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-20-331
Decision No. CR5902
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 criteria listed in the LCD. One criterion is that the beneficiary initiate TTFT within seven weeks from the last dose of concomitant chemotherapy or radiotherapy, whichever is later (Seven-Week Criterion). Noridian Healthcare Solutions, LLC (Noridian), one of the Medicare contractors that drafted L34823 and the party defending its validity, asserts that the only clinical study showing TTFT’s effectiveness (the EF-14 Study) in treating newly diagnosed GBM limited participation in the study to individuals who started the trial no later than seven weeks after receiving chemotherapy or radiotherapy. Therefore, according to Noridian, it cannot be certain that TTFT will be effective if started beyond the seven-week period.
The Aggrieved Party (AP) challenges Noridian’s Seven-Week Criterion based on clinical evidence presented by five expert witnesses who testified in these proceedings.1 The expert witnesses testified that it is medically improper to strictly apply the standards used for admitting individuals to a clinical trial as the only parameters for providing a treatment to patients generally. Rather, clinical trials must set entrance requirements to
achieve a degree of uniformity in the group being studied to ensure that sufficient members of that group complete the clinical trial and to avoid confounding factors that may invalidate the clinical trial. The experts testified that, for a deadly and aggressive form of brain cancer like GBM, the clinical trial needed to start treatment soon after the completion of the standard treatment for GBM (resection surgery and chemotherapy or radiotherapy) to ensure that sufficient individuals in the trial could complete the trial before death or other medical or logistical issues intervened. Further, the experts all testified that, in their considerable clinical experience, TTFT is effective when initiated more than seven weeks after the completion of chemotherapy or radiotherapy. The experts emphasized that there is often the need for patients to start TTFT more than seven weeks after completing standard treatment. Patients with GBM are many times elderly and may be too weak to start TTFT or unable to quickly arrange to start TTFT within the seven-week period following surgery and chemotherapy/radiotherapy. This is particularly the case because individuals must start adjuvant chemotherapy again when commencing TTFT treatment.
In essence, the expert witnesses found the Seven-Week Criterion to be irrational because it inappropriately applies a clinical trial entrance requirement for coverage and fails to recognize that clinical trials show a treatment’s effectiveness more broadly than the specific parameters of the study. The clinical trial must be scientific in its approach (to avoid confounding factors), but the effective practice of medicine and employment of treatments are not constrained by the scientific methods of testing a treatment.
In these proceedings, I am to consider both scientific and clinical evidence to determine whether the challenged provision is reasonable. Noridian expressly only considered the entrance requirements from the EF-14 Study when establishing the Seven-Week Criterion and decided not to consider clinical evidence of TTFT’s effectiveness beyond the Seven-Week Criterion. Further, Noridian did not provide any expert testimony of its own to support its use of a clinical trial entrance requirement as the basis for coverage. Therefore, I conclude that the AP, through unrebutted clinical evidence as expressed by the expert witnesses, has met the burden of proof that the Seven-Week Criterion is not properly supported.
The EF-14 Study showed TTFT to be highly effective in slowing the progress of newly diagnosed GBM. The success of TTFT as a treatment for newly diagnosed GBM has been widely accepted as valid and has a Level 1 recommendation from National Comprehensive Cancer Network (NCCN) Guidelines, a document that helps to establish the standard of care in the United States for cancer treatments, and NCCN did not recommend a seven-week limitation on the start of TTFT. The oncological medical community, as a whole, does not appear to question the effectiveness of TTFT commenced at times beyond the seven-week clinical trial entrance requirement. Therefore, I conclude that the Seven-Week Criterion is not valid under the reasonableness standard in the Social Security Act (Act). 42 C.F.R. § 426.450(a)(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 may file a complaint to challenge the LCD or a provision in the LCD. In a proceeding that is distinct from a Medicare claims appeal, an administrative law judge evaluates the reasonableness of the challenged LCD or provision of the LCD based on the LCD record and evidence submitted during the proceeding. In doing so, the administrative law judge will “defer only to the reasonable findings of fact, reasonable
interpretations of law, and reasonable applications of fact to law by the Secretary.” 42 U.S.C. § 1395ff(f)(2)(A)(i)(III). When challenging an LCD or a provision of an LCD, the beneficiary has the burden of proving the allegations in his or her complaint by a preponderance of the evidence. 42 C.F.R. § 426.330. The standard of proof is the preponderance of the evidence standard. 42 C.F.R. § 426.330.
A party may appeal the administrative law judge’s decision to the Departmental Appeals Board (DAB) and the DAB’s decision is subject to judicial review. 42 U.S.C. § 1395ff(f)(2), (5); 42 C.F.R. pt. 426.
II. Procedural History
On February 28, 2020, the AP filed a complaint (Complaint) challenging the validity of the coverage requirement in LCD 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. Complaint ¶¶ 7, 17, 33, 38, 41. The AP has GBM, but did not receive TTFT within seven weeks of completing chemotherapy. Complaint ¶¶ 4, 5. Nonetheless, Scott Turner, M.D., a physician treating the AP’s GBM, stated in a declaration that “consistent with the standard of care, I recommended TTFT to manage her GBM.” A. Ex. 2 ¶ 18. The AP’s claim for Medicare coverage was denied. Complaint ¶ 11. Accompanying the Complaint, among other things, was a document appointing Debra Parrish, Esq. as her representative.
On March 11, 2020, I issued an Acknowledgment of Receipt of Acceptable Complaint; Order to File LCD Record; and Briefing Schedule. See 42 C.F.R. §§ 426.410(d)(3), 426.425(a)-(b). On March 24 and 31, 2020, Noridian filed 50 exhibits (CMS Exs. 1-50) as the record for L34823. Subsequently, the AP filed a statement as to why the LCD record was not complete or adequate to support the validity of the challenged provision along with approximately 400 exhibits (A. Exs. 1-418). On June 10, 2020, Noridian filed its defense of the validity of L34823.
On June 26, 2020, I issued an Order in which I concluded that L34823’s record, as submitted by Noridian, was insufficient to support the validity of that LCD. Tumor Treatment Field Therapy LCD ID No. L34823, ALJ Ruling No. 2020-13 (HHS CRD June 26, 2020). Noridian had not submitted all of the documents in the record for L34823, as required under the regulations, and Noridian had also submitted additional documents that had not been in L34823’s record. Further, the AP submitted numerous documents and physician statements concerning the efficacy of TTFT commenced outside the seven-week period required in L34823. As a result, I concluded that a full evaluation of evidence was necessary to determine the validity of the challenged provision. Therefore, I established a schedule for the parties to engage in discovery and to receive evidentiary submissions. Tumor Treatment Field Therapy, ALJ Ruling No. 2020-13 at 6-7; see 42 U.S.C. § 1395ff(f)(2)(A)(i)(I); 42 C.F.R. § 426.425(c)(1), (3).
In July 2020, Noridian declined to seek any discovery from the AP. However, the AP served interrogatories and requests for the production of documents on Noridian. In addition, on July 22, 2020, Noridian filed the missing documents from the record in L34823 as CMS Exhibits 51 through 73.
In an August 14, 2020 Order, I noted that discovery was completed and set dates for the submission of additional exhibits, including written direct testimony from expert witnesses. Noridian submitted CMS Exhibits 74 through 81, none of which were written direct testimony from expert witnesses. The AP submitted A. Exhibits 419 through 427, which included the written direct testimony for six expert witnesses (A. Exs. 422-427).
Noridian did not object to any of the AP’s proposed exhibits but did request to cross-examine the AP’s expert witnesses. The AP objected to CMS Exhibit 74 because it was not produced as part of the LCD record, was not listed as having been considered by Noridian when publishing L34823, was not proffered to facilitate the testimony of an expert, and may not be relevant. Noridian responded that the AP submitted Noridian’s entire response to interrogatories as an exhibit and that CMS Exhibit 74 had been mentioned in the response to interrogatories and had been included in the document production to the AP. As a result, Noridian pointed out, the AP submitted the document marked as CMS Exhibit 74 as part of A. Exhibit 419.
Following coordination with the parties and witnesses, on October 20, 2020, I issued a Notice of Joint Telephonic Hearing and Ruling on Evidentiary Objections (Notice) for the present LCD challenge case and the LCD challenge case docketed under C-19-1011. I did this for the following reasons: the APs in the respective cases are represented by the same representative; Noridian is represented by the same representatives in both cases; both cases involve challenges to provisions in L34823; and the purpose of both hearings was for Noridian to cross-examine the same six expert witnesses. The Notice stated that I would hold the hearing on two days based on the availability of the witnesses and the previously stated schedules of the parties’ representatives: November 19, 2020, and December 11, 2020. Further, in the Notice, I overruled the AP’s objection to CMS Exhibit 74 filed in this case. In addition, I addressed Noridian’s objection to the November 19, 2020 hearing date because one of Noridian’s representatives had developed a conflict. I concluded that Noridian had three other representatives who were all legally trained who could appear at the hearing. Finally, in the Notice, I stated procedures for the hearing, which included the requirement that questions on cross-examination would be calculated to assist the party in supporting its case or to call into question the written direct testimony of the witness. I prohibited questioning of the type used in depositions. The Notice made clear that the parties must file any final motions before the start of the hearing and that I would not entertain motions at the hearing that could have been made before the hearing.
On October 27, 2020, Noridian withdrew its objection to the November 19, 2020 hearing date, indicating that its representative with a conflict had been able to resolve the conflict.
Based on information from the parties, on November 6, 2020, I gave notice of adjustments to the times at which the experts would appear on the days set for the hearing.
On November 19, 2020, I held a telephonic hearing at which Noridian cross-examined the following expert witnesses for the AP: Scott Turner, M.D. (A. Ex. 424; Hearing Transcript (Tr.) at 16-75); Louis Nabors, M.D. (A. Ex. 425; Tr. at 81-129); and Anand Shivnani, M.D. (A. Ex. 426; Tr. at 131-172). Tr. at 1-184. At the hearing, I admitted all of the AP’s proposed exhibits that appear on the AP’s September 14, 2020 amended exhibit list and all of Noridian’s proposed exhibits that appear on the Noridian’s September 14, 2020 amended exhibit list. Tr. at 12.
On December 11, 2020, I held a telephonic hearing at which Noridian cross-examined the following expert witnesses for the AP: Eric T. Wong, M.D. (A. Ex. 423; Tr. 193-267); and Steven Toms, M.D. (A. Ex. 422; Tr. 280-335). Dr. George Ansstas was to appear but did not without explanation. Therefore, I excluded his written direct testimony from the record (A. Ex. 427). Tr. 270, 277-78; see 42 C.F.R. § 426.440(e).
On February 11, 2021, the AP filed a post-hearing brief (A. Br.). On March 15, 2021, Noridian filed a post-hearing brief (N. Br.). On March 29, 2021, the AP filed a reply brief (A. Reply). On June 2, 2021, I stayed this proceeding and provided notice that my review of the record as a whole indicated that new evidence submitted by the AP had the potential to significantly affect my evaluation of the Seven-Week Criterion in L34823 under the reasonableness standard and that Noridian had until June 14, 2021, to decide if it wanted to reconsider that provision. 42 C.F.R. § 426.340(d). Noridian did not provide notice that it would reconsider the Seven-Week Criterion; therefore, I issue this decision based on the record in this case.
III. Noridian’s Party Status and the Appointment of Noridian’s Representatives
At and between the two days of hearing in this case, the AP’s representative raised objections to the appearance of Fred Mamuya, M.D., Ph.D., as one of Noridian’s representatives at the hearing and questioned whether CMS or Noridian was the party defending the LCD. Due to the serious nature of the AP’s representative’s accusations and the circumstances surrounding her objections, I discuss the issue in detail. However, as indicated at the hearing, there is no doubt that Noridian is the party defending the LCD in this case and that the Secretary’s regulations permit any person, whether an attorney or a non-attorney, to be appointed as a representative in LCD challenge cases.
In a March 23, 2020 Notice of Appearance, Lynn Brott, J.D. and Peter Gurk, M.D. indicated that they were Noridian’s authorized representatives in this case. In a July 8, 2020 Amended Notice of Appearance, Lynn Brott, J.D., Fred Mamuya, M.D., Ph.D., Jeanne Narum, Associate General Counsel, and Ranga Nutakki, Associate General Counsel, indicated that they were Noridian’s representatives.
In an October 19, 2020 email from one of Noridian’s representatives, Noridian stated, among other things, that Dr. Mamuya would be conducting the cross-examination of the AP’s expert witnesses. In an October 27, 2020 email, one of Noridian’s representatives confirmed that Dr. Mamuya would participate at the November 19, 2020 hearing.
Two of Noridian’s representatives, Dr. Mamuya and Ms. Narum, appeared at the November 19, 2020 hearing. At the beginning of the hearing, I addressed a request from Noridian’s representatives, made before the hearing, that one representative be responsible for questioning witnesses (Dr. Mamuya) and another be responsible for responding to objections (Ms. Narum). Tr. at 4. The AP’s representative objected to that arrangement and Noridian withdrew its request, indicating that Dr. Mamuya would conduct the questioning of witnesses and respond to all objections. Tr. at 4-5, 9.
For the first time in this proceeding, the AP’s representative objected to Dr. Mamuya, a non-attorney, serving as a representative for Noridian at the hearing. Ms. Parrish stated that “it is against the law [in her state] and unethical for a non-lawyer to represent a corporation in a proceeding before any tribunal.” Tr. at 5. The AP’s representative concluded that Dr. Mamuya would be engaging in the unauthorized practice of law if he questioned the witnesses in this case. Tr. at 5. Further, the AP’s representative wanted to know if Noridian’s other representative, Ms. Narum, investigated whether it was ethical in the jurisdiction where Dr. Mamuya was located for him to represent a corporation. Tr. at 5. The AP’s representative specified she was concerned that there would be violations of both the unauthorized practice of law rules and violations of the rules of professional responsibility. Tr. at 5.
I asked the AP’s representative why she only made this objection at the start of the hearing because Noridian had stated weeks earlier that Dr. Mamuya would conduct the cross-examination. The AP’s representative responded that the request for Ms. Narum to have a role in the hearing is what prompted the question. Tr. at 5-6. I stated that the Act permits non-attorney representation and that non-attorney representation occurs regularly before administrative law judges at the Office of Medicare Hearings and Appeals. Tr. at 6. The AP’s representative agreed but stated she was concerned that Ms. Narum did not conduct an analysis as to whether Dr. Mamuya could appear as a representative. Tr. at 6. The AP’s representative thought representation by non-attorneys might be limited to acting on behalf of individuals. Tr. at 7.
I stated that, “[w]ith having no time to look into this objection,” the Civil Remedies Division (CRD) has allowed non-attorney representation in LCD cases. Regarding Noridian, as a contractor, I pointed out that 42 C.F.R. § 426.415 discusses representation of CMS or a contractor in terms of identifying the “person” who will represent it. Tr. at 7-8. I also noted that 42 C.F.R. § 426.405 provides the administrative law judge with the authority to regulate the course of the hearing and the conduct of the representatives. I noted the use of the word “representatives” and indicated that it is significant that the term “counsel” had not been used to denote exclusive attorney representation. Tr. at 8. Finally, I said that I was conducting a federal, and not a state, proceeding and that federal regulations supersede state unauthorized practice of law rules. Therefore, I overruled the objection and recognized Dr. Mamuya as Noridian’s representative. Tr. at 8.
Following testimony from the witnesses, Ms. Parrish again raised Dr. Mamuya’s ability to represent Noridian. I stated that the AP had not raised this issue earlier even though Dr. Mamuya had been identified as one of Noridian’s representatives from an early date and Noridian had made it clear he would conduct the cross-examination. I told Ms. Parrish that she was free to file a motion before the December 11, 2020 hearing date, indicating the legal authority for her position. I also stated that Ms. Parrish should file the motion “with enough time so that Noridian can respond to it before the next hearing date. So if it comes in too late again, we’ll have the same . . . problem” discussing a motion at the hearing rather than resolving it before the hearing. Tr. at 180-81.
In a December 4, 2020 email to the representatives of the parties, the CRD attorney assisting me on this case informed the parties on my behalf that:
Judge Anderson needs to know if the parties intend to file any motions the resolution of which will require some further discussion at the hearing before Dr. Wong testifies in order to add additional time before Dr. Wong is to testify. By reply email to me, each party must indicate if the party anticipates filing any motions before the hearing and, if so, the general topic of the motions. The parties are reminded that Judge Anderson’s original Notice of Hearing indicated that he will not consider motions on the day of the hearing that the parties could have filed before the hearing. If a party does not anticipate filing any motions before the December 11 hearing, the party must send an email indicating that.
The parties need to respond as soon as possible so CRD can issue the MS Teams Hearing Connection Email.
DAB E-File Document No. 97 at 3 (emphasis added).
Five days later and less than two days before the December 11, 2020 hearing date, on December 9, 2020, the AP’s representative filed an 11-page Aggrieved Party’s Motion to Exclude Non-Attorney as Cross-Examiner. Specifically, Ms. Parrish sought to exclude Dr. Mamuya from serving as the Noridian representative who would conduct the cross-examination of the AP’s witnesses at the December 11, 2020 hearing. Ms. Parrish argued in her motion that a corporation may not represent itself in a proceeding, but can only be represented through a licensed attorney. The cases cited by Ms. Parrish involved appearing in courts of law. Ms. Parrish also complained that Dr. Mamuya was not administered an oath at the November 19, 2020 hearing before being permitted to appear.
Later, on December 9, 2020, Ms. Narum responded by email to the CRD attorney assisting me on this case, objecting to the tardiness of the motion to exclude Dr. Mamuya. She stated, in part:
Noridian believes that the filing of this motion was a tactical decision to distract it from finishing preparations for the December 11 hearing, with counsel waiting until the eleventh hour to file this motion about an issue that she has known about since October 19, when we advised you and Ms. Parrish that Dr. Mamuya would be performing the cross examinations. This motion should never have been filed, but it is all the more inappropriate to have this motion filed on the eve of the December 11 hearing in direct contradiction to Judge Anderson’s instruction during the prior hearing. Noridian objects to having to shuffle its resources to respond to this motion.
DAB E-File Document No. 97 at 2.
Also on December 9, 2020, in an email to the parties’ representatives sent from the CRD attorney assisting me on this case, I conveyed that, while Ms. Parrish’s motion was filed in a grossly untimely manner, I decided to fully address this issue. The email indicated that 42 C.F.R. § 426.415 authorized CMS to appoint the persons who would represent Noridian if CMS so chose to make the appointment. The email indicated that the notice of appearance for Noridian’s representatives did not indicate whether CMS or Noridian appointed them. As a result, the email indicated that Noridian had until the close of business on December 10, 2020, to submit a notice of appointment signed by an appropriate CMS official or documentation showing Noridian’s authority to appoint its own representatives. The email stated that if Noridian could not timely comply, then I would reschedule the hearing to permit Noridian to comply. DAB E-File Document No. 97 at 1.
On December 10, 2020, Ms. Parrish objected to the course of action stated in the December 9, 2020 email.
Also on December 10, 2020, Noridian filed a Notice of Appointment with a secure digital signature used by the Department of Health and Human Services. The signature was applied to the document on December 10, 2020. The signatory was Larry D. Young, the Director for CMS’s Medicare Contractor Management Group. Director Young stated:
CMS permits its Medicare Administrative Contractors to represent CMS in the LCD review process. In this case Noridian represents CMS in C-19-1011 and C-20-331, In Re LCD Complaint: Tumor Treatment Field Therapy (L34823). Pursuant to 42 CFR 426.415, I acknowledge in my capacity as CMS’ Director of the Medicare Contractor Management Group, that each of the following Noridian representatives have and have had authority to represent Noridian, and therefore, CMS, in C-19-1011 and C-20-331, In Re LCD Complaint: Tumor Treatment Field Therapy (L34823), including full participation in any ALJ hearing, such as by conducting cross-examinations:
Contractor Medical Director Dr. Wilfred Mamuya;
Associate General Counsel Jeanne Narum;
Associate General Counsel Ranga Nutakki; and
Director of Operations Lynn Brott
DAB E-File Document No. 99.
At the beginning of the December 11, 2020 hearing, I overruled the AP representative’s motion to exclude Dr. Mamuya and provided my reasoning for doing so. Tr. at 188-191.
When Dr. Mamuya introduced himself to the next witness, he indicated that Noridian was a Medicare contractor and an agent of CMS through its contract and that Noridian was appearing in this case as a representative. Further, Dr. Mamuya indicated that, on behalf of Noridian, he and Ms. Narum were appearing as CMS representatives. Tr. at 194. The AP’s representative requested that Dr. Mamuya clarify whether he represented CMS. Tr. at 195. I asked Dr. Mamuya to clarify who was the party defending the LCD and Dr. Mamuya stated: “For the record, Your Honor, Noridian is the party to this matter and that’s, that’s my understanding.” Tr. at 196.
Later in the hearing, Dr. Mamuya wanted to further clarify that the December 10, 2020 Notice of Appointment indicates that Noridian represents CMS and that Dr. Mamuya and Ms. Narum represent Noridian and thus CMS. Tr. at 272-73. The AP’s representative
then said the Notice of Appointment simply confused matters and that it does not make sense for CMS to appoint the representative for another entity given that it is not a party to the case. Tr. at 273-74. I disagreed, pointing to 42 C.F.R. § 426.415, which permits CMS to decide who will represent either the contractor, when the contractor is the party defending the LCD, or CMS, if CMS is defending the LCD. I further stated that CMS has not been a party to the proceeding, and I did not recognize CMS as a party to this case. Tr. at 274-75.
The issues raised by the AP’s representative are not very complicated or confusing. The AP’s representative made it more complicated because of the timing of her initial objection, which violated my order concerning motions on the day of the hearing, and the extreme tardiness of her written motion before the second day of the hearing, which also violated the instructions I gave on the first day of the hearing and between the first and second day of the hearing. The AP’s representative’s actions needlessly distracted from the important witness testimony I needed to hear. Such conduct is not proper and may, in the future, result in sanctions. See 42 C.F.R. § 426.405(c)(15), (21) (administrative law judge has authority to regulate the conduct of representatives and exclude parties from an LCD proceeding for failure to comply with an administrative law judge’s order or procedural request without good cause show); Civil Remedies Division Procedures § 23.
Although I ruled on the AP’s objections at the hearing, I stated that I would fully address those issues in my decision. Therefore, I do so here.
By statute, CMS primarily administers the Medicare program through contractors, which may be public or private entities. One court summarized the broad nature of the role of contractors in the Medicare program as follows:
Section 1842(a) of the Medicare Act, 42 U.S.C. § 1395u(a), states that “[t]he administration ... shall be conducted through contracts with medicare administrative contractors under section 1874A.” Section 1874A(a)(1), 42 U.S.C. § 1395kk–1(a)(1), states that “[t]he Secretary may enter into contracts with any eligible entity to serve as a medicare administrative contractor with respect to the performance of any or all of the functions described in” Section 1874(a)(4). The statute defines “medicare administrative contractor” to include any “agency, organization, or other person with a contract under this section,” without regard to whether that agency, organization, or person is private or public. 42 U.S.C. § 1395kk–1(a)(3)(A). The “functions” described in Section 1874(A) include “determining ... the amount of the payments required pursuant to this title to be made to providers of services, suppliers and individuals” and “performing such
other functions ... as are necessary to carry out the purposes of this title.”
Fayad v. Sebelius, 803 F. Supp. 2d 699, 705 (E.D. Mich. 2011) (emphasis omitted). As indicated earlier, Congress expressly provided Medicare contractors with the responsibility to create and publish LCDs. 42 U.S.C. §§ 1395y(l)(5), 1395ff(f). Therefore, contractors are to support CMS regarding LCDs.
In LCD challenge cases, the regulations define the word “Party” to mean the AP, and “as appropriate, a contractor or CMS.” 42 C.F.R. § 426.110. The preamble to the proposed rule states that CMS chooses whether the contractor or CMS will be the party. 67 Fed. Reg. 54,534, 54,539 (Aug. 22, 2002) (“In the case of an LCD review, we [CMS] may choose whether to be a party.”) Simply because CMS decides that the contractor will be the party defending an LCD does not mean the contractor has ceased to act on CMS’s behalf.
I interpreted the December 10, 2020 Notice of Appointment’s language that Noridian is representing CMS to be nothing more than CMS designating Noridian as the party defending the LCD in CMS’s place. Such a statement serves to clarify, not confuse, that the contractor, and not CMS, is the party defending the LCD.
The AP’s representative questioned how CMS could appoint individuals to represent Noridian, because such an action makes no sense to her. However, it makes sense when taking into consideration that the contractor is acting on CMS’s behalf. CMS’s proposed text for § 426.415 stated that CMS “will” designate the person representing the contractor and did not mention designating a person to represent CMS. 67 Fed. Reg. at 54,551. Therefore, the original focus of § 426.415 was entirely on CMS’s authority to always appoint the person who would represent the contractor. 67 Fed. Reg. 54,541 (“In § 426.415, we would provide information identifying the person who would represent the contractor in the LCD review process to the [administrative law judge], and all parties to the LCD review. We would make a decision whether the agency or the contractor would participate in the LCD review.”). The final rule gave CMS the choice to designate the person who would represent the contactor or CMS, leaving room for the contractor to appoint its own representatives if CMS decided not to do so.
We must also look to the regulations to answer the question as to whether a non-attorney, like Dr. Mamuya, may represent Noridian in this proceeding. The Secretary gave CMS the authority to provide “information identifying the person who represents the contractor or CMS, if necessary, in the LCD review process.” 42 C.F.R. § 426.415 (emphasis added). Because the regulation uses the generic term of “person,” the regulation is not limiting representation to attorneys. Cf. 42 U.S.C. § 406(a)(1) (contrasting attorneys with agents and “other persons” who are permitted to represent
parties before the Commissioner of Social Security and, through 42 U.S.C. § 1395ii, the Secretary).
This interpretation is consistent with the regulatory provisions in 42 C.F.R. part 426 regarding representation for the AP, which always use the generic term of representative and not “attorney” or “counsel.” 42 C.F.R. §§ 426.400(c)(2), 426.405(d)(8)(i), 426.489(a)(1); cf. 67 Fed. Reg. 54,541-42, 54,553 (proposed rule originally stated in proposed § 426.432(a)(2)(i) that the parties had the right “to select and use an attorney or other representative during the discovery process,” but removed the entire provision in the final rule); 5 U.S.C. § 500(f) (Agency Practice Act referring to either an attorney or a non-attorney accountant as a “representative.”). Further, in giving the presiding administrative law judge the authority to “[r]egulate . . . the conduct of representatives, parties, and witnesses,” the regulation is also using that generic term of representative for the person or persons representing Noridian or CMS and the AP. When the Secretary wants to limit representation to attorneys, the Secretary knows to use that term rather than the word representative. Compare 42 U.S.C. § 1320a-7a(c)(2) (providing that a person is entitled to be represented by counsel when the Secretary takes certain adverse actions) with 42 C.F.R. § 1005.3(a)(1) (the Secretary interpreting 42 U.S.C. § 1320a-7a(c)(2) to give a right to be “accompanied, represented, and advised by an attorney.”).
In the present case, neither the applicable statute nor regulation indicates that only attorneys may appear in LCD challenge proceedings and, to the contrary, the regulation indicates that non-attorneys may appear. LCD challenge cases are adjudicated by administrative law judges and the DAB, which are not courts of law but administrative tribunals within the Department of Health and Human Services. There is no reason to believe that CMS could not choose any person or persons that it wanted to represent CMS or one of its contractors in such a forum.
The sole issue that I decide in this case is:
Whether the Seven-Week Criterion in L34823 is valid under the reasonableness standard.
In various filings in this proceeding, the parties have discussed or challenged other provisions in L34823. However, the AP’s Complaint expressly challenged only the validity of the Seven-Week Criterion and did not challenge any other provision of L34823. Complaint ¶¶ 17, 41; see also Tumor Treatment Field Therapy, ALJ Ruling No. 2020-13 at 3 n.1. Therefore, I must confine my review to the provision challenged in the Complaint. 42 C.F.R. § 426.431(a)(1).
In post-hearing briefing, the AP extensively argued that Noridian failed to properly publish L34823 under the requirements in 42 U.S.C. §§ 1395y(l)(5)(D) and 1395hh, and Noridian responded to those arguments. A. Br. at 3, 6-11; N. Br. at 7-19.
I do not have jurisdiction to consider this new issue because the AP did not raise it in the Complaint. Further, the statute under which I am conducting the present review limits an administrative law judge to evaluating the factual record to determine if the substantive provisions of the LCD are reasonable and not whether the LCD was properly published. 42 U.S.C. § 1395ff(f)(2)(A)(i)(I).
V. Findings of Fact
1. 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 able to live five years after a GBM diagnosis.
Although GBM is a rare form of malignant tumor generally, “[GBM] is the most common and aggressive primary brain tumor with an annual incidence of 3.19 per 100000. The disease course is typically rapid, with only approximately 1 in 4 patients alive 2 years after diagnosis, and only 5% to 10% of patients alive at 5 years.” CMS Ex. 62 at 2; see CMS Ex. 68 at 1; CMS Ex. 33 at 1 (stating world-wide gliomas, including GBM, occurs in six out of every 100,000 people); CMS Ex. 34 at 2 (calling GBM “the most aggressive primary brain tumor with an incidence of 3-5 cases per 100,000 inhabitants per year.”). GBM disproportionately occurs in older adults with approximately half of all cases involving individuals 65 years of age or older. CMS Ex. 64 at 1; see CMS Ex. 51 at 2.
Generally, the “[s]tandard treatment consists of maximal safe surgical resection or a diagnostic biopsy, followed by radiotherapy (60 Gy) with concomitant daily temozolomide chemotherapy, and then maintenance treatment with temozolomide for 6 to 12 months.” CMS Ex. 61 at 3; see CMS Ex. 33 at 10 (stating that radiotherapy has been the standard treatment for GBM since the 1980’s); CMS Ex. 34 at 3 (noting that “[s]urgery represents the first therapeutic approach” and identifying radiotherapy plus concomitant and adjuvant temozolomide as the standard treatment for patients 18 to 70 years old. Maximum safe resection . . . produces survival benefits.”). Surgical resection alone only leads to a median survival of three to six months, the addition of radiation after surgery has an approximate median survival of one year, and the further addition of temozolomide extends survival to more than 14 to 16 months. CMS Ex. 53 at 1. When a tumor recurs or progresses after standard treatment, it is known as “recurrent GBM.” CMS Ex. 67 at 12.
Despite treatment, “most patients will die within 1 to 2 years . . . During the last decade [before 2015], all attempts to improve the outcome for patients with glioblastoma have
failed when evaluated in large randomized trials.” CMS Ex. 61 at 3; see CMS Ex. 68 at 1. Therefore, GBM “has a poor prognosis, and, as tumors grow, patients often experience a progressive decline in neurologic function and health-related quality of life . . . The current standard of care is not curative but results in prolongation of life.” CMS Ex. 63 at 2.
2. TTFT is a treatment for GBM that uses electric fields to slow the progression of GBM. The final analysis of the EF-14 Study concerning the effectiveness of TTFT in treating newly diagnosed GBM indicated that patients receiving TTFT and temozolomide had statistically significant improvement in progression-free survival and overall survival than patients who were only treated with temozolomide.
TTFT is “an antimitotic treatment that selectively affects dividing glioblastoma cells by delivering low-intensity, intermediate frequency (200 kHz) alternating electric fields via transducer arrays applied to the scalp. [TTFT] cause[s] mitotic arrest and apoptosis of rapidly dividing cells.” CMS Ex. 62 at 2. In short, TTFT uses electric current to slow down the progression of GBM. That electric current is delivered by a device named Optune™ (developed by Novocure Ltd.) consisting of “[four] transducer arrays placed on the shaved scalp and connected to a portable device set to generate 200-kHz electric fields within the brain.” CMS Ex. 61 at 3.
In a randomized phase 3 clinical trial involving 237 patients with recurrent GBM (called the EF-11 Study), which compared TTFT with chemotherapy, the study showed that the use of TTFT “did not prolong profession-free survival or overall survival, but [TTFT] was associated with better quality of life without the typical chemotherapy-associated toxic effects.” CMS Ex. 61 at 3.
Subsequently, from July 2009 to November 2014, another phase 3 trial (the EF-14 Study) was conducted at 83 centers in the United States, Canada, Europe, Israel, and South Korea, with the objective to evaluate the efficacy and safety of TTFT used on patients with GBM in combination with maintenance temozolomide (chemotherapy) after initial treatment with temozolomide and radiotherapy. CMS Ex. 61 at 2-3. The interim analysis in 2015 of this study was that TTFT with temozolomide “significantly prolonged progression-free and overall survival.” CMS Ex. 61 at 2. The final analysis of the EF-14 Study in 2017 was that TTFT with temozolomide versus temozolomide alone “resulted in statistically significant improvement in progression-free survival and overall survival.” CMS Ex. 62 at 1.
The EF-14 Study limited the population of the study to patients who had histologically confirmed GBM, were progression-free after having undergone maximal safe debulking surgery when feasible or biopsy, had completed standard concomitant chemoradiotherapy with temozolomide, were 18 years of age or older, had a Karnofsky Performance Status
(KPS) score of 70% or higher,2 and adequate bone marrow, liver, and renal function. CMS Ex. 61 at 3. The EF-14 Study included 466 patients who would receive the TTFT along with temozolomide and 229 patients who received temozolomide alone. CMS Ex. 61 at 2. For the patients receiving TTFT, TTFT “was to be initiated within 4 to 7 weeks from the last dose of concomitant temozolomide and radiotherapy.” CMS Ex. 61 at 3.
During the EF-14 Study, patients were seen monthly for medical follow-up and routine laboratory examinations. CMS Ex. 61 at 4-5. In October 2014, the EF-14 Study’s independent data and safety monitoring committee met and determined that the study met the predetermined parameters for success (i.e., improvement of both progression-free and overall survival) resulting in a recommendation that the EF-14 Study terminate early and allow patient participants not receiving TTFT to receive it. CMS Ex. 61 at 5.
The initial assessment of the EF-14 Study showed that the median progression-free survival was 7.1 months for patients who received TTFT plus temozolomide compared with 4.0 months for temozolomide-only patients. CMS Ex. 61 at 6. Median overall survival was 20.5 months for the group with TTFT plus temozolomide and 15.6 months with temozolomide alone. CMS Ex. 61 at 7. Two years following enrollment in the study, 43% of patients receiving TTFT and temozolomide were still alive and 29% of temozolomide-only patients were alive. CMS Ex. 61 at 7.
Following the initial assessment, in 2015, an editorial in the Journal of the American Medical Association (JAMA) expressed concern that EF-14 patients receiving TTFT also received a higher quantity of temozolomide than the patients who only received temozolomide, as well as concerns with some other aspects of the study. CMS Ex. 52. A 2016 article in Neuro-Oncology also questioned a number of factors related to the EF-14 Study and offered a skeptical assessment of TTFT. CMS Ex. 55 at 1-2; see also CMS Ex. 56 at 5; CMS Ex. 57 at 4; CMS Ex. 66. However, also in 2016, an article in Oncotarget documented the results of experiments involving the effects of TTFT and ionized radiation on GBM cells that “further provides a preclinical basis for the application of TTF[T] in combination with radiotherapy in the clinic.” CMS Ex. 59 at 10.
The final assessment of the EF-14 study showed that the median progression-free survival was 6.7 months for patients who received TTFT plus temozolomide compared with 4.0 months for temozolomide-only patients. Median overall survival was 20.9 months for the group with TTFT plus temozolomide and 16 months with temozolomide alone. Two years following enrollment in the study, 43% of patients receiving TTFT and temozolomide were still alive and 31% of temozolomide-only patients were alive. After
three years, 26% of patients were alive who received TTFT and temozolomide as compared to 16% who only received temozolomide. Finally, after five years, 13% of the patients were alive when receiving TTFT and temozolomide as compared to 5% of patients who received only temozolomide. CMS Ex. 62 at 6.
The final assessment noted that “[p]atients 65 years or older had shorter survival than patients younger than 65 years. In both age groups, TTF[T] plus temozolomide was associated with significantly increased survival compared with temozolomide alone for older . . . and younger patients.” CMS Ex. 62 at 7.
In 2017, an article on the European Association for Neuro-Oncology guideline for patient care involving GBM briefly discussed the EF-14 Study results and merely noted that there were still questions concerning the interpretation of data, the effect on quality of life, and the cost effectiveness of TTFT. CMS Ex. 33 at 11.
Also in 2017, an article on the Spanish Society of Medical Oncology guidelines for the diagnosis and treatment of GBM stated that the EF-14 Study demonstrated improvement in GBM outcomes and that TTFT had been approved by the Food and Drug Administration (FDA) and the European Medicines Agency; however, the article noted, similar to the European Association for Neuro-Oncology, “due to low cost/benefit ratio, it has not been approved by most European countries.” CMS Ex. 34 at 4.
Another article in 2017 documented the views of a roundtable of experts concerning TTFT. There were diverse opinions concerning TTFT; however, they agreed to the following:
The roundtable attendees came to a general consensus that TTF[T] plus [temozolomide] should be considered a new standard of care for those patients with newly diagnosed glioblastoma who are without contraindications, and willing to undergo this therapy. Additional research remains to be done to clarify how best to optimize this therapy, and to identify patients who will benefit. The panel concluded that when clinical practice guidelines for newly diagnosed GBM are updated, TTF[T] plus [temozolomide] after radiotherapy should be identified as a treatment option.
CMS Ex. 70 at 5. The roundtable generally believed that the most likely patients to benefit from TTFT were those who are “able to understand the [TTFT] device and how to use it with high compliance.” CMS Ex. 70 at 5.
In 2018, JAMA Oncology published an article about a secondary assessment of the EF-14 Study that indicated TTFT has been shown to prolong progression-free and overall
survival and that improved survivability came without a negative influence on health-related quality of life. CMS Ex. 63 at 2.
Also in 2018, a subgroup study based on the EF-14 Study found that “patients with monthly compliance > 90% had maximal survival benefit with a median survival of 24.9 months (28.7 months from diagnosis) and a 5-year survival of 29.3%. This effect was independent of other prognostic factors such as performance status, age, and MGMT methylation status.” CMS Ex. 54 at 4.
3. The FDA approved TTFT for the treatment of newly diagnosed GBM. The FDA approval required that the patient first receive maximal debulking surgery and completion of radiation and concomitant chemotherapy. Despite providing a variety of requirements, the FDA did not adopt the Seven-Week Criterion as part of the approval.
In an April 8, 2011 letter, the FDA approved the use of NovoCure’s TTFT device for the treatment of recurrent GBM. A. Ex. 5.
In an October 5, 2015 letter, the FDA approved the use of NovoCure’s Optune TTFT device for the treatment of newly diagnosed GBM. A. Ex. 6. The FDA stated the following indications for the TTFT device’s use and the restrictions the FDA placed on the TTFT device.
This device is indicated as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Optune™ with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.
* * * * *
The sale and distribution of this device are restricted to prescription use in accordance with 21 CFR 801.109 and under section 515(d)(1)(B)(ii) of the Federal Food, Drug, and Cosmetic Act (the act). The device is further restricted under section 515(d)(1)(B)(ii) of the act insofar as the labeling must specify the specific training or experience practitioners need in order to use the device. FDA has determined that these restrictions on sale and distribution are necessary to provide reasonable assurance of the safety and effectiveness of the
device. Your device is therefore a restricted device subject to the requirements in sections 502(q) and (r) of the act, in addition to the many other FDA requirements governing the manufacture, distribution, and marketing of devices.
A. Ex. 6 at 1-2. While the FDA acknowledged that TTFT was to be used following surgery and concomitant radiation and chemotherapy, the FDA did not place any restriction as to when TTFT could be used as a treatment following the last dose of the concomitant radiation and chemotherapy.
Noridian rightly points out that Medicare coverage is not required just because the FDA approved TTFT for the treatment of newly diagnosed GBM. N. Br. at 24-25. The AP does not dispute this, but the AP asserts that the FDA will include time restrictions when the FDA believes that a drug or device will not be effective after a certain period of time. A. Reply at 18.
Without drawing too many inferences from the FDA’s approval of TTFT for newly diagnosed GBM, it is clear that the FDA understood and required that TTFT only be used following maximal debulking surgery and concomitant radiation and chemotherapy, but did not require TTFT to be commenced within a certain time period following completion of those preliminary treatment steps. Therefore, the FDA approval does not support the reasonableness of the Seven-Week Criterion and provides some support for the AP’s challenge.
4. 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 ask the CAC for advice as to whether or not the Seven-Week Criterion should be included, and Noridian and CGS declined to consider the opinions of clinicians in the field of oncology who had experience with TTFT when deciding to implement the Seven-Week Criterion.
On August 1, 2014, LCD L34730 became effective and included a single substantive provision: “[TTFT] will be denied as not reasonable and necessary.” CMS Ex. 29 at 2-3. Noridian retired L34730 on September 30, 2015. CMS Ex. 29 at 2.
Effective October 1, 2015, Noridian and CGS published LCD L34823, which continued to categorically prohibit Medicare coverage for TTFT. See CMS Ex. 36 at 2, 16. However, in a June 20, 2018 letter, Novocure, the manufacturer of the TTFT delivery
device called Optune, requested that CGS reconsider L34823’s prohibition on coverage for TTFT. CMS Ex. 35. Novocure posited that CGS should permit coverage for the use of TTFT for patients who either have newly diagnosed GBM or recurrent GBM. CMS Ex. 35 at 1. Novocure based its request on the two randomized controlled trials it conducted (i.e., the EF-11 Study and EF-14 Study) and FDA approval for the use of the Optune TTFT device to treat newly diagnosed and recurrent GBM. CMS Ex. 35 at 1-2. Novocure also cited four peer-reviewed published articles based on the information derived from the randomized controlled clinical trials, as well as the 2018 NCCN Guidelines as showing the general acceptance of TTFT by the medical community. CMS Ex. 35 at 3. CGS informed Novocure in an August 7, 2018 letter that Novocure’s reconsideration request to cover TTFT to treat newly diagnosed GBM was a valid request. A. Ex. 13 at 2.
Noridian participated with CGS in conducting the reconsideration of the prohibition on coverage for TTFT, which included empaneling a 13-member 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; CMS Ex. 75; CMS Ex. 81.
Regarding the CAC, nine of the CAC members were physicians from government agencies, medical schools, and other entities focusing in oncology and neuro-oncology. CMS Ex. 79. The CAC held a meeting on March 6, 2019, which was open to stakeholders to attend in-person or by teleconference. CMS Ex. 75.
At the March 6, 2019 meeting, Novocure presented experts to speak on behalf of the efficacy of TTFT. CMS Ex. 76 at 8-9.
Novocure’s Executive Chairman, Bill Doyle, stated at the CAC meeting:
I also want to clarify here that the LCD request, our request for Medicare coverage is for TTFT with temozolomide, is covered for the treatment of adult patients with newly diagnosed supratentorial glioblastoma, following maximal debulking surgery and completion of radiation therapy, together with concomitant standard-of-care chemotherapy. I want to point out that this is exactly the same request as is covered in our FDA label.
CMS Ex. 76 at 9 (emphasis added).
Later in the CAC session, a CAC member asked Mr. Doyle ”so you’re not asking for coverage beyond” the FDA approval label and beyond the patients studied in the EF-14 Study? Mr. Doyle answered in a single word: “Correct.” CMS Ex. 76 at 42.
Noridian appears to conclude that this exchange is dispositive that Novocure was seeking Medicare coverage only for individuals who could meet all of the enrollment requirements met by the patients in the EF-14 study. See N. Br. at 5. The AP responded to this issue as follows:
Although Noridian suggests that Novocure accepted the Restriction based on its statements at the CAC, the Restriction was never discussed at the CAC meeting and thus Novocure could not have indicated its consent. In either event, this challenge is filed by a Medicare beneficiary seeking Medicare coverage of a life-saving treatment, not the supplier Novocure.
AP Reply at 19 n.22 (citation omitted).
I agree with the AP and do not conclude that Novocure conceded the Seven-Week Criterion during the CAC meeting. Chronologically, Noridian had yet to publish its proposed revisions to the LCD by the date of the CAC meeting; therefore, Mr. Doyle would not have necessarily understood the general question posed to him meant that Noridian would adopt all of the enrollment requirements for patients in the EF-14 Study as criteria to be added to the LCD.
Further, Mr. Doyle, at the outset of the CAC meeting and as quoted earlier, was seeking coverage terms the same as the FDA approval. As discussed above, the FDA required surgical intervention and concomitant radiation and chemotherapy before using TTFT, but the FDA specifies no timeframe to commence TTFT. The question posed to Mr. Doyle and his answer ultimately appear to confirm that Novocure was seeking coverage on the same terms as the FDA approval label. In any event, as the AP points out, she is the party to this case and not Novocure. Mr. Doyle’s answers to the CAC do not bind the AP and do not affect the AP’s right to review of the Seven-Week Criterion on the merits.
Other than this exchange with Mr. Doyle, the CAC does not appear to have discussed the criteria for Medicare coverage, just whether Noridian ought to allow coverage at all.
On May 9, 2019, Noridian and CGS published a proposed revised version of L34823. CMS Exs. 77-78, 80. Significantly, the proposed revised LCD permitted Medicare coverage for TTFT for beneficiaries with newly diagnosed (not recurrent) GBM when certain criteria were met, including that “[TTFT] is initiated within 7 weeks from the last dose of concomitant chemotherapy or radiotherapy.” CMS Ex. 77 at 4.
In addition, in the proposed revision, Noridian and CGS published the CAC’s responses to the questions posed to them. CMS Ex. 77 at 6-8. The CAC was confident that there is sufficient evidence that TTFT for newly diagnosed GBM can provide positive health
outcomes in the Medicare-eligible population, although various members of the CAC were concerned with a variety of aspects of the EF-14 Study. CMS Ex. 77 at 7. The CAC had some concerns over the relatively small number of patients in the EF-14 Study who were of Medicare eligible-age, but the CAC had intermediate confidence the evidence demonstrated adequate predictors of success for patients treated with TTFT in that age group. CMS Ex. 77 at 7. The CAC had intermediate confidence that TTFT is generally accepted by the medical community for newly diagnosed GBM, that the scientific evidence supports mitotic spindle disruption and cellular apoptosis as the mechanism of action of TTFT, and that there are no significant gaps in evidence that may impact positive health outcomes in the Medicare-eligible population. CMS Ex. 77 at 77-8. The CAC was not asked its opinion about specific coverage requirements, such as the Seven-Week Criterion. CMS Ex. 77 at 8.
Noridian and CGS notified the public that they would hold a public meeting concerning the proposed revisions on June 20, 2019, and would accept public comments until June 24, 2019. CMS Ex. 77 at 13.
Many oncologists submitted written comments in response to the opportunity for the public to comment on the revised LCD. See A. Exs. 372-418. This included comments from the following:
- Timur Mitin, M.D., Ph.D., Associate Professor of Radiation Medicine at the Oregon Health and Science University and Medical Director of the Tuality/Oregon Health and Science University Cancer Center, commented: “I also urge you to liberalize the 7 weeks requirement after completion of radiation therapy . . . . There is no clinical evidence that Optune therapy is no longer effective if it starts beyond 7 weeks after completion of [radiation therapy].” A. Ex. 373 at 1 (emphasis added).
- Fabio Iwamoto, M.D., Deputy Director, Neuro-Ocology Division, Department of Neurology, Columbia University Medical Center, commented: “Furthermore, [Noridian and CGS] are proposing that Medicare patients must start treatment within 7 weeks post chemoradiation in order to receive coverage. There are many reasons why a patient may not be able to start treatment within that 7 week window. One such issue may be participation in a clinical trial, or they could need more time to heal post-surgery or radiation. No commercial insurance coverage policies impose this requirement and the Medicare program should allow access to patients without an arbitrary limit on when patients can start Optune.” A. Ex. 375 at 2 (emphasis added).
- Gordon Wong, M.D., Precision Cancer Specialists, commented: “The proposed coverage policy also seeks to place arbitrary limits on when Optune can be initiated by a Medicare patient. While the clinical trial in newly diagnosed GBM
- did have subjects start Optune within 7 weeks post chemoradiation, there are many patients who may still be recovering from surgery or radiation treatment and may need extra time before starting Optune. I have had many patients including Medicare patients who have received significant benefit from Optune even if they did not start within the 7 weeks of completing radiation. Most payers do not have this requirement. Please make this more reasonable so that Medicare patients have comparable access to therapy.” A. Ex. 376 at 1 (emphasis added).
- Joon H. Uhm, M.D., Professor of Neurology, Chair, Division of Neuro-Oncology (Mayo Clinic, Rochester), Departments of Neurology & Oncology, Enterprise Director of Neuro-Oncology (Mayo Arizona, Florida, Minnesota), commented: “In current draft form, this LCD indicates that TTFT will not be a covered benefit unless it is initiated within 7 weeks from the last dose of concomitant chemotherapy or radiotherapy. While many patients will fit this treatment window, some patients require extra recovery time between treatment modalities. It is unfair and out of line with other coverage policies to withdraw this treatment option based on an arbitrary timeline. There is no clinical rationale for this requirement and forcing Medicare beneficiaries to make treatment decisions based on a coverage timeline will cause them unnecessary stress.” A. Ex. 378 at 1 (emphasis added).
- Leia Nghiemphu, M.D., Associate Professor of Clinical Neurology, Department of Neurology, UCLA Health, commented: “The recently released LCD, in its draft form, states that TTFT will only be covered for the treatment of newly diagnosed GBM when it is initiated within 7 weeks from the last dose of chemotherapy or radiotherapy. While this timeline is reasonable in an ideal situation, oncology care is extremely individualized and requires flexibility. Some patients, particularly the elderly, may need additional recovery time after surgery or radiation before initiating TTFT. This proposed coverage restriction is out of step with commercial reimbursement policies and will put Medicare beneficiaries at risk for inequitable care. In a disease with so few treatment options to begin with, it is wrong to exclude this option to our nations’ [sic] elderly just because they may require extra time between treatments.” A. Ex. 382 at 1. The following physicians/oncologists made substantially similar comments: June L. Chan, M.D., Assistant Professor, Department of Radiation Oncology, University of Michigan, Radiation Oncologist – Ascension Providence Hospital (A. Ex. 379 at 1); Kevin Roof, M.D., Radiation Oncologist, Novant Health (A. Ex. 383 at 1); Nicole Shonka, M.D., Associate Professor, Department of Internal Medicine, Division of Hematology/Oncology, University of Nebraska Medical Center (A. Ex. 384 at 1);
- Kiran Devisetty, M.D., Radiation Oncologist, Karmanos Cancer Institute, commented: “I am concerned about some of the coverage criteria included in the draft version; primarily the issue of TTFT only being covered if it is ‘initiated
- within 7 weeks from the last dose of concomitant chemotherapy or radiotherapy.’ As with adjuvant radiation therapy which is ideally initiated within 6 weeks of surgery, occasionally timelines have to be altered to accommodate each patient’s tolerance of therapy. It would be unjust to find TTFT not reasonable and necessary for clinically appropriate Medicare beneficiaries just because they may require some extra time after [radiation therapy] to recuperate.” A. Ex. 380.
- Lauren A. Lukas Vanderspek, M.D., Assistant Clinical Professor, Radiation Oncologist, City of Hope Comprehensive Cancer Center, commented: “I respectfully request that you revise the policy to eliminate the strict therapy timeline.” A. Ex. 381.
The June 20, 2019 public meeting included two hours and twenty minutes for public comments and presentations. CME Ex. 81.
Noridian and CGS published a final revised version of L34823 that provided Medicare coverage for TTFT to treat beneficiaries who had newly diagnosed GBM. CMS Ex. 36 at 4, 9; CMS Ex. 38 at 4-5. The revised LCD retained many of the proposed requirements that beneficiaries had to meet to obtain 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.
In Local Coverage Article A56688 (with an effective date of July 18, 2019) published contemporaneously with the revised LCD, Noridian and CGS responded to the public comments it received. CMS Ex. 38. Item 5 stated: “Several commenters asked that the criterion, requiring initiation of TTFT within 7 weeks of the end of chemoradiation therapy, be eliminated from the criteria or the timeframe for initiation of TTFT be extended.” CMS Ex. 38 at 5. Noridian and CGS stated in response that: “The commenters did not provide any clinical evidence to support this position. The final LCD is based on the best currently available clinical literature.” CMS Ex. 38 at 5.
5. The NCCN guidelines for 2018 and 2019 indicated that TTFT to treat newly diagnosed GBM received a Level 1 recommendation (i.e., the highest level of recommendation). The NCCN guidelines recommended that TTFT should follow surgery and concomitant radiation and chemotherapy; however, the guidelines do not specify a timeframe for commencing the use of TTFT. The chair of the NCCN committee that approved this recommendation testified that setting a timeframe for commencing TTFT based on the EF-14 Study enrollment requirements is not appropriate.
Since at least 2018, NCCN has given its highest-level recommendation (Level 1) for the use of TTFT to treat newly diagnosed GBM. CMS Ex. 49 at 18-19; CMS Ex. 50 at 14-15. “The NCCN Guidelines® are a statement of evidence and consensus of the authors
regarding their views of currently accepted approaches to treatment.” A. Ex. 49 at 5; A. Ex. 50 at 3. “A level one recommendation means that there was uniform agreement based on a high level of evidence that an intervention should be considered.” A. Ex. 425 ¶ 25. This is significant because the NCCN committee is composed of over 30 physicians from institutions across the United States, including renowned cancer hospitals such as: the Mayo Clinic Cancer Center; Yale Cancer Center; the Cancer Center at Johns Hopkins; Memorial Sloan Kettering Cancer Center; St. Jude Children’s Research Hospital; and the Duke Cancer Center. CMS Ex. 49 at 2; CMS Ex. 50 at 2.
Dr. Nabors, one of the expert witnesses who testified in this proceeding, has been, for the past ten years, the chair of the NCCN committee that creates the guidelines for Central Nervous System Cancers, such as GBM. Tr. at 85; CMS Ex. 49 at 2; CMS Ex. 50 at 2. Dr Nabors testified that “[t]he NCCN guidelines translate clinical trial data and publications into practice guidelines, i.e., the NCCN guidelines translate medical discoveries into clinical care recommendations.” A. Ex. 425 ¶ 18.
Dr. Nabors testified that “[t]he NCCN guidelines are evidence-based, consensus-driven management decisions and interventions to ensure that patients receive the best treatments and supportive services that are most likely to lead to an optimal outcome for each individual patient.” A. Ex. 425 ¶ 13. Dr. Nabors explained how his committee decides what it will recommend, the evidence they use, and the importance of these recommendations in the medical community.
The NCCN guidelines are developed and updated by over 1500 clinicians and oncology researchers from the 30 NCCN member institutions. To ensure the guidelines reflect the consensus of each disease subspecialist, each guideline is circulated among the multidisciplinary faculty at each NCCN member institution for comment.
The NCCN guidelines are based on the best evidence available when they are derived and are updated continuously as new data and clinical information become available.
Because the NCCN guidelines are drafted by experts in the management of the relevant cancer and their expert interpretation on the appropriate translation of clinical trials and publications into practice guidelines, the NCCN guidelines are recognized as the standard for clinical decision-making and policy and are used not only in the United States, but around the world.
A. Ex. 425 ¶¶ 14-16 (emphasis added).
In both the 2018 and 2019 NCCN Guidelines related to the treatment of GBM, NCCN distinguished between patients who are 70 years of age and younger, and those who are over 70. However, for both groups, its recommendations related to the use of TTFT were essentially the same. For patients in both groups with a KPS of 60 or above, NCCN recommended standard brain radiation plus concurrent temozolomide and then adjuvant temozolomide and TTFT. NCCN did not include a recommended timeframe when TTFT should be commenced following the radiation with concurrent temozolomide. CMS Ex. 49 at 18-19; CMS Ex. 50 at 14-15; CMS Ex. 61 at 3.
Noridian asserts in this proceeding that the NCCN Guidelines are not evidence of the efficacy of TTFT as a treatment for newly diagnosed GBM if it is initiated more than seven weeks after completion of chemoradiation. N. Br. at 17. Noridian apparently holds this view because “the NCCN Guidelines do not address the temporal question at all.” N. Br. at 18. As Noridian further stated regarding this issue: “While the AP’s Brief seeks to make much of the NCCN’s lack of discussion about the seven-week restriction . . . it cannot transform a lack of evidence into evidence in the affirmative.” N. Br. at 24.
However, Dr. Nabors’ testimony clarified that the NCCN Guidelines constitute a compilation and evaluation of evidence related to treatments. “I understand that Noridian has asserted that the NCCN guidelines are simply an opinion of some clinicians. However, the NCCN guidelines are evidence-based and consensus-driven by those who have expertise in treating the condition and are familiar with the full body of peer-reviewed literature and patient care considerations.” A. Ex. 425 ¶ 17.
Noridian’s defense of the Seven-Week Criterion is entirely based on Noridian’s view that only data from a clinical trial may be considered when establishing the requirements for coverage. In fact, Noridian’s representative questioned Dr. Nabors at the hearing as to whether he knew of any peer-reviewed clinical trial results that supported the effectiveness of TTFT commenced more than seven weeks after completion of radiation and chemotherapy, to which Dr. Nabors responded that he did not as to TTFT specifically. Tr. at 112-13.
On re-direct, Dr. Nabors was asked if it is possible to conduct a clinical trial on every subset of individuals and on every possible timeline for a treatment, to which Dr. Nabors testified: “No. It’s not feasible to take into all considerations for the different subtypes of even [GBM] or coordination of the treatment schedule.” Tr. at 114. When further asked if clinicians understand that the seven-week initiation period is not a limitation on clinical practice but has to do with clinical trial design, Dr. Nabors replied: “I would agree with that.” Tr. at 114. As Dr. Nabors had previously testified: “Although chemotherapy trials for GBM also had enrollment criteria and a timed sequence of the administration of a chemotherapy agent, I am not aware of any payer that premises
coverage of a chemotherapy agent based on a physician prescribing it to patients who satisfied the enrollment criteria or timeline of the clinical trial of the drug.” A. Ex. 425 ¶ 38.
As discussed below, I am to consider clinical evidence (i.e., the views of clinicians) in addition to scientific evidence. As just quoted above, NCCN is an excellent source of clinical evidence because NCCN gathers evidence widely from physicians in the appropriate field and seeks consensus among the committee of experts to provide nation-wide treatment recommendations which are based on more than clinical trials that necessarily must have strict enrollment requirements for participating patients.
Therefore, while Noridian has limited itself to the parameters and results of the EF-14 Study, Dr. Nabors testified that he and his committee of experts assess treatments more broadly, taking clinical experience into account. As he stated:
Clinical trials attempt to recruit as homogeneous a population as possible so that the effectiveness of the intervention being tested can be more clearly isolated from other confounding factors. In contrast, clinicians try to tailor treatment to an individual patient’s need when rendering care outside a clinical trial setting.
In a clinical trial, researchers attempt to recruit relatively healthy subjects so they will be less likely to be lost to the treatment of other co-morbidities or death. Nonetheless, in most cases, the clinical trial is likely to provide valuable clinical management information for those patients who are not as healthy as those enrolled in the clinical trial.
When drafting practice guidelines, the NCCN recognizes the goals of a clinical trial is to create generalizable knowledge to a target population that is much broader than those who participate in a clinical trial.
The NCCN does not make recommendations that are limited to patients who would either satisfy the enrollment criteria of a seminal clinical trial or the timing of events in the clinical trial.
Accordingly, based on the evidence available and customary translational conventions, the NCCN guidelines did not restrict its TTFT recommendations to patients who initiated treatment within seven weeks of completing chemoradiation,
who used TTFT a prescribed number of hours, or who had a KPS of 70 or greater.
A. Ex. 425 ¶¶ 19-23.
The final point that Dr. Nabors made in the quote above is similar to his written testimony: “The experts in treating tumors of the central nervous system, based on their review of the published peer-reviewed literature, believe the scientific evidence supports that TTFT is a reasonable and medically necessary treatment option for those who have newly diagnosed GBM and who have a KPS of 60 or greater, regardless of when that individual initiates TTFT and regardless of whether they are able to submit to TTFT 18 hours a day.” A. Ex. 425 ¶ 39. Therefore, just as the NCCN committee’s recommendation for patients to have a minimum KPS score of 60 to receive TTFT deviates from the enrollment criteria for the EF-14 Study (i.e., a KPS of 70), NCCN also considered, based on the evidence it accumulates and analyzes, that a rigid seven-week time requirement was not warranted. See CMS Ex. 49 at 18-19, CMS Ex. 50 at 14-15.
When questioned specifically about the Seven-Week Criterion, Dr. Nabors stated that nothing in the EF-14 Study indicated that TTFT would not be effective to treat newly diagnosed GBM if it started on day 50 (i.e., a day after the end of the seven-week timeframe). Tr. at 115. Further, when asked if Dr. Nabors thought there was a timeframe beyond which TTFT would not be effective, Dr. Nabors answered that there is likely a point at which TTFT would not be effective, but that the determining factor would be the biology of each patient and not the parameters for enrollment in the EF-14 Study. Dr. Nabors testified:
I do not believe that there is a rigid barrier at seven weeks that after which initiating with maintenance chemotherapy would preclude the use of [TTFT].
* * * * *
[C]linical trials on average reflect less than five percent of a population of patients with the disease who have a functional status in age much younger and better than the typical patient. Also, clinical trials are mainly done at large academic centers or major community hospitals, so the access to these can be difficult for patients who are in more rural areas or underserved areas. And so this specific timing, relative to seven weeks, I would not believe nor support. I would however believe that there is a limitation beyond which the lack of institution of an adjunct therapy would limit the benefit for that particulate [sic] therapy. I don't know that
that’s known for different types of therapy. But for -- if you were to ask an opinion of me, then I think it needs to be based on the underlying molecular biology of the patient and the therapy being deployed. And so you can certainly come up with windows beyond which the treatment probably bears no benefits.
* * * * *
I would agree that the clinical implementation in day-to-day practice will deviate from the metrics required of a clinical trial related to timeframe and initiation of various formed components of the therapy.
Tr. at 117, 120-21, 126.
I accord both the NCCN Guidelines and Dr. Nabor’s testimony significant evidentiary weight. Although the Guidelines do not specify a timeframe by which a patient with newly diagnosed GBM should commence TTFT, I accept NCCN’s judgment that, based on its extensive clinical evidence collection and the judgment of its committee of experts from leading institutions, such a timeframe should not be specified. I accept Dr. Nabors’ testimony that such a timeframe will vary among patients and that the enrollment criteria for a clinical study is not meant to establish a rigid timeframe to initiate a treatment like TTFT.
I afford Dr. Nabor’s opinion significant weight in part because of his high level of expertise related to the treatment of GBM as well as his academic qualifications. After graduating from medical school, Dr. Nabors completed a residency in neurology and a fellowship inneuro-oncology, and became board certified by the American Board of Psychiatry and Neurology. A. Ex. 425 ¶ 4. At the University of Alabama at Birmingham, Dr. Nabors is: the Director of the Center for Clinical Translational Science’s Clinical Research Unit; on the medical staff at its hospital; is an associate scientist in the Neuro-oncology Program; and holds additional appointments in the Department of Biomedical Engineering and the Department of Cell Biology. A. Ex. 425 ¶¶ 6-7.
In addition, Dr. Nabors has served as the Chair of the NCCN CNS [Central Nervous System] Tumor Guidelines Committee from 2011 to present, which is “the committee that sets the guidelines for brain tumor care in the United States.” A. Ex. 425 ¶ 8. Dr. Nabors testified that his expertise includes clinical evaluation of novel cancer therapies, and Dr. Nabors has been the principal investigator for a significant number of clinical trials focusing on tumors of the CNS. A. Ex. 425 ¶¶ 10-11; see A. Ex. 425 at 25-27. In the field of oncology, Dr. Nabors has published numerous peer-reviewed articles and
multi-book chapters as well as serving as editor and reviewer for peer-reviewed journals. A. Ex. 425 ¶ 12; A. Ex. 425 at 14-22, 24-25. Although Dr. Nabors participated in one of Novocure’s clinical trials, he testified that neither he nor the division at the University of Alabama that he is in charge of received compensation from Novocure. Tr. at 84. Finally, Noridian quotes Dr. Nabors several times in its brief without challenging his testimony. N. Br. at 20, 22, 27, 29.
6. Based on the unrebutted testimony of the expert witnesses in this case, it is not proper to strictly apply the enrollment requirements for patients in the EF-14 Study as the parameters for the effective use of TTFT to treat newly diagnosed GBM. Further, based on the expert witnesses’ extensive clinical experience and training, TTFT is effective when commenced beyond the Seven-Week Criterion.
The AP provided five expert witnesses to testify in this case. I have discussed one of those experts, Dr. Nabors, in conjunction with the NCCN Guidelines above due to his direct connection to those Guidelines. Here, I discuss the other witnesses and note that they testified consistently with Dr. Nabors regarding the inappropriate use of the enrollment requirements from a clinical study as strict criteria on which to base the effectiveness of TTFT to treat newly diagnosed GBM. They also testified as to their clinical experience that TTFT is effective when commencing it after seven weeks.
Eric T. Wong, M.D.
Dr. Wong, a physician and professor of neurology at Harvard Medical School, is a leading expert in neuro-oncology and TTFT. Dr. Wong’s experience and training in the field of neuro-oncology is impressive, including fellowships following medical school at both Memorial Sloan-Kettering Cancer Center and MD Anderson Cancer Center. A. Ex. 423 ¶ 3. In addition to being a Harvard Medical School associate professor, he is also a Neuro-Oncology Protocol Review Committee member at the Dana Farber/Harvard Cancer Center, and Director of the Brain Tumor Program and Neuro-oncology fellowship training program at the Beth Israel Deaconess Medical Center. A. Ex. 423 ¶ 4. Dr. Wong has authored 72 peer-reviewed articles as well as chapters in books, primarily on oncology-related subjects, including articles and chapters involving GBM and TTFT. A. Ex. 423 at 32-38; see A. Exs. 74, 86, 152, 159, 191, 193.3
Dr. Wong has served or is serving as principal or co-investigator in many clinical trials and translational research projects involving GMB, including as an investigator on clinical trials involving various chemotherapy agents and TTFT. A. Ex. 423 ¶ 9. Dr. Wong testified that he participated as an investigator with the EF-11 TTFT clinical trial. Tr. at 204.
In this proceeding, Dr. Wong testified concerning clinical trial design, stating that “[t]he goal of clinical trials generally is to create generalizable knowledge regarding a particular intervention.” A Ex. 423 ¶ 15. “The vast majority of clinical trials are designed to contribute knowledge about treatments that will benefit a much larger population than either the study sample or study population.” A. Ex. 423 ¶ 17. This is true even though the eligibility criteria for individuals to participate in a clinical trial “are set to minimize patient/subject heterogeneity and to control for confounding factors so that it is clear if there is a benefit from the drug/treatment that is the subject of the investigation.” A Ex. 423 ¶ 14 (emphasis added).
Further, “[t]he timing and sequence of interventions and evaluations in a clinical trial are established to ensure a trial is promptly completed to reduce the likelihood of confounding events, and reduce the risk of loss of the subject from the study for both medical reasons and psycho-social reasons.” A Ex. 423 ¶ 22. It is then up to institutional review boards and regulators to “assess whether the study population and ultimately the study sample (which is the subset of the study population enrolled in the study) will create the generalizable knowledge for the target population.” A Ex. 423 ¶ 16 (emphasis added). Ultimately, “[c]linicians and regulators routinely must translate clinical trial eligibility into clinical practice and regulatory approval.” A. Ex. 423 ¶ 19. As Dr. Wong stated during the hearing:
So the data from clinical trial is just a foundation, and we have to apply that knowledge to different patients with a heterogeneous medical and also social background. So no two patients are the same. And we have to apply that knowledge. So we cannot categorically say that if the patients don't start TTFT within seven weeks that, that particular patient would not benefit from it.
Tr. at 255.
Dr. Wong testified that “[i]t would be highly unusual for any regulatory approval or clinical practice guideline to mandate a particular time frame for limiting coverage based on the timing of events in a clinical trial protocol.” A. Ex. 423 ¶ 23. Further, Dr. Wong testified that the “American Society of Clinical Oncology (ASCO) repeatedly has recognized that most oncologists do not limit the application of a medical intervention to those who met the eligibility criteria for a clinical trial that showed the efficacy of the intervention. A. Ex. 423 ¶ 20.
Dr. Wong also testified that “[m]ost practice guidelines and regulatory approvals do not mandate an initiation date because many individuals cannot access healthcare on a prescribed timeline . . . .” A Ex. 423 ¶ 26. In regard to therapy that is concomitant with chemotherapy, “a significant issue of when to initiate the therapy is driven by the
patient’s overall health status and toxicity experience with chemotherapy, i.e., is the patient healthy enough to begin another round of chemotherapy or do they need time to recover or get stronger.” A Ex. 423 ¶ 25. Dr. Wong stated that “no basis exists for restricting coverage of TTFT to those individuals who only satisfy the strict eligibility criteria for those participating in the clinical trials of GBM.” A. Ex. 423 ¶ 13 (emphasis added).
More specifically, Dr. Wong testified that “[n]o basis exists to exclude coverage of TTFT based on when a beneficiary starts TTFT treatment” and that “current data and peer-reviewed publications show TTFT is a safe and effective treatment for individuals . . . who do not initiate treatment within seven weeks.” A. Ex. 423 ¶¶ 31, 35; Tr. at 254. Dr. Wong supported his opinion by noting that neither the FDA approval of TTFT nor NCCN guidelines restrict coverage to patients who initiate treatment within a particular time-frame after completing chemo-radiation. A Ex. 423 ¶¶ 28-29. Further, Dr. Wong utilized his own experience as a physician who has prescribed TTFT to 102 patients since 2011. A. Ex. 423 ¶ 33. Dr. Wong, as an expert in this field, testified that “[t]here is no evidence that individuals who initiate TTFT within eight weeks, ten weeks, twelve weeks or later have clinically inferior outcomes to those who initiate TTFT within seven weeks.” A. Ex. 423 ¶ 30; see Tr. at 254. Dr. Wong made it clear that the clinical trials involving GBM were “designed to create knowledge for the benefit of all those afflicted with a GBM.” A. Ex. 423 ¶ 27.
On cross-examination, Dr. Wong agreed that there are no peer-reviewed clinical trials that indicate that patients with newly diagnosed GBM who begin at any time, for example, later than five years or one year after completion of chemoradiation, have outcomes that are clinically equivalent to those patients who initiate treatment within seven weeks. Tr. at 210-11. Dr. Wong testified that he believed that, in general, the earlier the treatment, the better the results. Tr. at 214.
But Dr. Wong also emphasized:
That seven-week requirement is just for the purpose of running clinical trial to make sure that we have a comparable population in the two arms that we can effectively compare the efficacy signal. So do I believe that when patients start using TT fields seven weeks and one day after they completed radiation that TT field would still work? Of course I do. So I think at any time point -- I don’t think TT field efficacy would be limited by the timeframe that is, that is -- that we apply this therapy.
* * * * *
I think this is similar to chemotherapy. When we use chemotherapy, we don’t mandate patients must get chemotherapy within a prespecified timeframe. And quite frankly, we are dealing with a population that is very fragile. They may be in rehabilitation. They may not be [sic] show up in time. They cannot drive. They have to rely on other people to get to the medical center. So that seven-week requirement is onerous to this population of patients.
Tr. at 253.
In briefing, Noridian quotes Dr. Wong for the unremarkable fact that he agreed with an NCCN 2019 Guidelines’ footnote that the benefit of treatment with temozolomide beyond six months is unknown. N. Br. at 21; Tr. at 218. The NCCN Guidelines’ footnote states: “Benefit of treatment with temozolomide for glioblastomas beyond 6 months is unknown.” CMS Ex. 50 at 14. While Noridian may appear to interpret this footnote to mean that the six-month period of effectiveness commences after concomitant radiation and chemotherapy, it could also mean that the six-month period starts once TTFT and adjuvant temozolomide is commenced. Noridian did not attempt to explore the exact meaning of this footnote with Dr. Wong and provided no witness of its own to explain it. Therefore, given Dr. Nabors’ testimony concerning the NCCN Guidelines, I find no reason to conclude that the footnote is significant regarding the reasonableness of the Seven-Week Criterion.
Noridian also levels a charge of financial bias against Dr. Wong, asserting that Dr. Wong has received significant compensation from Novocure. N. Br. at 30. However, Noridian fails to mention that Dr. Wong testified that this “compensation” is primarily grant money provided to the institution he works for to pay for the costs related to the clinical trial. Tr. at 240. Dr. Wong testified: “I don't personally benefit from running the clinical trials or doing any scientific research at my institution.” Tr. at 266.
Since 2007, Dr. Wong has received three grants (i.e. funding) from Novocure that went to the institution where he works (2007 or 2008, 2010 or 2011, and 2015) for translational research in the laboratory to investigate the basic mechanism of action of TTFT. Tr. at 197,199. He received a grant of approximately $100,000 for the EF-11 TTFT study and less than $100,000 for the 2015 study. Tr. at 198-200. In 2018, based on another trial opening, he received $30,000 in grant money and, based on future work, the amount might reach approximately $150,000. Tr. at 200-01. Dr. Wong also testified about another grant from 2010 to the present that is about $250,000 in direct costs with additional indirect costs charged by Dr. Wong’s institution. Tr. at 202. Dr. Wong also estimated that he personally received less than $20,000 from Novocure for work done on Novocure advisory boards, and about $2,000 for giving lectures on behalf of Novocure. Tr. 202-04, 207.
I credit Dr. Wong’s testimony. Dr. Wong’s resume shows that his medical career since his graduation from medical school in 1989 has been devoted to neurology and oncology. A Ex. 423 at 5-7, 19-30, 44-54. Dr. Wong has published extensively in those fields, serving as an editorial member with the Journal of Clinical Oncology, Central Nervous System Tumors, as well as being an ad hoc reviewer for many neurology and oncology publications. A. Ex. 423 at 7-8. As mentioned above, Dr. Wong has published 72 peer-reviewed articles on or related to oncology and neurology, some of which involve GBM and TTFT specifically. A. Ex. 423 at 32-38. He also has authored chapters in ten books on the same subjects, including two on TTFT. A. Ex. 423 at 42-43.
While Noridian wants me to disregard Dr. Wong’s testimony because his institution has received grant money to conduct clinical trials, I believe that Dr. Wong’s lengthy and deep experience using TTFT as a treatment for GBM makes him one of the best persons to provide an opinion in this case. He does not work for Novocure but for Harvard Medical School. He is an expert in clinical trials and participated as an investigator in the EF-11 Study. I have no reason to question the integrity of Dr. Wong based on the limited personal compensation he has received from Novocure. Further, Dr. Wong’s testimony is consistent with that of Dr. Nabors, an expert witness in this proceeding who took no money from Novocure. In addition, in 2015, Dr. Wong was the principal author of a published article on TTFT and GBM in which the first sentence of the section entitled “TTFields therapy as used in clinical practice” stated: “Patients who received treatment from the TTF[T] device in clinical practice may have different clinical characteristics and outcomes from those who participated in the registration trial.” A. Ex. 159 at 8. Such an observation is consistent with his testimony in this case that clinical trials must meet scientific standards to establish whether a treatment works; however, those results must be translated to the clinical setting.
Although a distraction from the substance of this case, I must digress to comment on Noridian’s improper attempt to introduce evidence not admitted into the record to prove that Dr. Wong has a financial conflict of interest. Noridian placed this information in a footnote. SeeN. Br. at 30 n.14. Noridian ended the footnote claiming that: “Due to Noridian’s inability to conduct discovery on these apparent conflicts [of interest] before the hearing, Noridian’s opportunity to question the witnesses about these reported payments at the hearing was limited.” Noridian also claims the following:
Noridian’s representative probed the AP’s experts’ opinions and apparent conflicts of interest for the first time during the hearing, see, e.g., Dkt 103a at 198:4–207:17. Despite the Tribunal’s possible suggestion otherwise, Dkt 103 at 31:21–32:12, Noridian did not have an opportunity to engage in earlier discovery of the experts because expert lists were not due until September 14, 2020, when the AP’s counsel submitted her list, see Order (Dkt 70) at 2 (Aug. 14, 2020),
and discovery had closed more than a month prior to that date, see Order (Dkt 61) at 7 (June 26, 2020) (ending discovery on Aug. 10, 2020). Noridian’s questioning at the hearing was therefore limited both in scope and by witness time allocations, as Noridian effectively was required to conduct both discovery and cross examination simultaneously at the hearing.
N. Br. at 28 n.13.
Noridian’s claims are misleading.
I provided both parties with an opportunity to serve discovery demands on the other party and informed the parties that the rules governing discovery were located at 42 C.F.R. § 426.432. Tumor Treatment Field Therapy, ALJ Ruling No. 2020-13 at 7. That regulation states that discovery in LCD challenge cases consists of requests for production of documents and/or up to ten written interrogatory questions. 42 C.F.R. § 426.432(c).
While Noridian may posit that it was unable to engage in discovery because the AP’s prehearing exchange, which included the full written direct testimony for each expert witness, was not submitted until after discovery closed, this simple chronology fails to account for the fact that Noridian should have served interrogatories on the AP requesting the names and a summary of expected testimony for any and all witnesses that the AP intended to present in the case. Noridian should have also asked about the expected witnesses’ financial conflicts of interests. Further, Noridian should have requested document production regarding the AP’s expected witnesses. Instead, Noridian filed on July 10, 2020, a document entitled Notice of Contractor Not Seeking Discovery. DAB E-File Document No. 65. That notice was signed by all of Noridian’s representatives, three of whom are legally trained.
Having failed to make use of its right to discovery, Noridian could still have requested that I permit additional discovery after receiving the AP’s subsequent prehearing submission with the written direct testimony of the expert witnesses. Noridian could also have made a late submission of the documentation it obtained (and now summarizes in footnote 14 of its brief) so that I could have considered whether that documentation could be admitted into the record and used at the hearing. However, Noridian opted to wait until the telephonic hearing to question the expert witnesses about documents not in the record that they could not see. Tr. at 19-20, 262, 287-89. I did not permit that, but I permitted Noridian to submit a motion after the hearing with the documents it wanted included in the record and I would rule on their admissibility. Tr. at 20, 22.
Unfortunately, Noridian did not avail itself of any of the legitimate means to enter its documentation into the record and now attempts to include the information in its brief. N. Br. at 30 n.14. As a result, I strike footnote 14 on page 30 of Noridian’s post-hearing brief from the record.
I make one further note regarding Noridian’s allegations. At the hearing, I gave Noridian’s representative leeway to question the witnesses concerning their potential financial conflicts of interest. Tr. at 18-25, 83-84, 134, 197-208, 282-93. Further, although Noridian appears to complain that it was limited due to the time slots scheduled for each witness, I note that one of Noridian’s representatives stated in an October 19, 2020 email that “Noridian expects to spend less than 30 minutes with each witness, however depending on the responses, it is possible that some witnesses may take longer.” DAB E-File Document No. 85. I allocated two hours each for four witnesses and one and one-half hours each for two witnesses. DAB E-File Document No. 91.
In sum, I give significant weight to Dr. Wong’s expert testimony, given his background, training, and scholarly achievements in the field of neuro-oncology as well as his detailed knowledge of TTFT as a treatment for GBM.
Steven A. Toms, M.D.
Dr. Toms, a physician and professor at Brown University’s Medical School, is another significant expert in neuro-oncology who testified in this proceeding. Dr. Toms completed a residency in neurological surgery at the Cleveland Clinic Foundation and a fellowship in neurosurgical oncology at MD Anderson Cancer Center. He is board-certified by the American Board of Neurological Surgeons and a Fellow of the American Association of Neurological Surgeons. Dr. Toms is a professor in the Departments of Neurosurgery, Medicine, and Health Policy at Brown University’s Medical School. He is the Vice-Chairman of the Department of Neurosurgery and Director of the Brain Tumor Program at Lifespan Health System. He has been the principal investigator for a number of clinical research studies, including studies on the development of therapeutic approaches for primary brain tumors and cancer metastasis to the brain. He also served as an investigator on studies related to TTFT to treat GBM. Dr. Toms has published over ninety peer-reviewed articles and various chapters in books, including articles concerning GBM and TTFT, which were submitted into the record by Noridian (i.e., CMS Ex. 54 (principal author on a subgroup analysis of the EF-14 Study); CMS Exs. 61 and 62 (contributing author of JAMA articles presenting the interim and final analyses of the EF-14 Study)). A. Ex. 422 ¶¶ 2-9; A. Ex. 422 at 6-8, 11-19.
Dr. Toms testified that he strongly disagreed that Medicare coverage of TTFT should be limited to those who initiated TTFT within seven weeks of completing chemoradiation. A. Ex. 422 ¶ 9. Dr. Toms testified that:
As an investigator in the EF-14 trial, it was logical to have a timeline for the initiation of the intervention, TTFT, that was being evaluated. Clinical trials are designed with a timeline to ensure that study subjects progress through the clinical trial in a consistent and systematic manner. Consistency of clinical trial milestones is important when trying to limit the number of variables and reduce the possibility of participant attrition due to intervening health issues, competing clinical trials, intervening social issues (e.g., moving away from the study site, loss of a caretaker who facilitated participation in the trial, loss of transportation to the study site, inability to pay co-payments for related healthcare expenses), or death.
A. Ex. 422 ¶ 10.
However, he further testified, when physicians actually treat patients, they decide when to initiate treatment based on a patient’s individual health, social, and psychological situation, and there are many reasons why a new treatment may be delayed, such as not having physically recovered from the toxicity of a prior intervention like chemoradiation. A. Ex. 422 ¶¶ 12-13, 16. “Some patients may want to delay TTFT initiation because it is used concomitantly with chemotherapy, which has many side effects, patients may wish to defer those debilitating effects for a period greater than seven weeks.” A. Ex. 422 ¶ 17. Dr. Toms also provided additional reasons that there may be a legitimate delay in commencing TTFT beyond seven weeks following chemoradiation, (A. Ex. 422 ¶¶ 18-19) and opined “[t]he requirement that patients begin TTFT within seven weeks of completing chemoradiation is not medically appropriate, it is unreasonable, and should be removed as a requirement for Medicare coverage.” A. Ex. 422 ¶ 24 (emphasis added); See Tr. at 328 (Question: “I think you've already answered this question, but is it your understanding that it is not customary to limit the initiation of treatment to the timelines established in a clinical trial?” Answer: “It is not customary.”).
During cross-examination, Dr. Toms agreed that there is no peer-reviewed published data concerning TTFT’s effectiveness when commenced after seven weeks; however, he noted that the EF-14 Study included a subgroup analysis that showed effectiveness. Tr. at 295-96. On re-direct, Dr. Tom’s discussed his answer in more detail as follows:
You know, my practice is in part based on clinical evidence, as I'm sure the good doctor did when he was practicing. And I have had a number of patients who for various reasons were unable to start at -- within that seven-week time period, or had difficulty with the decision making, difficulty in recovering from surgery. So I have had many patients who have begun after that seven-week time and had a good result.
And in addition, two physicians who were involved in the EF-14 trial whom -- whose judgment and ethics I trust, Santosh Kesari and Zvi Ram, did an analysis of the EF-14 data specifically looking at those patients who had recurrent disease and stayed on treatment to try to see if there was a difference between those on tumor treating fields and those on just best standard of care. And it suggested -- although that trial was neither designed nor powered for that, it did reach statistical significance and strongly suggested that tumor treating fields were effective, you know, when delivered even at a later period.
Further, on cross-examination, when asked about clinical trial evidence to show TTFT’s effectiveness outside the seven-week timeframe, specifically at eight or 14 weeks, Dr. Toms responded that conducting a study just to check a later timeframe in this context is unethical: “That answer would be no published data, but nor is there any similar published data that I've seen in any other cancer trial that would intentionally delay treatment before giving a therapy that has a proved efficacy. It would not pass the ethics test.” Tr. at 299 (emphasis added). When asked whether there was any peer-reviewed clinical trial evidence regarding starting TTFT more than five years following radiation and chemotherapy, Dr. Toms explained why it could not be done:
Well, that is a fascinating question given that fewer than four percent of patients survive five years with glioblastoma with standard therapy, meaning radiation and chemotherapy. So I don't know how anyone would put a trial together and have enough -- you would need over 1,000 patients enrolling to have 40 survivors after five years who you could then divide into two groups and initiate, so that is not a practical question in the treatment of glioblastoma. And if you also go back to progression free survival median is only about nine months with no progression, so – and once progression occurs, you call it a recurrent glioblastoma. So I have never in my career of treating several thousand glioblastoma patients seen someone get radiation, chemotherapy with temozolomide alone and still have no progression at five years that you could even enroll in such a hypothetical trial.
Tr. at 298-99. Essentially, in response to questions on cross-examination, Dr. Toms testified that conducting another trial just to prove or disprove the effectiveness of TTFT when started later than seven weeks of concomitant radiation and chemotherapy is either
unethical because it would intentionally delay treatment for such a study or impractical given the very short life expectancies of those diagnosed with GBM.
Noridian only attempts to discredit Dr. Toms through alleged financial conflicts of interest with Novocure. However, Noridian’s sole argument appears in footnote 14 on page 30 of its post-hearing brief. As discussed in detail above, I have stricken that footnote from the record because it relies on evidence not admitted into the record.
On cross-examination, Dr. Toms testified that Novocure did not provide funding to him personally for any of his research. Tr. at 282. He confirmed that Novocure was providing funding to Lifespan, the medical facility that Dr. Toms is affiliated with, for a trial on which Dr. Toms would participate as an investigator. Tr. at 282. “The hospital is getting research funding. I am not receiving anything for my lab nor is it a grant that I’ve applied for and received funding for.” Tr. at 283. When asked further questions, Dr. Toms replied: “I personally have received no dollars for research directly from them. The hospitals at which I have worked have received whatever administrative charges they charge back to the company for running these trials.” Tr. at 285. Dr. Toms had attempted to determine some of the amounts paid by Novocure for trials it had requested, in part because a report indicated Dr. Toms had received $420,000; however, Dr. Toms denied receiving any of that money. Tr. at 285-86, 289-90 (“I still cannot even fathom where that money came from or went.”).
In terms of other payments unrelated to trials which he received from Novocure, Dr. Toms testified that he received personal compensation of about $2,000-$3,000 from Novocure for providing international lectures and about $1,500 to $2,000 for serving on a strategic advisory board. Tr. at 287. Dr. Toms estimated that the compensation he personally received represented less than one-half of one percent of his overall income. Tr. at 325.
Dr. Toms is an expert in oncology and has significant and lengthy experience with TTFT, including serving as an investigator in the EF-14 Study. He contributed to the published interim and final analyses of the EF-14 Study (CMS Exs. 61-62), and, in 2018, was the principal author of a subgroup analysis of the EF-14 Study in the Journal of Neuro-Oncology, in which the article concluded that the greater compliance patients in the study had with TTFT and temozolomide therapy, the longer the patients survived. CMS Ex. 54 at 1. While he has taken modest amounts of money from Novocure, I cannot disregard, as Noridian would have me do, his opinions related to this case. Dr. Toms is one of a few individuals who has the ability to provide nearly authoritative views related to TTFT and newly diagnosed GBM. Further, Dr. Toms testified consistently with the other experts in this case. Therefore, I credit his testimony and give it significant weight in this decision.
Scott Turner, M.D.
Dr. Turner, a physician and a professor of Neurology at the University of Missouri-Kansas City, is another expert in neuro-oncology who testified in this proceeding. After receiving his medical degree, Dr. Turner completed a residency in neurology and a fellowship in neuro-oncology at the State University of New York at Stony Brook and Duke University, respectively. A. Ex. 424 ¶ 2. He is board-certified by the American Board of Psychiatry and Neurology and has exclusively practiced neuro-oncology. A. Ex. 424 ¶¶ 4-5. Dr. Turner was the Director of Neuro-Oncology at St. Luke’s Marion Bloch Neuroscience Institute and Assistant Professor of Neurology at the University of Missouri-Kansas City School of Medicine from 2018 to 2020, but was in the process of moving to a position at the University of California at Irvine. A. Ex. 424 ¶ 3. His expertise includes clinical therapeutic treatments of primary brain tumors. A. Ex. 424 ¶ 6. Dr. Turner has authored a number of articles on oncological subjects. A. Ex. 424 at 7-8.
Dr. Turner participated as an investigator in the EF-11 Study and the EF-14 Study. A Ex. 424 ¶ 9. He described the EF-14 Study as a comparison between treating newly diagnosed GBM patients with a combination of TTFT and chemotherapy versus treatment with chemotherapy alone. A Ex. 424 ¶ 19. Dr. Turner testified that the EF-14 Study demonstrated significant superiority of TTFT with chemoradiation, which was in part shown by the fact that patients in the chemotherapy control arm were allowed to cross-over and receive TTFT before the end of the study. A Ex. 424 ¶¶ 20-21. He testified:
Some people are skeptics, but it is one of only a few FDA approved treatments for GBM. Roger Stupp, when he presented the interim analysis for the EF-14 trial, he himself said that he considers it the standard of care. And that's how I view it and how many of my colleagues view it.
Tr. at 68.
Dr. Turner testified that the NCCN guidelines gave a Level I recommendation for treating newly diagnosed GBM with TTFT and that those guidelines do not limit its recommendation to initiating TTFT within a certain timeframe. A Ex. 424 ¶¶ 22-23. Dr. Turner testified that:
Clinical trials are designed to limit as many variables among the enrolled subjects as possible, but outside of the clinical trial, clinicians treat individual patients who present with individual circumstances. When treating a patient outside the clinical trials context, a clinician is not trying to create
generalizable knowledge - the clinician is trying to help that patient achieve the best outcome for that patient.
A Ex. 424 ¶ 27.
Dr. Turner readily admits that earlier interventions are the most beneficial, but also testified that “the consensus . . . in the field” is that patients receiving the treatment later can still obtain significant clinical benefits. Tr. at 63; A Ex. 424 ¶ 29. For this reason, Dr. Turner recommends TTFT to patients even if they do not initiate TTFT within seven weeks of completing chemoradiation. A Ex. 424 ¶ 30. Dr. Turner views the LCD’s Seven-Week Criterion as “antithetical to fundamental translational principles wherein study results generate knowledge about how a larger population is likely to respond to a particular treatment,” and noted the inconsistency that Medicare coverage often does not depend on following the administration schedule in a clinical drug trial. A Ex. 424 ¶¶ 25-26. Dr. Turner considers the Seven-Week Criterion as “particularly inappropriate in view of the NCCN Level I recommendation.” A. Ex. 424 ¶ 33.
Noridian did not specifically argue that I should not credit Dr. Turner’s testimony but did allege that all of the expert witnesses had potential conflicts of interest. N. Br. at 29. I find no evidence of this regarding Dr. Turner. Dr. Turner testified that he has not received money from Novocure but has been occasionally taken to dinner by a Novocure representative. Tr. at 18. Noridian mentions this in its brief without attributing it to Dr. Turner. N. Br. at 29-30. Dr. Turner also served on an advisory board for Novocure, which Dr. Turner thought was limited to reimbursement of travel costs involved with that work. Tr. at 20, 24. Finally, Dr. Turner participated in the EF-14 Study, but did not receive compensation for that. Tr. at 26.
I credit Dr. Turner’s expert testimony. It is consistent with the testimony of the other experts. Dr. Turner participated in the EF-14 Study with no compensation and on an advisory board with no cash remuneration. I will not disregard the testimony of a physician who has direct and detailed knowledge of both GBM and TTFT because he received a few dinners in the past from Novocure. Serving on an advisory board for TTFT shows that Dr. Turner is sufficiently knowledgeable such that Novocure wanted his input. Dr. Turner’s involvement in helping to test a treatment for a disease like GBM shows his interest in ensuring proper care for his patients.
Anand Thanwar Shivnani, MD
Dr. Shivnani is a board-certified radiation oncologist and has been a radiation oncologist since 2006, following completion of his residency in the Radiation Oncology Department at Northwestern University Medical School. Dr. Shivnani authored nine published articles that primarily deal with radiation and chemotherapy in the treatment of cancer. A. Ex. 426 ¶¶ 2-5; A. Ex. 426 at 4, 5. Dr. Shivnani has also made presentations on that
subject, or related ones, and received a 2018 award as an investigator in the US Oncology Radiation Research Program. A. Ex. 426 at 5-6.
Dr. Shivnani testified that “I have treated many patients who have a GBM.” A. Ex. 426 ¶ 10; see Tr. at 139. Further, he served as “an investigator in many clinical trials, including clinical trials involving GBM,” as well as one involving “TTFT and lung cancer.” A. Ex. 426 ¶¶ 7-8. Dr. Shivnani opined that, as a clinician, he had observed patients having variations in their response to treatments and that “[b]ecause of this response variation to treatment, which is well-recognized in the literature, it is not logical for Medicare coverage to be limited to patients that begin a particular intervention within a particular time frame. In particular, the requirement that patients begin TTFT within seven weeks of completing chemoradiation, does not appear consistent with the real-world practice of medicine.” A Ex. 426 ¶¶ 11-12.
Dr. Shivnani is aware that although the TTFT clinical trial “had a schedule for interventions, treating clinicians understand those schedules typically are not adhered to when the learning of a clinical trial is applied in the practice setting.” A. Ex. 426 ¶ 13. “In a clinical trial, the researchers are trying to treat everyone the same to be able to show the effectiveness of an intervention.” A. Ex. 426 ¶ 16. However, “[i]f the teachings of a clinical trial were so limited, we would not be able to treat most patients based on the results of a clinical trial as few patients satisfy the enrollment criteria of the clinical trial and can adhere to a particular schedule.” A Ex. 426 ¶ 14. Regarding TTFT, Dr. Shivnani does not believe there is evidence that beginning TTFT 12 weeks after chemoradiation is less effective than at seven weeks. A. Ex. 426 ¶ 17. Dr. Shivnani opined that some patients need additional recuperation time before commencing TTFT or simply are unable to access TTFT within the seven-week period. A. Ex. 426 ¶ 18.
When asked on cross-examination whether there was any evidence that TTFT was effective if started more than twelve weeks after concomitant radiation and chemotherapy, Dr. Shivnani responded: “yes, the data [from the EF-14 Study] for recurrent GBM are patients who have started tumor treatment fields more than 12 weeks after therapy.” Tr. at 165; see Tr. at 167. Dr. Shivnani further testified: “So the fact that they had the tumor treating fields on before they recurred, I don't think takes away from the benefit that was observed after they recurred.” Tr. at 169.
Noridian did not specifically argue that I should not credit Dr. Shivnani’s testimony but did allege that all of the expert witnesses had potential conflicts of interest. N. Br. at 29. Dr. Shivnani testified that he received approximately $5,000 from Novocure. Tr. at 134. But he clarified that this money was paid to U.S. Oncology Research and Dr. Shivnani did not receive it personally or directly. Tr. at 168. Dr. Shivnani previously participated in one Novocure clinical study and is going to participate in a second. Tr. at 134.
I credit Dr. Shivnani’s testimony. There is insufficient evidence of a financial conflict of interest. Dr. Shivani’s testimony is also consistent with the comment he submitted during the public comment period for the revised LCD. Dr. Shivani stated, in pertinent part: “Patients respond to therapies in different ways, and I urge you to eliminate the 7 week requirement after completion of radiation therapy. Some patients require extra recuperation time between therapies, and it is punitive to exclude TTFT as a treatment option because they require individual care.” A. Ex. 374 at 1.
VI. Conclusions of Law and Analysis
Congress set the parameters for the review of an LCD as follows:
The administrative law judge.—
(I) shall review the record and shall permit discovery and the taking of evidence to evaluate the reasonableness of the determination, if the administrative law judge determines that the record is incomplete or lacks adequate information to support the validity of the determination;
(II) may, as appropriate, consult with appropriate scientific and clinical experts; and
(III) shall defer only to the reasonable findings of fact, reasonable interpretations of law, and reasonable applications of fact to law by the Secretary.
42 U.S.C. § 1395ff(f)(2)(A)(i).
Based on this statute, the Secretary’s regulations define the “reasonableness standard” that I am to apply as the following:
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 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 I apply the reasonableness standard and conclude that the challenged provision is invalid, I must give the basis for such a finding, including reference to the contractor’s findings of fact, interpretations of law, and applications of fact to law. 42 C.F.R. § 426.450(b)(4). My decision may not: specify terms to be included in the challenged LCD; order the contractor to add any language to the LCD; set a time limit for the contractor to establish a new or revised LCD, or order a contractor to implement an LCD in a certain way. 42 C.F.R. §§ 426.405(d), 426.455(a), (c), (f). If I invalidate an LCD provision and no appeal is filed by the contractor or CMS, it simply causes the provision to be ineffective for claims adjudicated during the Medicare claims process. 42 C.F.R. § 426.460(b). Finally, a contractor may reinstitute the invalidated provision if “the contractor has a different basis (such as additional evidence) than what the [administrative law judge] evaluated.” 42 C.F.R. § 426.463.
1. Noridian’s interpretation of law, that it may only consider scientific evidence (i.e., a peer-reviewed clinical trial) and not clinical evidence (i.e., evidence and testimony from knowledgeable physicians in the relevant field) is erroneous and, therefore, unreasonable.
Noridian’s defense of the Seven-Week Criterion is based on the fact that there is only one peer-reviewed clinical study regarding the use of TTFT to treat newly diagnosed GBM (i.e., the EF-14 Study) and, due to the clinical study’s patient enrollment requirement that TTFT be initiated no later than seven weeks after the last dose of concomitant radiation and chemotherapy, there is simply no evidence that TTFT is effective if started after the seven-week timeframe. N. Br. at 6. As Noridian stated in more detail:
The supporting evidence for the seven-week restriction in LCD L34823, which was finalized in 2019, was the EF-14 trial. That trial was at the time (and remains) the only definitive, randomized clinical study in the peer-reviewed literature of TTFT for patients with newly diagnosed GBM, and it demonstrated that TTFT was effective in patients when initiated withinseven weeks after completion of chemoradiation; it did not study TTFT’s efficacy when initiated more than seven weeks later. In the absence of evidence of effectiveness of therapy extending beyond seven weeks, a timeframe other than the one shown to be effective in the EF-14 trial would have been an arbitrary determinationby Noridian, in the absence of evidence, and thus not reasonable due to the evidentiary requirements for policy development outlined in [Medicare Program Integrity Manual] § 13.5.3.
N. Br. at 19-20 (internal citations and emphasis omitted); see N. Br. at 22 (“Whether today or on the date the LCD was issued, there are no peer-reviewed published clinical trials that support the effectiveness of TTFT when initiated more than seven weeks after the completion of chemoradiation in patients with newly diagnosed GBM. Importantly, this fact is not in dispute. When Dr. Nabors responded to the question of whether there is ‘any peer-reviewed literature that initiating therapy after seven weeks . . . has shown benefit,’ he admitted that there is ‘[n]o data peer-reviewed or published that would show a benefit beyond seven weeks.’”).
Noridian discounted the testimony of the expert witnesses in this case. Noridian said:
More specifically, the AP’s counsel proffered five expert witnesses in an attempt to support the efficacy of TTFT when initiated beyond seven weeks of the completion of chemotherapy in patients with newly diagnosed GBM. These witness testimonials were not part of the record for the LCD and did not exist until they were prepared for this litigation. While the Aggrieved Party had the right to introduce the testimony into the record developed before this Tribunal, it is not persuasive evidence and did not establish that a rational person would not include the seven-week restriction on the use of TTFT for patients with newly diagnosed GBM.
N. Br. at 27. Noridian primarily argues that the expert witness “testimonials” are not persuasive for the following reason:
Because the EF-14 trial did not investigate the efficacy of TTFT beyond this seven-week window, and because these written testimonies do not cite any other peer-reviewed published evidence, these testimonies fail to rely upon evidence enumerated in [Medicare Program Integrity Manual] § 13.5.3 and do not support the AP’s allegations that Noridian’s policy determination was unreasonable. CMS Ex. 41 at 12. Indeed, none of the expert witnesses testified, whether in declarations or at the hearing, to the existence of peer-reviewed clinical trial evidence that TTFT was effective when initiated beyond seven weeks of completing chemoradiation in patients with newly diagnosed GBM.
N. Br. at 28-29 (emphasis in original).
Noridian’s defense is comprehensible after reviewing its responses to two interrogatories posed by the AP during discovery. In them, Noridian asserts that it applied a hierarchy of
evidence set forth in a Medicare Program Integrity Manual (MPIM) provision, which no longer exists, and did not consult any experts because a provision for consultation was added only after it published the challenged LCD provision in this case:
Chapter 13 of the [MPIM] (CMS Internet-Only Manual 100-08) in-effect in 2018-2019 did not mandate the consultation of specific clinicians, societies or experts. Thus, during policy development for beneficiaries with newly diagnosed GBM in 2018-2019, Noridian did not consult with any clinicians, societies or experts regarding coverage criteria, including specifically as to when to initiate TTFT following chemoradiation for patients with newly diagnosed GBM. The [Medicare contractors] used published authoritative evidence derived from the only definitive randomized clinical study in the peer-reviewed literature available at that time – the EF-14 trial – which initiated TTFT within 7 weeks after completion of chemoradiation, and which sub-regulatory guidance prioritizes among potential sources of evidence. See CMS Exs. 36, 62 and 63. A time-frame other than the one used in the EF-14 study would have been an arbitrarydetermination by the [Medicare contractors], and thus not reasonable due to the evidentiary requirements for policy development outlined in Chapter 13 of the [MPIM].
* * * * *
The 2017 EF-14 publication is the onlydefinitive randomized clinical study in the peer-reviewed literature that was available during the LCD reconsideration process in 2018-2019. The Challenged Restrictions in this Matter were the ones used in that pivotal study, which sub-regulatory guidance prioritizes among potential sources of evidence. See Section 13.7.1 of Chapter 13 of the [MPIM] (CMS Internet-Only Manual 100-08) citation in our response to Interrogatory #1.
In the absence of other clinical trialsthat utilized different criteria in patients with newly diagnosed GBM, any change by Noridian to the Challenged Restrictions based on submissions to it in 2018-2019 during policy development would be an arbitrary determination, and
thus not reasonable due to the evidentiary requirements for policy development outlined in Chapter 13 of the [MPIM].
A. Ex. 419 at 2-3, 11-12 (emphasis added to some text and emphasis in original for some text, and emphasis of some text has been omitted).
In response to the AP’s interrogatories, as quoted above, Noridian cited MPIM § 13.7.1. However, this provision no longer exists. As quoted earlier from Noridian’s post-hearing brief, Noridian cites MPIM § 13.5.3. This provision, along with MPIM § 13.5.2, appear to have been effective during the revision process that led to the adoption of the Seven-Week Criterion.
Therefore, the applicable provisions permit contractors to consult with “healthcare professional expert(s), professional societies, etc., prior to the drafting of a proposed LCD, and include this information in the proposed LCD.” MPIM § 22.214.171.124. Further, contractors have discretion to seek consultation with CAC experts. MPIM § 126.96.36.199. Further, contractors “shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.” MPIM § 13.5.3.
To the extent that Noridian bases its interpretation of the law on the MPIM as to the evidence that may or may not be considered during the creation or revision of an LCD, it is important to note that the MPIM does not have the force and effect of law. See Erringer v. Thompson, 371 F.3d 625, 633-34 (9th Cir. 2004) (concluding that plaintiffs had not proved that the MPIM provisions concerning the requirements for the creation of LCDs “carry the force of law” and that “there is still no indication that the manual provisions should be determined to be legislative.”). Although Erringer did not believe that the Secretary needed to promulgate the MPIM provisions as regulations to be effective under 42 U.S.C. § 1395hh(a)(2), the Supreme Court’s opinion in Azar v. Allina, calls that view into doubt. 139 S.Ct. 1804, 1810-14 (2019) (holding that § 1395hh(a)(2)’s notice and comment rulemaking for Medicare policies is broader than the Administrative Procedure Act’s notice and comment provision).4 In any event, the MPIM provisions that Noridian cites are not law. Therefore, I must look to the Act and the regulations to
determine if those legal authorities provide rules concerning the type of evidence that is to be considered in relation to LCDs.
The Secretary promulgated a regulation indicating the type of documents that constitute the record while developing or revising an LCD. These include:
(2) Any medical evidence considered on or before the date the LCD was issued, including, but not limited to, the following:
(i) Scientific articles.
(ii) Technology assessments.
(iii) Clinical guidelines.
(iv) Statements from clinical experts, medical textbooks, claims data, or other indication of medical standard of practice.
42 C.F.R. § 426.418(a)(2) (emphasis added). Therefore, despite Noridian’s argument that the MPIM stated that scientific clinical studies were atop a hierarchy of evidence and that consulting clinical experts was not mentioned, the longstanding regulations expressly envision that the LCD record could include clinical expert statements and other evidence of the medical standard of practice.
Significantly, the Secretary overtly rejected a hierarchy of evidence when promulgating the regulations for LCD challenges, affirming that clinical experience from practicing physicians would be considered. In the preamble to the final rule establishing the LCD regulations, the following appears in the section entitled “Scope and Weight of Evidence”:
Comment: One commenter believed that the proposed rule would have the effect of excluding highly relevant information such as physicians’ standards of practice and their professional opinions from the review process. Another commenter believed that we should define the hierarchy of evidence strength to assure proper weighting by the ALJ or Board when considering scientific and clinical information.
Response: 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
[administrative law judge]/Board may seek input from clinical and scientific experts at their discretion. There is no prohibition against the [administrative law judge] or the Board seeking the input of practicing physicians or considering standards of practice.
68 Fed. Reg. 63,692, 63,700 (Nov. 7, 2003) (emphasis added).
The Secretary’s recognition of the importance of clinical expert input is probably due to the Act’s express authorization that administrative law judges may “consult with appropriate scientific and clinical experts” during an LCD challenge case. 42 U.S.C. § 1395ff(f)(2)(A)(i)(II) (emphasis added). Surely, if the Act contemplates input from clinical experts during the review of the validity of an LCD, clinical evidence must also be considered when creating the LCD.
Such an interpretation is supported by the regulatory provision that states the contractor in an LCD challenge case may review any new evidence, including “evidence produced when the [administrative law judge] consults with scientific and clinical experts” and submit a statement to the administrative law judge as to whether the new evidence is “significant” under § 426.340 (i.e., significant enough for the contractor to reconsider and revise the challenged LCD provision). 42 C.F.R. § 426.417(a)(4), (b) (emphasis added). If evidence from a clinical expert could result in reconsideration of an LCD provision, then such evidence would be relevant at any stage of the LCD review process.
The rest of the Secretary’s LCD regulations support the importance of clinical evidence in determining the validity of an LCD. The regulations state: “New evidence means clinical or scientific evidence that was not previously considered by the contractor or CMS before the LCD . . . was issued.” 42 C.F.R. § 426.110 (emphasis added). The use of the disjunctive means that clinical evidence alone can constitute new evidence. The sentence also assumes that the contractor may have considered clinical evidence already because new evidence is merely clinical evidence that has yet to be considered.
Further, 42 C.F.R. § 426.400(c)(6) requires that an acceptable LCD complaint have “[c]opies of clinical or scientific evidence that support the complaint.” Grammatically, the use of the disjunctive indicates that clinical evidence alone could support an LCD complaint. Therefore, clinical evidence can be used to successfully challenge an LCD.
In addition, as mentioned in the Act, the Secretary’s regulations reiterate that an administrative law judge may “[c]onsult with scientific and clinical experts on his or her own motion concerning clinical or scientific evidence.” 42 C.F.R. § 426.405(c)(6); see 42 C.F.R. § 426.431(b)(1). But the regulations go further and allow the administrative law judge to “permit the parties to introduce the testimony of expert witnesses on scientific and clinical issues . . . [and] may require that the testimony of expert witnesses
be submitted in the form of a written report, accompanied by the curriculum vitae of the expert preparing the report.” 42 C.F.R. § 426.440(d). The Secretary would hardly add this provision if clinical expert testimony were not relevant to LCDs.
It is important to note that the Secretary wanted clinical and scientific experts in LCD cases who were truly experts. The regulations provide that “Clinical and scientific experts means experts that are consulted by the [administrative law judge] or Board as independent and impartial individuals, with significant experience and/or published work, pertaining to the subject of the review.” 42 C.F.R. § 426.110. While this definition applies to experts consulted by an administrative law judge, the Secretary obviously desired experts provided by the parties to be accomplished in their field because, as stated above, the Secretary expressly authorized the administrative law judge to require the submission of the curriculum vitae for each of the experts called by the parties. Such a document would aid in determining the qualifications of the experts.
Regarding the Seven-Week Criterion, Noridian may have acted in conformity with the MPIM, as Noridian interpreted the MPIM. However, Noridian’s interpretation does not take into account the Secretary’s regulations. When promulgating the LCD challenge regulations, the Secretary provided the following guidance as to when a legal interpretation is not reasonable: “For legal interpretations, the reasonableness standard would not be met if an interpretation is in direct conflict with the plain language of the statute or regulation being interpreted.” 68 Fed. Reg. at 63,704. Based on the provisions of the Act and the regulations cited above, Noridian’s exclusion of clinical experts and evidence from the LCD revision process leading to the Seven-Week Criterion contradicts the plain language requirements in the regulations that clinical evidence/experts is evidence that has value and is to be considered. Assuming that the MPIM conflicts with or differs from the regulations, I must conclude that the Act and regulations, and not the MPIM, establish the authoritative legal standard. See 42 C.F.R. § 426.405(d)(13) (an administrative law judge may not find invalid applicable federal statutes, regulations, CMS Rulings, or National Coverage Determinations.). Therefore, I conclude that Noridian’s interpretation of law that clinical expert testimony and/or clinical evidence cannot be considered is unreasonable and I do not defer to it.
2. Noridian’s finding of fact, that TTFT is only effective when commenced no later than seven weeks after the end of concomitant radiation and chemotherapy, is not reasonable. Noridian’s use of an enrollment requirement which was used for patients in the EF-14 Study, i.e., the Seven-Week Criterion, mistakenly applies a parameter in a scientific clinical study, meant to generate scientific data free from confounding factors, as a requirement for treatment and coverage. Further, clinical expert testimony and the NCCN Guidelines support the effectiveness of TFFT when commenced more than seven weeks following the end of concomitant radiation and chemotherapy.
As indicated above, Noridian based the Seven-Week Criterion on the EF-14 Study enrollment requirement that study participants initiate TTFT between four and seven weeks following the end of concomitant radiation and chemotherapy. N. Br. at 6 (“Given the lack of any evidence of TTFT’s efficacy without the seven-week restriction, Noridian certainly had a logical reason to include the seven-week restriction when granting coverage.”). Noridian discounted other evidence that TTFT was effective when initiated beyond seven weeks, indicating there are no studies in the record that support a timeframe for effectiveness that is beyond seven weeks. Noridian stated:
While the AP’s Brief speaks broadly about FDA approval, NCCN guidelines, and commercial payor practices for TTFT, the fact remains that there are no studies in the record, peer-reviewed or otherwise, that have demonstrated TTFT to be effective when initiated more than seven weeks after the last dose of concomitant chemotherapy or radiotherapy.
N. Br. at 5-6.
I am to defer to reasonable findings of fact by Noridian in reviewing the LCD. However, Noridian’s LCD revision process said little concerning the Seven-Week Criterion.
Noridian and CGS convened a CAC meeting, but the contractors did not ask the CAC’s view on the Seven-Week Criterion. See CMS Ex. 36 at 7-9; CMS Ex. 76; CMS Ex. 77 at 6-9. In the proposed LCD, the EF-14 Study is discussed in the Summary of Evidence section without reference to the seven-week enrollment requirement. CMS Ex. 77 at 5-6. Other than mention of the proposed Seven-Week Criterion, nothing else is said of that criterion. CMS Ex. 77 at 4.
As discussed in detail in this decision, seven physicians specializing in oncology, plus Dr. Shivnani who testified in this proceeding, provided written comments that the Seven-Week Criterion was not appropriate based on their clinical experience. Dr. Mitin stated that there is no clinical evidence (meaning, this has not been observed) that TTFT is no longer effective if it starts beyond the seven-week period after radiation and chemotherapy. A. Ex. 373 at 1. Dr. Iwanmoto comments that the Seven-Week Criterion was an arbitrary limit. A. Ex. 375 at 2. Dr. Gordon Wong commented that many of his patients received significant benefit from TTFT even when starting later than seven weeks after completing radiation. A. Ex. 376 at 1. Dr. Uhm, Chair of the Mayo Clinic’s Division of Neuro-Oncology, commented that “[t]here is no clinical rationale for [the Seven-Week Criterion].” A. Ex. 378 at 1. Several additional oncologists commented that “oncology care is extremely individualized and requires flexibility.” A. Exs. 379, 382-84.
These comments from practicing oncologists, including a top oncologist at the Mayo Clinic, indicating that clinical practice did not support the Seven-Week Criterion should have resulted in Noridian and CGS considering the validity of these views. However, the Seven-Week Criterion was published in the final LCD without further discussion in the Summary of Evidence section or any section of the LCD. See CMS Ex. 77 at 5-6. In the LCD article in which the contractors summarized public comments and their responses, the summary of comments merely stated that several commenters asked that the Seven-Week Criterion be eliminated without providing the commenters’ reasons. Equally brief, was the response that the commenters had not provided any clinical evidence to support this position. CMS Ex. 38 at 5.
In the present case, as explained at length above, the AP provided evidence from clinical experts that the Seven-Week Criterion is an improper use of a clinical study enrollment requirement to determine treatment and that, in their clinical experience, TTFT is effective when initiated beyond the seven-week period following completion of radiation and chemotherapy. The experts who testified in this case were not only consistent with each other but with the oncologists who commented on the proposed LCD.
Drs. Eric Wong, Toms, and Nabors all have significant experience in clinical trials, and all of the experts had participated in clinical trials. They have all published many peer-reviewed articles. Dr. Nabors has been the long-standing chair for the NCCN committee that establishes the standards of treatment for central nervous system cancers. All of these individuals easily meet the regulatory requirements for an expert, described above, of having significant experience and/or having been published. These individuals all testified that there are scientific reasons why enrollment criteria are selected for clinical studies, which is to ensure that the study can provide valid data from which a determination can be made as to whether the tested treatment is effective. However, the need to create a homogenous population that will live long enough to ensure that there is sufficient data does not mean that the strict requirements of the clinical trial should be the treatment parameters in real-world practice. Rather, clinical evidence must aid in that determination.
Consistent with the oncologists who commented on the Seven-Week Criterion, all of the expert witnesses stated that their clinical experience shows that TTFT is effective when commenced later than seven weeks following radiation and chemotherapy. The NCCN Guidelines, which are based on clinical evidence provided by a large number of clinicians, did not adopt the seven-week requirement. Although the parties appear to disagree over whether NCCN would provide a cut-off date for treatment, Dr. Nabors testified, as summarized earlier, that NCCN does not believe the requirement to commence treatment within seven weeks should act as a restriction to treatment. I accept that testimony since he is the chair of the relevant NCCN committee that established the Guidelines.
The Secretary said in the preamble to the final rule promulgating the LCD regulations that “[w]e 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.” 68 Fed. Reg. at 63,700. I have evaluated the clinical experts in this case and conclude I should afford their views significant weight. Noridian provided no experts of its own and did not attempt to show there was clinical evidence that supported the Seven-Week Criterion. The expert witnesses’ testimonies stand unrebutted.
The Secretary provided guidance as to when the fact-finding in an LCD was reasonable.
So long as the outcome is one that could be reached by a rational person, based on the evidence in the record as a whole (including logical inferences drawn from that evidence), the determination must be upheld. This is not simply based on the quantity of the evidence submitted, but also includes an evaluation of the persuasiveness of the material. If the contractor or CMS has a logical reason as to why some evidence is given more weight than other evidence, the [administrative law judge] and the Board may not overturn the determination simply because they would have accorded more weight to the evidence in support of coverage.
68 Fed. Reg. at 63,703.
Under this standard, I must conclude that Noridian’s factual finding in support of the Seven-Week Criterion is unreasonable. While the enrollment requirements of a clinical study provide some evidence of the requirements needed for a treatment to be effective, clinical evidence must be considered as well. The witnesses have significant expertise and knowledge and it is not logical for Noridian not to have consulted experts of its own, such as the CAC. The comments received in response to the proposed LCD should have resulted in further fact-finding as to the Seven-Week Criterion, but none took place. Noridian does not have a logical reason for giving the enrollment requirements to the EF-14 Study controlling weight when it determined the Seven-Week Criterion.5
Finally, I note that Noridian’s belief that the expert witnesses are financially conflicted in this case is an insufficient reason for me to disregard their testimony. There is no evidence that any of the experts have an ownership interest in Novocure or will financially benefit from Medicare covering TTFT more broadly than it does now. Although some of the experts have received relatively small sums personally from Novocure, and some of the experts’ academic institutions received reimbursement for conducting studies for Novocure, I find it impossible to credit such small amounts of money as a reason to discount their combined testimonies. These experts have devoted their professional lives to treating and finding treatments related to cancers of the nervous system. I do not have a reason to believe they would lie as to their clinical experience about the treatment of terribly ill patients. Further, whether the experts had taken money, simply accepted a dinner or two, or nothing at all from Novocure, they all testified consistently, and I accept their testimonies.
Therefore, I conclude that the AP has met the burden of proving that TTFT is effective for individuals with newly diagnosed GBM when started more than seven weeks following radiation and chemotherapy. As the experts acknowledged, at some point in time, TTFT will become less effective if started too late. However, the AP was not required to prove when TTFT will no longer be effective, only that it is still effective when initiated beyond seven weeks. This, the AP has accomplished.
For the reasons stated above, the Seven-Week Criterion in LCD L34823 is unreasonable and not valid.
Scott Anderson Administrative Law Judge
1. An AP is a Medicare beneficiary, or his or her estate, who challenges the provision(s) of an LCD that directs the denial of Medicare coverage for a needed health care item or service. 42 U.S.C. § 1395ff(f)(2)(A)(i), (5); 42 C.F.R. §§ 426.110 (definition of Aggrieved party), 426.320(a). For privacy, this decision does not identify the AP.
- back to note 1 2. “[T]he KPS score describes the general condition of a patient; a KPS score [of greater than or equal to] 70% ensures some independence in activities of daily living.” CMS Ex. 61 at 3.
- back to note 2 3. A. Ex. 191 is incorrectly marked as A. Ex. 192.
- back to note 3 4. It is possible that CMS’s evidentiary requirements for the creation of LCDs should be promulgated as regulations. In the subparagraph entitled “Factors and Evidence Used in Making National Coverage Determinations,” the Act expressly grants the Secretary authority to “develop guidance documents” concerning the “factors considered in making national coverage determinations of whether an item or service is reasonable and necessary.” 42 U.S.C. § 1395y(l)(1). The Act provides no such authority regarding LCDs. Without that authorization, the rules for evidence to consider when publishing LCDs may default to the requirements in 42 U.S.C. § 1395hh(a)(2).
- back to note 4 5. The record has numerous scientific and medical articles and book chapters related to TTFT. Most of the articles and book chapters discuss the use of TTFT in patients with newly diagnosed GBM. It is striking that few of these articles and chapters mention a seven-week timeframe in which to commence TTFT following radiation and chemotherapy. For the articles that do, it is usually in the context of describing the parameters of the EF-14 Study. However, many articles, even when describing the EF-14 Study, omit reference to the seven-week enrollment requirement for patients. Although the AP bears the burden of proof in this case, it is difficult to disprove something that appears to be a nonissue for the medical community. It is, therefore, understandable why the AP must rely on expert testimony to meet the burden.
- back to note 5