Wednesday, September 9, 2026

You Better Learn the Biggest Myth About Payor Coverage of Diagnostics

 

"The Coverage Myth in Diagnostics"

In an interview, I was asked, "What's the biggest myth you hear repeated?'  

That led to the (AI assisted) essay below.  

For entry points, here, here, here, here.  Traditional view of "the payer mind" here and here (both POC).  ADVI on need for integrated planning here

So I maintain that the rare case is a specialty lab meets with a payor, the payor listens carefully, and they "win" unexpected coverage for that one test, that one payor.  i'd say: it's a myth, don't hold your breath.  But of course, there are exceptions!  For example, UHC comes out early for doverage of Guardant Shield here.   C2N gets Anthem coverage for its ALZ test ... here. (Note, that latter "coverage win" is tied to broader Anthem coverage of Tau-217.)



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The Biggest Single Coverage Myth in Diagnostics

There is a comforting myth in diagnostics reimbursement: that coverage is a rational contest, conducted by serious people, in which the best evidence wins. In this myth, the startup publishes several good papers, writes a strong PowerPoint deck, secures a payer medical-director meeting, brings along one or two respected KOLs, and the payer thoughtfully concludes that the test is clinically valuable and should be covered.

That world may exist in every pitch deck. It rarely exists in real reimbursement.

The reality is far more institutional, slower, and less responsive to scientific persuasion than investors want to believe. 

In molecular diagnostics, the practical route to coverage usually requires one of two things: either the lab benefit manager decides to approve the test, or major clinical guidelines make the test effectively required. Both pathways are very slow. Both are opaque. Neither is well suited to a startup running on a finite cash runway.

The problem is not that evidence does not matter. Evidence matters a great deal. But evidence is not self-executing. A publication does not automatically become a policy. A favorable KOL quote does not become a claims edit. A well-designed clinical utility study does not force a lab benefit manager, MolDx, a MAC, a commercial payer committee, or a guideline panel to move on a venture-backed timeline.

This is where investors often misprice diagnostics. They build reimbursement timelines as if each step takes six months: six months for coding, six months for evidence, six months for payer engagement, six months for coverage. But novelty does not move through the system like a Gantt chart. Novelty gets bogged down. Two or three years is not a disaster scenario; it may be the optimistic scenario. Five years is not unheard of. For some technologies, the system simply times-out again and again.

Examples are everywhere. 

  • I saw an improved imaging test for osteoporosis and bone-density screening became tangled in CMS processes for years. 
  • National coverage decisions can sit for three, four, or more years. 
  • MolDx and other MAC processes, including Noridian, can take years to resolve novel technologies. 
  • The automated retinal imaging code 92229 illustrates the same pattern: coding arrived in 2019, publication followed in early 2021, but payment and RVU issues dragged on because software novelty did not fit comfortably into existing physician-fee-schedule machinery. 
    • By 2024 - there were 5000 Medicare sales for $200,000 ($40/each).
  • The test may be useful, the clinical logic may be strong, and the code may exist — yet the reimbursement system can still stall.

The same warning now applies to computational pathology. For stakeholders in this vibrant new field, AMA CPT appeared to impose what felt like a moratorium on new codes for two years or more. Then, instead of continuing the earlier PLA-code pathway used by some whole-slide imaging and digital pathology tests, CPT shifted new computational pathology services into Category III codes. That may be defensible as coding policy, but from a business-planning perspective it leaves companies in limbo. CMS pricing is still up in the air: will these services be paid on the Clinical Lab Fee Schedule, through physician-fee-schedule RVUs, through contractor pricing, or through some future software-specific payment system? For a startup, that uncertainty is not an academic detail. It can determine whether the product is commercially viable.

The Deeper Lesson

The deeper lesson is that coverage is not merely an evidence review. It is an operating system. It includes coding, payment, benefit-category logic, medical-necessity language, claims edits, utilization management, guideline incorporation, payer committee cycles, lab benefit managers, MAC jurisdictional variation, and sometimes CMS national policy. Any one of those components can delay or defeat a test.

Don't Use "A Fairy Tale" for Planning

This makes the standard market-access fairy tale dangerous. It encourages startups to believe that if they are scientifically right, the system will eventually recognize them in time. But “eventually” is not a business model. A company with $10 million, or even $30 million, may not have enough runway to survive a multi-year reimbursement slog, especially if the product requires continued evidence generation, field sales, KOL cultivation, coding work, payer engagement, and operational claims support.

The most important reimbursement question for a diagnostics investor is therefore not simply, “Is the test good?” It is: “Who has to say yes, through what mechanism, on what timeline, and can the company survive until then?”

In diagnostics, the best test does not always win. The test that wins is the one that becomes operationally unavoidable — through guidelines, through lab benefit manager approval, through entrenched clinical workflow, or through a payer system that finally knows how to pay for it.

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tagmyth

AI Corner: The strange path to remote monitoring coding, and the latest twist

 Somone asked me about the "complexified" coding of remote monitoring, a current hot topic at CMS.

I'm not a native expert, so I asked Chat GPT for some orientation.  As below.

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From Holter to Remote Monitoring: How a Simple Coding Logic Produced 17 Codes—and Why CMS May Collapse Them to Four

The current RPM and RTM code families can appear bewildering to anyone entering the subject for the first time. By 2026, the portion of the Medicare remote-monitoring universe now under CMS review comprises 17 separate CPT codes. Taken together, they distinguish initial setup, device supply, duration of monitoring, type of therapeutic monitoring, and different increments of professional management time. 

  • In the CY 2027 Physician Fee Schedule proposed rule, CMS is now asking whether that elaborate architecture should be replaced, for Medicare payment purposes, by just four G-codes. (public-inspection.federalregister.gov)

That apparent complexity has a fairly simple origin. Monitoring has long been treated as a service that can be divided into recognizable economic components: someone starts the patient on the service and explains the device; someone supplies the technology and acquires the data; someone processes or organizes the information; and a physician or other professional reviews it and acts on it. Those functions may occur at different times and may be performed by different entities.

The idea predates contemporary digital health by decades.

Holter Monitoring as the Historical Template

Traditional ambulatory ECG monitoring provides the cleanest example. The current Holter family, 93224–93227, first appeared in CPT in 1990. The wording has changed over time, but the underlying structure has endured for roughly 36 years. (codingahead.com)

CPT 93224 represents the global Holter service. The component codes divide that global service into distinct activities: 93225 for recording, including connection and disconnection; 93226 for scanning analysis and report; and 93227 for physician or other qualified health professional review and interpretation. Medicare continues to recognize this same division. (cms.gov)

This differs from the usual radiology convention. A radiology service ordinarily has one CPT code, and its two economic pieces can be identified by appending -TC for the technical component or -26 for the professional interpretation. Holter coding does not rely on that convention. CPT supplies separate component codes, and Medicare expressly instructs contractors not to use -TC or -26 with the Holter family. (cms.gov)

The reason is easy to see operationally. One practice might connect the monitor and instruct the patient. A separate organization might receive the recording and perform the technical analysis. A cardiologist might perform the professional interpretation. The code set permits each component to be identified separately, while still allowing a single global code when one organization furnishes the whole service.

That same logic survived the transition to newer ambulatory ECG technology. When CPT created codes for extended continuous ECG monitoring, including modern patch-monitor systems such as Zio-like services, it again separated recording, technical analysis, and professional interpretation. CMS itself referred back to the existing 93224–93227 Holter family when valuing the newer extended-monitoring codes. (cms.gov)

The hardware therefore evolved much faster than the coding philosophy.

The Odd Medicare Rule for ECG Interpretation

ECG coding also sits on top of an unusual provision of Medicare law.

Section 1848(b)(3) of the Social Security Act requires the Secretary of Health and Human Services to make separate payment for the interpretation of electrocardiograms when the ECG is performed or ordered in conjunction with a physician visit or consultation. At the same time, Medicare must remove the corresponding interpretation work from the relative value of the visit so that the same work is not paid twice. (ssa.gov)

The statute doesn't command CPT to create an interpretation-only code. It is a requirement for separate Medicare payment, not a statutory specification of coding mechanics. Still, ECG coding fits that requirement neatly. A routine 12-lead ECG has a global code, a tracing-only code, and a dedicated interpretation-and-report code rather than depending only on the generic -TC and -26 modifiers.

Bonus: The Topsy Turvy History 

The history is unusually convoluted. 

In the Omnibus Budget Reconciliation Act of 1990, Congress initially adopted essentially the reverse rule: when an ECG accompanied a physician visit, Medicare generally was not to make separate payment for the interpretation. (uscode.house.gov

Congress changed direction in the Omnibus Budget Reconciliation Act of 1993. From 1993 forward, Medicare law requires separate payment for ECG interpretation. The current U.S. Code preserves both the present rule and the history of the earlier language that barred such separate payment. (uscode.house.gov)

That statutory change did not produce the Holter family; 93224–93227 were already present in CPT in 1990. But it fits comfortably with a broader Medicare tradition in which the technical production of ECG information and its professional interpretation are treated as distinct services.

That is useful context for RPM and RTM. Separating monitoring into setup, technology, data acquisition, and professional work is not a newly invented digital-health payment theory. It is a familiar coding concept being applied to a newer kind of longitudinal care.

The Same Logic, Applied Over a Month

RPM and RTM are clinically different from Holter monitoring, but structurally they are close relatives.

RPM generally concerns remotely acquired physiologic information such as blood pressure, weight, pulse oximetry, or respiratory parameters. RTM occupies a somewhat different space, including monitoring of therapy adherence, therapy response, and therapeutic intervention, with device-supply codes divided into areas such as respiratory, musculoskeletal, and cognitive behavioral therapy monitoring.

The crucial difference is that Holter monitoring is usually an episode. The patient wears the device for a defined interval, data are recorded and processed, and the physician interprets the result. RPM and RTM are typically longitudinal management services. The device may remain with the patient, data can flow repeatedly during the month, clinical staff or professionals may communicate with the patient, and management may continue month after month.

Even so, the correspondence is easy to recognize:

Coding function"Traditional" Holter monitoringModern RPM/RTM
InitiationConnection, recording setup and patient instructionInitial device setup and patient education
Technology/dataRecording and technical processingDevice supply, data recording/transmission and monitoring infrastructure
Professional workReview and interpretationReview, patient interaction and treatment management
Complete serviceGlobal Holter code availableMultiple recurring components currently billed separately; CMS is considering rebundling them

The newer code families add another dimension that traditional Holter coding largely does not: time. Holter coding mainly asks what part of the service was performed and by whom. RPM and RTM also ask how many days of monitoring occurred and how much treatment-management time was furnished during the month.

Why the Code Family Kept Growing

The present 17-code structure did not appear all at once. It accumulated through individually plausible distinctions.

There is a setup code because patient onboarding is an initial service rather than a monthly recurring activity. Device-supply codes recognize the cost of hardware, connectivity, and data infrastructure separately from professional management. Treatment-management codes recognize time spent reviewing information, interacting with the patient, and adjusting care.

RTM then adds another layer because its device-supply services are separated according to the therapeutic domain being monitored.

CPT added still more detail in 2026. Previously, the principal device-supply codes generally contemplated 16–30 days of monitoring within a 30-day period, and the principal treatment-management codes generally began at 20 minutes per month. Effective in 2026, CPT introduced shorter-duration alternatives. RPM gained 99445 for 2–15 days of device data and 99470 for the first 10 minutes of treatment management. RTM gained 98984–98986 for 2–15 days of device data in different therapeutic categories and 98979 for the first 10 minutes of treatment management. (apma.org)

Each change can be defended on its own. Twelve days of legitimate monitoring may require meaningful resources. Ten minutes of actual clinical management is still professional work. Different RTM applications may use different devices and carry different costs.

The difficulty appears when all of those reasonable distinctions are multiplied together.

By 2026, the set CMS is now examining contains 17 CPT codes: seven RPM codes and ten RTM codes. Across the family, CPT distinguishes setup, shorter versus longer data-collection periods, 10 versus 20 minutes of initial management, additional time, and—in RTM—different therapeutic applications. (public-inspection.federalregister.gov)

This is a familiar coding paradox. Added precision is readily justified one decision at a time; the final matrix can nevertheless become much more complicated than the clinical service it is meant to describe.

CMS Considers a Much Simpler Model

The CY 2027 Physician Fee Schedule proposed rule begins to move in the opposite direction.

CMS has made several formal proposals involving the existing RPM and RTM codes. These include requiring a separately reportable initiating visit when remote monitoring begins, limiting RTM to established patients, restricting payment for certain services furnished by contracted rather than practice-employed clinical staff, and revising practice-expense values because CMS believes some remote-monitoring devices may now be less costly than initially estimated. (cms.gov)

Beyond those proposals, CMS is also considering something more fundamental. It is soliciting comment, rather than yet formally adopting a replacement coding system, on whether the 17 existing RPM/RTM CPT codes should be bundled into only four HCPCS G-codes. (public-inspection.federalregister.gov)

Under the concept CMS describes, GRPM1 would cover initial RPM setup and patient education, while GRPM2 would cover the recurring monthly RPM service, combining device supply and data transmission with treatment management. GRTM1 and GRTM2 would provide the parallel structure for RTM.

The contemplated monthly RPM code illustrates how much bundling CMS has in mind. CMS describes a monthly service that would include device supply, at least two days of transmitted data, treatment-management services, at least one real-time interactive communication with the patient or caregiver, and at least 20 minutes of management time. (public-inspection.federalregister.gov)

The four-code model would therefore preserve only two principal distinctions: RPM versus RTM, and initial setup versus ongoing monthly service. Most of the present subcategories would disappear.

The Policy Issue Is Larger Than Administrative Simplification

CMS is not interested in consolidation merely because 17 codes are cumbersome.

The agency expressly points to the proliferation of remote-monitoring codes and to findings from the HHS Office of Inspector General. OIG reported that about 43% of Medicare beneficiaries receiving RPM did not receive all three principal components of the service. CMS cites that finding in explaining why the current code structure may not fully ensure that beneficiaries receive remote monitoring as the integrated service policymakers intended. (public-inspection.federalregister.gov)

That finding exposes the tradeoff inherent in component coding.

Separating a service into billable parts can be highly useful because payment can follow the entity actually performing the work. But once each element becomes separately billable, Medicare may find itself paying for individual pieces of a clinical process without necessarily purchasing the complete process.

The contemplated G-codes would shift the unit of payment. Instead of separately purchasing technology, data, and treatment-management pieces, Medicare would move closer to paying for an integrated month of remote monitoring that includes the technology, transmitted information, patient interaction, and clinical management.

That is a more consequential change than simply reducing the number of billing codes.

A Coding Pendulum

Viewed over several decades, the history forms a recognizable progression.

The Holter system established the value of separating important components of a monitoring service. RPM and RTM extended that approach to longitudinal care, separating setup, device supply, monitoring duration, professional time, and therapeutic category. Over time, component coding became increasingly fine-grained.

CMS is now testing the opposite proposition: perhaps some of those distinctions are no longer worth preserving for Medicare payment.

The emerging sequence is therefore straightforward:

Holter: divide a monitoring test into its major technical and professional components.

RPM/RTM: apply that component logic much more finely to an ongoing digital service.

CMS 2027 concept: combine most of those pieces again and pay for a more complete monthly service.

Seen in that light, today's code proliferation is not simply the product of inexplicable coding bureaucracy. The individual codes grew from a legitimate and longstanding idea: different work should be separately identifiable when different parties may perform it or when the resources differ.

The harder question is where that process should end.

For a Holter service that has been coded in component form for roughly 36 years, separating recording, technical analysis, and professional interpretation remains easy to understand. For recurring remote care that combines a device, transmitted data, patient communication, and treatment management, CMS is now asking whether the better unit of payment is not each constituent part, but the month of monitoring care as a whole.

 

Monday, September 7, 2026

AI Guest Author: A New Report on Better External Control Arms via N-Power Medicine Series B

 

I saw a headline that N-Power Medicine, which promises new ways to do oncology trials, had raised $32M by large investors, including LabCorp.   Their game is a next-generation approach to "external control arms," or ECAs, for clinical trials.   I've run across ECAs at regular intervals, and I asked Chat GPT to provide me an update, in the form of a report.

Happy to share it - find it here:

https://drive.google.com/file/d/178h4Q4oenGRBVp-z-9lcH1M3FVnxndSx/view?usp=sharing




Sunday, September 6, 2026

Humor: From Cocktail Napkin Scribble to Sophisticated Diagram

Last week, I published a white paper arguing that the "transformation event" in digital pathology will be when  AI can read slides, and write reports, and present them for validation to the pathologist.   (FDA has recently approved software that can do this for certain applications within radiology, while saving 40% of radiologist time to review rather than write.)

Blog here.  ("Is digital pathology close to a billion-dollar explosion in value?")  For more about advances in pathology reporting by AI, blog here. ("How far away are AI generated path reports? Closer than you knew!")

Stage 1; A few days later, a graphic occurred to me and I scribbled it down to remember it:



Stage 2.  I spent a few minutes making a powerpoint crude mock up of my idea:


Stage 3.  Here is the AI (Chat GPT0 graphic design, after a few comments and tweaks by me.

The idea is that in current digital pathology, the lab proudly presents the pathologist with a sharp clear DICOM image on the monitor.  He then reviews the case, types or dictates a report, and signs it out.  The result, on a good day, is level 2 or maybe 3 on a hierarchy of report quality (Srigley report level, 1 to 6). Click to enlarge.



The new vision is that in certain areas  such as prostate needle biopsies - the AI will soon read the slides, write the report, and present to the pathologist to validate, verify, sign out.  The report is ALWAYS a Srigley level 6 (ICD10 perfect, SNO-MED perfect, etc).  


Draft:  Prostate needle biopsy has 7 cores, measuring 1x4mm to 2x10mm.  Four cores have tumor.  Tumor area is 30% in total.  Gleasan grade is 7 (4+3).   Perineural invasion is seen at two points (highlighted).  

Or side by side:



Or with annotation:



AMA Lab Code Application Revisions are Large and Important

Header: Tab 94 for the next AMA CPT Editorial Meeting proposes massive revisions to the code change application (CCA) for laboratory/pathology services.   You may want to track - and you can!

##

See the webpage for the AMA CPT September 17-18 meeting here.

See the public agenda here.  Tab 94, code change application (for the laboratory-pathology Category I, III codes).

The request deadline for pathology issues and also for non-pathology issues is September 16, although the comment deadline was August 10 for non pathology issues and in July for pathology issues.  (Here).  

Late-Breaking September 4 Updates!

  • An updated revision to Tab 94, called "Ballot C," was posted by AMA on September 4.
  • Also, AMA announced a 7 am meeting on September 17 to discuss the Path-Lab CPT application changes.

I Can't Explain, But I Can Hint at the Importance

The changes to pathology-laboratory code applications are LARGE and IMPORTANT.  They are nearly impossible to read, due to the heavy layers of markeup.  I made a very clear and clean AI version of the changes, with useful annotations, but I don't believe it can be circulated.

However, here below is the header about the changes, as found in the AI document I can't circulate: Click to enlarge.  While you can't get "this" (my 16 page insightful AI pdf) you can get the (hard to read) Ballot C from AMA until September 16, by following instructions in the meeting agenda pdf.

Click to enlarge:



According to AI, change topics at Ballot C include:

1. FDA LDT Framework
2. AI documentation in 3 paths
3. Changes ini dedicated CLIA questions
4. Consolidate redundant text but be careful
5. Evidence and utilization questions
6. Tie literature to claims, procedures
7. Other edits e.g. MAAA codes

AMA's Appendix S: Don't Incorporate Into Code Decisions Until it is Fixed

Header:  As we prepare for the September AMA CPT meeting in Minneapolis, one proposal brings new "Appendix S" strongly into the Category I, Category III Code Change Application (MSP Tab 94).  But "Appendix S" has major flaws as a classification architecture, and it should be fixed before importing it any further into CPT operations.  A new 10-page white paper explains it all.

SUMMARY

AMA's 2027 Appendix S is an important attempt to create stable terminology for software-enabled CPT services, but its three familiar categories remain logically unstable because they combine several different classification axes. 

This paper shows why even a simple three-question decision tree fails under the present definitions, then proposes a clean-sheet replacement: neutral Class I, Class II, and Class III categories built from exclusive rules and validated empirically before publication.

  1. Why Appendix S Matters
  2. What the 2027 Revision Gets Right
  3. The Central Design Problem: Vocabulary Came Before Logic
  4. What a CPT Taxonomy Must Be Able to Do
  5. The Minimalist Three-Question Test
  6. Why the Minimalist Matrix Fails Under the Current Appendix S
  7. The Failure Reveals the Real Problem: Multiple Classification Axes
  8. Case Study: A Molecular Test at the CPT Deadline
  9. The MAAA Problem: Development Method Is Not Runtime Function
  10. The Lower Boundary: Risk, Scores, and Mathematical Simplicity
  11. The Highest Boundary: Radiology, Laboratory Medicine, and Final Results
  12. Why the Current Experience Argues for a Clean-Sheet Numbered System
  13. Proposed New Taxonomy: Class I, Class II, Class III
  14. A Minimal Decision Procedure for the New System
  15. Keep Human-Control Architecture Separate from the Three Classes
  16. Validate the Taxonomy Empirically Before Publication
  17. Conclusion: From Negotiated Vocabulary to a Tested Classification System
Download the white paper HERE.




Thursday, September 3, 2026

Humor: Sorry We Have No Design Suggestions

Sorry, We have No Design Suggestions For This Slide.

(click to enlarge)




FDA is Really Doing It: Downclassify CDx based on ISH-FISH (August 2026)

 

FDA Quietly Moves Oncology ISH/FISH Companion Diagnostics From PMA to 510(k)

A Biden-era deregulatory promise survives the LDT court loss — and continues under the Trump FDA

On August 17, 2026, FDA did something that should matter to almost anyone following oncology companion diagnostics: it reclassified a defined family of oncology in situ hybridization (ISH) companion diagnostic tests from Class III/PMA to Class II/510(k)

The category includes important FISH applications as well as chromogenic ISH. The final order becomes effective September 16, 2026 [eg at 30 days]. FDA/Federal Register: August 2026 Final Order

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Kudos to Julie Ramage for highlighting this news on Linked In - here - it's gotten little trade press so far.  The big picture - the August 2026 final rule for FISH, finishes a June 2025 proposal.   A broader November 2025 proposal is still waiting for its release as final.

MolDx Issues Bonanza of New LCDs in Late August 2026

 MolDx issues a bonanza - a triplet - of new proposed LCDs.

Two provide defined coverage.  One general NGS LCD for heme malignancies,  one for whole genome mapping in heme neoplasms.

The renal biomarker LCD finds that there is much activity in the field but that the power or utility of the stratification biomarkers do NOT yet meet MolDx standards for coverage.  Expect brisk comments or updated literature.  (The request is dated 2022. Some citations go to 2025.  Guidelines are cited.)

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Wednesday, September 2, 2026

MolDX MACs Delay Finalization of Prelude DCISion-RT LCD

MolDx released a draft non coverage LCD for the DCISion-RT test last year, and it's not finalized yet.

It may be a while: they've announced an official delay.

https://www.cgsmedicare.com/parta/pubs/news/2026/07/news-206951.html

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July 13, 2026

Notice Regarding MolDX: Biomarker Testing for Risk Stratification in DCIS (DL40246)

Medicare Administrative Contractors (MACs) carefully considered all feedback received from interested parties regarding proposed Local Coverage Determination (LCD) DL40246: MolDX: Biomarker Testing for Risk Stratification in DCIS.

Given the impact of this determination, MACs will delay finalization of the proposed LCD issued on 7.17.2025. Additional information will be forthcoming in the following months.

#####

Here's what GOOGlE automatically offered as a summary of the state of play when I googled the topic;

The Backlash & Editorial Responses
  • Corporate Resistance: PreludeDx’s CEO publicly criticized the draft policy, pointing out that DCISionRT has over a decade of use, more than 10 published studies, and backing from breast cancer specialists. [1]
  • Patient and Provider Advocacy: Patient advocacy groups (such as Learn Look Locate) and oncologists launched public campaigns, petitions, and formal commentary pushes. They argue that withdrawing coverage takes away a vital tool for personalized medicine, potentially forcing thousands of women into undergoing expensive, unnecessary, and invasive radiation therapies. [1, 2, 3, 4]
  • Clinical Arguments: Supporters emphasize data from trials like the PREDICT registry, which showed that DCISionRT results changed radiation treatment recommendations for roughly 42% of patients, leading to a net reduction in over-treatment. [1, 2]
Google also cited my blog:

  • The "Rhetorical Proof" Critique: In its editorial guidance and teaching rationales, MolDX criticized reliance on "decision-support narratives". They stated that using a test merely to provide peace of mind or reassure a patient about skipping radiation ("rhetorical proof") is insufficient for Medicare coverage without statistically robust, multi-factor validation.


OPPS Rule: Ditching Digital Pathology from CLFS and CLIA? Stakeholder Organizations Comment

(Rapid AI Blog)

This summer, in both OPPS and PFS proposed rules, CMS proposed to "nix" software-intensive lab services from the CLFS and perhaps even from CLIA.  (Concurrently, but no coincidence, CLIA held a Request for Information on moderning CLIA, including open-ended questions about the status of digital-only and software-intensive services.)

This is a 180-degree position relative to AMA CPT (and CAP at AMA) which requires CLIA licenses, letters from CLIA medical directors, etc., for these software-intensive lab services.  See: 180 Degrees.

Below, see summaries of the comments of several major organizations.  

At bottom, you'll find links to each PDF, and a link to additional AI analyses.  Also at bottom, you'll find a short supplement that updates us on the remarks of AdvaMed and of DPA Digital Pathology Association.

Tuesday, September 1, 2026

Is Digital Pathology Close to the BIllion-Dollar Explosion in Value?

Mini Summary:

Structured pathology reporting is quietly laying the groundwork for AI-generated reports. We argue that this will transform digital pathology from image digitization into a productivity engine—and triggering its long-awaited billion-dollar hockey stick for digital pathology.  Find the white paper here.

Full Summary:

Digital pathology has largely been evaluated at the front end of the workflow: converting glass slides into digital images and selectively adding algorithms that detect, measure, or classify features. This paper argues that the more consequential endpoint lies at the opposite end—when digital systems can assemble much of the finished pathology report.

The thesis builds on two six-level frameworks. 

  • Fryback and Thornbury asked whether diagnostic technologies ultimately improve clinical decisions, outcomes, and societal value. 
  • Ellis and Srigley described the evolution of pathology reporting from narrative prose to structured, computable, interoperable data. AI now connects these two traditions. Structured pathology data can be transformed into draft reports, while image-analysis systems increasingly generate the findings that populate those reports.

A related proposal from Lennerz and colleagues envisions the pathologist as a “diagnostic architect,” integrating morphology, genomics, imaging, clinical information, and computational outputs. AI-assisted report generation could create the capacity for that higher-order role.  

The paper therefore proposes an emergent “seventh level”: not another reporting standard, but an economic inflection point where structured data, AI, and workflow integration transform digital pathology into a major productivity engine.  Find the white paper here.


click to enlarge



See PDF in cloud here.

I also have a version written by Claude Opus; each has its  pro's and con's; hopefully I'll see how to merge into a best product at some point.  Claude version here.

Sunday, August 30, 2026

You've Never Seen This: The CMS Digital Pathology Rule as Exciting "Harvard Case Study"

 New from Discoveries in Health Policy (DHIP)

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This DHIP Case Study uses the Harvard Business School approach to make an unusually dense Medicare policy dispute come alive through personalities, institutional stakes, and a real-time strategic dilemma. 

In this fictional case, Jill Tillman, newly promoted at CAP, must respond by August 31—before seeing how other stakeholders have lined up. CMS would move computational pathology out of the clinical laboratory framework and into SaMS, threatening CAP’s leadership across CLIA, digital pathology, and CPT. 

Her choices—cooperate, confront, build a coalition, seek legislation, or prepare for litigation—carry consequences far beyond reimbursement.

###

see what happened on September 2 here.

###

See the business school case study here;

https://drive.google.com/file/d/18Do5Yu4EEbzWE6vkYIOb86c1nOgMhEMM/view?usp=sharing



Wednesday, August 26, 2026

Piling on to Software as a service; MEDPAC Plans

 Everyone's piling onto Software as a Medical Service (SaMS), and related terms.  AMA CPT has been working on its Appendix S software coding paradigms.  CMS in July offered radical changes to come, beginning with a new acronym, SaMS.   Now the advisory body MEDPAC piles on.

Here's  how Google Gemini summarizes some new MEDPAC initiatives:

  • The MEDPAC agenda specifically highlights ongoing work to analyze Medicare’s payments for Software as a Medical Service (SaMD) and Prescription Digital Therapeutics (PDTs).
  • MedPAC breaks this digital health framework into two distinct buckets: 
    • SaMD / Software as a Service (SaaS): Algorithm-driven software designed to aid clinicians in diagnostic decisions or clinical assessments (e.g., AI image analysis, computational pathology, diagnostic algorithms).
    •  While Medicare has paid for some SaaS tools under fee schedules or inpatient new technology add-on payments (NTAP), MedPAC continues to question whether current relative values accurately reflect true costs.
  • Prescription Digital Therapeutics (PDTs): Patient-facing software applications delivered via personal devices to treat illness or injury. Because most PDTs do not fit into traditional Medicare benefit categories (like Durable Medical Equipment), coverage remains severely limited.
  • (MEDPAC is not using CMS's latest summer-2026 terminologies.)

See the MEDPAC agenda here:

https://www.medpac.gov/medpacs-analytic-agenda-for-the-2026-2027-meeting-cycle/


Revisited: CAP and CMS Go in Opposite Directions on Digital Pathology

In July rulemaking, in both OPPS (hospital outpatient) and Physician (aka Part B) proposed rules, CMS announced it will evict digital pathology / computational pathology services from CLIA services, and therefore strip them of their position on the Clinical Laboratory Fee Schedule.

Whether you love or hate CLIA, love or hat the CLFS, my reading of the SSA 1834A PAMA statute is that "clinical laboratory tests" go on the CLFS, and there is no mention of exceptions.  On the other hand, if a service is not a clinical laboratory service (the CL in CLIA), it can't go on the CLFS.

So, as far as I can tell, the only way CMS can reach its goal of tossing digital pathology out of CLFS, is to toss it out of CLIA.

But this is 180 degrees opposite CAP and CPT.  CAP and CPT are looking to have MORE CLIA requirements for computational pathology - copies of CLIA licenses, special letters from CLIA lab director to CPT, etc.  

On this theme, I asked Chat GPT if it could find documentation where CAP clearly places computational pathology under CLIA (and CAP-CLIA inspections, etc.

AI came back with alot.  If you want to comment to CMS, that computational pathology is a CLIA service, which CMS is directly denying, here are some bricks and stones you can throw.

This blog concludes with a model letter -- though too long -- to CMS about SaMS and CLIA and digital pathology.