In re LCD Complaint: Surgical Treatment of Nails (L34887), DAB CR6491 (2024)

DECISION DISMSSING COMPLAINT 

In an acknowledgment dated May 9, 2024, the Civil Remedies Division of the Departmental Appeals Board acknowledged that it had received correspondence, dated April 11, 2024, from individuals complaining about the “validity and accuracy” of Medicare nail avulsion procedures and guidelines.  We have treated this as a challenge to the Medicare contractor’s local coverage determination (LCD) governing nail avulsion procedures. 

In the May 9 acknowledgment, I explained that the regulations governing these proceedings do not allow me to accept an incomplete complaint and that I had determined that the complaint filed does not meet the regulatory requirements.  42 C.F.R. § 426.410(b)(1) and (2).  Pursuant to 42 C.F.R. § 426.410(c)(1), I offered the parties an opportunity to file an acceptable complaint and directed them to do so no later than June 10, 2024. 

First, I explained that only an aggrieved party may challenge an LCD.  An aggrieved party is a Medicare beneficiary who is entitled to benefits under Part A, enrolled under Part B, or both, and needs coverage for a service that is denied based on an LCD.  42 C.F.R. § 426.110.  Unless they identify an aggrieved party, I must dismiss this case. 

Second, I explained that I must determine whether the complaint was filed timely.  42 C.F.R. § 426.444(b)(2).  If an aggrieved party chooses to file an LCD challenge after receiving a service, the complaint must be filed within 120 days of the initial denial notice.  An initial denial notice was not included in the parties’ submission.  

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Third, I advised that the amended complaint should include the following information, which is required by 42 C.F.R. § 426.400(c): 

1.  Beneficiary-identifying information:   
(i) Name 
(ii) Mailing Address 
(iii) State of residence, if different from mailing address 
(iv) Telephone number 
(v) Health Insurance Claim number, if applicable 
(vi) Email address, if applicable. 

2.  If the beneficiary has a representative, the representative-identifying information must include the representative’s name, mailing address, telephone number, email address, if any, and a copy of the written authorization to represent the beneficiary. 

3.  Treating Physician Written Statement.  A copy of a written statement from the treating physician that the beneficiary needs the service that is the subject of the LCD.  This statement may be in the form of a written order for the service or other documentation from the beneficiary’s medical record (such as progress notes or discharge summary) indicating that the beneficiary needs the service. 

4.  LCD-identifying information.  
(i) Name of the contractor using the LCD.  
(ii) Title of the LCD being challenged.  
(iii) The specific provision (or provisions) of the LCD adversely affecting the aggrieved party.  

5.  Aggrieved party statement.  A statement from the aggrieved party explaining what service is needed and why the aggrieved party thinks that the provision(s) of the LCD is (are) not valid under the reasonableness standard. 

6. Clinical or scientific evidence.  Copies 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.  

I explained that the regulations provide for an additional opportunity to file an acceptable complaint (42 C.F.R. § 426.410(c)(1)) and directed the parties to submit, no later than June 10, 2024, an amended complaint that includes the following information: 

• Beneficiary-identifying information.  42 C.F.R. § 426.400(c)(1);

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• If the beneficiary has a representative.  42 C.F.R. § 426.400(c)(2);
• Treating physician written statement.  42 C.F.R. § 426.400(c)(3);
• LCD-identifying information.  You must provide the name of the contractor using the LCD and the specific provision(s) of the LCD adversely affecting you.  42 C.F.R. § 426.400(c)(4);
• Aggrieved party statement.  You must provide a statement explaining not only what service is needed but also why you think that the provisions of the LCD are not valid under the reasonableness standard.  42 C.F.R. § 426.400(c)(5);
• Clinical or scientific evidence.  You must include clinical or scientific evidence to support the complaint, along with an explanation for why you think that this evidence shows that the LCD is not reasonable.  42 C.F.R. § 426.400(c)(6). 

Because the parties have not, within the timeframe established, submitted an acceptable amended complaint, I dismiss this action pursuant to 42 C.F.R. § 426.410(c)(2).