In re LCD Complaint: Trigger Point Injections (L34211), DAB CR6512

DECISION DISMISSING UNACCEPTABLE COMPLAINT

On May 20, 2024,¹ the Civil Remedies Division received a complaint filed by Medicare beneficiary and Aggrieved Party, J.B.,² challenging a Local Coverage Determination (LCD) titled Trigger Point Injections.  I am designated to review this LCD challenge.  42 C.F.R. § 426.410(b).

I.     Background

Upon initial review of J.B.’s complaint, I was unable to determine whether it was filed by an aggrieved party, meaning a Medicare beneficiary who, among other things, “[h]as obtained documentation of the need [for a service that is denied based on an applicable LCD] by the beneficiary’s treating physician.”  42 C.F.R. § 426.110; see 42 C.F.R. § 426.400(a) (“An aggrieved party may initiate review of an LCD by filing a written complaint . . .” (emphasis added)).  J.B.’s complaint did not include a valid written statement from a treating physician.  At the same time, I was also unable to determine whether J.B. timely filed her complaint because timeliness depended on the date of a valid treating physician statement.  42 C.F.R. § 426.400(b).

Even assuming proper status as an aggrieved party and timely filing, however, I concluded J.B. had not filed an otherwise acceptable and valid LCD complaint under the applicable regulations.  See 42 C.F.R. § 426.410(b).  Therefore, on June 3, 2024, I issued an Acknowledgment of Receipt and Order to Amend Unacceptable Complaint (Order to Amend).  In that order, I informed J.B. that her initial complaint was deficient and

Page 2

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(c).  I explained J.B.’s initial attempt to file a valid complaint failed because it did not provide the following information:

• Treating Physician Written Statement:  J.B. did not provide documentation from her treating physician explaining she needed a service that is the subject of the LCD.  Instead, she submitted documentation from a nurse practitioner.
• Aggrieved party statement:  J.B. identified the LCD she wished to challenge but did not identify the specific provision(s) of the LCD adversely affecting her or explain why those provisions were not valid under the reasonableness standard.
• Clinical or scientific evidence:  J.B. did not provide copies of clinical or scientific evidence in support of her complaint or explain why she believed such evidence showed the LCD was not reasonable.

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

J.B. timely responded to my Order to Amend, submitting a written statement from a treating physician asserting her need for trigger point injections and a copy of the attachments that were previously submitted with her initial complaint.  DAB E-File Dkt. No. C-24-458, Doc. No. 3.  This statement is virtually identical to the first one except it is signed by a physician.

II.    Discussion

As explained below, J.B.’s recent submission corrects some but not all the deficiencies I identified in my Order to Amend.  While I recognize J.B.’s good-faith effort to amend her complaint, I must find her complaint unacceptable.

1. J.B.’s complaint is timely.

42 C.F.R. § 426.400(b)(1) permits an aggrieved party to challenge an LCD provision 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.  J.B.’s initial complaint demonstrated she wished to challenge the LCD before receiving trigger point injection services.  Her recent submission includes a letter signed by a treating physician that documents J.B.’s need for that treatment.  That letter is dated June 27, 2024, within the

Page 3

last six months, therefore establishing J.B.’s complaint is timely.  42 C.F.R. § 426.400(b), (c)(3).  The physician’s letter also confirms J.B.’s status as an aggrieved party.  42 C.F.R. §§ 426.110, 426.400(3).

2. J.B. satisfied the requirement to submit a treating physician statement.

An acceptable complaint must include a “copy of a written statement from the treating physician that the beneficiary needs the service that is the subject of the LCD.”  42 C.F.R. § 426.400(c)(3).  J.B. previously submitted a letter of medical necessity signed by a nurse practitioner, not a physician.  Her submission of a letter signed by her treating physician that addresses her need for trigger point injection services satisfies this regulatory requirement for an acceptable complaint.

3. J.B. did not satisfy the requirement to explain why she believes the LCD provision 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).  J.B. previously identified the LCD she wished to challenge but did not identify the specific provision(s) of the LCD adversely affecting her or explain why she believed those provisions were not valid under the reasonableness standard.  J.B.’s latest submission still does not identify specific provision(s) of the LCD adversely affecting her or explain why those provisions are not valid under the reasonableness standard.  J.B.’s amended complaint therefore fails to satisfy this regulatory requirement.

4. J.B. 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, J.B. 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 application of the LCD at issue here would not be reasonable.  J.B.’s amended complaint therefore still fails to satisfy this regulatory requirement.

Page 4

III.   Conclusion

As explained above, I must dismiss J.B.’s complaint for several reasons.  She has not identified the specific provision(s) of the LCD adversely affecting her or explained why she thinks those provisions are not valid under the reasonableness standard.  Nor has she provided copies of scientific or clinical evidence to support her complaint or explained how such evidence shows application of LCD No. L34211 would be unreasonable.  Because J.B.’s complaint remains unacceptable under 42 C.F.R. § 426.410(b)(2), I am required to dismiss it.  42 C.F.R. § 426.410(c)(2).  J.B. 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.

Endnotes

¹  J.B.’s complaint is postmarked May 16, 2024, which for purposes of this decision I deem the date of filing.

²  I refer to the Aggrieved Party by her initials to protect her privacy.  See 68 Fed. Reg. 63,691, 63,708, 63,711 (Nov. 7, 2003).