In re LCD Complaint: Tumor Treatment Field Therapy, ALJ Ruling 2020-12 (HHS CRD June 17, 2020)

ORDER

The aggrieved party (AP) complained that Local Coverage Determination (LCD) No. L34823 unreasonably prohibits Medicare coverage for Tumor Treatment Field Therapy (TTFT) (E0766) to treat recurring glioblastoma multiforme (GBM).  In response, Noridian Healthcare Solutions, LLC (Noridian), one of the Medicare contractors that developed L34823, filed documents from the record for L34823.  The AP then filed hundreds of documents as new evidence concerning the challenged provision in L34823.  Noridian submitted a written defense of L34823.  At this juncture, I must decide whether the record for L34823 alone supports the validity of the challenged provision or whether I need to allow for discovery and the taking of evidence.  42 C.F.R. § 426.425(c). 

I conclude that the LCD record submitted by Noridian is incomplete and may no longer support the validity of the challenged provision because:  1) Noridian failed to submit the entire record for L34823; 2) Noridian did not update L34823’s record as to the challenged provision when it revised L34823 in 2019; 3) Noridian now believes the AP should receive coverage to treat recurrent GBM with TTFT; and 4) the AP submitted documentation that detracts from the validity of the challenged provision. 

This conclusion is similar to denying summary judgment and does not undermine L34823’s validity.  Only a final decision that the challenged provision in L34823 is invalid has any legal effect outside the present adjudication.  42 C.F.R. § 426.460(b).

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This order sets forth dates related to the parties’ right to seek discovery.  Following the completion of discovery, I will issue an order for the submission of additional evidence and written witness testimony.  

I.  Legal Framework

An LCD is “a determination by a fiscal intermediary or a carrier . . . respecting whether or not a particular item or service is covered [under the Medicare program] 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 of the Department of Health and Human Services (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 Medicare 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).  As to the next level of appeal, the LCD “shall not be binding on the qualified independent contractor in making a decision with respect to a reconsideration” but “the 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 appealed to an administrative law judge (ALJ) at the Office of Medicare Hearings and Appeals or to the Medicare Appeals Council at the Departmental Appeals Board, neither the ALJ nor the Council are bound by the LCD, but must explain why they are not following an LCD.  42 C.F.R. § 405.1062. 

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

A CMS contractor may retire or revise an LCD under review at any time before an ALJ issues a decision.  42 C.F.R. § 426.420(a)-(b).  When this happens, the CMS contractor must notify the ALJ that it has retired or revised the LCD.  42 C.F.R. § 426.420(c).  Upon receiving such notice, an ALJ must dismiss the complaint concerning the retired or revised LCD (if the provision challenged in the complaint has been completely removed).

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42 C.F.R. §§ 426.420(e)(1), 426.444(b)(6).  Significantly, when a contractor retires or revises an LCD during the LCD complaint process, that retirement has the same effect as an ALJ decision finding the challenged LCD provision invalid.  42 C.F.R. §§ 426.420(a)-(b), 426.460(b).  For claims that have 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)(i).  If a claim had not yet been submitted to a CMS contractor, then once a claim is filed, “the contractor adjudicates the claim without using the provision(s) of the LCD that the ALJ found invalid.”  42 C.F.R. § 426.460(b)(1)(iii).  Further, “the claim and any subsequent claims for the service provided under the same circumstances is adjudicated without using the LCD provision(s) found invalid.”  42 C.F.R. § 426.460(b)(1)(iv). 

II.  Background

On August 6, 2019, the AP filed a complaint challenging the validity of the provision in L34823 that categorically prohibits Medicare coverage for TTFT as not reasonable and necessary.  The AP has recurrent GBM. 

In conformance with 42 C.F.R. §§ 426.410(d)(3) and 426.425(a)-(b), on August 22, 2019, I issued an Acknowledgment of Receipt of Acceptable Complaint; Order to File LCD Record; and Briefing Schedule.  On September 24, 2019, Noridian filed what it purported to be the record for L34823.  On September 25, 2019, the AP moved for an order compelling Noridian to submit additional documentation as part of the record, which Noridian opposed in an October 30, 2019 filing.  On November 21, 2019, I granted the AP’s motion in part, denied it in part, and ordered Noridian to refile all of its exhibits in a manner that comported with my August 22, 2019 Order.

Noridian complied with my November 21, 2019 Order and filed 50 exhibits as the record in L34823 (CMS Exs. 1-50).  Subsequently, the AP filed his statement as to why the LCD record was not complete or adequate to support the validity of the challenged provision (A. Statement) along with nearly 400 exhibits (A. Exs. 1-392).

On February 5, 2020, Noridian moved for dismissal of the AP’s complaint because Noridian had fully reevaluated the AP’s denied claims for TTFT for his recurrent GBM and decided that the AP should receive Medicare coverage despite the LCD’s prohibition on coverage.  In essence, Noridian argued that the AP no longer had standing to maintain this action. 

The AP opposed dismissal, asserting that his claims had not been allowed as alleged by Noridian.  In support of the opposition, the AP submitted A. Exs. 393 and 394.  On March 3, 2020, I ordered Noridian to submit copies of the revised determinations proving that the AP’s claims related to TTFT had been allowed.  Noridian responded to the March

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3, 2020 Order; however, on March 27, 2020, I denied Noridian’s motion to dismiss because several claims that Noridian denied were pending review by either the qualified independent contractor or ALJs.  Therefore, I concluded that the AP still had standing to maintain the complaint in the present matter.  See 42 U.S.C. § 1395ff(f)(5); 42 C.F.R. § 426.110 (definition of Aggrieved party). 

On April 16, 2020, Noridian filed its defense of the validity of L34823 (Noridian Defense). 

On June 8, 2020, the AP provided notice that Noridian had denied another claim for TTFT submitted to Noridian.  On June 10, 2020, Noridian filed notice that it revised the determination to allow the claim.

III.  LCD L34823

Noridian submitted a copy of LCD L34730, which Noridian describes in its exhibit list as “Original LCD for Tumor Treatment Field Therapy August 1, 2014; DME MAC’s published LCD for TTFT.”  This LCD stated that “[TTFT] will be denied as not reasonable and necessary.”  CMS Ex. 29 at 3.  Further, the LCD provided a list of sources of information on which it based that determination.  CMS Ex. 29 at 5-6.  L34730 was effective for services performed on or after August 1, 2014, but was retired as of September 30, 2015.  CMS Ex. 29 at 2. 

On October 1, 2015, L34823 became effective and replaced L34730.  LCD L34823 attached to Complaint at 2; CMS Ex. 36 at 2, 16.  As such, prior to its 2019 revision, L34823 also stated that “[TTFT] will be denied as not reasonable and necessary.”  LCD L34823 attached to Complaint at 4. 

In a June 20, 2018 letter, Novocure, the manufacturer of a TTFT delivery device, requested reconsideration of L34823’s total prohibition on coverage for TTFT.  CMS Ex. 35.  Noridian participated in conducting the reconsideration of the total prohibition on coverage for TTFT, which included empaneling a 13-member Contractor Advisory Committee, holding a public meeting, and receiving and responding to public comments concerning Medicare coverage for TTFT.  CMS Ex. 36 at 7-9; CMS Ex. 38 at 3-9.  However, these efforts to reevaluate the efficacy of TTFT were focused only on coverage for beneficiaries who had newly diagnosed GBM because Novocure’s reconsideration request related to recurrent GBM was rejected.  CMS Ex. 36 at 9; CMS Ex. 38 at 4-5.  As a result, although L34823 was revised, effective September 1, 2019, to provide coverage of TTFT for treating newly diagnosed GBM, L34823 maintained a categorical prohibition on coverage for TTFT in regard to recurrent GBM.   CMS Ex. 36 at 5.

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IV.  Effect of LCD L34823’s revision

The AP filed his complaint shortly before revisions to L34823 became effective.  Consequently, the AP challenged L34823’s original provision that categorically prohibited Medicare coverage for TTFT.

An ALJ must confine his or her review to the provision challenged in the LCD complaint.  42 C.F.R. § 426.431(a)(1).  However, there is an exception when an LCD has been revised, but the revision does not remove the challenged provision altogether, in which case, the ALJ will continue the review of the challenged provision.  42 C.F.R. § 426.420(e)(2).

In the present matter, the revised L34823 indicates that coverage of TTFT for recurrent GBM is not covered.  This total prohibition on coverage related to recurrent GBM is the successor provision to the previous provision that categorically prohibited coverage for TTFT in its entirety.  Therefore, I review the validity of L34823’s prohibition on coverage for TTFT in relation to recurrent GBM.

V.  Review of LCD L34823’s record

The statute governing ALJ review of LCDs states that if the ALJ determines that the LCD record is incomplete or lacks adequate information to support the validity of the determination, the ALJ will permit discovery and the taking of evidence.  42 U.S.C. § 1395ff(f)(2)(A)(i)(I).  The Secretary interpreted this provision to mean that a contractor will file the LCD record with the ALJ, and the parties would file written arguments as to why the record did or did not support the validity of the LCD or the challenged provision of the LCD.  42 C.F.R. §§ 426.410(d)(3), 426.425(a), (b).  If an LCD is revised during an LCD challenge proceeding and the ALJ continues to review the LCD because the challenged provision was not removed altogether, then the contractor must submit the supplemental LCD record related to the revision.  42 C.F.R. § 426.420(e)(2).  Further, the AP may submit new evidence to support the challenge to the LCD at any time before an ALJ closes the record in the case.  42 C.F.R. § 426.403. 

When the parties have made their submissions, the ALJ must determine if the LCD record is complete and adequate to support the validity of the LCD under the reasonableness standard.  42 C.F.R. § 426.425(c)(1).  The reasonableness standard states that an ALJ “must uphold a challenged policy (or a provision or provisions of a challenged policy) if the findings of fact, interpretations of law, and applications of fact to law by the contractor . . . are reasonable based on the LCD . . . record and the relevant record developed before the ALJ . . . .”  42 C.F.R. § 426.110 (definition of Reasonableness standard).  If the ALJ finds that the record is complete and adequate, then the ALJ issues a decision upholding the LCD.  42 C.F.R. § 426.425(c)(2).  However,

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if the ALJ does not conclude that the record is complete or adequate, then the ALJ permits discovery and the taking of evidence.  42 C.F.R. § 426.425(c)(3).

In the present case, Noridian argues that L34823’s record is sufficient to support the prohibition on coverage for TTFT for recurrent GBM because:  1) there has only been one clinical trial (EF-11) regarding TTFT to treat recurrent GBM; 2) this trial had various problems and suggested that TTFT did not improve patient survivability; 3) the Food and Drug Administration’s (FDA) panel that reviewed the TTFT trial noted several issues that cast doubt on its efficacy for treating recurrent GBM; 4) the AP’s new evidence mostly consists of in-vitro studies, opinions, editorials, reviews, or restatements of findings from the EF-11 trial; 5) a review of the National Comprehensive Cancer Network (NCCN) Guidelines shows that the NCCN changed its recommendation three times regarding TTFT’s use for recurrent GBM without an intervening new study; 6) a variety of recent articles from foreign sources dispute or fail to support TTFT’s efficacy for treating recurrent GBM; and 7) the Medicare Program Integrity Manual (MPIM) indicates that the acceptance of a treatment by individual practitioners or groups of health care providers does not indicate general acceptance of that treatment.  See Noridian Defense.

The AP argues that the LCD record does not support the validity of the challenged provision because:  1) the LCD record is missing numerous medical/scientific papers regarding the treatment of recurrent GBM with TTFT; 2) the FDA approved TTFT for use in treating recurrent GBM; 3) NCCN Guidelines are the recognized standard for clinical policy in the treatment of cancer and, by 2013, concluded TTFT is a viable treatment for recurrent GBM; 4) statements of numerous experts and clinicians in the field support the use of TTFT for recurrent GBM; and 5) a second clinical trial (EF-14) for TTFT, conducted for individuals with newly diagnosed GBM and which included individuals with recurrent GBM, also supported the efficacy of TTFT for individuals with recurrent GBM.  See A. Statement. 

In evaluating these arguments,1 I reviewed the preamble to the final rule establishing the LCD challenge regulations.  I think it significant that the present stage of the LCD challenge process was described as follows:  “After evaluating the materials and the record, our revised procedures will permit the ALJ[] to make a prompt decision in the nature of a summary judgment if the case warrants this approach.”  68 Fed. Reg. 63,692, 63,700 (Nov. 7, 2003).  Although it does not indicate that the summary judgment standard should be strictly applied, it is useful to recall that summary judgment does not involve the weighing of evidence.  Cf. 42 C.F.R. § 426.405(c)(18). 

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Further, I find it significant that the preamble appears to differ from the MPIM, as interpreted by Noridian, concerning evidence in LCD challenge cases: 

We are not accepting the recommendation to include a hierarchy of evidence in order to allow flexibility in analyzing evidence.  We recognize that many types of evidence have value, and will consider clinical experience, as well as other forms of medical, technical, and scientific evidence in making LCDs and NCDs.  We note that the ALJ[] may seek input from clinical and scientific experts at their discretion.  There is no prohibition against the ALJ or the Board seeking the input of practicing physicians or considering standards of practice.

68 Fed. Reg. at 63,700.

As indicated above, I cannot conclude that the LCD record submitted in this case is complete to support the validity of L34823. 

As an initial matter, a review of the voluminous record in this case shows that Noridian did not submit all documents in the record for L34823.  Noridian submitted all of the documents listed in the record for L34730.  However, Noridian failed to submit perhaps as many documents referenced in L34823.  See CMS Ex. 36 at 12-14.  Although the AP’s extensive submission includes many of the missing documents, there are still as many as 11 documents missing from the record.  Therefore, the LCD record in this matter is not complete. 

Further, even if Noridian submitted all of the missing documents from the record in L34823, the recent reconsideration process excluded consideration of coverage for recurrent GBM from the outset.  In defending the validity of L34823, Noridian primarily relies on the record for L34730, which has documents dated no newer than from 2013 and as old as 2003.  The AP submits many newer documents that, for purposes of my present review, show increased acceptance of TTFT for recurrent GBM.

Noridian also seeks to add documents not listed as sources in the LCD.  See CMS Exs. 18-20, 22, 24-26, 30-32, 39, 45-48, 50.  New evidence from Noridian may only be considered at the next stage of review in this case.

In addition, Noridian has concluded that the AP should receive Medicare coverage for TTFT for his recurrent GBM.  As noted above, Noridian advised me that it has granted individual review of the AP’s claim and has been allowing his claims.  However, if it is reasonable and necessary to cover TTFT for one Medicare beneficiary with recurrent GMB, it is more likely that a categorical prohibition on TTFT coverage for recurrent

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GBM may no longer be supported.

Finally, the AP has submitted numerous documents and statements from physicians as to the efficacy of TTFT’s use with recurrent GBM.  While I make no finding as to the ultimate outcome in this case, for purposes of deciding whether I should allow discovery and the taking of evidence, these documents support the existence of a dispute in material facts related to the challenge provision in this case.

VI.  Discovery

The parties may engage in discovery as permitted under 42 C.F.R. § 426.432. 

A party must serve a discovery demand on the other party by July 1, 2020.  Although the discovery demands should not be uploaded to the record in this case, any party seeking discovery from the other party will upload notice by July 1, 2020, that the party is seeking discovery.  If a party does not seek discovery, then by July 1, 2020, the party will upload to the record in this case a notice that the party does not seek discovery. 

If a party receives a discovery request, the party will comply with the request by July 31, 2020.  If the party seeks a protective order, the party will file a motion as soon as practicable, but no later than July 21, 2020.  If a party seeks a protective order, the party will upload to the record in this case the original discovery request that prompted the motion.

At the conclusion of discovery, I will issue an order regarding the submission of evidence.

• 1. The parties’ written arguments were deficient in citation to the exhibits referenced by the parties. Noridian merely used the name of documents without citing the exhibit number and relevant pages. The AP did better and generally provided the exhibit number, but did not provide the relevant page number(s). In all future filings, the parties will provide a pinpoint citation for each referenced exhibit.