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                              2022
                              In re LCD Complaint: Tumor Treatment Field Therapy, LCD ID Number: L34823 Contractor: Noridian Healthcare Solutions, LLC, DAB CR6181 (2022)
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*In re* LCD Complaint: Tumor Treatment Field Therapy, LCD ID Number: L34823 Contractor: Noridian Healthcare Solutions, LLC, DAB CR6181 (2022)








  
  
    

  
      
Department of Health and Human Services 
    DEPARTMENTAL APPEALS BOARD
          Civil Remedies Division





*In re* LCD Complaint:
Tumor Treatment Field Therapy
LCD ID Number: L34823
Contractor: Noridian Healthcare Solutions, LLC
Docket No. C-21-657Decision No. CR6181October 31, 2022

        
              
    

      DECISION

Local Coverage Determination (LCD) L34823 permits Medicare coverage for Tumor Treatment Field Therapy (TTFT) (E0766) to treat newly diagnosed glioblastoma multiforme (GBM) when a Medicare beneficiary meets certain criteria listed in the LCD.  However, L34823 prohibits coverage of TTFT to treat GBM when it recurs following initial treatment.  The Aggrieved Party (AP) challenges this provision in L34823.

Last year I issued a decision upholding the validity of L34823’s prohibition on coverage for the treatment of recurrent TTFT under the reasonableness standard in the Social Security Act and the regulations.  *Tumor Treatment Field Therapy* *LCD ID No. L34823*, DAB CR5915 (2021).  Although the AP in the present case differs from the AP in CR5915, the cases are otherwise nearly identical.  Both APs are represented by the same attorney and, in both cases, Medicare contractor Noridian Healthcare Solutions, LLC (Noridian) defended L34823.  Further, with the exception of some minor additional exhibits, the arguments and evidence in both cases are substantially the same.

Under the regulations, I may consider a previous decision when rendering a decision.  After reviewing the AP’s additional exhibits submitted in this case, I find that the AP did not meet her burden of proof.  Based on my previous decision (CR5915) and my review of the evidence submitted, L34823’s record concerning the prohibition on coverage for TTFT to treat recurrent GBM is complete and adequate, and the challenged provision is valid under the reasonableness standard.

**Page 2**

I.     Local Coverage Determinations

The Medicare program is a public insurance program primarily for individuals 65-years-old and above that pays most of the costs associated with hospital, post-hospital, home health, and hospice services, as well as physician and other health care practitioner services, tests, and treatments.  *See* 42 U.S.C. §§ 1395c, 1395j, 1395k.  However, the Medicare program only covers the cost of health care items and services that are reasonable and necessary.  42 U.S.C. § 1395y(a)(1)(A).

An LCD is “a determination by a fiscal intermediary or a carrier under part A or part B [of the Medicare program], as applicable, respecting whether or not a particular item or service is covered on an intermediary- or carrier-wide basis under such parts, in accordance with [42 U.S.C. § 1395y(a)(1)(A)].”  42 U.S.C. § 1395ff(f)(2)(B).  Fiscal intermediaries and carriers are collectively known as contractors.  *See* 42 C.F.R. § 426.110 (definition of *Contractor*).

Contractors must, at least 45 days before an LCD becomes effective, make the following information available on its internet website and on the Medicare website:  the entire LCD; where and when the proposed LCD was first made public; hyperlinks to the proposed determination and a response to comments submitted to the contractor concerning the proposed determination; a summary of the evidence that was considered by the contractor during the development of the LCD 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 Health and Human Services (Secretary) coordinates the LCDs issued by the various contractors and determines when to adopt LCDs nationally.  42 U.S.C. § 1395y*(l)*(5)(A)-(C).

When a contractor relies on an LCD to deny a claim, the contractor must disclose such reliance in the determination.  42 U.S.C. § 1395ff(a)(4)(A)(i).  Although contractors follow their own LCDs, LCDs “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).  At the next two stages of the Medicare claims review process, adjudicators “are not bound by LCDs . . . but will give substantial deference to these policies if they are applicable to a particular case.”  42 C.F.R. § 405.1062(a).

If an LCD prohibits Medicare coverage for a health care item or service that a beneficiary needs, the beneficiary (now called an AP) may file a complaint challenging the LCD or a provision in the LCD.  In a proceeding that is distinct from a Medicare claims appeal, an administrative law judge first evaluates the LCD record to determine whether it is

**Page 3**

incomplete or lacks adequate information to support the validity of the LCD.  42 U.S.C. § 1395ff(f)(2)(A)(i)(I).

Procedurally, following the filing of an acceptable complaint, the relevant Medicare contractor files a copy of the LCD record.  42 C.F.R. § 426.410(d)(3).  The AP then files an explanation as to why the LCD record is incomplete or inadequate, and the relevant Medicare contractor files a response defending the LCD’s validity.  42 C.F.R. § 426.425(a)-(b).  Once those documents are filed, the administrative law judge applies the “reasonableness standard” to determine whether the LCD record is complete and adequate to support the challenged LCD.  42 C.F.R. § 426.425(c)(1).

The regulations define the “reasonableness standard” as follows:

In determining whether LCDs . . . are valid, the adjudicator 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 or CMS are reasonable based on the LCD . . . record and the relevant record developed before the ALJ or the Board.

42 C.F.R. § 426.110; *see* 42 U.S.C. § 1395ff(f)(2)(A)(i)(III); 42 C.F.R. § 426.405(b) (“An [administrative law judge] defers only to reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.”).

If an administrative law judge decides that the LCD record is complete and adequate to support the LCD, then the administrative law judge issues a decision.  42 C.F.R. § 426.425(c)(2).  If the administrative law judge determines that the LCD record is not complete and adequate to support the LCD, then the administrative law judge permits discovery and the taking of evidence.  42 C.F.R. § 426.425(c)(3).  When challenging an LCD or a provision of an LCD, the AP has the burden of proving the allegations in his or her complaint by a preponderance of the evidence.  42 C.F.R. § 426.330.  After an administrative law judge closes the record in a case, a decision is issued.  42 C.F.R. § 426.447.

A party may appeal the administrative law judge’s decision to the Departmental Appeals Board within 30 days of the issuance of the decision.  42 U.S.C. § 1395ff(f)(2)(A)(ii); 42 C.F.R. §§ 426.465, 426.490.

II.     Procedural History

On April 12, 2021, the AP, through her representative, electronically filed a Complaint and associated documents with the Civil Remedies Division (CRD).  The Complaint substantively challenged LCD L34823’s prohibition on Medicare coverage for the use of

**Page 4**

TTFT for recurrent GBM as well as certain requirements for coverage related to the use of TTFT for newly diagnosed GBM.  Complaint ¶¶ 1, 3, 19-20, 36-46.  The Complaint also alleged that L34823 was not published in accordance with federal law.  Complaint ¶ 47.  The AP requested that either L34823 be declared invalid or the specific provisions of L34823 identified in the Complaint be deemed invalid.  Complaint ¶¶ 48-49.

Factually, the Complaint asserted that the AP was diagnosed with GBM in June 2019, received chemoradiation that ended in August 2019, but suffered a recurrence of GBM in September 2019.  Complaint ¶¶ 5-7.  The AP’s physicians prescribed TTFT to treat the recurrent GBM, which the AP began to receive in November 2019.  Complaint ¶ 8.

CRD docketed the Complaint and assigned it to me for adjudication.  In an April 22, 2021 Order, I acknowledged receipt of the AP’s Complaint and that the AP was challenging L34823’s prohibition on Medicare coverage for the use of TTFT to treat recurrent GBM.  In the April 22 Order, I also directed the AP to provide documentation to prove that the Complaint had been filed in a timely manner.

On April 28, 2021, the AP filed the necessary documentation.  In a May 6, 2021 Order, I found the AP’s Complaint to be acceptable and established prehearing procedures as well as a prehearing submission schedule based on 42 C.F.R. §§ 426.403, 426.410(d)(3), and 426.425(a)-(b).  Again, in the May 6 Order, I stated that the AP was only challenging L34823’s prohibition on Medicare coverage for the use of TTFT to treat recurrent GBM.

On June 7, 2021, Noridian submitted 95 marked exhibits that constituted the LCD record for L34823 as well as associated evidence that was not part of the LCD record.  On June 8, 2021, Noridian filed an additional exhibit.  On June 11, 2021, the AP objected to the associated evidence that Noridian submitted because the regulations do not permit Noridian to submit more than the LCD record at that point in the proceeding.  Noridian’s position was that 42 C.F.R. §§ 426.410(d)(3) and 426.458(a) contemplated the submission of “associated evidence” with the LCD record.  In a June 14, 2021 Order, I stayed the prehearing submission schedule.

In a July 7, 2021 Order, I sustained the AP’s objection to the “associated evidence” that Noridian submitted with the LCD record because the reference to “associated evidence” in 42 C.F.R. § 426.410(d)(3) refers to evidence that an AP provided with his or her LCD complaint.  *See*42 C.F.R. § 426.400(c)(6).  Because Noridian had incorrectly marked its exhibits in its original submission, I ordered Noridian to refile its exhibits but limited the refiling to documents in the LCD record.

In the July 7 Order, I addressed in detail the scope of the review in this case, indicating that the only challenge I could consider in this case was to the prohibition on Medicare coverage for TTFT to treat recurrent GBM because the AP’s Complaint asserted that the AP did not start using TTFT until after the GBM recurred.  I also stated that the AP’s

**Page 5**

challenge to the validity of L34823 based on an alleged failure to publish the LCD in compliance with federal law was not an issue before me because the statute governing my review of the LCD only discussed a substantive review of the content of the LCD.  *See* 42 U.S.C. § 1395ff(f)(2)(A)(i).

On July 13, 2021, Noridian resubmitted 52 exhibits (N. Exs. 1-52) as the documents constituting the LCD record.  On August 13, 2021, the AP filed her statement in support of her challenge to L34823 (A. Statement) along with numerous exhibits (A. Exs. 1-491).  On September 13, 2021, Noridian filed its response to the AP’s statement (N. Response).

In a June 6, 2022 Order, I informed the parties that I needed to determine whether the record for L34823 alone supports the validity of the prohibition on Medicare coverage for TTFT for recurrent GBM or whether I need to allow for discovery and the taking of additional evidence.  In the Order, I observed that the present case is identical in several respects to another case I adjudicated under CRD docket number C-19-1011.  I stated that, although the cases were brought by different APs, both APs were represented by the same representative, Noridian was the contractor defending the LCD in both cases, and several of Noridian’s representatives were the same in both cases.  I stated further that, in C-19-1011, I determined that the LCD record submitted by Noridian was incomplete and may no longer support the LCD’s prohibition on Medicare coverage of TTFT for recurrent GBM.  Therefore, in C-19-1011, I permitted discovery and the submission of additional evidence, and held a hearing at which the AP’s expert witnesses were cross-examined.  Further, I indicated in my June 6, 2022 Order that I had issued a decision (CR5915) in that case in which I concluded that the prohibition on Medicare coverage for the use of TTFT to treat recurrent GBM was reasonable and valid.

I noted in the June 6, 2022 Order that the AP’s statement in this case did not reference CR5915, other than in a footnote to make a relatively limited point.  I also indicated that Noridian’s response in this case asserted that many, if not all, of the AP’s arguments in this case are the same as offered in C-19-1011.  I further stated that many of the exhibits that the AP filed in this case were the same as those filed in C-19-1011 and that the AP had also submitted as exhibits in this case the following documents from C-19-1011:  Noridian’s response to interrogatories; the written direct testimony from expert witnesses; and the hearing transcript.  *See* A. Exs. 398, 401-407.  In addition, concerning the LCD record that Noridian filed for L34823 in this case, I noted that Noridian Exhibit 52 was the same as an exhibit that I had excluded in C-19-1011.  *See* CR5915 at 7.

Finally, in the June 6, 2022 Order, I directed the AP to submit a list identifying the exhibits submitted in this case that were not submitted in C-19-1011.  I also directed Noridian to submit a list of exhibits that it submitted that were not part of the original record for L34823.

**Page 6**

On June 16, 2022, Noridian responded that it was withdrawing Noridian Exhibit 52, that Noridian Exhibits 1 through 51 constitute the entire LCD record, and that Noridian did not wish to submit additional evidence that is not part of the LCD record.

On June 20, 2022, the AP provided a list of exhibits that the AP submitted in this case that had not been submitted in C-19-1011.

III.    Evidence

This decision is issued before the formal taking of evidence under 42 C.F.R. §§ 426.425(c)(3) and 426.440.  *See* 42 C.F.R. § 426.425(c)(2).  At this stage in the process, Noridian has submitted the documents that constitute the record for L34823.  Further, the AP has submitted evidence both with the Complaint and with the filing of the AP’s statement explaining why the record for L34823 is incomplete or inadequate.

At this point in the proceedings, I am to determine whether the LCD “record is incomplete or lacks adequate information to support the validity of the determination.”  42 U.S.C. § 1395ff(f)(1)(A)(iii)(I).  Stated another way, following receipt of the AP’s statement and the contractor’s response, an administrative law judge “applies the reasonableness standard to determine whether the LCD record is complete and adequate to support the validity of the LCD.”  42 C.F.R. § 426.425(c)(1).

In this case, Noridian argues that an administrative law judge’s review is limited to only reviewing the LCD record and that the AP’s evidence is irrelevant.  N. Response at 1 n.1, 2, and 2 n.2.  Noridian’s argument fails to explain how the AP can show that the LCD record is incomplete or inadequate unless the AP shows that there is missing material evidence from the LCD record.  Further, the regulations appear to support the conclusion that I must consider the evidence submitted by the AP when reviewing the completeness and adequacy of L34823’s record.

The regulations place the burden of proving that a challenged provision in an LCD is not valid on the AP and require APs to file with their complaint “[c]opies of clinical or scientific evidence that support the complaint.”  42 C.F.R. §§ 426.330, 426.400(c)(6).  If an AP fails to file that clinical or scientific evidence with the complaint, then the complaint is unacceptable and dismissed.  42 C.F.R. §§ 426.410(b)(2), (c)(2).  There would be no need for this provision if an administrative law judge were not to review that evidence when considering the completeness and adequacy of the LCD record.

Further, the regulations permit APs to “submit additional new evidence” after filing the complaint.  42 C.F.R. § 426.403.  This regulation does not limit the filing of evidence until after an administrative law judge determines that an LCD record is incomplete or inadequate.  If an administrative law judge were not to consider this evidence when reviewing for the completeness and adequacy of the LCD record, then the regulations

**Page 7**

would have limited submission of new evidence to the stage in the process when the administrative law judge authorizes the taking of evidence.  *See* 42 C.F.R. §§ 426.431(c)(3), 416.440.

Finally, the AP’s evidence must be considered when determining whether the LCD record is incomplete or inadequate because a finding that the LCD record is complete and adequate to support the challenged LCD provision “ends the review process.”  42 C.F.R. § 426.425(c)(2).  Therefore, under Noridian’s interpretation of the regulations, an AP’s evidence may never be reviewed if the LCD record appears to be complete and adequate.  This interpretation is tantamount to depriving the AP of her statutory right to challenge the LCD provision in question.  Therefore, I reject Noridian’s position.

For purposes of this decision, I admit all of the exhibits submitted by the parties into the record, with one exception.

The AP submitted a declaration of George Ansstas, M.D. (A. Ex. 406) that was prepared and submitted for inclusion in the record of C-19-1011 as the written direct testimony for Dr. Ansstas.  Because Dr. Ansstas failed to appear for the hearing in C-19-1011 to be cross-examined, without explanation, I excluded his declaration from the record in that case.  CR5915 at 6.

In this case, Noridian argues that the AP improperly submitted the declaration given that I excluded it from the record in C-19-1011.  N. Response at 32 n.18.  I agree with Noridian that the AP should not have submitted this declaration.  A declaration of a witness who is ultimately unwilling to be examined as to the contents of his declaration, or even to be asked to authenticate the declaration, is not evidence that I should consider when reviewing the LCD record to determine if it is incomplete or inadequate.  Therefore, I do not admit A. Exhibit 406.1

IV.    Issue

The sole issue that I decide in this case is:

Whether L34823’s denial of Medicare coverage for TTFT to treat recurrent GBM is valid under the reasonableness standard.

**Page 8**

As mentioned above in the Procedural History of this case, the AP’s Complaint raised two other issues that I will not consider in this decision.  One of the issues is a challenge to the validity of criteria for TTFT coverage to treat newly diagnosed GBM.  The other is an argument that Noridian failed to comply with federal law when adopting L34823.

Regarding the challenge to criteria involving newly diagnosed GBM, the AP’s Complaint only sufficiently pled a challenge to L34823’s provision that categorically prohibits Medicare coverage for the use of TTFT to treat recurrent GBM.  While the AP specifically challenged L34823’s provisions concerning both the prohibition on coverage for recurrent GBM and two criteria for coverage for use of TTFT for newly diagnosed GBM (i.e., TTFT must be commenced within 7 weeks from the last dose of concomitant chemotherapy or radiotherapy (seven-week requirement) and that the beneficiary has no evidence of progression by Response Assessment in Neuro-Oncology criteria), *see* Complaint ¶¶ 20, 49, the rest of the Complaint does not support a challenge to the coverage criteria involving newly diagnosed GBM.

Factually, the AP asserted that she was diagnosed with GBM in June 2019, was treated with chemoradiation which ended in August 2019, and “[u]nfortunately, due to its extremely aggressive nature, [the AP’s] GBM recurred in September 2019.  [The AP’s physicians] prescribed TTFT for [the AP] for her recurrent GBM which she began in November 2019.”  Complaint ¶¶ 5-8.  Therefore, according to the Complaint, the AP was only prescribed and received TTFT following recurrence of GBM and not before.

Further, the Complaint highlights that it is really a challenge to the prohibition on coverage for TTFT for recurrent GBM because the AP stated that “[a]n LCD complaint for the same treatment is pending . . . under C-19-1011.”  Complaint ¶ 1.  The sole issue in C-19-1011 was whether L34823’s prohibition on Medicare coverage for TTFT to treat recurrent GBM was reasonable.  CR5915 at 7.  Given that the AP’s representative has represented all of the APs in the cases I have been assigned concerning challenges to L34823, I take the specific reference to only C-19-1011 as significant because the Complaint did not reference another case also pending before me at the time the Complaint was filed, i.e., C-20-331, which was a challenge to the seven-week requirement concerning newly diagnosed GBM.  *Tumor Treatment Field Therapy* *LCD ID No. L34823*, DAB CR5902 at 13 (2021).

As indicated in the Procedural History section above, I have consistently indicated in my orders from the outset of this case that the only issue I will decide is whether L34823’s prohibition on Medicare coverage for TTFT to treat recurrent GBM is reasonable.  The AP has never objected to this; however, in the AP’s August 13, 2021 statement in support of her challenge, the AP briefly raised a challenge to the seven-week requirement by seeking to incorporate by reference the arguments presented in a post-hearing brief in C-20-331.  A. Statement at 2 n.6.

**Page 9**

Noridian objected to cross-referencing an argument from a brief in a different case.  N. Response Br. at 10.  Under the regulations, the AP was to file “a statement explaining why the contractor’s LCD record is not complete, or not adequate to support the validity of the LCD under the reasonableness standard.”  42 C.F.R. § 426.425(a).  Therefore, the AP’s statement in this case must provide that explanation.  While I do not believe a challenge to the seven-week requirement is properly before me, even if it were, I conclude that the AP has abandoned that challenge because the AP did not present, in her statement, an explanation as to why the LCD record is not complete or adequate regarding that provision.

The AP provided in her statement an argument as to why she thinks that L34823 “should be stricken as invalid because it is fatally flawed procedurally.”  A. Statement at 2.  The AP asserted that Noridian failed to properly publish L34823 in conformance with the requirements in 42 U.S.C. §§ 1395y(*l*)(5)(D) and 1395hh.  *See* A. Statement at 2-3, 21-25.  In response, Noridian argued that 42 U.S.C. § 1395ff(f)(2)(A)(i)(I) limits administrative law judge review of LCDs to an evaluation of the reasonableness of the LCD and does not include a review as to whether there were any procedural failings in the adoption of the LCD.  N. Response Br. at 10.  I agree with Noridian that my jurisdiction to review the validity of the LCD is limited to substantive provisions in the LCD and not as to the manner in which Noridian adopted it.

V.     Consideration of CR5915’s Findings, Conclusions, and Analysis

As mentioned earlier, the present case mirrors C-19-1011.  Based on my consideration of the decision in C-19-1011, i.e., CR5915, and the record and arguments in this case, I have decided that it is appropriate and efficient to adopt the findings, conclusions, and analysis from CR5915 into this case.

When reviewing the LCD record under the reasonableness standard, the regulations permit an administrative law judge to do the following:

Consider any previous [administrative law judge] decision made under § 426.447 regarding the same provision(s) of the LCD under review and for the same clinical conditions.

42 C.F.R. § 426.431(b)(2).

The decision in CR5915 meets this standard for consideration.  The decision in CR5915 was issued in conformance with § 426.447 and involved the same provision in L34823, i.e., the prohibition on Medicare coverage for TTFT as a treatment for recurrent GBM.  CR5915 at 1, 3.  Further, both the AP in the present case and the AP in CR5915 were

**Page 10**

diagnosed with the same clinical condition, i.e., recurrent GBM.  Complaint ¶¶ 5-8; A. Statement at 4; CR5915 at 3.  Therefore, I may consider CR5915.

The term “consider” does not require an administrative law judge to follow an earlier administrative law judge decision concerning a challenge to the same LCD or LCD provision.  The reason why the Secretary did not make previous administrative law judge decisions binding on other administrative law judges was because “[i]t is possible that a later challenger may introduce pertinent clinical or scientific evidence that was not submitted in the previous proceedings.”  67 Fed. Reg. 54,534, 54,542 (Aug. 22, 2002).  Therefore, if a subsequent case mirrors a case that has been decided, and the subsequent case does not include clinical or scientific evidence that would change the outcome from the case that was previously decided, then an administrative law judge has discretion to follow the previous decision in a subsequent case.

As already mentioned above, C-19-1011 and this case are particularly similar in that both APs are represented by the same attorney who submitted substantially the same arguments, exhibits, and expert testimony.  Noridian’s final submission of the LCD record in both cases is the same.  As I discuss later in this decision in detail, I have reviewed the exhibits that the AP submitted in this case that were not submitted in C-19-1011, and do not find them to materially affect my analysis from C-19-1011 as to whether L34823’s provision prohibiting Medicare coverage of TTFT to treat recurrent GBM is valid under the reasonableness standard.  Therefore, I adopt and republish below the numbered findings of fact and conclusions of law from the decision for C-19-1011.  Further, while I do not republish it here, I adopt my previous analysis as well.

**GBM is the most common and aggressive type of malignant brain tumor in humans, with most patients dying within two years of diagnosis and only five to ten percent alive five years after a GBM diagnosis.  Following initial treatment, GBM generally recurs within nine months, at which point there is no clear standard of care.  Chemotherapy is the primary treatment option at recurrence.  CR5915 at 8.
	TTFT is a treatment for GBM that uses electric fields to slow the progression of GBM.  CR5915 at 9.
	The only Phase 3 clinical trial to test TTFT as a treatment for recurrent GBM, the EF-11 Study, failed in its designed purpose to show that TTFT, as a monotherapy for recurrent GBM, was superior to chemotherapy.  An analysis by the physicians who conducted the EF-11 Study posited that the study showed TTFT to be at least equivalent to chemotherapy.  CR5915 at 9.
	The FDA approved TTFT as a monotherapy treatment for recurrent GBM.  The Chair of the [Food and Drug Administration (FDA)] Neurologica**l******Page 11**

**Devices Panel (FDA Panel) had to cast the deciding vote because the FDA Panel evenly split on whether there was a reasonable assurance that TTFT was effective.  CR5915 at 11.**

**Subsequent to the EF-11 Study, another Phase 3 clinical trial was conducted in order to test the effectiveness of TTFT, in conjunction with chemotherapy, to treat newly diagnosed GBM.  This study, the EF-14 Study, was highly successful.  The EF-14 Study did not directly involve the treatment of recurrent GBM; however, it accumulated data from a portion of the study’s patients who continued to receive TTFT and chemotherapy to treat their later recurring GBM.  While the data collected indicated that TTFT and chemotherapy were more effective than chemotherapy alone to treat recurrent GBM, this evidence did not support TTFT’s efficacy as a monotherapy to treat recurrent GBM.  Further, this data was collected from a patient population that was heterogenous, thus reducing the conclusions that could be drawn from the data.  Finally, the data regarding the patients with recurrent GBM was not gathered as part of a clinical trial but as a post hoc adjunct to the EF-14 Study, further limiting the conclusions that could be made from it.  CR5915 at 14.
	Based on the EF-14 Study, the FDA approved TTFT in conjunction with chemotherapy as a treatment for newly diagnosed GBM.  The FDA approval did not include treatment of recurrent GBM with TTFT and chemotherapy.  CR5915 at 16.
	From 2011 to 2013, a Patient Registry Dataset (PRiDe) tracked the length of survival of patients who received TTFT to treat recurrent GBM.  Despite positive results, the PRiDe did not track how many of the patients used TTFT in conjunction with other treatments, such as chemotherapy; therefore, it cannot clearly support TTFT as a monotherapy treatment for GBM.  Further, the possibility of patients on the PRiDe exhibiting pseudoprogression after receiving chemotherapy could not be ruled out and may have affected the results.  CR5915 at 16.
	The [National Comprehensive Cancer Network (NCCN)] Guidelines provide a Level 2B recommendation for the use of TTFT to treat recurrent GBM.  A Level 2B recommendation is one that lacks uniform consensus among the NCCN panel of experts and is based on “lower-level evidence.”  NCCN first gave a Level 2B recommendation in 2013 but rescinded that recommendation in 2014.  However, NCCN subsequently reinstated the Level 2B recommendation.  The chair of the NCCN panel that approved this recommendation testified that the EF-11 Study was the basis for the recommendation but thought that panel members were influenced by the****Page 12**

**success of the EF-14 Study in reinstating the Level 2B recommendation.  The 2019 NCCN Guidelines added the following disclaimer:  “Due to lack of clear efficacy data for alternating electric field therapy in EF-11, the panel is divided about recommending it for the treatment of recurrent [GBM].”  CR5915 at 18.**

**In 2015, CMS contractors Noridian and CGS Administrators, Inc. (CGS) published LCD L34823 categorically denying Medicare coverage for TTFT.  In 2019, based on a reconsideration request and following a lengthy process that included a meeting of a [Contractor Advisory Committee (CAC)], public meetings, and the submission of public comments, Noridian and CGS permitted Medicare coverage for TTFT to treat newly diagnosed GBM if beneficiaries met certain criteria.  Noridian and CGS did not reconsider the prohibition on coverage for TTFT to treat recurrent GBM, and the revised LCD categorically prohibited coverage to treat recurrent GBM.  CR5915 at 21-22.
	The AP’s expert witnesses all testified in support of the use of TTFT as a treatment for recurrent GBM.  However, most of the expert witnesses acknowledged weaknesses in the EF-11 Study and/or divisions in the medical community as to TTFT’s effectiveness with regard to recurrent GBM.  CR5915 at 24.
	Noridian could reasonably conclude that TTFT, as approved by the FDA to treat recurrent GBM (i.e., as a monotherapy), lacks sufficient evidence of efficacy for Medicare coverage.  Noridian reasonably considered the flaws with the EF-11 Study and its analysis, the fact that the FDA Panel split on the issue of whether TTFT was effective to treat recurrent GBM, and the NCCN Guidelines’ lowest level recommendation for its use with a disclaimer that the NCCN panel is divided on the issue of efficacy.  CR5915 at 33.**VI.    Consideration of New Exhibits

Because I am adopting the findings, conclusions, and analysis in CR5915 and the record in both cases is nearly identical, I do not need to re-evaluate all of the evidence submitted in this case.  However, I must consider the new evidence that the AP submitted in this case that was not submitted in C-19-1011.  As explained below, none of this evidence materially affects the review of the challenged LCD provision under the reasonableness standard that was previously conducted in CR5915.

I directed the AP to identify all exhibits that she submitted in this case that were not submitted by the AP in C-19-1011.  The AP noted the following exhibits:  A. Exs. 2, 4, 9,

**Page 13**

19, 21-41, 130, 162, 163, 165, 397, 200-371, 407, 408-485, 486-491.  E-File Document No. 73a.

****A. Exhibit 2 – Notes from one of AP’s Physicians****A. Exhibit 2 is a Neuro-Oncology Attending Clarification Note from March 2021 related to the AP.  The AP’s physician indicated that recurrent GBM “has limited treatment options, and with difficult prognosis.”  A. Ex. 2 at 1.  The physician also stated that “[b]oth bevacizumab [chemotherapy drug also known as Avastin] and Optune [TTFT] appeared to continue to confer good treatment effect . . . As such, my treatment recommendations [sic] is for continuing both Avastin and Optune treatments, as long as there is no evidence for progression.”  A. Ex. 2 at 2.

This document was originally submitted with the AP’s Complaint in compliance with the requirement that an AP submit a treating physician written statement.  42 C.F.R. § 426.400(c)(3); E-File Document No. 1b.  Therefore, it is not likely meant as evidence to support the LCD challenge.

However, if I were to assess its contents as evidence of the effectiveness of TTFT to treat recurrent GBM, I would not give the physician’s comments weight.  As stated in  Findings of Fact 3 and 4 above, the EF-11 Study only tested the efficacy of TTFT as a monotherapy for recurrent GBM and the FDA approved TTFT as a monotherapy for recurrent GBM.  As indicated in Finding of Fact 7, the use of chemotherapy in conjunction with TTFT was one of the reasons that the PRiDe registry could not be used to support the efficacy of TTFT as a monotherapy to treat recurrent GBM.  Therefore, the AP’s use and success using both chemotherapy and TTFT do not alter the analysis in CR5915.

****A. Exhibit 4 – AP’s Appointment of her Representative****This document shows that the AP appointed her current attorney to represent her in this matter.  *See*42 C.F.R. § 426.400(c)(2)(v).  This is not a clinical or scientific document.

****A. Exhibit 9 – Medicare Reconsideration Denials of Coverage for TTFT****This exhibit consists of multiple denials for the AP’s claims for Medicare coverage of TTFT at the reconsideration level of appeal by a qualified independent contractor.  These are not clinical or scientific documents.

**Page 14**

****A. Exhibits 19, 21-41 – Private Health Insurance Companies’ Policies Concerning Coverage of TTFT****The AP submitted various private health insurance companies’ policies on coverage for TTFT.  The AP indicated that policies from all of these companies had been submitted in C-19-1011; however, she submitted the most recent version of the policies in this case.

Noridian argued they are of little value in this case, quoting a circuit court opinion in a Medicare coverage case that stated:  “With respect to other insurers’ coverage of the BIO-1000, the district court erred in holding that that fact alone established the medical community’s general acceptance of the BIO-1000.”  *Int’l Rehab. Scis. Inc. v. Sebelius*, 688 F.3d 994, 1003 (9th Cir. 2012); N. Response at 30-31.  These policies are not clinical or scientific evidence themselves, although some of them summarize evidence or provide reference lists of documents that were considered.  Therefore, they do not alter the analysis in CR5915.

****A. Exhibit 130 – Abstract on EF-19 Post-Approval Registry Study****This exhibit is just over a page long and is an abstract.  The document states in pertinent part:

This non-inferiority, prospective, non-randomized, post approval registry trial enrolled 192 recurrent GBM patients . . . All patients were treated with TT[FT] . . . **Result:**  Median [overall survival] in patients treated with TT[FT] versus EF-11 [best standard of care] was 7.4 vs. 6.4 months . . . In the [per protocol] population, the median [overall survival] with TT[FT] versus EF-11 [best standard of care] was 8.1 months vs. 6.5 months, respectively . . . The overall incidence of adverse event was lower in the TT[FT] arm (67% vs. 95%) vs. EF-11 [best standard of care] arm.

A. Ex. 130 at 1.

Noridian argued that this exhibit was not dispositive in this case.  Noridian first stated that this was evidence of another post-approval registry, similar to the PRiDe registry, which has not yet undergone a peer review.  N. Response at 13.  Noridian also asserted that the abstract’s survival rate comparison between patients in 2020 and those in the EF-11 Study, which occurred years earlier, was not valid due to the differences in the chemotherapy received by the two groups of patients.  Further, Noridian noted that the comparison group from the EF-11 Study, i.e., the patients who did not receive TTFT but

**Page 15**

received the best standard of care at the time, suffered from flaws relating to how that group was handled during the study.  N. Response at 14.

This brief exhibit is insufficient to alter the analysis in CR5915.  The information is cursory and limited.  It describes a registry with little specifics.  Further, I agree that a comparison between the patients on the registry and the patients in the EF-11 Study who did not receive TTFT has modest value given all the flaws in the EF-11’s handling of that group of patients.  *See* CR5915 at 11-13 (describing irregularities and concerns with the handling of the group that did not receive TTFT in the EF-11 Study).  In explaining why Noridian reasonably could determine that TTFT should not be covered for individuals with recurrent GBM, I stated:

The EF-11 Study has many flaws that gave members of the medical community concern.  And the record reveals that most of the articles discussing the efficacy of TTFT to treat recurrent GBM point to the EF-11 Study and the FDA approval.  Therefore, if Noridian remains reasonably unconvinced of the EF-11 Study, which was not properly powered to determine TTFT’s equivalence to chemotherapy, then Noridian would properly have concerns in determining whether Medicare should cover TTFT to treat recurrent GBM.

CR5915 at 39.  The comparisons in A. Ex. 130 could be reasonably rejected for the same reasons that the EF-11’s results were found to be insufficient for Medicare coverage purposes.  Therefore, the content of A. Ex. 130 does not affect the analysis in CR5915.

****A. Exhibit 162 – Article on TTFT use to Treat GBM during the COVID-19 Pandemic****This article is a summary of a panel discussion of neuro-oncology experts on May 9, 2020, “to assess the risk-to-benefit ratio and provide guidance for using TT[FT] in GBM during the COVID-19 pandemic.”  A. Ex. 162 at 1.  The “[t]opics discussed included support and delivery of TT[FT] during the COVID-19 pandemic, concomitant use of TT[FT] with chemotherapy, and any potential impact of TT[FT] on the immune system in an intrinsically immunosuppressed GBM population.”  A. Ex. 162 at 1.  The article indicated that TTFT did not have any known suppressive effect on immune systems.  A. Ex. 162 at 2.  “The expert panel agreed that TT[FT] provides safe and effective practices for newly diagnosed as well as established and recurrent GBM patients on clinical trials which limits exposure risks during the COVID-19 pandemic.”  A. Ex. 162 at 4.  The overall conclusion of the article was that TTFT is a treatment for newly diagnosed and recurrent GBM that can be safely administered during the COVID-19 pandemic.  A. Ex. 162 at 5.

**Page 16**

Noridian argued that this expert panel was compromised because it was funded by and made up of individuals closely associated with Novocure, the company that makes the Optune® TTFT device.  After all, the article states “[t]he May 2020 Advisory Board was funded by Novocure Inc.”  A. Ex. 162 at 5.  Further, Noridian stated that this article relied on the EF-11 Study to support the efficacy of TTFT on recurrent GBM, which is a flawed study.  N. Response at 15.

This article does not alter the analysis in CR5915.  The meeting summarized in this article was primarily to discuss whether patients with GBM, who inherently have compromised immune systems, can safely receive TTFT during the COVID-19 pandemic.  The fact that the article summarizes that the panel’s experts believed that TTFT is safe and effective for treating recurrent GBM provides no insight as to why they believe that or why they accept the results of the EF-11 Study despite many valid objections and concerns about it.  This is not surprising given the purpose of the meeting.  Because of this, the article is simply not directly on point to the issue presented in this case.  Therefore, it is of little value.

****A. Exhibit 163 – Article on Effect of Alternating Electric Fields used on Animal Tumors and Human Brain Tumors****This article, from 2007, detailed a study involving the use of electric fields on animal tumors as well as a ten-person study using TTFT to treat recurrent GBM.  This study is too remote in time and only involved a very small sample of patients to be useful in this case.  It does not alter the analysis in CR5915.

****A. Exhibit 165 – Noridian’s Response to AP’s Statement in C-19-1011****This brief document, which was filed in C-19-1011, is not evidence and does not affect the analysis in CR5915.

****A. Exhibit 397 – Excerpts from 2020 and 2021 NCCN Guidelines for Central Nervous System Cancers****This exhibit provides the 2020 and 2021 NCCN Guidelines concerning the treatment of GBM.

Like the previous NCCN Guidelines (other than the 2014 NCCN Guidelines that did not recommend use of TTFT to treat recurrent GBM), the 2020 and 2021 NCCN Guidelines continue to provide a Level 2B recommendation (i.e., consensus that the particular intervention is appropriate based on lower-level evidence) for using TTFT to treat recurrent GBM.  A. Ex. 397 at 4, 8; *see also* CR5915 at 18-19.  Further, NCCN continued to consider all of the suggested treatments (including TTFT) for recurrent GBM as

**Page 17**

“suboptimal” and to “highly encourage[]” eligible patients to consider treatment in a clinical trial.  A. Ex. 397 at 4, 8;*see also* CR5915 at 40.  Therefore, this exhibit does not affect the analysis in CR5915.

****A. Exhibit 407 – Transcript of Hearing in C-19-1011****This is the transcript of a hearing held over two days in November and December 2020.  This transcript was part of the record in C-19-1011, and the transcript from the hearing was extensively cited in CR5915.

****A. Exhibits 200-371, 408-485, 486-491 – Medicare Claims Decisions****These exhibits are decisions rendered by Office of Medicare Hearings and Appeals administrative law judges concerning claims related to TTFT.  The decision in A. Exhibits 486 through 491 involve decisions in the AP’s Medicare claims.  However, the results in none of these decisions are relevant to the present case.

While administrative law judges adjudicating Medicare claims are not required to follow LCDs, an administrative law judge’s “decision to disregard such policy applies only to the specific claim being considered and does not have precedential effect.”  42 C.F.R. § 405.1062(b).  Further, the administrative law judge “may not set aside or review the validity of an . . . LCD for purposes of a claim appeal.”  42 C.F.R. § 405.1062(c).  Therefore, these decisions do not affect the analysis in CR5915.

VII.   The Record for L34823 is Complete and Adequate

Procedurally, this case differs from C-19-1011 because I am issuing this decision to find that the record in L34823 is complete and adequate, and that the challenged provision is valid under the reasonableness standard.  In C-19-1011, I concluded 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.

*Tumor Treatment Field Therapy*, ALJ Ruling No. 2020-12 at 1 (HHS CRD June 17, 2020).  In reaching that conclusion, I stated that Noridian had simply failed to submit all of the documents in the record for L34823.  ALJ Ruling No. 2020-12 at 7.  Noridian later

**Page 18**

submitted them, but at that stage, I was reviewing the LCD record for completeness and adequacy, and Noridian had not submitted the complete record.  Further, I was concerned with upholding the challenged provision in L34823 because Noridian had granted some of the AP’s individual claims for TTFT, thus diverging from its own LCD.  ALJ Ruling No. 2020-12 at 7.  In addition, Noridian’s response to the AP’s statement as to the incompleteness and inadequacy of the LCD record did not cite to documents by exhibit number and page number, making it difficult to confirm Noridian’s arguments.  ALJ Ruling No. 2020-12 at 6 n.1.  This, along with the AP’s sprawling submission of exhibits, resulted in my determination that the case (i.e. C-19-1011) needed to be adjudicated at the next step in the appeals process.

When I decided the case in C-19-1011 following the hearing, I ultimately upheld the challenged LCD provision primarily based on the documents in the LCD record.  I discussed the AP’s exhibits and the testimony of its witnesses at length; however, the main grounds for upholding the challenged provision were the documents related to the EF-11 Study and its flaws, the FDA panel considerations, and the NCCN Guidelines’ low-level recommendation for using TTFT to treat recurrent GBM.  CR5915 at 39-40.  These were documents in the LCD record.  And, as explained above, the new exhibits that the AP submitted in the present case do not cause me to question the completeness or adequacy of the LCD record.

Despite the comprehensive review of evidence in CR5915, the AP in the present case only mentioned CR5915 once in the AP statement.  The AP stated that, in CR5915, “the fact that clinical trials for an unproven treatment is recommended as much as TTFT was deemed to undercut the recommendation for TTFT.  However, the NCCN guidelines clearly state ‘NCCN believes that [t]he best management of any patient with cancer is in a clinical trial.’  Thus, such a statement cannot be considered an undercut of the recommendation of TTFT as that is applie[d] to all the NCCN recommendations.”  A. Statement at 20 n.35.  While it is true that the NCCN generally believes the best cancer treatment management is in a clinical trial, my discussion in CR5915 pointed out that the NCCN stated that it “highly encouraged” eligible patients with recurrent GBM to enter a clinical study because the current options for treatment, including TTFT, were “suboptimal.”  CR5915 at 40.  Contrary to the AP’s assertion, the NCCN’s notation is not a mere statement of policy but a strong suggestion that patients with recurrent GBM should be in a clinical study because none of the treatment options are truly effective.  Therefore, the AP’s statements do not cause me to doubt the findings and conclusions in CR5915.

**Page 19**

VIII.  Conclusion

I conclude that, under the reasonableness standard, the record for LCD L34823 is complete and adequate to support the validity of the prohibition on Medicare coverage for treating recurrent GBM with TTFT.

Endotes

1  Even if I had considered Dr. Ansstas’ written testimony, I would not have concluded that it served as a basis for finding the record in L34823 incomplete or inadequate.  While Dr. Ansstas states that “[f]or recurrent patients . . . TTFT works outstandingly well,” this statement is brief and is not fully explained.  A. Ex. 406 ¶ 12.  Further, although Dr. Ansstas states that he published a case series concerning recurrent patients, the written testimony does not provide a title, date, or other information about the publication (such as an exhibit number if it had been submitted by the AP).
  
          /s/
        Scott Anderson

                      Administrative Law Judge Back to top
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