MolDx LCDs x 2: LCD for Thoracic Aortic Disease and LCD for Transthyretin

On August 29, 2024, MolDx MACs released two new LCDs for public comment.

THORACIC AORTIC DISEASE

The first is DL39933 for genetic testing related to thoracic aortic disease (e.g. Marfan's syndrome and others).

The MOLDX version of the LCD (DL39933) lists Niranjan Shekar as the requester, while the Noridian version (DL39946) states the topic is MAC initiated.

I got a few "dead link" errors on the request letter PDF -- but it later worked.   WPS version links to a 2 page cloud PDF, which is the front page of a request packet dated February 10, 2023 (18 months ago).  The cover letter applies to both thoracic artery disease and amyloidosis, and (not shown) there were underlying separate chapters for each clinical condition and coverage.

Read the full LCD for details but coverage hinges on aortic dilation before age 60 OR ELSE with syndromic features (e.g. Marfan's), OR family history OR familial sudden death.  Tests must have at least minimal genetic content, as found in guidelinese.

TRANSTHYRETIN AMYLOIDOSIS

This proposal DL39935 is also lsited as requested by Niranjan Shekar.    

The patient has a working clinical diagnosis of transthyretin amyloidosis (hATTR) including a clinical diagnosis of ATTR, OR ELSE suggestive features plus secondary factors like African-American descent, a first degree relative with ATTR, etc.  The test has at least minimum genetic content per guidelines.

While the request letters seem to have linkage problems right now, Niranjan Shekar worked at Invitae from 2021 to early 2024.

Comments run until October 12.

Coding

The aortic LCD contemplates use of the AMA CPT aortic gene panels (81410 81411) or 81479.  The transthyretin LCD lists only 81479 + Z code as coding.

Race Based Criteria

I have no discussion point regarding the inclusion of race-based criteria in one of the LCDs, following guidelines.  I would point out, based on a summer NEJM article, there are new alternative viewpoints being shot back and forth in some circles about whether race should be used as a concept when writing medical care guidelines (here). (Sidebar).

AI CORNER

Chat GPT 4o comments.

Note that below, AI suggests that MolDx cover family members or "genetic counselors".  

Both these are outside the control of MolDx.  

MolDx does cover "genetic counseling" (illness discussions as part of illness care) 

reimbursable by physicians or NPs/PAs.

Overview of MolDx Proposed Local Coverage Determinations (LCDs)

The MolDx program has proposed two new Local Coverage Determinations (LCDs) concerning molecular diagnostics for specific conditions: Heritable Thoracic Aortic Disease (HTAD) and Hereditary Transthyretin Amyloidosis (hATTR). Each of these LCDs outlines specific criteria for Medicare coverage, evidence supporting the policy, and the rationale for favorable coverage decisions.

1. Genetic Testing for Heritable Thoracic Aortic Disease (HTAD)

Coverage Criteria:

• Eligibility: Coverage is extended to patients presenting with aortic root/ascending aortic dilation, aneurysm, or dissection and who meet one or more of the following:
  • Presentation before age 60.
  • Presence of syndromic features (e.g., Marfan syndrome, Loeys-Dietz syndrome, vascular Ehlers-Danlos syndrome).
  • Family history of thoracic aortic disease, peripheral/intracranial aneurysm, or unexplained sudden death in a first- or second-degree relative.
• Testing Requirements: The test must include a genetic panel with well-established evidence for clinical decision-making. It should exclude unnecessary genetic content that may be harmful.
• Technical Assessment: The test must have successfully completed a Technical Assessment (TA) by MolDx.

Evidence and Rationale:

• Disease Overview: HTAD includes conditions that predispose individuals to thoracic aortic aneurysms (TAAs) and dissections. These conditions can be life-threatening, and timely diagnosis is crucial.
• Importance of Genetic Testing: Genetic testing is essential for diagnosing HTAD and guiding management, especially in patients with a family history or syndromic features. The evidence supports that early intervention and proper management, informed by genetic data, significantly improve outcomes.
• Multigene Panel: A multigene panel approach is recommended over single-gene testing unless a known familial variant is being evaluated. This approach ensures that all relevant genetic information is captured, facilitating comprehensive patient care and risk assessment.

The policy underscores that HTAD-related genetic testing is a valuable tool for managing patients, especially in a high-risk population, and should be part of standard care​.

2. Molecular Testing for Hereditary Transthyretin Amyloidosis (hATTR)

Coverage Criteria:

• Eligibility: Coverage is provided for molecular diagnostic tests used in the evaluation and management of patients suspected of having hATTR when one or more of the following criteria are met:
  • Clinical diagnosis of ATTR or cardiac features suggestive of ATTR-cardiomyopathy.
  • African American descent with specific features or first-degree relatives diagnosed with hATTR.
  • Progressive sensorimotor and/or autonomic neuropathy.
  • Counseling on test implications and usage in treatment decisions.
• Testing Requirements: The test should include genes or variants with definitive clinical utility and exclude those that might harm the patient. A technical assessment (TA) is also required.

Evidence and Rationale:

• Disease Overview: hATTR is a systemic disease characterized by the deposition of amyloid fibrils in various organs, leading to severe outcomes if untreated. The disease manifests in multiple phenotypes, making it difficult to diagnose without genetic testing.
• Importance of Early Detection: Early and accurate diagnosis using molecular testing can significantly impact treatment strategies and outcomes. Given the availability of therapies that can slow disease progression, genetic testing is considered reasonable and necessary.
• Utility of Multigene Panels: Similar to HTAD, a multigene panel is recommended to capture all relevant genetic information, aiding in precise diagnosis and effective treatment planning. This approach helps in managing a disease with such varied presentations and overlaps with other conditions.

The policy emphasizes the importance of molecular diagnostics in identifying and managing hATTR, particularly given the variability in clinical presentation and the availability of targeted therapies​

Conclusion

These two proposed LCDs by MolDx reflect a robust approach to using molecular diagnostics in managing complex genetic conditions. By setting stringent criteria and emphasizing the need for comprehensive genetic panels, these policies aim to ensure that patients receive precise diagnoses and appropriate care. The engagement with experts and ongoing review of evidence also ensures that these guidelines evolve with advances in medical science.

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I notice that both refer to the importance of genetic counseling.  While such counseling can, of course, be done by physicians, this brings to mind that Medicare does not have a benefit for the clinical specialty known as genetic counselors.

You're correct in noting that both proposed LCDs highlight the importance of genetic counseling as a crucial part of the diagnostic and treatment process for hereditary conditions like Heritable Thoracic Aortic Disease (HTAD) and Hereditary Transthyretin Amyloidosis (hATTR). Genetic counseling ensures that patients understand the implications of their genetic test results, including the potential risks, benefits, and limitations, and how these results may affect their treatment options and familial risk.

Medicare's Lack of a Specific Benefit for Genetic Counselors

Currently, Medicare does not recognize genetic counselors as independent providers eligible for reimbursement, meaning that their services are not directly covered under Medicare benefits. This limitation exists despite the critical role genetic counselors play in managing genetic conditions. Instead, genetic counseling services must be provided by or under the supervision of a physician, nurse practitioner, or other Medicare-eligible provider.

This gap in coverage has been a subject of ongoing discussion within the medical community and among policymakers. Genetic counselors are specially trained to provide detailed and focused counseling that can be beyond the scope of many physicians' expertise, particularly in the context of complex and rapidly evolving genetic information.

Implications for Coverage and Patient Care

The absence of a specific Medicare benefit for genetic counselors can lead to several potential issues:

• Access to Expertise: Patients might not have access to specialized genetic counseling services unless their physician is well-versed in genetic counseling or collaborates closely with genetic counselors.
• Increased Burden on Physicians: Physicians may need to allocate more time to providing genetic counseling, which could detract from other aspects of patient care or lead to less comprehensive counseling.
• Potential Barriers for Patients: Patients may face logistical or financial barriers to accessing high-quality genetic counseling if they are referred to non-Medicare providers.

Potential Solutions and Advocacy

There is ongoing advocacy within the genetic counseling community and among healthcare organizations to establish Medicare reimbursement for genetic counselors. Recognizing genetic counselors as independent providers under Medicare would likely enhance access to genetic services, improve patient outcomes, and ensure that counseling is provided by those with the most specialized knowledge in this area.

In the meantime, it is essential for healthcare providers working with Medicare patients to be aware of this limitation and find ways to incorporate genetic counseling into their practices, either through direct counseling or by working collaboratively with genetic counselors within the existing framework.

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Do you see any gaps in coverage that might be needed by doctors and patients?  And do you see any ways the LCDs are ambiguous or confusing (you might not).

The proposed Local Coverage Determinations (LCDs) for Heritable Thoracic Aortic Disease (HTAD) and Hereditary Transthyretin Amyloidosis (hATTR) are comprehensive, but a few potential gaps and ambiguities might affect how doctors and patients navigate coverage. Here are some areas where these LCDs could be improved or clarified:

1. Potential Gaps in Coverage

• Comprehensive Coverage for Genetic Counseling: As you pointed out, while the LCDs emphasize the importance of genetic counseling, Medicare's lack of a specific benefit for genetic counselors could create a gap. Without direct coverage for genetic counseling, patients might not receive the specialized support they need to understand their test results, especially those with complex or uncertain outcomes. Ensuring access to this service, either by expanding coverage or clarifying how it can be accessed under existing benefits, would be critical for patient care.

• Coverage for Family Members: The LCDs do not explicitly address the coverage of genetic testing for family members who may be at risk due to their relationship with the patient. Cascade testing (testing of family members once a pathogenic variant is identified) is essential in hereditary conditions like HTAD and hATTR, but the LCDs are not clear on how or if Medicare would cover this. Without explicit coverage, family members may face barriers to testing, potentially leading to delayed or missed diagnoses.

• Expanded Genetic Panels: Both LCDs allow for the use of multigene panels, but there is a concern about whether the coverage will extend to panels that include genes beyond the core set identified in guidelines. As new genes are discovered and their relevance to these conditions is established, coverage may need to be adjusted. There’s a need for flexibility in coverage to accommodate advances in genetic research without the need for frequent policy revisions.

2. Ambiguities or Confusion in the LCDs

• Criteria for Syndromic Features: The HTAD LCD refers to "syndromic features" of conditions like Marfan syndrome, Loeys-Dietz syndrome, or vascular Ehlers-Danlos syndrome, but the criteria for what constitutes these features are not fully detailed. This could lead to variability in interpretation by providers, potentially resulting in inconsistent access to genetic testing. More specific guidelines or examples of syndromic features could reduce ambiguity.

• Definition of “Well-Established Guidelines”: Both LCDs require that genetic tests include content supported by "definitive or well-established guidelines-based evidence." However, the definition of what constitutes “well-established” could vary. It might be helpful for the LCDs to reference specific guidelines or provide criteria for how these guidelines are to be interpreted, ensuring consistent application across different providers and laboratories.

• Handling Variants of Uncertain Significance (VUS): The LCDs discuss the necessity of including relevant genes in genetic panels, but they don’t clearly address how to handle variants of uncertain significance (VUS). Genetic tests frequently return VUS, which can create uncertainty in clinical decision-making. The LCDs could benefit from additional guidance on how VUS should be managed in clinical practice, especially in terms of coverage for follow-up testing or additional counseling.

• Technical Assessment (TA) Requirements: Both LCDs require that tests complete a Technical Assessment (TA) by MolDx, but the specifics of this assessment are not fully detailed. This could lead to confusion about what is needed to meet these requirements. Clarifying the process, criteria, and timeline for TA could help providers and labs better prepare and align their testing with coverage requirements.

3. Suggestions for Improvement

• Explicit Inclusion of Genetic Counselors: Consider advocating for a policy change to explicitly include genetic counselors as Medicare providers or offer alternative routes for ensuring patients have access to these services. [BQ, this is not relevant at the MAC level but at the Government level]

• Clarify Testing Coverage for Family Members: The LCDs could explicitly address whether and how Medicare covers genetic testing for at-risk family members, especially in cases of positive findings in the proband (initial patient tested). [BQ generally family members are not covered as they are not Medicare patients]

• Flexible Updates for Genetic Panels: The LCDs could include a mechanism for regularly updating covered genetic panels as new genes and variants are identified, potentially through an annual review process.

• Provide More Detailed Examples and Case Studies: Including detailed examples of how the LCD criteria should be applied in different clinical scenarios could help reduce ambiguity and ensure more consistent application.

Addressing these gaps and ambiguities could enhance the clarity and effectiveness of the LCDs, ultimately improving patient outcomes by ensuring more consistent access to necessary genetic testing and counseling.

MolDx x 3: Allograft LCD on Hold; New Guide for Germline Assessments; Transcript of DCIS Meeting

 A flurry of new articles over at the MolDx website.

#1 

Germline

MolDx publishes guides, usually in Excel, for technical assessments of your LDT.  The "Inherited Cancer Testing" guide is updated on July 17, 2024.  See the TA page here.

#2 

Changes to Transplant Testing: On Ice

CMS published a press release at cms.gov that MolDx's LCD for transplant testing would not be revised, at least not, until another version is proposed.   MolDx echoes the fact, in fewer words.  Here.  

#3

Public Meeting on Stratifying DCIS: Transcript

MolDx and its minion MACs held a July 15, 2024, public meeting on stratification tests for DCIS.   See the transcript now (and recordings).   Here.

The agenda had a detailed roster of 8 probing questions - here. The transcript is a heroic 157 pages long - though it's only 2 hours.

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AI Corner (Chat GPT 4o)

The Medicare Contractor Advisory Committee (CAC) meeting on July 15, 2024, focused on Biomarker Risk Stratification Testing in Ductal Carcinoma In Situ (DCIS) involved an in-depth discussion centered around clinical outcomes, treatment decisions, and the role of biomarker testing in guiding these decisions. Below is a summary of key points discussed during the meeting:

Background and Questions Framework

The meeting was structured around 12 pre-defined questions that sought to clarify various aspects of risk stratification in DCIS patients, particularly concerning the use of Radiation Therapy (RT). The questions explored the relevance of clinical outcomes such as ipsilateral breast tumor recurrence (IBTR), invasive cancer, and mortality as endpoints for treatment decisions. They also addressed the potential of biomarkers to identify low-risk Medicare patients who might be treated with breast-conserving surgery (BCS) alone, without the need for adjuvant RT.

Key Discussions and Findings

1. Clinical Outcomes and Treatment Decision-Making:

   • The panel emphasized that while DCIS itself does not lead to mortality, the recurrence of invasive cancer is a critical endpoint. There was consensus that both IBTR and invasive cancer are important metrics for evaluating treatment efficacy.
   • The importance of patient-specific factors, including life expectancy and individual risk tolerance, was highlighted. The panelists noted that clinical decision-making should balance the risks and benefits of RT, with some suggesting that in certain cases, especially for older patients with limited life expectancy, BCS alone might be appropriate.

2. Role of Biomarkers:

   • There was considerable debate regarding the utility of biomarkers in predicting the benefit of RT. While some panelists argued that biomarkers could help identify patients who would not benefit from RT, others expressed skepticism, noting that current biomarker tests, such as the Decision RT test, lack sufficient validation.
   • The discussion also touched on the limitations of existing risk stratification tools, such as the Van Nuys Prognostic Index (VNPI) and Oncotype DX, with several panelists questioning their effectiveness in clinical practice.

3. Utility and Evidence for Biomarker Testing:

   • The clinical utility of biomarker tests in guiding treatment decisions for DCIS was a central theme. Panelists pointed out that while biomarkers might offer additional information, their ability to improve patient outcomes over traditional clinical stratification methods remains unproven.
   • Concerns were raised about the statistical robustness of studies supporting biomarker use. For instance, the Prelude RT data was criticized for its low power and lack of statistically significant findings, casting doubt on its reliability.

4. Clinical Practice Implications:

   • The panel recognized the complexity of treating DCIS and the need for shared decision-making between physicians and patients. There was agreement that while biomarkers could potentially guide treatment decisions, they should not replace clinical judgment, especially given the current limitations of the evidence.
   • The discussion underscored the importance of individualized patient care, where treatment decisions are made based on a combination of clinical, pathological, and potentially biomarker data, tailored to the specific circumstances of each patient.

Conclusion

The workshop highlighted the ongoing challenges in using biomarkers for risk stratification in DCIS. While biomarkers hold promise, the panel stressed the need for further validation and stronger evidence before they can be confidently integrated into clinical practice. The meeting also reaffirmed the importance of using a comprehensive approach that combines clinical insights with available tools to guide treatment decisions, ensuring that they are both evidence-based and patient-centered.

This summary should provide stakeholders with a clear understanding of the key discussions and conclusions from the Medicare CAC meeting on DCIS biomarker testing, focusing on the complex interplay between clinical outcomes, treatment options, and the potential role of biomarkers in improving patient care.

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Risk stratification (typically by tests based on RNA gene expression, such as mitotic biomarkers) - is a standard of care for invasive breast cancer.   Does the concensus emerge that this is equally important when it is "just" DCIS, or is the DCIS field further behind, or perhaps will the tests simply not be so successful in DCIS.

During the Medicare Contractor Advisory Committee (CAC) meeting on July 15, 2024, there was a significant discussion around the role of risk stratification in DCIS, particularly in comparison to its established use in invasive breast cancer. Here's a summary of the consensus and key points related to this question:

Risk Stratification in DCIS vs. Invasive Breast Cancer

1. Current State of Risk Stratification in DCIS:

   • The consensus among the panelists was that while risk stratification, particularly through RNA gene expression tests, is a well-established standard of care for invasive breast cancer, its application in DCIS is not as advanced or universally accepted. 
   • The panel recognized that the evidence supporting the use of such biomarkers in DCIS is less robust compared to invasive breast cancer.

2. Challenges in DCIS:

   • Several panelists highlighted that DCIS poses unique challenges that may limit the success and applicability of risk stratification tests. Unlike invasive breast cancer, where the need for aggressive treatment is clearer, DCIS often presents with a lower immediate risk of progression to invasive cancer, making the benefits of risk stratification less evident.
   • There was a strong emphasis on the variability in outcomes for DCIS patients and the current inability of existing biomarkers to consistently predict who would benefit from additional treatments like radiation therapy. This variability and lack of predictive power were seen as significant barriers to adopting risk stratification tests as a standard practice in DCIS.

3. Future of Risk Stratification in DCIS:

   • Despite these challenges, some panelists were cautiously optimistic about the potential for risk stratification tests to eventually play a more significant role in DCIS management. However, they stressed the need for more research and validation studies to establish the clinical utility of these tests in DCIS.
   • The discussion indicated that while DCIS is "further behind" compared to invasive breast cancer in terms of risk stratification, there is still a possibility that future advancements could bridge this gap. However, the consensus was that the current evidence does not support the routine use of these tests in DCIS as it does in invasive breast cancer.

Conclusion

The consensus from the meeting suggests that the field of DCIS is indeed behind invasive breast cancer in terms of the integration and success of risk stratification tests. The applicability and effectiveness of these tests in DCIS are still uncertain, with many experts expressing skepticism about their current utility. Therefore, while risk stratification is crucial for invasive breast cancer, its role in DCIS remains limited and less well-established at this time.

Journal Club: 360Dx on FDA's DownClassification Plans for Genomics

On January 31, 2024, FDA issued a press release that it planned to reclassify - to downclassify - "most high risk IVDs."   Here.   The new director for diagnostic tests (OIVD), Courtney Lias PhD, reiterated this last week at the annual "NextGenDx" conference in Washington.

This would have a huge impact on how implements its plan to regular lab-developed tests, but it would also greatly change the landscape for Class II, or moderate-risk, tests in general.  It could tilt the economics and the landscape further towards kitted tests rather than RUOs and LDTs.

If you have a subscription to Genomeweb/360Dx, there's an excellent deep dive report on the topic published August 22 by Kelsy Ketchum.   Find the article here (subscription).

Expert insights came from Christine Bump  and Kate Simon.

 

Why Not Faster?

FDA plans to do this over a period of years, but I think it would be a dramatic improvement to move a lot faster.   CMS makes hundreds - even thousands - of pages of rulemaking and policy making each year in 4-month cycles (such as start July 1, finish November 1).   It's never been clear to me why FDA senior staff say, "We could do that, but it would take notice and comment rulemaking, and that requires five years."

A Few Tidbits

Just a quick peek at a couple highlights.

* Reclassification could streamline CDx approvals, but validation may still be complex.  (I can see this for new gene-drug pairs, or if a particular is especially complex, not just a known mutation.)

* The shift from PMA to 510(k) may leave behind policy levers like modular submissions.

* Smaller players may be able to produce Class II kits whereas PMA kits were too costly and slow.

* Look for big impacts on the promised LDT regulatory scheme.

Illumina Announces FDA Approval of "TSO Comprehensive" - NGS for solid tumors

Header: On August 27, 2024, Illumina announces FDA PMA approval of "TSO Comprehensive," an NGS tumor tissue test reporting 500+ genes.  

Press release here.  TSO stands for, 'TruSight Oncology."   Genomeweb here.  Endpoints here.

What You Get

The test has several specific companion diagnostic approvals.  These are NTRK fusions used with VITRAKVI (larotrectinib) in pediatric and adult solid tumors.  And, RET fusion rearrangements in NSCLC, where the paired drug is REVELMO (selpercatinib).  The test also reports TMB.

Illumina stock as trended upward from $110 to $130 over several months, but didn't have any additional bump for this news.  

My reading of the news is that the test will qualify for national coverage under Medicare NCD 90.2, which gives on-label coverage to NGS tests which are companion diagnostics.  Illumina's remarks also state this CMS coverage.

Web Page for TSO FDA

Illumina releases a webpage on the FDA product here.  The workflow is listed as 4-5 days TAT.  Illumina also posts a 21-page datasheet and a 7-page FAQ (includes full gene lists). They remark, "Kits will ship in November 2024."  Kits will run on NextSeq 500Dx.

FOIA on the CMS NCD Backlog - with Notes on "TCET"

See update adding CRC Screening (bottom of this page)

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Recently, CMS released its final verson of TCET - transitional coverage for emerging technologies. 

They say they plan to do up to five TCET NCDs per year.  These are uniquely for FDA breakthrough devices, which will work with CMS up to a year in advance, and which should receive an NCD with CED (coverage with evidence development) within 6 months of FDA approval.

Is it practical?  CED or pragmatic trials are among the hardest types to design well, and few at CMS have clinical trial experience (e.g. working in leadership roles on large clinical trials recently at major universities, or working in pharma as a clinical trial medical director).   In addition, the output of NCDs in the last twelve months was only 4, and one of those was merely deleting an existing NCD (amyloid PET).

The NCD Backlist at CMS.gov

CMS publishes a backlist of NCD requests at CMS.gov - here.

https://www.cms.gov/files/document/ncd-dashboard.pdf

The most recent is from May 15, 2024, and shows 2 NCDs in process, 4 completed in 12 months, and 8 on backlog (request on backlog).

I submitted a FOIA request for NCD requests comprises the backlog, on October 15, 2023.  It arrived today (August 26, 2024).

First, let's compare the August 2023 backlog and the May 2024 backlog (click to enlarge):

click to enlarge

Of 7 NCD requests backlogged in August 2023, one was opened (pulmonary pressure sensor; "status open May 2024").   Two NCDs were added to backlog, raising the total from 7 to 8.

Now let's see some statistics from the 276-page PDF of requests I got from FOIA:

click to enlarge

The NCD requests were from 1.5 to 10.6 years old, with an average of 3.2 years.   

The NCD requests were from 2 to 91 pages long.   Some had a lengthy journal article attachments; others went on with many, many pages of their own original text.   

Some topics (like HPV screening or HCV screening) had multiple requests from different stakeholders over 2 years.

NCD Backlist vs TCET

If CMS has a capacity of 4-6 NCDs per year (including simple ones) and a backlog of five to ten 3-year-old requests, could it add 5 complex CED NCDs per year via the TCET process?  Would they displace most of the non-TCET NCDs?   Or will it all work out OK?

Update: CMS updated the list on 8/15/2024 by adding Colorectal Screening to the top of the list.

  

 

MolDx, Transplants, and the Mysterious Wall Street Journal Reliance on "FOIA"

Earlier this month, I covered a CMS press release that a MolDx LCD regarding transplant genomic test monitoring would not be finalized.  See the August 16 blog here.  Therein I noted there had been 5 or 6 WSJ Op Eds about the topic, since March 2023.  Indeed, the newest WSJ Op Ed on the topic was as recent as August 21, 2024.

One of the Op Eds, on April 18, 2024, was based on FOIA documents from CMS about CareDx and its test coverage.

By coincidence, today, I got a CMS FOIA response of my own on this topic.  (Oddly, my CMS letter arriving in today's email is dated 6/24/2024.)

CMS says it is responding to my FOIA request of 5/2/2024, meaning they are getting back to me in about three months (or less than two months, if you use the letterhead date of 6/24/2024).

But it's downhill from there.

They sent me:

• A letter from Noridian to the Willkie Farr law firm in New York, dated October 20, 2022, which says Noridian FOIA is responding to the law firm's September 21, 2022, letter to Noridian regarding Allosure correspondence.  Noridian says it is working on it.
• A letter from CMS to the Willkie Farr law firm in New York, dated January 3, 2023, referring to another Willkie FOIA request to Noridian (written by Willkie on November 30, 2022, and received by Noridian on December 2, 2022.)  Again, CMS is working on it.
• Then Noridian sends the definitive letter to Willkie Farr on November 9, 2023.  
• Noridian says this pertains to Willkie Farr's September 21, 2022, letter to Noridian.  Noridian completed the document search in May 2023.   
• And Noridian forwarded documents found to CMS in May.  Because, Noridian determined the records regarding Allosure could not be released, but it seems to have conveyed this to Willkie Farr on November 9, 2023.
• Noridian says the unreleasable documents have been forwarded under seal to Office of Program Operations and Local Engagement, and Noridian advises Willkie Farr to pursue any further questions with them (opolefoia@cms.hhs.gov).  

So, it's murky, but the WSJ FOIA documents might have resulted (1) from further Willkie Farr appeals up the food chain at CMS, between November 2023 and March 2024, or (2) from a different chain of events entirely.

Brief Blog: Noridian Releases Updated "MolDx" Webpage

 Noridian lets us know, it has updated a "one stop shopping" webpage for MolDx rules and policies.   

https://med.noridianmedicare.com/web/jeb/policies/moldx

I've made a cut-paste below but it will look better at the actual website (above).

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Molecular Diagnostic Services

The Molecular Diagnostic Services (MolDX) Program was developed by Palmetto GBA in 2011 to identify and establish coverage and reimbursement for molecular diagnostic tests. This program performs the following functions.

• Facilitates detailed and unique identification through registration of molecular diagnostic tests to facilitate claims processing and to track utilization.
• Establishes clinical utility expectations.
• Completes technical assessments of published test data to determine clinical utility and coverage.
• Establishes reimbursement.

View MolDX Molecular Test Registration and Claims Submission

View MolDX: Molecular Test Registration Requirement for Hospital Laboratories

View the Molecular Diagnostic Program (MolDX®) Manual

View the DEX® registry

Claim Submission Reminders

• Submit only one DEX Z-Code® identifier per CPT that requires one
• Submit DEX Z-Code® identifier in Loop 2400/SV101-7
• If no DEX Z-Code® identifier is submitted, CPT will deny unprocessable
• Do not submit any other characters or test names. Doing so will slow claims processing and possibly cause incorrect denials

Noridian’s MolDX LCDs and MolDX Articles

Active MolDX LCDs - View all Active MolDX Local Coverage Determinations (LCDs)

Active MolDX Billing and Coding Articles and Educational Articles - View all active MolDX Billing and Coding and Educational Articles

Proposed MolDX LCDs - View all proposed MolDX LCDs

MolDX Open Public Meetings

Responsibilities

MolDX Contractor	Noridian	Providers in Noridian's Jurisdictions
Determinations regarding coverage Pricing Coordination with Change Healthcare to establish a unique identification numbers Coordination/communication with Noridian on all claims processing guidelines	Implement MolDX guidelines in cooperation with MolDX contractor Process claims using MolDX guidelines Conduct Appeals/Reopenings for claims processing for Noridian providers	Continue to send new test documentation in regards to coverage consideration to MolDX contractor Submit claims to Noridian after unique identifiers have been assigned Send policy/coverage questions to Palmetto at moldx@palmettogba.com Contact Noridian Provider Contact Center with claims processing questions Submit Reopening/Appeals requests to Noridian

Last Updated Aug 20 , 2024

Decibio Webinar on Future of NGS: Online Now by VOD

Header:  There's video-on-demand for the August 20, 2024, multi-panelist webinar from Decibio, on the future of NGS, centralized, decentralized, or too complex to call.

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Decibio sponsored an all-star panel discussing the future of centralized and decentralized NGS, and it's archived in the cloud, viewable with email registration.  (In the process you'll also be given a second step to quickly request a copy of the 6-slide deck that was used.)

https://www.decibio.com/insights/the-future-of-clinical-oncology-next-generation-sequencing-decentralized-vs-centralized-webinar

What to Expect:

• Presentation: Key findings on market structures in NGS
• Panel Discussion: Insights from top experts in the industry
• Q&A Session: Your chance to ask questions and engage with the panel

‍Speakers:

• George Daneker Jr. MD, Chief Clinical Officer, GM of Oncology at Myriad
• Vik Vaz, Head of Strategy, Market Intelligence at Illumina
• David Westenberg, Managing Director, Equity Research at Piper Sandler
• Amber Leigh, Amber Leigh Consulting
• Jerome Madison, Vice President of Product Management at Labcorp
• Shawn Levy, Chief Science Officer at Element Biosciences

I don't want to flag the conclusions in advance, but here are 8 quick takeaways as offered by Chat GPT after it watched the seminar.

1. Centralized labs excel in complex testing and economies of scale.
2. Decentralized labs offer faster results, enhancing patient care access.
3. Regulatory and cost challenges hinder decentralized NGS adoption.
4. Reimbursement for decentralized MRD testing remains uncertain and complex.
5. Liquid biopsy fills gaps where tissue samples are inadequate.
6. Universal germline testing could improve early detection and prevention.
7. Multi-omics expands biological insights but adds complexity.
8. The future likely combines centralized and decentralized NGS models.

AI Tip!

After Chat GPT gave its initial 8 bullets, I asked it to try to put them in a better order [shown above].

AI Humor!

See takeaways expressed "in a verbose and confusing style," and a review of the webinar by comedian Lewis Black - sidebar here.

Brief Blog: FDA Advisory Panel on PDL1 - September 26, 2024

Header: Via the Federal Register, FDA announces an advisory committee on September 26, 2024, to discuss PDL1.  The focus will be on its use with checkpoint inhibitor therapies in gastric cancer.

This blog provides links; a Chat GPT generated summary; and a Scite.ai generated mini-review.  It closes with a Chat GPT comparison of two versions of the Scite.ai output.

Links:

FDA in Fed Reg:

https://public-inspection.federalregister.gov/2024-18970.pdf

Coverage in STAT:

https://endpts.com/fda-to-host-adcomm-on-pd-l1-as-a-predictive-biomarker-for-checkpoint-inhibitors/

New Nature Cancer paper (Bergstrom) on better biomarkers for immuno-oncology, here.

AI CORNER

Chat GPT 4o:

FDA to Host Advisory Committee Meeting on 

Immune Checkpoint Inhibitors for

Gastric and Esophageal Cancers

The FDA has scheduled an important advisory committee meeting on September 26, 2024, to discuss the use of immune checkpoint inhibitors in treating unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma, as well as esophageal squamous cell carcinoma. 

This meeting is of particular interest to those involved in oncology and biomarker research, as it will address the role of PD-L1 expression as a predictive [drug selection] biomarker for these treatments.

Meeting Objectives

The Oncologic Drugs Advisory Committee (ODAC) will evaluate several key topics during the meeting:

• PD-L1 as a Predictive Biomarker: The committee will examine the current evidence supporting PD-L1 expression as a biomarker for predicting the efficacy of immune checkpoint inhibitors in these cancer types.
• Subpopulation Risk-Benefit Analysis: The committee will consider how differences in PD-L1 expression might affect the risk-benefit profile of these treatments across various patient subgroups.
• [For example, if high expressors have a 50% chance of response, and low expressors have a 30% chance of response, they might both be treated, but the risk/benefit profile is stronger for high expressors. BQ]
• Consideration of Approval Restrictions: The discussion will also focus on whether the FDA should limit the approval of immune checkpoint inhibitors to patients with specific PD-L1 expression levels.

Relevance to Biomarker Development

The outcomes of this meeting may have implications for the future of biomarker-driven treatment strategies, particularly in refining the use of immune checkpoint inhibitors based on PD-L1 expression. This could impact ongoing and future research efforts aimed at improving the precision and effectiveness of cancer immunotherapies.

Participation and Comments

The FDA invites public participation in this meeting. Stakeholders can submit comments electronically or in writing until September 25, 2024, and may attend the meeting either in person at the FDA's White Oak Campus or virtually. The FDA has established a public docket to collect and consider these comments.

Conclusion

This FDA advisory committee meeting will address critical regulatory questions regarding the use of PD-L1 as a biomarker in the treatment of certain cancers. The discussion and any resulting decisions could influence the development and application of more targeted cancer therapies in the future.

SCITE.AI Mini Review (Auto)

Note that below this article and citations, there is another one, focused on 2022-2023-2024.

The role of PD-L1 as a predictive biomarker for checkpoint inhibitor therapy in gastric and esophageal cancers has garnered significant attention in recent years. PD-L1 expression is often evaluated to predict patient responses to immune checkpoint inhibitors (ICIs), particularly in the context of gastric and esophageal adenocarcinomas. However, the predictive value of PD-L1 is complex and varies across studies and clinical settings.

PD-L1 expression has been recognized as a potential biomarker for selecting patients who may benefit from PD-1/PD-L1 inhibitors. In gastric cancer, studies have indicated that PD-L1 overexpression can be found in approximately 40% of cases, suggesting that a substantial subset of patients may be candidates for immunotherapy (Shaib et al., 2016). However, the predictive capability of PD-L1 alone is often described as modest. For instance, the KEYNOTE-061 trial demonstrated that pembrolizumab did not significantly improve overall survival in gastric cancer patients, even among those with high PD-L1 expression (Cheong et al., 2022). This finding underscores the need for additional biomarkers or combined approaches to enhance predictive accuracy.

Moreover, the clinical utility of PD-L1 as a standalone biomarker is limited due to variability in testing methodologies and interpretation of results. Different immunohistochemistry (IHC) assays and scoring systems have been developed, but discrepancies in cut-off thresholds and inter-reader concordance remain challenges (Alderdice et al., 2021; Lu et al., 2019). This variability can lead to inconsistent patient stratification for ICI therapy, emphasizing the necessity for more robust and standardized biomarker assessments.

In addition to PD-L1, other biomarkers such as microsatellite instability (MSI) and tumor mutational burden (TMB) are also critical in predicting responses to ICIs. MSI-H status, for example, has been associated with favorable responses to PD-1 inhibitors in various cancers, including gastric cancer (Chao et al., 2021). The integration of PD-L1 testing with these other biomarkers may provide a more comprehensive predictive framework, potentially improving patient outcomes.

Recent research has also explored the functional aspects of PD-L1 binding to its receptor PD-1 as a predictor of response to therapy. This approach aims to assess not just the presence of PD-L1 but its functional activity, which may correlate more closely with therapeutic efficacy (Herpe & Cutsem, 2023). Such advancements could refine patient selection and enhance the effectiveness of immunotherapy in gastric and esophageal cancers.

In conclusion, while PD-L1 serves as a valuable biomarker for predicting responses to checkpoint inhibitor therapy in gastric and esophageal cancers, its predictive power is enhanced when considered alongside other biomarkers and functional assessments. Ongoing research is essential to establish more reliable and standardized approaches for biomarker evaluation, ultimately leading to improved patient stratification and therapeutic outcomes.

References:

Alderdice, M., Craig, S., Humphries, M., Gilmore, A., Johnston, N., Bingham, V., … & McArt, D. (2021). Evolutionary genetic algorithm identifies il2rb as a potential predictive biomarker for immune-checkpoint therapy in colorectal cancer. Nar Genomics and Bioinformatics, 3(2). https://doi.org/10.1093/nargab/lqab016

Chao, J., Fuchs, C., Shitara, K., Tabernero, J., Muro, K., Cutsem, É., … & Wainberg, Z. (2021). Assessment of pembrolizumab therapy for the treatment of microsatellite instability–high gastric or gastroesophageal junction cancer among patients in the keynote-059, keynote-061, and keynote-062 clinical trials. Jama Oncology, 7(6), 895. https://doi.org/10.1001/jamaoncol.2021.0275

Cheong, J., Wang, S., Park, S., Porembka, M., Christie, A., Kim, H., … & Hwang, T. (2022). Development and validation of a prognostic and predictive 32-gene signature for gastric cancer. Nature Communications, 13(1). https://doi.org/10.1038/s41467-022-28437-y

Herpe, F. and Cutsem, É. (2023). The role of cmet in gastric cancer—a review of the literature. Cancers, 15(7), 1976. https://doi.org/10.3390/cancers15071976

Lu, S., Stein, J., Rimm, D., Wang, D., Bell, M., Johnson, D., … & Taube, J. (2019). Comparison of biomarker modalities for predicting response to pd-1/pd-l1 checkpoint blockade. Jama Oncology, 5(8), 1195. https://doi.org/10.1001/jamaoncol.2019.1549

Shaib, W., Nammour, J., Gill, H., Mody, M., & Saba, N. (2016). The future prospects of immune therapy in gastric and esophageal adenocarcinoma. Journal of Clinical Medicine, 5(11), 100. https://doi.org/10.3390/jcm5110100

PLEASE FOCUS ONLY ON 2022-2023-2024 PAPERS

The predictive value of PD-L1 biomarkers in checkpoint inhibitor therapy for gastric and esophageal cancers has been a focal point of recent research. PD-L1 expression is often used to guide treatment decisions for immune checkpoint inhibitors (ICIs), particularly in advanced gastric and esophageal cancers. However, the efficacy of PD-L1 as a standalone predictive biomarker is nuanced and varies across studies.

Recent literature indicates that PD-L1 expression correlates with the response to ICIs in gastric cancer. For instance, a study by highlights that a PD-L1 combined positive score (CPS) of ≥5 is associated with increased efficacy of PD-1 checkpoint inhibitors in advanced gastric cancer (Jang et al., 2023). This suggests that PD-L1 can serve as a useful biomarker for patient selection in this context. However, the predictive capability of PD-L1 is often described as modest. noted that while PD-L1 expression is a common criterion for therapy selection, its predictive power alone is limited, as evidenced by the KEYNOTE-061 trial, which found no significant survival benefit from pembrolizumab in patients with high PD-L1 expression (Cheong et al., 2022).

In esophageal cancer, the relationship between PD-L1 expression and treatment outcomes is similarly complex. The JUPITER-06 trial demonstrated that PD-L1 levels on tumor cells positively correlated with the efficacy of PD-1 blockade combined with chemotherapy (Wang et al., 2022). This finding reinforces the notion that PD-L1 can be a valuable biomarker in this setting, although the variability in expression levels and the existence of other predictive factors complicate its use.

Moreover, the integration of PD-L1 testing with other biomarkers, such as tumor mutational burden (TMB) and microsatellite instability (MSI), is gaining traction. emphasized that TMB status and PD-L1 expression are independent biomarkers that can enhance predictive accuracy for PD-1 inhibitors (Jang et al., 2023). This multi-biomarker approach may improve patient stratification and therapeutic outcomes in both gastric and esophageal cancers.

Furthermore, emerging research is exploring the functional aspects of PD-L1 binding to PD-1 as a predictor of treatment response. suggest that the functional binding of PD-L1 ligands may provide a more accurate prediction of response to anti-PD-1 treatments, highlighting the need for further investigation into the functional dynamics of PD-L1 in the tumor microenvironment (Kaufman et al., 2023; Kaufman, 2023). This perspective could lead to more refined predictive models that incorporate both expression levels and functional activity.

In summary, while PD-L1 serves as a significant biomarker for predicting responses to checkpoint inhibitor therapy in gastric and esophageal cancers, its predictive value is enhanced when considered alongside other biomarkers and functional assessments. Ongoing research is essential to establish more standardized and reliable approaches for biomarker evaluation, ultimately leading to improved patient outcomes.

References:

Alderdice, M., Craig, S., Humphries, M., Gilmore, A., Johnston, N., Bingham, V., … & McArt, D. (2021). Evolutionary genetic algorithm identifies il2rb as a potential predictive biomarker for immune-checkpoint therapy in colorectal cancer. Nar Genomics and Bioinformatics, 3(2). https://doi.org/10.1093/nargab/lqab016

Chao, J., Fuchs, C., Shitara, K., Tabernero, J., Muro, K., Cutsem, É., … & Wainberg, Z. (2021). Assessment of pembrolizumab therapy for the treatment of microsatellite instability–high gastric or gastroesophageal junction cancer among patients in the keynote-059, keynote-061, and keynote-062 clinical trials. Jama Oncology, 7(6), 895. https://doi.org/10.1001/jamaoncol.2021.0275

Cheong, J., Wang, S., Park, S., Porembka, M., Christie, A., Kim, H., … & Hwang, T. (2022). Development and validation of a prognostic and predictive 32-gene signature for gastric cancer. Nature Communications, 13(1). https://doi.org/10.1038/s41467-022-28437-y

Cheong, J., Wang, S., Park, S., Porembka, M., Christie, A., Kim, H., … & Hwang, T. (2022). Development and validation of a prognostic and predictive 32-gene signature for gastric cancer. Nature Communications, 13(1). https://doi.org/10.1038/s41467-022-28437-y

Herpe, F. and Cutsem, É. (2023). The role of cmet in gastric cancer—a review of the literature. Cancers, 15(7), 1976. https://doi.org/10.3390/cancers15071976

Jang, J., Jeon, Y., Jeong, S., Lim, S., Kang, W., Lee, J., … & Kim, S. (2023). The optimal tumor mutational burden cutoff value as a novel marker for predicting the efficacy of programmed cell death-1 checkpoint inhibitors in advanced gastric cancer. Journal of Gastric Cancer, 23(3), 476. https://doi.org/10.5230/jgc.2023.23.e29

Kaufman, B. (2023). Functional binding of pd1 ligands predicts response to anti-pd1 treatment in patients with cancer. Science Advances, 9(21). https://doi.org/10.1126/sciadv.adg2809

Kaufman, B., Abramov, O., Yevko, A., Apple, D., Shlapobersky, M., Greenshpan, Y., … & Porgador, A. (2023). Functional binding of pd1 ligands predicts response to anti-pd1 treatment in cancer patients.. https://doi.org/10.1101/2023.02.09.527671

Lu, S., Stein, J., Rimm, D., Wang, D., Bell, M., Johnson, D., … & Taube, J. (2019). Comparison of biomarker modalities for predicting response to pd-1/pd-l1 checkpoint blockade. Jama Oncology, 5(8), 1195. https://doi.org/10.1001/jamaoncol.2019.1549

Shaib, W., Nammour, J., Gill, H., Mody, M., & Saba, N. (2016). The future prospects of immune therapy in gastric and esophageal adenocarcinoma. Journal of Clinical Medicine, 5(11), 100. https://doi.org/10.3390/jcm5110100

Wang, Z., Cui, C., Yao, J., Zhang, Y., Li, M., Feng, J., … & Wang, F. (2022). Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (jupiter-06): a multi-center phase 3 trial. Cancer Cell, 40(3), 277-288.e3. https://doi.org/10.1016/j.ccell.2022.02.007

CHAT GPT 4o:  

Please compare the FIRST SCITE article and the SECOND SCITE (2022 2023 2024) article.

Comparison of Data and Conclusions in ARTICLE ONE and ARTICLE TWO

Both ARTICLE ONE and ARTICLE TWO focus on the role of PD-L1 as a predictive biomarker for checkpoint inhibitor therapy in gastric and esophageal cancers, but they approach the topic with slight differences in emphasis and scope.

1. Predictive Value of PD-L1 as a Standalone Biomarker:

• ARTICLE ONE emphasizes that PD-L1 is recognized as a potential biomarker, but its predictive capability is often described as modest. The article points out the variability in results across different studies and clinical settings. It highlights the KEYNOTE-061 trial, which found that pembrolizumab did not significantly improve overall survival in gastric cancer patients with high PD-L1 expression, suggesting that PD-L1 alone may not be sufficient as a predictive biomarker.
• ARTICLE TWO echoes this sentiment, acknowledging that while PD-L1 expression correlates with responses to ICIs, its predictive power alone is limited. It also references the KEYNOTE-061 trial, underscoring the modest nature of PD-L1’s predictive capability in both gastric and esophageal cancers.

2. Variability and Limitations in PD-L1 Testing:

• ARTICLE ONE discusses the limitations of PD-L1 as a biomarker due to variability in testing methodologies, such as differences in immunohistochemistry (IHC) assays and scoring systems. This variability leads to challenges in consistent patient stratification for ICI therapy.
• ARTICLE TWO similarly notes the complexity of using PD-L1 as a standalone biomarker due to variability in expression levels and other predictive factors. However, it focuses more on the need to integrate PD-L1 testing with other biomarkers to improve predictive accuracy.

3. Integration with Other Biomarkers:

• ARTICLE ONE emphasizes the importance of considering other biomarkers, such as microsatellite instability (MSI) and tumor mutational burden (TMB), alongside PD-L1 to improve the predictive framework. The article suggests that a combined approach might enhance patient outcomes and addresses the need for more comprehensive assessments.
• ARTICLE TWO also stresses the value of integrating PD-L1 with other biomarkers like TMB and MSI. It highlights recent literature that supports a multi-biomarker approach, which could potentially improve patient stratification and therapeutic outcomes in gastric and esophageal cancers.

4. Functional Aspects of PD-L1:

• ARTICLE ONE touches on emerging research exploring the functional aspects of PD-L1 binding to its receptor PD-1 as a more accurate predictor of therapy response. This research could refine patient selection and enhance immunotherapy effectiveness.
• ARTICLE TWO delves deeper into this area, suggesting that the functional binding of PD-L1 ligands might offer a more precise prediction of response to PD-1 inhibitors. The article cites ongoing research that could lead to the development of more refined predictive models incorporating both expression levels and functional activity.

5. Conclusion:

• ARTICLE ONE concludes that while PD-L1 is valuable as a biomarker, its predictive power is enhanced when used alongside other biomarkers and functional assessments. The article emphasizes the need for ongoing research to establish more standardized approaches for biomarker evaluation.
• ARTICLE TWO reaches a similar conclusion, affirming the importance of PD-L1 as a significant biomarker while advocating for a more comprehensive approach that includes other biomarkers and functional assessments. The article also underscores the necessity of further research to improve biomarker reliability and patient outcomes.

Summary of Comparison:

Both articles agree on the modest predictive value of PD-L1 as a standalone biomarker and advocate for its integration with other biomarkers to enhance accuracy. They both highlight the variability in PD-L1 testing and the potential of functional assessments to improve predictive models. The articles conclude with a similar call for ongoing research to refine and standardize biomarker evaluation methods, ultimately aiming to improve patient stratification and therapeutic outcomes in gastric and esophageal cancers.

Why a Texas Ruling Against FTC Bolsters the ACLA/AMP Lawsuits About LDTs

Header: Explain why a Texas federal court decision which throws out an FTC regulation, is good news for the legal efforts to derail FDA control of LDTs.

##

Update: See an August 26 NYT article on the Fifth Circuit (LA/TX) and the conservative judges in Texas that feed into it.

Update: See an article where a Texas judge vacates an HHS ruling against hospitals web-tracking visitors; "promulgated in clear excess of HHS's authority under HIPAA;"  here.

• The latter, by Judge Pittman, is a wild read citing everyone from Thomas Jefferson to the Book of Luke, and affirming that sending the ACLA and AMP cases to Texas (in 2 different districts) is like throwing a T-bone steak to a den of hungry tigers.

##

On August 20, 2024, a Trump-appointed judge in Texas (Ada Brown), struck down a recent Biden FTC regulation that (1) banned noncompete agreements nationally, and (2) disempowered them retroactively as well.

Here's the judge's 24-page ruling.   Here's the WSJ article explaining it.

Traditionally, non-competes have been creatures of state law.  They're generally not valid in California, and generally OK in Texas (WSJ).

Paragraphs the ACLA and AMP Would Love to See

My copies of both documents are heavily highlighted in yellow.  

First, the judge agrees with plaintiffs that the FDA lacks statutory authority to make substantive regulations.  Indeed, it has rarely done so (although a few in the 1960s survived court challenges then.)  As WSJ summarizes, "The commission's authority to police unfair methods of competition, couldn't be used to issue [regulations] banning an entire category of conduct."  The judge wrote, an agency does what it is "told [to do] by Congress, not [what] the agency thinks it should do."  

On separate grounds, the judge ruled the FTC ban was arbitrary and capricious "because  it was unreasonably overbroad."   

Per WSJ ,the judge also wrote, that FTC can limit "deceptive practices that mislead consumers," not "how firms compete" in general (outside of deceptive consumer practices.)

The scope of the ruling is nationwide, not just Texas, and fits a "conservative Supreme Court that has taken a dim view of government agencies invoking new regulatory powers" [WSJ].

As I've remarked on the ACLA FDA case, a change in administration could be highly impactful.  DJT is going to poll noticeably better with the endorsement of RFK Jr (who has about 5% of voters behind him).  A second DJT administration might elect not to appeal a [possible] FDA LDT loss and its injunction blocking the FDA LDT rule.

The Judge's Ruling

The ruling contains numerous conclusions or even paragraphs that would fit into a negative ruling against the FDA LDT regulation.   In particular, the Texas judge writes, "The Rule is based on inconsistent and flawed empirical evidence, fails to consider the positive benefits [of non-compete agreements], and disregards the substantial body of evidence supprting these agreements."  A judge could use the same sentences to say she agrees with arguments in the ACLA and the AMP cases against the FDA ruling.  And the judge notes there is no question that judges can set aide regulations; they have explicit authority to do so in the Administrative Procedures Act (quoting that "APA directs the reviewing court to hold unlawful and set aside agency action, findings, and conclusions found to be arbitrary and capricious.")   

And - The appeals court for Texas (the Fifth Circuit) takes the position that such APA-based bans have "nationwide effect, are not party restricted, and affect persons in all judicial districts equally."  

There's another fit with ACLA-AMP - obviously, ACLA and AMP don't want the FDA LDT regulation set aside solely in Texas.  

Judge and Plain Meaning

The judge notes that the FTC's regulatory authority - if it exists - is buried in a reading of a phrase deep inside a lengthy section of statute about investigatory powers (holding hearings, etc).  She writes that "the appropriate starting point when interpreting any statute is its plain meaning."   Similar, the ACLA and AMP cases that the plain meaning of the words "a medical device" in 1976 did not include a complex multi-day laboratory procedure across many people and many independent machines.   

For example, it seems unlikely to me that FDA can find a 1976 dictionary would refer to laboratory procedures as "medical device.s" Or that FDA can find a 1976 university course in "medical devices" whose syllabus or textbook including laboratory developed test operations as a chapter right alongside "medical devices" like pacemakers, heart valves, prosthetics, and glucose meters.  

AI Corner

Chat GPT 4o summarizes the court case, and answers some of my (non-attorney) questions about it.

###

In the recent Texas federal court case presided over by Judge Ada Brown, the court ruled against the Federal Trade Commission (FTC) concerning its "Non-Compete Rule." This rule, introduced by the FTC, sought to ban most non-compete agreements nationwide and required existing agreements to be rescinded.

Case Background and Parties Involved

The case was brought forward by the plaintiff Ryan, LLC, along with several prominent business organizations, including the Chamber of Commerce of the United States of America, Business Roundtable, Texas Association of Business, and Longview Chamber of Commerce (collectively referred to as "Plaintiffs"). The plaintiffs challenged the FTC's authority to enforce this new regulation, arguing that it exceeded the statutory powers granted to the FTC by Congress.

Key Legal Issues

1. FTC's Statutory Authority: The central issue in this case was whether the FTC had the statutory authority under the Federal Trade Commission Act (FTC Act) to promulgate the Non-Compete Rule. The FTC argued that its authority to issue such a rule derived from Section 6(g) of the FTC Act, which allows the Commission to "make rules and regulations for the purpose of carrying out the provisions of this subchapter."

2. Arbitrary and Capricious Standard: The plaintiffs also argued that the FTC's rule was arbitrary and capricious. They contended that the FTC failed to adequately consider the economic impact and benefits of non-compete agreements and that the rule was overly broad without sufficient justification.

Court's Findings

1. Exceeding Statutory Authority: Judge Brown ruled that the FTC exceeded its statutory authority in issuing the Non-Compete Rule. The court emphasized that while the FTC Act grants the FTC certain powers, including the prevention of unfair methods of competition, it does not explicitly authorize the creation of substantive rules such as the Non-Compete Rule. The court noted that Section 6(g) of the FTC Act, which the FTC cited as the basis for its authority, primarily concerns procedural and housekeeping matters rather than substantive rulemaking.

2. Arbitrary and Capricious: The court also found that the FTC's rule was arbitrary and capricious. The judge noted that the rule was based on flawed empirical evidence and failed to consider important benefits of non-compete agreements, such as protecting trade secrets and fostering business investments. Additionally, the court criticized the FTC for not adequately exploring less restrictive alternatives to a complete ban on non-compete agreements.

3. Nationwide Impact: The court's ruling emphasized that the decision to set aside the FTC's rule would have nationwide implications. The court referenced the Administrative Procedures Act (APA), which directs courts to hold unlawful and set aside agency actions that exceed statutory authority or are arbitrary and capricious. This ruling, therefore, effectively nullifies the FTC's Non-Compete Rule across the entire United States.

Conclusion

Judge Ada Brown's decision to strike down the FTC's Non-Compete Rule highlights significant limitations on the regulatory powers of federal agencies like the FTC. By ruling that the FTC lacked the authority to issue such a sweeping regulation and that the rule was arbitrary and capricious, the court reinforced the principle that federal agencies must operate within the bounds of the authority explicitly granted to them by Congress. This ruling is particularly relevant in the broader context of ongoing legal challenges to other federal agency regulations, including those concerning Laboratory Developed Tests (LDTs), as it underscores the judiciary's role in checking potential overreach by administrative bodies.

##

It seems the judge doesn't really answer clearly enough why black and white authority to issue "regulations" carrying out the statute, doesn't include this type of regulation, which FTC argues is merely a regulation to carry out its known scope of authority.

The judge has to deal with the black letter of statute giving authority to make regulations to carry out FTCs scope.

You're right that the judge in this case had to navigate the tension between the FTC's statutory authority to issue regulations and the specific challenge to the Non-Compete Rule. While the statute does give the FTC the authority to issue regulations, the judge found that this authority doesn't extend as far as the FTC claimed.

Key Points in the Judge's Reasoning:

1. Scope of Regulatory Authority (Section 6(g)):

   • The judge acknowledged that the FTC has statutory authority under Section 6(g) of the FTC Act to "make rules and regulations for the purpose of carrying out the provisions of this subchapter." However, she concluded that this authority is limited to procedural or "housekeeping" rules rather than substantive rules like the Non-Compete Rule.
   • The court argued that Section 6(g) is primarily concerned with the administrative functions necessary to enforce the FTC Act, such as classifying corporations or setting procedures for hearings, rather than creating new substantive obligations that directly impact broad sectors of the economy.

2. Lack of Historical Precedent and Penalty Provisions:

   • The judge pointed out that for the first several decades of its existence, the FTC did not assert that it had substantive rulemaking authority under Section 6(g). It wasn’t until 1962 that the FTC began to issue substantive rules, and even then, the court noted that this was not consistent with earlier interpretations of the agency’s power.
   • Importantly, the court highlighted the absence of statutory penalties for violating rules made under Section 6(g), which is a hallmark of substantive rulemaking authority. In contrast, when Congress intends for an agency to have substantive rulemaking power, it typically includes explicit penalties for violations, underscoring that the rules have the force of law.

3. Textual and Structural Interpretation:

   • The judge relied heavily on a textual and structural analysis of the FTC Act, emphasizing that substantive rulemaking powers are not mentioned explicitly in Section 6(g) and are instead focused on in other sections like Section 18, which deals with unfair or deceptive acts or practices.
   • The court reasoned that the placement and wording of Section 6(g) within the broader statutory scheme suggest it was not intended to confer broad substantive rulemaking authority. The judge saw Section 6(g) as a provision meant to support the procedural and investigatory functions of the FTC, not to enable the agency to create entirely new categories of prohibited conduct like the Non-Compete Rule.

4. Judicial Precedent and Congressional Intent:

   • The ruling leaned on judicial precedent that emphasizes the need for clear congressional authorization for substantive rulemaking. The court highlighted that the judiciary remains the final authority on statutory construction and that agencies cannot expand their powers beyond what Congress has explicitly provided.
   • The judge also referenced amendments to the FTC Act over time, noting that when Congress wanted to grant the FTC substantive rulemaking authority (e.g., in the context of consumer protection under the Magnuson-Moss Act), it did so explicitly and included specific procedural safeguards, which were absent in Section 6(g).

Conclusion:

The judge’s reasoning centers on the interpretation that while the FTC does have authority to issue regulations, the kind of substantive, economy-wide rule represented by the Non-Compete Rule exceeds what Congress intended when it granted the FTC the authority to make rules under Section 6(g). The ruling suggests that the authority to make rules “to carry out the provisions of this subchapter” was intended more for procedural and administrative regulations rather than for broad, substantive changes to competition law, which Congress did not explicitly authorize the FTC to undertake.

##

Yes, but the judge also quotes some regulations of the FTC that withstood challenge in the 1960s at the appellate level - though in a different circuit. She notes those "wins" for FTC regulations in court, but seems to forget about them thereafter.

Indeed, the judge does mention earlier instances where the FTC successfully defended its rulemaking authority in the 1960s, particularly in the National Petroleum Refiners Association v. FTC case. In that case, the D.C. Circuit Court upheld the FTC's authority to promulgate substantive rules under Section 6(g). This precedent was significant because it recognized the FTC's ability to issue binding rules, even in the absence of explicit congressional authorization for substantive rulemaking.

The Judge's Treatment of the 1960s Precedent:

1. Acknowledgment of Precedent:

   • The judge does acknowledge the FTC's earlier success in defending its substantive rulemaking authority in the National Petroleum case, where the D.C. Circuit upheld the agency's power under Section 6(g) to issue Trade Regulation Rules. This case was a key moment in the FTC's history, as it marked the first time the agency asserted its authority to create substantive rules with the force of law.

2. Distinguishing the Current Case:

   • Despite this precedent, the judge distinguishes the present case from those earlier rulings. She points out that while the National Petroleum decision supported the FTC's rulemaking authority, it did so under a specific set of circumstances and within a different legal and regulatory context.
   • The judge emphasizes that the statutory and regulatory landscape has evolved since the 1960s, particularly with the passage of the Magnuson-Moss Warranty—Federal Trade Commission Improvement Act in 1975, which explicitly granted the FTC rulemaking power in certain areas but also imposed procedural safeguards and limitations.

3. Historical Context and Congressional Intent:

   • The judge argues that the National Petroleum decision, while valid in its time, does not necessarily reflect the broader intent of Congress regarding the FTC's authority under Section 6(g). She suggests that Congress's subsequent actions, including the Magnuson-Moss Act, indicate a more limited view of the FTC's rulemaking power.
   • The judge also notes that the FTC did not consistently assert substantive rulemaking authority after National Petroleum, which suggests some uncertainty or reluctance on the part of the agency to fully embrace or test this authority in other contexts.

4. Downplaying the 1960s Wins:

   • After acknowledging these earlier wins, the judge seems to downplay their significance by focusing on the lack of substantive rulemaking by the FTC in the decades that followed. She argues that the FTC's lack of action in this area for many years, coupled with subsequent congressional amendments that specifically addressed rulemaking authority, undermines the applicability of the 1960s precedent to the present case.
   • The judge's decision to emphasize more recent legal and legislative developments suggests a preference for a more constrained interpretation of the FTC's authority, one that aligns with the view that substantive rulemaking requires explicit and unambiguous congressional authorization.

Conclusion:

While the judge does acknowledge the FTC's earlier legal victories regarding its rulemaking authority, she ultimately downplays their relevance to the current case. Her reasoning is that the legal and regulatory context has changed since those decisions, and that more recent developments, including the Magnuson-Moss Act and the FTC's own historical behavior, suggest a more limited scope for the agency's substantive rulemaking authority under Section 6(g). In doing so, the judge appears to prioritize a more recent and restrictive interpretation of the FTC's powers, which aligns with her overall conclusion that the Non-Compete Rule exceeds the FTC's statutory authority.