In re LCD Complaint: Facet Joint Injections, Medical Branch Blocks, and Facet Joint Radiofrequency Neurotomy (L34995), DAB CR5366 (2019)

DECISION DISMISSING UNACCEPTABLE COMPLAINT

On December 6, 2018, a Medicare beneficiary (L.N.1 or the Aggrieved Party) filed a complaint in the Civil Remedies Division challenging a Local Coverage Determination (LCD) titled Facet Joint Injections, Medical Branch Blocks, and Facet Joint Radiofrequency Neurotomy. I was designated to review her LCD challenge.

I. Background

Upon initial review of L.N.'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). I was also unable to determine whether L.N. had timely filed her complaint, meaning within six months after her treating practitioner issued a written statement explaining the need for the service. 42 C.F.R. § 426.400(b).

Even assuming timely filing, however, I concluded L.N. had not filed an otherwise acceptable and valid LCD complaint under the applicable regulations. See 42 C.F.R. § 426.410(b). Therefore, on December 19, 2018, I issued an Acknowledgment of Receipt and Order to Amend Unacceptable Complaint (Order to Amend). In that order, I informed L.N. that her initial complaint was deficient and provided her one opportunity to submit an acceptable complaint. See 42 C.F.R. § 426.410(c)(1).

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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 L.N.'s initial attempt to file a valid complaint failed because it did not provide the following information:

• Treating Physician Written Statement: L.N. did not provide any documentation from her treating physician explaining that she needs a service that is the subject of the LCD. Instead, she submitted such documentation from a nurse practitioner.
• Aggrieved party statement: L.N. 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: L.N. 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 L.N. to file an amended complaint that corrected these deficiencies by January 18, 2019. I advised L.N. 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).

L.N. timely responded to my Order to Amend and attempted to correct the above-identified deficiencies by providing a written statement, a letter from her treating physician, and some of her medical records. DAB E-File Docket No. C-19-207, Doc. Nos. 3, 3a, 3b, 3c, 3d, and 3e.

In her written statement, L.N. explains that she needs radiofrequency (RF) ablations following multiple spinal surgeries that failed to eliminate her severe back pain.  Id. at Doc. No. 3. However, L.N. asserts the LCD she challenges limits the number of RF ablations she can receive in a given 12-month period based on the region of the spine. Id. As she quotes from the LCD, "[a] maximum of five (5) facet joint injection sessions inclusive of ... RF ablations may be performed per rolling 12 month year in the cervical/thoracic spine and five (5) in the lumbar spine." Id.

L.N. contends the LCD arbitrarily limits the number of RF ablations she can receive, since the policy permits a number of facet injections equal to the total number of facet joints in the lumbar spine (five), but not the total number of facet joints in the cervical and thoracic region of the spine (19). Both L.N. and her physician believe she requires far more injections than the LCD allows her to receive.2 Id. at 3, 3a.

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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, among other things, meet the requirements for a valid complaint in 42 C.F.R. § 426.400. 42 C.F.R. § 426.410(b)(2).

L.N.'s initial filing did not meet three of the requirements for a valid complaint; it lacked a treating physician's written statement, a statement from the Aggrieved Party, and clinical or scientific evidence accompanied by an explanation to show that evidence demonstrates the LCD is not reasonable. 42 C.F.R. § 426.400(c)(3), (5), (6)(i). In addition, without a written statement from a treating physician, I could not determine whether L.N. had timely filed her complaint or was, in fact, an aggrieved party. 42 C.F.R. §§ 426.110, 426.400(b).

I therefore ordered L.N. to file an amended complaint to correct these deficiencies. But while I recognize L.N.'s good-faith effort to amend her complaint, I must find her complaint unacceptable.

First, I note L.N. has corrected two out of the three deficiencies I identified in my Order to Amend. The letter from her treating physician does establish that she needs a service that is the subject of the LCD identified in the complaint. It also demonstrates she is an aggrieved party and filed her complaint timely. See 42 C.F.R. §§ 426.110, 426.400(b), (c)(3). And L.N.'s own statement adequately explains why she believes the LCD she is challenging is not valid under the reasonableness standard. See 42 C.F.R. § 426.400(c)(5). However, she has not provided sufficient clinical or scientific evidence in support of her complaint, or explained how such evidence shows the LCD in question is not reasonable.

Here, to satisfy the requirement for submission of clinical and scientific evidence imposed by the regulations, L.N. submitted her own medical records. The plain language of the governing regulations does not explicitly preclude the submission of an individual's own personal medical records; they merely require submission of "[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).

But it does not appear that the drafters of the LCD challenge regulations intended an individual's personal medical records to satisfy this requirement. The LCD challenge process is separate and distinct from the claims appeal process that individual beneficiaries use to appeal denial of coverage of a procedure by Medicare. 42 C.F.R. § 426.310(a) ("LCD ... reviews are distinct from the claims appeal processes set forth in

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[42 C.F.R.] part 405, subparts G and H; [42 C.F.R.] part 417, subpart Q; and [42 C.F.R.] part 422, subpart M ....").

As the drafters explained in the preamble to the final LCD rule, the individual Claims Appeal Process allows a beneficiary of the Medicare program to challenge such denials and eventually receive review from an independent ALJ; that appeals process "enables beneficiaries to submit any relevant information pertaining to an individual claim." 68 Fed. Reg. 63,692, 63,693 (Nov. 7, 2003) (emphasis added).3 An ALJ in that context could rely on a beneficiary's own medical evidence to find application of an LCD unpersuasive and pay an individual claim, without any need to overturn the LCD itself. Id.

By contrast, the LCD Review Process is different "because the nature of the challenge and the relevant evidence is different." Id. Rather than determining whether the LCD can be reasonably applied to one individual, as the Claims Appeals Process allows, review in an LCD challenge "requires examination of an entire policy, or specific provisions contained therein, and not just one claim denial. Therefore, such reviews may lead to changes that impact other beneficiaries if the policies are found to be unreasonable." Id.

In that context, the regulatory requirement to provide "clinical and scientific evidence" is clearly intended to require the aggrieved party to provide evidence showing the entire LCD policy is unreasonable, not that it is improperly applied to him or her. This suggests such evidence is more likely newfound data emanating from clinical or scientific study that supports a change in the medical premises undergirding an LCD policy.4

But even allowing for the possibility of using individual medical records to challenge an LCD, L.N. has not provided an explanation for why they demonstrate the LCD at issue is unreasonable. Nor can I say on my own review that the medical records submitted by L.N. are adequate to do so.  At best, these records demonstrate why she might need more than five RF ablations in her cervical/thoracic spine in a 12-month period. But they do not support a challenge to the reasonableness of the LCD as generally applied. As such, L.N.'s request for coverage of the number of facet injections recommended by her doctor

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would more properly be raised in an individual claim determination,5 not a general LCD challenge.

III. Conclusion

For the foregoing reasons, I find L.N.'s medical records do not constitute clinical or scientific evidence that support her complaint as required by 42 C.F.R. § 426.400(c)(6)(i). Furthermore, she has not explained why she thinks her records show the LCD at issue is not reasonable. Accordingly, L.N.'s complaint remains unacceptable under 42 C.F.R. § 426.410(b). I am thus required to dismiss the complaint. 42 C.F.R. § 426.410(c)(2). L.N. 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, in accordance with 42 C.F.R. § 426.465.

1. I refer to the beneficiary by her initials to protect her privacy. See 68 Fed. Reg. 63,691, 63,708, 63,711 (Nov. 7, 2003).
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2. L.N.'s physician recommended more than double the LCD-authorized number of RF ablations to certain parts of her spine. DAB E-File Docket No. C-19-207, Doc. Nos. 3a, 3b, 3c, 3d.
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3. The Civil Remedies Division does not hear such individual claims, which are instead heard by ALJs in the Office of Medicare Hearings and Appeals.
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4. The regulation requiring submission of clinical or scientific evidence reinforces this view, as it contemplates protecting proprietary data in such submissions, including such data that may have been submitted to the FDA. 42 C.F.R. § 426.400(c)(i),(ii).
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5. L.N. may not seek review of an individual claim determination before ALJs in this division. 42 C.F.R. §§ 426.325(b)(11), 426.410(b)(2). However, as I explained earlier, she may be entitled to seek such review in a different proceeding designed for individual claims. See, e.g., 42 C.F.R. §§ 405.904 (describing generally the process under 42 C.F.R. part 405 for reviewing claims for Medicare benefits under Medicare Parts A and B), 422.560-422.626 (establishing a grievance and appeal process for enrollees in Medicare Advantage plans seeking coverage or payment of health-care items of services), 417.600 (making the procedures in 42 C.F.R. §§ 422.560-422.626 applicable to Medicare contracts with health maintenance organizations (HMOs) and competitive medical plans (CMPs)).
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