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.

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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 public starting point was CMS’s unusually broad February request for information. The RFI ranged across provider enrollment, payment suspensions, ownership and identity verification, Medicare Advantage and Part D, laboratories, DMEPOS, artificial intelligence, claims deadlines and other program-integrity tools. It specifically asked how CMS could gain more authority and flexibility to intervene quickly against suspected fraud and how analytics could be connected more effectively with those interventions. (Federal Register)

Earlier background on the CRUSH initiative and its arrival at OMB is available in Discoveries in Health Policy: CRUSH Reaches White House / OMB and CRUSH at OMB: The Next Stage of a Twenty-Year Medicare Anti-Fraud Campaign.

While CRUSH has been at OMB, CMS has issued two unusually prominent anti-fraud announcements involving precisely two sectors emphasized in the RFI. On August 28, CMS announced more than $1.6 billion in laboratory-related enforcement actions. On September 8, it announced action involving $3.4 billion in suspected DMEPOS billing. (Centers for Medicare & Medicaid Services)

A press release is not a leaked regulation.

It would be a mistake to treat either announcement as a clandestine preview of particular CFR amendments. The communications staff preparing an enforcement announcement need not be the attorneys drafting the CRUSH rule, and common terminology can simply reflect an administration-wide program-integrity campaign.

But the opposite mistake would be to assume the announcements tell observers nothing. By the time a proposed rule has been sent to OMB, CMS is no longer brainstorming. It has selected policies, drafted regulatory language and assembled a proposed rule package for executive-branch review. At approximately the same time, senior CMS officials are deciding which fraud problems, enforcement mechanisms and success stories deserve public emphasis.

The announcements therefore can reasonably be read not as leaked provisions, but as evidence of what CMS currently considers important program-integrity problems and effective solutions.

Two Press Releases That Fit CRUSH Remarkably Well

The August 28 laboratory announcement is notable because CMS did considerably more than announce arrests or recoveries.

The agency described a technology-powered enforcement system using advanced analytics, including artificial intelligence and machine learning, to identify unusual combinations of testing, billing, documentation and relationships. High-risk patterns can cause claims to be flagged for review and, where appropriate, held, rejected or denied before Medicare money is released. CMS reported investigations involving 600 laboratories, 185 payment suspensions, 157 provider revocations and hundreds of millions of dollars in overpayments and prevented payments. (Centers for Medicare & Medicaid Services)

CMS: “CMS Prevents $1.6 Billion in Fraudulent Medicare Laboratory Payments” — August 28, 2026

This fits extremely well with one of the clearest themes of the February CRUSH RFI. CMS expressly asked how it could improve payment suspensions, medical review and other oversight; how it could gather actionable information more rapidly; and what analytics and data-driven approaches could identify fraud prospectively. (Federal Register)

The September 8 DMEPOS announcement may be even more revealing.

CMS identified 11 suppliers associated with $3.4 billion in suspected fraudulent billing. Four had already been revoked from Original Medicare and subsequently began billing Medicare Advantage plans. CMS then used the Preclusion List to prevent the companies from obtaining future MA and Part D payments. (Centers for Medicare & Medicaid Services)

CMS: “CMS Cracks Down on Massive $3.4 Billion Medical Equipment Supplier Fraud Scheme” — September 8, 2026

That is strikingly close to a specific structural problem identified in the CRUSH RFI. CMS wrote that providers revoked from Traditional Medicare can shift billing into Medicare Advantage and asked how the Preclusion List should be strengthened to close that gap. (Federal Register)

The September enforcement announcement therefore reads almost like a real-world case study for the policy problem that CRUSH was designed to address.

The Emerging Philosophy: Stop the Money Earlier

Taken together, the two announcements reinforce a broader governing philosophy.

The objective is increasingly to stop questionable money before it leaves the government, rather than paying first and attempting recovery years later. Payment suspensions, automated claim edits, prepayment medical review, enrollment revocation and rapid administrative intervention can act long before a criminal prosecution or False Claims Act case reaches a conclusion.

CMS already possesses many of those tools. CRUSH therefore may be less about inventing an entirely new anti-fraud architecture than about making the existing architecture faster, more interconnected and easier to activate.

The February RFI itself describes existing enrollment screening, payment suspension, data analytics, automatic prepayment edits, audits, revocations and law-enforcement coordination, and asks what regulatory changes would give CMS greater authority and flexibility to deploy them more expeditiously. (Federal Register)

The recent press releases make that interpretation increasingly persuasive.

Analytics May Matter More Than “AI Regulation”

The laboratory announcement also provides a useful clue about artificial intelligence.

AI received explicit attention in the CRUSH RFI, which could lead observers to expect extensive regulations governing artificial intelligence itself. Yet the August release presents AI primarily as an instrument inside the enforcement machinery.

Algorithms identify anomalous patterns. The important governmental action comes afterward: additional review, denial, a payment hold, a site visit, revalidation, suspension or revocation.

That distinction could matter enormously to providers. CRUSH might contain relatively little operative language about machine-learning models while nevertheless producing a substantial increase in automated scrutiny. The legally consequential change would be the action CMS can take on the signal, rather than the technology producing the signal.

Laboratories and DMEPOS Are Still Holding the Spotlight

The sectors highlighted in the two releases are themselves significant.

The February RFI devoted a separate section to laboratory tests, particularly genetic and molecular diagnostics. CMS noted that genetic tests accounted for only about 5% of Medicare Part B laboratory test volume in 2024 but 43% of spending—approximately $3.6 billion. CMS asked what new authorities, analytics and program-integrity tools might be appropriate and specifically raised the experience of MolDX registration. (Federal Register)

A separate RFI section focused on fraud involving DMEPOS suppliers in Medicare Advantage. (Federal Register)

The fact that CMS subsequently chose laboratories and DMEPOS for two major fraud announcements while CRUSH is undergoing OMB review does not prove that any particular proposal survived the drafting process. But it makes it increasingly difficult to regard those sectors as incidental.

Possible CRUSH emphasisCurrent inference
Earlier intervention and prepayment safeguardsVery likely
Analytics connected to review, denial, suspension or enrollment actionVery likely
Stronger enrollment, revocation and revalidation mechanismsLikely
Propagation of sanctions across Original Medicare, MA and Part DVery likely
Specific DMEPOS attentionVery likely
Specific laboratory attentionVery likely
AI as a large body of standalone regulationLess likely than AI as an enforcement tool
Better molecular-test identification or registrationPlausible
Immediate nationwide MolDX administrationStill uncertain
Broad identical restrictions on every laboratoryLess likely than risk-targeted controls

The Harder Question: What Happens to Legitimate Molecular Diagnostics?

The laboratory industry's more difficult concern is not whether CMS should pursue sham laboratories. Few legitimate stakeholders would object to stopping claims for tests never performed, fake beneficiaries or nonexistent laboratory operations.

The harder question is spillover.

Advanced molecular diagnostics can possess some of the same superficial characteristics that naturally draw the attention of a fraud-detection system: relatively high payment amounts, rapid utilization growth, nationwide specimen flows, sophisticated referral relationships, repeated testing and substantial aggregate Medicare expenditures.

Consider comprehensive genomic profiling or molecular residual disease testing. Companies such as Natera and other established molecular laboratories may be furnishing medically necessary testing under well-developed clinical pathways. Nevertheless, the resulting claims can be expensive, rapidly growing and unusual when compared with conventional laboratory medicine.

Those characteristics do not indicate fraud. But they can make legitimate diagnostics conspicuous to an analytic system specifically designed to find outliers.

Indeed, CMS's own RFI acknowledges the policy tension. Immediately after describing rapid growth in genetic-testing expenditures and fraud concerns, it asks what tools and authorities would improve program integrity. The challenge is therefore not merely to increase enforcement. It is to discriminate successfully between suspicious business models and legitimate high-value medicine. (Federal Register)

Spillover Does Not Require a Dramatic New Rule

The most consequential effects on legitimate laboratories may arise from provisions that sound relatively modest in a Federal Register notice.

CMS could intensify prepayment review for selected molecular billing patterns. It could require stronger confirmation of the ordering-provider relationship. Certain laboratory profiles might trigger additional-documentation requests or enhanced enrollment scrutiny. CMS could seek clearer identification of the individual test being performed, additional registration information, or greater disclosure of marketers, referral arrangements or affiliated parties.

None of those mechanisms necessarily changes Medicare coverage for MRD or comprehensive genomic profiling.

Yet each can change how reliably and rapidly a covered test gets paid.

That distinction is commercially important. A laboratory does not need to be accused of fraud to be harmed by an anti-fraud mechanism. If a meaningful fraction of otherwise legitimate claims is diverted into prepayment review, documentation requests or payment holds, the consequences can include slower cash collection, higher administrative costs, uncertainty in revenue recognition and additional burden on ordering physicians.

Eventually, reimbursement friction can become clinical friction. Physicians may become less willing to order a test that repeatedly produces paperwork, payment delays or patient confusion.

Thus, the legitimate molecular industry's concern should not be framed only as, “Could CRUSH deny coverage for our test?”

A more useful question is:

Could CRUSH alter the operational pathway between a medically necessary test and a paid Medicare claim?

The Challenge Is Discrimination

A sophisticated program-integrity system should be capable of distinguishing very different patterns.

A high-value molecular test ordered by an oncologist for a patient with documented cancer, repeated at clinically expected intervals and billed by an established laboratory should look very different from a newly enrolled laboratory suddenly generating enormous molecular-testing volume through beneficiaries who have little or no relationship with the purported ordering physicians.

That appears to be where CMS itself wants analytics to go. In the August laboratory announcement, the agency described models that examine not simply dollar amounts but combinations of testing, billing, documentation and relationships. (Centers for Medicare & Medicaid Services)

That is more reassuring than a crude policy based merely on price or test category.

But sophisticated policies can still produce crude implementation. A carefully designed risk model may ultimately be translated into contractor edits, documentation requirements or payment holds whose boundaries are less precise than their creators intended.

For legitimate molecular laboratories, that may be the most important aspect of CRUSH to examine when the proposed rule becomes public.

Reading Signals Without Inventing Them

The recent CMS announcements therefore warrant two forms of caution at once.

The first is caution against overinterpretation. A press release is not a leaked regulation. No outside observer can reconstruct the exact CRUSH regulatory text from CMS newsroom language.

The second is caution against underinterpretation. While CRUSH is undergoing executive review, CMS has chosen to showcase the same high-risk sectors prominently identified in the RFI and to emphasize the same tools repeatedly: analytics, payment intervention, enrollment authority, prepayment controls and cross-program enforcement.

That convergence may not reveal which subsection of Title 42 CMS will amend.

It may reveal something more strategically useful: what CMS currently believes an effective program-integrity system should do.

For the legitimate molecular diagnostic industry, the resulting message is mixed. Nothing now visible suggests that CMS intends to equate sophisticated genomic testing with fraud, and risk-targeted approaches would make considerably more policy sense than indiscriminate restrictions on advanced diagnostics.

But legitimate laboratories should not conclude that a fraud regulation is therefore someone else's problem.

CRUSH can affect innovative testing without ever questioning its clinical validity or formally changing its coverage. More aggressive analytics, prepayment intervention, enrollment scrutiny or test-identification requirements could create significant operational consequences for entirely legitimate companies.

The real policy test for CRUSH will therefore not simply be whether CMS succeeds in becoming more aggressive against fraud.

It will be whether CMS can become more aggressive without making legitimate advanced diagnostics collateral damage of the fraud war.

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.

Start at the Beginning: Congress Appropriated the Money

The Rural Health Transformation Program was created in Section 71401 of Public Law 119-21, the large reconciliation legislation enacted on July 4, 2025.

The statutory language is unusually straightforward. Congress appropriated $10 billion for each fiscal year from 2026 through 2030, for a total of $50 billion, to the CMS Administrator for allotments to states. (GovInfo)

That sequence matters.

The Trump Administration strongly supported the legislation, and President Trump signed it. HHS and CMS subsequently designed and administered the program. The White House can therefore reasonably claim an important policy role.

But in the constitutional and budgetary sense, the money begins with Congress. Congress enacted the appropriation. A White House press release does not appropriate federal dollars, and OMB does not create an appropriation. The executive branch administers money that Congress has provided by law.

CMS opened the Rural Health Transformation Program application process in September 2025. (Centers for Medicare & Medicaid Services) Then, on December 29, 2025, CMS announced FY2026 awards for all 50 states. Those first-year awards averaged about $200 million per state, ranging from approximately $147 million to $281 million. CMS also explained that the $50 billion would be distributed over five years. (Centers for Medicare & Medicaid Services)

Thus, by the end of 2025, a great deal was already known about where the FY2026 money was going.

What Is “New” in September 2026?

That does not mean the 2026 announcements are meaningless.

There is a real progression from congressional appropriation to federal award to state allocation to specific projects and finally to implementation. A state may receive a $200 million annual award and only months later decide—or publicly disclose—that $25 million will support broadband, $15 million will purchase equipment, or $10 million will fund a workforce initiative.

Those later decisions can legitimately be news.

The distinction is between a new use of previously appropriated money and new federal money.

Michigan illustrates the point nicely. CMS announced on September 4 that the Trump Administration was investing $25 million to modernize technology, expand telehealth and improve high-speed internet connectivity. Yet CMS had already announced Michigan's total FY2026 Rural Health Transformation award—$173.1 million—in December 2025. The September release described one particular deployment of that larger award. (Centers for Medicare & Medicaid Services)

New York's September 4 announcement similarly highlighted $76 million for regional coordination and technology-enhanced care, although New York had already been awarded about $212 million for FY2026. (Centers for Medicare & Medicaid Services)

In other words, these can simultaneously be real implementation milestones and recycled communications opportunities.

Press-Release Evergreening

The strategy resembles, in a loose sense, pharmaceutical “evergreening.”

A drug company may begin with one underlying product and extend its commercial life through new formulations, indications, delivery systems or patents. Each development may be perfectly real, while also extracting additional value from the original asset.

Government communications can do something similar.

A single $50 billion appropriation can generate successive rounds of news:

Congress enacts the program → HHS launches the program → states apply → CMS announces state awards → states announce project allocations → individual programs receive money → equipment arrives → facilities open → patients begin receiving services.

One statutory appropriation can therefore support scores, and potentially hundreds, of separate announcements over several years.

That is evergreen government communications: keep finding legitimate new news pegs attached to an underlying policy achievement.

The technique is not inherently improper. In fact, communicating what federal programs actually accomplish is part of governing. A $50 billion line in a statute is abstract. “New ambulances for every county,” “telehealth for rural clinics,” or “125 new health professionals recruited to West Virginia” tells taxpayers what the program does.

But presentation matters. A headline saying that the “Trump Administration Announces $76 Million” naturally sounds more like a new decision to provide $76 million than like the latest downstream allocation from a state award originating in legislation enacted fourteen months earlier.

That ambiguity is politically valuable.

The HHS and CMS Message: Transformation, Not Just Subsidy

For HHS and CMS, there is also a substantive policy story to tell.

The Rural Health Transformation Program was deliberately designed as more than a conventional rural-hospital subsidy. CMS emphasizes workforce development, new delivery models, prevention, information technology, telehealth, data infrastructure and technology innovation. (Centers for Medicare & Medicaid Services)

That helps explain the conspicuous number of technology-oriented announcements. Arkansas's September announcement, for example, included telehealth, remote patient monitoring, imaging, digital integration and AI-enabled “SMART rooms.” Hawaii emphasized ambulances, workforce and emergency communications. Indiana emphasized maternal and infant health, primary and behavioral care, transportation and workforce development. (Centers for Medicare & Medicaid Services)

From CMS's perspective, repeated project announcements demonstrate that “transformation” is becoming something concrete.

That is a reasonable administrative message.

The Trump Message: “We Delivered”

The political messaging is considerably less subtle.

The recent CMS releases routinely describe the funding as a Trump Administration investment and quote CMS Administrator Mehmet Oz saying that President Trump made a “historic commitment” to rural America.

More strikingly, multiple releases explicitly remind readers that the legislation was passed by Republicans in Congress and unanimously opposed by Democrats. Michigan's release includes a congressional quotation declaring that Republicans delivered the Rural Health Transformation Program and that every Democrat voted against the legislation. (Centers for Medicare & Medicaid Services)

This tells us that the purpose is not merely to explain an HHS grant program.

It is also credit attribution.

The desired political narrative is simple: President Trump and Republicans brought this money to your state.

From a communications standpoint, state-by-state announcements are far more useful than a single national announcement about $50 billion. A representative from Indiana does not have to explain an enormous reconciliation statute. He or she can point to $120 million for Indiana. A Michigan member can point to $25 million for technology. A rural newspaper gets a local number, local projects and quotations from local elected officials.

The national legislative achievement becomes a collection of locally tangible achievements.

The White House Message: Make a 2025 Law Pay Dividends in 2026

There is an obvious broader political advantage as well.

A major piece of legislation has its greatest communications value when voters encounter its consequences repeatedly rather than hearing about it once on the day it passes.

The Rural Health Transformation Program lends itself unusually well to this treatment because it contains $50 billion, reaches every state, extends over five years and permits a wide range of highly visible projects.

There may therefore be many bites at the communications apple.

The original legislation was news in July 2025. The program launch was news in September. Applications were news in November. Fifty state awards were news in December. Project allocations are news throughout 2026. Implementation can become news in 2027 and beyond.

And each time, the Administration can reasonably say that something actually happened.

That is what makes the strategy effective. It does not require inventing news. It requires dividing one long implementation process into a succession of newsworthy moments and attaching political ownership to each one.

A Useful Translation for Readers

When encountering one of these announcements, it may help to mentally translate the headline.

“Trump Administration Announces $XX Million for Rural Health in State Y” may mean:

Congress appropriated the $50 billion program in July 2025; CMS awarded State Y its FY2026 share in December 2025; and State Y and CMS are now announcing how $XX million of that previously awarded money will actually be used.

Sometimes there may indeed be a genuinely new award or additional funding mechanism, so each announcement deserves to be read on its own terms. But the recent Rural Health Transformation releases repeatedly acknowledge that the featured projects are portions of larger FY2026 state awards.

That doesn't make them fake announcements.

It makes them evergreen press releases.

The Administration has taken a large congressional appropriation, a five-year implementation schedule, 50 states and hundreds of potential projects and turned them into a renewable communications resource.

It is smart political marketing. It is also real health policy.

Readers simply need to keep straight which part is new: the money, the award, the project—or the press release.

 

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!

##

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

###

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.)

##

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.