In re LCD Complaint: CT of the Head (L34417), DAB CR6438 (2024)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

I must dismiss the complaint filed by the Aggrieved Party (AP) challenging local coverage determination (LCD) L34417.  As explained below, the complaint failed to meet necessary requirements in order for it to be considered acceptable. 

I.   Background and Procedural History

LCDs are policies issued by Medicare fiscal intermediaries or carriers, generally known as contractors.  42 C.F.R. § 426.110 (definition of Contractor).  The regulations define an LCD as follows: 

A decision by a fiscal intermediary or a carrier under Medicare Part A or Part B, as applicable, whether to cover a particular service on an intermediary-wide or carrier-wide basis in accordance with section 1862(a)(1)(A) of the [Social Security] Act.  An LCD may provide that a service is not reasonable and necessary for certain diagnoses and/or for certain diagnosis codes. 

42 C.F.R. § 400.202.  LCDs may be challenged under 42 U.S.C. § 1395ff(f) and 42 C.F.R. pt. 426.  Only individuals qualifying as an “aggrieved party” may file a complaint challenging the validity of an LCD.  42 C.F.R. § 426.320. 

After receiving a complaint, an administrative law judge must first determine if the complaint is valid and acceptable under the requirements in 42 C.F.R. § 426.400.  42 C.F.R. §§ 426.405(c)(1), 426.410(b). 

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In the present case, the AP filed a complaint on January 22, 2024, which the Civil Remedies Division (CRD) docketed as a complaint challenging the validity of LCD L34417.  CRD assigned the case to me for adjudication. 

A review of the AP’s complaint revealed that it did not include LCD-identifying information, an aggrieved party statement, or clinical or scientific evidence to support the complaint.  42 C.F.R. § 426.400(c)(4)-(6).  I notified the AP of this conclusion in an Acknowledgment of Receipt and Order to Aggrieved Party to Amend Unacceptable Complaint (Order), dated January 25, 2024.  In the Order, I advised that the AP’s complaint was missing the following information that was necessary to constitute a valid LCD complaint:¹  

LCD-identifying information:  (i) the name of the contractor using the LCD; (ii) the title of the LCD being challenged; (iii) the specific provision(s) of the LCD adversely affecting the AP;

Aggrieved Party statement:  A statement from the AP explaining why he thinks that the relevant provision(s) of the LCD is (are) not valid under the reasonableness standard; and

Clinical or scientific evidence:  Copies of clinical or scientific evidence that support the complaint and an explanation for why the AP thinks that this evidence shows that the LCD is not reasonable

The Order stated that the AP had one opportunity to amend the complaint under 42 C.F.R. § 426.410(c)(1).  I advised that if the AP did not submit an acceptable amended complaint, then I must issue a decision dismissing the unacceptable complaint.  42 C.F.R. § 426.410(c)(2).  My Order directed the AP to submit a valid amended complaint within 30 days of the date of the Order. 

To date, CRD has not received a response from the AP. 

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II.   Discussion

The regulations provide the following rules for complaints that are not acceptable under the regulations: 

1. If the ALJ determines that the complaint is unacceptable, the ALJ must provide the aggrieved party (or parties) one opportunity to amend the unacceptable complaint. 
2. If the aggrieved party (or parties) fail(s) to submit an acceptable amended complaint within a reasonable timeframe as determined by the ALJ, the ALJ must issue a decision dismissing the unacceptable complaint. 
3. If a complaint is determined unacceptable after one amendment, the beneficiary is precluded from filing again for 6 months after being informed that it is unacceptable. 

42 C.F.R. § 426.410(c)(1)-(3). 

The AP failed to file an amended complaint in response to my Order.  Thus, this complaint remains unacceptable within the terms of 42 C.F.R. § 426.410(b).  Accordingly, I must dismiss the complaint.  42 C.F.R. § 426.410(c)(2).  The AP cannot file a new complaint for six months.  42 C.F.R. § 426.410(c)(3). 

III.   Conclusion

I dismiss the AP’s complaint because it is not acceptable under the regulations. 

Endnotes

¹  I also advised the AP that it was unclear whether the complaint was intended to challenge the validity of an LCD or to appeal the denial of a Medicare claim.  My Order provided instructions on how to appeal the denial of a Medicare claim, if that was the intent instead of an LCD challenge.  See Order at 4-5.