Thursday, October 15, 2026

A Final Reg, A Proposed Bill: Information, Transparency, Coverage

 CMS has released a final regulation on (mostly PRICE) transparency in coverage.  See Fed Reg, see Press Release, Fact Sheet.  Here, in this blog, see an AI summary.

Meanwhile, the House has posted HR 9393, a bill called Lower Costs, More Transparency Act.

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AI discusses.

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Transparency in Coverage:
Clearer Prices, but How Much Clearer Coverage?

The new Transparency in Coverage final rule, announced October 5 and published October 6, improves the usability of health insurers’ price disclosures. CMS’s press release promises clearer information about both what insurance covers and what patients will pay. The operational changes, however, primarily concern price transparency.

The rule updates the 2020 framework for non-grandfathered group and individual health coverage. Insurers must produce smaller, more meaningful machine-readable files: consolidate in-network rates by provider network, remove implausible provider-service combinations, identify networks and insurance products more clearly, and expand available out-of-network payment data. New attestations strengthen accountability for accuracy. In-network and out-of-network files move from monthly to quarterly updates. Personalized cost-sharing information must also be available by telephone. Implementation is phased through 2027.

The business logic is straightforward: enormous, confusing files technically disclose prices without necessarily enabling useful comparisons.  (That might be the goal of some stakeholders - block discovery.) 

Better data should help employers negotiate, researchers analyze markets, and software developers build shopping tools. Whether patients actually switch providers—and whether prices fall—remains a separate question.

What about coverage transparency? The existing consumer-tool rules already require personalized deductible and cost-sharing information and notification of prerequisites such as prior authorization or step therapy. But they also expressly require a warning that a cost estimate does not guarantee benefits. The new telephone requirement expands access to this information; it does not turn an estimate into a binding coverage determination.

There is also a narrower, genuinely new disclosure: “taxonomy” files expose provider-specialty mappings used to exclude implausible rates, while utilization files identify actual reimbursed provider-service combinations. These illuminate aspects of payment operations, but do not establish a comprehensive public repository of medical-necessity criteria, investigational exclusions, or patient-specific coverage decisions.

Short Compare: HR 9393

H.R. 9393, the bipartisan Lower Costs, More Transparency Act of 2026, pursues closely related goals through legislation. Its introduced text would codify and expand transparency requirements across hospitals, laboratories, imaging providers, ambulatory surgical centers, and health plans. Section 6 closely parallels the rule’s consumer estimates and public pricing files, while adding provisions such as spreadsheet-readable summaries and pharmacy benefit manager spread-pricing disclosures.

The relationship is therefore substantive, but the rule does not implement H.R. 9393: it rests on existing statutory authority. Both initiatives seek to make healthcare markets more understandable and competitive. Neither should be mistaken for a general expansion of covered benefits.

Still, the new HHS final rule partly anticipates H.R. 9393, making portions of 9393 less novel operationally. We see the remaining significance for legislation ini 9393 to grant statutory durability, broader provider obligations, and additional disclosures.


A closer look at H.R. 9393

Representatives Brett Guthrie and Frank Pallone introduced H.R. 9393 on June 23, 2026. The supplied congressional record shows a July 21 committee vote ordering it reported with a substitute, 45–0; the attached legislative text is the introduced version, so the provisions described here should be distinguished from any subsequent substitute.

Much of the bill would take effect in 2028. Hospitals would publish standard charges and consumer-friendly prices for at least 300 shoppable services, where available, with completeness and accuracy attestations. Separate provisions address imaging and ambulatory surgical centers.

For laboratory readers, Section 3 deserves attention. Applicable laboratories receiving Medicare payment would publish discounted cash prices—or gross charges when no cash price exists—for designated tests, including customary ancillary services. They would update prices at least annually and attest to accuracy. Following notice and an opportunity to comply, penalties could reach $300 per day.

Crucially, this provision does not encompass every genomic test: it applies to laboratory tests on CMS’s specified shoppable-services list and expressly excludes statutory advanced diagnostic laboratory tests (ADLTs). That exclusion is narrower than “all advanced molecular diagnostics.”

Section 6 addresses insurers’ negotiated rates, out-of-network payments, personalized estimates, benefit-limit accumulations, and prior-authorization or similar requirements. It also seeks clearer disclosure of PBM spread pricing—the difference between specified amounts charged to the plan and paid to the pharmacy—and annual pricing summaries readable in ordinary spreadsheet software. These are concrete efforts to make disclosed information easier to interpret and use.


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Update! Does this week's final rule cast light on updates for HR9393?

Yes—the HHS regulationi increases the overlap and reduces the incremental impact of some H.R. 9393 provisions. The final rule already advances several of the bill’s goals: more usable pricing files, reduced duplication, stronger accountability, and telephone access to personalized estimates.

But the bill still adds substance. It would place requirements directly into statute, extend explicit disclosure obligations to laboratories, imaging providers, and ambulatory surgical centers, and add provisions such as spreadsheet-readable summaries and PBM spread-pricing disclosures.

For your blog: “The final rule partly anticipates H.R. 9393, making portions less novel operationally. The bill’s remaining significance lies in statutory durability, broader provider obligations, and additional disclosures.”

That comparison is to the introduced bill text supplied, rather than the committee substitute.

Source documents: 2026 CMS 1005 Press release on TRANSpARENT COVERAGE.pdf 2026 HHS CMS 1006 (price) Transparency in coverage 120p.pdf 2026 HILL HR 9393 Transparency Coverage ETc ACT.pdf

Program Integrity - Something New Every Month - Exclusion Authority Added to CMS, Formerly Only the OIG

 Medicare's exclusion authorities - kicking you out of the program for 10 or 20 years - was previously handle by the legal eagles in the OIG.

With a quick announcement in the Federal Register, that exclusion can now also be handled by CMS staff, in the name of the Administrator (RFK/HHS). 

Find more news here:

The HHS (CMS) answer to the President via the Cabinet.  The OIG is "an independent unit within government department" but has "dual reporting" to Agency Head or to Attny General DOJ, and to Congress.

Why it matters - I'd take the lesson that CMS/HHS is very serious on enforcement, is very "action oriented," and there is news of some kind (CRUSH etc) every month.  They're not dozing at their desks, they start the day with three Red Bulls.
  



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CMS gains exclusion authority—but exclusion does not automatically mean a lifetime ban

By Chat GPT 6

An October 14, 2026 Federal Register notice delegates to the CMS administrator the Secretary’s permissive exclusion authority under Social Security Act §1128(b), effective immediately. CMS can now exercise this authority alongside HHS’s Office of Inspector General, whose existing powers remain intact. The notice does not delegate mandatory exclusion authority under §1128(a). CMS must follow existing departmental rules and procedures; authority to conduct hearings or issue regulations is expressly excluded. fed reg eclusion 2026-21001

This is Powerful

The change brings a powerful enforcement tool directly into the agency administering Medicare and Medicaid. Permissive exclusion grounds include certain misdemeanor convictions, professional-license sanctions, unnecessary or substandard services, kickbacks, and material falsehoods in enrollment applications. Some grounds require no criminal conviction. Exclusion generally prevents federal healthcare programs from paying for services an excluded person or entity furnishes, orders, or prescribes—even when someone else submits the bill. oig.hhs.gov

How Long?  "Sentencing Guidelines"

How long does exclusion last? The attached coverage’s references to permanent bans need qualification: there is no universal lifetime or ten-year term. Pasted text(20261015-182940)

BasisDuration framework
Certain permissive conviction groundsThree-year baseline, adjustable for aggravating or mitigating circumstances
License revocation or suspensionGenerally tied to the underlying licensing sanction; potentially indefinite
Unnecessary or substandard servicesMinimum one year
Fraud/kickbacks under §1128(b)(7)No prescribed minimum; duration depends on the case
Mandatory exclusion for qualifying convictionsGenerally at least five years; qualifying repeat convictions can trigger ten years or permanent exclusion

The ten-year and permanent repeat-conviction provisions belong to the mandatory exclusion framework, which this delegation does not transfer to CMS. These are statutory benchmarks, not evidence of the average exclusion actually imposed. oig.hhs.gov

What Happens When It's Over?

Moreover, reinstatement is not automatic when a stated term expires. Under OIG’s established process, the excluded party must apply and receive written approval. Consequently, a nominal five-year exclusion can remain operative longer. oig.hhs.gov

Take Home Lesson?

For laboratories and other providers, my assessment is that the principal change is institutional: CMS gains direct exclusion leverage alongside its payment oversight responsibilities. That could accelerate enforcement and increase settlement pressure. However, the brief notice does not explain how CMS and OIG will coordinate cases. It establishes parallel authority, leaving the practical division of enforcement work unresolved.  


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SSA 1128(a) is mandatory exclusions (e.g. conviction for Medicare fraud.)  1128(b) is elective exclusion (e.g. conviction for other financial crime.)   Note that 1128B is the following page, which is criminal penalties.

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Appeals

Yes—there is an explicit appeal process. But your concern is justified: for many exclusions, the sanction can take effect before the appeal is decided.

Section 1128(f) expressly provides notice, an opportunity for a hearing, and judicial review. The new CMS delegation does not eliminate those rights. Its statement that CMS cannot “conduct hearings” reserves that adjudicative function; it does not mean providers lose their hearing rights. ssa.gov fed reg eclusion 2026-21001

The established OIG procedures provide the relevant framework, although the brief delegation notice does not explain all the mechanics of CMS’s implementation.

For most permissive exclusions, the sequence is:

  1. Notice of intent. The provider generally gets a written explanation and 30 days to submit evidence and arguments against exclusion. For excessive charges or unnecessary/substandard services under §1128(b)(6), the provider can also request oral argument before an OIG official. ecfr.gov
  2. Exclusion decision. If the agency proceeds, its letter must identify the basis, duration, applicable factors supporting that duration, and appeal rights. Under the ordinary rule, exclusion becomes effective 20 days after the notice’s date. ecfr.gov
  3. ALJ appeal. The provider generally has 60 days after receiving the notice to request a hearing. Review addresses whether a legal basis for exclusion exists and whether its length is unreasonable. The evidentiary standard is preponderance of the evidence, not proof beyond a reasonable doubt. Further review runs through the HHS Departmental Appeals Board and then federal court. ecfr.gov

The crucial distinction is whether appealing postpones exclusion:

GroundDoes a timely hearing request ordinarily prevent exclusion from taking effect before the ALJ decision?
§1128(b)(6): excessive charges, unnecessary or substandard servicesNo. The ordinary 20-day effective-date process applies.
§1128(b)(7): fraud, kickbacks, other prohibited actsYes, unless an earlier exclusion is warranted to protect patient health or safety.

That second category has an express pre-exclusion hearing safeguard. Thus, different items within subsection “b” carry materially different procedural protection. oig.hhs.gov

There is another limitation: the ALJ does not have unrestricted authority to reconsider whether exclusion was a wise exercise of discretion. The regulations distinguish reviewing the legal basis and duration from reviewing OIG’s discretionary choice to exclude once the grounds exist. An exclusion appeal also generally cannot reopen an underlying conviction or other already-adjudicated determination. ecfr.gov

So, a letter imposing ten years is contestable, and the duration needs support under the applicable rules. But appeal rights do not necessarily preserve the business while that contest proceeds. For the more judgment-dependent grounds you flagged, that timing issue deserves substantial attention in discussing CMS’s new authority.


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Humor




MEDPAC Updates its Basics of Payment series

 MEDPAC has a dozen short articles, usually two-pagers, on the different payment systems (one of which is Clin Lab Fee Schedule.)

It's says they're updated for 2026; I suppose most had little change from the last version.  

Find them here:

https://www.medpac.gov/document-type/payment-basic/



Oh Noooo... MACs Forbid Coverage of AI for MRI

 I think I've seen this LCD from another contractor, here it comes from Palmetto GBA.

On October 1, Palmetto released for comment LCD DL40464, "Automated Detection and Quantification of Brain MRIs."   The take-home lesson is simple:

  • This is a non-coverage policy for artificial intelligence (AI) assistive software tools for automated detection and quantification of the brain.

Examples include ARIA detection and quantification (vascular and tissue abnormatlies in dementia therapy. Petrella 2026).

Obviously, the same principle could be applied to detection and quantification of features and properties of glass slides intead of MRI images.





75 footnotes. Links to an NCD 200.3for  monoclonal treatment of Alzheimer's.  Draft billing article DA60550. [boilerplate re ABN etc]    Comment to 11/14/2026.

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The MAC writes,

INTRODUCTION

There is interest in AI algorithms, including machine learning and deep learning, that automate neuroimaging in an effort to improve accuracy, reduce bias, and aid clinical decision-making. Machine learning is used to evaluate candidate biomarkers for assessing multiple sclerosis and disease severity, with random forest models commonly performing well, while deep learning remains less widely adopted. Translating these methods into clinically meaningful decision-support tools is limited by insufficient data quality and quantity, as well as a lack of shared standards. Advancing clinical impact will require robust, shared data resources and integrated analyses across multiple data modalities rather than isolated, single-purpose solutions.

ANALYSIS

Investigations have explored the potential of automated quantification technology for the evaluation of ARIA, MS, TBI, epilepsy, brain tumors, and other neurologic conditions. However, progress has been limited by the lack of established measurement standards and insufficient access to large, diverse datasets for training these tools. While expert radiologists interpret imaging based on visual patterns, these programs quantify brain volumes. Although this approach is promising, there are currently no standardized reference values defining normal brain volumes, and each program relies on proprietary data that is not interchangeable across platforms. In addition, the datasets used to train these models lack sufficient diversity to account for variations related to age, gender, or ethnicity. This limitation is particularly relevant in the Medicare population, where age related changes in brain volume are common. Without standardized data, it is difficult to determine whether subtle changes reflect true pathology or normal variation. At this time, there is insufficient evidence of clinical utility or validity, and use of this technology is considered investigational and therefore not covered. Palmetto GBA will continue to monitor the evolving research related to these devices.

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It's important to note this is not a fixed or statutory position, not a benefit category exclusion.  The conclusion seems to be based on today's analysis of utility data.

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This is a concensus paper, Petrella 2026 (not cited in LCD), abstract in full:

Amyloid-targeted monoclonal antibody therapies have introduced a new era in the treatment of early Alzheimer disease. However, their use has increased the importance of detecting and monitoring amyloid-related imaging abnormalities (ARIA) on MRI, as such findings may influence treatment continuation, dose modification, and patient safety assessment. As anti-amyloid therapies expand into routine practice, increasing surveillance MRI volumes, interreader variability, and the potential for missed subtle abnormalities have generated interest in artificial intelligence (AI)–based clinical decision support tools. 

A multidisciplinary panel of neuroradiologists and Alzheimer disease clinicians examined the extent of evidence supporting clinical implementation of AI-assisted ARIA detection tools, these tools' safe integration into practice, and remaining evidence gaps. The panel concluded that AI-assisted ARIA detection is likely to enhance patient safety when used as clinical decision support within a radiologist-in-the-loop framework. 

Panelists also noted substantial variation among commercially available tools in regulatory status, technical capabilities, and validation evidence. Moreover, they emphasized the need for further studies to assess the impact of improved detection on clinical outcomes. Overall, the panel supported conditional implementation with radiologist oversight, ongoing quality assurance, and prospective monitoring of clinical performance.


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Here is an AI response to the LCD, in 300 words:

Palmetto’s proposed LCD deserves credit for reviewing a substantial literature, distinguishing clinical applications, and examining individual products. Its central concern is legitimate: improved image interpretation does not automatically establish improved patient outcomes. Nevertheless, the policy’s categorical noncoverage conclusion warrants reconsideration, particularly for AI-assisted monitoring of amyloid-related imaging abnormalities (ARIA).

The LCD acknowledges that AI assistance improved radiologists’ sensitivity from 71% to 87% for ARIA-E and from 69% to 79% for ARIA-H. It reasonably questions the clinical consequences, especially because additional findings frequently involve mild abnormalities that may not require stopping treatment. But continued treatment does not make detection irrelevant: identified abnormalities can affect surveillance intensity and subsequent management. The incremental value of these changes requires evaluation.

Rather than blanket noncoverage until the LCD is revised, Petrella and colleagues’ 2026 multidisciplinary consensus, not cited in the LCD, supports a more conditional approach. The panel considers AI-assisted ARIA detection likely to enhance safety with radiologist oversight, quality assurance, and prospective monitoring. However, its endorsement is explicitly guarded: products vary in regulatory status, capabilities, and validation, and improved clinical outcomes remain to be demonstrated. Expert consensus supports consideration; it does not close the evidence gap or independently establish entitlement to reimbursement.

The disagreement therefore concerns the appropriate response to uncertainty. Palmetto should more explicitly assess whether demonstrated improvements in detection, connected to established treatment-management pathways, provide sufficient indirect evidence of utility for narrowly specified uses. That assessment should include false positives, unnecessary treatment interruptions, and performance outside research settings.

A revised policy need not cover every product or indication. It could identify qualifying evidence and safeguards for selected applications while retaining noncoverage elsewhere. If Palmetto finds even restricted coverage premature, it should specify the management or outcome evidence needed for reconsideration.

Medicare should demand credible clinical value. It should also explain why demonstrated diagnostic gains remain insufficient when the abnormalities detected already guide consequential treatment decisions.

When Digital Pathology is as much fun as Da Vinci - Sales will Follow

 Could AI-drafted pathology reports become something physicians actively want to use—as some surgeons came to love da Vinci robotics? 

This white paper explores that possibility through surgeons’ experiences describing their enjoyment of robotic surgery.


Find the 7-page cloud white paper   HERE.

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I also draw two personal examples - how the technology of literature searches has massively changed since 1985, and  how their is a new. also massively different kind of hybrid writing between author and AI (used in this white paper).

Of those two personal experiences, adoption and integration have taken opposite journeys.  Literature searching  became an unnoticed part of my work flow - like opening a Coke.*   And opposite that,    human-AI-writing has become a highly engaging, fascinating, novel combination of AI and author, one I find fascinating and intriguing. (And more analogous to robotic surgery or enjoying being a airplane pilot).

So: from urologists talking about their use of robotics to the transition from costly MEDLINE searches to everyday PubMed access, and my own absorbing partnership with AI—including writing this essay. As I've raised before, for the topic of automated first draft pathology reports, we also ask whether pathology’s reliance on locally validated RUO applications favors small tools over comprehensive clinical systems. Widespread adoption may require both a scalable foundation of clinical evidence and a way of working that pathologists find fluent, empowering, and rewarding.

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* I wrote about this in July.

Wednesday, October 14, 2026

AGILENT-Proscia. ROCHE-PathAI. Deep Dives into Business Strategy and Impact

 

Roche acquires Path AI, Agilent acquires Proscia.  Tempus acquires PAIGE.   In a carefully guided Chat GPT 6 essay, we try to figure out what it means and where we're going.

This is an AI  generated report. It should not be taken as ground truth ,but as an example of currrent AI abilities to grasp, plan, and write multi-part essays.

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Access this white paper as a 15-page PDF here.


Two Presentations, Two Acquisitions, and the Future of Clinical Digital Pathology

Dr. Maria Wilson and the meetings described below are fictional. The demonstrations are a teaching device, not accounts of actual vendor presentations or comparative product testing. Company and product descriptions draw on the public sources linked throughout.

At 1:45 p.m., Dr. Maria Wilson, chair of a large academic pathology department, looks over her afternoon schedule.

The department is preparing to go digital. Scanners have been selected. Storage and networking are being arranged. But the software decision remains unsettled: what will the pathologists actually use, and how will it change their clinical work?

Representatives from PathAI and Proscia will each have thirty minutes. At five, Maria will discuss the proposals with five departmental leaders and two representatives of the Dean’s office.

She sends both vendors the same instruction:

“Please walk us through a prostate biopsy, a breast biopsy with immunostains, and a colon resection with multiple blocks and lymph nodes. Begin when the scanned slides become available. Finish when the pathologist signs the report.”

She adds one more request:

“Show us an ordinary working day, including the things that go wrong.”

The First Presentation: PathAI

The PathAI representative begins with the names.

“PathAI is the company. AISight is our software platform. AISight Dx is our FDA-cleared image-management product for primary diagnosis.”

Maria appreciates the distinction. She had initially thought PathAI might chiefly be an algorithm that finds cancer. Instead, the proposal concerns the environment in which a pathologist could review an entire digital caseload. PathAI’s public materials describe case and image management alongside analytical applications. AISight Dx.

For the prostate biopsy, Maria asks the representative to begin with the worklist.

“How do I know all the slides are here? How do I move among the cores? Where do I see the specimen information? What happens when another level arrives after I have begun reviewing the case?”

Then she turns to analytical assistance.

“Suppose an application identifies suspicious tissue. Show me how I examine that finding, decide whether I agree, and incorporate anything useful into my report.”

She is interested in the whole sequence. A colored overlay might help, but she wants to know what it saves her from doing—and what additional checking it creates.

For the breast case, she asks how a quantitative result would be associated with the correct stain and specimen. For the colon resection, she asks how the system keeps numerous slides organized and helps the physician avoid overlooking an incomplete part of the case.

The representative describes the platform and available analytical offerings. Maria insists on separating what can be demonstrated now from what would require another product, an interface project, local development, or future software.

“Please don’t let a promising feature become an assumed capability in our purchasing decision.”

PathAI’s analytical expertise interests her. Its broader business includes developing tissue-analysis tools and diagnostic applications. But she redirects any discussion of pharmaceutical studies.

“That may matter to another committee. Today our question is whether our clinical faculty can complete patient cases more efficiently and reliably.”

With ten minutes remaining, she asks for a regulatory map.

“For each proposed function, identify the product, its intended use, the supported equipment, and its status. We need to distinguish a cleared diagnostic viewer from an authorized analytical application—and both from a research demonstration.”

Finally, she asks about report generation.

“Does the software prepare a diagnostic draft from the case? Does it populate selected findings? Or does it mainly help me review images before I dictate the report myself?”

Those are three different levels of assistance. Maria does not want the attractive phrase “AI-enabled workflow” to conceal which one she is buying.

Her first take-home lesson is that PathAI offers a clinical workplace as well as analytical capabilities. The department must evaluate how those pieces function together in the actual proposed configuration.

The Second Presentation: Proscia

At three, the Proscia representative begins.

“Proscia is the company. Concentriq is our software platform.”

Maria writes it down. PathAI makes AISight; Proscia makes Concentriq.

She presents exactly the same cases and asks exactly the same questions.

This time, she pays particular attention to the connections among images, specimen information, additional slides, analytical outputs, and the laboratory information system.

“Assume the prostate case is missing a slide.”

“Assume a breast immunostain arrives tomorrow.”

“Assume I send the colon case to a colleague at our second hospital. What does that person receive, and where does the consultation return?”

The discussion reveals the importance of work that is less dramatic than identifying cancer: assembling the correct case, preserving context, making the right material available, and preventing staff from repeatedly moving information between systems.

Concentriq’s public descriptions emphasize connecting scanners, laboratory systems, images, applications, and people. That gives Maria a useful framework for the demonstration, but she still needs the vendor to establish what the proposed installation will actually do. Agilent’s description of Proscia.

Then the representative introduces more ambitious AI capabilities.

Maria hears about automatic analyses, case context, and assembling reportable findings. She recognizes movement toward the prepared case she wants: useful work completed before the physician opens the images.

But she repeats the regulatory question.

“Which of those capabilities belong to the diagnostic product we could deploy clinically?”

That question matters. Proscia’s fifth-generation materials describe substantial AI functionality while distinguishing research-use-only capabilities from its separate FDA-cleared Concentriq AP-Dx product. An impressive demonstration does not establish that every demonstrated function is available for clinical diagnosis. Proscia’s product disclosures.

Maria ends with the same reporting question she asked PathAI:

“When I finish examining the case, how much reporting work remains?”

She asks to see how a physician would reject an incorrect suggestion, revise a measurement, and trace a statement back to its supporting tissue image. These become requirements for the evaluation, rather than assumed features.

Her second take-home lesson is that Proscia offers an analytical environment as well as image management. Calling it simply a storage or viewing company would be as misleading as calling PathAI simply a cancer-detection algorithm.

The Five O’Clock Meeting

Maria faces the surgical pathology director, the breast service lead, the quality director, the laboratory manager, and the informatics lead. The Dean’s office has sent representatives responsible for clinical operations and finance.

She begins:

“Both companies are credible candidates for our clinical digital workplace. Neither should win because its presentation used the word ‘AI’ more often.”

She displays a short table.

What the department needsWhat must be established
Digital primary diagnosisThe proposed product and equipment configuration support the intended clinical use.
Analytical assistanceEach application’s scope, performance, and regulatory status are clear.
Efficient reportingFindings reach the report without burdensome duplication or correction.
Reliable daily operationsMissing slides, additional stains, consultations, and downtime are handled safely.
Future draft reportsThere is a credible development path, without treating future promises as current capabilities.

The surgical pathology director asks, “What was the practical difference between the two presentations?”

“PathAI’s broader analytical-development expertise was prominent,” Maria answers. “Proscia’s emphasis on connecting the case, users, systems, and applications was prominent. But both companies work across those areas. We must compare the products offered to us, rather than buy a simplified story about the companies.”

The breast service lead asks whether better algorithms should determine the choice.

“Only if we establish that we can use them clinically and that they improve the complete task,” Maria says. “A measurement can be excellent while the process of checking it and transferring it into the report is cumbersome.”

The quality director asks about errors.

“We need to examine both the software’s mistakes and our response to them,” Maria replies. “A plausible suggestion can make us too comfortable. A confusing display can make correct information difficult to verify. Human factors are part of clinical performance.”

The laboratory manager asks who will deal with rescans, incomplete cases, and software exceptions.

“That belongs in the cost assessment. Saving physician time by quietly adding substantial technical work may still be worthwhile, but we need to see the full calculation.”

The finance representative asks the inevitable question.

“What are you recommending?”

  • “A matched clinical evaluation of both proposed configurations, followed by a purchase decision against criteria agreed in advance.”

Maria does not recommend an indefinite pilot. She proposes a bounded evaluation using representative cases, routine pathologists, technical staff, and the actual laboratory-system interface. Appropriate governance would determine how the evaluation is conducted before clinical deployment.

They will measure total physician time, technical work, clinically important discrepancies, reporting effort, and the frequency of exceptions. They will examine the experience of an ordinary faculty member, not only the department’s most enthusiastic digital pathologist.

“We should give substantial weight to dependable clinical use today,” she says. “Future capability matters, but it needs a separate score.”

The informatics lead asks about data portability, interfaces, and dependence on particular scanners or algorithms.

“Those belong in the contract,” Maria answers. “We need to understand the cost and difficulty of changing an application, adding equipment, exporting our information, or eventually changing platforms.”

A Dean’s representative asks whether the acquisitions settle the question.

“Roche backing PathAI and Agilent backing Proscia matter,” Maria says. “They may strengthen development, regulatory, and support resources. But neither corporate name proves that our installation will work well. We need product-level evidence and contractual commitments.”

Finally, the surgical pathology director asks:

“When do we get the system that has already reviewed the case and written a useful first draft?”

“That is the destination I want us positioned to reach,” Maria says. “But we must distinguish buying today’s digital workplace from buying that future reporting capability.”

Her recommendation is firm: select the system that best performs the department’s clinical work under a fair comparison, while preserving a credible route to more advanced assistance.

“The deciding demonstration,” she concludes, “is what happens when one of our pathologists opens an ordinary case on an ordinary Monday.”


The Alternate Universes: What If the Buyers Had Been Reversed?

The acquisitions can be understood more clearly by imagining the opposite pairings.

Roche agreed to acquire PathAI; Agilent agreed to acquire Proscia. Both transactions build on earlier commercial relationships. Roche and PathAI had established a particularly close collaboration in AI-enabled companion diagnostics, while Agilent had distributed Proscia’s software since 2022. Roche–PathAI; Agilent–Proscia.

But neither pairing was technologically inevitable.

In an Agilent–PathAI universe, Agilent would acquire AISight as a potential clinical workplace and PathAI’s capabilities for developing analytical and diagnostic applications. It could seek to connect its tissue-diagnostics products with software that interprets resulting images and ultimately helps prepare reports.

For Maria, that might look quite similar to the PathAI presentation she just attended. The ownership change would principally affect the resources, development priorities, commercial arrangements, and integration choices behind the product.

This hypothetical transaction would also have to address PathAI’s existing Roche agreements. Acquisition would not automatically remove contractual obligations. The 2024 collaboration explicitly described exclusivity in companion-diagnostic algorithm development within stated terms and boundaries. Collaboration announcement.

In a Roche–Proscia universe, Roche would acquire Concentriq’s clinical workflow infrastructure, relationships, and expanding analytical capabilities. Roche could seek to combine those with its staining systems, scanners, diagnostic assays, and internally developed or partner-supplied algorithms.

Again, Maria could encounter a recognizable Concentriq proposal. The difficult work would concern product integration, support, clinical evidence, and deciding which functions to develop next.

The hypothetical swap exposes an important point: both targets bring a digital workplace, and both have analytical ambitions. PathAI’s analytical-development business and Proscia’s emphasis on connecting the digital workflow are useful distinctions, but they do not divide the companies into mutually exclusive categories.

Roche’s own investor materials emphasize AISight image management as part of the PathAI acquisition. Proscia’s materials describe increasingly sophisticated models and automated work within Concentriq. Neither transaction is adequately described as buying only algorithms or only infrastructure.

For a clinical department, the ultimate question survives the swap unchanged:

Which combination will deliver a supported clinical system that performs useful work before the physician arrives—and makes completing the case demonstrably easier?

That leads to the larger question behind both acquisitions.

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SIDEBAR

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Sidebar:
Bruce’s Prime Question—Can Pathology Escape the RUO Death Spiral?

Bruce’s premise is that software capable of preparing diagnostic reports for efficient pathologist review could unlock explosive growth in digital pathology—and that the industry underestimates this opportunity. The decisive product would combine reliable interpretation with superb human interaction: findings, supporting images, and a proposed report presented so clearly that the physician can verify, correct, and finalize the case substantially faster.

The question is whether pathology’s accustomed way of developing and adopting software can deliver that product to ordinary hospitals.

“Bob Will Validate It”

Imagine a department with a Dr. Bob, a capable pathologist who likes computers. He obtains a modest program that counts mitotic figures. He troubleshoots it, checks its performance, and spends several months making it useful in the laboratory. Everyone appreciates the result. “Bob will validate it” becomes a familiar answer to software adoption.

Then a vendor presents a system that interprets slides, considers additional studies, drafts the microscopic description and diagnosis, and organizes the entire case for sign-out.

Everyone turns to Bob.

The difficulty is the expectation his earlier success established. Debugging and validating a 300-line counting program gives little indication of the resources required to evaluate a two-million-line diagnostic system. Those numbers are illustrative; code length itself is no measure of clinical risk. The important change is the breadth of the system’s judgments, its possible failures, and the consequences of relying on it.

A sensible beginning, an unsustainable destination

A historian of innovation might call this path dependence leading to institutional lock-in. Reasonable decisions made for small applications establish habits that persist as the technology changes. The vendor supplies capabilities; the hospital makes them clinically usable. Each incremental step seems manageable, until the accumulated responsibility exceeds what most hospitals can carry.

The frog in the metaphorical pot never expected to face the task of validating a comprehensive diagnostic reporting system. The responsibility grew gradually. The kind of responsibility changed fundamentally.

From a go-kart to a Boeing 777. 

A talented workshop can build ("validate") an excellent go-kart. 

Developing and supporting a passenger airliner requires an organization capable of coordinating engineering, testing, manufacturing controls, training, maintenance, and continuing accountability. 

The workshop’s achievement can be admirable without establishing that its methods will scale to the airliner.

Likewise, an exceptional academic center might build a sophisticated diagnostic system around its own personnel, equipment, and practices. Its success could even obscure the adoption problem. When an ordinary hospital asks to purchase the system, must it also assemble a development team, reconstruct the evidence, maintain custom interfaces, and investigate every consequential update?

A technology can work brilliantly at its birthplace and still lack a workable route to a broad market.

How the RUO Death Spiral Develops

Difficult adoption limits the customer base. A small customer base discourages investment in standardized clinical products. The shortage of those products leaves hospitals dependent on local projects, keeping adoption difficult.

This is the proposed RUO death spiral.

Research-use-only products and laboratory-developed tests are distinct categories; an RUO label does not itself provide a clinical-use pathway. The concern is the broader allocation of development, validation, and support responsibilities to individual institutions. Local innovation has produced valuable advances. The question is how much institutional reinvention the next generation of software can require before its market becomes untenably narrow.

The MRI sales pitch nobody would accept!

Consider another thought experiment. An executive is selling a medical center a top-of-the-line MRI scanner. During the presentation, the executive explains that several essential diagnostic software functions are research-use-only and that the hospital must spend months establishing their clinical performance.

The purchasing committee might wonder what, exactly, it was buying.

This is an invented scenario. Imaging departments have substantial installation, verification, and quality responsibilities. Nevertheless, there is a consequential difference between implementing a supported clinical product and assuming responsibility for turning its essential components into one.

Dr. Wilson’s whiteboard reveals the same problem. In the main essay, she needs to map the products, functions, permitted uses, and responsibilities before she can understand the proposed purchase. Her diligence is appropriate. The amount of disentangling required is itself part of the adoption burden.

The Billion-Dollar Application

The familiar digital workflow puts a scanned slide in front of the pathologist, who examines it, perhaps opens analytical applications, and begins composing a report. The proposed “super app” performs substantial work before the physician arrives: it evaluates the supported case material, identifies findings, assembles relevant images, and prepares a draft interpretation.

Its value depends critically on human interaction. Can the physician move directly from a proposed finding to its image evidence? Correct an error without fighting the interface? Recognize uncertainty and missing information? Reject the draft without having to undo a cascade of dependent entries?

An impressive report that requires laborious checking could increase physician work. A system that reliably reduces work by approximately half on eligible cases could transform purchasing decisions. That remains a performance hypothesis, not an established result for comprehensive pathology reporting. But even across a limited, commercially meaningful range of cases, such savings could support a business case through capacity, turnaround time, and staffing flexibility.

Preparing the case before the physician arrives

The opportunity could extend to preparing the workup itself. In a hypothetical case, software identifies a pattern warranting a special stain. It might recommend the stain, prepare an order for approval, or—within a specifically established scope—initiate the order before physician review. These are three different allocations of responsibility.

At the most ambitious level, the pathologist could encounter the additional stain and preliminary interpretation together, avoiding an entire cycle of opening the case, requesting more work, setting it aside, and returning later. The gain would include elapsed time as well as physician minutes.

Who could establish that this sequence works reliably? Evaluation would need to address missed findings, unsupported statements, inappropriate orders, tissue consumption, erroneous combinations of information, and physician responses to persuasive but incorrect drafts. It would also need to measure the quality and efficiency of the completed case across supported laboratory conditions.

A manufacturer could fund that shared evidence and accept responsibility for a defined, maintained clinical product. Hospitals would retain local implementation, validation, and quality obligations; CAP’s guidance emphasizes those responsibilities. The economic opportunity is to avoid repeatedly recreating the underlying development effort.

Which Pairing Could Break the Cycle?

This brings the argument back to Roche–PathAI and Agilent–Proscia.

Roche–PathAI: building the diagnostic application

Roche–PathAI offers a plausible route through diagnostic development: combine PathAI’s analytical capabilities and AISight workspace with Roche’s tissue-diagnostics experience, regulatory resources, and distribution. A strategy could begin with a defined specimen type and reporting task, establish the complete physician-reviewed workflow, and expand as evidence accumulates. Its strength would be translating analytical expertise into supported diagnostic products.

Agilent–Proscia: organizing the complete clinical workflow

Agilent–Proscia offers a plausible route through the clinical workspace: use Concentriq to assemble cases, connect laboratory systems, coordinate analyses, and present prepared work. Agilent could combine that infrastructure with its diagnostics capabilities and algorithms developed internally or by partners. Its strength would be making multiple capabilities function as one usable clinical system.

These are differences of emphasis. Both platforms encompass workflow and analytical functions. Neither combination should be reduced to “algorithms” on one side and “image storage” on the other.

Which is better positioned to break the cycle? Roche–PathAI presents a strong starting hypothesis for building and establishing diagnostic applications. Agilent–Proscia presents a strong starting hypothesis for organizing their delivery within everyday work. But the proposed breakthrough requires both. The eventual advantage may depend less on the acquired asset than on the purchaser’s willingness to fund—and accept responsibility for—the entire product.

An acquisition alone does not establish that commitment. A compelling plan would specify the initial clinical scope, physician-time target, evidence program, regulatory pathway, integration requirements, support model, and milestones for expansion. Neither announcement establishes an authorized comprehensive draft-report system.

Investing for the Market That Could...Should... Exist

Imagine, finally, a sponsor committing an illustrative $100 million to this undertaking. Skeptics point to slow adoption and limited reimbursement. The sponsor’s competing hypothesis is that demand has been suppressed by incomplete products and the work required to adopt them. A coherent clinical system could create a much larger market than today’s individual applications reveal.

Success would require financing the difficult parts between an impressive demonstration and dependable deployment at the hundredth hospital. Superb human interaction would be central to that investment.

“Built to fail”—if unchanged. That describes the danger if the existing allocation of responsibility persists. Like Scrooge’s encounter with the future, the warning matters because a different course remains possible.

The software may be built to succeed. The system for adopting it may be built to fail. The opportunity for either purchaser is to redesign both together.




Digital Pathology Association Releases 3 Reimbursement Policy Documents

 We're in the run-up to Visions 2026, the annual digital pathology  conference in San Diego this weekend.  Find it here.

DPA has released 3 policy documents on AI and software-intensive reimbursement.

Find the new October Fask Force blog here.

Find the DPA CMS PFS comment letter here.

Find the DPA CMS OPPS comment letter here.


They're summarized individually then holistically below. (Chat GPT 6).  For "Holistic," I stir into the mix their April 2026 blog about new initiatives, plans, and zeal re: reimbursement policy.   DPA April.

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1. October blog — DPA Reimbursement Task Force

30-word summary

The DPA warns that Medicare’s proposed reclassification of diagnostic algorithms threatens payment predictability and laboratory billing, with implications for investment, commercialization, and access extending well beyond the nominal reimbursement rate.

Extended summary

The Digital Pathology Association’s October 10 blog presents Medicare’s proposed 2027 payment changes as a consequential restructuring of reimbursement for diagnostic software. According to the post, CMS proposes removing ten software-only diagnostic algorithms, including several digital pathology laboratory-developed tests, from the Clinical Laboratory Fee Schedule (CLFS). Payment would instead move to Medicare contractor pricing under the Physician Fee Schedule or temporary hospital outpatient payment categories. CMS’s terminology, “Software as a Medical Service” (SaMS), provides the umbrella for this approach.

DPA emphasizes three risks: less transparent rate setting, geographic payment variation, and uncertainty about laboratories’ ability to bill directly. Its defense of the CLFS rests on the system’s established crosswalk and gapfill procedures, opportunities for public participation, and market-based payment updates. Contractor pricing, by comparison, could leave laboratories uncertain about both the amount and timing of reimbursement.

The association advances four positions: retain diagnostic algorithms on the laboratory fee schedule; postpone reclassification while federal agencies reconsider oversight of data-only facilities; establish national prices if services move; and preserve direct laboratory billing without arbitrary reductions for multiple distinct algorithms applied to one specimen.

From a business perspective, the central issue is the predictability of the revenue model. A developer evaluating a diagnostic product needs to estimate who will purchase it, who will submit the claim, what payment will follow, and how long collection will take. Uncertainty across those variables can weaken an investment case even before CMS reduces any published rate. Requiring hospital billing could also change the laboratory’s commercial relationship, making hospital contracting and purchasing decisions more influential in adoption.

The post is therefore best understood as an accessible statement of DPA’s advocacy priorities, rather than a detailed economic assessment. It does not quantify potential payment losses, establish that every affected product would fare worse, or demonstrate that CLFS prices necessarily measure clinical value. Its strongest strategic message is that payment classification can reshape the market for diagnostic innovation. For companies developing algorithms—and equipment suppliers whose growth depends on their adoption—the final policy’s operational details may matter as much as its headline reimbursement provisions.

2. Physician Fee Schedule letter — September 13, 2026

30-word summary

DPA’s physician payment letter defends laboratory classification for diagnostic algorithms, seeks national pricing and direct billing protections, and supports targeted coding reforms while resisting disruptive changes to established reimbursement infrastructure.

Extended summary

DPA’s Physician Fee Schedule letter challenges CMS’s proposal to reclassify algorithm-only laboratory services as “other diagnostic tests,” remove them from the CLFS, and establish payment through local Medicare contractors. Its foundational argument is that computational analysis remains laboratory testing when it depends on information derived from human specimens. Separating the analysis in time or location from the original laboratory procedure should not determine its payment classification. DPA also argues that reclassification is premature while CMS is considering CLIA oversight of data-only facilities.

The letter defends the CLFS as an established framework for pricing proprietary algorithms. It suggests improving transparency through confidential submission of algorithm characteristics, development expenditures, and other relevant information. DPA contrasts private-payer-based CLFS pricing with physician fee schedule resource accounting, which it considers poorly suited to research-intensive software. Economically, however, negotiated market prices and demonstrated clinical value are different concepts; the letter’s case is stronger as an argument for an appropriate pricing framework than as proof that existing prices represent value.

Its fallback requests are concrete. Laboratories should retain direct billing rights, with immunohistochemistry and in situ hybridization offered as precedents for laboratory billing under the PFS. If CMS instead requires enrollment as an Independent Diagnostic Testing Facility, DPA requests at least a year’s delay. It also seeks national pricing derived from the proposed New Technology APC bands, rather than fragmented contractor decisions.

The letter separately supports retaining AMA’s coding infrastructure while improving stakeholder representation, transparency, consistency, and participation in pathology coding deliberations. It rejects ICD-10-PCS as a suitable replacement in its current form. On duplicate testing, DPA distinguishes unnecessary repetition from clinically appropriate serial or complementary testing and urges CMS to address ordering decisions rather than impose the determination on performing laboratories.

The business theme is transition risk across an interconnected reimbursement system. Coding, provider enrollment, pricing, and claims submission must work together before a service can generate dependable revenue. DPA’s strategy combines institutional continuity with targeted reform: preserve functioning infrastructure, improve its weaknesses, and avoid forcing laboratories to rebuild billing operations during a short implementation window. For developers, these provisions affect launch timing, working capital, and the cost of maintaining Medicare access.

3. Hospital Outpatient Prospective Payment System letter

30-word summary

DPA’s outpatient letter challenges moving laboratory algorithms into hospital payment, highlighting billing eligibility, pricing methodology, multiple algorithm discounts, and service dates as determinants of commercial viability and patient access nationwide.

Extended summary

DPA’s OPPS letter examines CMS’s proposed transfer of algorithm-only laboratory services from the CLFS to separately payable New Technology Ambulatory Payment Classifications (APCs). It supports the concept of “Software as a Medical Service” terminology but cautions against treating laboratory-developed algorithms, FDA-authorized laboratory software, and imaging software as interchangeable. It also requests coordination with the ongoing CLIA review before payment policy settles questions about the status of computational laboratory services.

The preferred position is to retain algorithm-only LDTs on the CLFS. DPA argues that these analyses depend on human specimens and remain laboratory services despite using digital inputs. It favors established laboratory pricing processes over hospital cost-and-charge methodologies, which may poorly represent the economics of developing and validating proprietary algorithms.

The letter nevertheless offers a differentiated fallback. For laboratory software devices that other provider types may perform, DPA supports interim New Technology APC placement. Existing CLFS prices should inform APC assignments for previously priced services; hospital invoice prices should inform assignments for new services.

Direct billing is a central concern. Because OPPS pays hospital outpatient departments, independent laboratories could lose their ability to bill directly and instead have to contract with hospitals. From a business perspective, that would alter the sales channel and bargaining relationship: laboratories would depend more heavily on hospital procurement, contract terms, and payment practices. Preserving a nominal Medicare rate would not necessarily preserve the laboratory’s realized revenue or margin.

DPA also opposes automatic discounts for multiple algorithms applied to the same data, emphasizing independent development, validation, and clinical purposes. The economic distinction deserves care: separate development costs do not establish that shared operational efficiencies are impossible. A persuasive payment policy would distinguish demonstrable shared costs from the value and costs of distinct analyses.

Finally, DPA requests that, if reclassified, these services use the report-return date as their date of service, supporting billing after outpatient discharge. It also seeks faster, more predictable APC application decisions.

The letter thus addresses the mechanics of commercialization as much as reimbursement levels. Billing eligibility, service dates, discounts, and administrative timelines collectively determine whether a technically reimbursable product can sustain a workable business model.

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PULLING IT ALL TOGETHER

and adding also their April 2026 v"big viewpoint' blog.

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Read together, these four documents reveal a field making progress in organizing its advocacy while confronting a harder question: what, exactly, is the economic product that digital pathology expects Medicare to purchase? April’s ambitions encompass digital pathology infrastructure, clinical implementation, and AI adoption. The later letters concentrate on protecting reimbursement for particular algorithmic diagnostic services. Those objectives overlap, but success on the second does not automatically finance the first.

The shift from April’s “Full Speed Ahead” to October’s defensive posture is revealing. April announces two institutional investments: a recommendation statement on clinical AI and an experienced Washington advisory partner. The subsequent letters demonstrate the value of the latter through detailed, operationally informed advocacy. Defending an existing payment pathway against disruption is meaningful work. Nevertheless, the documents establish a stronger case that DPA has developed an advocacy capability than that the industry has developed a comprehensive reimbursement strategy. These are different stages of progress.

The strongest arguments concern commercial continuity. The letters recognize that a payment rate is useful only when an eligible entity can submit a payable claim. Questions about laboratory enrollment, direct billing, service dates, and implementation periods therefore reach the foundations of the business. A company can survive an imperfect reimbursement methodology more readily than a period during which nobody knows how it can collect payment.

The business consequences extend beyond administrative expense. Moving a laboratory from direct Medicare billing into hospital contracting changes who controls customer access and negotiates the laboratory’s compensation. Even an unchanged Medicare payment could produce a lower laboratory margin, longer collection times, or slower adoption. Conversely, hospitals might favor services that fit their procurement and clinical workflows over otherwise attractive products requiring bespoke contracts. Payment classification can influence market structure without CMS explicitly choosing commercial winners.

DPA is particularly persuasive in exposing these transition risks. Its broader claim that computational services belong on the CLFS requires more careful handling. The letters themselves cite laboratory services already paid under the PFS, including immunohistochemistry. Consequently, showing that an algorithm is a laboratory service—or that its provider requires CLIA certification—does not by itself settle the appropriate payment system. Regulatory identity and payment classification are related questions, but they are not interchangeable. The stronger economic defense of CLFS placement concerns the nature of the diagnostic service, the suitability of its pricing mechanisms, and the costs of disrupting an established pathway.

April’s discussion of evidence also deserves a sharper distinction. A recommendation statement can improve validation practices, establish professional expectations, and make clinical implementation more credible. Those are valuable contributions. But a statement describing how AI should be validated is not itself evidence that a particular product changes management, improves outcomes, or merits a particular price. The April blog sometimes compresses that distance when describing the pending statement as the evidence base for future payment requests.

The missing bridge is product-specific execution. Who will fund the studies, select the clinical indications, recruit participating laboratories, establish meaningful comparators, and pursue coverage decisions? These four documents do not answer that question. That does not establish that such work is absent elsewhere; it means the published strategy should not be mistaken for a funded development program. An association can create standards and improve the policy environment. Individual sponsors still need to turn those advantages into reimbursable products.

The letters’ economic arguments likewise mix several distinct concepts: development expenditure, service delivery cost, negotiated market price, and clinical value. High development costs explain why a company needs substantial revenue across its installed base. They do not independently establish what Medicare should pay for each analysis. Private-payer prices provide market evidence, but they are not direct measurements of patient benefit. The argument would be more durable if these were presented as complementary considerations rather than interchangeable justifications.

This distinction becomes especially important in the opposition to multiple-algorithm discounts. DPA reasonably argues that independently developed tests answering different clinical questions should not be treated as redundant simply because they use the same image. But its categorical assertion that additional algorithms generate no marginal efficiencies is vulnerable. Shared image preparation, data transfer, integration, reporting, and commercial infrastructure could produce efficiencies even when each algorithm required separate validation. A stronger position would demand evidence of actual shared costs before imposing a discount, while protecting payment for distinct diagnostic contributions.

Looking ahead, the largest strategic tension may be between proprietary tests and integrated software platforms. The letters largely defend a model in which a discrete algorithm generates a discrete billable result. That model can support valuable diagnostics. Yet an increasingly capable platform could combine several predictions, quality checks, measurements, and reporting functions within one workflow. If each incremental function requires a separate reimbursement campaign, commercial integration could advance faster than payment policy can accommodate.

Companies therefore need to distinguish among three economic propositions: a diagnostic test purchased for its clinical information; a workflow tool purchased for productivity or capacity; and infrastructure purchased to enable a broader service. Some products combine them, but the purchasing rationale remains important. A tool that substantially reduces interpretation time may have a compelling business case through operating savings. A separately ordered prognostic test may depend much more heavily on coverage and a defined payment. Scanner adoption may depend on the combined economics of both. “Digital pathology needs reimbursement” is too broad to guide investment across these categories.

For equipment suppliers, that creates an additional question: does a policy victory expand the overall digital pathology market, or mainly protect revenue for a limited group of proprietary tests? Both can be worthwhile, but they offer different returns to the ecosystem. A scanner manufacturer’s interest in widespread adoption will not always coincide perfectly with an algorithm developer’s interest in preserving payment for each individual analysis.

The next stage should make April’s promise of measurable progress concrete: named clinical applications, accountable sponsors, evidence budgets, coding and coverage milestones, and explicit assumptions about who purchases and bills each service. The later letters provide capable protection against foreseeable policy disruption. The larger opportunity is to connect that advocacy to an executable commercial program—one that can explain which products become viable, for which customers, on what evidence, and over what period.

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Handy Reference: AMA, ASCO, CAP Positions on the Awful 14-Day Rule

The 14-day rule or Date of Service rule is generally unpopular with oncologists and cancer patients and societies.   Here are some recent (2024) positions from ASCO, AMA, CAP.

The topic is found on page 22 of a 40 page summary document from AMA.

The topic is also found on pages 136-137 of the longer meeting handbook.

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2024 AMA Governing Council Report (40pp)

https://www.ama-assn.org/system/files/i24-omss-report-a.pdf

See page 22 of 40 (aka Item 18).


RESOLVED, that our American Medical Association actively lobby the federal government to readdress and change laboratory date of service rules under Medicare, e.g. the Medicare 14-Day Laboratory Date of Service Rule (Medicare 14-Day Rule), such that complex laboratory services performed on pathologic specimens collected from an inpatient hospital procedure be paid separately from inpatient bundled payments, consistent with Outpatient rules. (Directive to Take Action). 

Note this is for inpatients, as the outpatient rule as fixed in 2017.

Note the main sponsor was, ASCO.

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2024 Minutes of Reference Committee B (142pp)


See pages 136-137 (as item 225).

Opening:


2024 CAP Policy Update   11-14-2024


Elimination of Medicare 14-Day Rule

The CAP supported a resolution asking the AMA to actively lobby the federal government to readdress and change laboratory date of service rules under Medicare, eg the Medicare 14-Day Laboratory Date of Service Rule, such that complex laboratory services performed on pathologic specimens collected from an inpatient hospital procedure be paid separately from inpatient bundled payments, consistent with outpatient rules.

The CAP appreciates the improvements to Medicare’s laboratory DOS policy to date. However, these improvements did not address hospital inpatients and payment for some tests is still problematic. Regardless of the place of service, a revised DOS policy that allows the performing laboratory to bill directly for molecular pathology tests and ADLTs, rather than receiving payment from the hospital, would reduce administrative/billing complexity for hospitals, clinical laboratories, treating physicians and Medicare beneficiaries, and promote timely access to patient testing.

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Full text of Minutes, Committee B, Item 225 (seen above) p 136-137

Whereas, our American Medical Association adopted D-330.903 at I-17, which asks our AMA “actively lobby the federal government to change laboratory Date of Service rules under Medicare such that complex diagnostic laboratory services performed on pathologic specimens collected from a hospital procedure be paid separately from inpatient and outpatient bundled payments”; and

Whereas, AMA advocacy on the CY 2018 Medicare Outpatient Prospective Payment System Rule was successful in getting complex molecular testing unbundled from outpatient diagnostic procedures – such as outpatient interventional radiology biopsies; and

Whereas, the Medicare 14-Day Laboratory Date of Service Rule (Medicare 14-Day Rule) provides billing requirements for diagnostic tests ordered for Medicare patients and determines whether the clinical laboratory performing the tests will directly bill Medicare or bill the hospital where the specimen was collected; and

Whereas, the Medicare 14-Day Rule was not changed for specimens collected during an inpatient encounter, with complex molecular tests ordered within 14 days of hospital discharge continuing to be bundled into inpatient Medicare payments; and

Whereas, performing complex molecular tests on inpatient samples parallel the criteria established for unbundling testing of outpatient samples: including it being medically appropriate to have been collected during the hospital inpatient encounter, the results of the test not guiding treatment during the hospital inpatient encounter, and the test being reasonable and medically necessary for the treatment of an illness; and

Whereas, the real-world effect of an inpatient Medicare 14-Day Rule is to routinely delay the initiation, until 14 days after discharge, of complex molecular tests on pathologic samples collected during an acute hospitalization, such as cytology from an inpatient thoracentesis for a new diagnosis of lung cancer; and

Whereas, diagnostic delay of pivotal molecular data due to the inpatient Medicare 14-Day Rule causes harm to patients, such as forcing an initial round of an inferior cytotoxic chemotherapy on newly diagnosed lung cancer patients while awaiting candidacy for a more efficacious targeted agent; therefore be it

RESOLVED, that our American Medical Association actively lobby the federal government to readdress and change laboratory date of service rules under Medicare, e.g. the Medicare 14-Day Laboratory Date of Service Rule (Medicare 14-Day Rule), such that complex laboratory services performed on pathologic specimens collected from an inpatient hospital procedure be paid separately from inpatient bundled payments, consistent with Outpatient rules. (Directive to Take Action).

 

Fiscal Note: Modest – between $1,000 - $5,000 

Received: 9/24/2024 

 

REFERENCES 

1.   American Medical Association. Follow-Up on Implementation of Resolutions and Report Recommendations, AMA House of 

Delegates Interim Meeting - November 8-11, 2017. https://www.ama-assn.org/system/files/2018-11/i17-followup-status-
report_0.pdf   

2.   Centers for Medicare & Medicaid Services. Laboratory Date of Service Policy. https://www.cms.gov/medicare/payment/fee- schedules/clinical-laboratory-fee-schedule-clfs/date-service-policy    

3.   Foundation Medicine. 14-Day Rule Billing Requirements for Foundation Medicine Tests. 
https://www.foundationmedicine.com/sites/default/files/media/documents/2024-
08/14%20Day%20Medicaid%20Rule_One%20Pager_LaboratoryDateOfService_June%202024_US-PF-2200092_R4.pdf   

 

RELEVANT AMA POLICY 

Elimination of Laboratory 14-Day Rules Under Medicare D-330.903 

Our AMA will actively lobby the federal government to change laboratory Date of Service rules under 
Medicare such that complex diagnostic laboratory services performed on pathologic specimens collected  from a hospital procedure be paid separately from inpatient and outpatient bundled payments