Wednesday, July 2, 2025

RFK Jr on Tucker Carlson: An AI-Generated Summary

 On June 30, 2025, the channel TuckerCarlson.com published a one hour video interview with Secretary of Health RFK Jr.   Watch the full interview here:

https://tuckercarlson.com/tucker-show-rfk-jr-2025


Below, I attach a Chat GPT "neutral article" about the interview, based on an auto-transcript.  AI pull-quotes may not be exact.   (Later, I found a full corrected transcript here.)  (A review at Gizmodo is here).

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AI CORNER

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Here is a detailed, neutral news article summarizing the July 1, 2025, interview between Secretary of Health and Human Services Robert F. Kennedy Jr. and Tucker Carlson, along with a sidebar listing 10 notable takeaways.

RFK Jr. Lays Out Health Reform Vision in Interview with Tucker Carlson

WASHINGTON, DC – July 1, 2025 — In a sweeping one-hour interview with Tucker Carlson, Secretary of Health and Human Services Robert F. Kennedy Jr. detailed his plans to reform the U.S. public health system, calling for greater transparency in vaccine science, pharmaceutical marketing, and the structure of scientific oversight. Speaking candidly on topics ranging from autism research to AI in regulatory agencies, Kennedy sought to position himself as both a reformer and a disrupter.

During the conversation, Kennedy repeatedly emphasized his intention to overhaul what he described as a system plagued by “perverse incentives.” He accused longstanding health bureaucracies and media institutions of suppressing data and failing to conduct meaningful scientific studies, particularly on vaccine safety and pharmaceutical outcomes.

“We’re going to give people gold-standard science,” Kennedy said. “We’re going to publish our protocols in advance… and we’re going to require replication of every study, which never happens at NIH now.”

Autism Studies Revisited

Kennedy confirmed that his department has launched a major effort to revisit the possible connections between vaccines and rising autism rates—a long-debated topic that played a key role in his early estrangement from the Democratic Party. He criticized past CDC studies as inadequate and announced the release of federal databases to independent scientists for transparent reanalysis. He expects initial findings by September and broader conclusions within six months.

Vaccine Advisory Shake-up

Among the more dramatic administrative moves since assuming office, Kennedy confirmed the firing of members of the CDC’s Advisory Committee on Immunization Practices (ACIP), citing undisclosed financial conflicts and lack of placebo-based safety trials in prior vaccine approvals.

“We fired that board because it was just an instrument. It was a sock puppet for the industry that it was supposed to regulate,” Kennedy said.

Pharmaceutical Advertising and Trust

Kennedy reiterated his concerns over direct-to-consumer pharmaceutical advertising, calling it misleading and distorted by financial entanglements. While legal precedent limits how much HHS can restrict such ads, he suggested that HHS is examining rule changes to mandate greater transparency in how risks and benefits are portrayed.

He claimed media outlets were financially dependent on pharmaceutical advertising, referencing former Fox News CEO Roger Ailes as having privately admitted that any coverage critical of vaccines was effectively prohibited due to advertising revenue concerns.

Use of Artificial Intelligence in Health Policy [See "AI Appendix" below]

A forward-looking section of the interview centered on Kennedy’s commitment to AI as a transformative tool for regulatory science. He said HHS is recruiting top-tier engineers to apply AI across drug evaluation, fraud detection at CMS, and outcome studies across vast national datasets.

“We have the potential now to use AI in ways that are going to revolutionize medicine,” he said.

Legal and Ethical Legacies

When asked about vaccine injury liability, Kennedy discussed potential reforms to the National Vaccine Injury Compensation Program, originally enacted in 1986 to shield vaccine manufacturers from civil lawsuits. He indicated that efforts are underway to reopen access for individuals with claims related to COVID-19 vaccines, particularly those who fell outside of the narrow statute of limitations.

On the controversial topic of Anthony Fauci’s legacy and possible gain-of-function research ties to the Wuhan lab, Kennedy called for a “truth commission” akin to those held in post-conflict societies. He also voiced support for the full declassification of JFK, RFK, and MLK assassination documents.

Cross-Party Alliances and Trump Collaboration

Throughout the interview, Kennedy described his collaboration with the Trump administration in warm terms. He praised cabinet members like Pam Bondi and Marco Rubio, noting ideological differences in the past but emphasizing current policy alignment. He also emphasized President Trump’s role in “restoring hope” and credited him with reshaping not only the Republican Party but also driving policy reactions among Democrats.

Sidebar: 10 Noteworthy Takeaways from the RFK Jr.–Tucker Carlson Interview

  1. Autism-Vaccine Study Reboot: RFK Jr. has launched a full-spectrum analysis using CMS and VSD data, aiming to resolve questions about vaccine safety and neurodevelopmental outcomes.

  2. AI Across HHS: Artificial Intelligence is being deployed not only to streamline drug approvals (reducing reliance on animal models) but also to track national health outcomes in real time.

  3. ACIP Overhaul: Kennedy fired the entire vaccine advisory panel due to long-standing financial conflicts of interest and absence of placebo-controlled safety trials.

  4. DTCA Restrictions in the Works: HHS is considering policy changes to limit or restructure pharmaceutical advertising, especially those deemed misleading in imagery or emotional appeal.

  5. Public Access to Raw Data: For the first time, researchers worldwide will get access to HHS-controlled vaccine and outcomes databases under open grant programs.

  6. Malinformation as Censorship Tool: Kennedy described how factual but inconvenient information about vaccines was allegedly reclassified by federal agencies as "malinformation" to justify its suppression.

  7. Revamp of Vaccine Injury Compensation: Efforts are underway to expand the federal vaccine injury program, including extending the statute of limitations and introducing transparency reforms.

  8. COVID Vaccine as a Clinical Trial: A new version of the COVID-19 vaccine is being offered under a clinical trial framework, with required follow-up to collect real-world safety data.

  9. Fauci and the Wuhan Lab: Kennedy stated that Fauci-funded scientists gave Chinese researchers techniques to obscure viral engineering, questioning the public health rationale.

  10. Empathy in Trump’s Cabinet: Kennedy praised Trump for assembling a “deep and thoughtful” cabinet and spoke positively of Trump’s empathy, particularly in discussions about war and public health.

Author’s Note: This article aims to provide a factual overview of the interview for stakeholders in public health policy, research, and regulation. Statements and viewpoints expressed during the interview are presented without editorial endorsement and may be subject to future policy or legal developments.

[END CHAT GPT]

 AI APPENDIX from TRANSCRIPT

We’re going to absolutely change VAERS [adverse event AE data] and we’re going to make it, we’re going to create either within VAERS or supplementary to VAERS, a system that actually works. And you know that right now even that system is antiquated because we have access to AI.

And one of the, you know, we are creating here at HHS an AI revolution. We’ve been able to attract the top people from Silicon Valley. People have walked away from billion dollar businesses and they don’t want prestige, they don’t want position, they don’t want power, they want to change, they want to make the system work.

And we’re, we’re going to, we are at the cutting edge of AI. We’re implementing it in all of our departments at FDA where we’re accelerating drug approvals so that you don’t need to use primates or even animal models. You can, you know, you can do the drug approvals very, very quickly with AI.

And we’re also implementing a CMS to detect waste, abuse and fraud, which is, it’s extraordinary at that. But we’re also going to use it at CDC and throughout our system to look at the megadata that we have and be able to make really good decisions about interventions.

For example, if you look at the population as a whole and say, okay, we’re using three different diabetes drugs with five different statin drugs or all these SSRIs and others. You can then look drug by drug and you can tell on the population whether it’s working or not and which one is giving you the best bang for the buck. Which one has the most side effects. We have a potential now to use AI in ways that are going to revolutionize medicine.

Monday, June 30, 2025

Brief Blog: Billing for G0452 (Molecular Pathology Interpretation) in 2023

CMS recently released Part B billing records for doctors and labotatories, for CY2023 (here).

I pulled the records for G0452, Molecular Pathology Interpretation (about $50).

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Medicare Part B paid for 152,659 services of G0452,  for a total of $7.2M dollars allowed.

The top-billing provider was a laboratory in Arizona, with 12,234 services or 8% of the total.

Of the top-20 billing entities, 2 were registered as clinical laboratories.  Of the other 18, 5 had MD-PhD degrees and the rest MD.   Most of the MDs were facility-based (e.g. in a pathology service or department or practice that is hospital-based).

19 providers billed for >1000 cases of G0452.  Of 680 total providers, the top 20 had 32% of G0452 revenue.  Click to enlarge.

Click to enlarge



Friday, June 27, 2025

The Supreme Court Birthright Decision - Would It Have Changed a Single Texas Judge "Tossing Out" FDA LDT Regulation?

 On June 27, 2025, the Supreme Court issued a ruling that (for now) prevents single federal district courts from issuing national junctions.  The test case was a birthright citizenship case.

But in March 2025, a Texas judge "threw out" an FDA regulation about LDTs, saying the regulation was outside the FDA's legal scope for medical devices, and void.

Here's the $60,000 question - 

What if the March 2025 Texas FDA decision had come after today - after today's limitation on national injunctions.   Would it be different?  I am not an attorney, and this is for entertainment only, but here is what Chat GPT says.   

Chat GPT read both the March FDA case and the Birthright case, Trump v Casa.

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AI CORNER

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Yes, the FDA lab-developed test (LDT) Texas ruling would likely be impacted or at least called into question by the new June 27, 2025 Trump v. CASA decision on universal injunctions—though the outcome wouldn't necessarily reverse the substance of the FDA ruling.

Here’s how they intersect:

✅ Texas Ruling on LDT Regulation (March 31, 2025)

  • The Texas federal court vacated the FDA’s 2024 LDT final rule nationally, ruling that FDA exceeded its statutory authority under the FDCA.

  • The judge concluded that LDTs are services, not “devices,” and are comprehensively regulated under CLIA, not FDA.

  • The ruling applied nationwide, not just to the plaintiffs. The judge explicitly dicussed & justified nationwide relief, likely referencing precedents like Texas v. United States and 5th Circuit reasoning allowing broader relief in APA cases.

⚖️ SCOTUS Birthright Citizenship Decision (June 27, 2025)

  • In Trump v. CASA, the Supreme Court rejected universal (nationwide) injunctions unless necessary to give “complete relief” to the named plaintiffs.

  • Barrett, writing for the Court, held that injunctions should be party-specific, as traditional equity never allowed nationwide remedies.

  • The Court vacated nationwide injunctions against a Trump executive order and instructed lower courts to limit relief to actual plaintiffs.

🔁 Implications for the FDA LDT Ruling

  • The LDT ruling vacated the FDA rule under the APA (Administrative Procedure Act), not just enjoined it.

  • But the APA has its own framework: courts “shall… set aside” unlawful agency rules (5 U.S.C. § 706(2)). Courts have debated whether that means facial invalidation or plaintiff-specific relief.

  • Trump v. CASA leans heavily against sweeping remedies, so litigants or the DOJ could now argue that the LDT ruling should be narrowed to apply only to the plaintiffs in the case, not all labs nationwide.

  • However, the Texas judge in the LDT case seemed to anticipate this debate and explicitly justified nationwide vacatur, which some appellate courts (e.g., D.C. Circuit) still permit in APA cases.

🔍 Bottom Line

  • Yes, the SCOTUS CASA decision could prompt the FDA or DOJ to seek modification or narrowing of the Texas LDT ruling—especially if it moves to appeal.

  • Whether that would alter the outcome or enforcement effect depends on whether the 5th Circuit (which covers Texas) embraces CASA’s limits strictly, or defers to APA precedents supporting broad vacatur.

  • Strategically, it introduces new risks to relying on the LDT ruling as a shield for non-party labs, and the FDA could continue enforcing the rule against others not named in the case—unless and until enjoined again.

Let me know if you'd like a one-paragraph advisory version for client communications.

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"Natioanl Injunctions" in Trump/CASA.  "National Vacatur" in FDA LDT.   ???

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Yes, the distinction between injunction and vacatur matters a great deal in this context—especially in light of the Trump v. CASA ruling.

🔹 Injunction vs. Vacatur: What’s the Difference?

  • An injunction tells the government not to enforce a rule or policy—typically against the plaintiffs.

  • A vacatur (under the APA, 5 U.S.C. § 706(2)) nullifies the agency’s rule entirely—treating it as legally void if found unlawful.

⚖️ How Trump v. CASA Changes the Terrain

In Trump v. CASA, the Supreme Court held that universal injunctions—i.e., barring enforcement against non-parties—exceed the equitable authority of federal courts. That decision was about injunctions, not vacatur.

But this doesn’t automatically apply to vacatur under the APA, which has been interpreted differently across the circuits:

  • The D.C. Circuit and some others treat vacatur as automatic and nationwide when a rule is invalidated.

  • The 5th Circuit (where the Texas LDT case sits) has been more skeptical and may now lean toward party-specific relief, especially post-CASA.

🧩 Why the Distinction Matters

  • If the Texas ruling had only enjoined FDA from enforcing the LDT rule against the plaintiffs, CASA would clearly limit its scope.

  • But because the Texas court vacated the rule under the APA, it arguably treated the FDA rule as void across the board—a different legal act.

However, post-CASA, FDA or DOJ could argue that vacatur is functionally no different from a universal injunction, and that courts must now narrow even APA vacatur to apply only where needed for plaintiff relief.

🟨 Conclusion

The fact that the Texas LDT ruling used vacatur rather than injunction gives it a stronger claim to nationwide effect—but that ground is now legally unsettled after Trump v. CASA. The FDA may test this distinction in appeals or enforcement discretion. For labs not party to the case, relying solely on the Texas vacatur is now riskier than before.


##

I'd add, the FDA regulation is still on the books, so, for example, could the FDA try imposing the FDa regulation, exactly as it is, against a lab in Ohio, or Minnesota, next week?   When the lab protests, FDA could say the Texas decision applied only to Texas, in light of the Birthright case.  (Only a hypothetical).

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Again, this is an AI opinion and for entertainment only.

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AI:

In light of the Supreme Court’s June 27, 2025 decision in Trump v. CASA, which sharply limited the use of nationwide injunctions, the March 2025 Texas court decision vacating FDA’s LDT rule may no longer be securely applicable to all labs nationwide. While the Texas ruling explicitly set aside the FDA rule under the APA, Trump v. CASA calls into question the legitimacy of such broad relief unless strictly necessary to protect the named plaintiffs. As a result, FDA or DOJ may now argue that the Texas court’s ruling should apply only to the specific plaintiffs in the case, leaving other labs potentially subject to enforcement unless they obtain their own relief. This development introduces uncertainty regarding the scope of protection the Texas ruling provides and may warrant a cautious review of compliance and legal exposure for non-party labs.

Supreme Court Preserves ACA Preventive Requirements for Private Plans; Rejects Challenge to USPSTF

 The Affordable Care Act of 2010 requires private insurance to cover preventive benefits endorsed by the USPTF.   The legitimacy of the USPSTF to set such requirements was challenged, and the challenge "won" in district court and federal appeals court.   However, the USPSTF authorities were preserved on June 27 2025, in a 6-3 decision.   Thomas, Gorsuch, and Alito dissented.

Find coverage at NYT here.  Genomeweb here.  AJMC here.  NPR here.  Reuters here. MedCityNews here. USAToday here.

Find the actual decision here, Braidwell case.  The case is 86 pages, with the dissent beginning on page 49.  The main point is whether the USPSTF members are inferior officers subject to management, or, if not, are they indeed "principal" officers who should require Senate confirmation.

Separate topic - How the administration funds, staffs, or controls USPSTF is "TBD."

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AI CORNER

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Summary for Health Policy Experts and Legal Audiences:

In Kennedy v. Braidwood Management, Inc., the Supreme Court ruled (6–3) that members of the U.S. Preventive Services Task Force (USPSTF) are inferior officers under the Appointments Clause and thus lawfully appointed by the Secretary of HHS, rather than requiring presidential nomination and Senate confirmation.

The case centered on the ACA’s provision mandating that health insurers cover preventive services graded “A” or “B” by the USPSTF at no cost to patients. The plaintiffs, including Braidwood Management, objected to covering certain services and argued that USPSTF members were principal officers—with legally binding power but no clear supervision—rendering their appointments unconstitutional.

Lower Court Victories for Braidwood:

  • Both the district court and the Fifth Circuit agreed with Braidwood, finding that USPSTF members were not meaningfully supervised and thus principal officers, improperly appointed under Article II.

Supreme Court Reversal:

  • Justice Kavanaugh, writing for the majority, reversed the Fifth Circuit. The Court held that Task Force members are inferior officers because:

    • They are removable at will by the Secretary of HHS.

    • The Secretary has statutory authority to review and block recommendations before they take legal effect (under ACA provisions like 42 U.S.C. §300gg-13(b) and §202).

    • Their authority is non-final without the Secretary’s approval—thus preserving executive chain-of-command accountability as required by Edmond v. United States.

Key Legal Finding:
The majority reasoned that “independent” in the statute (42 U.S.C. §299b–4(a)(6)) does not imply for-cause removal or insulation from review. Instead, “independent” refers to freedom from external stakeholder influence, such as hospitals or academic affiliations.

Dissenting Opinion (Thomas, joined by Alito and Gorsuch):

  • The dissent strongly objected to the majority’s interpretation, arguing that the USPSTF holds binding policymaking authority without genuine oversight.

  • It rejected the idea that mere removal or post-hoc review powers constitute “supervision” under Article II.

  • The dissent warned that this decision blurs the distinction between principal and inferior officers and invites future constitutional abuse by allowing politically consequential decisions to be made by officials not confirmed by the Senate.

Policy Implications:

  • The decision preserves the ACA’s preventive services mandate infrastructure, avoiding immediate disruption to insurance coverage requirements.

  • It sets a clearer boundary for what constitutes sufficient executive supervision to qualify federal officers as “inferior” under the Constitution.

  • It may limit future constitutional challenges to similar advisory or expert panels—so long as a cabinet-level officer retains power to remove members and review their output before legal force attaches.

Bottom Line:
Despite initial wins in the district and appeals courts, Braidwood’s challenge to the USPSTF structure ultimately failed at SCOTUS. The Court reaffirmed a broad view of executive supervision sufficient to satisfy the Appointments Clause—while the dissent viewed this as a dangerous dilution of constitutional safeguards.




##
We read it's "remanded for further proceedings."  ???

“Remand for further proceedings” is a common legal phrase, and yes, it’s important—but not dramatic.

In this context, the Supreme Court reversed the lower courts’ rulings (which had struck down the USPSTF appointments) and sent the case back (“remanded”) to the lower courts to apply the Supreme Court’s new decision and handle any remaining issues.

Here's what it means:

  • "Reversed": The Supreme Court disagreed with the Fifth Circuit and district court, ruling that Task Force members are not principal officers.

  • "Remanded": The case goes back to the lower court to clean up the details, implement the ruling, and resolve any leftover matters (e.g., how exactly the injunctions are lifted or narrowed).

Is it important?

Yes, but mostly procedural now:

  • It confirms that Braidwood doesn’t win on the Appointments Clause claim.

  • But the remand allows the lower court to finalize what this means for the actual injunction and the parties (for example, what remains under the Religious Freedom Restoration Act claim, which was not appealed and still stands in part).

In short: The big question is settled, but the paperwork’s not done.

Thursday, June 26, 2025

Brief Blog: Cancer Inpatients, Cancer Outpatients: Both Have High Antibiotic Resistance Risks

June 26, 2025, Eckardt publishes in Forbes an article about the high prevalence and mortality risks of antimicrobial resistance (AMR) in cancer patients - both inpatients and outpatients.  

As an experiment, here is an AI-created essay about the Forbes article and Gupta 2024, Gupta 2025.

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Gupta 2024, cancer inpatients.  Gupta 2025, cancer outpatients.

Forbes news article, Eckardt June 26.

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AI Corner

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A growing body of evidence now confirms that patients with cancer—both hospitalized and ambulatory—face significantly elevated rates of antimicrobial-resistant (AMR) infections, with incidence and odds ratios for key pathogens often exceeding 1.5 to 2.0 compared to non-cancer populations.

These findings underscore the immunologic vulnerability of oncology patients and the compounding risks posed by chemotherapy, mucositis, and indwelling devices. But the implications for clinical microbiology and molecular diagnostics go beyond recognition of risk. Laboratories must now operationalize cancer-specific strategies for AMR surveillance, prioritize rapid diagnostics that can guide empiric therapy within hours rather than days, and collaborate with oncology and stewardship teams to recalibrate local antibiograms and testing workflows for high-risk populations. 

The data support not only enhanced testing frequency and faster turnaround, but also selective deployment of molecular resistance panels or metagenomic tools where culture-based methods are too slow or insensitive to support timely cancer care.

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Here is a concise, expert-level blog summary of the recent studies on antimicrobial resistance (AMR) in cancer patients by Gupta et al. (2024–2025), plus the Forbes news article, aimed at a genomics and microbiology-savvy audience:

A New Front in the War on Cancer: 
Antimicrobial Resistance (AMR) in Oncology Care

Summary of Two Landmark Studies from the Cancer AMR Consortium (Gupta et al., 2024–2025)

The Cancer AMR Consortium—a collaboration involving Becton Dickinson, the AMR Action Fund, and UICC—has published a trilogy of studies that comprehensively characterize the burden of antimicrobial resistance in cancer patients, both hospitalized and ambulatory. The results highlight a silent but rapidly escalating threat to cancer care delivery, underscoring urgent needs in diagnostics, surveillance, and infection control.

1. Inpatient Setting: Multicenter Analysis Across 168 U.S. Hospitals

Published in Cancer Medicine (2024)

This study evaluated over 4.6 million hospital admissions, including ~297,000 admissions of cancer patients. Key findings:

  • AMR rates were 1.5–2x higher in hospitalized cancer patients vs non-cancer patients for multiple resistant pathogens:

    • VRE: IRR 1.95

    • ESBL-producing Enterobacterales: IRR 1.48

    • Carbapenem-nonsusceptible Enterobacterales: IRR 1.46

    • MDR P. aeruginosa: IRR 1.31

  • AMR isolate proportions (non-susceptibility % of isolates) were significantly higher in cancer patients for VRE and ESBLs, even after adjusting for hospital size, urban/rural status, and teaching affiliation.

  • The authors emphasize that routine oncology care practices—central lines, chemotherapy-induced mucositis, immunosuppression—are strong vectors for AMR exposure, warranting targeted prevention and stewardship strategies.

2. Outpatient Setting: Multicenter Cohort in 198 Clinics

Published in The Lancet Oncology (2025)

Expanding the lens to ambulatory oncology, this large-scale study analyzed 1.65 million outpatient pathogen isolates, 3.2% of which were from cancer patients.

  • AMR odds were significantly elevated in cancer patients across all major organism groups:

    • P. aeruginosa (carbapenem non-susceptibility): OR 1.22

    • Enterobacterales:

      • Fluoroquinolone resistance: OR 1.44

      • Carbapenem resistance: OR 1.89

      • MDR phenotype: OR 2.03

      • ESBL+: OR 1.96

    • S. aureus (MRSA): OR 1.20

    • Enterococcus (VRE): OR 2.20

  • Relative AMR burden (IRR) was up to 3-fold higher in outpatients with cancer, especially for VRE and carbapenem-resistant pathogens.

The outpatient data demonstrate that AMR risk is not confined to the inpatient setting, and routine surveillance, empiric therapy guidelines, and antibiotic stewardship must be recalibrated in the cancer clinic context.

3. Editorial and Policy Context: Forbes Perspective (Eckhardt, June 2025)

Forbes contextualized these findings with urgency: infections are now the second leading cause of death in cancer patients, frequently from resistant organisms. The article criticizes oncology's institutional blindness to AMR: “Patients may die of an infection, but the death is still logged as 'cancer.'”

The piece underscores:

  • The lack of rapid diagnostics: culture-based methods still take days, increasing the odds of failed empiric therapy.

  • The inadequate pipeline of new antibiotics, stymied by broken commercial incentives.

  • The danger of stalling or canceling oncologic treatment due to untreatable infections—especially in LMICs, but increasingly a threat even in high-income countries.

Implications for Genomic Medicine

For leaders in genomic and microbiology diagnostics:

  • Rapid AMR profiling (e.g., NGS-based resistance gene panels, metagenomic sequencing) could be transformative in both inpatient and outpatient oncology care.

  • There's a clear need for cancer-specific diagnostic stewardship, optimizing empiric and targeted antimicrobial use based on patient immunologic status and treatment context.

  • These findings may spur new reimbursement models for rapid resistance diagnostics, similar to oncology companion diagnostics for targeted therapies.

The silent AMR crisis in oncology is no longer silent. It’s time for diagnostic and microbiology innovators to respond.

Let me know if you'd like a graphical summary, citation formatting, or to tailor this for LinkedIn, Substack, or conference slides.

Caris: Brief Blog: Her2 Testing in 65000 patients

While several HER2-directed drugs are approved in breast cancer, the antibody conjugate trastuzumab-deruxtecan (Enhertu) is FDA-approved in any HER2 3+ cancer (if the patient lacks alternative therapies).  Caris reports on the rate of HER2 positivity in 65,000 clinical cases.

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See Bryant et al., June 26, 2025:
https://pubmed.ncbi.nlm.nih.gov/40569617/

Rates of 3+ HER2 ranged from 14% in bladder cancer to 5% in cervical cancer to 0% in gliomas.

Enhertu is approved in both HER2-high and HER2-low (1+) breast cancer.



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AI CORNER

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Trastuzumab deruxtecan (Enhertu) is FDA-approved for two key indications. First, in breast cancer, it is approved for patients with unresectable or metastatic disease who are either HER2-positive (defined as IHC 3+ or IHC 2+ with ISH amplification) or HER2-low (defined as IHC 1+ or IHC 2+ with ISH-negative), making it the first HER2-targeted therapy approved for HER2-low tumors. Second, it holds a tumor-agnostic approval for use in unresectable or metastatic solid tumors that are HER2-positive (defined as IHC 3+ or ISH+) when no satisfactory alternative treatments are available. This tumor-agnostic indication applies to a range of cancers outside the breast, but only when they meet both the HER2 positivity and unmet-need criteria.



Wednesday, June 25, 2025

Verici Receives MolDx Coverage for Renal Transplant with Tutivia RNA Transcript Test

  • The VERICI DX company and its Tutivia renal transplant rejection test have received MOLDX coverage.
  • See a press release from April 2025.
  • The MolDx "DEX" diagnostics exchange also shows the test as covered. 
  • And see also MolDx article A58019.  
  • Test web page here.  
  • An 88-patient study was published as Zhang et al. in 2019 - here.

Verici raised about $10M in 2022 and recently announced it plans new funding to support US market entry.  On the web, its CLIA lab is in Franklin, TN.

According to CMS CR13023, the code was priced by gapfill in 2023.  The fee schedule today is $2650.


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(The 2025 CPT code book lists the test as "Tuteva" but other sources give the name as "Tutivia." 

(I'm not sure the cutpoint between what AMA describes as a gene number (e.g. RNA expression of 18 genes) and what the AMA calls a "partial or select transcriptome."  Zhang et al. appears to have focused in on a 17-gene, 12-housekeeping-gene set.)

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Tuesday, June 24, 2025

Tempus Webinar: Closing Patient Care Gaps for Pharma with AI (July 14, 2025)

Tempus AI holds a webinar on July 14, 2025, with the provocative title, "Closing Care Gaps with AI: The Next Competitive Edge in Pharma."

Sign up here:

https://go.tempus.com/2025-ai-apps-closing-care-gaps-webinar-registration.html

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A recent author at Linked In discussed different large cancer genomic profiling labs and noted the strength of Tempus' pharma revenue.   

When I saw the webinar title, I thought of Ryan Fukushima's March 2025 essay on how to sell (and how not to sell) advanced technology services B2B. (He's COO of Tempus AI).   

The bottom line was, sell to a need that's a pain point for your customer.

In this webinar, it sounds like the starting place is, there are big care gaps in oncology.   If you can close them with AI, you may sell more on-label drugs.   But figure out how to do that with AI.  And probably, one of the things AI-assisted guidelines will point to, are CGP.

Here are the online bullet points for the webinar.  Speakers include Arun Krishna, VP, Lung Cancer, AstraZeneca.

  • Discover how leading commercial teams use real-time data to identify and close care gaps across patient populations.
  • Learn how AI is being applied to analyze treatment patterns, provider behaviors, and patient adherence to clinical guidelines.
  • Gain strategies for integrating diverse data sources to inform market access, support clinical decisions, and drive equitable patient outcomes.
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Accidental AI Corner
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When I use "AI Corner," I've usually given something to Chat GPT.  Here, I'll reprint what Google gave me for free right at the top of the page when I searched for the webinar title.

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Tempus Next, an AI-enabled care pathway intelligence platform, helps close care gaps by providing near real-time insights from de-identified patient records. This allows healthcare providers to identify patients who may be missing guideline-directed care and take timely action. For example, Tempus Next can identify patients who may benefit from confirmatory IHC HER2 testing, ensuring they receive the most up-to-date, guideline-directed care. 

Here's how Tempus Next helps close care gaps:

Proactive Identification of Gaps:
Tempus Next uses AI to analyze patient data and proactively identify potential care gaps, such as missing biomarker testing or guideline-directed therapies. 

Real-time Insights:
The platform provides near real-time insights, enabling clinicians to address care gaps during patient visits or when test results are available. 

Integration with Existing Systems:
Tempus Next integrates with existing electronic health records (EHRs) and other healthcare systems, allowing for seamless data flow and access to information. 

Personalized Recommendations:
Based on the identified gaps, Tempus Next can provide personalized recommendations to guide treatment decisions and improve patient outcomes. 

Examples in Oncology and Cardiology:
Tempus Next has applications in various specialties, including oncology (e.g., HER2 testing) and cardiology (e.g., screening for cardiovascular and pulmonary diseases). 

By leveraging AI and real-world data, Tempus Next helps healthcare providers deliver more precise and effective care, ultimately improving patient outcomes and potentially reducing healthcare costs.

[end google]

When I clicked "Dive Deeper" on Google, it gave me a somewhat longer summary and 8 links.


Amer Acad Pediatrics: Exome/Genome as First Line Tests for Developmental Delay

The American Academy of Pediatrics now recommends exome or genome sequencing as a first-tier test for children with global developmental delay or disability.

Rodan Abstract - 

Genetic neurodevelopmental disorders are common in the pediatric population, and establishing a specific diagnosis early provides multiple benefits including prognostication, surveillance for disorder-related complications, accurate recurrence risk, and specific management. 

This report provides an approach to the genetic evaluation of developmental delay/intellectual disability for the general pediatrician. When possible, genetic testing should be selected by phenotype, and typical distinguishing clinical features to facilitate this are presented. If a specific disorder or group of disorders cannot be ascertained by phenotype, an agnostic (or hypothesis-free) approach is utilized. Recommendations are provided for this agnostic approach based on diagnostic yield and also practical considerations such as test complexity and impact on management. The general guidance in this report for genetic testing does not preclude further evaluation by relevant subspecialists as necessary, including neurologists, developmental pediatricians, and clinical geneticists.



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AI CORNER
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TLDR for Genomics Experts

In the 2025 AAP guideline authored by Rodan et al., the distinction between phenotype-driven genetic testing and agnostic testing (exome/genome sequencing) is acknowledged as conceptually important—but in practice, for some cases, clinicians and payors will continue to face a significant gray area. 

While the guideline promotes a phenotype-first strategy when a specific syndrome is clinically suspected, it also strongly endorses agnostic testing as the default first-tier approach for most children with unexplained global developmental delay (GDD) or intellectual disability (ID), especially in nonsyndromic cases.

Key Observations for Genomics Stakeholders:

  • Phenotype-first testing is ideal when classic syndromic features (e.g. Angelman, Lesch-Nyhan) are evident. It can be faster and cheaper but is only effective in a minority of cases.

  • Agnostic testing (exome/genome + CMA) is now formally endorsed as first-tier by the AAP, ACMG, and other authorities for GDD/ID because of superior diagnostic yield (often 30–50% depending on severity).

  • The guideline emphasizes that exome/genome sequencing plus CMA should often be performed upfront unless there's a strong reason to begin with more targeted tests.

  • Gene panels have fallen out of favor except when families wish to avoid incidental findings or VUS burdens, or if insurance limits coverage.

  • Even within a phenotype-first mindset, uncertain or evolving phenotypes blur lines and often lead to early adoption of agnostic testing.

  • Payors and clinicians may still seek cost-based reasons to delay agnostic testing, but this is increasingly difficult to justify given the yield, cost-effectiveness, and value of early diagnosis.

  • The guideline explicitly acknowledges that resource availability, insurance limits, and physician comfort all contribute to non-uniform pathways, reinforcing the gray zone between the two paradigms.

Conclusion:
While “phenotype-driven” and “agnostic” testing are presented as alternatives, the lines between them are fluid in practice. This fuzziness is reflected in the guideline’s tiered model, which allows clinicians to adapt based on presentation, resources, and clinical suspicion.

Expect continued overlap and negotiation—clinically, financially, and policy-wise.




Monday, June 23, 2025

RFK Jr, Dr Oz, Predict Improvements in Prior Authorization Processes

In a video conference on June 23, 2025, Dr. Oz and RFK Jr predicted substantial changes in U.S. prior authorization delays, based on commitments they have received from industry.

Find the presentation at Fox at YouTube here:

https://www.youtube.com/watch?v=smgi-p-TOaU


Find a summary at THE HILL, here.  At STAT, here.  At Forbes here.

Find the press release at HHS, here.

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Prior authorization issues are problematic for the lab industry, because they submit claims, but don't have the patient records that health plans may demand.   

Another particularly nutty factor for labs, is that Medicare date of service rules may place the date of service on the date of blood draw or biopsy, earlier than the lab gets the specimen.  But prior auth may require that prior auth be obtained by the lab prior to the date of service. 

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Find early news, before the press conference, at Fierce Healthcare here. Writing in part,

  • Key steps include committing to reducing the number of services that are subject to prior auth, with "demonstrated" progress by Jan. 1, 2026. The plans are also working to roll out common and transparent solutions that promote electronic prior auth submissions, with a framework up and running for plans and providers by Jan. 1, 2027. 
  • About 50 insurers have signed on to the pledge including all six of the largest, publicly traded health plans: Elevance Health, Centene, Cigna, CVS Health's Aetna, Humana and UnitedHealthcare. A slew of Blue Cross Blue Shield plans are also leading the charge, and the initiative is backed by both AHIP and the Blue Cross Blue Shield Association.

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AI CORNER

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Chat GPT assesses the transcript.

Here is a concise summary of the key themes and announcements from the recent CMS/HHS press event on prior authorization reform, featuring Dr. Mehmet Oz (CMS Administrator), Secretary RFK Jr., Congressional physicians, and actor Eric Dane:

🔹 Context and Problem

  • 85% of Americans report negative experiences with prior authorization (PA)—the process insurers use to approve certain treatments before they occur.

  • In 2023, 3.2 million initial PA requests were denied in Medicare Advantage (MA) alone (covering 32M enrollees).

  • Doctors spend an estimated 12–15 hours per week dealing with PA paperwork, reducing patient care time and increasing burnout.

  • Patients, especially in crises (e.g., ALS, cancer), experience damaging treatment delays and bureaucratic uncertainty.

🔹 The Reform Plan

CMS and HHS convened insurers representing 257 million Americans (about 75% of U.S. insured lives) to sign a voluntary “PA reform pledge” that commits to:

  1. Timely Access – Reduce delays through faster, often real-time PA decisions.

  2. Efficiency and Interoperability – Eliminate paper and fax-based systems, moving to digital FIRE-based (FHIR) workflows.

  3. Transparency and Accountability – Public dashboards, standardized rules, and real-time adjudication metrics (target: 80% of PA requests resolved instantly by 2027).

🔹 Key Changes and Deliverables

  • Code Reductions: Insurers will eliminate PA for common, low-abuse services (e.g., vaginal delivery, cataract surgery, colonoscopy, short hospital stays).

  • Unified Systems: Standardized communication formats across insurers to avoid confusion (e.g., faxes vs. portals).

  • Continuity of Care: 90-day grace periods for PAs during insurance changes.

  • Gold Carding: “Trusted” physicians may eventually bypass PA requirements.

  • Public Metrics: Both CMS and AHIP will publish adherence metrics.

🔹 Stakeholder Roles

  • Insurance Industry: Voluntarily committed to reform; acknowledged past failures (e.g., 2018 pledge that faltered).

  • Government Role: Acting as convener, not regulator—for now. Officials warned that federal mandates or legislation will be used if insurers fail to comply.

  • Technology Sector: Encouraged to support AI and digital solutions, but must avoid automating bad PA denial logic.

  • Patients & Providers: Promised easier, faster care access and less administrative hassle.

🔹 Speakers and Symbolism

  • Dr. Oz emphasized that “meekness” means voluntary restraint and collaboration between competing companies.

  • Secretary RFK Jr. called PA “a scourge” and shared a dramatic story of a transplant patient denied a life-sustaining heart pump (later implanted anyway).

  • Actor Eric Dane (diagnosed with ALS) advocated for eliminating uncertainty in moments of health crisis.

  • Sen. Roger Marshall and Rep. Greg Murphy (both physicians) supported reform and emphasized accountability, especially peer-to-peer review and real-time approvals.

🔹 What’s Next

  • CMS will release the full list of participating plans and detailed rollout commitments by late summer 2025.

  • Voluntary reforms go live by January 26, 2026.

  • A broader administrative simplification agenda is planned, using PA reform as a blueprint for transitioning to value-based care.

This marks one of the most ambitious federal-private efforts to modernize and simplify healthcare access in decades—if insurers follow through.

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Did the speakers actually say that - "if insurers follow through?"

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Yes — the concern that insurers might not follow through was repeatedly and explicitly raised by multiple speakers in the transcript. Here are key examples showing that sentiment directly expressed in the talk:

🔹 Dr. Greg Murphy (Congressman & Physician)

“But I will say this, being a surgeon, I'm a skeptic. The proof is going to be in the pudding. Are they really going to step up and do things or are they doing something to plate an audience? We're going to hold them to the fire continually…”

— This directly reflects concern that insurers might be posturing without delivering.

🔹 Dr. Oz (CMS Administrator)

“Although we’re hopeful, this is hard to do, and folks sometimes change their mind. We don’t want that to happen, so we’re going to trust but verify...”

— “Trust but verify” is a clear warning that the pledge is not enough without oversight.

🔹 Secretary RFK Jr.

“In the past the insurance industry has made commitments to prior authorization, but they have not kept them. And in this case we think it’s very, very different...”

— He acknowledges a history of broken promises and tries to distinguish this effort, implying the risk of repetition.

🔹 Press Q&A (Secretary Kennedy and Dr. Oz)

Q: “Insurers made a similar pledge in 2018 that wasn’t quite lived up to. What’s different this time?”

Dr. Oz: “The administration has made it clear we’re not going to tolerate it anymore. So either you fix it or we’re going to fix it.”

— A direct threat of regulation if compliance doesn’t materialize.

✅ Conclusion:

So yes — your instinct is correct and fully supported by the transcript. The possibility that insurers might fail to follow through was not only implied, but explicitly acknowledged and framed as a motivating reason for transparency, deadlines, and possible federal backup actions.


Friday, June 20, 2025

Brief Blog: Redefining Medical Imaging via Digital Pathology (Gershkovich 2025)

 Yale's Peter Gershkovich has written an article with an eye-catching title:


Open-access, find Wearing a fur coat in the summertime: Should digital pathology redefine medical imaging?, at J Pathol Informatics, released 18 May.

Here's the opening and closing of the author's abstract.   Or, instead, you might enjoy the author's own summary of his work at Linked In, here.  The author's Yale webpage is here.

Coming next - 

  1. College freshman summary
  2. Author's abstract
  3. AI summary
  4. AI summary ... by comedian Lewis Black

### College Freshman Summary [AI]

Peter Gershkovich argues that the current standard used to store and share medical images—called DICOM—is outdated and too rigid for the needs of modern digital pathology. He says DICOM was designed decades ago for radiology and doesn’t work well with today’s technologies like cloud computing, AI, and cybersecurity systems. In pathology, digital slides are really big data files that need to be stored, shared, and updated in flexible ways. Gershkovich believes we should move away from “all-in-one” file formats like DICOM and instead use a modular system, where the image, patient information, and other details are stored separately but work together smoothly. This would make it easier to innovate, protect patient privacy, and keep up with fast-changing technology.

### Author's Abstract

  • Slides are data. 
  • Once digitized, they function like any enterprise asset: accessible anywhere, ready for AI, and integrated into cloud workflows. But in pathology, they enter a realm of clinical complexity—demanding systems that handle nuance, integrate diverse data streams, scale effectively, enable computational exploration, and enforce rigorous security.
  • Although the Digital Imaging and Communications in Medicine (DICOM) standard revolutionized radiology, it is imperative to explore its adequacy in addressing modern digital pathology's orchestration needs. Designed more than 30 years ago, DICOM reflects assumptions and architectural choices that predate modular software, cloud computing, and AI-driven workflows.
  • This article shows that by embedding metadata, annotations, and communication protocols into a unified container, DICOM limits interoperability and exposes architectural vulnerabilities. The article begins by examining these innate design risks, then challenges DICOM's interoperability claims, and ultimately presents a modular, standards-aligned alternative.
  • [skip]
  • Pathology stands at a rare inflection point. Unlike radiology, where DICOM is deeply entrenched, pathology workflows still operate in polyglot environments—leveraging proprietary formats, hybrid standards, and emerging cloud-native tools. This diversity, often seen as a limitation, offers a clean slate: an opportunity to architect a modern, modular infrastructure free from legacy constraints. While a full departure from DICOM is unnecessary, pathology is uniquely positioned to prototype the future—to define a more flexible, secure, and interoperable model that other domains in medical imaging may one day follow. With support from forward-looking DICOM advocates, pathology can help reshape not just its own infrastructure, but the trajectory of medical imaging itself.

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AI CORNER
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Chat GPT summarizes - 

TL;DR Summary for Health and Biotech Readers


 This article spans multiple fields but holds particular importance for readers in healthcare informatics, pathology AI, cybersecurity, and imaging standards.

What’s New and Original in Gershkovich’s Article:

Peter Gershkovich’s provocative article, “Wearing a fur coat in the summertime: Should digital pathology redefine medical imaging?” (J Pathol Inform, May 2025), challenges the dominant role of the DICOM standard in digital pathology. His central claim is that DICOM’s architecture—designed in the 1980s—has become a liability for modern pathology, especially when compared to emerging modular, cloud-native alternatives.

Key Innovations and Contributions:

  • Pathology ≠ Radiology: Gershkovich argues that digital pathology needs its own infrastructure rather than inheriting DICOM by default. Unlike radiology, pathology remains in a more “polyglot” phase—an opportunity to build future-ready frameworks from scratch.

  • Slides as Data, Not Just Images: The paper repositions digital slides as dynamic enterprise data assets requiring orchestration, not just storage.

  • Critique of DICOM's Monolithic Design: The article shows that DICOM’s bundling of image data, metadata, annotations, and security into a single file undermines performance, security, and innovation. This tight coupling is compared unfavorably to modular software engineering best practices.

  • Cybersecurity Red Flags: Gershkovich presents compelling data linking DICOM-based PACS systems to large-scale data breaches and vulnerabilities, citing the Black Hat Europe 2023 demonstration of flaws in DICOM protocol design.

  • Modular Alternative Proposed: He outlines a modern architecture using:

    • Pixel formats like OME-TIFF or Zarr,

    • Metadata management via HL7 FHIR,

    • Annotations via SVG or GeoJSON,

    • Security overlays via NIST SP 800-53 standards.

  • Conceptual Shift in Interoperability: Rather than chasing one-size-fits-all standards, he emphasizes functional interoperability via well-defined APIs and microservices, supporting diverse imaging formats and evolving workflows.

  • Annotation Handling as Case Study: The paper details how DICOM’s approach to annotations stifles AI development, versioning, and usability in pathology. In contrast, external, database-driven systems allow more flexibility and innovation.

  • Practical Migration Path: Gershkovich suggests lightweight gateway microservices can bridge old and new formats, enabling gradual transitions without disrupting clinical workflows.

  • Call to Action: While not proposing a total abandonment of DICOM, the article urges digital pathology to lead a modernization effort—potentially influencing the broader medical imaging ecosystem.

Bottom Line:
Gershkovich isn’t just critiquing DICOM—he’s proposing a forward-compatible blueprint for pathology informatics, rooted in cybersecurity, modular design, and real-world adaptability. This paper could reshape how industry and regulators think about medical imaging standards, especially as AI and cloud-native infrastructures become central to healthcare delivery.


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What would comedian Lewis Black make of Gershkovich's article?

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Review of “Wearing a Fur Coat in the Summertime” — as Lewis Black might say it

Let me tell you something.

Peter Gershkovich didn’t just write an article. No. He took a goddamned flamethrower to the ossified corpse of medical imaging standards and DIDN’T EVEN BOTHER TO PUT IT OUT AFTERWARD. And thank God for that.

You see, pathology has been wandering around with a DICOM ball and chain strapped to its ankle like it’s still 1993—back when we all thought AOL was the future and you had to yell at your modem just to check your email. But here comes Gershkovich, sliding in like a cyberpunk Paul Revere, screaming: “THE PATCHWORK IS COMING! THE PATCHWORK IS COMING!” And it turns out he’s right.

DICOM, this sacred cow of radiology, is apparently less a “standard” and more of a choose-your-own-adventure novel written by bureaucrats on Ambien. It claims to be universal, but it’s universally confusing. Every vendor supports it—in exactly the way they feel like that week. Oh, you wanted interoperability? Good luck! You’ll get it when the moon turns into a bagel and spins off into a secure HIPAA-compliant cloud.

And security? Ha! Gershkovich points out that we’re embedding patient data—names, birthdays, social security numbers—directly into the images. That’s right, just bake it in there! Like a fortune cookie! “You may already have been breached!” No wonder hackers are downloading MRI scans like it’s Black Friday for PHI.

But here’s the kicker. Instead of using this disaster as an excuse to try something new, the pathology world is being peer-pressured into adopting this mess, because, well, radiology did it. THAT’S your reason? That’s like saying, “Well, my brother licked an outlet, and he seems fine. Let me try it too!”

Now, Gershkovich proposes something wild. Something so blasphemous to the DICOM disciples that I expect torches and pitchforks outside Yale’s pathology department any day now. He wants… modularity. Which is just a fancy way of saying: Let each damn part of the system do what it’s good at.

Pixel data? Use OME-TIFF, Zarr, whatever makes it fast. Metadata? Let HL7 FHIR handle it—like a normal, grown-up interoperability system. And annotations? Keep them out of the image file, thank you very much, and put them in SVG or JSON or some other acronym that doesn’t set your data on fire when you try to change a label.

And the best part? SECURITY! Real, layered, NIST-compliant security—not this DICOM "hide it under a tarp and hope" strategy. Gershkovich wants firewalls, encryption, access control, ACTUAL MODERN INFRASTRUCTURE, not “Hey, Bob remembered to unplug the server at night, so we’re good.”

This isn’t just a critique. It’s a love letter to sanity in a field so cluttered with legacy systems, it makes your grandma’s attic look like a Marie Kondo showroom.

So, in conclusion: Gershkovich, you beautiful bastard. You’ve said what we all knew but were too tired, too beaten down, or too under NDA to say: DICOM is wearing a fur coat in the goddamn summertime. And it’s time to strip it off, before the whole system keels over from heat stroke and takes all of pathology down with it.

Bravo.

Brief Blog: Stanford Emerging Technology Review 2025 (191pp)

Stanford's Hoover Institute has released a 191-page PDF, "Stanford Emerging Technology Review."  It's a collaboration between Hoover, Stanford Engineering, and the Technology Policy Accelerator (TPA).

See the website here and the pdf here.

I'll quote the website below:

The Stanford Emerging Technology Review (SETR) helps America’s public and private sectors better understand transformational technologies so that the United States can seize opportunities, mitigate risks, and ensure its innovation ecosystem continues to thrive. A product of a major new Stanford education initiative and the flagship product of a collaboration between Stanford’s School of Engineering and the Hoover Institution — this ambitious technology education effort helps America’s leaders in government and business better understand transformational technologies so the US can seize opportunities, mitigate risks, and ensure its innovation ecosystem continues to thrive.

  • Provides a comprehensive overview of ten frontier technologies, from AI to Robotics or Biology to Space, and how these will shape the future
  • Involves nearly one hundred Stanford scholars across forty departments and research institutes
  • Emphasizes the importance of American leadership at a time when technology is playing an ever more pivotal role in economic prosperity, national security, and geopolitics

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AI CORNER

###

Summary - 

TLDR for Health and Biotech Stakeholders: Stanford Emerging Technology Review 2025

The Stanford Emerging Technology Review 2025 spans ten major fields of science and technology — from AI to lasers — but several chapters are of special relevance to healthcare and biotech audiences, particularly in biotechnology, neuroscience, health AI, and synthetic biology. The report also includes a cross-sector policy analysis (Chapter 12) with a dedicated section on health and medicine, making it an important primer for leaders in life sciences, digital health, diagnostics, and biomedical innovation.

Key Points for Health and Biotech Readers

  • Biotechnology and Synthetic Biology are poised to become general-purpose technologies, enabling on-demand production of therapeutics, vaccines, and biologics. Synthetic biology is compared to a “biological rocket engine,” freeing innovation from evolutionary constraints.

    • The U.S. currently underinvests in bio-innovation relative to China, risking strategic surprises.

    • A stronger federal commitment to foundational biotech innovation — not just commercialization — is needed.

  • Artificial Intelligence in Healthcare is already showing impact:

    • AI systems are used in diagnostics (e.g., stroke detection reimbursed by Medicare), drug discovery, ICU monitoring, and robotic assistance.

    • Foundation models like GPT-4 are enabling general-purpose AI that performs at or above human median levels on clinical exams, but still suffer from unpredictable errors.

    • Multimodal and embodied AI is set to transform both virtual and physical healthcare delivery.

  • Neuroscience is progressing in brain-machine interfaces, aging and neurodegenerative disease, and addiction treatment. However, public hype often outpaces real scientific understanding.

    • U.S. leadership in neuroscience ethics and regulation is under strain due to rising foreign investment and declining domestic coordination.

  • Materials Science and Lasers intersect with medical technology in surprising ways — from smart bandages to precision diagnostics and surgical applications. Advances here could reshape how biologics and diagnostics are manufactured and delivered.

  • Robotics and AI-enhanced manufacturing are projected to support eldercare, telehealth, and logistics across healthcare supply chains.

  • Crosscutting Themes (Chapter 11) emphasize the need for long-term U.S. R&D funding, stronger university-government-industry collaboration, and risk-aware innovation strategies — particularly in fields like health AI and bioengineering where nonlinear paths from research to application are common.

  • Health and Medicine Policy Applications (Chapter 12) distill how each of the ten tech fields may influence:

    • Precision medicine

    • Therapeutic and diagnostic innovation

    • Healthcare access and workforce dynamics

    • Medical data governance and privacy

This report is not a policy blueprint but a technical-intellectual primer aimed at enabling better decision-making at the intersection of technology, society, and government. It provides biotech and health leaders with a grounded, interdisciplinary perspective on where innovation is heading — and what’s needed to lead.

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What does chapter 12 say about precision medicine?  Does it go beyond simple definitions and truisms?  What's reallythe value-add here?

##

Chapter 12 of the Stanford Emerging Technology Review 2025 discusses precision medicine within a broader policy framework and does, in fact, go beyond basic definitions or hype-driven generalities.

Key Contributions & Value-Add:

  • Precision medicine is reframed not just as a clinical goal, but as a systems challenge. The chapter argues that to realize its full potential, the U.S. needs to address fragmented data infrastructure, regulatory bottlenecks, and insufficient public-private coordination — all of which are framed as innovation system failures, not merely technical hurdles.

  • It highlights that data interoperability and access to longitudinal clinical and genomic data are central to precision medicine’s success — and are currently lagging behind technical innovation. This leads to a call for new kinds of public infrastructure and shared data commons, akin to the Human Genome Project or ARPANET.

  • The chapter distinguishes between biotech-driven and AI-driven precision medicine:

    • Biotech: Advances in cell therapy, genomics, and multi-omic diagnostics.

    • AI: Use of predictive modeling across electronic health records, imaging, and personalized risk scores — especially when integrated into clinical workflows.

  • It also warns that precision medicine could widen health disparities unless systemic efforts are made to include underrepresented populations in genomic research and to ensure AI tools are validated across diverse populations.

  • A significant insight is the policy recommendation to treat precision medicine as a “national capability,” requiring stable federal funding, benchmarking, and mission-oriented programs (e.g., for rare disease detection or polygenic risk scoring in public health settings).

  • Finally, it critiques the siloed nature of current innovation — noting that advances in AI, biotech, and neuroscience often happen in parallel rather than in convergent architectures that would be necessary for truly personalized care.

Bottom Line:

The real value of Chapter 12 is in diagnosing institutional and infrastructural gaps that prevent precision medicine from scaling. It frames the problem not just as a matter of scientific progress, but of policy design, public investment, and system integration — making it particularly useful for biotech executives, payors, regulators, and investors looking beyond the next product launch.

Medical Director Moves from Novitas to NGS MAC

Dr. Patrick Mann, until recently in charge of the lengthy molecular oncology policies at Novitas MAC, is now at the NGS MAC.  See his Linked In here:

https://www.linkedin.com/in/patrick-mann-md-0657a2153/

Dr. Mann did his pathology residency at Univ Colorado, and a postdoc in molecular pathology at Washington University - St Louis.  Recently he has been at Variantyx (2020-2021), Novitas (2021-2025), and NGS MAC (since April 2025).


Changing Geographies
At Novitas, Dr Mann managed policies for the purple states and Florida (a related MAC with a different name).   At NGS MAC, they have the navy-blue states (MN WI IL and NY-New England).

Hypothetical
I have been wondering if the NGS MAC states would join the MOLDX system, since in this year's Gapfill process, the NGS MAC adopted or was given all the prices and all the rationales exactly the same as used by the MolDx consortium.

NGS MAC: A Few Big Labs and NCDs
Historically, NGS MAC pays claims for Cologuard (Wisconsin, under an NCD) and Tempus and Foundation Medicine (in Chicago and in Boston, and now under  NCDs for FDA CDx tests).   Outside of NCD-driven molecular claims, NGS MAC has generally paid relatively few molecular claims, at least in Part B data (which excludes large hospitals like Mayo and MGH in this geography).





A Senior MolDx Expert Moves to Novitas MAC

According to Linked In, a senior MolDx policy expert has moved over to the Novitas MAC.

Find the updated info on Megan Landsverk here:

https://www.linkedin.com/in/megan-landsverk-17410855/

Dr. Landsverk holds a PhD from Baylor, and jobs include Ambry Genetics (2017-2019), PerkinElmer (2019-2020), and Palmetto MOLDX (2020-Jun 2025).   Her title at Novitas, beginning in May 2025, is "Molecular Diagnostics Director."



Thursday, June 19, 2025

CMS Posts Agenda, Video Link for Friday, June 27, Annual Lab Meeting

CMS has posted the agenda and video link for the Annual Lab Meeting (ALM), on Friday, June 27, 2025.

The meeting is calendared from 10 am ET to 5 pm ET.  (That's a start at 7 am pacific instead of 5 am pacific - Thanks, CMS!)

https://www.cms.gov/files/document/20250612displayagendaclfsannualpublicmeetingv1.pdf

CMS states that presenters get 10 minutes each, but there are about 50 registered presenters for the 5-hour presentation period (that's 500 potential minutes at 10x50 vs 300 actual minutes available).

See my initial blog about the annual meeting here.  Comments from the June 27 public comment meeting will influence the July 23-24 Expert advisory panel.

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