In re LCD Complaint: Trigger Point Injection, DAB CR6506 (2024)

DECISION DISMISSING COMPLAINT

On May 28, 2024, the Civil Remedies Division received a mail submission dated May 22, 2024, from the Aggrieved Party consisting of a cover letter, a physician statement from H. Steven Coss, MD, and treatment records documenting care by two other physicians, Dr. Taddei and Dr. Pellegrino. In her cover letter, the Aggrieved Party reported that she receives “trigger point injections and a ketorolac shot every 4 weeks” from Dr. Pellegrino and receives “an injection in each terres [sic] minor approximately every 3 months” from Dr. Coss. The Aggrieved Party explained that physicians had informed her that “Medicare has changed their National Coverage Decision by cutting the number of injections a patient may have.” The Aggrieved Party challenged the “cut in services to three injections per year, as this limitation will be substantially detrimental to [her] health.”

In an Order dated May 31, 2024, 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 she had not filed an acceptable complaint.

I 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. See 42 C.F.R. § 426.400(b)(1). Although I acknowledged that the complaint was timely with respect to a challenge to the frequency of trigger point injections administered by Dr. Coss, I

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ordered the Aggrieved Party, to the extent she seeks to challenge the frequency of the trigger point injections administered by Dr. Pellegrino, to submit a written statement from Dr. Pellegrino.

I discussed that an acceptable complaint must address the “specific provision or provisions of the LCD adversely affecting the aggrieved party.” 42 C.F.R. § 426.400(c)(4). Because the complaint did not identify a specific LCD provision being challenged, I ordered the Aggrieved Party to amend her complaint to include the specific LCD by name, the Medicare contractor, and the specific provision or provisions of the LCD that adversely affect her.

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

I also explained 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 her complaint accordingly.

I directed the Aggrieved Party to file a response within 30 days, addressing the missing information outlined above. 42 C.F.R. § 426.410(c)(1). The Aggrieved Party has not filed a response to my May 31, 2024 Order, nor has she otherwise submitted an amended complaint.1 Because the Aggrieved Party failed to submit an acceptable complaint, even after being afforded an additional 30 days to amend her complaint, I “must issue a decision dismissing the unacceptable complaint.” 42 C.F.R. § 426.410(c)(2). Therefore, I dismiss the Aggrieved Party’s complaint.