Monday, November 3, 2025

Podcast: MedTech Talk. Valuation bubble; Reimbursement challenges.

Recently I ran across the podcast, MEDTECH TALK, and I'll mention a few that caught my attention.  (I'm citing a couple from 2023, 2024, but the channel has podcasts right to October 2025).

Find the home page here:

https://medtechmvp.com/media/medtech-talk-podcast

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Hear about the career path and priorities of Liz Kwo MD MBA, who is now Chief Commercial Officer of Everly Health.   July 2024.  Find it here. #189.

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There was a huge valuation bubble in biotech, genomics, etc, during 2020/2021.   In this podcast, recorded in July 2023, a panel looks back on the very recent bubble, and predicts the next year.   Find it here. #179.

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Justin Klein, an MD JD who went straight into venture capital, discusses his career and priorities, also from 2023.  The focus is "the Medtech Ecosystem," how important it is.  There's a substantial section about "reimbursement" as being an opaque unpredictable barrier, a weak link in that ecosystem.  (Around minute 20.)  Find it here.  #182.

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Valuation bubble.  Biodesix (genomic testing) IPO at $250, peak $480, rapid decline over 90% to $30 and under ($6 today).   Many diverse genomic companies had 2020/2021 valuation spikes, even if they had no connection to Covid testing or therapies.  Invitae rapidly went from $15 to $50 to $15 to 0.







CAP's Newest Podcast - CIPI Council on Informatics and Pathology innovation

 CAP launches a new podcast, CIPI CONNECTIONS.
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CIPI Cup

One of the several Councils of the College of American Pathologists (CAP) is CIPI - The College on Informatics and Pathology Innovation.   Home page here.  They have five committees:

  • Artificial Intelligence
  • Cancer
  • Digital and Computational Pathology
  • Informatics 
  • Pathology Electronic Reporting (PERT0
The CIPI podcast is subtitled, 'Insights, Updates, and the People Behind the Innovation."

Find a podcast hosting page here;

Find the "debut episode" August 8, 13 minutes.  The link, above, also offers a transcript. Here's the tag line:

  • Welcome to the debut episode of CIPI Connections, the official podcast of the College of American Pathologists' Council on Informatics and Pathology Innovation (CIPI). Co-hosts Dr. Giovanni Lujan and Dr. M.E. de Baca introduce the podcast’s mission and discuss Dr. de Baca’s inspiring journey from ophthalmology in Germany to leading innovation in pathology. Learn how CIPI and its five committees are shaping the future of digital pathology, AI, cancer reporting, and more—and what listeners can expect from future episodes.
See also a listing of "CAP Podcasts" which includes CIPI Connections and a new series under the banner, "Horror Stories in Pathology Informatics."

Here's an entry point from the CAP / Publications / Podcasts index page:


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AI CORNER
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Here are AI summaries of two recent podcasts.
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CIPI Connections Podcast 1 — “Pathology Meets Artificial Intelligence”

This episode of CIPI Connections from the College of American Pathologists explores how existing laboratory validation frameworks can guide the safe implementation of artificial intelligence in pathology. Hosted by Dr. M.E. de Baca, the discussion features Drs. Matthew Hanna, Nick Spies, and Larissa Furtado from the CAP AI Committee, who examine parallels between AI model validation and familiar laboratory processes such as immunostain verification and molecular assay quality control. They emphasize that AI should be treated as another diagnostic test, requiring analytical and clinical validation, documentation, and continuous performance monitoring. The speakers identify gaps in current CAP checklists—particularly around data quality, explainability, and model updating—and highlight the emerging role of AI implementation specialists to ensure safe, effective deployment. Their consensus: existing laboratory rigor provides a strong foundation for AI adoption, but evolving guidance and education will be essential to maintain patient safety and trust as laboratories integrate machine learning tools into clinical workflows.


CIPI Connections Podcast 2 — “Horror Stories in Pathology Informatics: Unflagged and Overlooked”

In this inaugural episode of the Horror Stories in Pathology Informatics series, Drs. Alexis Carter and Omar Baba dissect a real-world case involving a missed low cortisol result that went unflagged in an electronic health record, delaying diagnosis of adrenal insufficiency. The case—stripped of identifiers but based on actual events—illustrates how informatics design decisions can compromise patient safety. Because cortisol has time-dependent reference ranges, the lab displayed both ranges in a free-text comment, preventing the system from automatically flagging the abnormal value. The physicians discuss how structured data fields, discrete order codes for morning and afternoon tests, or “ask-on-order-entry” prompts could have prevented the oversight. They also caution against overreliance on visual flags as shortcuts for reviewing lab results, emphasizing the need for clinician education, structured data standards, and interdepartmental communication. The episode concludes with practical takeaways: build structured informatics solutions wherever possible, ensure reference ranges are machine-readable, and reinforce the clinician’s responsibility to review all results—not just those flagged as abnormal.


Sunday, November 2, 2025

CMS Releases PFS Final Rule Despite Shut-Down. OPPS Final Rule Pending.

Each fall, CMS normally releasing the final PFS rule and final OPPS rule on November 1, giving them 60 days to take effect (January 1).   CMS got the CY2026 PFS rule out the door on Friday October 31.  The OPPS rule isn't out yet.

See the PFS press release here - "CMS Modernizes Payment Accuracy."  

The main headline is a 2.5% cut in reimbursement for surgical and similar services that CMS believes have "become more efficient."  Stakeholders argued the opposite, that patients had become more complex (a greater and greater percent are over 70).  See MedPage Today here.

  • This cut continues an effort, which finally bloomed after years of debate, of shifting some dollars from specialists to primary care.  A couple years ago CMS introduced a G-code which adds about $16 to primary care visits, a perturbation that decreased RVUs for non-E&M visits.  In an effort to increase the number of Infectious Disease doctors, CMS also introduced some special coding for them a couple years ago.

See the PFS Fact Sheet here, which is more detailed and granular than the press release.

CMS notes that much of its practice expense information dates to 2008, but declines to accept a 2014 update from an AMA survery.

CMS may expand its method of using Medicare hospital outpatient rates as a proxy for office-setting rates.   Otherwise, CMS uses an extremely detailed accounting method with pennies and dollars for supplies, capital equipment, staff time, physician time, overhead, and other factors.  

While a telemedicine "cliff" is still in the air, as COVID legislation expires, CMS continues to tweak with rules for virtual services which do exist, such as "virtual direct supervision" rather than "present in the office suite" supervision, for some incident-to services.

Responses to public comments solicited for "software as a service" (in general) at page 447ff, merely remarkng that "comments were appreciated."

The Fed Reg publication will be Wednesday November 5.  A typescript copy is available here (2375pp!)




PLA Codes at Novitas: Vastly Less Controlled than at MolDx

The Novitas MAC seems to go through one payment disaster after another, with notoriously high and bizarre-looking payments for 81408 (rare gene, full sequence) and adjacent codes in 2019-2021.  The OIG's report cited a "billion dollars" in misspending.   Now, in 2023, 2024, the Novitas cash seems to be directed to some otherwise rare gene panels (e.g. for mitochondrial disorders, or for inherited diseases of childhood like cystic fibrosis), and also for code 87798, a microbiology code that is uncontrolled at Novitas.  (See also blog.)

Rare Gene Panels (81419, 81430, 81433, etc); 87798 

The typical labs billing for these in the US are in Texas or Florida, and they recently obtained NPI numbers as LLCs.   The same codes (81408; the rare-gene panels; 87798) are very rarely billed to Medicare by labs like LabCorp, GeneDx, Ambry, Quest, etc.  

In each case, billing in Texas and Florida (but not elsewere) exploded such as multiples of 100X over a couple years.

Novitas and PLA Codes - Striking Lack of Controls Compared to MolDx

I looked at 2023 billing to Medicare Part B for all "U" codes - the PLA codes.  Total billing was $519M.  The distribution was 64% MolDx, 14% Novitas, and 22% NGS MAC.  

However, had NGS MAC not been paying for FMI codes which are under an NCD (0037U, 0239U), NGS MAC PLA payments would drop to just $36M or 7% of national.

In each case, the PLA codes were highly concentrated, with 90% to 97% of PLA payments to the top 10 providers in each MAC system.  (And, as shown below, most PLA payments went to the top 3-4 codes).

  • We noticed something strange when we looked up each PLA code in the Medicare Coverage Database.  
  • All of the top 10 PLA codes at MolDx fall under NCDs or LCDs.  
  • In the Novitas MAC, I could identify only 2 of 10 PLA codes that fell under an LCD or NCD, using the same Medicare Coverage Database.

In both Novitas and NGS MAC, many of the payments (not under LCDs) were for 0240U, 0241U, microbiology codes.  Although MolDx had 64% of all PLA payments, none of the top 10 at MolDx were microbiology codes.

Caveats

  • This is first-pass work; I haven't double checked everything or had anyone replicate it.  
  • We compare 2023 payments to current 2025 policies.  
  • I entered CPT codes one by one in the Medicare Coverage Database and took the result.

Click to enlarge. MAC index = 1, MolDx, 2, NOV/FCSO, 3, NGS MAC.

click to enlarge

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The CMS cloud database is here.  It has all 2023 Part B claims.  You can filter for codes ending in "U" = PLA codes.


Thursday, October 30, 2025

Chat GPT Asks: How Do Commercial, Medicare, and Medicare Advantage Rates Compare?

The point of this blog is just to show how Chat GPT 5 performs, to a request for a medical policy essay.

Issue:  Now and then I see an article comparing Medicare FFS prices with some other price list.  But I don't record and file those articles.  So, below you can see instant, AI-generated research on this topic.  

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Prompt  Can you please search the internet looking for recent articles that survey what Medicare fee for service pays versus what either regular commerical or medicare advantage pay? There is probably the most data on relative pay rates for office visits. I work in the lab industry, so any published comparative pricing (against medicare part B as a baseline) for pathology or laboratory medicine would be ideal. Please be agentic or thorough.

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Absolutely—here’s a tight, source-backed roll-up of what the best recent evidence says about Medicare fee-for-service (FFS) versus commercial and Medicare Advantage (MA) payment levels, with a spotlight on office visits and lab/pathology.

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EXECUTIVE SUMMARY

In recent analyses, Medicare fee-for-service (FFS) payment levels for physician services—including office visits—provide a stable baseline against which commercial and Medicare Advantage (MA) payments can be compared. The predominant finding is that commercial insurers pay roughly 30–40% more than Medicare FFS for similar physician services, with the most recent data showing commercial PPO rates averaging around 140% of Medicare. In contrast, MA plans tend to negotiate provider payments that sit much closer to Medicare FFS levels rather than commercial rates, particularly in hospital outpatient settings and other facility-based services. This dynamic reflects MA plans’ reliance on Medicare benchmarks and regulatory constraints that tether payment growth more tightly to FFS than to the wider commercial market.

In the laboratory and pathology sector, the pricing landscape shows further nuance. For independent clinical laboratory tests covered under the Clinical Laboratory Fee Schedule (CLFS), Medicare rates are essentially derived from the weighted median of private-payer rates by statute, thereby narrowing the gap between commercial and Medicare payments for those services.  [Historically, before 2014, at least some commercial lab rates were below Medicare. BQ]

However, for pathology professional services that fall under the Medicare Physician Fee Schedule (MPFS), commercial-to-Medicare differentials resemble those seen in other physician specialties—commercial payments are commonly 20–50% higher than Medicare. At the same time, when services are rendered in hospital-outpatient settings, commercial payment multipliers may be substantially higher, given the elevated mark-ups typical in hospital-facility billing contexts.

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DATA AND LINKS

Big picture (latest, credible sources)

  • Physician services, overall (incl. office visits): Commercial PPO payment rates now average ~140% of Medicare FFS (up from 136% in 2022; long-run trend rising from ~122% in 2011). (medpac.gov)
    CBO’s broader review is directionally consistent (~25% higher for physicians), and KFF’s lit review shows a typical range of ~118%–179%. (cbo.gov)

  • Medicare Advantage (MA) provider prices: For hospital services, MA negotiated prices are much closer to traditional Medicare than to commercial; same-insurer/same-hospital comparisons show commercial prices ≈ 2–3× MA. For physician services in MA, empirical work finds MA rates are generally tethered to Medicare FFS, not commercial. (Mark K. Meiselbach)

  • Hospitals (useful context for outpatient labs/E/M): Employers/private plans pay hospitals ~254% of Medicare on average (2022), with wide state variation. (rand.org)

Office visits (E/M) as an anchor

  • E/M office visits sit inside the physician trend above; think commercial ≈ 1.3–1.4× Medicare on average, with variation by market and insurer. That average comes directly from MedPAC’s PPO data series (not code-specific but dominated by E/M volume). (medpac.gov)

Pathology & Laboratory medicine

Two different payment systems matter here:

  1. Clinical lab tests (CDLTs) under the CLFS (Part B):
    Since PAMA, Medicare sets CLFS rates from the weighted median of private-payer rates. In other words, for most CDLTs, Medicare amounts are pegged to the commercial market median (repriced on a multi-year cycle). This means “commercial vs Medicare” is intentionally narrow for independent lab test codes—though contract-to-contract variation still exists. (Centers for Medicare & Medicaid Services) [In some reports, some commercial rates were below Medicare in 2012. BQ.]

  2. Pathology professional services (e.g., 88xxx under the MPFS):
    These behave like other physician services, so commercial ≈ 1.2–1.5× Medicare on average, with specialty- and market-level variance (MedPAC overall ~1.40×; Urban Institute shows wide specialty dispersion). Specialty-specific breakouts for pathology are sparse in public summaries, but the directional physician-category uplift applies. (medpac.gov)

Hospital-based lab pricing: When the same lab test is billed as hospital outpatient, commercial prices often rise with hospital outpatient markups. RAND’s latest round shows commercial outpatient prices several multiples of Medicare—important if your client work involves hospital outreach labs or site-of-service shifts. (rand.org)

Handy ratios you can cite (and where they come from)

  • Commercial vs Medicare (physician/clinician services overall): ~140% (2023 average PPO). (medpac.gov)

  • Commercial vs Medicare (historical context): 122% → 140% from 2011→2023. (medpac.gov)

  • MA vs Commercial (hospitals, same insurer/hospital): Commercial ≈ 2–3× MA (2022 machine-readable data). (Mark K. Meiselbach)

  • Commercial vs Medicare (hospitals, all-payer view): ~254% in 2022 (national mean, inpatient+outpatient). (rand.org)

  • CLFS lab tests vs commercial: Medicare ≈ weighted median of private rates by rule (thus generally close to commercial medians for independent labs, with timing/refresh caveats). (Centers for Medicare & Medicaid Services)

Nuances & caveats (worth knowing for client work)

  • Market power & site of service drive variation. Commercial-to-Medicare gaps widen in concentrated hospital markets and for hospital-outpatient services; office-based settings are closer to Medicare baselines. (rand.org)

  • MA pricing is policy-tethered. Because MA benchmarks tie to local FFS spending, MA provider prices tend to cluster nearer FFS than commercial—especially on facility services. (PMC)

  • Pathology exposure to MPFS updates. Year-to-year conversion-factor moves (and RVU tweaks) hit pathology like other specialties (e.g., 2024–2025 adjustments), even as CLFS amounts for CDLTs follow separate PAMA cycles. (medpac.gov)


Sources you can quote in decks

  • MedPAC (Dec 2024 & Jan/Jun 2025): Private PPO ≈ 140% of Medicare for clinician services; time trend from 122% → 140% (2011–2023). (medpac.gov)

  • CBO (2022): Commercial physician prices ~25% higher than Medicare on average. (cbo.gov)

  • KFF literature review (2020): Private physician payments average ~143% of Medicare across studies (range 118–179%). (KFF)

  • Health Affairs (2023): Commercial hospital prices two–three times MA in same hospitals. (Mark K. Meiselbach)

  • RAND Round 5 (2024): Employers/private plans pay hospitals ~254% of Medicare (in/outpatient combined). (rand.org)

  • CMS CLFS/PAMA (2024 page & guidance): Medicare sets CDLT rates from private-payer weighted medians. (Centers for Medicare & Medicaid Services)

If you want, I can also:

  • Pull specific 99213/99214 localities (Noridian/Jurisdiction E etc.) and pair them with Transparency-in-Coverage E/M rates from a target insurer in LA for an apples-to-apples snapshot, or

  • Build a pathology-focused mini-table (e.g., 88305, 88184) comparing CLFS vs MPFS vs sample commercial (independent lab vs hospital outpatient), using recent public files.

AMA Releases PLA Applications for 4Q2025

 Each quarter, AMA receives and processes a couple dozen PLA code applications.  The ones for this quarter are posted.  There will be an AMA meeting to vote for the codes next week, November 5.  Codes were accepted til September 9, the PLA committee met on October 23.

Find the PLA page here:

https://www.ama-assn.org/practice-management/cpt/cpt-pla-codes

Find the agenda here:

https://www.ama-assn.org/system/files/november-2025-pla-public-agenda.pdf

There are 28 agenda items, of which about 5 are revisions or deletions.  


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AMA is currently collecting CPT Category I applications, and those will be available for comment about November 15-30.  They will be voted at the editorial meeting in February in Palm Springs.

AMA Publishes Summary of Panel Actions for CPT September 2025

You may have attended AMA CPT September 2025 for its infamous "Tab 94," the proposal to create a novel coding appendix (sort of a SAMD registry) with novel codes.  The novel codes would be called "CMAA," for Clinically Meaningful Algorithmic Analyses.   This would be exclusively for software-dominant services that do not require physician work.   It's caught the attention of the lab community because AMA PLA has categorized several software-based whole slide imaging tests as PLA tests, but recently began rejected further such applications in PLA, on what I understand to be the theory that "those are dry lab services which are not eligible for PLA codes."  

This is the home page for CPT panel actions here.   This is the report for September 2025 here.  

Tab 94

There were 95 agenda items or "tabs."  Regarding Tab 94, we read,

  • The Panel engaged in a robust discussion of this proposal for a framework to report algorithmic and AI-enabled clinical services that do not include traditional interpretative physician or other qualified health care professional (QHP) work. The CPT Panel heard testimony for one hour from over 20 stakeholders representing nearly every sector of the health care industry. This proposal was for discussion only and no vote was taken at this meeting

Labs

Tab 44, genetics of inherited renal conditions, withdrawn.  Tab 45, genetics of inherited immune conditions, accepted.  Tab 45, genetics of Alport syndrome, accepted.  Tab 46 Bladder MAAA, rejected.  Tab 47 Code 0007M deleted. 

Withdrawn!   Rejected!

A rule of thumb is that applications informed they are likely to fail (they are given formal feedback) are usually withdrawn rather than voted and rejected.

There were 34 "withdrawn" items and 18 were rejected.   These 52 codes were over half of all agenda items.


Wednesday, October 29, 2025

Legislation Watch: The Health Technology Investment Act of 2025; S. 1399

It's become a cliche' that most action occurs in the Executive Branch, with a sleepy agenda on the Hill.

But one topic of interest is the Health Technology Investment Act, S.1399, introduced in April 2025 by Senators Mike Rounds (R SD) and Martin Heinrich (D NM).   

  • Find the Senate press release here.
  • Find the legislative language here.
  • See support by AdvaMed here.


  • Sidebar: Funding.  
    • A new article in Healthcare Dive writes that, "Digital health funding outpacing last year as huge rounds increase.  Investment in 2025 has reached $9.9 billion."   
  • Sidebar: CMS Policy Struggles
    • CMS wrestling with paying digital services, the topic of S.1399.  
    • This past summer, CMS sought public advice on pricing SAAS-SAMD; entry point here.
  • Sidebar:  No Money!
    • The "Investment Act" does not actually contain any money.  Rather, it instructs CMS to set up payment systems that are friendlier to software-dominant diagnostics and therapies.

PBS Runs Documentary on the Life of Secretary of Health, RFK Jr


This week, I watched the two-hour documentary on PBS Frontline about his career and controversies. 

See the video (currently streaming) here.
See a review of the film online at MedPage Today - here.  

  • The LA Public Library had several books by or about RFK Jr (*):


Here's a Chat GPT 5 summary of the documentary, after it listened to the whole transcript.

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AI CORNER

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Senate Letter Criticizes the "AMA Monopoly" on the U.S. Coding System

October saw a sharply worded letter from Senator Cassidy to the AMA, criticizing the "monopoly" (his term) on the US main coding system.  That monopoly, though, was granted by Congress in the U.S. HIPAA law and subsequent CMS regulations, to ensure a uniform coding system for communications between providers and payers.   

click to enlarge


Sources:

  • Press release from Senator Cassidy, with full letter link (October 8).  Here
  • Report at Inside Health Policy (subscription).  Here.
  • At Modern Healthcare (subscription).  Here.
  • Article at MedPage Today.  Here.
  • Report at Fierce Healthcare.  Here.
  • At Medical Device Mfgrs Assoc.  Here.
  • At Politico Pro (subscription.)  "Cassidy and RFK Jr have something to disagree on."  Here.
SIDEBAR - Going Without AMA?

Interestingly, for Medicare claims, MolDx could run genomic test transactions without the AMA CPT. 

A huge part of MolDx payments are now coded as 81479, "other molecular test," and processed with the Z-code.  CMS could create a G code like - G1479 = "other molecular test."  This G-code wouldn't involve AMA and would be royalty-free for labs and payers to use.   As it chooses, MolDx (CMS) might use "G1479" for current 81479 claims only.   Or MolDx could use "G1479" for all types of molecular tests (whether or not they have Cat I or PLA codes from AMA), adjucating via the Z code.   This could pull out several billion dollars a year of services now coded with AMA CPT codes.

Science Policy; Banned Words at NIH; Is This the Time to Do a PhD?

Two interesting science policy articles this week.   I think both are firewalled, so I'll include short summaries.  Here are the titles:


At STAT, Anil Oza provides a long-format, deep-dive article, on the vocabularies of "banned words" at NIH and the need to change grant titles and abstracts to avoid "banned words" which trigger a fatal withdrawal of funding.   Find it here:

https://www.statnews.com/2025/10/29/nih-banned-words-analysis-grant-title-changes/

At CHRONICLE of Higher Education, an article has the surprising or paradoxical title, "There has never been a better time to start a PhD."  Find it here:

https://www.chronicle.com/article/there-has-never-been-a-better-time-to-start-a-ph-d

Friday, October 24, 2025

Peer Review Is Too Slow; How Impactful Can AI Be?

In Annals of Internal Medicine, Kieran Quinn et al. ask, how can we re-think how we disseminate medical research?   Can we expand the status and role of preprint archives?   And see their Citation 8, Liang et al., in NEJM-AI.  They empirically study how LLM contributes to peer review, and the percentage of reviewers who are favorable is high.  80% of reviewers said LLM review was more helpful than at least some of the available human reviews.

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Alzheimer tests and FDA: Location, location, location.

HEADER:  FDA’s 2025 Alzheimer’s test approvals reveal a new split in strategy—Fujirebio’s plasma ratio test is indicated for centers for diagnosis, while Roche’s Tau181 test is limited to “rule-out” use, but in primary care.

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There are some surprising nuances to recent Alzheimer test approvals at the FDA.

 In May 2025, FDA approved the first-ever PLASMA test for Alzheimer's disease, a combined Tau217 and Amyloid42 test from Fujirebio.  (Fujirebio  previously had a CSF test for Alzheimer's.)   The test has a double cut-off; below the lower cut, Alzheimer's is unlikely; above the higher cut, Alzheimer's is likely, and for a few patients in-between, the test is indeterminate.

Recall that the "intended use" is from the viewpoint of the physician, and "indicated use" is the patient condition or situation for use.   The Lumipulse Plasma Ratio is "intended to aid healthcare providers to identify patients with amyloid pathology associated with Alzheimer's disease."  The Plasma Ratio is "indicated for adult patients, age 50 and older, presenting at a specialized care center with signs and symptoms of cognitive decline."  This FDA wording on the label foots to the title of the July 2025 guideline for Alzheimer blood testing, which also uses the phrase "in a specialized care center."  (Palmquvist 2025).

Typically, a sign is objective (fever), a symptom is subjective (headache).  See Fujirebio's detailed FDA summary here.

In contrast, we have a headline in Genomeweb, October 2025, "Roche Targets Primary Care Setting With Newly FDA-Cleared Alzheimer's Rule-Out Test."  This plasma Tau181 test is only intended to "rule out" (which is driven by a one-sided low value), while the indicated setting is "primary care" rather than "a specialized care center."

The new October Genomeweb article on Roche tracks back to a May 2025 article on these debates in the field (here), and a JAMA IM op ed by Wider and Covinsky on settings for blood testing. 


AMA Upgrades Its RVU Database - RBRVS Data Manager

AMA creates CPT codes, an obligatory code set for communications between providers and payers in the US, under HIPAA law.  It also values the codes, through an elaborate, data and committee driven process (the relative value unit or RVU system).   These codes and values are generally adopted by CMS for Medicare.

For years, AMA has had a product called RBRVS Data Manager - originally on CDs! - for years now, on the internet with a subscription (mine as an AMA member is $240/yr).

They did a big update & modernization to RBRVS Data Manager a couple years ago.  I *think* they've done some extra updating this year, too.

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For example, here's I've searched on 95165 - preparation and provision of allergens - and you can see that there are no less than 9 different tabs, each pretty rich in information.


The tabs are

  • General information
  • Work RVU history
  • Vignette/Service
  • RUC rationale
  • Geographic adjustment
  • Physician time
  • Claims data
  • Billed together
  • PE Inputs
The system has lab codes (8nnnn) but not PLA codes (nnnnU).  

For lab codes - like 81455, tumor gene panel >50 genes - you don't have valuation or RUC data but you do still get the tab for Claims Data, with voume (going back to 2013, over ten years), ICD10 codes billed, and other demographics.

You get to see the Patient Vignette and Service (work) description, which might help you if you are writing a CPT application yourself.   Some Cat I lab codes have no vignette or service, some do.

  • 81455 Vignette   A 65-year-old male presents with lung and liver lesions. Pathologic evaluation of biopsies of these lesions reveals a poorly differentiated neoplasm of uncertain primary origin. Tumor tissue is submitted for a targeted genomic sequence analysis of a panel of 250 genes known to be informative in a broad array of cancers.
  • 81455 Service     Isolate high-quality DNA from the patient's tumor tissue and perform massively parallel sequencing on the tumor DNA, looking for mutations in 250 genes, which may be genomic targets for therapeutic management. Send the analytical results to a pathologist or other QHP for identification of mutations, interpretation, and preparation of a written report that specifies the patient's mutation status, which may contain information about diagnosis, prognosis, and patient management, to include information about targeted drug therapy.
And here's for Cologuard (original):
  • 81528 Vignette:   A 55-year-old asymptomatic male presents for a routine annual examination. A colonoscopy for screening was recommended however the patient declined. The patient is offered a non-invasive screening with a multi-target DNA colorectal cancer screening test.  
  • 81528 Service:     The test is comprised of a stool collection kit, fecal occult hemoglobin determination, and quantitative real-time target and signal amplification of 10 DNA markers. The quantitative biomarker results are analyzed through a logistic regression algorithm to produce a qualitative, single dichotomous patient result of negative or positive.
And here's for ROMA ovarian cancer test:
  • 81500 Vignette: Patient is a 64-year-old white female who presents with complaints of pelvic pressure and pain. The pelvic exam find an 8 cm firm fixed right adnexal mass. The patient is sent for a pelvic ultrasound which shows a complex cystic and solid adnexal mass The physician and patient agree to surgery. Prior to scheduling the surgery, the physician requests a ROMA test so as to determine whether the case should be triaged to a physician with special expertise in gynecologic malignancy management. 
  • 81500 Service: The patient's serum is analyzed for CA125 using chemiluminescent microparticle immunoassay (CMIA) methodology and for HE4 using an enzyme immunometric assay (EIA) methodology.  The results of the CA125 and HE4 assays along with the patient's menopausal status are entered into computer software which uses an algorithm to combine the results of the assays and menopausal status into a numeric score.
And for Tau217:
  • 81493 Vignette:  A 65-year-old female presents for neurologic evaluation of gradual cognitive decline. Measurement of phosphorylated Tau is requested. 
  • 81493 Service:  Test the patient's sample for phosphorylated Tau by quantitative immunoassay and report the results.
I think current CPT committees edit back the vignette and service pretty short, more like Tau 81493 and less like Tumor 81455.  The longer examples above are maximums, and your experience with today's committees may look more like 81493.

To take another example, 87798 (other pathogen, amplified probe) was used 8,429,396 times in 2023, 57.5% in patients over 75, 0.95 eligible per ESRD, 36.45 male, and the top Dx code was N39, other urinary disorders, which was used 40% of the time.

SEE ALSO - RUC Records Too

Separately from the subscription RUC database above, if you sign up for a AMA logon, you can get voluminous RUC records for code valuations.

https://www.ama-assn.org/about/rvs-update-committee-ruc

https://www.ama-assn.org/about/rvs-update-committee-ruc/ruc-recommendations-minutes-voting




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AI CORNER
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What is known about the AMA software, RBRVS Data Manager?
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Direct AI output below - not proofed or vetted.
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Here’s the short version:

What it is. The AMA’s RBRVS DataManager Online is a web-based reference for CPT® and HCPCS Level II codes with the RVUs, payment logic, and valuation background those codes carry in the RBRVS/Medicare Physician Fee Schedule. It’s aimed at coding, auditing, reimbursement policy, and internal education. (American Medical Association)

What you get.

  • Code content & search: >19,000 CPT/HCPCS code descriptors plus ~5,500 AMA-exclusive CPT clinical scenarios that spell out pre/intra/post service work. (American Medical Association)

  • Payment details: tools to calculate geographically adjusted Medicare payments (GPCIs/CF), plus direct practice-expense inputs (clinical staff, supplies, equipment) for each code. (American Medical Association)

  • Rationale & RUC material: proprietary valuation insights and RUC rationales for work and PE recommendations—useful when you need to see why a code is valued the way it is. (American Medical Association)

  • Utilization & crosswalks: >10 years of Medicare utilization per code and an ICD-10-CM ↔ CPT crosswalk (top five related codes). (American Medical Association)

Typical use cases. Revenue-cycle/audit, payer policy analysis, utilization review, and training physicians/analysts on how codes are valued and paid. (American Medical Association)

Pricing & access (historical reference). AMA lists it as an online subscription (the public store has shown list ~$320/yr; AMA member ~$240/yr in past listings). Exact current pricing may vary by year and member status. (American Medical Association)

Context & adoption. The product is cited by regulators and in workers’ comp rules as the source for RVU data/methodology, underscoring its use beyond provider offices. (Michigan.gov)

Recent note. In early 2024 the AMA expanded/modernized the online RVU database experience (widely noted by industry watchers), but the subscription concept and purpose remained the same. (Discoveries in Health Policy)

If you want, I can compare it feature-by-feature to alternatives (e.g., Optum’s Essential RBRVS data files or EZ-Fees fee-schedule tools) to clarify when AMA’s product is the better fit for a given task. (OptumCoding)


ARPA-H Gets New Leader: Alicia Jackson

 ARPA-H was recently in the news for its major initiatives in oncology and oncology diagnostics (ADAPT).   (Puzzlingly, this burst of agency-driven press about itself came out at the same time, as the new WH budget proposed a massive funding cut for ARPA-H. Blog here.)

ARPA-H swears in a new Director this week, Alicia Jackson, with an impressive resume'.   The Biden director was out in February; and Jason Roos was the interim director.

Jackson has been a deputy director at DOD DARPA, CEO of Evernow (women's telehealth), co-founder of Drawbridge Health (home blood sampling), advisor to women's health Oova, board member of Immuno Bridge.  

Per Linked In, she holds a 2007 PhD in materials science and nanotechnology from MIT.



##

  • ExecutiveGov.com here.
  • Politico here.
  • The Well  here.
  • Bloomberg here.
  • Sese an elaborate, all-AI-article about Jackson here.



Wednesday, October 22, 2025

Webinar November 5, 2025: When AI Meets LDT - How to Do It

 At Linked In, Xander van Wijk posts a free one-hour webinar on lab-developed LDTs that are also AI.

It's November 5, 9 pacific, 12 eastern.  "AI Meets LDT: Navigating the New Frontier of Clinical Diagnostics."  A program from ADLM  - Innovation & Technology Division.

Register with name and email here:

https://myadlm-org.zoom.us/meeting/register/zL7qD_yiSwGhqAy7krF27Q#/registration

"Join us for an engaging webinar exploring the intersection of artificial intelligence and medical diagnostics.  The session will demystify how AI components - especially SaMD - are reshaping laboratory workflow, regulatory oversight, and risk management.  Get practical insights into FDA authority, risk calculation strategies, and proactive planning for AI integration.  

Whether you're a lab director, compliance officer, or clinical scientist, this webinar will equip you with the tools to navigate this evolving landscape."

I don't know if the video will be archived after the live event, or not.

##

Speakers are Christine P. Bump JD, Penn Avenue Law & Policy, and Shannon Bennet MS MBA Mayo Clinic.  See Shannon's comment here.  

"FDA may not have oversight of laboratory developed tests (LDTs), but they DO have regulatory oversight of software as a medical device. It's a critically important distinction."



Tuesday, October 21, 2025

Brief Blog: Chat GPT 5 Writes Article on New AMA Digital Health Center

This is an article on the new AMA Center for Digital Health and AI. The article here is sourced entirely from public sources by Chat GPT in Agentic mode.  

(Prompt   Search the internet and use AGENTIC mode to aggregate and report information on AMA's new CENTER FOR DIGITAL HEALTH and AI, recently announced.)

## AI writes,

Here’s a concise, sourced rundown of the AMA’s newly announced Center for Digital Health and AI:

What launched (and when). On Oct 20–21, 2025, the American Medical Association announced a new Center for Digital Health and AI (“the Center”). Its stated aim is to embed physicians across the lifecycle of digital tools—especially AI—so technologies fit clinical workflows and improve patient and clinician experience. American Medical Association+2American Medical Association+2

Why AMA says it matters. AMA frames the Center as a way to ensure physician leadership in fast-moving AI and digital health, building partnerships with regulators, policymakers, and tech leaders to shape safety/effectiveness benchmarks and implementation guidance. American Medical Association

Leadership & resources. The Center is among the first initiatives of AMA CEO John Whyte, MD, MPH (started July 1, 2025). In a STAT interview, Whyte said AMA will spend “millions of dollars” on the Center and is beginning a search for a senior vice president to lead it. American Medical Association+1


Initial focus areas (as described by AMA & trade press).

  • Physician-in-the-loop development & deployment of AI/digital tools; education/support for adoption. American Medical Association+1

  • Policy engagement & standards: positioning AMA to help shape national AI policy/regulatory conversations. Healthcare IT News

  • Operational playbooks & governance: extension of AMA’s existing digital health resources (e.g., STEPS Forward® AI governance toolkit, implementation playbooks). American Medical Association

Context & recent AMA activity. Prior to the Center’s launch, AMA and affiliated bodies have been probing AI payment/coding pathways (e.g., a 2025 listening session on potential new AI code categories) and publishing digital implementation resources—now consolidated under the Center’s umbrella. STAT+1

What to watch next.

  • SVP appointment & org chart for the Center (signals priorities and pace). STAT

  • Concrete deliverables: updated AI governance guidance, coding/payment frameworks, and collaboration MOUs with agencies or standards bodies. American Medical Association+1

  • Budget and programs tied to physician training, practice transformation, and evaluation of AI tools in real settings. STAT

Quick take. AMA is centralizing its digital/AI work into a funded Center, explicitly keeping physicians at the table in AI development, deployment, and policy—backed by leadership attention (Whyte) and near-term hiring. Expect more visible AMA engagement on standards, payment pathways, and practical governance toolkits that health systems and vendors can use. STAT+2 American Medical Association+2

###

###

Convey most or all of this information but this time, write in the style of a med tech trade journal article about the new center.

###

###

Title: AMA Launches Center for Digital Health & AI, Elevating Physician Leadership in Health-Tech Ecosystem

In a pivotal move for the health-tech and med-tech industries, the American Medical Association (AMA) announced on October 20–21, 2025, the creation of its Center for Digital Health and AI (the Center), with the express mission of placing physicians at the centre of the innovation lifecycle for digital tools and artificial intelligence (AI) in medicine. (American Medical Association)


Why this matters to med-tech

As AI, cloud-based analytics, remote monitoring, and other digital health modalities proliferate, the risk of deploying tools that misalign with clinical workflows or create unintended burdens for physicians has become a strategic concern. The AMA frames its new Center as a response to exactly that gap: “without physician leadership and input, technology developers risk creating unintended burdens on medical professionals and risk consequences on patient care.” (Healthcare IT News)

In other words, for vendors, device manufacturers, SaaS platforms, and health-system CIOs, the message is clear: physician voice and clinical workflow alignment will no longer be optional—they will increasingly be foundational for adoption, reimbursement, and long-term sustainability.


Core mandates of the Centre

According to the press release and subsequent coverage, the Center will focus on four high-priority pillars: (American Medical Association)

  • Policy and regulatory leadership: Working with regulators, policymakers and tech-leaders to create benchmarks for safe, effective use of AI and digital health tools.

  • Clinical workflow integration: Embedding physicians into tools’ lifecycle to ensure alignment with day-to-day practice so the technology actually delivers value rather than disruption.

  • Education & training: Equipping physicians and health systems with knowledge, tools and resources to integrate AI and digital health innovations efficiently and effectively.

  • Collaboration across ecosystem: Building partnerships spanning technology vendors, research institutions, government agencies and health care organizations to ensure innovation remains patient-centric and physician-informed.

Notably, AMA CEO & Executive Vice President John Whyte, MD, MPH emphasized: “Augmented Intelligence will be a defining force in the future of health care, but right now we are barely scratching the surface of its potential … even the best tools will never be fully implemented if you don’t understand clinical practice or clinical workflow.” (American Medical Association)


Market context & physician sentiment

The timing of the Center’s launch corresponds with an uptick in physician engagement with AI‐enabled tools, but also persistent concerns around implementation. The AMA reports that approximately two-thirds of physicians have incorporated some form of AI in practice; however, about one in four remain more worried than excited about its implications. (Becker's Hospital Review)

In February 2025, an AMA survey documented a jump from 38% to 66% of physicians reporting use of AI-tools from 2023 to 2024; yet key barriers remain—data privacy assurances, EHR integration, liability concerns, and lack of oversight. (Medical Economics) For med-tech innovators, that signals both opportunity (a growing willingness) and risk (the trust gap remains).


Implications for med-tech companies & vendors

  • Product development: Vendors should plan to involve physicians early and often—not just in usability testing, but in real-world scenario development, workflow mapping and post-deployment monitoring. The AMA’s emphasis on “physician throughout lifecycle” suggests that clinical adoption will increasingly depend on this alignment. (American Medical Association)

  • Regulatory / reimbursement strategy: The policy-focus of the Center means vendors may benefit from aligning with AMA frameworks, standards and guidance as early adopters of tools that comply with physician-centric criteria.

  • Adoption & training: Education of clinicians is explicitly part of the Center’s mandate—vendors partnering with health systems should invest in training/enablement programs, integrating AMA’s resources and physician feedback loops.

  • Ecosystem partnerships: Given AMA’s focus on cross-sector collaboration, med-tech companies should expand stakeholder engagement beyond the usual — including health systems, physician organisations, government agencies and standards-bodies — to align with evolving governance models.

  • Risk mitigation: Given that a quarter of physicians still express concern about AI (privacy, liability, reliability), vendors will need transparent governance, explainability, audit trails and monitoring to gain clinician trust.


Noteworthy open questions

  • Leadership & resourcing: While the AMA says the Center is being launched, many structural details remain to emerge (e.g., who will lead it, budget size, staffing, advisory boards).

  • Timeline for deliverables: To what extent the Center will roll out concrete tools, certifications, vendor partnerships or pilots in 2026 remains to be seen.

  • Measurement of impact: How the AMA will measure success (e.g., physician adoption rates, reduction of burden, improved outcomes) will be watched closely.

  • Vendor-alignment/adoption: Will medical device companies, digital health startups and legacy EHR/analytics players engage proactively with the Center, or will it become a physician-only forum?

  • Scope beyond AI: While the acronym emphasises AI, the “digital health” portion suggests broader focus (telehealth, remote monitoring, wearables); companies in these adjacent fields should also evaluate the relevance.


Conclusion

For the med-tech industry, the launch of the AMA Center for Digital Health and AI marks a strategic inflection point: physician leadership in digital innovation is moving out of the “nice-to-have” category and into the mainstream. Vendors and health-tech companies that proactively align clinical workflow integration, physician enablement and robust governance will likely gain competitive advantage. Those that don’t may face heightened friction in adoption, reimbursement and clinician trust.

In short: the Center signals that physician voice = innovation-licence, and the industry should tune in accordingly.

##


## ai humor ##

Lewis Black reviews.

Monday, October 20, 2025

Brief Blog: AMA's Major Digital Health Center; AMA's 39-Page Digital Medicine eBook

AMA announces new "Center for Digital Health and AI" on October 20.  According to STAT,

  • The American Medical Association on Monday announced a new Center for Digital Health and AI to influence how novel technology is used and regulated in health care.
  • The center is one of the first major initiatives from CEO John Whyte, who took the helm of the physician lobbying group earlier this year after seven years as the chief medical officer of WebMD. Whyte told STAT he plans to spend millions of dollars on the new center and is now commencing a search for a new senior vice president to lead the effort.
Stat publishes a (subscription) interview with Whyte.  More to come, I'm sure.
See also coverage of the AMA Center for Digital Health at MedCityNews and HealthCare IT.

_______________

On a more pedestrian level:

AMA has a 39-page book on coding digital medicine, scenarios for physicians.  Tag line: "Master the appropriate use of digital medicine CPT codes effortlessly."

See's the October 10, 2025, AMA announcement regarding several aspects of digital medicine:

Find the ebook's home page here:

Shortcut to the PDF book here:


The focus is on e-visits and remote physiologic monitoring, and it will be interesting to see where they take this in the future.

###

AI CORNER

##

Here’s a concise blog-ready summary for your readers:


AMA’s New Handbook on Digital Medicine Coding

The American Medical Association has released a 39-page handbook titled Digital Medicine Clinical Scenarios: Coding Handbook (March 2025), offering physicians a practical, example-driven guide to applying CPT® codes for digital health encounters. The document walks readers through 14 real-world scenarios—ranging from video and audio-only telehealth visits to remote monitoring, chronic care management, and interprofessional e-consults—clarifying which codes, modifiers, and place-of-service designations apply in each case.

The handbook is especially valuable because 2025 introduces major new CPT telemedicine codes (98000-98016) that distinguish between synchronous audio-video, audio-only, and brief technology-based services. Notably, CMS has not yet adopted these codes for payment, meaning physicians will need to navigate divergent AMA and Medicare policies while confirming payer-specific guidance.

The guide also includes a taxonomy of digital-medicine services—from clinician-to-patient and clinician-to-clinician interactions to remote physiologic and therapeutic monitoring and algorithmic diagnostics—making it one of the clearest snapshots of how digital care is now represented in CPT.


Would you like me to add a short “why it matters” paragraph—e.g., implications for digital pathology, AI diagnostics, or genomics testing workflows—to make it fit more seamlessly with your blog’s theme?

YES

AMA’s New Handbook on Digital Medicine Coding

The American Medical Association has released a 39-page handbook titled Digital Medicine Clinical Scenarios: Coding Handbook (March 2025), a practical guide for physicians applying CPT® codes to the rapidly expanding field of digitally enabled care. It walks through 14 detailed scenarios—video and audio telehealth visits, remote monitoring, therapeutic tracking, and interprofessional e-consults—showing which codes, modifiers, and place-of-service designations apply.

This edition matters because 2025 introduces an entirely new CPT series (98000–98016) for synchronous audio-video, audio-only, and brief technology-based encounters. The catch: CMS has not yet adopted these for payment, so physicians must juggle dual frameworks—AMA’s CPT guidance and Medicare’s continuing reliance on older in-person visit codes with modifiers.

For innovators in digital pathology, AI diagnostics, genomics, and remote physiologic testing, the handbook signals how the coding ecosystem is catching up with hybrid care. It clarifies how digital tools—algorithms, connected devices, or asynchronous image review—map into CPT structure. In that sense, it’s not just a coding manual but a policy weather vane: an early look at how AMA and CMS may eventually reconcile definitions of “telehealth,” “monitoring,” and “algorithmic interpretation.”

##

Key Takeaways for Innovators

  • The CPT framework is finally catching up to the realities of hybrid and data-driven care. The 98000-series codes formally recognize digital encounters as distinct from in-person visits—an important conceptual shift that lays groundwork for AI- and software-mediated care models.

  • CMS is lagging—but watching closely. For now, Medicare still requires billing under legacy E/M codes with modifiers, but the AMA’s structure shows what future CMS telehealth adoption may look like once utilization and cost data mature.

  • A roadmap for AI and digital diagnostics. The taxonomy in Appendix R explicitly accommodates autonomous and algorithmic diagnostic services (e.g., CPT 92229 for AI retinopathy screening, multianalyte assays with algorithmic analyses). It previews how machine learning, digital pathology, and genomic interpretation tools can be positioned within CPT’s existing logic—turning “AI output” into a billable clinical act.

####
And here are some high-level highlights aggregated by Chat GPT5.
###

The American Medical Association (AMA) has announced a major new initiative — the Center for Digital Health and AI — intended to shape how emerging technologies are used and regulated in health care. The effort is among the first major projects launched by new AMA CEO John Whyte, who previously served as chief medical officer of WebMD. Whyte said that the AMA plans to invest millions of dollars and is already searching for a senior vice president to lead the center. He describes its mission as broad: to provide thought leadership, education and training, and to serve as a convener of stakeholders across medicine, government, and technology. Within the first year, Whyte expects the center to issue reports on how both physicians and consumers view these new tools, and to participate in benchmarking discussions with regulators on what “the right amount of regulation” might look like.

A central tenet of the AMA’s philosophy is that artificial intelligence should augment physicians rather than replace them. Whyte repeatedly uses the organization’s preferred term, “augmented intelligence,” to underscore that distinction. He envisions systems that collate and present data in meaningful ways and perhaps offer preliminary insights—but always under the oversight of a clinician. Tools that act autonomously or deliver diagnoses directly to patients, he warns, create unacceptable risks of harm. As an example, he notes that if an AI system can help radiologists detect tumors more accurately on mammograms, it should become part of standard practice—so long as the human professional remains in charge. “I’m not replacing the radiologist in any way,” he says. “I’m helping them do a better job.”

At present, many digital health applications focus on what Whyte calls “back-office” functions—AI scribes, scheduling, or billing—but he argues that the real promise of AI lies in clinical decision-making and therapeutic guidance. He imagines a future where community oncologists routinely use AI tools to confirm or refine treatment plans, ensuring that every cancer patient effectively receives a second opinion. These are the kinds of high-impact uses, he says, that deserve more public attention and thoughtful implementation.

The AMA’s role will not be limited to education and ethics; it also extends into coding and reimbursement, areas where the organization already wields significant influence. The AMA’s CPT Editorial Panel is currently developing a framework for “algorithmic and AI-enabled clinical services” that do not require direct physician work, such as automated interpretation of lab data or imaging. Whyte acknowledges that regulators and payers remain uncertain about how to classify and pay for such technologies—many are new, and their appropriate use is not yet fully understood—but he sees the AMA as uniquely positioned to bring together regulators, clinicians, and industry to work through these challenges constructively.

Whyte is also mindful of the political cross-currents surrounding AI oversight. The launch of the new center comes as the Trump administration has criticized the Coalition for Health AI (CHAI) for being too industry-driven. Whyte agrees that regulators should ensure no single set of companies has undue influence, but he is not worried about the AMA becoming a political target. The association, he insists, has no financial stake in the technologies themselves, only a professional and ethical stake in how they are used. “When people are invested in those things,” he told STAT, “then you do have to be concerned about a regulatory perspective. I think the administration is taking a reasonable approach in looking at that.”

When asked about the risks of AI adoption, Whyte’s greatest concern is that patients will begin to rely on tools such as chatbots for diagnosis and treatment advice without any physician oversight. In his view, this trend could lead to misdiagnosis, confusion, and poor outcomes. Even in seemingly harmless contexts, people can lose track of whether they are speaking to a person or an algorithm; he jokes that he himself was uncertain when chatting with an airline’s virtual assistant. The line between convenience and confusion, he suggests, is far thinner in medical contexts than most assume.

Ultimately, the new AMA center reflects a recognition that AI is already embedded in health care, and the question is no longer whether to adopt it but how to integrate it safely, effectively, and fairly. The AMA intends to position physicians at the center of that process—balancing innovation with responsibility, and ensuring that the technology enhances, rather than undermines, the human relationship between doctor and patient.