Friday, February 24, 2023

LCD Challenge: Unusual Example of a Winning Case (Glioblastoma therapy)

In 2003 (the year before I started a 4-year job as a Medicare medical director), CMS instituted regulations that govern the appeal (or "challenge") of an LCD or NCD.   Prior to this, a party could only challenge an LCD one single case at a time (claim by claim appeal), even if it always won.

CMS has an online information sheet here and the very long and detailed regulations are here at 42 CFR 426.  My blog today is a policy summary based on some online documents, and is not a legal document.  If you have any interest in this process, seek legal advice.

In the Name of a Beneficiary

Technically, the challenges can only be in the name of a beneficiary who needs the service in question.  However, I believe in most cases a provider of the service takes over and manages the case, with permission of the beneficiary, hiring one or more attorneys to bring the case through the CMS legal system (panels of judges).

There is a single consolidated record of all NCD challenges since 2004 (almost none has ever won).  At least one way to find some LCD decisions is to simply search ALJ decisions for the exact phrase LCD challenge (search here).  For a case that got up to federal court, here.

A Winning Case for a Patient - Glioblastoma Therapy under Noridian LCD

Many cases lose and many are not filed in precisely the right way and lose on technical grounds.

I stumbled across an interestingly, lengthy, and apparently winning case, DAB CR5902 in 2021 (link below).  This involved a brain tumor patient who wanted (and whose doctor ordered) Tumor Treatment Field Therapy, TTFT.  The service was blocked by Noridian because it was started more than 7 weeks after glioblastoma diagnosis, and Noridian's LCD limited to care starting within 7 weeks, because a key clinical trial had used 7 weeks as a cut-off for starting therapy.   

  • Teaching Case / Point 1.  This is a good teaching example of a MAC LCD reaching past the labeling or indication for a procedure, and imposing earlier clinical trial entrance criteria as a condition of care for all future patients.  If you ever need an example where MACs reach into the clinical trial patient criteria to write coverage, here 's one.
  • Teaching Case / Point 2.  It is also a good teaching example of a MAC not backing down in the face of a court challenge it could lose (arguing that since the clinical trial enrolled to 7 weeks, therefore, a patient at 7 weeks and 1 day was invalid for care.)  

On July 9, 2021, the judge ruled that based on the MAC's arguments, their experts, publications, and the appealing party's arguments and experts, the LCD restriction to 7 weeks for start of therapy was not reasonable, and was not accepted by the neurology or neuro-oncology community in general.  It was not, for example, in NCCN guidelines.  The case is 50 pages long and has a two page summary.

The LCD.  Find LCD L34823 online here.  It was last revised (R8) in 1/2020, so not revised since the July 2021 case.  See the Johns Hopkins webpage about the tumor field therapy, here.

As background reading, see testimony of the attorney in this case, Debra Parrish, at a CMS public meeting in July 2019.

The case ran from February 2020 to July 2021.  A few sentences give a flavor of the case:

...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.  .....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....Noridian did not object to any of the AP’s proposed exhibits but did request to cross-examine the AP’s expert witnesses....  

The case record goes on like this for 50 pages.  Along the way, the judge notes that CMS challenged the expert witnesses for the patient who may have received research funding in the field.  
[Judge Anderson writes] 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. 


In my search of ALJ records by keyword, there was only one hit for "MolDx," which was a dismissed LCD challenge re L36159 Factor V Leiden, in 2021, C-22-13, CR5997.

This is a ChatGPT summary made with the help of Chrome Plug-in, "ChatGPT Suite."

This article discusses the challenge process for Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs) and a winning LCD challenge case for Tumor Treatment Field Therapy (TTFT) for a patient with glioblastoma.

🏥 Challenges can only be made in the name of a beneficiary who needs the service, but providers often manage the case.
📜 There is a consolidated record of all NCD challenges since 2004, and LCD decisions can be found by searching ALJ decisions.
🤕 The winning case involved a patient with glioblastoma who needed TTFT, which was initially blocked by Noridian's LCD.
🧑‍🏫 The case is a teaching example of a MAC LCD imposing earlier clinical trial entrance criteria as a condition of care and not backing down in the face of a court challenge.
📄 The LCD can be found online and was last revised in January 2020.
🕰️ The case ran from February 2020 to July 2021 and involved a lengthy legal process.
💰 There was one dismissed LCD challenge re L36159 Factor V Leiden in 2021.