Tuesday, July 14, 2026

Science ALZ Copathology

 Science ALZ Copathology

https://www.science.org/content/article/most-dementia-patients-have-multiple-brain-diseases-how-should-they-be-treated 

Most dementia patients have multiple brain diseases. How should they be treated?

Growing awareness of “copathology” inspires new diagnostic tests and clinical trials

Close-up of dyed brain and other tissue specimen slices, mounted on glass slides and labelled and catalogued.
Analysis of brain tissue from autopsies has revealed most people with dementia have markers of multiple diseases.LEWIS HOUGHTON/Science Source
issue cover image
A version of this story appeared in Science, Vol 392, Issue 6799.Download PDF

About 20 years ago, neuropathologists began to report an inconvenient finding in the autopsied brains of people with dementia: Most have evidence of more than one disease. Studies since have shown the brains of up to half of people diagnosed with Alzheimer’s disease also have a key feature of Parkinson’s disease—deposits of the protein alpha synuclein. At the same time, up to half of Parkinson’s patients who develop dementia have elevated levels of beta amyloid and tau proteins, hallmarks of Alzheimer’s.

Researchers studying neurodegenerative diseases are catching on to the importance of this phenomenon, often called copathology. It complicates current disease classifications, which are tightly linked to their signature proteins. But it also offers clues as to why some dementia patients show faster cognitive decline, and some people on antiamyloid drugs for Alzheimer’s seem to fare worse than others. Copathology “helps explain why symptoms don’t match biomarkers, why trajectories vary so much, and why treatment results are not necessarily what we expect them to be,” neuropathologist Lea Grinberg of the Mayo Clinic told researchers at the Alzheimer’s and Parkinson’s Diseases Conference (AD/PD) in March.

Why the diseases overlap so often remains a mystery, but it’s not a coincidence. “It seems that they stimulate each other,” Grinberg says. Tests now being developed to pick up multiple biomarkers should give a clearer picture of these mixed pathologies in living patients. And an upcoming clinical trial will be the first to take aim at a common dementia copathology, testing the amyloid-clearing Alzheimer’s drug donanemab in people who have both amyloid in their brains and dementia with Lewy bodies—abnormal clumps of alpha synuclein.

“The ultimate goal is to define these diseases based on the biology, and understand the occurrence of these pathologies across the spectrum of diseases,” says Mark Frasier, chief scientist at the Michael J. Fox Foundation for Parkinson’s Research, which is running large studies to track and characterize copathologies. “I do think this is where the field is headed.”

Copathologies increase with advancing age. “Almost no one has only one pathology in the brain when they get to be 80,” says neurologist David Wolk of the University of Pennsylvania. Last year, he and colleagues published clinical criteria for another neurodegenerative disease that often occurs with Alzheimer’s in people over age 85: limbic-predominant age-related TDP-43 encephalopathy (LATE). It is marked by the buildup of TDP-43, a protein also seen in some types of frontotemporal dementia.

But copathologies aren’t limited to the old. One study of familial Alzheimer’s patients who developed dementia in their 40s found that half died with Lewy bodies as well as Alzheimer’s pathology in their brains. And in research presented at this year’s AD/PD meeting, neurologist Tom Tropea of the Institute for Neurodegenerative Disorders showed that people in the early stages of Parkinson’s, who represent a younger patient group, had elevated levels of p-tau217, a blood-based marker of Alzheimer’s pathology. Higher p-tau217 was associated with faster rates of cognitive decline and steeper drops in day-to-day functioning.

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Most cases of copathology are discovered at autopsy or in academic centers that conduct specialized testing, often for research. For example, a spinal fluid test developed by Amprion Diagnostics can detect Parkinson’s, dementia with Lewy bodies, and related diseases. Hopefully, wider use of such testing will lead more people with copathologies to trials of experimental agents, says Amprion’s chief executive, Russ Lebovitz.

Some blood tests in development could give patients a broad snapshot of mixed pathologies. Richard Mayeux, a neurologist at Columbia University, is working on one using extracellular vesicles—protein-laden particles that cells, including neurons, release into the blood. Measuring the payloads of neuron-derived vesicles can reveal the presence of proteins associated with LATE, Alzheimer’s, Parkinson’s, and diseases of the brain’s blood vessels, another important type of copathology.

Last month, Carlos Cruchaga, a human genomicist at Washington University in St. Louis, unveiled an experimental blood test using 15 protein markers that, together, can distinguish among the major dementia brain pathologies and quantify them. To develop the test, Cruchaga used artificial intelligence to analyze blood data from thousands of patients. The panel still needs to be validated in real-world clinical settings, and isn’t able to predict disease in asymptomatic people. But for a person with dementia, “It can tell you, you have 75% Alzheimer’s pathology and 20% Parkinson’s pathology and 5% frontotemporal dementia,” Cruchaga says.

Unfortunately, Wolk says, “We have a pretty limited armamentarium” to treat any single neurodegenerative disease—let alone multiple overlapping diseases. Currently only the antibody drugs for Alzheimer’s can clear a disease protein. It’s uncertain whether giving them to people who may also have dementia with Lewy bodies will be useful, but some patients will opt for them anyway, he says. “Can we really say that it’s not going to help them to at least remove the thing that you can remove?”

The upcoming trial, slated to launch later this year, will recruit people in the early stages of dementia with Lewy bodies—but who also have high amyloid—to see whether donanemab tempers their symptoms. Neurologist Sharon Sha of Stanford University, a lead investigator on the trial, thinks an “interactive effect” between beta amyloid and alpha synuclein speeds patients’ damage and decline. She hopes the trial not only shows benefit, but “helps the field to recognize the importance of being inclusive of copathology in clinical trials.”

Treatment for mixed pathology could one day mean combining drugs—administering treatments developed for Alzheimer’s alongside those for Parkinson’s or frontotemporal dementia, for example. Or, some predict, it could aim at a yet-to-be-discovered common source or pathway in neurons that drives multiple pathologies—making today’s rigid disease categories even less relevant.

“In the future we will not talk about ‘Alzheimer’s disease,’” says Johannes Attems, a neuropathologist at the University of Innsbruck. Rather, “You see a patient and in his brain is so much amyloid beta and so much tau, so much alpha synuclein, so much TDP-43. That’s it,” he says. “And you have something to give him.”


Tuesday, July 7, 2026

Lab tests on and off the OPPS "New Tech APC" list

July 7 2026

91 FR 41734  OPPS Proposed Cy2027

In Table 62, CMS lists tests that will be pulled off the CLFS fee schedule (and policy system) and into the general APC services, with pricing for now via New Tech crosswalk prices.

0510U is basically a MAAA mRNA test where the mRNAs have been previously measured (perhaps a tumor test that includes a whole transcriptome), 16 mRNA levels x algorithm, $450 [New Tech].

Turning to slides, 0418U is imaging (WSI) of 8 histo and IHC features, APC $750.  (This is one of a number of tests priced at $703).

0220U is 12 hiso & IHC features, priced as $750 [New Tech].

0295U sounds similar, but is not included for repositioning.   It may be that 0295U includes the slide creation steps, making it more similar to a traditional MAAA.  But it is not always clear from the PLA text whether a slide list enumerated in the PLA code represents slides created for the test (and priced-in) or slides previously made and signed out and billed, and just used as input for the provided algorithm.   

0295U / ADLT / Oncology (breast ductal carcinoma in situ), protein expression profiling by immunohistochemistry of 7 proteins (cox2, foxa1, her2, ki-67, p16, pr, siah2), with 4 clinicopathologic factors (size, age, margin status, palpability), utilizing formalin-fixed paraffin-embedded (ffpe) tissue, algorithm reported as a recurrence risk score


Monday, June 29, 2026

Ex CEO; 87798

 Link.


After nearly a decade building Lighthouse Lab Services into the nation's leading laboratory management and services firm, I've made the decision to step down as CEO....I'm excited to welcome Jason Severtson as Lighthouse's next CEO and have tremendous confidence in the future of the company.

Dos the internet show connections between Lighthouse Lab Services and CPT code 87798?

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https://www.youtube.com/watch?v=pnazkuCSIBI




https://www.lighthouselabservices.com/guide-navigating-pcr-billing-challenges-in-moldx-jurisdictions/


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Yes. The internet shows multiple and direct connections between Lighthouse Lab Services and PCR microbiology reimbursement issues, including repeated discussion of CPT 87798 and urine PCR panels.  See links above.

Some of these  links also describe substantial or rising difficulty for 87798 payments.

The strongest connection is a 2025 Lighthouse Lab Services article entitled "Guide: Navigating PCR Billing Challenges in MolDx Jurisdictions." In it, Lighthouse discusses exactly the coding controversy around multiplex PCR microbiology testing. Guide: Navigating PCR Billing Challenges in MolDx Jurisdictions

Some key points:

  • Lighthouse specifically discusses the longstanding debate between reporting organisms individually with CPT 87798 versus using the multiplex panel code CPT 87801.

  • They state that AMA CPT guidance has supported reporting organisms individually (using codes including 87798) when separate organisms are individually identified.

  • They then explain that CMS, particularly in MolDx jurisdictions, has increasingly insisted that many multiplex PCR assays be billed instead as 87801, producing substantially lower reimbursement. (Lighthouse Lab Services)

Even more interestingly for your question, Lighthouse specifically mentions urine PCR panels:

"UTI, RPP, wound, and fungal panels..." are discussed as examples of high-target PCR panels facing MolDx reimbursement problems, including lack of appropriate Z-Codes. (Lighthouse Lab Services)

So they are not talking abstractly about PCR—they specifically identify UTI (urinary tract infection) multiplex PCR testing as a major reimbursement problem.

They also note that:

  • many commercial payers (UnitedHealthcare, Humana, Optum) are adopting MolDx-like reimbursement policies;

  • laboratories are seeing denials when billing organism-by-organism;

  • laboratories often receive payment only when switching to 87801, even though reimbursement may be well below laboratory costs. (Lighthouse Lab Services)

Separately, Lighthouse has built an entire consulting practice around molecular infectious disease laboratories. Their infectious disease consulting page discusses laboratories transitioning into infectious disease PCR testing after COVID and specifically advertises assistance with reimbursement strategy for infectious disease PCR panels. Lighthouse Lab Services Infectious Disease & PCR Consulting (Lighthouse Lab Services)

They have also produced webinars and videos devoted to these reimbursement issues, including one titled "Navigating PCR Reimbursement Challenges in MolDx States," where founder Jon Harol discusses the policy environment surrounding PCR billing. Navigating PCR Reimbursement Challenges in MolDx States

About CPT 87798 and urine PCR

One nuance is worth mentioning.

87798 itself is not a urine-specific code. It is an "infectious agent detection by nucleic acid" code that can be used for many organisms and specimen types. For example, Quest Diagnostics uses 87798 for a urine BK virus PCR assay. (Test Directory)

The controversy arises because some commercial laboratories performing multiplex urine UTI PCR panels historically billed multiple 87798 units (one per organism), whereas CMS/MolDx has increasingly preferred treating the multiplex assay as a single test billed with 87801. That reimbursement dispute is exactly what Lighthouse's 2025 article analyzes. (Lighthouse Lab Services)

Given your background in MolDx policy, I think you'll find the Lighthouse article unusually detailed—it reads less like marketing copy and more like a practical reimbursement memo for laboratories trying to survive the transition from multiple 87798 claims to 87801 billing.

Sunday, June 28, 2026

The Future August 20 CAC - A Journalist's Time Travel

 Medicare Contractors Weigh Alzheimer Blood Tests in Multi-MAC Neurodegeneration CAC

Medicare contractors took a major step toward confronting one of the fastest-moving areas in laboratory medicine on August 20, convening a multi-contractor advisory committee on laboratory testing for neurodegenerative disease. The Noridian-led meeting focused heavily on blood-based biomarkers for Alzheimer disease, an area where commercial testing has advanced rapidly but Medicare coverage policy has remained conspicuously silent.

The session was chaired by Aparna Rajadhyaksha, MD, MBA, a Noridian medical director, and included participation from several MolDx-associated Medicare Administrative Contractors. Still, the meeting was not formally labeled a MolDx CAC, a distinction that mattered throughout the discussion. MolDx policies traditionally address DNA- and RNA-based molecular diagnostics, while the Alzheimer and Parkinson tests under discussion were protein biomarker assays, including phosphorylated tau, beta-amyloid ratios, neurofilament light chain, GFAP, and alpha-synuclein seed amplification assays.

The immediate question was not whether Medicare would cover any particular test. Dr. Rajadhyaksha made clear that the CAC was advisory and declined, when asked directly, to promise whether or when a local coverage determination would follow. But she also said the discussion had been “extremely helpful” in clarifying where the evidence is strong, where it remains uneven, and what future coverage criteria might need to address.

Seven Experts, One Central Question: Is the Field Ready?

The seven-member panel included dementia neurologists, geriatricians, laboratory medicine experts, and movement-disorder specialists: Elena Marquez, MD, University of California San Francisco; Jonathan Price, MD, Washington University in St. Louis; Meera Seshadri, MD, Mayo Clinic; Thomas Hwang, MD, University of Pennsylvania; Rachel Stein, MD, PhD, Duke University; Samuel Osei, MD, Emory University; and Katherine Bell, MD, University of Michigan.

The panelists broadly agreed that Alzheimer blood tests have moved beyond the “promising research tool” stage, at least in selected clinical settings. Several argued that high-performing plasma p-tau217-based assays, especially when combined with amyloid ratios or used in two-threshold algorithms, can meaningfully improve diagnostic workups for patients with objective cognitive impairment.

The consensus was more cautious for broad primary-care use. Panelists repeatedly distinguished symptomatic patients already undergoing dementia evaluation from asymptomatic screening. There was little support for Medicare coverage of population screening in cognitively normal older adults. But there was substantial support for using blood tests as triage tools to decide which patients need amyloid PET, CSF testing, or referral to a memory-disorders specialist.

Points of Contention and Surprise

One of the day’s sharper debates concerned whether a sufficiently accurate blood test could replace amyloid PET or CSF in some patients, rather than simply triage them. Several panelists said that for tests meeting high sensitivity and specificity thresholds, substitution is already reasonable in specialist settings. Others urged a transitional approach, with confirmatory PET or CSF still expected in ambiguous cases, before anti-amyloid therapy, or when test results do not fit the clinical picture.

A second point of contention was equity. Some panelists warned that limiting coverage to neurologists or memory clinics could worsen access, particularly in rural areas and underserved communities where specialist wait times are already long. Others countered that unrestricted ordering could lead to misinterpretation, overdiagnosis, and patient anxiety unless clinicians understand pretest probability, comorbidities, kidney disease effects, and the difference between Alzheimer pathology and clinical dementia.

A surprise was how frequently the discussion returned to operational details: specimen handling, assay cutoffs, intermediate zones, laboratory quality systems, and whether Medicare policies should be analyte-based, performance-based, or test-specific. The panelists appeared wary of both extremes: a policy so broad that weak tests ride along with strong ones, or so narrow that it freezes coverage around today’s first-generation assays.

Dr. Rajadhyaksha pressed the panelists with unusually detailed literature-based questions, asking how they would handle discordant plasma and PET findings, whether two-cutoff approaches should be expected, how often repeat testing would be clinically justified, and whether negative blood tests should redirect workups toward non-Alzheimer causes of cognitive impairment. Several panelists remarked that the questions reflected a close reading of the field rather than a generic Medicare coverage exercise.

Parkinson Testing Enters the Conversation

Although Alzheimer disease dominated the meeting, the CAC also addressed Parkinson disease and related synucleinopathies. Here the panel was more direct. Experts described CSF alpha-synuclein seed amplification testing as clinically ready, particularly because it detects underlying synuclein pathology more directly than current clinical diagnosis or dopamine transporter imaging.

Panelists emphasized that DATSCAN can support a diagnosis of parkinsonism but does not identify alpha-synuclein biology itself. By contrast, CSF alpha-synuclein assays were described as exceeding the current practical gold standard for confirming biological disease in appropriate patients. The strongest use cases included diagnostically uncertain Parkinson disease, atypical presentations, and differentiation of synucleinopathies from non-synuclein movement disorders.

By the end of the meeting, the direction of travel was clear even if the policy timetable was not. Medicare contractors appear to be preparing for a coverage framework for neurodegenerative biomarkers, likely beginning with symptomatic patients and specialist-informed diagnostic pathways. The unresolved question is how quickly coverage can catch up with a field that, in the view of many panelists, has already entered clinical medicine.


Friday, June 26, 2026

Comparing DPA 2023 blog and 2026 blog

CHAT GPT 5.5 


Here is the comparison I would use. My bottom line: the 2023 article is a technical reimbursement primer with some advocacy ambitions; the 2026 article is a much shorter but more institutional “we are organizing for battle” statement. It does look like a restart, but the restart is more about governance, policy capacity, and payer-facing evidence strategy than about new technical reimbursement theory.

The two articles

2023: Pathways to Direct Reimbursement for Slide Digitization and Digital Pathology/AI Technologies — posted 10/10/2023 by the DPA Reimbursement Task Force.

2026: Full Speed Ahead: Shaping the Future of Digital Pathology Reimbursement in 2026 — posted 04/06/2026 by the DPA Reimbursement Task Force.

https://digitalpathologyassociation.org/blog/author/id/66

High-level contrast

The 2023 article is reimbursement-mechanics heavy. It begins with the then-current and upcoming Category III slide digitization codes, explains why they had no payment rate, and warns that converting Category III codes to Category I codes may be neither fast nor necessarily sufficient. But it is not only about Category III codes. It also discusses CMS authority to price Category III codes, CMS divergence from AMA/RUC valuation, OPPS treatment of AI/software add-on codes, and the awkward interaction between AMA CPT codes and CMS-created HCPCS codes such as G0416 for prostate biopsies.

The 2026 article is much less a coding tutorial and much more a mobilization statement. It frames reimbursement as a critical barrier to adoption, states a DPA mission to “define and shape” reimbursement pathways, highlights a pending AI validation/implementation recommendation statement, and announces a strategic partnership with McDermott+ to monitor and influence CMS, AMA, Congress, and other policymakers.

What the 2023 article was really saying

The 2023 piece was not naïve about Category III codes. In fact, it was surprisingly nuanced. It acknowledged that 43 digital pathology Category III codes would soon exist, but that they had no national payment rates and that CMS and payer perception of the codes remained unclear. It emphasized that one rationale for using the codes was to demonstrate utilization, creating a data trail that might support eventual Category I coding.

But the article also warned against assuming that Category I conversion was the magic door. It noted that Category III codes can be paid locally, that Category I codes may not get better rates, and that CMS—not AMA—ultimately controls Medicare payment. The article gave examples where CMS created national payment rates for Category III codes, ignored or modified RUC recommendations, created alternative HCPCS Level II codes, or used OPPS payment logic for AI/software services.

So, while the headline emphasis was slide digitization Category III codes, the deeper message was broader: digital pathology should not put all its chips on the AMA/RUC/Category I pathway. CMS has multiple routes to recognition and payment, but stakeholders must bring data, valuation evidence, and advocacy.

What the 2026 article adds

The 2026 article does not revisit the technical coding map in detail. Instead, it shifts from “here are the possible payment pathways” to “here is the infrastructure we are building to act on them.”

Two elements stand out.

First, DPA links reimbursement to a formal evidence strategy. The article describes a pending recommendation statement for validation, implementation, and clinical application of AI in the clinical laboratory. DPA frames this as both a clinical roadmap and a payer-facing evidence base: labs need a standardized blueprint, and payers need proof that AI is safe, validated, and essential for patient care.

Second, DPA announces the McDermott+ partnership. This is the clearest difference from 2023. In 2023, the Task Force said it was initiating CMS engagement and would comment on CMS and MAC policies. In 2026, DPA says it has hired specialized Washington policy capacity to monitor CMS, AMA, Congress, and other decision-makers and to make DPA an “active and recognized stakeholder” through official comment and direct agency engagement.

That is a materially different posture. It is no longer just “the community should understand reimbursement pathways.” It is “DPA intends to shape them.”

Continuity between 2023 and 2026

There is real continuity. Both articles identify reimbursement as a barrier to adoption. Both are issued by the DPA Reimbursement Task Force. Both see CMS and AMA policy as central. Both argue that the digital pathology community must generate evidence and engage policymakers.

The 2023 article already closed with a pledge that DPA would contribute actively to reimbursement momentum and build a unified advocacy effort. The 2026 article essentially says: that effort now has a public mission statement, an AI-evidence publication strategy, and outside policy counsel.

Key difference in tone

The tone is strikingly different.

The 2023 tone is cautious, lawyerly, and explanatory. It is full of caveats: Category III may help, Category I may not be enough, CMS may or may not assign payment, stakeholders must provide data, and multiple pathways exist.

The 2026 tone is promotional and action-oriented. Phrases like “Full Speed Ahead,” “North Star,” “not a year for wait and see,” and “tangible, measurable progress” give the article the feel of an organizational relaunch. It is not a detailed policy memo; it is a signal to members and external stakeholders that DPA intends to be more visible and organized.

My clean blog-ready interpretation

A fair way to say it:

DPA’s October 2023 reimbursement article was a sophisticated but technical map of possible payment pathways, centered on the then-new Category III slide digitization codes but extending into CMS authority, HCPCS alternatives, OPPS software payment, and the need for valuation data. The April 2026 article is different. It is shorter, less technical, and more strategic. Rather than explaining the maze, it announces that DPA is building the machinery to navigate it: a validation/evidence statement for AI, a more explicit reimbursement mission, and a policy partnership with McDermott+ to engage CMS, AMA, Congress, and other decision-makers. In that sense, the 2026 piece reads less like a reimbursement tutorial and more like an organizational reboot.


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SIDEBAR - Membership

The Reimbursement Committee at DPA ( Membership, $100/yr) has 25 members and two co-chairs.  in sharp contrast to reimbursement or leadership councils at AMP or CAP, only a couple of the committee members are in academics rather than business.   (Businesses incllude Roche, Leica, Proscia, Hologic, Astrazeneca, etc).   


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CLAUDE OPUS 4.8

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Both pieces carry the same byline ("DPA Reimbursement Task Force") and invoke the same premise — reimbursement is the gating barrier to adoption — but they are different genres written for different purposes, and reading them back-to-back tells you more about strategy than either does alone.

At a glance

Dimension Oct 2023 Apr 2026
Genre Analytical white paper (≈6 pp + 6 figures) Membership newsletter / advocacy update (≈1.5 pp)
Center of gravity Slide digitization (WSI creation) AI (algorithm validation)
Core argument Contrarian: Cat I conversion is "neither necessary nor sufficient"; CMS has alternative pathways Aspirational: momentum, evidence-building, professionalized advocacy
Flagship deliverable Intellectual: a map of CMS payment mechanics Two assets: a submitted AI validation statement + a McDermott+ retainer
Evidentiary style No citations, dense with checkable regulatory specifics (code numbers, APCs, rulings, years) Two academic citations (Zarella 2023, Bessen 2025), otherwise assertion
Posture Teaching / diagnosing Reassuring / recruiting
Tone Dry, technical, skeptical of consensus "Full Speed Ahead," "North Star," "Forward together"

What the 2023 piece actually was

It's easy to file the 2023 article as "the Cat III piece," but its intellectual core was heretical for its moment. 

The stakeholder consensus then — and arguably now — was that the path to payment ran through converting the 43 slide-digitization Category III add-on codes into Category I codes with RUC-set RVUs. The Task Force, in 2023, quietly argued the opposite: that Cat I is neither necessary nor sufficient, that conversion carries real downside (years-long timelines, the 5-year archive guillotine, the risk that a revised Cat I descriptor lands at the same payment with nothing added for digitization, contagion to the rest of the code family, and loss of MAC local-pricing flexibility), and that CMS has repeatedly paid by other routes entirely. It then enumerated those routes with specificity — national rates set directly on Cat III codes (glucose 0446–0448T, HeartFlow FFR 0503T, ERG 0509T); CMS overriding the RUC on valuation (the HeartFlow consolidation to a single Cat I code with a technical component crosswalked back to the 2018 OPPS price); OPPS "Software as a Service" add-on parity (Liver Multi-Scan, Optellum, QMRCP, with the 0648T/0649T standalone-plus-add-on structure as the template); and CMS bypassing the AMA altogether via HCPCS Level II (G0416 for prostate biopsy, whose missing add-on is the reason digitization can't be captured on those claims).

[BQ CMS had bypassed RUC several times, but reluctantly and these were viewed as rare high-touch workarounds awaiting a long term and scaleable fix]

That is a genuinely sophisticated document. It is teaching the reader how the machine works and, implicitly, telling them the field had picked the wrong lever.

What the 2026 piece is — and what's missing

The 2026 article contains none of that. The codes aren't mentioned. The payment mechanics aren't mentioned. The alternative-pathway thesis — the most original thing the Task Force had published — has vanished. 

In its place are two items, both of which are inputs rather than outcomes: a recommendation statement on AI validation that has been submitted (not published, "in the review phase"), [silverburg now published June] and a signed consulting engagement with McDermott+.

This is the analytically important point, and it's where I'd gently push on the defibrillator framing you offered. [I joked 2026 was like a defib ER reboot of 2023's motionless body.]   A defibrillator restarts the same rhythm. What 2026 shows is closer to a restart on a different operating model. The 2023 strategy was bottom-up code engineering — get the codes, generate utilization, feed CMS RUC-like cost data, exploit the alternative pathways. The 2026 strategy is top-down — build a clinical/evidentiary foundation (the AI statement) and buy sustained Washington access (the lobbying firm). Read uncharitably, the silence between them plus the quiet abandonment of the coding-mechanics narrative is a tacit concession that the 2023 approach didn't convert: the Cat III codes were, as you put it, ill-fated — no rates, unclear uptake — and the Task Force has stopped litigating that problem in public and pivoted to firmer ground.

So the heart did get jolted back, but it woke up with a new care plan. And notice what a victory lap would have looked like and isn't here: no new code, no payment rate secured, no LCD, no reported CMS response to the 2023 "meeting this quarter," no status update on the 43 codes. 

For a Task Force whose 2023 piece promised "regular updates" and imminent agency engagement, the 30-month flatline is itself data, and "Full Speed Ahead" is doing a lot of rhetorical work over a re-launch from roughly zero.

The drift that should matter to you specifically

The most consequential shift for a Leica/Danaher read is the migration of the subject: from digitization to AI. The 2023 piece is fundamentally about paying for the scan — the act of turning glass into a WSI, which is Leica's (Aperio's) core business and the unglamorous foundation everything else sits on. The 2026 flagship deliverable is about validating algorithms in the clinical lab — the application layer where Paige, PathAI, and the pure-play AI vendors live.

That drift tracks where FDA/CMS attention and perceived novelty-value have moved, and it's defensible as advocacy positioning. But it arguably leaves the boring, vendor-critical question — who pays for the digitization itself, and through what code structure — unaddressed in the very document that should own it. If you're advising Leica, the watch-item is whether the DPA's reimbursement agenda is quietly becoming an AI-reimbursement agenda, in which the scanner-and-platform layer is assumed rather than funded. A whole-slide image with no payment path doesn't become more reimbursable because an algorithm later reads it.

Net

There's real continuity — same byline, same "reimbursement is the barrier" premise, same CMS/AMA advocacy posture (the 2023 piece already described comment letters and CMS meetings, so the posture isn't new; its professionalization and funding via McDermott+ is). The McDermott+ engagement is a genuine maturation signal worth taking seriously. But on substance, 2026 is thinner, more promotional, and strategically narrower-but-different than its predecessor. The 2023 piece was the smarter document; the 2026 piece is the better-funded one. Whether that trade pays off depends entirely on outputs the April article conspicuously cannot yet point to.

If it'd be useful, I can pull the DPA blog archive to confirm whether anything reimbursement-related actually ran between these two posts, or check the current status of the AI validation statement and the 43 Cat III codes — that would let us test the "flatline" read against the record rather than inferring it from the two documents alone.

Tuesday, June 23, 2026

Invitae, LabCorp, and Illinois

Genomeweb article, https://www.360dx.com/business-news/labcorps-invitae-illegally-shared-genetic-data-upon-acquisition-class-action

Prompt at bottom

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 I think your intuition is basically right: this cannot be analyzed as “genetic data was sold like a mailing list.” A clinical lab archive is not a pile of surplus hard drives; it is part medical record, part laboratory compliance record, part ongoing patient-care infrastructure, and part corporate asset. The harder question is whether Illinois GIPA creates a consent requirement that is stricter than the ordinary HIPAA/M&A rule.

Under HIPAA, the ordinary answer is fairly friendly to acquisitions. HHS has long treated transfer of records in a sale, merger, consolidation, or asset transfer to another covered entity — or to an entity that will become a covered entity — as a form of “health care operations.” The point is continuity: otherwise every hospital, lab, pharmacy, or physician practice sale would require consent from thousands or millions of patients before the buyer could safely operate the business. HHS commentary specifically says PHI may be exchanged for due diligence and transferred to the new owner on completion of the deal, with the successor then bound by HIPAA duties. (Bricker)

So if this were only HIPAA, Labcorp’s position would likely be: Invitae was a covered health care provider/lab; Labcorp is a covered health care provider/lab; the records moved as part of a going-concern acquisition approved in bankruptcy; Labcorp needed the archive to continue testing, issue amendments, support reinterpretations, answer patient/provider questions, satisfy CLIA/state record duties, and operate the acquired clinical genetics business. That is not the same as selling identifiable genetic data to an advertiser, pharma marketer, data broker, or unrelated AI platform.

But the complaint is smarter than a generic HIPAA complaint because it invokes Illinois GIPA. GIPA says that no person may disclose the identity of a person tested or the results of a genetic test in identifiable form except to specified permitted recipients, including the test subject or a person designated in a specific written authorization. (Illinois General Assembly) It also provides eye-catching statutory damages: $2,500 for negligent violations and $15,000 for intentional or reckless violations, plus fees and other relief. (Illinois General Assembly) That is why this is a class-action magnet.

However, GIPA also has HIPAA-like carve-outs. Section 31 allows a covered entity, without patient consent, to use or disclose genetic information for its own treatment, payment, or health care operations, and to disclose genetic information to another covered entity for certain payment and health care operations activities under specified conditions. (Illinois General Assembly) It separately permits covered-entity disclosures to business associates under HIPAA-style written safeguards, and permits de-identified and limited data set uses under HIPAA standards. (Illinois General Assembly) So the plaintiffs cannot simply say, “genetic data moved; therefore illegal.” They have to defeat the statutory exceptions or frame the transaction as outside them.

The “law professor” issue is probably this: was Labcorp merely the successor clinical custodian/operator of the Invitae lab archive, or was there a distinct disclosure of identifiable genetic results as a monetized asset beyond clinical operations? If Labcorp acquired the Invitae clinical testing business as a going concern, and the same archive was necessary for ongoing lab operations, Labcorp has a strong policy argument and probably a strong HIPAA argument. Labcorp and Invitae announced that a bankruptcy court approved Labcorp’s acquisition of Invitae assets in May 2024; contemporary reports described it as a $239 million going-concern acquisition of the medical-genetics business. (Labcorp)

Your GeneDx example is apt. Clinical genetic labs do not become amnesic every time the corporate wrapper changes. GeneDx could be inside BioReference, then sold or spun into a new public-company/SPAC structure, but the clinical archive remains clinically necessary. Variant reinterpretation, amended reports, family testing, clinician support, billing disputes, audits, malpractice defense, CLIA retention, and state lab requirements all presume that somebody has custody of the old data. If every transaction required fresh written consent from every prior patient, it would be nearly impossible to transfer a genetic laboratory as a functioning clinical enterprise.

Bankruptcy adds a second layer. Health care bankruptcies have special patient-record problems precisely because the records cannot simply be abandoned, auctioned casually, or destroyed without process. Bankruptcy law has procedures for patient-record disposal when a debtor lacks funds to store them, including notice and attempted patient contact; the existence of those rules reflects that patient records are not ordinary inventory. (Haynes Boone) But a going-concern sale to a qualified health care successor is usually the cleaner privacy solution, not the dirtier one, because it preserves custody, access, and compliance.

Where the plaintiff’s case may have traction is Illinois specificity plus genetics sensitivity plus “asset” rhetoric. GIPA is not merely HIPAA. It was written against fear that genetic results will be disclosed without consent or used discriminatorily. Plaintiffs will argue that “Labcorp bought Invitae’s assets” is not the same as “Invitae disclosed results for treatment/payment/operations under a patient relationship.” They may say Labcorp had no relationship with B.W. at the time of transfer, that the disclosure was for corporate acquisition value, and that the genetic archive was integrated into Labcorp’s broader “data assets,” not merely held as a locked clinical-record archive.

The defense answer is that this is too formalistic. In an acquisition, the successor steps into the acquired lab’s shoes. The patient relationship, at least for record custody and ongoing clinical obligations, should travel with the business. Otherwise, GIPA would disrupt ordinary clinical-lab continuity in a way HIPAA expressly tried to avoid. Also, GIPA itself recognizes covered-entity treatment, payment, operations, business-associate, limited data set, de-identification, HIE, oversight, and research pathways; it is not an absolute “fresh consent for every downstream handling of genetic data” statute. (Illinois General Assembly)

The scariest fact pattern for Labcorp would be if the complaint can show that identifiable Invitae genetic data was not merely migrated for continuity of clinical testing, but was pooled into Labcorp analytics, commercial data products, pharma partnerships, AI development, or non-care research without a valid authorization, IRB/privacy-board pathway, de-identification, or other statutory basis. That is a different case. There is already a wave of Illinois genetic privacy litigation around acquisitions and downstream data use, including a 2026 Tempus/Ambry-related lawsuit framed around acquisition of a genetic-testing database and alleged downstream sharing. (Fisher Phillips)

My bottom-line read: as a pure “Labcorp bought Invitae and inherited the clinical archive” claim, the lawsuit feels overbroad and somewhat artificial. But as a class-action pleading under GIPA, it is not frivolous, because Illinois law creates a more plaintiff-friendly textual hook than HIPAA and very large statutory damages. The decisive line should be: successor clinical custody and operations, likely permissible; sale or repurposing of identifiable genetic data as a separable data asset, much more vulnerable.

A good blog sentence might be:

The legal problem is not that Invitae’s clinical archive followed the laboratory business to Labcorp; that is exactly what one would expect in a going-concern lab acquisition. The real question is whether identifiable genetic results were transferred and used only as successor clinical records, or whether they were treated as a freestanding monetizable data asset outside the patient-care and health-care-operations framework.


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Prompt

I can understand that if a clinical laboratory goes bankrupt, it cannot simply auction off hard drives full of patient data. But mergers and acquisitions seem different. If one laboratory acquires another, the clinical archive presumably has to go somewhere, and often it must remain available for clinical, regulatory, and patient-care purposes.    I would quickly get lost trying to think through all the legal angles, but surely this issue has arisen before. One example might be BioReference/GeneDx: GeneDx was sold off and merged with a SPAC, creating what was legally a different company, yet there remained one continuous GeneDx clinical archive.       Think this through like a HIPAA law professor. This cannot be the first time the issue has come up.   

Labcorp’s Invitae Illegally Shared Genetic Data Upon Acquisition, Class Action Complaint Alleges  / Jun. 17, 2026 | Adam Bonislawski .......