Sunday, August 23, 2026

CRUSH Reaches White House / OMB, Who Will Release the Proposed Regulations

 

NEWS: CMS Sends Major CRUSH Anti-Fraud Rule to OMB

The February request for information has quietly become an actual proposed rule, with new Medicare enrollment and enforcement provisions potentially only weeks away.

A major anti-fraud regulatory proposal is on the desk of management officials at the White House Office of Management and Budget, awaiting signoff for publication.

CMS transmitted its proposed Comprehensive Regulations to Uncover Suspicious Healthcare—better known as CRUSH—to OMB on August 7, 2026. The proposal remains under review by OMB’s Office of Information and Regulatory Affairs. It is officially classified as a proposed rule, not a final rule, and is not designated economically significant. The OMB regulatory-review page is here.

Saturday, August 22, 2026

Blog 5 of 5: AI Rewrites My Human Blog #3 (88305 Super-Providers)

In this series of 5 blogs, Blog 3 (national and super-provider utilization) was written by Quinn by hand.  Here is  Blog 3, rewritten from source material entirely by Chat GPT 5.6.

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88305: Blog 5 of 5 — What Medicare’s Biggest Users Tell Us About the 25-Minute Problem

The developing Medicare controversy over CPT 88305 can be approached from two directions. The Maryland Health Care Commission approached it at the level of the provider-day: multiply the number of 88305 services billed by Medicare’s assigned physician time, and ask whether the resulting workload can fit into an actual day. Sometimes it cannot. Maryland found hundreds of days on which 88305 alone translated into more than 24 hours of nominal physician work.

There is another way to look at the same issue. Instead of studying individual days in Maryland, one can pull back and examine an entire year of national Medicare utilization. CMS’s CY2024 Medicare Physician & Other Practitioners — by Provider and Service public-use file offers exactly that perspective. Filtering the enormous database to a single code, 88305, reveals both the scale of the business and some remarkable concentrations of utilization.

The national data cannot determine how many minutes a pathologist actually spent on a particular slide. Nor should they be treated as if they could. But as a broad reality check on the longstanding assumption that a typical 88305 contains 25 minutes of pathologist intraservice work, they are unusually provocative.

Blog 4 of 5; We Discover the Source of the CMS 88305 Data: Mesta et al., June 2026!


50-word summary

CMS’s July 2026 CY2027 Physician Fee Schedule proposal reproduced striking Maryland data suggesting CPT 88305 may be overvalued -- without naming the source. 

Discoveries in Health Policy has discovered that the trail leads to Maryland Health Care Commission officials Mesta, Chappel, and Jacobs in Health Affairs

Their open-access article adds useful detail—and methodological questions that pathologists will find worth raising now.

Friday, August 21, 2026

88305: Blog 3 of 5: National and Busy-Individual Usage for 88305 in Medicare Part B

In summer rulemaking, CMS proposed surgical biopsy billion-dollar-code 88305 as a mispriced code.  Blog #1 here.    I also had Chat GPT research the policy history of the odd surg path coding system (it took 26 minutes!).  Blog #2 here.

In this third blog, I look at provider-by-provider Medicare Part B data for 88305.  (I got the 88305 data from  here.  It's CY2024.)

Note; See the same scope of data reviewed and written solely by AI - Blog 5 here.

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17,430 different providers were paid for 88305.   $931M.

576 were Clinical Laboratories, paid $226M or about 20% of all dollars.  All the other dollars went to entities enrolled as providers (pathologists, dermatologists, etc.)

13,680 rows were pathologists.  1719 were dermatologists.  904 were gastroenterologists.  Just 33 were urologists (Medicare pays for prostate biopsies as a blanket lab fee, not per core).

Thursday, August 20, 2026

FDA Approves De Novo Software that Makes Diagnosis on Brain MRI: NeuroPacs

August 7, we published a blog on software diagnosis in radiology and asked how fast it might come to pathology.   Here.  And we've already updated that once, August 14.  Here.

Below, FDA approves de novo software that auto classifies MRIs as Parkinson disease vs several other disorders.  Brave new world.

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AI Corner

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A few weeks ago, this blog reviewed DeepHealth SMART-B, an FDA-cleared breast-ultrasound system that detects and characterizes lesions and generates draft findings and impressions for radiologist review. That clearance prompted a broader discussion of the outlook for report generation in pathology—already visible in several U.S. research-use-only products and in some software cleared for clinical use in Europe.

Here is another timely example from a different corner of diagnostic medicine. FDA has granted De Novo classification to neuropacs, machine-learning software that analyzes diffusion MRI and produces a diagnostic classification report for Parkinson disease and two related parkinsonian disorders.

88305: Blog 2 of 5: The Ancient History of Surg Path Coding (88305 1960s?)

Here's a challenge I gave to Chat GPT 5.6.  What's the origin of the coding system for surgical pathology - biopsies 88305, etc.   CPT produces Surg Path Levels "I" to "VI," scattered between 88300 and 88309.

The levels are different than Tier II genetic procedure levels, where one is to use a level ("I" to "IX") only if your specific gene is named there.  For Surg Path levels, CPT says use the level that is the closest match to the specimen you examined.

But where did this system come from?  Does anybody know?  Chat GPT thought for a remarkable 26 minutes before printing the answer below.

(I also asked Claude Opus, which answer was directionally similar but less detailed).

(See an article on CMS proposed revaluation of 88305 here.)

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The short answer is: the recognizable surgical-pathology ladder—88300, 88302, 88304, 88305, 88307 and 88309—is securely documented in the fourth edition of CPT in 1977

Wednesday, August 19, 2026

88305: Blog 1 of 5: CMS Proposes Review of Code 88305. Chat GPT Writes White Paper Report.

 In July, when CMS released the proposed policies for physician fee schedule aka Part B, it included a proposal to review the valuation of code 88305, one of the most frequently used pathology codes.  The proposal came over the transom from State of Maryland.

  • Below, summaries of a white paper report written by Chat GPT on the topic.  
  • Find the 20-page AI report HERE.





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50-Word Summary

CMS’s 2026 scrutiny of CPT 88305 challenges a 25-minute pathologist time assumption re-surveyed and affirmed by the RUC in 2010. Maryland claims data suggest that assumption can produce impossible workdays. Historical radiology and pathology practice-expense resets show Medicare has previously rebased payment when older resource models no longer matched practice.

Tuesday, August 18, 2026

Chat GPT Reviews History of McDermott Plus Consulting - After News from Politico

We're waiting for confirmation of a news item in Politico that McDermott Plus is closing in August 2026.

While we wait, Chat GPT ran a internet search for information about the history of the firm.  This article is AI-written.  It can be used as an example of current AI ability to understand a task, do research, organize it, and write it up.  It should not be taken as ground truth.

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McDermott+: A 12-Year Experiment in Health Policy, Reimbursement and Washington Advocacy

On August 18, Politico reported that McDermott+, the health policy consulting and lobbying organization affiliated with McDermott Will & Schulte, will close at the end of August, with dozens of employees entering the Washington job market. Assuming the report is correct, the closure will bring to an end a distinctive 12-year experiment in combining health policy consulting, reimbursement strategy, data analytics and conventional Washington lobbying under one roof.

For many people in health policy, McDermott+ was sufficiently familiar that its unusual corporate structure could be easy to overlook. It looked and sounded like part of the McDermott law firm, occupied the same Washington address, shared personnel and frequently worked alongside McDermott lawyers. But it was not a law practice.

A deliberate spinout — but never an independent one

McDermott Will & Emery formally launched McDermott+Consulting, or McDermottPlus, in April 2014. The announcement described it as a “separate and distinct, wholly-owned subsidiary” of the law firm. Its original menu was unusually broad: 

  • congressional and executive-branch lobbying, 
  • budget-impact and cost-effectiveness modeling, 
  • political communications, 
  • public- and private-payer coverage, coding and pricing strategy, and 
  • healthcare data analysis. 
  • The firm explicitly promoted the ability to use project fees and retainers rather than limiting engagements to traditional law-firm hourly billing to the tenth of the hour. (KSL)

Thus, McDermott+ was less a conventional corporate spinout than a closely held consulting affiliate. That distinction remained important. McDermott’s current legal notices state explicitly that McDermottPlus LLC is wholly owned by McDermott Will & Schulte and does not provide legal advice or legal services. (McDermott) Earlier McDermott+ publications similarly cautioned that communications with the consulting company did not carry attorney-client privilege.

The arrangement nevertheless allowed extremely close integration. A client could be working with McDermott+ consultants on reimbursement economics, CMS policy or lobbying and, when a question required legal analysis, bring in lawyers from the parent firm. A later McDermott case study on Medicare coverage of over-the-counter COVID-19 tests describes exactly that sequence: McDermott+ organized and advocated for a coalition, then drew on McDermott lawyers to develop the legal theory supporting a potential CMS coverage pathway. (McDermott)

The practice existed before the name

The intellectual roots of McDermott+ predated the 2014 corporate launch.

McDermott already had a prominent Washington health-policy and reimbursement practice spanning Medicare payment, coverage, coding, FDA regulation and congressional advocacy. Paul Radensky, MD, JD, and Eric Zimmerman were conspicuous participants in that world. For example, both appeared on the agenda of CMS's 2013 annual Clinical Laboratory Fee Schedule meeting, with Zimmerman representing McDermott and the Coalition for 21st Century Medicine and Radensky appearing for McDermott separately. (Centers for Medicare & Medicaid Services)

The creation of McDermott+ essentially gave that kind of work a larger nonlegal platform.

At the 2014 launch, Radensky and Zimmerman were both identified as principals. Zimmerman said the objective was a “one-stop shop” combining lobbying, analytics and policy work; Radensky emphasized the growing need for quantitative analysis and for strategies that could move new technologies through complex government regulatory and payment systems. (KSL)

Zimmerman was later explicitly described by McDermott+ as a co-founder. (McDermott+)

Paul Radensky and the reimbursement side of McDermott+

For many in the diagnostics, medical-device and biotechnology communities, however, Paul Radensky became one of the people most closely identified with McDermott+.

His background was unusual even by Washington health-policy standards: an MD from the University of Pennsylvania, internal-medicine training and a fellowship in liver disease, followed by a Harvard JD. His practice joined regulatory law to the highly specialized mechanics of obtaining Medicare coverage, coding and payment for new medical technologies. McDermott credits him with work leading to national and local Medicare coverage decisions, Coverage with Evidence Development protocols and reimbursement strategies for pharmaceuticals, biologics, devices and clinical laboratory technologies. (McDermott)

That expertise helped give McDermott+ a character different from that of a general K Street shop. A client might arrive not because a bill was moving through Congress but because a diagnostic needed a coding pathway, a medical device faced an unfavorable Medicare payment methodology, a laboratory test needed a coverage strategy, or a manufacturer needed to understand the interaction among FDA status, Medicare benefit categories, CPT or HCPCS coding and CMS payment rules.

Radensky was particularly visible in diagnostics. McDermott+ work during the period included laboratory payment policy under PAMA, advanced diagnostics, medical devices, drug reimbursement and Medicare coverage. His representative activities also included the Coalition for 21st Century Medicine and coalitions involving diabetes testing and other diagnostic technologies. (McDermott+)

Radensky subsequently stepped back from his former partner status. McDermott's current website lists him as Counsel, while still stating that he serves as a principal of McDermott+; the McDermott+ site also continued to list him among its professionals in August 2026. (McDermott) In other words, the public record suggests a gradual change in role rather than a disappearance from the organization.

From reimbursement boutique to broader health-policy operation

McDermott+ also expanded well beyond the product-reimbursement work for which Radensky was known.

By 2018, four years after its founding, the firm said it had grown to ten consultants and had deliberately recruited former executive-branch officials, congressional staff and experienced policy consultants. That year it added Mara McDermott, formerly a senior federal-affairs executive for America’s Physician Groups, and Rachel Stauffer, who had worked on Capitol Hill and in the Office of the National Coordinator for Health IT. (McDermott+)

Over time, the roster became a recognizable cross-section of Washington healthcare expertise. Debbie Curtis brought 24 years of congressional experience, including work for Rep. Pete Stark and the House Ways and Means Health Subcommittee. Rodney Whitlock had worked for Rep. Charlie Norwood, Sen. Chuck Grassley and the Senate Finance Committee. Jeffrey Davis had spent eight years at HHS before working at the American College of Emergency Physicians. (McDermott+)

Others brought expertise in Medicare Advantage, Medicaid, hospital prospective payment systems, medical devices, health economics, CMMI models and claims-data analysis. By August 2026, the public professional roster included roughly two dozen names spanning policy, lobbying, reimbursement and analytics. (McDermott+)

The resulting organization could operate at several levels of the healthcare-policy system simultaneously.

For manufacturers, McDermott+ offered product-level market-access work involving coverage, coding and payment. For hospitals and health systems, it worked on Medicare payment systems, rural-hospital policy and broader federal reimbursement issues. For plans and other organizations, it developed expertise in Medicare Advantage and Part D. For provider organizations and investors in delivery-system reform, it became active in accountable care and CMMI payment models. And for associations, coalitions and corporations, it offered traditional congressional and agency advocacy.

That breadth became the firm's defining proposition. Its website in August 2026 still described McDermott+ as combining consulting, policy and lobbying with data analytics and specialized knowledge of reimbursement, coding, coverage and quality reporting. (McDermott+)

A lobbying shop, but not only a lobbying shop

McDermott+ nevertheless became a substantial registered federal lobbying operation.

One recent academic analysis using OpenSecrets data found that McDermott+ reported about $4.39 million in federal lobbying revenue from 33 clients in 2024. Of that amount, approximately $1.11 million came from seven hospital-industry clients, placing McDermott+ among the larger firms lobbying for hospitals that year. Those figures capture disclosed lobbying revenue, not the company's separate consulting, analytics or reimbursement-strategy business. (JAMA Network)

Its work also illustrates how lobbying could be combined with technical policy expertise. McDermott+ represented hospital coalitions, technology companies, diagnostics firms and other healthcare interests before Congress and executive agencies. Zimmerman, for example, has served as Washington representative for Trinity Health, rural-hospital coalitions, diabetes-testing interests and the Coalition for 21st Century Medicine. (McDermott+)

Coalitions became another recurring feature of the model. During the COVID-19 pandemic, Radensky and Zimmerman led an effort bringing together five competing suppliers of at-home testing products to seek Medicare coverage. In another case, a McDermott+ team worked with a coalition of more than 25 organizations around Medicare direct contracting and what became the ACO REACH model. (McDermott)

Those engagements captured what McDermott+ could do that a reimbursement boutique, analytics shop or lobbying firm alone might have found harder: combine the technical policy argument, its economic implications, stakeholder organization and the Washington campaign required to move it.

It also became a health-policy publisher

A quieter part of the McDermott+ story was its development into a significant public-facing source of health-policy information.

The McDermottPlus Check-Up began providing regular Washington health-policy summaries by 2019. The organization added the Health Policy Breakroom podcast, regulatory commentary, election and policy previews, Medicare data tools and interactive dashboards. By 2026, its website included dedicated products for Medicare data analytics, NTAP strategy, Medicare Advantage and Part D, physician and hospital payment dashboards and a premium information service called McDermott+ Insider. (McDermott+)

In April 2024, co-founder Eric Zimmerman appeared on the Health Policy Breakroom specifically to mark McDermott+'s tenth anniversary and discuss its first decade. (McDermott+)

The public-content operation mattered partly because it kept McDermott+ visible well beyond its paying clients. Hospital executives, laboratory-policy specialists, trade-association staff, Washington lawyers and reimbursement consultants routinely encountered its summaries of proposed and final CMS rules even if they were not currently working with the firm.

That makes the reported shutdown unusually conspicuous. As recently as August 7, 2026, the McDermott+ website was still publishing its weekly Check-Up, and in early August it had posted analyses of the FY 2027 inpatient final rule and other major Medicare regulations. (McDermott+)

A changing parent organization

The closure also occurs against a changed backdrop at the parent law firm.

McDermott Will & Emery merged with New York-based Schulte Roth & Zabel effective August 1, 2025, creating McDermott Will & Schulte, a firm of roughly 1,750 lawyers across more than 20 offices. McDermott brought particular strength in healthcare, while Schulte was especially known for private capital and investment-fund work. (Reuters)

There is not yet enough public information to attribute the reported McDermott+ closure to that merger or any other factor.  The parent firm continues to maintain a major healthcare practice, and several McDermott+ principals have simultaneously held roles at the law firm.

An unusual niche in Washington healthcare

McDermott+ lasted from the early years of Affordable Care Act implementation through MACRA and alternative payment models, PAMA laboratory reform, Medicare Advantage expansion, COVID-19 emergency policy, the Inflation Reduction Act and another major shift in federal health policy after the 2024 election.

Its enduring distinction was not any single one of those subjects. It was the attempt to place several professions that normally sit beside one another — health lawyers, former Hill staff, CMS and HHS veterans, reimbursement specialists, clinicians, lobbyists, economists and data analysts — inside one small organization.

For some clients, McDermott+ was essentially a Washington lobbying firm. For others, it was a Medicare reimbursement consultancy. For still others, it was a source of payment modeling, policy intelligence, coding strategy or coalition management.

And because the organization remained wholly owned by one of the country's best-known healthcare law firms, it occupied an unusual space between Big Law and K Street without being quite either one.

If the reported August 2026 shutdown proceeds as described, that hybrid organization will disappear. Much of its expertise almost certainly will not. In Washington health policy, where former agency officials, congressional staff, lawyers and consultants regularly reassemble in new combinations, the more consequential story may be where the McDermott+ people — and the functions they performed — turn up next.


Sunday, August 16, 2026

New Proposal Introduces Broader Authority for Political Input to NIH Grant Decisions

Back in May 2026, OMB issued a proposed rule that would lay out the authority and framework for political appointees to have a much stronger hand in grant approval decisions.  See article by AP here.  AP also linked back to a Executive Order on the topic back in August 2025 - here.  It might reduce the chance the political grant cuts would get contested in court as happened when grants were abruptly defunded around March-April 2025 (here).  

  • See 108pp OMB proposal here; comment ran to July 13.
  • The OMB policy stated in part:
  • Although Federal spending through grants and other types of Federal financial assistance has grown exponentially since the initial establishment of OMB's policies in earlier Circulars and 2 CFR, corresponding policies capable of ensuring transparency, accountability, and oversight for this increased level of spending remain deficient in the current regulatory text. As a result, Federal programs, and the activities performed under Federal awards, have not always remained properly aligned with core purposes authorized by law, nor served the needs of the American public as intended.
  • This lack of transparency, accountability, and proper oversight became increasingly clear between 2021 and 2024. Federal awards were often used during those years to promote a “woke” policy agenda that did not reflect the values of the vast majority of the American public...

Here comes what may be a related document in the set, from NIH, about presentation of data from NIH grant reviews - here.  Dated August 14, 2026. It's titled, Request for Information (RFI) on Proposed Changes to Reporting Outcomes from NIH Peer Review, Notice Number: NOT-OD-26-088.  Issued 8/14, your comments due 10/13.



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I'll let Chat GPT discuss the details.

See also a ten-page AI generated white paper on this topic  >>>  here   <<< .

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NIH has issued something notable. And it fits almost hand-in-glove with the OMB proposal from May 2026, although the NIH notice here is itself framed as a technical reform intended to reduce false precision in peer-review scoring.

The chronology makes the architecture clearer. In November 2025, NIH adopted its Unified Funding Strategy, effective with the January 2026 Council round, expressly moving away from rigid paylines and toward decisions that balance peer review with health priorities, scientific opportunities, workforce considerations, portfolio balance, and available funds. (Grants.gov

Then on May 29, 2026, OMB proposed its government-wide rule requiring senior appointees to independently review discretionary awards rather than routinely defer to peer-review recommendations. (Federal Register); 108pp.  Comments closed. 

Now: on August 14, NIH proposes to remove the principal quantitative output of peer review from everybody downstream of the study section. (Grants.gov)

That last point is more substantial than the headline suggests.

  • Today, an R01 might emerge from study section with, say, an impact score of 18 and 2nd percentile. The PI sees it. Program sees it. Institute leadership sees it. Council sees it. Everybody knows that this was an exceptionally highly ranked application.
  • Under the proposal, the reviewers would still score it numerically, and NIH would still calculate the final impact score behind the curtain—but the PI, institution, program staff, ICO leadership and Advisory Council would not receive either that score or the percentile. They would be told merely:

CurrentProposed
Impact score 18, 2nd percentileMost competitive
Impact score 27, 23rd percentileMost competitive
Impact score 31, 28th percentileCompetitive
Below discussion thresholdNot discussed

The first two applications therefore become formally indistinguishable in the information delivered to the people making the funding decision—even though the study section may have regarded one as markedly stronger. 

NIH says this is intentional: exact scores have “imperfect discriminative ability,” and removing them will cause program officials to pay greater attention to critiques and exercise judgment about NIH priorities and portfolio considerations. (Grants.gov)

There are really two stories here

One is a perfectly respectable science-of-peer-review argument. A score of 18 versus 21 isn't a laboratory measurement. Reviewer composition, study-section dynamics and random variation matter; the literature has long questioned whether tiny score differences justify cliff-edge funding decisions. NIH's argument is basically: stop pretending a noisy ordinal judgment is a micrometer. That's defensible, and NIH specifically says that critiques, criterion scores, discussion summaries, and the actual peer-review process remain. (Grants.gov)

But the second story is governance.

NIH isn't merely saying, “Don't fetishize the score.” It proposes to withhold the score altogether from program officials, Institute directors, Advisory Councils, applicants and institutions. That substantially reduces the externally visible constraint imposed by peer review. The old system made departures from review rank conspicuous: Why was a 3rd-percentile application passed over while an 18th-percentile application was funded? Under the proposed system, both may simply read MOST COMPETITIVE.

And that intersects remarkably with the Unified Funding Strategy. NIH already says ICOs should no longer use paylines and should instead integrate scientific merit with institutional priorities, health priorities, workforce, portfolio and financial considerations. (Grants.gov) The new proposal removes much of the numerical information that could constrain—or at least make visible—how far those discretionary decisions depart from study-section ranking.

Then put the OMB May 29 proposal next to it. OMB's proposed government-wide regulation says senior appointees should exercise independent judgment rather than routinely defer to recommendations and explicitly makes peer-review recommendations advisory. (Federal Register)

So I would distinguish intent from institutional effect. The NIH RFI does not say, “We want political appointees overriding scientists,” and it would be overstating the document to describe it that way. But institutionally, the sequence is striking:

  • November 2025: abolish dependence on paylines →
  • May 2026 OMB: emphasize independent judgment of political leadership over discretionary grants →
  • August 2026 NIH: collapse peer-review results into three broad categories and conceal exact scores from downstream decision-makers.

That combination transfers information and discretion away from an easily auditable numerical peer-review ranking and toward programmatic/leadership judgment.

One additional detail caught my eye [writes Chat GPT]: NIH released NOT-OD-26-088 on Friday, August 14—the same day NIH held its previously scheduled public webinar, “Understanding NIH's Unified Funding Strategy: What the Research Community Needs to Know.” (Grants.gov) So this appears less like an isolated CSR housekeeping proposal than another deliberate step in implementing the Unified Funding Strategy.

And there's a terrific blog headline hiding in the mechanics:

NIH Peer Review: The Score Will Still Exist. You Just Won't Be Allowed to See It.

The RFI comment deadline is October 13, 2026. (Grants.gov)

This is considerably more interesting when framed as the third act of the 2025–26 story—Unified Funding Strategy → OMB grant rule → NIH score suppression—rather than as a standalone item that “NIH changes peer review details.” 

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A negative reaction to the NIH RFI - here.

Why CMS MAC Questions for Synuclein Diagnostics Miss the Main Point

This week, on August 20, several Medicare MACs will hold a public session on the literature on alpha-synuclein tesitng for Parkinson's and related disorders (synucleinopathies).  

It's an important opportunity for the neurologic community as most physicians get very little training in neurology.  I suspect as few as ten percent take a full elective month in neurology (they only get a few electives) and once they're off in residency track (surgery, ER, pediatrics, immunology, etc) neurology is far in the rear view mirror. [*]

Questions for the advisory meeting have been posted:

 https://med.noridianmedicare.com/web/jeb/policies/lcd/cac/cac-questions-biomarkers-utilized-in-the-diagnosis-of-synucleinopathies-key-question

While there may be too many questions, and some are repetitive, they seem to question whether diagnostics matter at all in neurology.  Whether diagnosis affects management would usually be out of scope of a specific diagnostic study, and here, there is not one outcome (like "survival" in cancer) but diverse ones across the diverse presentation of disease.   The most important metric for Patient A may be a symptom patient B doesn't even have.

Parkinson's itself has protean symptoms - what other disorder causes both visual hallucinations and foot cramps?  And in between there's swallowing disorders, gastroparesis, orthostatic hypotension, constipation, bladder disorders, balance disorder with falls, restless leg syndrome, insomnia (sometimes to a toxic degree), and others.   In this sense, Parkinson's has protean entry points and outputs, like lupus.

Here's some clarification from Chat GPT:

“Protean” disease is a familiar medical concept, not an argument against the importance of diagnosis. In several classic disorders, the underlying disease is critical to figure out, precisely because a patient may enter the healthcare system through very different symptoms and may require management across multiple organ systems.

Six useful comparators:

  1. Syphilis — the archetypal “great imitator.” Depending on stage and site, it can present with dermatologic, neurologic, psychiatric, ocular, auditory, and cardiovascular disease; neurosyphilis itself ranges from meningitis and cranial neuropathies to stroke, tabes dorsalis, and general paresis. (CDC)

  2. Systemic Lupus erythematosus. One patient may present with arthritis or rash, another with nephritis, cytopenias, seizures or cognitive problems, pleuritis, pericarditis, or vasculitis. NIH explicitly notes that manifestations vary greatly among individuals and can change over time. (NIAMS)

  3. Sarcoidosis. Usually thought of as pulmonary disease, but it can involve lymph nodes, skin, eyes, heart, liver, salivary glands, and the nervous system. Thus two patients with the same underlying granulomatous disease can look almost unrelated clinically. (NHLBI, NIH)

  4. Systemic vasculitis — particularly ANCA-associated disease. Depending on which vessels are involved, presentation can be sinus disease, pulmonary hemorrhage, renal disease, rash, neuropathy/foot drop, eye disease, constitutional symptoms, or gastrointestinal involvement. The very diversity of manifestations makes establishing the unifying diagnosis especially consequential. (MedlinePlus)

  5. Systemic amyloidosis. The same protein-deposition process can manifest as cardiomyopathy, nephrotic renal disease, peripheral or autonomic neuropathy, hypotension, gastrointestinal dysfunction, hepatic disease, carpal tunnel syndrome, or combinations of these. NIDDK specifically emphasizes that different patients have different organs and tissues involved. (NIDDK)

  6. Multiple sclerosis — a particularly useful neurologic analogy. Although confined principally to the CNS rather than being truly systemic, its clinical expression is extraordinarily heterogeneous: optic/visual disease, sensory symptoms, weakness, spasticity, gait and balance problems, pain, cognitive problems, fatigue, and bowel/bladder dysfunction can appear in different combinations and at different points in the disease course. (MedlinePlus)

The analogy to Parkinson's is quite strong. The Australian “iceberg” (pic below) is not simply an advocacy graphic making Parkinson's look complicated. It reflects the fact that PD will simultaneously be a movement disorder, autonomic disorder, sleep disorder, gastrointestinal disorder, neuropsychiatric disorder, cognitive disorder, and bulbar disorder. Hallucinations and foot dystonia [cramps] may indeed belong to the same disease as gastroparesis, orthostatic hypotension, RBD, urinary dysfunction, sudden falls, dysphagia, constipation, and bradykinesia.



That matters directly the somewhat odd premise running through the MAC  questions. MACs acknowledge that synucleinopathies encompass “multiple diseases and a broad array of signs and symptoms,” yet repeatedly asks what useful outcome, if any, could follow diagnosis in the absence of curative (disease-modifying0 therapy.  (And a trial could only pick one or two definitive endpoints; for synuclein diagnostics in early patients, surely that can't be 20-year survival).

In a protean progressive disease, heterogeneity is a powerful reason why diagnosis matters: identifying the unifying disease organizes otherwise disconnected symptoms, directs surveillance, anticipates complications, informs medication and referral choices, and gives meaning to new manifestations as they emerge.

Syphilis, lupus, sarcoidosis, vasculitis, amyloidosis—and PD—would all be vastly harder to manage if medicine insisted that "diagnosis had little value" until there was a curative treatment.

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[*] I have some content knowledge here.  I did a two year postdoc in basal ganglia research before residency, and I spent a month at the PD iinstitute affiliated with the royal neurologic hospital - Queen's Square - in London, before getting board-certified in Neuropathology.

You Can Still Register for "CAC" Meeting on Synuclein Testing (Neurodegeneration)

On Thursday, August 20, 2026, Noridian and some other MACs will hold a listen-only conference on neurodegeneration, specifically, use of alpha-synuclein testing.  This is typically for Parkinson's and related conditions.  The webinar is 2-4 central, 12-2 pacific, 3-5 eastern.

Find the home page here, and see the bar at upper right for "Register."

https://events.teams.microsoft.com/event/8e7d3e2c-b57f-4625-bc2e-32df0234c0d1@d949fb00-e2f5-40e9-a077-ad0421619953

You can also reach that page by going to this webpage and scrolling for Upcoming Meetings and clicking "Registration."  This webpage also has questions-to-be-asked.

https://med.noridianmedicare.com/web/jeb/policies/lcd/cac#upcomingmeetings


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I registered Sunday and got an email with a "join event" link in a minute.  It says Reg is open to 8/20, but I'd suggest not waiting til the last minute.

Noridian made me a calendar invite, but it doesn't seem to hold the link (at least not in my system) so you may need to track the link from the email itself.

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Palmetto GBA, Wellpoint Administrators, and Noridian Healthcare Solutions will host a Multi-Jurisdictional Contractor Advisory Committee (CAC) Meeting via Microsoft Teams Webinar on August 20, 2026, from 2-4pm CT. Discussions will focus on Biomarkers Utilized in the Diagnosis of Synucleinopathies.

The Centers for Medicare & Medicaid Services (CMS) assigned Medicare Administrative Contractors (MACs) the task of developing Local Coverage Determinations (LCDs). The purpose of the CAC meeting is to provide a formal mechanism for healthcare professionals to be informed of the evidence used in developing an LCD and promote communications between the MACs and the healthcare community. The CAC panel will discuss the clinical literature related to Biomarkers Utilized in the Diagnosis of Synucleinopathies. Discussions will occur between CAC panelists and Contractor Medical Directors. 

The public may attend; however, questions from the public will not be entertained.

 

Interested stakeholders are invited to attend via Microsoft Teams; however, advanced registration is required.




Saturday, August 15, 2026

Patient Rights Group Sues AMA Over the "CPT Monopoly"

 AMA CPT was in the spotlight in mid-July, when CMS released a "request for information" that was highly concerned about both the AMA CPT (coding) and AMA RUC (valuation).  Entry point from my blog at the time, here.

Now, headlines that the "Patient Rights Advocate" organization has sued AMA over the CPT "monopoly" (so called).   Find PRA here, find the legal case here, find news at Fierce Healthcare here.


Here's a summary:

  • PatientRightsAdvocate.org has sued the AMA in federal court, seeking authority to publish CPT freely online. The 25-page complaint argues that CPT cannot remain privately controlled because federal and state governments have incorporated it into law and require its use across Medicare, Medicaid, HIPAA transactions, and much of healthcare billing. Alternatively, PRA argues that free nonprofit publication is fair use and that AMA’s copyright remains unenforceable because of earlier copyright misuse. 
  • The case arrives only a month after CMS, in its July 2026 Physician Fee Schedule RFI, explicitly questioned AMA’s CPT licensing monopoly and the related CPT/RUC payment processes. 
  • Sen. Bill Cassidy has separately attacked the “government-backed monopoly” and licensing fees. 
    • Both developments were reported unusually quickly and prominently by Dan Diamond at the Washington Post
  • A sweeping invalidation of CPT copyright is uncertain, but narrower victories—especially fair use, mandated free access, or revised federal licensing—appear considerably more plausible.
  • .
  • Chat GPT did an online search and summary about the moving party, the P.R.A.  Its results are here.    See the online 20-page PDF version of this story >> here << .

Friday, August 14, 2026

AI Guest Author: How Far Away Are AI-Generated Path Reports? Closer Than You Knew! (Ver2)

 Only seven days ago, we published a white paper asking, “How Far Away Are AI-Generated Pathology Reports?” Since then, we encountered several important papers, commercial programs, and industry reports that we had not incorporated in the original review—and they materially change the answer. In particular, current prostate-biopsy AI is considerably closer to assembling and prepopulating a pathology report than we had appreciated. We therefore went back to the evidence and substantially revised the white paper. The original August 7 version is available here; the new August 14 edition reflects this much more advanced pathology landscape.

Find the new paper: >>   here   <<



Summary

Medical imaging AI is moving beyond detection and measurement toward systems that assemble the diagnostic work product. The clearest regulatory example is DeepHealth SMART-B, an FDA-cleared breast ultrasound system that analyzes lesions and generates report findings and impressions for radiologist review. Pathology is approaching the same boundary faster than expected, particularly in prostate biopsy. Current commercial systems can identify cancer, assign Gleason patterns and Grade Groups, measure tumor length and percentage involvement, and transfer structured results directly into reporting interfaces. European products from Aiforia and Ibex already describe first-read and automated-reporting workflows, while U.S. FDA authorizations remain more conservative and largely adjunctive or second-read.

Research systems push further. HistoGPT generates dermatopathology reports from whole-slide images; TITAN and PRISM2 demonstrate report generation or completion of structured pathology fields. Importantly, the first useful pathology reports may not require an unconstrained language model. A validated image-analysis stack can produce structured diagnostic facts, and a deterministic template can convert those facts into an editable draft linked to supporting image evidence. The remaining barriers are less about fluent writing than reliable case assembly, uncommon findings, laboratory variability, workflow integration, safety, provenance, and FDA authorization. Prostate needle biopsy may be the first major U.S. test case.

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See a Linked In essay by Jonathan Govette about the importance of AI actually drafting diagnostic reports - here.

Also at Linked In, Branko Perunovic discusses how the powerful digital platforms will in turn transform the nature of the departments that use them - here.

Also from Agatha Krason here.

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Update here:

Update.   FDA has approved machine learning software (de novo) to diagnose Parkinson's from alternative disorders. "neuropacs"  Press here.  Vallaincourt, JAMA Neurol 3/2025.


AI Guest Author: A New White Paper, The Ten-Year Outlook of Pathology and AI

This week, I ran across an interesting article in Modern Healthcare on radiology, AI, and rural hospitals.  And that led to a new 22-page report from BAAI on the ten-year outlook of AI in radiology and how it could affect the field as a profession.

I put those together with about ten other sources and asked Chat GPT to write about the ten-year outlook for AI in Pathology.   Find it here:

https://drive.google.com/file/d/1zH3ALNo3PaeEw9QAOUxP429Rk0cR3GUm/view?usp=sharing



CMS NTAP: CMS Didn't Kill Breathrough Status, But Gave It a Leave-By Date

 For several years, CMS granted a special easier review path for new devices that had breakthrough status, and who wanted NTAP (hospital extra payment) or the equivalent in OPPS.

In Inpatient rulemaking released around August 1, CMS didn't kill the BT pathway, but gaved it a timed closure date.  You still get the easy road if you get BT from FDA by 9/30/2026, and if you get FDA approval by 5/1/2028.

9/30/2026 isn't coincidental, it gives you 60 days notice from August 1, and it is the day before the new Fiscal Year for FY policymaking.

Steve Farmer, a physician who held a senior role at CMs, discusses in detail at Linked In. And, they link to an even longer article.

https://www.linkedin.com/posts/activity-7493659447328927744-fBZl


For even more detail:

https://www.linkedin.com/pulse/breakthrough-reimbursement-shortcut-didnt-disappear-brown-md-mba-zldwe/


And a separate group discussing BT and NTAP, see David Davis here.