Wednesday, September 16, 2026

Can AI Get PAMA News From Investor Calls?

I asked both CLAUDE and CHAT GPT to scan recent lab industry investor calls for PAMA news and predictions.   I include CLAUDE below; the two were similar.   I include a cloud link to Chat GPT here.

This is direct AI output, offered as-is, I have not checked against original transcripts or audio files.

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CLAUDE Opus

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Please research public calls like investor calls for Carius, Tempus, Guardant, Natera, GenEDx, Neogenomics, Labcorp, and Quest, for evidence of specific remarks on PAMA pricing and how it might change their Medicare pricing and financial outlook.   Use investor calls around August 1 (July 15-August 30) reflecting the quarter ending June 30, 2026.     i am interested in specific quotes, for example, I understand that CARIS made a specific quote that its ASSURE test price would rise with the current PAMA cycle.  Provide specific links and quotes.

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PAMA on the Q2 2026 Earnings Calls:
What Eight Lab Companies Said About Medicare Pricing

The summer 2026 earnings season fell during the long-delayed PAMA private-payor data reporting cycle. The Consolidated Appropriations Act of 2026 postponed CLFS rate cuts until January 2027 and required laboratories to report first-half 2025 data during a mandatory window from May 1 to July 31, 2026. CMS will use that data to set CLFS rates for 2027–2029, with annual reductions for each test capped at 15%. No preliminary CY2027 rates appeared to be public as of mid-September.

This review covers calls for the quarter ending June 30, 2026, held between late July and early August, for Caris Life Sciences, Tempus AI, Guardant Health, Natera, GeneDx, NeoGenomics, Quest Diagnostics, and Labcorp. The companies split into three groups. Quest and Labcorp framed PAMA as a downside risk to be managed through legislation. Tempus and Guardant described Medicare price increases arriving through ADLT designation. Caris stood out as the one company projecting that the ordinary CDLT reset would raise its price. Natera and GeneDx did not address PAMA in the material reviewed.

Most full transcripts cited here are AI-generated and editor-reviewed by third-party services such as Investing.com and Benzinga. Speaker labels occasionally contain errors, and quotations should be verified against company webcast replays before further use.

Caris Life Sciences (August 5)

The most specific PAMA remark of the season came at the very end of Caris's Q&A. An analyst asked whether Caris Assure would gain more coverage as it approaches 200 million covered lives. CFO Luke Power said the company would keep pushing, noting that its code is now public on the clinical lab fee schedule, which is helping win contracts, with a strategy expected to play out into 2027. Chairman and CEO David Dean Halbert then added, per the Investing.com transcript: "We're expecting a price increase with PAMA." The sentence does not name Assure. It follows directly from the Assure discussion, but it can also be read as a company-wide statement (Investing.com transcript).

The CFO's prepared remarks were more measured. He reminded listeners that the clinical assays are billed as CDLTs and that Caris views its reimbursement position as "stable, with an expected update in September on the current PAMA reporting cycle" (StockAnalysis transcript).

The Q1 call in May supplies the background. Management explained that MI Cancer Seek was priced through crosswalk and Caris Assure through gapfill. Having not pursued ADLT status, both tests are subject to the three-year PAMA cycle. Caris submitted its data on May 1 and said it felt "very good about price stability" (Globe and Mail, Q1 transcript). Between May and August, the language moved from stability to an expected increase.

The PAMA mechanics explain why Caris would be optimistic. For a single-laboratory PLA code, the weighted median of private payor rates largely reflects that laboratory's own commercial payments. The 15% statutory limit applies only to reductions, not increases. A test initially priced by gapfill, whose commercial contracting expanded during 2025, is a plausible candidate for upward repricing.

Very Brief Blog; Convergent Genomics Exits via Veracyte Acquisition

 https://www.genomeweb.com/diagnostics/molecular/liquid-biopsy/gnw-veracyte-acquisition-convergent-genomics-20260915/

Here is the headline news:

NEW YORK – Veracyte said after the close of the market Monday that it has acquired Convergent Genomics, which has developed a urine-based DNA testing platform for cancer diagnostics.

The acquisition includes $150 million in upfront cash and up to $30 million in additional cash tied to milestones related to reimbursement efforts for the company’s UroAmp test for urothelial cancers.

Convergent has specifically validated its assay for non-muscle invasive bladder cancer (NMIBC) therapy response monitoring and post-treatment surveillance.

NMIBC is generally confined to the bladder and may shed only limited tumor DNA into the bloodstream, which can make blood-based detection challenging, Veracyte noted. Urine, by contrast, comes into direct contact with the tumor and contains urinary tumor DNA (utDNA).

UroAmp uses sequencing and machine learning to analyze 60 urothelial cancer genes while also measuring changes across the whole genome, according to the company’s website. The company has validated this approach to determine minimal residual disease (MRD) in patients with a history of bladder cancer before and after treatment to monitor therapy efficacy.


Watchdog Releases Documentation of WISER Prior Auth Problems; How to Upgrade FOIA to Lawsuit

The watchdog EFF Electronic Frontier Foundation has released 1000 pages of CMS documents, which in part lay out problems with launcher WiSER, Medicare's attempt to bring Ai and Prior Auth together into the rickety fee for service claims processing system.

There are a number of open access news stories, and you can link directly to the "treasure trove" of FOIA documents.  One tip - they didn't just file a plain-jane FOIA request, they got a first-class upgrade into a FOIA lawsuit.

  • Here's a long September 6 blog at EFF itself - here.
  • Here's what appears to be an EFF home page for the FOIA project - here.
  • Here's news at STAT - here.
  • Open access news at Fierce Healthcare here.

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One often hears FOIA requests takes years; EFF filed a legal complaint with a judge in late March (10pp) here.  I asked Chat GPT how the 10 page legal complaint differs from a "normal" FOIA request.

Very Brief Blog: CMS Updates NCD Wait List

CMS has provided a September 2026 update of its "wait list" for future NCDs.   CMS also flags recently completed NCDs.

Find it here:

https://www.cms.gov/files/document/ncddashboard.pdf



Sunday, September 13, 2026

Genomeweb: Alarm Over CMS Rule on Lab Algorithms

 


See a subscription article at Genomeweb about "algorithm only testts." By Adam Bonislawski, 9/11/26, here:

https://www.genomeweb.com/business-news/reimbursement/gnw-cms-acla-ai-reimbursement-20260910/

I covered the comments of the top organizations in a September 2 blog:

https://www.discoveriesinhealthpolicy.com/2026/09/opps-rule-ditching-digital-pathology.html

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Genomeweb cites public comments (as did my blog) as wel as a Nex Gen Summit panel in DC in late August.

I don't want to squeeze their copyright but a mini summary of Genomeweb is here, encouraging you to see the original:

  • CMS proposes moving “algorithm-only” laboratory tests from the CLFS into a new Software as a Medical Service category paid under OPPS. Clinical labs warn the shift could bring 20% patient coinsurance, budget-neutral payment pressure, billing complications, and removal from CLIA oversight. 
  • Industry groups argue these services remain part of the diagnostic laboratory process and suggest CMS modernize CLIA rather than separate software analysis from laboratory testing.

The first comment deadline (OPPS) is past but the PFS comments go to 9/14.   

Do Current Fraud Press Releases Flag the Pending CRUSH Regulation?

 Last winter, CMS introduced the CRUSH anti-fraud program, with an RFI in the Federal Register.  Since August 2026, that has matured to a proposed regulation that is percolating in review at OMB/WH.   But we just saw a flurry of CRUSH-CRIME press releases from CMS.   Do those press releases flag themes we'll be reading soon in CRUSH?   Let's look into it.


UPDATE:

This blog focuses on two CMS press releases about DME and LAB fraud, that HHS can use as fuel for its campaign to push through new CRUSH legal authorities.

Let's add an OIG report about bad goings-on in the DME world, HHS will also use this August 2026 OIG report (23pp) as additional fuel for the CRUSH fire, when the proposed regulations are released.

https://oig.hhs.gov/reports/all/2026/the-nations-challenge-to-combat-durable-medical-equipment-fraud-in-medicare/

Here's a Linked In article on the CMS Lab payment walls - here.

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AI CORNER
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Reading CRUSH Before It Arrives: What CMS’s Recent Fraud Announcements May Signal—and Why Legitimate Molecular Laboratories Should Care

CMS’s proposed Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) rule remains under review at the Office of Management and Budget. CMS transmitted the proposed rule on August 7; OIRA lists it as a proposed rule, with no statutory deadline and without an “economically significant” designation. (RegInfo)

The Evergreen HHS Press Release: Recyling Rural Health Investment News

Header: In July 2025, Congress passed a huge tax bill that included $billions in spending for rural health, especially rural health technology.   We show how HHS keeps the "news" surprisingly evergreen, including a flood of recent press releases.

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The Evergreen Press Release:
How One Rural Health Appropriation Keeps Becoming New News

The money is real. The projects are real. But many of the “new” investments trace back to one congressional appropriation enacted more than a year ago.

Anyone following CMS press releases in late August and early September 2026 may have noticed an unusual rhythm.

The Trump Administration announces $149.3 million for rural health in Arkansas. Then $58 million for Hawaii. Then $120 million for Indiana. Then $76 million for New York. Michigan gets $25 million for technology, telehealth and broadband. West Virginia gets another announcement for $4.8 million.

The announcements are coming fast enough to resemble a campaign itinerary conducted by press release.

There is nothing fictitious about the projects. Ambulances really may be purchased. Rural hospitals really may install better technology. Telehealth networks, workforce programs, maternal health initiatives and remote patient monitoring really may expand.

But there is an important piece of context: much of this money was not newly created when these press releases appeared.

It might be called press-release evergreening.

Thursday, September 10, 2026

AMA CPT Asks Weird Social Equity Questions; RFK Jr Goes on Attack

It's no secret that AMA CPT applications are full of now-sounds-dated language about whether an applicant's CPT code "perpetuates social bias" (? structural racism) and (even worse) "propagates" it.  (No, sir, I'm just measuring potassium).   

Now RFK Jr has launched a direct attack on AMA CPT as a "Monopoly" which favors "special interests" and he asks the American Public to comment to his RFI by September 14.  Transcript below.

Find the three-minute  HHS video here:

https://www.youtube.com/watch?v=Gam-7T9KnV8

Find coverage at Medical Economics here:

https://www.medicaleconomics.com/view/kennedy-asks-the-public-to-weigh-in-on-the-ama-s-control-of-cpt-codes-by-sept-14 



Here's a transcript:

Hi, I'm Robert F. Kennedy, Jr., your HHS secretary.

Every time that you receive a medical bill, you pay for more than your care. You also pay for a billing system that most Americans have never heard of. Today, we're taking the first step toward changing that.

The Trump administration has launched a formal request for information on the future of medical coding and billing. We want to hear from patients, doctors, nurses, hospitals, the innovators, and every American who believes that healthcare should serve patients, and not special interests.

Here's the problem. Every time your doctor bills your insurance company, or a federal program like Medicare or Medicaid, that claim includes medical billing codes called Current Procedural Terminology, or CPT codes. These CPT codes identify the tests, the procedures, the evaluations, and services that you receive.

CPT codes are owned exclusively by the American Medical Association, the AMA. Despite its name, only about 20 percent of America's physicians belong to the AMA. Decades ago, Congress gave the AMA a de facto monopoly over these codes to help manage our national healthcare billing system.

Today, the AMA licenses those codes and collects hundreds of millions of dollars in royalty payments every year from healthcare providers, insurers, and health IT companies that rely upon them. Last year alone, organizations across all of our healthcare systems paid the AMA more than $300 million just to use those CPT codes.

Those costs don't disappear. Healthcare providers, and insurers, and employers pass them on to their patients. Every American pays the price.

  • Washington created a system that put special interests ahead of the American people. 
  • President Trump is changing all of that. 
  • Now we need your help.

Visit the Federal Register, or click the link on this video's caption, and tell us how we can build a simpler, more transparent, and more affordable medical billing system.

We're cutting red tape. We're breaking the grip of special interests

And we're putting money back into Americans' pockets.

That's how we make America healthy and affordable again. Thank you.

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See a long form essay by Chat GPT here.
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Sidebar:  Regarding the lawsuits and RFIs against AMA - RFK Jr may not be going anywhere.  It's entirely possible we'll have another Republican administration - imagine a national playoff between VP Vance and AOC - and RFK Jr could stay on as HHS leader.   He comments carry a lot of weight and attention as Secretary of Health - he knows that.  And he can probably manage his personal workstyle and workload enough to run into a second term without burnout.

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

So I maintain that the rare case is:

A specialty lab meets with a payor, and, the payor listens carefully, and the lab "wins" unexpected coverage for that one test, for that one payor. 

I'd say: it's a myth, don't hold your breath for that day.  \

But of course, there are exceptions.  For example, UHC comes out early for doverage of Guardant Shield here.   Anthem just opened up coverage for Tau 217 ... here. (Note, this carried along the C2N multi-test including Tau 217, but Anthem woulda covered 217 alone.)



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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, occuring in real time, conducted by serious people, in which the best evidence wins. 

In this myth, the startup starts by publishing several good papers, then it writes a strong PowerPoint deck, and secures a payer medical-director meeting.  The startup brings along one or two respected KOLs, and the payer (who asked several thoughtful questions during the PowerPoint) 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 far 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, or MolDx, or any 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 for the diasaster cases where everything went wrong.   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!

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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)