Thursday, June 13, 2024

MedPAC Issues Annual June Report: Software in Medicare and Hospital-at-Home

Each June, MedPAC releases a lengthy Report to Congress on a selected list of Medicare policy topics.  The June 2024 edition is out.

Particularly novel or interesting chapters include:

  • Paying for software technologies in Medicare
  • Medicare's Acute Hospital Care-at-Home Program
  • Medicare Advantage: Prior Auth & Narrow Networks
Find the 269-page report here:


AI Corner

I gave the 30-page chapter on software to GPT4 for a summary, as below.  The actual chapter defies such a short summary, with many interesting tables and examples of CMS pricing history and complicated, different evolving policies for software.   MedPAC is always highly in favor of bundling - they never saw a service they didn't think was benefited by bundling rather than paid separately, and this is clear in the last several pages of the software chapter.   But, at a higher level, here's a good AI summary.

This MeddPAC report on CMS payments for software technologies in Medicare is extensive and detailed, focusing on the evolving landscape of software as a medical device (SaMD) in healthcare, particularly how these technologies are integrated, regulated, and reimbursed within the Medicare system. Here is a detailed summary, highlighting dilemmas and key points relevant to diagnostic tests:


The increased reliance on software technologies in healthcare, including AI and machine learning applications, poses new challenges and opportunities for Medicare. Technologies such as clinical decision support software and computer-aided detection (CAD) systems are growing more sophisticated, requiring updated regulatory and payment frameworks.

FDA Approval and Medicare Coverage

Software technologies must receive FDA clearance or approval as SaMD before they are eligible for Medicare coverage. The FDA classifies these technologies based on risk, and there are different pathways for their approval: premarket notification (510(k)), De Novo classification, and premarket approval (PMA).

Medicare Payment Systems

Medicare covers and pays for SaMD under various systems:

  • Part A and Part B services: Coverage depends on the software fitting into a Medicare benefit category and being reasonable and necessary for diagnosis or treatment.
  • Outpatient Prospective Payment System (OPPS) and Physician Fee Schedule (PFS): SaMD can be separately payable or bundled with other services, with specific codes assigned for billing purposes.

Dilemmas in Payment and Coverage

  1. Balancing Innovation and Cost: Medicare must balance the encouragement of innovation with the need to control costs and prevent overpayment for technologies that could be bundled with other services.
  2. Service Integration: Deciding whether a new technology should be paid separately or as part of a bundled payment presents a significant challenge, especially as some software can perform functions independently of hardware devices.

Diagnostic Tests: Specific Insights

  • Software used in radiology, pathology, and genetics, such as CAD systems for diagnostic imaging and AI-driven analysis tools, is critical. These systems analyze medical images and data to assist in diagnosis and management but pose unique challenges for integration into Medicare’s payment frameworks.
  • Technologies like the LumineticsCore for detecting diabetic retinopathy and CAD systems used in radiological assessments are examples where Medicare provides coverage under specific conditions.

Policy Recommendations

The report suggests continued evaluation and adjustment of payment models to accommodate the rapid advancement of medical software technologies. This includes considering the implications of AI and machine skill learning, where software not only supports but potentially replaces human decision-making in clinical settings.

This summary addresses the critical points of integrating new medical software technologies into the Medicare framework, focusing on both the potential benefits and the complexities of ensuring effective coverage and reimbursement without stifling innovation or increasing costs disproportionately. [/end chatgpt 4]

Medicare MACs Finalized LCDs for KidneyIntelX (NGS MAC) and Thyroid Nodule Stratification (MolDx)

 Two new final LCDs have been posted on June 13, 2024.


NGS MAC posts final version of L39726, "KidneyIntelX and KidneyIntelX.dkd Testing."  The process reflects a public meeting (CAC meeting) on August 24, 2023 (17pp; see link within LCD). NGS MAC writes,

  • “The current evidence concerning KidneyIntelX or KidneyIntelX.dkd as a test to identify and stratify patients with T2D and early-stage CKD into low, intermediate, and high risk for near-term rapid progressive decline in kidney function, suggests that the early identification of high-risk patients by the test allows for more intensive patient management, selection of appropriate medications, and appropriate specialty referral or consultation.”
  • “Also, the clinical principles, that more proactive care leads to better health outcomes and improved quality of life for patients, including slowed disease progression, avoidance or delay of kidney failure and need for hemodialysis, were supported by our CAC Subject Matter Experts.”

See LCD L39726 here.  Response to comments A59758 here.  Coding article A59595 here.

The LDT form of the test is "Kidney Intel X" while the FDA-cleared form of the text has the FDA-provided suffix ".dkd".   The text is coded as 0407U, $950.   

  • The code text is, "Nephrology (diabetic chronic kidney disease [ckd]), multiplex electrochemiluminescent immunoassay (eclia) of soluble tumor necrosis factor receptor 1 (stnfr1), soluble tumor necrosis receptor 2 (stnfr2), and kidney injury molecule 1 (kim-1) combined with clinical data, plasma, algorithm reported as risk for progressive decline in kidney function."
Share price for Renalytix has been as high as $32 (2021) and is currently trading around 45 cents, for a market cap of $35M. For the fiscal year ending June 2023, per Yahoo Finance, revenue was $3.4M and operating income negative $44M.  


Palmetto and other MolDx MACs post the final version of L39646, a foundational (general) LCD for thyroid nodule risk stratification,

Find LCD L39646 here.  Response to comments A59734 here.   Coding article A59470 here.

The LCD, effective in August 2024, is based on a request letter from Veracyte dated January 12, 2022.

Updates to the coverage bullet points were minor.  The LCD states somewhat obliquely that "if the patient has multiple nodules, concurrent or reflex testing may be medically necessary."  The Q&A document clarifies that if a nodule is positive for potential malignancy, indicating surgery, then testing of additional nodules on that side are not necessary (which makes sense).


I believe that the Veracyte Afirma test had previously been covered under a general-purpose LCD ("Molecular Diagnostic Tests L35160") and a short billing and coding article which will soon be retired (A54356).   Veracyte's request letter (2022) had been to include the Afirma MTC test as well as creating a broader (open ended or foundational) LCD.  MTC is a test version for medullary thyroid cancer.  In early trading on Thursday, Veracyte (VCYT) was down 2% at $21.62.  Its five-year high was $73 in 2021, low at $15 in late 2022.




It can be difficult to predict a consensus for market demand and market response in diagnostics (e.g. the share price of Renalytix ranges from $32 to <$1 in a couple years, during which, they hit progressive benchmarks like FDA approval).   I found the book "Heart of Innovation" helpful in thinking about utility cases and market response.


AI Corner.

Here is a Chat GPT 4 summary of the 17-page NGS MAC renal transcript.

The CMS transcript presents a detailed Contractor Advisory Committee (CAC) meeting conducted by Dr. Gina Mullen on August 24, 2023, focusing on the KidneyIntelX test, an AI-enabled prognostic testing platform. This test is intended to guide care management for adults with type 2 diabetes and chronic diabetic kidney disease. Key points discussed include:

  1. Overview and Purpose: Dr. Gina Mullen outlined the meeting's purpose—to evaluate medical evidence regarding the KidneyIntelX test as outlined in CMS IOM Publication 100-08, Chapter 13, Section Renalytix introduced two versions of the test, KidneyIntelX and KidneyIntelX.dkd, with the latter distinguished by a suffix and targeted for different CKD-EPI equations used in clinical practice.

  2. Expert Panel: A panel of five experts—Dr. Maryam Gondal, Dr. Jeffrey Rimmer, Dr. Mike Ross, Dr. Charles Jacobs, and Dr. Catherine Kimball—introduced themselves and confirmed no conflicts of interest. They represent diverse institutions and bring significant expertise in nephrology and family practice.

  3. Scientific and Clinical Evaluation: The panel engaged in a structured discussion based on 12 key questions addressing the scientific basis, clinical utility, and potential impact of the KidneyIntelX test. Topics included the adequacy of published evidence, the prognostic capability of the test, and its role in improving health outcomes and clinical management practices.

  4. Evidence Review and Discussion: Highlights from the discussion include:

    • Prognostic Utility: Dr. Gondal supported the test's integration into current practice, highlighting its ability to stratify patients into low, intermediate, and high-risk categories but noted that it should not be used as the sole method for predicting disease progression.
    • Clinical Impact and Utility: Dr. Ross detailed a study indicating that the test led to increased referrals and medication adjustments, suggesting improvements in clinical management but not necessarily in direct health outcomes.
    • Integration Challenges: Concerns were raised about the test’s integration into electronic health records and its dependency on specific clinical variables, which might limit its applicability across diverse health systems.
  5. Future Directions and Considerations: There was a consensus on the need for more randomized controlled trials to conclusively demonstrate the test’s efficacy in improving health outcomes. The discussion also touched upon the test's potential to reduce socioeconomic disparities in CKD management, provided its broader integration into healthcare systems.

  6. Concluding Remarks: Dr. Mullen appreciated the expert inputs, indicating that these would be considered in future deliberations and potential guidelines.

This transcript provides a comprehensive account of expert opinions and discussions regarding the KidneyIntelX test, illustrating the complexity and interdisciplinary approach required to evaluate and potentially integrate new medical technologies into clinical practice.   [ /end ChatGPT4 ]

CMS Updates ADLT Application Instructions - Just Slightly

The 2014  PAMA Medicare legislation updated the lab test pricing system as a whole.  It also created a novel test category, "ADLT," Advanced Diagnostic Laboratory Test, which has special pricing rules.

In June 2024, CMS made a minor update to its application instructions.   CMS continues to state (as per statute) the test must be "covered by Medicare."  However, CMS continues to take as little as "a paid claim" as proof of coverage.

Here's the update.  

  • CMS adds a sentence stating that while "proof" of coverage (such as a paid claim) is needed for ADLT approval, this is NOT the same as "establishment of coverage."  
  • Ongoing future coverage, if any, is dependent on ongoing future LCDs or NCDs.   
    • Creation of an ADLT code is not in itself evidence of any ongoing coverage.


The CMS web page for ADLT information is here:

This includes a list of ADLTs (about 15 since 2014), a 17-page application form, and a 30-page info document.   Both the 17-page application form and 30-page info document have the new inserted text (that ADLT creation isn't "proof" of ongoing coverage.)   Both PDFs have been updated and given a new issue date (6/2024).   Other changes are minor (like changing the issue date everywhere it appeared, to 2024).


I compared the documents with "" which offers some free online resources for PDF comparisons.


I've put the old and new documents in a cloud zip file.

click to enlarge

What's an ADLT?

The ADLT list is here:

In brief, omitting some details, an ADLT test is priced first at the test's list price (it mostly avoids a local pricing or national crosswalk process).  Thereafter the ADLT test is repriced annually at its commercial payor median rate.   

Wednesday, June 12, 2024

CMS Releases Ten Year National Health Expenditure Forecast

On June 12, 2024, CMS released national health expenditure projections which run forward to 2032.   

  • See the press release here.
    • Medicare growth rate, including the large aging population, is 7.4% for 2023-2032.  It's a bit less by 2030, when the last baby boomer will enroll, and the oldest baby boomers are dying off.
    • Medicaid costs, commercial insurance, and physician services all grow circa 5.5%.  
    • By 2032, health care spending as share of the economy will be 19.7% (20%).
  • See downloadable PDFs and charts here.
    • See in particular the PPT summary 14 pages here.
  • See the paired, open-access article at Health Affairs, Fiore et al., here.

  • CMS deck.
    Dalle 3 interprets HA Fiore et al.

CMS Closes Building: REDDIT Says "Legionnaire's"

CMS Lab Meeting Agenda

CMS has 130 total agenda items for its June 25, 2024 annual public comment meeting on new lab test pricing.   Stakeholders submitted 55 separate presentations which will be crammed in from 9 am to 5 pm on the day (6 am to  2 pm PT).    Read the five-page agenda (presenter list) here:

CMS had planned a "hybrid" meeting - on site & video - but the on site meeting is canceled.   The CMS lab website says "The CMS complex is closed due to an unforeseen issue."

Reddit Says "Legionella"

According to Reddit, the CMS site is closed due to Legionairres disease.

I don't have any independent confirmation beyond Reddit, but it's believable enough.  We know from CMS the building is closed, and for an extended time, and there aren't alot of things that will do that.   (Termites?  Carbon monoxide?)

CMS allocates presentation time 9:20-12:00 and 12:45-5;00.  This is 2h40m and 4h15m or 6h55m.   CMS gives each of 53 presenters 10 minutes, which would be 530 minutes or 8h50m.  
Six codes in the 814xx series (comprehensive genomic profiling) are under reconsideration, but don't seem to have any public commenters.   I think I heard at a meeting that if CMS got no public comment on those codes, it would drop them from reconsideration.  Not sure about that.  The codes are also currently in the national gapfill process, based on last year's CMS decisions.   

Gen Eng News: Update on TEMPUS IPO and Financials

Genetic Engineering News publishes an update on the pending IPO at TEMPUS.   It's open access here:

It's a little confusing as it intermingles NVIDIA and TEMPUS news.  The update includes amendment(s) to the initial TEMPUS IPO documents.

Here's some bullet points, pulled from GEN:

  • 11M shares at $35-37, raising ~$400M at a valuation of $6B
    • Veracyte market cap, $1.7B
    • Guardant market cap, $4B
    • Exact Sciences market cap, $8B
    • Nateral market cap, $14B
  • Sales history with 7000 physicians, 200 biotech, 19/20 top pharma
  • Data and services 30% of 1Q revenue  (so that leaves 70% genomics)
  • "Tempus expects AI to grow into a third product line"
  • Last year's revenue was $532M (net loss $215M)

Sunday, June 9, 2024

Washington Post: Personalized Medicine via "Shadow System" and "Regulatory Vacuums" in Home Testing

Washington Post runs a story on personalized medicine, cryptic diseases and allergies, and a boom in home-based testing that skips your own primary care and specialists.   It's a story that became more multi-faceted the further I got into it.

Nobody comes off too well - not primary care doctors and specialists that are said to sidestep difficult symptoms they can't understand; the lab industry that leapfrogs over primary care to reach frustrated families with sometimes-unusual tests, or the venture capital fueling this part of the US lab industry.  The WaPo authors aren't happy with regulators as well, by describing a "shadow system" that thrives in "regulatory loopholes."

Find the article here (subscription):

This article takes at-home testing and telemedicine in different directions that were probably envisioned a few years ago.   

Written by Elizabeth Dwoskin, Daniel Gilbert, and Tatum Hunter, the article had nearly 3000 comments by Sunday evening.

AI Corner

Here's a very short (intended as non-infringing) AI summary.

  • This narrative underscores a growing trend where individuals, disillusioned by conventional medical systems and empowered by access to information and tools, take health management into their own hands. 
  • The rise of home-testing, catalyzed by the COVID-19 pandemic and driven by a mistrust of established medical authorities, has been bolstered by Silicon Valley start-ups. These companies, supported by significant venture capital, offer a wide range of tests from food sensitivities to complex health conditions, effectively creating a direct-to-consumer health test market.
  • However, this shift raises significant concerns among the medical professionals interviewed.  They doubted the accuracy and efficacy of such tests, often highlighting the potential for misdiagnosis, unnecessary interventions, and increased anxiety among patients. 
  • Regulatory bodies like the FDA are beginning to impose stricter standards on these lab-developed tests to mitigate risk and ensure reliability. 
  • Despite skepticism from parts of the medical community, the demand for personalized, at-home diagnostic tools continues to grow, highlighting a new shift in the public's approach to health management and the pursuit of autonomy in healthcare.

Monday, June 3, 2024

MolDx MACS Draft Non-MolDx LCD: Artificial Intelligence in Coronary Imaging

On Thursday May 30, 2024, there's a new LCD from all the MolDx MACs (WPS, CGS, Noridian, Palmetto), although it's not listed as a "MolDx" LCD.  It's titled:

  • "Artificial Intelligence Enabled CT Based Quantitative Coronary Topography (AI-QCT)/Coronary Plaque Analysis (AI-CPA)"

See the LCD here.  See the 2/2023 request letter here (12pp).  See the draft billing article here.

The LCD notes that it's developed in part from a topical meeting held by the MACs on May 20, 2023.  See a transcript here.

The LCD provides coverage based on patient circumstances that make the test appropriately; a set of Category III codes are provided for billing (0623T-0626T).

In a nutshell, the coverage criteria atop the LCD state:

Artificial Intelligence Enabled CT Based Quantitative Coronary Topography/Coronary Plaque Analysis (AI-QCT/AI-CPA) using coronary computed tomography angiography (CCTA)* is considered reasonable and medically necessary as a diagnostic study when:

  • The patient is eligible for CCTA*, 
  • AND
  • The patient presents with acute chest pain and no known coronary artery disease (CAD)1 and is classified as (1 or both):
    • Intermediate risk** 
    • CAD-RADS 2 and CAD-RADS 3 category on CCTA***, 
  • AND
  • Cardiac evaluation is negative or inconclusive for acute coronary syndrome (ACS).


I haven't researched how the approach used here for coverage compares to the evidence analysis and thinking that went into the Heartflow LCDs for fractional flow reserve (FFR).  See L38238 at Palmetto here.  (Therein find an extensive comments and answers document).

It looks like the comment period on the new LCD runs to July 14, 2024.


Strategic Notes

  • Letter. The 12-page letter from CLEERLY seems well written and could used as an object of study by others.
  • Time.  It took 15 months from the February request to an (almost) June LCD in the next year.
  • MACs. The "MolDx MACS" put out the same LCD, but it's not labeled MolDx in any way.  This suggests the 5 MACs are sharing policies more broadly than just in the MolDx silo.  Interesting.
  • Alternatives.  I'm not up on advanced cardiology so it's hard for me to compare the CLEERLY tech here with other trends in advanced radiology (and AI).
  • Colorado.  It's interesting the company is in Colorado, a Novitas state, but Novitas is absent from the May 2023 public meeting and this draft LCD.
  • APCs.  As Category III codes, the services will be locally priced by MAC medical directors, but nationally priced in "APCs" when billed in a hospital setting.

If of interest, Chat GPT reads the Request, the CAC transcript, and the draft LCD.

AI writes:

To provide an overview and analysis of the materials you've provided regarding the coverage of advanced cardiac testing and the inclusion of AI technologies in Medicare, let's discuss the evolution of coverage for these technologies, focusing on the development and implications of Local Coverage Determinations (LCDs) for AI-enhanced quantitative coronary computed tomography angiography (AI-QCT).

Overview of Key Documents

  1. Request Letter from Cleerly Labs:

    • Cleerly Labs submitted a request for a new LCD to include AI-QCT for patients under evaluation for coronary artery disease (CAD). This request emphasized the limitations of traditional diagnostic tools like coronary angiograms and stress tests, which focus more on stenosis rather than the underlying atherosclerotic disease process. Cleerly Labs argues for the superiority of AI-QCT in providing detailed and actionable diagnostic information, potentially leading to more personalized and effective patient management.
  2. Medicare-Sponsored Conference Transcript:

    • A Contractor Advisory Committee (CAC) meeting discussed the evidence and utility of non-invasive technology for coronary artery plaque analysis. This meeting emphasized the importance of robust scientific evidence in LCD development as mandated by the 21st Century Cures Act. The discussion highlighted the potential of AI-QCT to provide comprehensive assessments of plaque burden and composition, which are crucial for effective CAD management. Various experts expressed support for the inclusion of AI-QCT in routine clinical practice, pending validation of its clinical utility and impact on patient outcomes.
  3. Draft LCD for Public Comment:

    • The draft LCD reflects the considerations and recommendations discussed during the CAC meeting. It outlines specific indications where AI-QCT could be considered medically necessary and reasonable, emphasizing the need for detailed documentation of medical necessity in patient records. The draft also lists various limitations and scenarios where AI-QCT would not be appropriate, ensuring that the use of this technology is well-regulated and targeted.

Analysis and Implications

  • Scientific and Clinical Validation:

    • The inclusion of AI-QCT in Medicare coverage is strongly supported by evidence of its diagnostic accuracy and potential to improve clinical outcomes. The technology allows for a more precise assessment of atherosclerotic plaque, which is crucial for determining the risk of heart attacks and guiding treatment decisions.
  • Policy and Healthcare Impact:

    • The adoption of AI-QCT could lead to significant changes in how CAD is diagnosed and managed, potentially reducing the reliance on invasive procedures and enhancing personalized treatment plans. The coverage of AI-QCT under Medicare would likely increase access to this advanced diagnostic tool, promoting its integration into standard clinical practice.
  • Stakeholder Engagement and Feedback:

    • The process of developing and refining the LCD for AI-QCT involves extensive stakeholder engagement, including feedback from medical experts, industry representatives, and public comments. This collaborative approach helps ensure that the final policy is balanced, evidence-based, and responsive to the needs of both providers and patients.
  • Future Directions:

    • As AI technologies continue to evolve, ongoing research and data collection will be essential to assess their long-term impact on health outcomes and cost-effectiveness. Medicare policies may need to be periodically updated to reflect new evidence and technological advancements.


The evolution of Medicare coverage for AI-enhanced cardiac testing reflects a broader shift towards more precise and personalized healthcare. The inclusion of AI-QCT in the Medicare program, supported by robust evidence and expert consensus, represents a significant step forward in the management of CAD. It highlights the potential of advanced technologies to transform clinical practice and improve patient outcomes in the context of an aging population and rising healthcare costs.

You remark that in the conference transcript, experts were supporting "pending clinical utility validation and impact on patient outcomes." Those seem like two pretty big warnings or caveats. Can you provide more context?

AI writes:

Indeed, the conference transcript does highlight important caveats regarding the clinical utility and impact on patient outcomes of AI-QCT. These concerns are central to determining whether this technology should be widely adopted and covered under Medicare. Here's a deeper look into these aspects based on the discussions captured in the transcript:

Clinical Utility Validation

  1. Definition and Consistency:

    • There was significant discussion about the precise definition of AI-QCT and how it is employed in clinical settings. The term AI-QCT has been used variably, referring to both "Artificial Intelligence-enabled Quantitative Coronary Computed Tomography" and "Atherosclerosis Imaging-Quantitative Computed Tomography." This indicates the necessity for a standardized definition to ensure consistency in its application and evaluation.
  2. Technological Versatility and Accuracy:

    • AI-QCT's ability to analyze plaque composition and burden is recognized, yet the utility hinges on the accuracy and reliability of these analyses. Experts debated the extent to which AI-QCT can replace or augment existing imaging techniques like IVUS (Intravascular Ultrasound) and how it might influence clinical decision-making processes.

Impact on Patient Outcomes

  1. Evidence of Effectiveness:

    • A significant part of the discussion focused on the need for robust evidence demonstrating that AI-QCT not only accurately assesses coronary artery disease but also improves patient outcomes. This includes whether AI-QCT's use in clinical practice leads to better management decisions, reduced rates of cardiac events, or other measurable health benefits.
  2. Comparative Advantages:

    • The panelists explored how AI-QCT compares to traditional methods in terms of outcomes. There's a consideration of whether the technology provides additional benefits over existing diagnostic tools, such as more precise risk stratification or avoidance of unnecessary invasive procedures.

Concerns Raised

  1. Integration into Clinical Guidelines:

    • The discussions highlighted a cautious approach to integrating AI-QCT into clinical guidelines without sufficient evidence. While AI-QCT shows promise, its adoption into routine clinical practice and guidelines should be based on clear proof that it leads to better clinical outcomes.
  2. Research and Validation Needs:

    • There's an emphasis on the need for ongoing research to validate the clinical utility of AI-QCT. This includes randomized controlled trials, longitudinal studies, and real-world evidence that can provide a clearer picture of how AI-QCT influences treatment strategies and patient health over time.
  3. Regulatory and Ethical Considerations:

    • The regulatory approval process for AI-QCT and its ethical use were also discussed, emphasizing the importance of ensuring that the technology is both safe and effective before widespread implementation.


The expert panel's discussion reflects a prudent and evidence-based approach to the adoption of new medical technologies under Medicare. While there is enthusiasm about the potential benefits of AI-QCT, the panelists advocate for a careful validation of its clinical utility and a thorough assessment of its impact on patient outcomes before it is recommended for broad use. This approach ensures that new technologies are not only innovative but also beneficial and safe for patients, aligning with the overarching goal of improving healthcare quality and efficacy.

Saturday, June 1, 2024

CMS Finalizes 130 New Lab CPT Codes for June 25, 2024 Pricing Meeting

In April, CMS set the June 25, 2024 date for this year's public comment meeting on how CMS should price new lab codes.  (Here).  While the public comments, on a CMS powerpoint template, were due May 30, that's about the same day that CMS finalized the agenda of codes, by picking up late-breaking codes from the May 2024 AMA CPT meeting.

Find the code list as a zip file at this CMS page.  Scroll down for meeting announcements and agendas.

The agenda opens with about a dozen reconsidered codes (appealed from last year's pricing).  There follow numbered PLA codes from 420U to 474U.  Not-yet-numbered PLA codes run further, from position 83 to 127.

Noteworthy: Revised Germline Codes; Profusion of New Alzheimer Codes

Among the 130 agenda items, I'd highlight two groups.

Germline Cancer Risk

81432, 18435, 81437 are revisions of three germline cancer risk codes (loosely, one for breast-ovarian, one for Lynch, one for neuroendocrine).   81432 is a decade-old code for heredtiary breast cancer, traditionally paired with 81433 for dup-del analysis.   The code number is struck down from 10 or more to 5 or more (which may block code-stacking of 6 to 9 codes).   The gene list is struck out (it used to be ten genes long including BRCA1-BRCA-2).   If this is priced in the 5-gene range and labs don't bill BRCA inside it, but on another day, it could create a bonus for doing BRCA on a different day (about +$1800).  

81435 continues to say "For Lynch syndrome," but is also rewritten to require only 5 or more genes and the gene list is struck out.   

I don't know if 81433 (dup del) and 81436 (dup del) are deleted because CMS lists only new or modified codes, and does not flag deletions which are not part of the new code pricing meeting.

81437 is a special code for 5 or more genes, neuroendocrine related panel (5 or more genes, no code list).  

Alzheimer Bonanza

Lotsa new Alzheimer codes.

Currently, there's a PLA code for the Fujirebio CSF test (FDA), a Quest blood amyloid test, and a MAAA test that combines ApoE and amyloid.

More neuro codes for 2024/2025:

  1. 0443U, NF light chain
  2. 0445U, Amyloid + tau
  3. 82XX0, Amyloid 40
  4. 82XX1, Amyloid 42
  5. 8X3X0, Tau, phospho (per each phospho position)
  6. 8X3XX, tau, total
  7. XX40U, Amyloid + tau
  8. 83XX0, NF light chain
  9. XX62U, Tau phospho217

Friday, May 31, 2024

Lighter Note: AI Corner: Novel Instant Uses of AI

If of interest, two instantly available uses of AI, doing tasks in an eyeblink that were impossible a couple years ago. 

In the first example, it gives instructions for the cryptic symbols on a European clothes washer.  In the second, I uploaded a photo of an article in an Italian newpaper about precision medicine, and it answers with an instant translation.

I posted the results on a separate blog -

Thursday, May 30, 2024

ACLA Slams FDA With Hard-Hitting Lawsuit over LDT Regulation

On May 6, FDA published a 160-page complex new regulatory regime for lab-developed tests, to be rolled out (with many carveouts and complications) by 2027.

Now, on May 29, FDA has filed a whopping 450-page case, including supporting documents  As I predicted at several conferences, it filed the case in Texas, where I think an initial ruling against the government is likely, which will start the ball rolling on various appeals and counter-attacks.   The Texas filing, I think, raises the chance of an injunction while issues simmer.  Grounds for this include the $101M in projected spending by labs to comply, just in the first months of the 5-year plan.

Much may depend on the next administration: if it is a change of regime they might provide a lukewarm defense, or less, of the regulation.  For example, some LGBT-related regulations have gone through three literal 180 degree flip-flops across the three Obama, Trump, and Biden administrations. 

Read About It

  • See the ACLA press release here.
  • See the 7 mb PDF download (450pp) here.
  • See coverage at CAP TODAY here.
  • See MedTech Dive here.
  • See 360Dx here.  (I think, open access).
  • See a supportive 23-page filing from ARUP, here, here.

ARUP notes, as does ACLA, that the regulation makes LDTs illegal, except only for the FDA's discretionary non-prosecution.

360Dx Quotes ACLA Press Conference

360Dx quotes a press conference held by ACLA.  Here's an important remark they provide from ACLA's President, Susan van Meter:

"Indeed, the fact that the FDA found it necessary to establish a complex regulatory system with multiple carve-outs only serves to emphasize that the [medical] device regime is a terrible fit for laboratory testing services."

The Case in Brief

While the full FDA posting is 450-pages, the first 59 pages are the pivotal new court document, building up to its request for a declaratory decision that the FDA proposal is contrary to law, and an order that enjoins the FDA from carrying it out.  (ACLA would want the regulation to be on hold during the subsequent legal appeals.)

There follows a supportive filing from Jay Reddy PhD, Denton Texas, regarding HealthTrackRx clinical lab operations in Texas.   This facilitates filing the case in a Texas jurisdiction of the federal courts.  This continues to PDF page 77.   

PDF page 78 kicks off with a statement of Marcia Eisenberg PhD, LabCorp.  She discusses adverse effects of the FDA plan.

PDF page 86 opens a statement by Yuri Fesko MD, Quest.  Again, the FDA plan is a very bad idea.

PDF page 96 opens a statement from Jonathan Gensen MD PhD, ARUP.   This was released separately by ARUP in a press release (above).

Page 120 opens a statement from William Morice MD PhD, Mayo.   

Page 146-162  is a very detailed, authoritative 2020 memo from the General Counsel of HHS under Trump, William Charrow, to the then-commissioner of FDA William Hahn, that FDA lacks legal authority to regulate LDTs.   As I recall, the Biden administration navigated this legal positioning not by rebutting it, but by simply deleting it from the HHS website.  

At 164ff, we have the FDA's very elaborate comments, and devastating refutation of the FDA's shadowy economic assertions, filed in December 2023. The economics, from Prof. Carrigan, begin at page 245.   

Page 272ff provides the FDA final rule in typescript form, not the typeset May 6 form.

I would add re Agency Discretion

In many ways, the FDA's plan is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.   

Stakeholders ask that FDA only make new major policies for LDTs "by regulations."  OK.  What we got is, FDA responds by a regulation, a few words long, that it can regulate any LDTs in any way it wants (by time-to-time agency use of discretion vs crackdown, on its own rolling basis, as it sees fit, without any further notice and comment regulation, ever again.)   (See section below about "major questions" doctrine).

As ACLA and ARUP make clear, the law makes LDTs "manufactured by a laboratory" illegal if not approved by FDA.   It's only that FDA gives discretion against prosecution.  This is like saying that IRS makes fraudulent  $100 charity deductions illegal, except that it will not prosecute them if they are $100 or less.  

AI Corner: Chat GPT 4 Reviews Filing

(Begin AI) 

The lawsuit filed against the FDA by the American Clinical Laboratory Association and HealthTrackRX focuses on challenging the FDA's plan to regulate laboratory-developed tests (LDTs) as medical devices. Here are the main points, key arguments, and requests for action from the plaintiffs:

Main Points

  1. Historical Regulation: LDTs have historically been regulated under a separate framework, the Clinical Laboratory Improvement Amendments (CLIA), which did not involve the FDA's device-oriented regulatory framework. The plaintiffs argue that LDTs are services performed by skilled professionals, not tangible medical devices that are manufactured and sold.

  2. FDA Overreach: The FDA's new rule seeks to redefine LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA), a move that plaintiffs argue exceeds the FDA's statutory authority. They contend that Congress has never granted the FDA the authority to regulate LDTs in this manner.

  3. Impact on Healthcare: Plaintiffs argue that the FDA's regulation would dramatically disrupt laboratory operations by imposing device approval requirements on tests that are currently under a different regulatory regime. This could hinder innovation, increase costs, and delay the availability of new LDTs, adversely affecting patient care.

Key Arguments

  1. Statutory Overreach: Plaintiffs claim the FDA's actions are contrary to law and exceed its statutory jurisdiction, arguing that LDTs are not "devices" under the definitions provided in the FDCA. They assert that these are professional services rendered using various tools, not products distributed in commerce.

  2. Administrative Overreach: The rule is described as arbitrary and capricious under the Administrative Procedure Act. The plaintiffs argue that the FDA has not justified the reclassification with substantial evidence and that the move does not consider the actual operation and context of LDTs in clinical settings.

  3. Impact and Practicality: The imposition of medical device regulations on LDTs is argued to be not only beyond the FDA's authority but also impractical and harmful, risking critical diagnostic services and potentially harming public health due to reduced access to essential tests.

Requests for Action

  1. Injunction and Vacatur: Plaintiffs request the court to vacate and set aside the FDA’s final rule. They seek a declaratory judgment that the rule is unlawful and an injunction to prevent the FDA from implementing or enforcing the rule.

  2. Declaratory Relief: The plaintiffs are seeking a judicial declaration that the FDA does not have the authority to regulate LDTs as medical devices and that its attempt to do so via the final rule is invalid.

  3. Judicial Review: The plaintiffs invite the court to review the FDA's rule under the standards of the Administrative Procedure Act to determine its legality and appropriateness under federal law.

In summary, the lawsuit focuses on defending the historical regulatory distinction between LDTs and medical devices, challenging the FDA’s statutory interpretation and its practical implications for healthcare services. The plaintiffs are seeking a court order to halt the FDA’s reclassification of LDTs as medical devices, arguing it is beyond the agency’s authority and would negatively impact the healthcare system.   (end AI)

More About Major Questions

As to the Major Questions Doctrine, ACLA writes,

FDA’s attempt to regulate laboratory testing services as devices also implicates the major questions doctrine. See West Virginia, 597 U.S. at 724. FDA’s rule would mean that the entire clinical laboratory sector, which is a significant part of the U.S. healthcare system, has been breaking the law for nearly 50 years, and possibly much longer. And it would mean that going forward, the entire profession is operating unlawfully and can be subject to civil and criminal penalties at any time, with its only protection coming from a policy of enforcement discretion that FDA insists it is free to revoke at any time. The rule would also wreak havoc on clinical laboratories and the doctors and patients they serve, imposing billions of dollars in immediate, unnecessary costs....

An agency cannot impose massive costs and place an entire profession under its thumb in this manner without, at minimum, a clear statement from Congress. The Supreme Court has repeatedly warned that agencies should not attempt, and courts should not abide, such drastic expansions of the agency’s authority under a “‘long-extant statute’”—especially where, as here, Congress has “conspicuously and repeatedly declined to enact” such an expansion itself. 

Tuesday, May 28, 2024

New York Times: Not Happy about Prior Auth Burdens in Medicare Advantage

Excessive and burdensome prior authorizations are a hotspot for the AMA, have gotten attention both in Medicare regulations and in Congress, and are increasingly discussed in trade journals for the lab industry, such as 360Dx this month (Adam Bonislawsky). See also Dark Daily.

Now the New York Times weighs in with a feature article about burdens of Medicare Advantage, in a detailed article appearing over the Memorial Day Weekend.   Find it here:

Written by Paula Span, the article got over 400 comments in the first couple days.

Here are some key points:

  • The case study is a woman on Medicare who, after a stroke, was in rehab and progressing well.  On a Wednesday, she and her husband were notified that her care was canceled by her Medicare Advantage plan, and they had to be "out the door" by Friday.
  • Only 11% of Medicare Advantage denials are appealed, yet of those, over 80% are overturned.
  • Medicare recently published new regulations and guidance documents about M.A. rules including for coverage and for prior auth.
  • Some of the new rules don't come into play until 2026.  But CMS promised the NYT that it would make efforts to enforce the updated (or clarified) policies.

See an article and case study at MedScape (registration required) here.

Thursday, May 23, 2024

Brief Blog: Journal Club: JAMA Reviews Surrogate Biomarkers

 A new review article in JAMA on the use of surrogate biomarkers (eg by FDA in clinical trials) takes a grim position.   Wallach et al. take all the surrogate biomarkers for non-cancer conditions, as listed by FDA, and perform a systematic literature review.  Their main index is whether there are systematic meta-analyses of each marker, and if so, how many.

They note they exclude cancer surrogate markers (like progression-free survival) while dropping a quick comment they view that data as poor (as "weakly associated" with clinical outcomes.)  

  • Expert Tip:  Although not identical, there are many conceptual parallels between saying (a biomarker is weakly associated with an outcome, its use as a surrogate decision tool is weak) and saying (a biomarker is not proving to have clinical utility for health outcomes, is not payable.)

Their table 1 lists all 37 FDA surrogate biomarkers (see also their 241-page online supplement.)  17 are viewed by FDA as s strong enough for traditional approval (when not so honored, surrogates would generally be for accelerated approval.)

Their bottom line - "Most surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases lacked high-strength evidence of associations with clinical outcomes from published meta-analyses."

 (Most surrogate biomarkers are lab tests, though some are physiological or functional, like forced expiratory air volume or progression-free survival or blood pressure.)

Difficult World for POCT: Cue Health Lays Off Everyone

According to Genomeweb, quoting San Diego Union-Tribune, Cue Health is shuttering all operations and laying off all remaining employees.  Here.

It's remarkable in light of its recent past history.  According to Tracxn, the company was founded in 2010 and raised $406M, including a $235M Series D in May 2021.   Just months later, in September 2021, its IPO brought in $200M at a $2B valuation, per MobiHealthNews and Fierce Biotech.

From September 2021 to yesterday, share price was down from $19 to 8 cents.  (It was $1 a year ago, in May 2023).  

Due to COVID testing, total revenue fell from $615M in 2021, to $474M in 2022, to $64M in 2023.  Pretax income peaked at $120M in 2021, falling to -$368M last year in 2023.

As sales tumbled in 2022/2023, costs were $450M direct costs of revenue, and another $550M in operating expenses, which includes their $320M in R&D in 2022/2023.


See my January 2024 white paper on valuation of genomics investments, here.

Wednesday, May 22, 2024

MolDx X 3: Proteomics Calendar; Breast Cancer Expert Meeting; Results of Recent Public Comments

Tracking "What's New" on the MolDx website...

  • Proteomics Under MolDx

For several years, 2021-2024, MolDx staff did not regulate proteomic tests.  (Think of it like FDA not regulating LDTs.)   However, some labs were caught in a game of keepaway between whether they could be assessed for coverage by MolDx or by Noridian.  Basically, this was like being in a corridor with an exit door on either end, one marked "Noridian" and one marked "MolDx," and both of them locked.

At the beginning of 2024, MolDx published a list - "Article A59636" - describing what proteomic tests would fall under its jurisdiction.   This is "good news, bad news" - MolDx would consider the listed tests for coverage under new LCDs, but, MolDx might ensure the listed tests under its control weren't paid in the meantime, either.  

On May 17, 2024, MolDx published a notice that this enforcement is delayed until January 31, 2025.

Simple (single or double protein) proteomic tests remain outside of MolDx; check the code listing in A59636 for updates.  Info here.

  • MolDx Public Meeting: Breast Cancer DCIS Tests July 15, 2024

Don't make any plans for July 15, 2024, from 2-4 ET, because you'll probably want to be at your local sports bar with your gang, watching the live telecast of this MolDx Contractor Advisory Meeting.  The topic is, "Biomarker Risk Stratification Testing in DCIS."   

The format is typically expert presentations and then discussion.  Public questions aren't entertained.  After a few months, a transcript is posted.  Results may inform future LCDs. Info here.

  • Posted:  Transcript of Open Public Meeting, Thyroid Risk Stratification, Pulmonary Nodule Stratification, Prostate Cancer Stratification.

The meeting was October 9, 2023, and this was a public comment meeting.  Recordings and transcript are posted here.   Transcript 26pp.


AI Corner

Here's an AI-generated meeting report from October 9.

Meeting Report: 

MolDX Public Comment Meeting on Thyroid, Lung, and Prostate Cancer Management

Date: October 9, 2023
Duration: 1 hour, 1 minute, 57 seconds
Moderator: Dr. Angella Charnot-Katsikas

1. Prostate Cancer Management

  • Speaker: Dr. Ashley Ross, Associate Professor of Urology, Northwestern Feinberg School of Medicine
  • Topic: Gene expression profiling for metastatic prostate cancer, specifically the Decipher test by Variscite.
  • Highlights:
    • Emphasis on the increasing incidence of metastatic prostate cancer.
    • Detailed presentation on treatment options and their impacts based on the Decipher genomic classifier.
    • Demonstrated how genomic classifiers like Decipher can predict survival rates and guide treatment intensification decisions.
    • Noted that prostate cancer is a major health issue, being the most common non-skin cancer in American men.

2. Lung Nodule Risk Stratification

  • Speaker: Dr. Ehab Billatos, Assistant Professor of Medicine, Boston University
  • Topic: Molecular biomarkers for risk stratification of indeterminate pulmonary nodules post-bronchoscopy.
  • Highlights:
    • Discussion on the challenges of managing lung nodules identified during cancer screening.
    • Advocated for the use of molecular diagnostics prior to invasive procedures like bronchoscopy to better manage nodule risk.
    • Stressed the importance of advancing diagnosis through less invasive methods, potentially improving early detection and management.

3. Thyroid Nodule Risk Stratification

  • Speaker: Dr. Paul Ladenson, Johns Hopkins University School of Medicine
  • Topic: Molecular testing for risk stratification of thyroid nodules.
  • Highlights:
    • Discussed the prevalence of thyroid nodules and the importance of molecular testing to avoid unnecessary surgeries.
    • Highlighted the specific challenges and benefits of molecular testing in predicting malignancy and guiding surgical decisions.
    • Presented the need for reliable tests to improve the accuracy of cancer detection in thyroid nodule management.

4. General Observations and Concerns:

  • Technological Challenges: Several speakers experienced technical difficulties during their presentations, affecting the smooth flow of the meeting.
  • Policy Implications: There were calls for policy updates to accommodate the evolving landscape of molecular diagnostics, particularly to expand the use of pre-procedural biomarker testing in lung and thyroid nodule management.
  • Engagement: The meeting did not allow for a question-and-answer session, directing participants to submit written comments instead.

Conclusion: The meeting provided valuable insights into the current and potential uses of molecular diagnostics in managing thyroid and lung nodules, as well as metastatic prostate cancer. Speakers advocated for policy shifts to embrace less invasive diagnostic practices and highlighted the need for precise risk stratification tools in clinical settings. The discussions underscored the critical role of advanced molecular testing in improving patient outcomes through tailored treatment strategies. -- Chat GPT 4.



AI Corner 2

Sports Version

"Clash of Titans: Innovations Compete at the MolDx Arena"

Venue: MolDx Public Comment Meeting

In an electrifying display that could rival any sports championship, the MolDx Arena was ablaze with cutting-edge discussions on the frontiers of cancer diagnostics! On October 9, 2023, the stage was set  for a powerhouse lineup of scientific titans clashing over the latest in molecular diagnostics. The battleground? Thyroid, lung, and prostate cancer management, where each speaker brought their A-game, aiming for a knockout with every fact and figure.

Round 1: The Prostate Cancer Showdown

Champion: Dr. Ashley Ross, Northwestern's Maestro of Urology In the left corner, wearing the lab coat and armed with the Decipher test, Dr. Ross dove into the fight against metastatic prostate cancer. With the precision of a seasoned fighter, she laid out how gene expression profiling isn't just a tool—it's a weapon that's revolutionizing how we attack prostate cancer. She deftly explained how this approach helps pinpoint aggressive treatments for those in dire need while protecting others from the harsh side-effects of unnecessary therapy. Her data-packed punches highlighted a survival strategy that left the audience in awe.

Round 2: Lung Nodule Challenge

Contender: Dr. Ehab Billatos, Boston University’s Pulmonary Strategist - Switching gears to the lung nodule competion, Dr. Billatos entered with a flurry of stats and screens, focusing on the perilous world of indeterminate pulmonary nodules. As he navigated the court, through lung cancer screening and risk stratification, Dr. Billatos championed less invasive diagnostics that promise to be a knock-out punch for unnecessary bronchoscopies. His vision offered a glimpse into a future where lung cancer management is as strategic as a chess match.

Round 3: The Thyroid Tactical Battle

Veteran: Dr. Paul Ladenson from Johns Hopkins.  The crowd cheered for the main competition, with Dr. Ladenson stepping up to discuss the molecular testing tactics that could outmaneuver the risks of thyroid surgery. With the finesse of a veteran, he argued for the necessity of reliable molecular tests that can discern benign from malignant nodules, potentially saving thousands from the scalpel. His detailed review of molecular testing underscored a proactive defense strategy against thyroid cancer, emphasizing precision in diagnosis and treatment.

Post-Game Analysis

As the dust settled on this high-stakes event, it was clear that each speaker not only shared groundbreaking data but also painted a vision of a future where cancer might just meet its match. Like any top-tier sports event, the MolDx meeting left fans—er, participants—buzzing with excitement and anticipation for what's next in the playbook of cancer diagnostics. Dr. Charnot-Katsikas, moderating this epic showdown, wrapped up the proceedings with a nod to the relentless pursuit of medical innovation, a field where the goal isn't just to win, but to save lives.

The echo of the day’s discussions resonated like the cheers in a stadium: loud, hopeful, and a testament to the progress in the relentless battle against cancer. As the attendees filed out, the message was clear: in the fight against cancer, the power of molecular diagnostics is a game-changer and it's just getting started.  - Chat GPT 4

Tuesday, May 21, 2024

TEMPUS Files for IPO; Actual SEC Document; Focus on Reimbursement Tactics

As widely noted in the biotech media, TEMPUS filed for an IPO on May 20, 2024.   The IPO value may be up to $100M.  Prior funding rounds had raised over $1B in total.  

News at Genomeweb, BloombergChicago Business, Fierce Healthcare.

Most of the articles don't link to the actual IPO document; it's online here:

As a PDF, it weighs in at 169 pages.

Per Fierce Healthcare, accumulated losses are $1.5B, with $530M in 2023 revenue and about a $200M burn rate.  There are currently 2,300 employees (p 220, paginated 212).  Their Chicago space is 180,000 sq ft.


The Word "Reimbursement" Occurs 120 Times

Reimbursement occurs about 120 times, Medicare about 70 times.

MACs.  There's substantial discussion of their "local MAC, NGS [MAC]" on PDF page 44 [paginated 40].  They recite steps towards coverage with NGS MAC (e.g. "March 25, 2021...July 29, 2021...").   They then pivot to discussing the MolDx Palmetto jurisdiction, which processes claims that come from their alternate labs in Raleigh and Atlanta.  They note they submitted a tech assessment to MolDx for their xT assay in 2022, receiving approval in October 2023.  They note they submitted a tech assessment for the xF assay in 2023, but are still awaiting response as of May 2024.

14 Day Rule.  The same part of the S-1, PDF page 44 [paginated 40], also discusses situations where "we cannot bill Medicare directly for tests provided for Medicare beneficiaries."  This hinges on a discussion of Date of Service aka 14 Day Rule considerations.  Memdicare policies are also discussed at 217-219 [paginated 209-211].

Also tied to 14-day rule, they discuss a Civil Investigative Demand (CID) regarding compliance with 14-day rule and other issues (72-73, paginated 67-68; March 2024).

See also this remark:  "Our status as both a healthcare company and a technology company presents unique complexities when attempting to comply with these myriad laws and regulations. For example, certain data services we provide as a technology company may result in compensating other healthcare providers for access to data or the right to commercialize de-identified data. While such services, standing alone, appear routine, the compliance issues become more complex when considering our status as a healthcare provider that performs clinical diagnostic testing on behalf of healthcare providers."  (72, paginated 68). 

CPT Codes. There is a discussion of new AMA CPT codes for some tests in their genomics line of business, and how these tests are in gapfill (preliminary prices May 1), because "CMS rejected the recommendations from experts" in 2023.

There is a discussion of new capabilities to bill DNA and RNA studies under separate CPT codes (PDF 44, paginated p 40).

LBMs.  Reimbursement discussion continues, into page 45 [paginated 41], discussing "third party benefit managers" and "laboratory benefit management programs" and how these can cause "additional pricing pressure" and "substantial administrative burden."   (See an article on the same topic in 360Dx on May 16.)

Payment.   Average reimbursement was $916 in 2022 and $1452 in 2023; CY2021-CY22 payments were 50% of cases  (PDF 202, paginated 194).

Monday, May 20, 2024

FDA's LDT Webinar; Avalere FDA White Paper; Geopolitical Molecular Strategies

On May 14, 2024, the FDA held a webinar to educate the public on its intentions for rapidly regulating lab-developed tests.   FDA has posted materials:

  • The FDA webinar home page is here.
  • The video archive is here.
  • The 19-page deck is here.
  • The 15-page transcript is here.
One highlight you might not have been aware of yet.  FDA cuts some slack for LDTs that have no IVD equivalent.  But, when a test is endorsed by 510(k), by de novo, by PMA, OR BY New York State approval of a similar test, that will tend to close out enforcement discretion [transcript p 13].   This is one of the remarks highlighted for us by Avalere's excellent white paper on the FDA rule, which Avalere released May 20 and it includes learnings from the FDA webinar.