In re LCD Complaint: Tumor Treatment Field Therapy, ALJ Ruling 2020-13 (HHS CRD June 26, 2020)

ORDER

The aggrieved party (AP) complained that Local Coverage Determination (LCD) No. L34823 unreasonably establishes a seven-week timeframe by which a Medicare beneficiary must commence Tumor Treatment Field Therapy (TTFT) (E0766) after receiving chemotherapy or radiation related to newly diagnosed 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 if the record for L34823 alone supports the validity of the challenged provision.  If it does not, then I must permit the parties to engage in discovery and the submission of evidence.  42 C.F.R. § 426.425(c).

For the reasons stated below, I conclude that the LCD record submitted by Noridian is incomplete and may not support the validity of the challenged provision in L34823. 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 would have any legal effect outside the present case.  42 C.F.R. § 426.460(b).

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.

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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 is 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).  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

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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 February 28, 2020, the AP filed a complaint (Complaint) challenging the validity of the coverage requirement in L34823 that a beneficiary must initiate TTFT within seven weeks from the last dose of concomitant chemotherapy or radiotherapy used to treat newly diagnosed GBM.1  Complaint ¶¶ 7, 17, 33, 38, 41.  The AP has GBM, but did not receive TTFT within seven weeks of completing chemotherapy.  Complaint ¶¶ 4, 5.

In conformance with 42 C.F.R. §§ 426.410(d)(3) and 426.425(a)-(b), on March 11, 2020, I issued an Acknowledgment of Receipt of Acceptable Complaint; Order to File LCD Record; and Briefing Schedule.  On March 24 and 31, 2020, Noridian filed 50 exhibits (CMS Exs. 1-50) as the record for L34823.  Subsequently, the AP filed her statement as to why the LCD record was not complete or adequate to support the validity of the challenged provision (A. Statement) along with approximately 400 exhibits (A. Exs. 1-418).  On June 10, 2020, Noridian filed its defense of the validity of L34823 (Noridian Defense).

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.  CMS Ex. 36 at 2, 16.  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.

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35.  Noridian participated in conducting the reconsideration of the total prohibition on coverage for TTFT, which included empaneling a 13-member Contractor Advisory Committee (CAC), holding a public meeting, and receiving and responding to public comments concerning Medicare coverage for TTFT.  CMS Ex. 36 at 6-9; CMS Ex. 38 at 3-9.  The result of the reconsideration was to provide Medicare coverage for TTFT to treat beneficiaries who had newly diagnosed GBM.  CMS Ex. 36 at 4, 9; CMS Ex. 38 at 4-5.  However, the revised LCD established various criteria that beneficiaries had to meet for coverage, including:  "[TTFT] is initiated within 7 weeks from the last dose of concomitant chemotherapy or radiotherapy, whichever is later."  CMS Ex. 36 at 4.

IV.  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).  The regulations state that "the contractor's LCD record consists of any document or material that the contractor considered during the development of the LCD . . . ."  42 C.F.R. § 426.418(a).  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, 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 the EF-14 TTFT trial is the only study concerning the use of TTFT with regard to newly diagnosed GBM and that most medical/scientific articles simply restate the results of that trial.  Noridian Defense at 2.  In regard to the challenged LCD provision, Noridian states that the seven-week timeframe was based on the parameters of the EF-14 trial and that there is no evidence of effectiveness of TTFT beyond the specific strictures of the trial.  Noridian Defense at 3.  Further, Noridian mentions that the CAC discussed various topics, including eligibility criteria for the EF-

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14 trial as well as the limitations of the study.  Noridian Defense at 4.  Noridian also notes that none of the "major clinical societies" involved with the treatment of TTFT commented during the LCD reconsideration process on the challenged provision, even though invited to do so.  Noridian Defense at 4.

The AP asserts that the LCD record is not complete or adequate to support the challenged provision because many documents, including peer-reviewed articles related to TTFT and the EF-14 trial, are missing from the LCD Record.  A. Statement at 4.  Further, the AP argues that the LCD record does not support the validity of the challenged provision because the seven-week timeframe appears to be based solely on the timeframe in the EF-14 trial.  A. Statement at 5.  However, the Food and Drug Administration's (FDA) approval for TTFT for newly diagnosed GBM did not impose any time restrictions for the commencement of TTFT.  A. Statement at 6.  In addition, the AP points out that National Comprehensive Cancer Network (NCCN) guidelines show a level one recommendation for the use of TTFT for newly diagnosed GBM, and NCCN provided no time constraint as to when TTFT could be commenced.  A. Statement at 7-8.  Finally, the AP asserts that the CAC never specifically discussed a timeframe for starting TTFT use, and the timeframe adopted in L34823 also conflicts with the views of experts.  A. Statement at 9-10.

In evaluating these arguments,2 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).

Further, I find the statement concerning the evaluation of evidence in this proceeding to be useful:

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

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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 the challenged provision in 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 many of the documents referenced in L34823.  See CMS Ex. 36 at 12-14.  Noridian admits as much when it acknowledges that it did not submit a 2017 publication about the EF-14 study that was considered by the CAC and listed in both the "Sources of Information" and "Bibliography" sections of LCD L34823.  Noridian Defense at 2.  According to Noridian, this is the only peer-reviewed article on the EF-14 study.  Noridian Defense at 2.  Despite having failed to file it previously, Noridian did not seek leave to file this document late.  Although the AP's extensive submission includes many of the missing documents from the LCD record for L34823, there are still eight documents missing from the record.  Therefore, the LCD record in this matter is not complete.

Noridian also seeks to add documents not listed as sources of information in the LCD.  See CMS Exs. 18-20, 22-26, 30-32, 39, 45-48, 50.  New evidence from Noridian may only be considered at the next stage of review in this case.  Noridian's submission of additional evidence supports the notion that the LCD record is not complete.

Finally, the AP has submitted numerous documents and statements from physicians as to the efficacy of TTFT's use outside of the seven-week required timeframe.  Further, while many peer-reviewed articles do not mention a timeframe for the use of TTFT for newly diagnosed GBM, at this juncture, I cannot disregard the possibility that this silence may reflect the view that a timeframe for the start of TTFT for newly diagnosed GBM is not applicable.3  While I make no finding as to the ultimate outcome in this case, I believe an evaluation of all relevant evidence is necessary in this case.

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V.  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 10, 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 10, 2020, that the party is seeking discovery.  If a party does not seek discovery, then by July 10, 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 August 10, 2020.  If the party seeks a protective order, the party will file a motion as soon as practicable, but no later than July 28, 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. Although the parties present arguments concerning other provisions in L34823, I must confine my review to the challenged provision identified in the LCD complaint.  42 C.F.R. § 426.431(a)(1).
• 2. The parties' written arguments were deficient with respect to citing the exhibits referenced by the parties.  While the parties generally provided citations to referenced exhibits by their exhibit number, they did not provide the relevant page number(s).  In all future filings, the parties will provide a pinpoint citation for each referenced exhibit.
• 3. During the reconsideration process for L34823, several commenters from the public requested the removal of the seven-week timeframe requirement or that a longer timeframe within which to commence TTFT be set.  The response to these comments was that "[t]he final LCD is based on the best currently available clinical literature."  CMS Ex. 38 at 5.  However, the response did not specify what that clinical literature was.