In re LCD Complaint: Tumor Treatment Field Therapy LCD ID Number: L34823 Contractor: CGS Administrators, LLC, DAB CR5546 (2020)

DECISION DISMISSING COMPLAINT

I dismiss the complaint filed against Local Coverage Determination (LCD) No. L34823 because CGS Administrators, LLC (CGS) removed the categorical prohibition on coverage for Tumor Treatment Field Therapy (TTFT) (E0766) from the LCD thereby enabling the Aggrieved Party (AP) to receive coverage relief.  42 C.F.R. § 426.420(e)(1); 68 Fed. Reg. 63,692, 63,709 (Nov. 7, 2003).  As a result, the regulations direct the relevant Medicare Advantage Plan, i.e., Medicare Plus Blue Group PPO (the Plan), to reopen the AP’s request for pre-approval and adjudicate that matter again.  42 C.F.R. §§ 426.420(b), 426.460(b)(1).  Because the Plan is not a party to this case, CGS will ensure that the Plan receives this decision so that the AP will receive individual claim review.

I. Background

The AP sought pre-approval for TTFT; however, the Plan denied that request based on L34823.  Further, a Qualified Independent Contractor and an administrative law judge (ALJ) with the Office of Medicare Hearings and Appeals also issued unfavorable decisions based on L34823.  A. Ex. 8.  The AP appealed the ALJ’s decision to the Medicare Appeals Council. 

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In addition to filing an appeal with the Medicare Appeals Council, on January 29, 2019, the AP filed a complaint with the Civil Remedies Division seeking review of the validity of L34823.  On February 12, 2019, I acknowledged receipt of the AP’s acceptable complaint and issued a prehearing order establishing a schedule for the submission of the LCD record, the AP’s new evidence related to L34823, and the parties’ arguments as to whether the LCD record was complete and adequate to support the validity of L34823 under the reasonableness standard.  42 U.S.C. § 1395ff(f)(2)(A)(i)(I); 42 C.F.R. §§ 426.403, 426.405(b), 426.425, 426.431.

On March 20, 2019, CGS filed the LCD record, which consisted of 42 exhibits (CMS Exs. 1-42).  CGS filed three exhibits, CMS Exs. 40-42, under seal, claiming that they were proprietary/privileged.  On March 22, 2019, CGS filed a privilege log.  On March 27, 2019, CGS withdrew CMS Exs. 1 and 37.  On March 28, 2019, the AP moved for production of the exhibits that CGS claimed as proprietary/privileged.  Following CGS’s response to the motion, on April 25, 2019, I issued an order in which I concluded that CMS Exs. 40-42 did not meet the standard of being proprietary or privileged under the definition for those terms in 42 C.F.R. § 426.110.  Therefore, I indicated that CGS needed to choose between disclosing those documents to the AP or withdrawing them as exhibits.  CGS gave notice that it did not object to the exclusion of CMS Exs. 40-42 because other documents in the LCD record were consistent with the information contained in CMS Exs. 40-42. 

On April 12, 2019, the AP filed his statement as to why L34823 was invalid along with new evidence related to TTFT (A. Exs. 1-129, 131-161, 190-196, 200-368).

On May 9, 2019, CGS filed notice that CGS and other Medicare contractors were formally reconsidering L34823 and had issued notice of a proposed revision to that LCD.  CMS Exs. 43-44.  CGS moved for dismissal of the AP’s complaint because L34823 was to be revised.  The AP opposed dismissal and submitted A. Exs. 369 and 370.  In a May 15, 2019 order, I denied CGS’s motion as premature since L34823 had not been revised yet.

On May 20, 2019, CGS filed its response in defense of the validity of L34823 along with CMS Exs. 45-47.

On May 28, 2019, I issued an order in which I concluded that the LCD record for L34823, which had not been updated since 2015, no longer supported the validity of L34823’s categorical prohibition on coverage for TTFT.  42 C.F.R. § 426.425(c).  I rejected CGS’s argument that the AP lacked standing to seek review of L34823.  I also rejected CGS’s argument that review in this matter was limited to whether the LCD record supported the validity of L34823 when L34823 was published.  CGS posited that to hold otherwise would subvert the LCD reconsideration process established in a CMS manual.  My order stated:

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CGS misunderstands both the LCD challenge process and how it relates to the LCD reconsideration process.  Congress established LCDs and provided some basic requirements related to the development of LCDs.  42 U.S.C. § [1395y](l)(5).  However, Congress also established an LCD review process, to be conducted by an [ALJ].  42 U.S.C. § 1395ff(f)(2).  This process is meant to determine the validity of the LCD.  Id. § 1395ff(f)(2)(i)(I).  In promulgating the regulations to implement this process to challenge an LCD, the Secretary of Health and Human Services (Secretary) made it clear that the process for challenging the validity of an LCD may be invoked because “a challenger may believe that a policy that was correct when it was issued has become outdated and is no longer valid in light of advances in medicine.”  68 Fed. Reg. 63,692, 63,700 (Nov. 7, 2003).  In fact, the Secretary expressly permitted aggrieved parties to submit new evidence concerning the LCD so that the ongoing validity of the LCD could be tested.  Id.; see also 42 C.F.R. § 426.403.

Further, the Secretary was fully aware of the LCD reconsideration process and provided procedures by which the contractor or the ALJ could evaluate whether new evidence submitted in the case warranted a reconsideration of the LCD.  42 C.F.R. §§ 426.340, 426.417.

* * * * *

Another major distinction between the LCD review process before an ALJ and the reconsideration process before a contractor is that an ALJ can only decide that an LCD provision is no longer valid, but cannot revise the LCD provision.  42 C.F.R. §§ 426.405(d)(14), 426.450(a)(2).

Because I concluded that the LCD record for L34823 no longer supported the validity of that LCD, I also ordered the parties to provide notice as to whether they wanted to engage in discovery and submit additional evidence.  42 U.S.C. § 1395ff(f)(2)(A)(i)(I); 42 C.F.R. §§ 426.425(c)(3), 426.432, 426.440.

The parties responded that they did not wish to engage in discovery.  The AP had no additional evidence to submit and CGS only submitted one non-substantive exhibit (CMS Ex. 48).  Further, CGS previously indicated that it did not want to cross-examine any of the AP’s witnesses and that CGS did not have any witnesses to offer.  Therefore, I issued

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an order on June 14, 2019, in which I admitted CMS Exs. 2-36, 38-39, and 43-48 and A. Exs. 1 – 129, 131-161, 190-350, and 352-371 into the record.  In that order I also closed the record, gave notice that the AP’s new evidence has the potential to significantly affect my evaluation of the reasonableness/validity of L34823, stayed the proceedings for ten days so that CGS could determine if CGS could complete its revision of L34823 within 90 days, and scheduled a conference with the parties.  42 C.F.R. § 426.340.  In regard to my finding that the new evidence has the potential to significantly affect my review of the LCD, I stated: 

This case involves three significant factors that make it necessary for me to inform CGS that the new evidence submitted in this case has the potential to significantly affect my evaluation of the current reasonableness/validity of L34823. 

1)  L34823 provides a categorical prohibition on coverage of TTFT.  Therefore, so long as the new evidence proves that some coverage for TTFT is now warranted, a categorical prohibition of coverage would no longer be reasonable.   

2)  L34823 has not previously been formally reevaluated and updated since its publication in 2015, but the medical community’s evaluation of the effectiveness of TTFT has not been static since that time.

3)  CGS and the other Medicare contractors accepted a request that they reconsider L34823 nearly a year ago and recently published a proposed revised L34823 permitting some coverage.

The Aggrieved Party has submitted many exhibits in this case.  Of these, 21 of the exhibits represent the majority of sources referenced in the proposed revision to L34823.  A. Exs. 5-6, 12, 70-72, 82, 95, 122-123, 125, 129, 136-137, 139, 143, 146, 150, 155, 157, 158; CMS Ex. 43 at 10-13.  However, to generalize, a review of the new evidence submitted in this proceeding shows a positive change in medical opinion about TTFT’s efficacy since 2015 when L34823 was first adopted.  The documents from 2018 increasingly indicated conclusions that TTFT was appropriate and effective, within certain parameters.  See e.g., A. Ex. 12; A. Ex. 70 at 1; A. Ex. 72 at 8; A. Ex. 82 at 5; A. Ex. 95 at 11; A. Ex. 137 at 6.  However, other articles indicated that

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questions remain as to the optimization of TTFT.  See e.g. A. Ex. 129 at 3; A Ex. 139 at 7.

The proposed revised L34823 had an analysis section that included polling a 13-member specialty-focused contractor advisory committee (CAC) on certain questions related to TTFT and explaining the current medical literature about TTFT.  CMS Ex. 44.  As CGS asserts in its most recent filing, the CAC represented a similar mixture of confidence in TTFT along with concerns about what is not yet known as to this treatment.

* * * * *

[A]t this juncture in the case, I need only determine whether the new evidence submitted in this case has the potential to significantly affect the evaluation of the reasonableness of the LCD provision being challenged.  The evidence of record does have that potential.

At the June 18, 2019 telephone conference I held with the parties, CGS discussed the process it was following to complete revisions to L34823.  The AP argued that CGS should not be given 90 days to complete its revisions because CGS had been reconsidering those revisions for a year.  In a June 27, 2019 order, I stayed proceedings for 90 days so that CGS could reconsider and revise L34823.  42 C.F.R. § 426.340(e).  On July 18, 2019, CGS filed the revised version of L34823, which would take effect in September 2019.  CMS Exs. 49-51.

On July 19, 2019, I ordered the parties to provide their views as to whether I should dismiss the AP’s complaint or conduct a review of the revised L34823.  I framed the issue as follows: 

When a contractor revises an LCD that is under review by an [ALJ], the ALJ will dismiss the LCD complaint if the contractor “revised the LCD to completely remove the provision in question.”  42 C.F.R. § 426.420(e)(1).  If dismissed, the aggrieved party receives a new individual claim review without the challenged LCD provision.  42 C.F.R. §§ 426.420(b), (e)(1), 426.460(b). 

However, if the contractor “revised the LCD provision in question but has not removed it altogether, the ALJ must continue the review based on the revised LCD.”  42 C.F.R.

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§ 426.420(e)(2).  In such an event, the contractor must file a copy of the supplemental LCD record and the aggrieved party has an opportunity to respond to the revised LCD and supplemental record.  42 C.F.R. §§ 426.340(g), 426.420(e)(2); see also 42 C.F.R. § 426.425(d).

CGS urged me to dismiss the AP’s complaint because the provision prohibiting coverage for TTFT was removed from L34823.  The AP argued for review of the revised L34823 because the AP could not meet the criteria for coverage established in the revision. 

In an August 21, 2019 order, I established a new submission schedule so that I could conduct a review of the revised L34823.  I did this because both parties’ arguments under the regulations appeared to have merit, but after consulting the preamble to the final rule for interpretative guidance, I became concerned that the AP would potentially have no coverage for TTFT and lose his statutory right (42 U.S.C. § 1395ff(f)(2)) to challenge the validity of L34823.  The preamble stated, in pertinent part:    

In § 426.420(a) and (b), we allow a contractor to retire the LCD under review or revise the LCD to remove or amend the provision in question before the date the ALJ issues a decision regarding the LCD.  Retiring an LCD (or provision of the LCD) means that the contractor may no longer use that LCD in the adjudication of claims on a prospective basis.  We also provide the aggrieved party individual claim review under § 426.460(b).  Thus, in most cases, there would no longer be a need for an LCD review because relief would be provided. . . . In § 426.420(b), § 426.420(c), § 426.420(d), § 426.420(e) and § 426.520(b), § 426.520(c), § 426.520(d), § 426.520(e), we describe the process for LCDs and NCDs that are revised or reconsidered while under review.  In cases where an LCD/NCD provision(s) has been revised, but not completely removed, the review continues because relief may not have been provided.  This responds to comments received, and will ensure that aggrieved parties receive coverage relief when they prevail.

68 Fed. Reg. 63,692, 63,709 (Nov. 7, 2003) (emphasis added).

As a result, and in accordance with my order, CGS filed the record for the revised LCD.  CMS Exs. 52-76.  The AP filed a motion to compel CGS to provide certain additional documentation related to the reconsideration process involving L34823.  I denied the AP’s motion in part, but also ordered CGS to provide access to its recordings of the CAC

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and public meetings held during the reconsideration process.  Subsequently, the AP submitted his statement concerning the validity of the revised LCD along with A. Exs. 162-65, 372-418. 

On January 22, 2020, the AP filed notice, under 42 C.F.R. § 426.310(b), that the AP “received approval from [the AP’s] Medicare Advantage Plan regarding a recent request for a predetermination of [TTFT] for his glioblastoma.”  See A. Ex. 419.  The AP noted that his appeal of the denial of his prior request for predetermination of coverage remains pending before the Medicare Appeals Council.   

As a result, on January 28, 2020, I ordered the parties to provide their views on this development.  I stated: 

This determination by the Medicare Advantage Plan indicates that the Aggrieved Party is able to receive coverage under the revised LCD.  As a result, I am reconsidering whether I am required, under 42 C.F.R. § 426.420(e), to dismiss the present LCD complaint and order the Medicare Advantage Plan to reopen the Aggrieved Party’s original predetermination request for an individual review. 

The parties timely responded to my order.

II. Analysis

An LCD is “a determination by a fiscal intermediary or a carrier . . . respecting whether or not a particular item or service is covered on an intermediary- or carrier-wide basis.”  42 U.S.C. § 1395ff(f)(2)(B).  At least 45 days before an LCD becomes effective, each Medicare administrative contractor must make the following available on its internet website and on the Medicare website:  where and when the proposed LCD was made public; hyperlinks to the proposed determination and a response to comments submitted to the contractor concerning the proposed determination; the entire LCD; a summary of the evidence that was considered by the contractor and a list of the sources of such evidence; and an explanation of the rationale that supports the LCD.  42 U.S.C. § 1395y(l)(5)(D).  The Secretary coordinates the LCDs issued by the various fiscal intermediaries and carriers and determines when LCDs should be adopted nationally.  42 U.S.C.  § 1395y(l)(5)(A)-(C).

When a fiscal intermediary or carrier issues an initial determination denying coverage of an item or service, the determination must state whether an LCD was used in making that determination.  42 U.S.C. § 1395ff(a)(4)(A)(i).  If a qualified independent contractor considers a claim on reconsideration, the LCD “shall not be binding on the qualified independent contractor in making a decision with respect to a reconsideration,” but “the

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qualified independent contractor shall consider the local coverage determination in making such decision.”  42 U.S.C. § 1395ff(c)(3)(B)(ii)(II).  If a case is further appealed to an ALJ at the Office of Medicare Hearings and Appeals or to the Medicare Appeals Council at the Departmental Appeals Board, the ALJ and the Council are not bound by the LCD, but must give the reasons for not following an LCD.  42 C.F.R. § 405.1062. 

Outside of the Medicare claims appeal process, a beneficiary entitled to Medicare Parts A and/or B may seek review of an LCD by an ALJ, who will only defer to reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law.  42 U.S.C. § 1395ff(f)(2)(A)(i)(III); see also 42 C.F.R. § 426.431.  The ALJ may uphold or invalidate the challenged LCD provision.  42 C.F.R. § 426.460.  The LCD review process is distinct from the claims appeal process.  42 C.F.R. § 426.310. 

In the present matter, CGS requests that I dismiss the AP’s complaint.  CGS argues that the language in the LCD that the AP originally challenged has been removed and replaced with “evidence-based coverage criteria.”  CGS went on to state that, after receiving approval of a recently filed request for pre-approval of TTFT, the AP has lost standing because he is no longer an “aggrieved party.”  Further, CGS states that “[b]ecause re-adjudication of the denial [by the Plan] is proper, the complaint should be dismissed.  Finally, CGS asserts, the LCD has, in fact, been revised in a way that allows coverage, so dismissal is proper under 42 CFR Section 426.420(e).”  CGS’s Response to January 28, 2020 Order at 2.  

The AP opposes dismissal of his complaint.  He argues that payment of a claim does not strip him of standing to challenge the revised LCD.  The AP asserts that his claim had been denied and that this was sufficient to confer standing for the duration of this case because the claims review process is separate from the LCD review process.  The AP also questioned whether the Plan could be compelled to reopen its previous determination since an appeal of that denial is presently before the Medicare Appeals Council.  If it is reopened, the AP asserts, then he should receive review without the application of either the prior or revised LCD.  AP’s Response to January 28, 2020 Order.

The parties frame the issue as one of standing.  In order to have standing, an individual must be entitled to benefits under Medicare Part A or enrolled in Medicare Part B, or both, and be “ in need of the items or services that are the subject of the [LCD].”  42 U.S.C. § 1395ff(f)(5).  Such an individual is referred to as an “aggrieved party.”  42 U.S.C. § 1395ff(f)(2)(A)(i).  The Secretary, likely believing that to be “aggrieved” under the statute an individual must not have received coverage of the needed item or service, added to the regulatory definition of an “aggrieved party” that he or she is in

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need of coverage for a service that is denied based on the LCD regardless of whether the service was received.1  42 C.F.R. §§ 426.110, 426.320(a). 

However, attempting to resolve this case through a standing analysis is unhelpful.  If the AP is no longer an “aggrieved party” because his most recent request for pre-approval for TTFT was allowed, then this LCD challenge must be dismissed without a further right to review of the original denial of pre-approval for the TTFT services that the AP purchased for himself.  42 C.F.R. § 426.444(b)(3).  On the other hand, if the AP could still be considered an aggrieved party because he has not yet received a favorable outcome to his first request for pre-approval for TTFT, the AP would continue forward in an LCD review process during which time his denied pre-approval could have been reopened and granted.  Therefore, I decline to rule on the parties’ conflicting arguments as to the AP’s standing. 

Rather, as indicated in my order, I focus on the regulatory provisions that envision the possibility that the LCD review process may reach a point where a revised LCD enables an aggrieved party’s claim to be favorably adjudicated.  When an LCD is revised during the LCD complaint process, that revision has the same effect as an ALJ decision finding that the challenged LCD provision is invalid.  42 C.F.R. §§ 426.420(b), 426.460(b).  For claims that have already been denied, this means that “the contractor, an M + C organization or another Medicare managed care organization must reopen the claim of the party who challenged the LCD and adjudicate the claim without using the provision(s) of the LCD that the ALJ found invalid.”  42 C.F.R. § 426.460(b)(1); see also LCD Appeal of Non-Coverage of Transfer Factor, DAB No. 2050 at 18 (2006) (explaining that § 426.460(b)(1) applies when a challenged LCD provision is retired or withdrawn).  The revised LCD only applies to “claim or appeal submissions or request for services delivered or services performed on or after the effective date of the revised LCD.”  42 C.F.R. § 426.460(b)(1)(ii).

An ALJ must dismiss the LCD complaint if the ALJ receives notice that the contractor has completely removed the LCD provision in question so that the aggrieved party “receive[s] individual claim review without the retired/withdrawn provision(s).”  42 C.F.R. § 426.420(e)(1).  Although I was previously concerned that the revised LCD could result in denial of the AP’s request for pre-approval for TTFT, the AP has successfully received approval for a subsequently filed pre-approval request for TTFT.  A. Ex. 419 at 2.  This makes it more likely that CGS was correct in its original view that it had removed the challenged LCD provision in its entirety and the AP would receive coverage.

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Therefore, I have reconsidered my original ruling in this case based on the AP’s pre-approval for TTFT and conclude that I should dismiss the LCD complaint so that the Plan can reopen his originally denied request for pre-approval and re-adjudicate it.  Should the Plan decide, on reopening, to once again deny the AP’s pre-approval, then the AP could appeal that denial.  68 Fed. Reg. at 63,705 (“When an M + C organization reopens and adjudicates an organization determination under § 426.460(b)(1), the M + C organization must issue a revised organization determination, which gives rise to appeal rights under parts 417 and 422.”).  Further, the AP could request that I reconsider this dismissal if the Plan issues an unfavorable determination following reopening.  See LCD Complaint:  Bioengineered Skin Substitutes for the Treatment of Diabetic and Venous Stasis Ulcers of the Lower Extremities, DAB No. 2814 at 5 (2017). 

The AP indicates concern that the Plan will not be able to reopen his pre-approval denial because the appeal of that case is presently pending with the Medicare Appeals Council.  I am without authority to direct the Medicare Appeals Council to take any action; however, I must comply with the regulations.  In this case, 42 C.F.R. § 426.420(e)(1) directs that I dismiss this case so that the AP can receive an individual claim review following the removal of the categorical prohibition on TTFT coverage.  The Medicare Appeals Council will act in accordance with its own interpretation of the regulations. 

III. Conclusion

For the reasons explained above, I must dismiss the AP’s complaint so that the Plan can reopen the denial of his request for pre-approval and re-adjudicate it without the categorical prohibition on TTFT coverage that was in the original L34823.

• 1. The clause “regardless of whether the service was received” merely allows beneficiaries to obtain a needed service at the time it was needed, while preserving their right to challenge the LCD that led to denial of coverage for the service.  68 Fed. Reg. at 63,695.