Tuesday, October 20, 2026

National Kidney Plan, 10/2026: Key Sightlines into CMS Innovation Frames

A new national kidney care plan was a major effort in the Trump-1 administration (2019 here).  One of the leaders, Abe Sutton, now heads CMMI.   

In October 2026, HHS announces an updated Kidney Plan.  Worth tracking. It gives important sightlines into how this CMS views healthcare innovation.

  • A Google-AI summary is here.
  • The new Kidney Care National Plan, KCNP, home page is here.
  • See the 17-page white paper here.
  • See the press release here.


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AI CORNER    

See the six page white paper PDF  here.



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HHS’s Kidney Care Plan: A Window into How CMS Thinks About Innovation

DaVita’s response exposes a central policy debate: how should government reward innovation while ensuring that established providers face meaningful competition?

HHS’s Kidney Care National Plan offers a revealing look at how federal officials think innovation happens and why it sometimes stalls. For readers following CMS policy, the significance extends beyond dialysis. The plan connects prevention, payment incentives, competition, and regulatory reform. DaVita’s response exposes the central tension: government sees entrenched structures that may impede progress, while a major provider argues that its scale helps deliver it. The next challenge is turning those positions into policy.

A Kidney Strategy with Broader Policy Implications

On October 20, 2026, HHS released its Kidney Care National Plan, outlining an agenda for earlier intervention, better dialysis options, and expanded transplantation. For readers following CMS innovation policy, the document deserves attention well beyond kidney care. It offers an unusually explicit argument about how government payment, regulation, and market concentration can shape—or suppress—innovation.

The HHS announcement describes a department-wide effort spanning payment policy, research, product regulation, and oversight. Its ambitions are broad: prevent kidney failure, expand patient choice, and improve transplantation. The accompanying plan goes considerably further in diagnosing why progress has been inadequate.

Its central contention is that disappointing outcomes reflect the incentives and institutions government helped create. Medicare is consequently both the payer confronting the consequences and a policymaker with considerable responsibility for changing them. The full argument appears in the supplied plan, especially its discussion of competition and prevention on printed pages 4–12.

DaVita’s response supports many of the goals while challenging that diagnosis. The exchange is a useful case study in what “innovation” means to an agency, a payer, and a major provider.

Looking at the Market Government Helped Build

The plan argues that dialysis facility requirements can impose substantial upfront costs on new entrants, including providers pursuing home-based approaches for which conventional facility infrastructure may be less necessary. It also questions whether established payment arrangements offer a durable business case for adopting better technologies.

This is a broader policy inquiry than deciding whether to increase a reimbursement rate. HHS is asking whether the conditions for receiving payment favor particular organizations, facilities, and delivery methods.

For an innovation company, those conditions can matter as much as the quality of its product. A technology may work clinically yet struggle commercially if providers cannot finance its adoption or prospective customers have little incentive to change.

The plan is also unusually confrontational about incumbent behavior. It discusses physician financial relationships, contracting restrictions, bargaining power with insurers, and third-party premium assistance. These are HHS’s concerns and policy arguments; the document should not be read as an adjudication that any particular company has violated the law. Nevertheless, their prominence signals that HHS sees competition policy as part of health innovation policy.

Prevention’s Problem: Who Pays, and Who Benefits?

The most interesting payment problem concerns who benefits from prevention. An insurer or employer may pay today for earlier detection and treatment, while Medicare receives much of the eventual financial benefit if kidney failure is delayed or avoided. Patients can change coverage before those benefits emerge. Providers likewise may have no practical way to capture the value of preventing an expensive event years later.

The plan therefore identifies a mismatch between the party making the investment and the party receiving the return.

That is a consequential diagnosis for CMS. Encouraging prevention through education alone does not solve it. Nor does an additional payment for a screening encounter necessarily create sustained incentives for treatment and follow-up.

The document proposes exploring accountability across the course of disease, earlier intervention, sustainable financing for new technologies, and coordination among payers. Its recommendation to consider a multi-payer summit acknowledges that Medicare cannot fully solve a problem created by patients moving among coverage arrangements simply by changing one Medicare payment.

The difficult implementation questions remain: Who pays upfront? Who receives credit for avoided kidney failure? How long must a model run? How should it distinguish a treatment effect from differences in the patients who enroll?

The plan identifies the economic problem more clearly than it specifies the contractual solution.

CMS Experiments: Better Outcomes Can Still Cost More

DaVita invokes the Kidney Care Choices model as evidence that value-based kidney care can meaningfully improve patients’ lives. CMS’s evaluation supports important parts of that argument—but adds a financial complication.

According to CMS, the model’s second performance year produced improvements in home dialysis, optimal starts to dialysis, and preemptive and living-donor transplantation. Yet it also produced an estimated $304 million net loss to Medicare in performance year 2023. CMS has continued the model through 2027 while changing its financial methodology and participation options.

Those findings deserve to be presented together. Better care is valuable. Better care does not automatically establish that a particular payment model saves money.

The HHS plan also acknowledges the termination of the separate ESRD Treatment Choices model after it failed to achieve its intended results or anticipated savings. The policy lesson is that a plausible incentive mechanism remains an experiment. Participation, enthusiasm, and improved intermediate measures are insufficient substitutes for evaluating the full result.

The proposed direction is to move intervention earlier. The plan points to CMS’s ACCESS model, which tests recurring payments for technology-supported chronic care, with full payment tied to measurable outcomes. Its covered conditions include stage 3a and 3b chronic kidney disease.

The plan indicates that HHS wants CMS to make preserving health a more dependable business proposition. That requires defining an outcome worth purchasing, establishing credible measures, and offering a payment structure under which organizations can deliver it.

DaVita’s Rebuttal: Scale Can Support Innovation

DaVita’s statement contains a particularly direct sentence:

“Where we differ is the suggestion that kidney care has lacked innovation or that scale stands in its way.”

The company describes investments in coordinated care, transplant navigation, proprietary technology, and a clinical innovation being deployed across its centers. It argues that organizational scale supplies the expertise and capital needed to develop improvements and spread them widely.

That is a substantive response. HHS emphasizes the possibility that concentration protects established practices and discourages entry. DaVita emphasizes the possibility that size enables investment and rapid adoption.

Both mechanisms can operate in the same market. A large provider can introduce a meaningful improvement while also benefiting from conditions that make competing delivery models difficult to establish. Evidence of innovation by an incumbent does not, by itself, settle whether the market produces enough innovation or gives patients sufficient choice.

Conversely, identifying concentration does not establish that smaller organizations would necessarily deliver better care. HHS will need evidence that particular changes in entry requirements, contracting, or payment actually improve access, quality, and costs.

DaVita also makes a clinically important distinction: preventing future kidney failure and treating people who already have it are simultaneous obligations. A prevention strategy must preserve effective care for patients whose need for dialysis cannot be eliminated by earlier intervention today.

Transplantation: Innovation Includes Institutional Reform

DaVita emphasizes the shortage of viable organs. HHS also examines the institutions governing organ procurement, allocation, and transplantation: regional monopolies, payment incentives, contractor arrangements, transparency, and accountability.

The difference in emphasis matters. An organ shortage can coexist with avoidable failures to identify donors, support living donation, recover organs, or complete transplantation. The plan treats those organizational processes as legitimate targets for innovation.

The press release connects this agenda to living-donor assistance, transplant system oversight, and a proposed national expansion strategy.

This also reveals a tension within the administration’s approach. The plan favors reducing barriers and limiting unnecessary regulation, while calling for stronger accountability and enforcement in selected areas. In practice, its proposed federal role is highly active: redesign payment, reconsider entry requirements, scrutinize market behavior, modernize procurement, and enforce performance expectations.

What Happens Next Matters More Than the Announcement

Many recommendations say HHS “should consider” an action or “could” explore a model. The plan itself does not establish a new nationwide prevention benefit, finalize a payment methodology, or complete the proposed regulatory reforms.

For CMS observers, the useful next questions are concrete:

  • Does a new model reach patients early enough to change disease progression?

  • Can new providers participate without reproducing the infrastructure of incumbent organizations?

  • Are outcomes measured over a credible period?

  • Do payments reward improvements that would otherwise not occur?

  • Are patients already dependent on dialysis protected as incentives change?

The document’s larger significance is its willingness to examine the relationship between public policy and private business models. HHS is arguing that innovation depends on what the healthcare system makes financially possible, attractive, and scalable. DaVita is arguing that established organizations already possess important capabilities for delivering that progress.

Effective policy will require CMS to preserve those capabilities while making room for approaches that the existing system has little reason to adopt.

Key Takeaways and Surprises

  1. HHS is questioning the market structure its own rules helped create. Facility requirements and payment arrangements are being examined as possible barriers to innovation and entry.

  2. Prevention faces a financial coordination problem. The organization paying for early intervention may never receive the savings. The proposed multi-payer discussion acknowledges that changing Medicare alone may be insufficient.

  3. A model can improve care while increasing Medicare spending. Kidney Care Choices illustrates why clinical gains and financial performance must be evaluated separately.

  4. DaVita and HHS disagree about the role of scale. HHS emphasizes protection from competition; DaVita emphasizes investment capacity and the ability to spread improvements. Both claims require evidence.

  5. “Less regulation” comes with an active federal agenda. The plan combines easier market entry with stronger oversight, scrutiny of business practices, and accountability for transplant organizations.

  6. Innovation includes changing institutions. Procurement arrangements, donor support, referral processes, and payment incentives can influence outcomes alongside new drugs and devices.

  7. The plan’s diagnosis is more definite than its implementation. Its criticism of existing structures is forceful, but many remedies remain proposals to consider. The decisive developments will be specific model designs, payment terms, and regulatory actions


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What's the logic of Da vita's rapid disagreement ???
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Yes—DaVita is explicitly putting its disagreement on the record. But it has chosen a fairly careful form of disagreement: support the administration’s goals, challenge its characterization of the industry, and offer continued cooperation. Whether responding within roughly four hours was smart depends partly on what HHS said publicly beyond the written plan; the exact interval hasn’t been verified here.

Your concern is reasonable. The sentence “Where we differ…” is conspicuous. It ensures that the response cannot be mistaken for an uncomplicated endorsement.

There are several reasons that might nevertheless be a calculated choice:

  • The criticism threatens DaVita’s legitimacy, not just a payment rate. HHS is suggesting that established market structures impede progress. Silence could allow the narrative to harden that large dialysis companies are obstacles to better care.
  • The audience includes investors, employees, physicians, and patients. A plausible purpose of the rapid response is to reassure those groups that the company has an answer and intends to defend its role.
  • DaVita needs to remain a potential implementation partner. Its emphasis on existing capabilities makes the argument that HHS can achieve some of its goals by working with the company.

The statement is diplomatically constructed. It begins with shared urgency, credits the plan with reflecting DaVita’s priorities, identifies a narrow disagreement, and closes with cooperation. It avoids naming or criticizing individual officials. That is controlled pushback, rather than a declaration of war.

But there is a strategic weakness: DaVita partly answers a broader structural criticism with examples of its own innovation. HHS could readily respond: “We did not say you have never introduced anything useful. We said the market could deliver more innovation with stronger competition.” Similarly, saying that scale finances innovation does not resolve whether particular contracting arrangements inhibit competitors.

The paragraph insisting that prevention must not be conflated with lifesaving dialysis is also pointed. It could be read as a necessary defense of current patients—or as suggesting that HHS does not understand an elementary clinical distinction. That is where the tone risks becoming irritating to officials.

On balance, a public response was defensible; the speed and explicit disagreement were optional. A softer formulation could have preserved the substance: “Achieving these goals will require both new entrants and the investment and clinical capabilities of established providers.”

The more revealing question is whether DaVita privately briefed HHS before issuing the statement. Advance notice could make this routine stakeholder positioning. A surprise rebuttal, hours after a flagship announcement, carries more relationship risk. The public statement alone does not tell us which occurred.

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One more time...why Da Vita says "something" today instead of "nothing" ???

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Silence was a perfectly reasonable option. The earlier answer overstated the risk that silence would be interpreted as agreement.

The argument against silence is that HHS had publicly challenged the industry’s structure and incentives. DaVita might want investors, employees, and physician partners to hear promptly that it disputes the implication that its size obstructs innovation. That is a reason to respond—but it does not require an immediate public rebuttal.

Silence would have offered several advantages:

  • Let HHS have its announcement without creating a second story about industry disagreement.
  • Allow private conversations to clarify which criticisms might become actual policy.
  • Preserve the opportunity to respond later with evidence and specific proposals.
  • Avoid defending the existing system before knowing precisely what changes HHS intends.

A company does not concede a policy argument by declining to contest it on announcement day. It could also issue a short statement welcoming prevention and patient choice, leaving its objections for private meetings or subsequent comments.

The strongest reason for an immediate rebuttal would be a concrete need to reassure stakeholders—for example, substantial investor concern or damaging public allegations. We have not established that such a need required this particular response.

So your instinct is sound: given a potentially sensitive agency and an exploratory plan, public restraint combined with vigorous private engagement could have been the smarter opening. DaVita’s statement was measured, but measured disagreement can still be unnecessary disagreement at that moment.

Four Transcripts and a Sale: LabCorp Adopts Myriad "Prenatal Health" Assets

Just days after LabCorp agrees to acquire BioReference from OPKO, LabCorp agrees to buy Myriad Prenatal Health assets for $210M.

Here, we let Chat GPT write the full case, including the assets, their origins, and how Myriad's public discussion of the business evolved over four quarters.

As always with these reports, they are AI generated reported and not ground truth.  However they service as examples of current AI capabilities to understand requests, research, organize, and write.



Find the 11-page PDF report   HERE.
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Summary.  Myriad’s $210 million prenatal divestiture marks a strategic retreat from a business assembled through acquisitions and expanded through internal innovation. Labcorp gains four products, an established customer base, and FirstGene, launched only three months earlier. Across four earnings calls, management’s narrative shifted from recovery after ordering disruptions to persistent commercial weakness and portfolio review. The evidence does not establish that software problems caused the sale. A stronger interpretation combines disappointing recovery, competitive pressure, reimbursement friction, and oncology investment priorities. For Labcorp, the transaction offers consolidation and integration opportunities; for Myriad, it exchanges uncertain future growth for cash and strategic focus.

Myriad’s Prenatal Exit:
What Four Earnings Calls Reveal
 About the Labcorp Transaction
Analysis as of October 20, 2026

The transaction. Myriad has agreed to sell its Prenatal Health testing business to Labcorp for $210 million in cash, plus inventory at closing. Labcorp projects approximately $160 million of first-year revenue, slight first-year adjusted earnings accretion, and profitability reaching its average Diagnostics segment margins by the end of year two. Closing is expected by early 2027, subject to regulatory clearance and other conditions. These are announced expectations, not completed results. The joint announcement is available here. Labcorp

The SEC filing adds useful substance. This is an asset transaction involving specified assets and liabilities, employee offers, a patent license agreement, and transition services. It is therefore more than a transfer of four trademarks, but it is not an acquisition of Myriad itself. The contractual initial outside date is February 19, 2027, with a potential regulatory extension to October 19, 2027. Certain regulatory termination circumstances could require Labcorp to pay a $10.5 million fee. sec.gov

What “Prenatal Health” means at Myriad. The company’s dedicated prenatal screening webpage describes a portfolio spanning reproductive carrier assessment, fetal chromosome screening, fetal single-gene risk assessment, and early fetal-sex prediction. The four products have distinct purposes:

ProductPrincipal purposePlace in the portfolio
ForesightIdentifies carriers of inherited conditions that could be transmitted to offspringRelevant before pregnancy as well as during pregnancy
PrequelUses maternal blood to screen for fetal chromosomal conditionsMyriad’s established noninvasive prenatal screening product
SneakPeekPredicts fetal sex from early pregnancyA consumer-facing offering, including at-home access
FirstGeneCombines patient carrier status, fetal single-gene risk, fetal chromosome screening, and fetal RhD assessmentAn integrated prenatal assay with one maternal blood draw

Myriad markets FirstGene for use beginning at eight weeks, without requiring a reproductive-partner sample. Its four components should not be confused with four separate acquisitions. Nor should its carrier component be assumed to reproduce the full breadth of every Foresight panel. Myriad Genetics

An important boundary: Myriad is selling prenatal testing, not all testing sold through women’s-health practices. Historically, its Women’s Health business included both prenatal products and hereditary cancer testing for unaffected patients. MyRisk remains in the Cancer Care Continuum category. Thus, the transaction does not imply abandoning OB/GYN relationships or hereditary breast and ovarian cancer assessment. investor.myriad.com

Where the assets came from—and what Myriad paid. The portfolio combines two acquisitions with subsequent development.

OriginDateFinancial termsPrincipal contribution
Counsyl acquisitionAnnounced May 28, 2018; completed July 31, 2018$375 million announced; subsequent SEC reporting recorded $405.9 million of total considerationForesight and the prenatal screening business then branded Prelude, subsequently Prequel
Gateway Genomics acquisitionNovember 1, 2022$67.5 million upfront, with up to $32.5 million contingent considerationSneakPeek and its consumer distribution capabilities
Myriad product developmentSubsequent years; FirstGene commercially launched July 21, 2026No separate FirstGene acquisition price identifiedIntegration and extension of prenatal technologies into FirstGene

The Counsyl announcement and closing release establish the 2018 chronology. The Prelude-to-Prequel lineage is also documented in the scientific literature. investor.myriad.com

The $375 million versus $405.9 million distinction deserves attention. The SEC acquisition note reports $278.5 million in cash and approximately three million Myriad shares valued at $127.4 million. Those shares were valued at the closing-date market price. The widely cited announcement price therefore differs from the subsequently recorded consideration. sec.gov

Gateway should not casually be described as a $100 million acquisition: that was the maximum upfront-plus-contingent opportunity. Myriad’s 2024 annual report valued the remaining Gateway contingent consideration at zero because achievement of the targets was not considered probable. myriad.gcs-web.com

Using Counsyl’s announced price plus Gateway’s upfront payment produces $442.5 million. Substituting Counsyl’s subsequently reported consideration produces $473.4 million. Both substantially exceed today’s $210 million headline sale price.

That comparison is striking, but it is not an investment-return calculation or an accounting loss estimate. The purchases and sale have different asset and liability boundaries; Myriad operated the businesses for years; cash flows occurred in the meantime; and additional development spending created products that did not exist at acquisition.

The original strategy was broader than prenatal testing. In 2018, Myriad envisioned combining Counsyl’s reproductive products with hereditary cancer testing to increase physician reach and provide a comprehensive women’s-health offering. In 2022, Gateway added an earlier consumer entry point: families buying SneakPeek could become aware of Myriad’s other genetic tests. investor.myriad.com

One interpretation is that the 2026 sale reverses that organizing principle. The earlier strategy emphasized a shared customer and life-stage relationship. The emerging strategy emphasizes disease-specific investment, particularly cancer. A common ordering physician does not necessarily make two businesses equally attractive destinations for capital.

The Four Call Record

The four-call record. The relevant window is Q3 2025, Q4 2025, Q1 2026, and Q2 2026. Myriad’s next quarterly call is November 4, after this announcement.

The reported prenatal figures provide an anchor for interpreting management’s language:

Reported quarterPrenatal revenueRevenue change, year over yearVolume change, year over year
Q3 2025$44.5 million+2%−3%
Q4 2025$44.9 millionFlat−6%
Q1 2026$41.9 million−15%−12%
Q2 2026$39.8 million−16%−9%

These are the prenatal product-category figures, not total Women’s Health revenue. The Q2 call rounded revenue to $40 million; the financial table reports $39.8 million. investor.myriad.com

November 3, 2025: recovery remained the working assumption. On the Q3 call, management described improvement after the second-quarter ordering disruption. Legacy Prequel and Foresight volumes were approximately flat year over year. The broader category’s 3% volume decline reflected lower SneakPeek demand, an important distinction between the clinical-testing narrative and the aggregate figures. Roic AI

Analysts Puneet Souda and David Westenberg pressed on competitive share shifts and why the ordering-system effects persisted. Management’s explanation was that large customers already used multiple laboratories and had shifted volume away during the disruption. Fixing the operational problem did not automatically restore their orders.

FirstGene remained a prospective growth catalyst. Nevertheless, oncology was already the first strategic priority, while prenatal and mental health were expected to grow within disciplined resource allocations. The emerging hierarchy preceded the sale: prenatal remained strategically useful, but oncology had first claim on incremental investment. Roic AI

February 23, 2026: the recovery timetable became more qualified. On the Q4 call, management described renewed prenatal volume softness and warned of a difficult first-quarter comparison. It still anticipated recovery from Q2 onward, supported by a more focused sales effort and FirstGene.

Analysts asked whether competition was contributing and how widespread the remaining customer problem was. Brian Donnelly said accounts unaffected by the ordering issue were growing at or above market. Sam Raha described the original implementation as a “self-induced error” and said the company had reviewed its other ordering systems.

FirstGene remained scientifically encouraging, but the CFO said guidance did not assume a sizable direct contribution from it. The product could also reopen conversations about the existing portfolio.

The important change was a more conditional recovery thesis: customer reactivation, commercial execution, and a new-product conversation all needed to work. The Motley Fool

May 5, 2026: analysts challenged the recovery premise directly. On the Q1 call, Brandon Couillard questioned whether annual prenatal volume growth remained realistic, given weak year-over-year results and only modest sequential improvement.

Management pointed to a dedicated prenatal sales team and FirstGene. Crucially, Raha said the order-to-report operational problems had been absent for several quarters. The remaining challenge was commercial execution.

The call also clarified FirstGene’s economic thesis: Myriad intended to launch using existing billing codes, expected higher average revenue per test, and believed that would more than offset somewhat higher processing costs. A dedicated code was a possible later development.

This was still an investment-and-recovery story. But it was explicitly no longer a story about waiting for broken software to be repaired. The unresolved question was whether restored operations and differentiated science would translate into renewed ordering and attractive economics. investing.com

July 30, 2026: disappointing execution became a portfolio question. On the Q2 call, management acknowledged less progress than expected in prenatal, citing sales-force expansion timing and competitive dynamics. It reported declines in both volume and average revenue per test. FirstGene had launched the previous week, and some customers were returning to trial it.

At the corporate level, management described a rigorous portfolio evaluation. The accompanying release connected the strategic review to growth, profitability, and liquidity. Myriad reduced its annual revenue outlook and suspended adjusted EBITDA guidance while assessing its operational initiative, Ascend.

The question had changed from how quickly prenatal would recover to where Myriad should allocate capital. That is the clearest public bridge to the October transaction. It does not establish when negotiations began or that management had already decided to sell during the July call. investing.com

Could a software problem really explain the divestiture? Your skepticism is warranted. The evidence supports a narrower causal chain:

  • Management attributed an initial loss of customer volume to the ordering rollout.
  • Management repeatedly distinguished fixing operations from recovering customer orders.
  • Subsequent disclosures broadened the problem to commercial execution, competition, and reimbursement.
  • The eventual sale was presented as the outcome of a strategic review.

The plausible mechanism is persistent customer displacement after a temporary disruption. A practice that already sends specimens to several laboratories can redirect orders quickly. Once another laboratory becomes the established workflow, the original provider must win those orders back.

But plausibility is not proof of magnitude. Public disclosures do not quantify how much lost revenue was attributable to the implementation, identify the affected accounts, or isolate the effects of competitor offerings and payer behavior. They certainly do not demonstrate that the software episode was the decisive reason for selling.

The stronger interpretation is that prenatal’s recovery disappointed while other businesses competed for management attention and investment. The incident may have contributed to that situation; the transaction reflects a broader judgment about ownership and capital allocation.

What the price and revenue tell us. The $210 million headline price represents approximately 1.31 times Labcorp’s projected first-year revenue. Myriad’s latest four reported prenatal quarters total approximately $171.1 million; annualizing Q2’s $39.8 million produces $159.2 million. Labcorp’s $160 million forecast is therefore close to the latest quarterly revenue pace. These are calculations from the disclosed figures, not company-provided valuation multiples. Labcorp

That alignment suggests a transaction underwritten around the current business, with potential improvement to follow. It does not demonstrate that Labcorp assigned FirstGene little value: the companies have not disclosed a product-level valuation or revenue bridge.

Nor does Myriad’s claim of growth accretion mean selling the business increases total revenue dollars. Removing a slower-growing or declining business can improve the remaining company’s percentage growth rate while reducing its size. Profitability improvement depends on the earnings contribution sold, expenses eliminated, and overhead left behind.

Myriad ended Q2 with $115.2 million in cash and reported $30.8 million of first-half adjusted free-cash outflow. Against that background, $210 million of gross proceeds is financially consequential, although it cannot simply be added to June cash to forecast the closing balance. sec.gov

Why Labcorp can see opportunity in a business Myriad is exiting. Labcorp already offers MaterniT prenatal screening and Inheritest carrier screening. Its MaterniT lineage includes the 2016 Sequenom acquisition. It also markets a combined prenatal collection kit designed to simplify ordering and specimen handling. This acquisition expands an established reproductive genetics business. International Distributors

The potential benefits are therefore partly operational: serving additional accounts through existing infrastructure, spreading costs across greater volume, coordinating collection and ordering, and choosing how to position overlapping and differentiated assays.

Those are analytical possibilities, not disclosed integration commitments. The announcement does not specify which brands, laboratories, platforms, or commercial arrangements Labcorp will ultimately retain. Its two-year margin target indicates that integration matters; the buyer is not promising immediate achievement of mature segment profitability.

For Myriad, selling can be rational even if FirstGene is promising. The relevant comparison is between the risk-adjusted value of continuing to fund prenatal and the value of cash, reduced complexity, and investment capacity elsewhere. For Labcorp, an existing operating platform may change that calculation.

The BioReference connection. The two announcements occurred five days apart. On October 15, Labcorp agreed to acquire selected BioReference assets for $722 million upfront, subject to adjustment, plus a possible $150 million 4Kscore earnout. Labcorp projected approximately $250 million in first-year revenue from that transaction. Both transactions remain subject to closing conditions. Labcorp

Announced acquisitionHeadline upfront priceProjected first-year revenueSimple price/revenue ratio
Selected BioReference assets$722 millionApproximately $250 million2.89×
Myriad Prenatal Health$210 million, plus inventoryApproximately $160 million1.31×

These ratios are descriptive, not directly comparable valuation judgments. They omit differences in margins, growth, liabilities, intellectual property, earnouts, and integration requirements.

The shared strategic pattern is more instructive: sellers are narrowing their focus while Labcorp is expanding the range and scale of diagnostic services it can operate. The same laboratory business can represent organizational complexity to one owner and an attractive addition to another.

Details to watch in the November discussion. The purchase agreement specifies that Myriad retains pre-closing accounts receivable. Selling the operating business therefore does not transfer every legacy collection issue to Labcorp. It also distinguishes purchased assets from shared systems and other retained assets, reinforcing that separation itself requires work. sec.gov

The most useful additional disclosures would be the business’s earnings contribution, stranded overhead, expected separation costs, net proceeds, and commitments to FirstGene development. Without those, it is premature to describe either an obvious bargain for Labcorp or a fully quantified financial improvement for Myriad.

The five most surprising features

  1. Counsyl’s familiar $375 million price understates the subsequently reported consideration. The SEC recorded $405.9 million. Adding Gateway’s $67.5 million upfront payment makes the historical acquisition spending substantially larger than the current sale price—even before subsequent development investment. That is a revealing capital-allocation comparison, although not a measure of realized loss. sec.gov

  2. FirstGene was commercially launched only 91 days before the sale announcement. Labcorp is acquiring a newly introduced platform alongside established products. The public record offers too little commercial history to treat the sale as a verdict on FirstGene’s market success or failure. globenewswire.com

  3. The old women’s-health bundling strategy is being unwound selectively. Myriad retains hereditary cancer testing, including testing delivered through women’s-health practices. What is being separated is the reproductive portfolio that earlier acquisitions were intended to combine with it. investor.myriad.com

  4. Labcorp’s first-year forecast almost exactly matches the latest quarterly revenue pace. Annualized Q2 prenatal revenue is $159.2 million versus Labcorp’s approximately $160 million forecast. The announced economics appear grounded in the existing business rather than requiring an immediate dramatic rebound. sec.gov

  5. Labcorp is buying into a field where it is already a substantial participant. Existing MaterniT and Inheritest capabilities make this a consolidation and integration opportunity, with FirstGene adding a distinct product proposition. The central strategic wager is that the portfolio will be worth more within Labcorp’s operating system than as an investment priority within Myriad. That final proposition is the deal’s economic hypothesis—not yet its demonstrated outcome. International Distributors



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Monday, October 19, 2026

Time for Pathology to Follow Radiology's Lead at FDA; Deep Dive on the FDA Radiology AI Contract

Over the last several months, this blog has covered rapidly advances in AI software that will prepare radiology and pathology reports ready for human review, validation, and sign-out.  

Radiology at Lightning Speed

The scale tends to be bigger in radiology, and the benchmarks further.  For example, AIDOC gets Breakthrough Status for FIRST READ, meaning it's well along in the FDA review pathway for software that drafts a full reading (ready-to-review) of chest x-rays.  And raises $150M (here, here).  See also breast ultrasound approval here.  See survey here.


Pathology Putters

I'm just back from PathVisions, the digital pathology conference.  Here on the pathology side, we see some demo's of "RUO" software that gets close to generating prostate pathology reports.  

  • But here in Path World, you'd fall out of your chair if a speaker at Path Visions calmly addded that his company was WELLunder FDA review, had WON its FDA breakthrough status, or had raised $150M.   


FDA Invests in Exciting Radiology Diagnostic Science

Another way radiology is ahead - FDA gave a $1.3M contract not to develop a particular software, but to create a regululatory science trail to punch out these approvals efficiently - in radiology.   (Paradigms, tools, standards, critical path, regulatory science, etc).  This makes sense for FDA, since it has tangible softwares (AI DOC, etc) in the review and approval pipeline. for radiology diagnostic reports.   (So far as I know, no parallel yet in the halls-of-FDA for pathology).

AI Researches the Cognita FDA AI Contract...500 words *or* 10pp

I asked Chat GPT to research and write up the FDA contract.  It did a great job.  After seeing its many pages of research, I asked it to file the information as a 500 word memo and as a 10 page full report.   As always, these AI reports should not be taken as ground truth but as examples of the current ability to understand a task, pursue it, and write it up.

500 word report on Cognita $1.2M Contract...HERE.

Ten page report on Cognita $1.2M Contract...HERE.


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Schematic - 

Pathology, like radiology, needs to view a draft report as the digital output of digitized medicine - not a DICOM file delivered to the pathologist or radiologist.


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Bonus - AMA essay and submission to FDA re regulatory path for LLM SAMD - here, here.

Sunday, October 18, 2026

Labcorp Gets Bioreference: "Four Transcripts and a Funeral"

According to plans announced, Labcorp will acquire most remaining assets of Bioreference labs from OPKO. 

 See this new 12-page report developed entirely by AI from existing records, especially the past year of Investor Call transcripts.

Find it HERE: https://drive.google.com/file/d/1e9dQl6vaZLcGq1q2561iAWz4tSCjlJoZ/view?usp=sharing 


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The PDF above is an AI-generated document. It should not be used as ground truth. It provides an example of current AI abilities to understand instructions then write a report.

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 On its first pass, Chat GPT initially just found and sifted the 4 investor call transcripts, here.  After reading that output, I asked for amplication into a "case study," as the PDF above.  It understood that "Case study" meant providing additional context, etc.   After that, I asked it to add a couple "sidebars," eg. on 4kScore.  Then, finally, "please make a PDF."

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See the same approach - the "last 4 transcripts" - applied to Invitae here.

Friday, October 16, 2026

MolDx Withdraws Proposed NonCoverage of Prelude DCISionRT (0360U)

 On October 15, 2026, MolDx announced it was canceling its draft non-coverage LCD for Prelude's DCISionRT.  This follows recent announcements (1) first, the draft would be delayed and (2) and second, a CAC meeting 10/13 on the topic.

See message from CEO here.

I have updated my September 21 blog to keep the storyline in one place.

https://www.discoveriesinhealthpolicy.com/2026/09/when-does-moldx-change-its-mind-prelude.html






Thursday, October 15, 2026

LabCorp Gets Bioreference, References 4K Score 81539

Bioreference acquisitioni by LabCorp features some  carve-outs for  4Kscore behavior.  Here's how it fared in recent Medicare Part B sales and in PAMA.

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In 2025, Part B sales for 81539 were $12.6M for 16,500 units.

In 2024, Part B sales for 81339 were $11.7M for 15,300 units.

In 2023, Part B sales for 81339 were $10.4M for 13,700 units.


In current PAMA price data, 81539 has a 2026 price of $760, but its PAMA target price falls to $532, a ($228) or 30% drop.

Interestingly 11 TINS of commercial insurers reported 81539 pricing to PAMA, so I thought CMS might have also issued granular PAMA survey data, but there is none.   

Wholly unrelated data, CMS payments outbound to labs, showed 4 npi geting paid by CMS, but 99% of volume in 2024 paid from CMS to Bioreference (Opko Labs).

click to enlarge

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LabCorp Gets Bioreference: Two AI Viewpoints

Below find a Chat GPT and a CLAUDE review of the Labcorp-Bioreference acqiusition.  

Each had the same prompt (350-400, use internet).

This is AI  writing and should not be taken as ground truth.  It can be taken as an example of current AI research and writing skills.

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Chat GPT

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BioReference:
From OPKO’s Growth Platform
to Labcorp’s Consolidation Opportunity

OPKO acquired BioReference in 2015 through a stock transaction announced at $1.47 billion, but valued at approximately $950 million at closing after OPKO’s shares declined. The strategic ambition was clear: BioReference’s national sales and laboratory infrastructure would accelerate adoption of OPKO’s 4Kscore prostate cancer test and future diagnostics. 

Eleven years later, that distribution strategy is effectively being handed to Labcorp. OPKO Health, Inc. (OPK)

After a pandemic booom, the post-pandemic reversal was severe. In third-quarter 2022, BioReference’s COVID PCR volume fell to approximately 200,000 tests from 2.2 million a year earlier. 

OPKO’s diagnostics segment swung from $19.7 million in operating income to a $49.5 million loss. Management cut staffing and digital-health investment, revealing how difficult it was to resize the business after emergency testing demand evaporated. OPKO Health, Inc. (OPK)

Retrenchment became a sequence of sales. Labcorp bought clinical and women’s-health assets outside New York and New Jersey for $237.5 million in 2024. In 2025, Labcorp acquired oncology and related testing assets for $192.5 million upfront, with contingent consideration. OPKO presented the remaining regional laboratory -- and 4Kscore franchise -- as a more focused route to "sustainable profitability."  OPKO Health, Inc. (OPK)

Recent investor disclosures show why that destination remained elusive. Diagnostics lost $18.3 million in fourth-quarter 2025 and $13 million in first-quarter 2026. Second-quarter 2026’s reported $4.8 million operating profit included an $18.1 million earnout benefit from the previous Labcorp sale. Subtracting that benefit leaves approximately $13.3 million of operating loss. Shrinking the footprint had reduced losses without establishing durable profitability. opko.com

Yet October’s proposed transaction carries substantial value: $722 million, plus up to $150 million contingent on 4Kscore revenue. The upfront price equals approximately 2.9 times Labcorp’s projected $250 million first-year revenue from the acquired business. That suggests Labcorp sees considerable value in the customer relationships, specialty testing and opportunities within its larger network. Closing remains subject to approvals. opko.com

The parallel with Labcorp’s $239 million acquisition of Invitae assets through bankruptcy in 2024 is instructive, although BioReference’s transaction today is a negotiated divestiture. My reading is that both illustrate the value of combining distinctive diagnostics with national operating scale. OPKO gains capital and a sharper biopharmaceutical focus; Labcorp gains assets it believes can perform better within its infrastructure. The original promise of broader access for 4Kscore survives—but with a different owner delivering it. Labcorp

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.

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

Update; See also a review of how legal cases have shaped our view of the exclusion statute - here. 

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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.

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

We saw this LCD topic as Final in February from CGS* and in Draft from Wellpoint Federal, here it comes from Palmetto GBA in draft in October..

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.

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.

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.”

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.

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.