In re LCD Complaint: Epidural Steroid Injections for Pain Management (L39054), CR6274 (2023)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

On February 27, 2023,1  the Civil Remedies Division received a complaint filed by Medicare beneficiary and Aggrieved Party, E.C.,2  challenging a Local Coverage Determination (LCD) titled Epidural Steroid Injections for Pain Management.  I am designated to review her LCD challenge.  42 C.F.R. § 426.410(b). 

I.    Background

Upon initial review of E.C.’s complaint, I was unable to determine whether she timely filed her complaint, meaning within 120 days of an initial denial notice after receiving service or if before receiving service, within six months after a treating practitioner issued a written statement.  42 C.F.R. § 426.400(b)(1),(2).  E.C.’s complaint also omitted several other elements required by the regulations.  Therefore, on March 1, 2023, I issued an Acknowledgment of Receipt and Order to Amend Unacceptable Complaint (Order to Amend).  In that order, I informed E.C. her initial complaint was deficient and provided her one opportunity to submit an acceptable complaint.  See 42 C.F.R. § 426.410(c)(1). 

My Order to Amend set forth the necessary elements of a LCD complaint, which are also found at 42 C.F.R. § 426.400.  I explained E.C.’s initial attempt to file a valid complaint failed because it did not provide the following information: 

• Timeliness:  E.C. did not provide sufficient information demonstrating her complaint was timely filed. 

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• Aggrieved party statement:  E.C. did not submit a statement explaining why she thinks that the LCD provision she is challenging is not valid under the reasonableness standard. 
• Clinical or scientific evidence:  E.C. did not provide copies of clinical or scientific evidence in support of her complaint.  Nor did she explain why she believes that such evidence shows that the LCD is not reasonable. 

My Order to Amend directed E.C. to file an amended complaint that corrected these deficiencies by April 14, 2023.  I advised E.C. that if she did not submit an acceptable amended complaint in that time, I would issue a decision dismissing this action.  42 C.F.R. § 426.410(c)(2). 

E.C. timely responded to my Order to Amend and attempted to correct the above-identified deficiencies by providing a written statement (Resp.) and an excerpt from the challenged LCD.  DAB E-File Dkt. No. C-23-219, Doc. No. 4a (LCD Excerpt). 

In her written statement, E.C. explains she requires six epidural steroid injections per year to alleviate severe pain following multiple failed spinal surgeries.  Resp. at 1.  The LCD she challenges, LCD No. L39054, limits beneficiaries to four epidural steroid injections in a 12-month period.  LCD Excerpt at 2.  E.C. contends application of this LCD to limit the number of epidural steroid injections she can receive is arbitrary.  Both E.C. and her physician believe she requires more injections than authorized by LCD No. L39054.  Req. for Hearing at 5; Resp. at 1.  E.C. does not contest the untimeliness of her appeal but claims she was unaware of the February 28, 2022 denial until some unspecified time thereafter.  Resp. at 1.  

II.    Discussion

Where an aggrieved party files an unacceptable LCD complaint and fails to submit an acceptable amended complaint within a reasonable timeframe, I am required to dismiss the complaint.  42 C.F.R. § 426.410(c)(2).  For a complaint to be acceptable, it must meet the requirements for a valid complaint in 42 C.F.R. § 426.400.  42 C.F.R. § 426.410(b)(2). 

E.C.’s initial filing did not meet three of the requirements for a valid complaint.  It did not include evidence of timeliness, a statement from the Aggrieved Party, or clinical or scientific evidence accompanied by an explanation to show the submitted evidence demonstrates the LCD is not reasonable.  42 C.F.R. § 426.400(c)(3),(5),(6)(i). 

I therefore provided E.C. an opportunity to file an amended complaint to correct these deficiencies.  But E.C. did not correct two of the three deficiencies I identified in my

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Order to Amend.  While I recognize E.C.’s good-faith effort to amend her complaint, I must find her complaint unacceptable. 

1. E.C.’s Complaint is not timely.  

E.C. has not demonstrated she timely filed her complaint.  The regulations permit an aggrieved party to challenge application of an LCD policy either 120 days after an initial denial by a CMS contractor or within six months after a treating practitioner issues a statement explaining the need for service.  42 C.F.R. § 426.400(b)(1), (2).  Here, the evidence of record indicates E.C. received the injections at issue before filing her LCD challenge and was denied coverage on February 28, 2022.  Req. for Hearing at 2-4.  The regulations therefore required her to file a complaint within 120 days of that notice, or by June 28, 2022.  42 C.F.R. § 426.400(b)(2).  E.C. filed her complaint in the Civil Remedies Division on February 21, 2023.  Her complaint is therefore untimely pursuant to 42 C.F.R. § 426.400(b)(1).3 

E.C. may have alternatively intended to rely on a statement issued by her physician which she submitted with her complaint to establish timeliness, not the February 2022 claim denial.  42 C.F.R. 426.400(b)(2) permits an aggrieved party to challenge application of an LCD policy before the service is provided if that appeal is filed within six months of a treating practitioner’s statement explaining the need for the service.  The physician’s statement submitted by E.C. does explain the need for the service at issue but is undated.  In my Order to Amend, I identified the issue of timeliness to E.C. and outlined the two bases to establish timeliness.  E.C.’s response does not provide sufficient information for me to conclude her complaint was filed within six months of the date of her physician’s statement.  I therefore have no basis to conclude it is timely.4 

2. E.C. satisfied the requirement to identify the service needed and explain why she believes application of the LCD Policy is unreasonable.

An acceptable complaint must also include “[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.”  42 C.F.R. § 426.400(c)(5).  E.C.’s response to my Amended Order does include a statement

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explaining how application of LCD No. L39054 is not reasonable because it is intended to apply to pre-surgical scenarios, not her own post-surgical chronic pain, for which she asserts the LCD policy concedes there is no consensus.  Resp. at 2, citing LCD Excerpt at 1-2.  E.C. further argues the policy limiting the total number of steroidal injections in a year was effectuated suddenly and without explanation.  Id.  Finally, she points out that the LCD policy concedes individual circumstances could warrant variation from its constraints.  Id. at 3 (“Lack of supporting evidence… must be balanced against patients who do have good results with injections and wish to avoid surgery when clinical benefit is evident.”). 

Whatever their ultimate merit, E.C.’s arguments at this stage are adequate to meet the regulatory requirement that she explain the service she needs and why application of the LCD policy is not reasonable in her case.  E.C.’s amended complaint satisfies the requirement set forth at 42 C.F.R. § 426.400(c)(5). 

3. E.C. did not satisfy the requirement to provide clinical or scientific evidence supporting her complaint or an explanation for why such evidence demonstrates the LCD Policy is unreasonable

Finally, an acceptable complaint must include “[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.”  42 C.F.R. § 426.400(c)(6)(i).  Here, E.C. has failed to submit copies of clinical or scientific evidence that could support her complaint.  Nor has she provided an explanation for why such evidence shows that application of the LCD at issue here is not reasonable.  E.C.’s amended complaint fails to satisfy this regulatory requirement.  

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III.    Conclusion

As explained above, I must dismiss E.C.’s complaint for several reasons.  She did not provide sufficient evidence for me to conclude she timely filed her complaint.  She has not provided copies of scientific or clinical evidence to support her complaint or articulated how such evidence shows LCD No. L39054 is unreasonable.  E.C.’s complaint remains unacceptable under 42 C.F.R. § 426.410(b)(2) and I am thus required to dismiss it.  42 C.F.R. § 426.410(c)(2).  E.C. may not file another complaint seeking review of the same LCD for six months.  42 C.F.R. § 426.410(c)(3).  She has 30 days from the date of this Decision to file an appeal with the Departmental Appeals Board.  42 C.F.R. § 426.465.