              2021
                              In re LCD Complaint: Implantable Continuous Glucose Monitors (I-CGM) (L38743), DAB CR5993 (2021)
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In re LCD Complaint: Implantable Continuous Glucose Monitors (I-CGM) (L38743), DAB CR5993 (2021)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





*In re LCD Complaint:*

Implantable Continuous Glucose Monitors (I-CGM)
LCD ID Number: L38743
Contractor: Palmetto GBA
Docket No. C-22-14Decision No. CR5993December 3, 2021

        
              
    

      DECISION DISMISSING COMPLAINT

On October 1, 2021, the Civil Remedies Division received the Aggrieved Party’s two-page submission, consisting of a letter, handwritten “Recent Glucose Readings” log, and a copy of the Aggrieved Party’s Medicare card.  The Aggrieved Party reported he was challenging local coverage determination (LCD) “L38743,” which is an LCD issued by Palmetto GBA, a Medicare administrative contractor for the Centers for Medicare & Medicaid Services.1
  The Aggrieved Party argued that he was denied coverage based on LCD L38743 and that the LCD “discriminates against people” who do not use insulin.  Complaint at 1.

In an order dated October 13, 2021, 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 he had not filed an acceptable complaint.

I explained that a timely complaint must be filed within 120 days of the initial denial notice, and that the complaint did not include evidence of the date of the initial notice denying the Aggrieved Party’s Medicare claim.  *See*42 C.F.R. § 426.400(b)(2).  I also

Page 2

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, and that the Aggrieved Party had not submitted a dated statement from a treating physician.  *See* 42 C.F.R. § 426.400(b)(1).  I ordered the Aggrieved Party to submit documentation supporting the timeliness of the complaint.

I discussed that an acceptable complaint must identify the name of the contractor using the LCD and the title of the LCD being challenged.  42 C.F.R. § 426.400(c)(4).  Because the complaint did not identify the contractor using the LCD or the title of the LCD, I ordered the Aggrieved Party to amend his complaint to include this information.

I also explained that the complaint lacked a statement explaining why “the provision(s) of the LCD is (are) not valid under the reasonableness standard.”  *See*42 C.F.R.
§ 426.400(c)(5).  I directed the Aggrieved Party to amend his complaint to include this information.

I discussed 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 thinks 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 his complaint accordingly.

When an Aggrieved Party files an unacceptable complaint, an administrative law judge (ALJ) must offer the Aggrieved Party an opportunity to amend the complaint, pursuant to 42 C.F.R. § 426.410(c)(1).  If the Aggrieved Party fails to submit an acceptable amended complaint within the timeframe set by the ALJ, the ALJ “must issue a decision dismissing the unacceptable complaint.”  42 C.F.R. § 426.410(c).

I afforded the Aggrieved Party an opportunity to amend his unacceptable complaint, yet the Aggrieved Party did not respond to my order or otherwise submit an amended complaint.2
  Because the Aggrieved Party neither filed an acceptable complaint nor submitted an acceptable amended complaint within the prescribed 30-day timeframe, I dismiss the complaint pursuant to 42 C.F.R. § 426.410(c)(2).


          /s/
        Leslie C. Rogall

                      Administrative Law Judge
      1. The Aggrieved Party listed a Merced, California return address.  In my order, I noted that it does not appear that Merced is within the geographic area covered by LCD L38743. back to note 1
                      2. The Aggrieved Party also did not comply with a directive to, within 10 days, register for DAB E-File and request access to this case, or else submit a waiver request. back to note 2 Back to top
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