Sidebar: Urologist Billing of 87798

The 30 MolDx states have LCDs that generally, make it hard to bill for panels of  >5  pathogens (with some rules and exceptions), and that, generally, make it hard to bill for urine pathogens with large molecular panels.

CMS recently released CY2024 national Part B payments for 87798, "othe pathogen, amplified probe."  Of around $450M in payments, about 90% went to labs and 10% went to clinicians ($49.3M to pathologists (by individual name) or clinicians (e.g. urologists).)  A urologist in the midwest garnered over $1M for 87798 billings alone; a urologist in mid-Atlantic, $650,000.   The former urologist had $2.7M in Part B payments, of which $1.7M from lab tests (8nnnn); he had about 3300 office visits (63/wk x 52 weeks.)

In total, tallying up 87798 clinician payments from 2024, these went to 396 urologists, 117 nurse practitioners,  87 podiatrists, 70 physician assistants, and 52 pathologists.  (With few exceptions, 87798 payments > $1M went to pathologists).

click to enlarge

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Others complained of great difficulty in getting 87798 payments, here.

Medicare Labs Intensely Billing 87798: Comparing Novitas/Texas and Noridian/California

See a June 2026 article on sentencing of a Burbank lab fraud case in the tens of millions of dollars.  And now in 2026, we're hearing about rising denials on code 87798.  

The MolDx system, like Noridian, has a quite strict LCD about pathogen panels, generally restricted them to 3-5 pathogens per patient (with some exceptions).   As far as I know, Novitas didn't have that clear an LCD.

I thought I'd heard top-level MolDx speakers say that if you can't bill a CPT panel code of >5 pathogens, you can't or shouldn't bill 87798 (other pathogen) as a large panel x 10...or x 20... or x 40.   

However, a data survey by Discoveries in Health Policy found that 87798-intensive labs were found in Noridian as well as Texas in 2024 - just that there were a lot more in Texas.   

We searched the Medicare database for Part B 2024 for high billers of 87798 inTX and in CA-AZ (Noridian).  Claude Opus 4.8 did a broad search of each of 15 labs under each MAC, stratified by scale (e.g. billing $10M for 87798 versus $1M versus $100,000).   

Here's what Claude found in essay format, which I have heavily redacted (Claude had tons of facts and details I've stripped out here.)

• Note that this blog isn't using a specially trained $10M CMS AI contract - this is just a few minutes of work by a consumer-grade $20 AI plan.  

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The Building on XXX Boulevard

What fifteen Noridian billers of CPT 87798 reveal about the geography of the popup lab

WRITTEN BY: CLAUD OPUS 4.8.  

A useful thing about studying laboratory fraud at the level of the Medicare claim is that the claim doesn't know it is supposed to look innocent. It records what was billed, by whom, from where, and once you line up fifteen labs that all billed the same code under the same MAC, the addresses start talking. The first batch I looked at — billers of CPT 87798 scattered mostly across Texas — taught a vocabulary of signals: the recent NPI, the absent website, the charge fingerprinted to the penny across "independent" labs. This second batch, fifteen laboratories that registered and billed 87798 under the Noridian jurisdiction of MolDX, speaks with a heavier accent. It is overwhelmingly a Southern California story, with a short Arizona subplot, and its defining feature is not dispersion but concentration. Several of these labs are, quite literally, in the same building.

As before, a caveat that is not boilerplate: what follows is a footprint inventory, not an accusation. Billing 87798 is lawful; some of these fifteen Noridian labs are clearly real laboratories. The exercise sorts the field by what each operation has left behind on the open web and in the federal registries, and asks which ones exist mainly as an electronic billing stream. 

Of the fifteen, I put four in the established-lab tier, two in a middle tier with real websites but significant live flags.  Then there are nine more: five with a CLIA certificate but little or no web presence, and four that are effectively invisible online. That distribution — a third clearly legitimate, a third deep in the shadows — is itself a headline.

The code, briefly, again

The mechanics that made 87798 attractive in Texas are unchanged here under Noridian, so I'll be brief. It is a "not otherwise specified" amplified-probe infectious-agent code, billed per target, reimbursed at a fixed Clinical Laboratory Fee Schedule rate that lands at almost exactly $34.39 for every one of these fifteen labs. There is no coinsurance to chase and no balance to bill. The submitted charge — which here ranges from $36 to $79.22 — is economically inert under a fixed schedule; it pays nothing extra, which is precisely why it functions as a behavioral tell rather than a price. 

The only levers a biller controls are how many beneficiaries and how many targets per beneficiary, and the second of those, services per beneficiary, again does most of the diagnostic work. The established labs in this set cluster low: LEGIT LAB at roughly 6, ANOTHER at 13.5. 

The outliers run the other way — XXX LAB in SMALL CITY, billed Noridian about 51 units per patient; another Noridian lab was paid 65 tests per patient. Few patients, enormous per-patient breadth, is the arithmetic of a big-panel invoice.

What legitimacy looks like here

It is worth fixing the honest end of the distribution first, because it calibrates everything else. Four labs carry the boring virtues of a real business. [Labs had NPIs or CLIA certifieates variably months or over a decade old].  None of this proves anything about the quality of their 87798 billing — AAA notably, presents publicly as a toxicology shop, so its unexpected infectious-disease volume is a pivot worth a glance — but these four Noridian labs have good evidence of actually existing.  

The building on NNNN STREET, L.A.

Now the concentration. In the Texas set, the suspicious labs were scattered across metro areas and linked only by softer signals — a shared charge, a common phone area code. Here the link is a street address. 111 LAB and 222 Lab share a single building: NNNNN SOMETHING Boulevard in [VALLEY], adjacent suites. Two blocks west, 3333 operates from nnnn; around the corner, 4444 bills from xxxx Avenue [as does a lab curiously named MOLDX LAB, now vanished, not included in these 15.)

.And NNNN SOMETHING is not a quiet medical office — it also houses a stack of separately licensed home-health agencies. That combination, multiple labs and multiple home-health entities sharing one nondescript Valley address, is the kind of co-location that recurs in lab-billing schemes, where a single back office can stand up and operate several nominally unrelated providers.

The people signals rhyme with the geography. A recurring profile in this set is the single-officer corporation in which one individual is simultaneously chief executive, chief financial officer, secretary, and registered agent, reachable at an 818 or 310 — San Fernando Valley and West-LA — telephone number. Examples of odd executive name lists. [....]  (JOHN SMITH), is listed in corporate records as the authorized person for thirty-one separate entities. A lab with a website is not automatically clean; a serial incorporator behind it is a question, not an answer.

Two of these — 5555 6666 — sit in my most-invisible tier not because of any one damning fact but because of an absence. Repeated searches surfaced no company website, no resolvable CLIA, and, for ONE GUY, no usable NPI-aggregator profile at all. 

The aggregators index essentially every NPI ever issued; returning nothing, while the lab two suites away returns nothing either, is its own kind of evidence. The absence is the finding.

The two that should not file themselves so neatly

Two labs in this set reward a second, closer look for reasons beyond a thin web footprint.

XXXX is recorded not as a Certificate of Compliance or Accreditation but as a Certificate of Registration — the provisional status a laboratory holds before it has been surveyed for compliance. 

Billing more than half a million dollars of a high-complexity molecular code while operating on an unsurveyed registration certificate, from a chain whose officer's mailing address resolves to an apartment, and at roughly fifty-plus units per beneficiary, is three independent flags converging on one lab. It is the highest-interest profile in the group.

The second is YYYYY.....

What the screen is for

The limits of this method are the same as before [for Texas] and worth restating, because they protect the innocent labs in the file as much as they flag the others. 

A quiet business-to-business reference lab can legitimately have no consumer website. A provisional CLIA can belong to a real startup mid-accreditation. A shared building can be an ordinary commercial sublease. The footprint screen does not adjudicate; it triages, and it converts vague unease into specific, testable questions. 

For every lab flagged here the next moves are concrete and available to anyone with the registries: pull the NPPES enumeration date and ownership, pull the QCOR CLIA history for the certificate type, issuance date, laboratory director and any sanction, pull the California or Arizona corporate filing and count the officer's other entities, and map the ordering-physician geography against a Valley address that may have none of its patients anywhere near it.  They might come from Florida, for example.

What this set adds to the Texas one is the lesson of geography. The popup lab's tell is not that it bills aggressively — honest labs bill 87798 hard, too.  It is that the billing is the only thing it does in public, and that when you plot the quiet ones on a map they stop looking like fifteen independent businesses and start looking like one operation wearing fifteen names. The building on XXXX STREET does not prove that case. It just tells you which afternoon to spend, and where.

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Prepared from a web- and registry-footprint review of fifteen CY2024 billers of CPT 87798 enrolled under the Noridian MAC (MolDX); companion spreadsheet contains per-lab detail, links, billing figures, and risk-group tallies (4 established / 2 mid / 5 CLIA-but-thin / 4 near-invisible). This is footprint analysis, not an allegation of wrongdoing; enumeration and CLIA dates should be confirmed at NPPES (npiregistry.cms.hhs.gov) and CMS QCOR (qcor.cms.gov).

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But:

Others complained of great difficulty in getting 87798 payments, here.  Others complained of rising denials, only after 1/2026, here.  Article compares 87798, 81408, here.

CMS Creates New "Office of Health Technology & Health Technology Products" - Led by Amy Gleason

 

It's a quiet Thursday, you're reading the new issue of Federal Register, not to much too see, turn the page, turn the page again...

And suddenly, HHS announces the creation of a new office at CMS, the "Office of Health Technology & Products," the OHTP.  See the presentation at 91 Fed Reg 35478-35482 Find it here:

https://www.govinfo.gov/content/pkg/FR-2026-06-11/pdf/2026-11743.pdf

See also coverage at HealthCareDive by Emily Olsen, here.

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AI CORNER (Chat GPT)

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CMS Creates a New Office of Health Technology and Products: Digital Rails 

CMS has created a new Office of Health Technology and Products — OHTP — by formal notice in the Federal Register. The office was approved by the Secretary of HHS on June 9, 2026, and became effective that same day. The detailed notice appears in the June 11, 2026 Federal Register, here: Federal Register / GovInfo PDF.

For Medicare watchers, the most important point is that this does not appear to be a new coverage, coding, or pricing shop for medical technologies. Rather, it is a high-level CMS technology and product organization.  (Read it as: "Office of Health Technology and ^Health Technology Products.") Its portfolio includes CMS digital products, beneficiary tools, provider and state-facing systems, claims and payment platform modernization, provider directory infrastructure, NPPES, PECOS, identity and trust services, Medicaid and CHIP technology, interoperability, open standards, and CMS-wide artificial intelligence strategy.

The Federal Register notice is detailed. It says OHTP will provide enterprise leadership for CMS healthcare technology modernization, digital products, and transformation of platforms and services supporting Medicare, Medicaid, CHIP, and other CMS programs. At the same time, the notice repeatedly emphasizes that the office must coordinate with the CMS Chief Information Officer and remain subject to CIO-led IT governance, cybersecurity, enterprise architecture, acquisition oversight, digital service delivery, customer experience, and public digital experience responsibilities.

The Eight Operating Components

The Federal Register notice lists these eight operating components under OHTP:

1. Open Source Program Group

2. Standards & Interoperability Group

3. Division of Data and Interoperability Platforms

4. Division of Policy

5. Product Development Group

6. Division of Core Products

7. Division of External Products

8. Digital Service at CMS

What Each Component Will Do

Open Source Program Group.
This group is intended to bring private-sector technology practices, software engineering talent, product managers, and open-source methods into CMS and HHS. The notice emphasizes reusable software, open-source guidance and contribution models, reduced duplication, shared platforms, open standards, and alignment with federal source-code and acquisition policies.

Standards & Interoperability Group.
This group will lead CMS’s enterprise interoperability strategy, with an emphasis on API-based, patient-centered, secure, scalable health data exchange. It is also described as CMS’s principal authority for interoperability strategy, implementation, policy, and standards alignment, including the evolution of administrative transaction standards.

Division of Data and Interoperability Platforms.
This division will build and operate the technical platforms that make interoperability real, including FHIR-based APIs and data exchange platforms. It will run pilots, support implementation, monitor adoption and performance, help beneficiaries and authorized entities securely access and share health data, and promote reuse through shared services and open-source technologies.

Division of Policy.
This division will develop interoperability policy, regulations, and sub-regulatory guidance across clinical and administrative data exchange. It will review legislation, work with ONC and standards development organizations, address electronic transactions, code sets, and identifiers, and provide outreach and technical assistance to providers, payers, technology developers, beneficiaries, and other stakeholders.

Product Development Group.
This is the main product delivery organization for OHTP. Its job is to apply modern product management, human-centered design, agile delivery, user research, product analytics, A/B testing, shared design systems, roadmaps, OKRs, release management, and lifecycle oversight to CMS’s digital product portfolio.

Division of Core Products.
This division manages CMS’s internal and enterprise technology platforms — the systems that process and power CMS programs. The notice specifically includes Medicare claims and payment processing systems, shared APIs and data services, provider-facing infrastructure such as the National Provider Directory and associated systems, and Medicaid and CHIP technology modernization.

Division of External Products.
This division manages CMS’s beneficiary-facing and public-facing digital products. The notice specifically names Medicare.gov and Medicare Plan Finder, and emphasizes accessible, secure, user-centered public digital experiences, customer experience, strategic industry partnerships, and modernization of public-facing technical systems.

Digital Service at CMS.
This component will conduct short-term discovery sprints and high-impact technology projects across CMS and HHS. It is intended to provide surge capacity, rapid user-centered delivery, sprint reports and recommendations, modern software practices, flexible hosting, automated testing and deployment, reusable security and privacy processes, and support for AI, interoperability, Medicaid/CHIP modernization, and beneficiary-facing services.

Amy Gleason

The Federal Register notice does not name the official who will lead OHTP. However, Emily Olsen at Healthcare Dive reports that the new office will be led by Amy Gleason, serving as CMS deputy administrator and chief product officer. Olsen also reports that Gleason has worked as a CMS strategic advisor and has spearheaded the agency’s Health Tech Ecosystem initiative. See: Healthcare Dive, Emily Olsen, June 12, 2026.

Gleason is not a traditional Medicare payment-policy figure. She is better understood as a health-technology operator and patient-data advocate. Public biographies describe her as a former nurse, former U.S. Digital Service official, former chief product officer at Russell Street Ventures, and leader of digital health work involving Main Street Health and CareBridge. A Health IT Summit bio says she worked on the national COVID-19 database, PRIME, and Data at the Point of Care, and that her work has been shaped by her family’s experience navigating care for a daughter with a rare disease. See: Amy Gleason bio, Health IT Summit 2025. AP has also profiled Gleason in connection with her role as acting administrator of the U.S. DOGE Service and her long-running interest in health record sharing. See: AP profile of Amy Gleason.

This background fits the structure of the new office. OHTP reads less like a Medicare reimbursement office and more like an attempt to put product management, data liquidity, software reuse, APIs, patient access, and digital infrastructure at the center of CMS operations.

Not the Same as TCPG

CMS already has a separate group that is much closer to the world of new medical technology coding and pricing: the Technology, Coding, and Pricing Group, or TCPG, in the Center for Medicare. CMS’s current medtech guide describes TCPG as responsible for DMEPOS and ambulance policy, drug and biological product data collection, CLFS data collection, and determinations on applications for NTAP, OPPS drug and device pass-through payments, ADLT designation under the CLFS, TPNIES, and TDAPA. See: CMS Guide for Medical Technology Companies — Overview of CMS Groups.

CMS’s leadership page for Jason Bennett states that he is Acting Deputy Director of the Center for Medicare and Director of TCPG. It describes TCPG as a focal point for manufacturers to engage with Medicare fee-for-service on coding and payment for new products, as well as other Medicare payment activities. See: CMS profile of Jason Bennett.

As far as the Federal Register notice shows, OHTP does not displace TCPG. The notice says OHTP must coordinate across CMS technology portfolios while “respecting Center and Office authorities,” and that CIO-led enterprise IT governance remains with the CMS CIO. That language strongly suggests that OHTP is additive and cross-cutting, not a replacement for the existing Medicare coverage, coding, and pricing machinery.

There is one nuance. OHTP will have responsibility for modernization of claims and payment systems, and the Division of Policy will touch administrative transactions, code sets, and identifiers in the interoperability context. That could matter over time.  

Beyond the Printed Page: What This Signals

The new office is a signal of priorities. CMS is saying, in a formal organizational notice, that digital infrastructure, interoperability, AI, beneficiary experience, provider directories, claims system modernization, open source, and product discipline are not side projects. They are enterprise priorities.

For industry, the first practical lesson is not to overread the word “products.” In this notice, “products” usually means CMS digital products — Medicare.gov, Plan Finder, claims platforms, APIs, identity tools, provider directories, and internal systems. It does not mean FDA-regulated products, diagnostics, devices, or new Medicare payment categories.

The second lesson is that CMS is likely to become more assertive around the digital rails of healthcare. Watch for movement around the National Provider Directory, Medicare.gov identity modernization, beneficiary-facing data access, FHIR-based APIs, prior authorization infrastructure, payer-provider data exchange, and administrative transaction modernization. These are not glamorous compared with a new coverage pathway, but they can have enormous operational impact.

The third lesson is that AI is now embedded in CMS organizational language. OHTP is charged with enterprise AI strategy and implementation across CMS digital products and platforms, as well as advising CMS leadership on AI opportunities, risks, and governance. In the next 6-12 months, it will be important to see whether this remains focused on internal productivity and beneficiary tools, or whether it begins to affect program integrity, claims review, quality measurement, prior authorization, or payment operations.

Several watch-outs follow.

First, will OHTP produce visible products? The most convincing evidence will not be speeches. It will be new APIs, public GitHub repositories, sprint reports, usable beneficiary tools, improvements to Medicare.gov and Plan Finder, better PECOS/NPPES workflows, provider directory progress, and measurable reduction in technical friction.

Second, how will OHTP interact with the CIO, the Center for Medicare, CAG, TCPG, HAPG, Medicaid, and CPI? The Federal Register notice is careful to preserve existing authorities. But ambitious technology offices often become influential because they control platforms, data flows, implementation timelines, and user experience, even when they do not formally control policy.

Third, how will CMS balance open-source aspirations with cybersecurity, procurement law, contractor relationships, and legacy systems? The notice reads like a modern product charter, but CMS still operates in a large federal acquisition and contractor environment. Implementation will be the test.

Fourth, how will industry partnerships be governed? CMS’s Health Tech Ecosystem is explicitly collaborative and private-sector-facing. That may accelerate innovation, but it also raises predictable questions about standards, neutrality, privacy, security, procurement boundaries, and who gets to shape the rails everyone else must use.

Fifth, will administrative interoperability finally move from aspiration to machinery? The notice’s references to administrative transactions, code sets, identifiers, APIs, and burden reduction are worth watching closely. Prior authorization, provider directory accuracy, payer-provider exchange, and claims-related data flows are all potential pressure points.

The bottom line: OHTP is probably not a new Medicare payment doorway for lab tests, devices, or digital health products. But it may become very important for the infrastructure on which Medicare and Medicaid increasingly depend. For alert readers, the question is not whether OHTP will pay for new technology. The question is whether it will change the systems through which CMS identifies providers, authenticates users, exchanges data, processes claims, governs AI, and presents Medicare to the public.

The Fascinating Context: Florida's Dr. Dunn, HR 8500 (LCDs), HR8890 (CLIA)

 [AI Corner, Chat GPT]

See also: Blog on HR 8500, LCD Reform, here
    Cosponsor: Barragan (D-CA), Tenney (R-NY)

See also: Blog on HR 8890, CLIA Reform, here
   Cosponsor: N.A. (6/12/2026)

##

HEADER

Retiring Florida Congressman Neal Dunn, M.D., has introduced two surprisingly substantive diagnostics bills: H.R. 8500 to discipline Medicare LCD timing and transparency, and H.R. 8890 to modernize CLIA as the home for LDT oversight. Though unlikely to pass standalone, both may become marker bills for future diagnostics policy.

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Neal Dunn’s Late-Term Diagnostics Bills: A Retiring Physician-Member Takes Aim at LCDs, CLIA, and the Future of LDT Oversight

One of the more interesting small dramas in 2026 Medicare diagnostics policy is that two substantial bills on highly technical laboratory and coverage issues have been introduced by a member of Congress who is, politically speaking, almost out the door. Congressman Neal Dunn, M.D., a Republican from Florida’s 2nd Congressional District, is a urologist, former Army surgeon, and five-term member of the House. In January 2026, he announced that he would not seek re-election, retiring end-of-2026.  Yet in the spring of 2026, with only months left in his congressional tenure, Dunn introduced two bills that go directly to the machinery of Medicare coverage and clinical laboratory oversight: H.R. 8500, the Ensuring Timely Access to Coverage Decisions Act, and H.R. 8890, the Enhancing Clinical Laboratory Innovation and Access Act, or Enhancing CLIA Act.

That is the first surprise. These are not symbolic resolutions about apple pie or naming a post office. They are technically meaningful bills in two areas where diagnostics policy has been stuck for years: Medicare local coverage determinations and the status of laboratory-developed tests under CLIA.

H.R. 8500 addresses the Medicare local coverage determination process. LCDs are the decisions by which Medicare Administrative Contractors decide whether particular services are reasonable and necessary in their jurisdictions. For laboratories, device firms, and specialty medicine, LCDs can be enormously consequential. They may determine whether a new test, procedure, or technology receives practical Medicare access, even without a national coverage determination from CMS. But the LCD process has long been criticized as slow, uneven, opaque, and variable across contractors.

Dunn’s H.R. 8500 is framed as a timeliness and transparency bill. It would require more structured handling of LCD requests, more timely completion of requests, more stakeholder involvement, and a formal review process for reconsideration decisions. In simple terms, it tries to make the LCD pathway less of a black box. The bill does not appear to be a grand rewrite of Medicare coverage law. Rather, it focuses on process: when a request is complete, when a contractor must act, how stakeholders are heard, and how reconsideration is handled.

For the diagnostics industry, this matters because LCDs are often where theoretical innovation meets operational Medicare reality. A test may have publications, expert enthusiasm, CPT coding, and even some commercial coverage, but Medicare access often depends on whether a MAC writes or revises an LCD. When that process is slow or indefinite, companies face reimbursement limbo. The policy intuition behind H.R. 8500 is that beneficiaries and innovators should not have to wait indefinitely for an answer, even if the answer is ultimately no.

H.R. 8890 is potentially broader, more novel, and more politically charged. The Enhancing CLIA Act would update CLIA for modern laboratory-developed testing services. It would reaffirm that LDTs are professional services regulated by CMS under CLIA, not medical devices regulated by FDA. But the bill is not simply an anti-FDA LDT bill, nor merely an industry deregulatory marker. It tries to do two things at once: preserve the CLIA/CMS framework as the center of gravity for LDT oversight, while adding transparency, validation visibility, error reporting, third-party review options, and clearer accountability.

The complexity of the bill is itself revealing. H.R. 8890 is a 45-page piece of statutory engineering. 

H.R. 8890 defines analytical validity, clinical validity, investigational use, clinical use, digital laboratory data, laboratory operations, performance specifications, and laboratory-developed tests. It creates a new “supplemental affirmation” pathway through approved third parties. It gives special recognition to New York State approval and favorable MolDx technical assessments. It treats FDA as an optional approved third-party reviewer, while expressly preventing FDA from applying ordinary device standards to LDTs submitted through that route. It creates a centralized CMS database for LDTs. It establishes test-error reporting for serious harm and death. It adds CMS authority to review analytical and clinical validity when credible concerns arise. It amends not only CLIA, but also the Federal Food, Drug, and Cosmetic Act and Medicare national coverage determination provisions. It even addresses companion diagnostics, stating that where a diagnostic test result is required for drug or biologic approval, that result may come from an FDA-regulated device or from an LDT with supplemental affirmation.

Second surprise: This is not the kind of language that appears to have been casually drafted from scratch by a junior congressional staffer. 

It reads like a highly worked-up stakeholder and legal proposal that found a suitable congressional sponsor. The bill reflects familiarity with the long LDT wars: FDA rulemaking, VALID Act negotiations, CLIA modernization debates, New York State laboratory review, MolDx technical assessments, companion diagnostic bottlenecks, and the practical business structures of large reference laboratories and genomic testing companies. It is filled with clauses aimed at real-world fact patterns: tests that modify FDA-cleared devices; lab-developed methods using third-party software, reagents, or intellectual property; self-collected specimens; multi-site laboratories under common corporate ownership; digital pathology; sequencing data; cloud or off-site software execution; and the use of previously generated patient-specific digital laboratory data.

A Plausible Back Story (??)

That suggests a plausible back story. After the FDA LDT rule controversy and litigation, laboratory stakeholders needed more than a negative argument. It was not enough to say, “FDA should not regulate LDTs.” They needed a positive alternative that could answer the obvious question: “If not FDA, then what?” H.R. 8890 supplies that answer: enhanced CLIA, public transparency, validation documentation, optional third-party affirmation, error reporting, CMS intervention authority, and periodic updating of CLIA to reflect molecular diagnostics, digital pathology, and next-generation sequencing.

The possible (speculative) intellectual universe behind the bill includes ACLA and its member laboratories, specialized FDA/CLIA counsel, large reference labs, genomic laboratories, pathology and laboratory medicine stakeholders, and policy veterans who have spent years negotiating the boundary between laboratory services and medical devices. That does not mean any single entity “authored” the bill, and it would be wrong to say so without evidence. But the structure, vocabulary, and embedded compromises strongly suggest outside stakeholder drafting or heavy outside technical assistance. ACLA’s public support is consistent with that hypothesis, though not proof of authorship. CAP and other professional laboratory groups also have long-standing interests in CLIA modernization, LCD reform, and preserving an oversight pathway that recognizes the professional-service nature of laboratory medicine.

The bill’s cleverness lies in its middle position. It is not pure deregulation. It does not simply say that CLIA as currently written is sufficient for modern LDTs. Nor does it accept the FDA view that LDTs should be regulated as medical devices. Instead, it attempts to build an “Enhanced CLIA” framework: CMS remains the principal regulator, but CLIA gains new muscles. Laboratories would have public database obligations, validity-support obligations, serious-error reporting obligations, and exposure to CMS action if credible evidence suggests that a test lacks analytical or clinical validity or is being offered with false or deceptive claims.

The inclusion of New York State, MolDx, and FDA as recognized pathways is especially sophisticated. New York State is a long-standing laboratory review authority. MolDx is not a regulator of lab quality in the formal CLIA sense, but its technical assessments have become deeply influential in Medicare coverage for molecular diagnostics. FDA, meanwhile, is not expelled from the field altogether; it is demoted, in effect, from sovereign device regulator to optional reviewer under CLIA-like standards. This is a subtle statutory maneuver. It tries to borrow credibility from existing review systems while preventing any one of them from becoming the mandatory gatekeeper for all LDTs.

The Medicare provisions are just as telling. By linking supplemental affirmation to national coverage determinations and companion diagnostic use, the bill recognizes that regulatory status and reimbursement status are intertwined. In oncology and precision medicine especially, a test is not useful merely because it is analytically impressive; it must be orderable, covered, and usable in connection with therapies and clinical pathways. H.R. 8890 therefore does not treat LDT oversight as an isolated laboratory compliance question. It treats it as part of the broader diagnostic-access ecosystem.

The timing is important. Dunn introduced H.R. 8890 in May 2026, after announcing in January that he would not seek re-election. Public reports later described a serious, previously nonpublic medical issue, which Dunn's office has not confirmed. The framing is that a retiring physician-member, with limited time left and significant health-policy credibility, became the vehicle for a sophisticated diagnostics package whose main purpose may be to plant legislative language for the future.

That makes Dunn an interesting sponsor. He is not a pathologist, molecular geneticist, or Silicon Valley-style innovation politician. He is a urologist and former Army surgeon from North Florida, representing a district anchored around Panama City, Tallahassee, and surrounding areas -- not Boston, Cambridge, San Francisco, or San Diego. That may actually strengthen the political framing. The bills are not presented as boutique biotech policy. They are presented as patient access, physician practice, Medicare fairness, and modernized laboratory oversight.

H.R. 8500 and H.R. 8890 also complement each other more than may first appear. H.R. 8500 addresses the coverage bottleneck: how long Medicare contractors may take to decide whether a service is reasonable and necessary, and how transparent and structured that process must be. H.R. 8890 addresses the regulatory identity problem: whether modern LDTs should be treated as medical devices under FDA or as professional laboratory services under an enhanced CLIA regime. Together, they point to a coherent diagnostics-policy agenda: faster coverage processes, clearer laboratory oversight, more transparency, and a regulatory architecture that treats advanced diagnostics as clinical services rather than ordinary widgets.

The third surprise is that these bills may matter even if they do not pass. In a crowded election-year Congress, standalone Medicare process reform and CLIA modernization are difficult lifts. H.R. 8500 has bipartisan appeal because timeliness and transparency in Medicare coverage are difficult to oppose in principle. H.R. 8890 is more contested because it sits squarely in the LDT regulation wars. But in Washington, marker bills matter. They define language, organize stakeholders, create a policy baseline, and give future sponsors and committees something concrete to inherit. They can be folded into larger Medicare, FDA, appropriations, or health-extender packages. They can also become the template for the next Congress.

Seen that way, Dunn’s late-term diagnostics package is not just a farewell gesture. It is a draft blueprint left on the table for the next round of policy fights. H.R. 8500 says Medicare contractors should not be allowed to leave coverage requests in indefinite limbo. H.R. 8890 says LDT oversight should be modernized inside CLIA, not transferred wholesale into FDA device regulation. Whether the bills pass in their current form is uncertain. But they are important because they crystallize two of the central questions in diagnostics policy: who decides whether a test is good enough to be used, and how long Medicare may take to decide whether beneficiaries can actually access it.

_____________________________________

For factual grounding: Dunn’s H.R. 8500 release describes the bill as targeting Medicare LCD delays, inconsistent standards, lack of transparency, stakeholder input, timely completion, and reconsideration review. (Neal Dunn) Dunn’s H.R. 8890 release says the Enhancing CLIA Act would modernize LDT oversight, preserve CLIA/CMS regulation, create an LDT database, and add validation and error-reporting mechanisms. (Neal Dunn) The uploaded bill text confirms the more technical provisions: definitions of digital laboratory data and LDTs, third-party supplemental affirmation, New York/MolDx/FDA pathways, CMS database, error reporting, FDCA amendments, NCD equivalence language, companion-diagnostic provisions, and CLIA updates for molecular diagnostics, digital pathology, and NGS. ACLA publicly welcomed the bill as enhancing LDT oversight within CLIA while preserving CMS’s role. (American Clinical Laboratory Association) Dunn’s retirement and the later public disclosure of a serious heart-related condition are reported separately; Dunn has not discussed a medical condition nor linked his bills to one. (New York Post)

Digital Pathology at CMS: Annual Lab Meeting Postpones It, But CLIA Reform Would Boost It

 If you follow digital pathology (whole slide imaging) at CMS, you'll know that Medicare placed around ten WSI tests on the Clinical Laboratory Fee Schedule through 2004.  Then, AMA CPT stopped making new PLA codes for WSI.  

Then, beginning in February 2026, AMA CPT has created at least four new Category III codes for WSI tests.  (AMA will release the full text on July 1, 2026).

However, CMS declined to add the four Category III WSI codes to the agenda of the June public comment meeting on some 100 other new CPT codes for lab tests.

But here's the remark CMS gave at the opening of the June 10 meeting:

• Finally, we are aware there are a few CPT codes that were recently established but are not reflected on today's agenda for presentation.  We've received some incoming letters and questions on these codes.
• We are reviewing these concerns, and we hope to have additional information soon.
• But for today, the agenda is set, and those codes will not be discussed to the public and the panel. Again, we sincerely appreciate your invaluable contributions of professional expertise and experience to this public process behind the clinical laboratory fee schedule.

But wait, there's more.  This week, Congress released the text of HR 8890, CLIA Reform 2026.  It would FIRMLY establish digital pathology / computational pathology as CLIA lab tests.  This should lock down their position on the Clinical Lab Fee Schedule - assuming HR 8890 passes into law.

Read more about HR 8890 on this blog here.

Congress Releases Full Text of 45-page CLIA Reform Bill

In May 2026, Congressman Dunn of Florida issued a press release about a new Enhance CLIA bill (here), and there was a policy article from the McDonald Hopkins law firm, Campbell et al. (here).  Around June 11, a full version of the 45-page legislation has been posted.  Find it here:

https://www.congress.gov/119/bills/hr8890/BILLS-119hr8890ih.pdf

Track updates to HR 8890 here.

It's important to note that HR 8890 was released without cosponsors, without a Senate complement, and Dr. Dunn retires at the end of this year.   Nonetheless, it's an elaborate and provocative legislative concept for CLIA. Read more here.

Download as a 9-page white paper here.

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SUMMARY (CLAUDE OPUS 4.8)

H.R. 8890, the Enhancing CLIA Act of 2026 (Rep. Neal Dunn, M.D.), codifies that laboratory developed tests are regulated by CMS under CLIA, not by FDA — statutorily carving LDTs out of the device definition and cementing the ACLA/AMP v. FDA vacatur. It creates a self-determined analytical-and-clinical-validity standard, a voluntary third-party "supplemental affirmation" (with FDA, MolDX, and New York as recognized pathways), a public LDT database, centralized error reporting, and for-cause CMS enforcement. It expands scope to digital laboratory data, aligns Medicare coverage and companion-diagnostic pathways, and modernizes CLIA specialties. Most provisions phase in two years after enactment.

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Contents

1. The jurisdictional core: CLIA in, FD&C Act out
2. The validity standard: real, but self-determined and evidence-flexible
3. Voluntary third-party affirmation — and the special status of FDA, MolDX, and New York
4. Transparency: the centralized public database
5. Safety signal: centralized error reporting
6. Enforcement teeth: the for-cause validity review
7. Digital laboratory data: the frontier definition
8. Medicare coverage and companion diagnostics
9. CLIA modernization (Section 4)
10. Transition and the device-to-LDT conversion glidepath

Sidebar 1 — Red flags the lab industry should be watching Sidebar 2 — Advocates, opponents, prospects, and the (negligible) score

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The Enhancing CLIA Act of 2026 (H.R. 8890): What the Full Bill Text Actually Does

An analysis for CLIA and laboratory-industry professionals, based on the 45-page introduced text (Dunn, FL-2; introduced May 19, 2026; referred to Energy & Commerce and Ways & Means).

Now that the legislative language is public, the bill turns out to be considerably more architecturally complete than the five-bullet press release suggested. The earlier Dunn release and the McDonald Hopkins alert captured the headline ideas — CMS not FDA, a public database, voluntary third-party review, error reporting — but the statutory text fills in the load-bearing details that determine whether this is a genuine framework or a slogan. Below is a plain-English walk through everything the bill changes, followed by two sidebars: one on the red flags the industry should be watching, and one on the politics, the coalition map, and the (probably trivial) budget score.

HHS OIG Releases Legal Viewpoint on MCED Supplemental Testing

 A favorite question the last five or ten years - if CMS pays you for one test (let's say CRC screening) can the lab provide an additional report (let's say kidney cancer screening)?   Does it imply Anti Kickback Statute concerns?

See an article on June 10, 2026, at National Law Review, that OIG's viewpoint is favorable with terms and conditions.

https://natlawreview.com/article/hhs-oig-issues-favorable-advisory-opinion-free-multi-cancer-detection-supplemental

Find the 9-page decision - issued May 15 - online here:

https://oig.hhs.gov/documents/advisory-opinions/11669/AO-26-11.pdf

I'm not a lawyer, neither is Chat GPT, but here's its mini summary.

• OIG Advisory Opinion 26-11 blesses, narrowly, an arrangement in which a Medicare-covered blood-based CRC screening test is accompanied by a free supplemental multi-cancer detection report generated from the same blood sample. 
• OIG found both AKS and Beneficiary Inducement CMP risk: the free report is valuable remuneration that could steer patients toward the company’s CRC test/lab and could generate follow-up physician visits. Still, OIG would not sanction because the risk was low: the patient already needed an independent physician order for the covered CRC test; no extra blood draw or Medicare payment was triggered; physicians were not paid; the company used neutral, limited educational materials; and several included cancers lack USPSTF-recommended screening options.
• Guardrails/failure points: this is requester-specific, fact-specific, and non-precedential. It could fail if facts change, if the MCD test becomes FDA-approved/covered, if marketing becomes promotional or DTC, if physicians are rewarded, if extra reimbursed services are induced, or if competing labs are disadvantaged.

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Sidebar: Longer AI article.

AI Guest Report: Claude Opus Reviews Annual Lab Meeting (June 10, 2026)

On June 10, 2026, CMS held its all-day Annual Lab Meeting for public comment on correct pricing of over 100 new lab test codes.

Claude Opus 4.8 studied the 5-hour transcript, the agenda (of 47 presenters), and the code list (about 110 code descriptors).   It then produced a nine-page meeting report.

Find the report here:

https://drive.google.com/file/d/1-On-eq4I_bsBB24ydul6XyDoJnv46VTz/view?usp=sharing

AI Guest Column 02: Does Medicare Still Use COBOL? A Book Chapter by Claude Opus 4.8

A previous blog entry provided a book chapter, written by Chat GPT, on Medicare claims processing software ("Is it really still in COBOL?")

Here is a second book chapter, by Claude Opus 4.8, which was given the earlier Chat GPT book chapter and asked to start again, and push it further in a new draft.

Offered as an example of current AI-managed writing products; not verified.

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Version 2, this time by Claude Opus 4.8

Below as blog; see also as 9-page PDF.

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CHAPTER by CLAUDE OPUS 4.8

The Machinery Beneath the Program

COBOL, the MACs, and the Common Working File

Every so often a senior official remarks, with a mixture of alarm and wonder, that Medicare still runs on COBOL. The remark is essentially true. It is also the least interesting thing one can say about how Medicare pays a claim.

AI Guest Column 01: Does Medicare Still Use COBOL? A Book Chapter by Chat GPT

AI CORNER:  Written by Chat GPT.

One of a series.  Offered as an example of current AI-managed writing products; not verified.

See also: A second version, alternatively created by Claude Opus 4.8, here.

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Medicare’s Hidden Infrastructure

June 10, 2026 / Chat GPT

This chapter explains the hidden technological infrastructure underlying Medicare fee-for-service claims processing, including the continued use of COBOL mainframe systems and the central role of the Common Working File (CWF). Far from being merely obsolete technology, these systems support one of the world’s largest and most complex financial transaction networks. The chapter describes how Medicare Administrative Contractors, national CMS systems, and the CWF coordinate eligibility, utilization tracking, duplicate detection, and payment integrity across the country. It also explains why modernization is extraordinarily difficult: Medicare’s legacy systems do not merely process claims, but encode decades of operational healthcare law and administrative logic.

AI Guest Column: Oz and Mulligan on Saving Healthcare Costs

 AI CORNER: Chat GPT

Two Senior CMS Officials on "Saving Costs" - June 2026

MedCityNews, June 9, 2026 (Katie Adams): CMS Dr. Oz on Making Healthcare Affordable
https://medcitynews.com/2026/06/dr-oz-cms-healthcare-affordability/

MedCityNews, June 8, 2026 (Katie Adams): Casey Mulligan on Healthcare Cost Incentives
https://medcitynews.com/2026/06/hhs-affordability-healthcare-costs/

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For experts, these two pieces in MedCityNews are less “two cost-control plans” than two different levels of the same policy stack. Oz is giving the CMS administrator’s operational/political affordability agenda: fraud, drugs, IT, prevention, deregulation. Mulligan is giving the HHS economist’s causal theory of cost growth: distorted incentives, especially Medicaid financing mechanics, propagate through the whole system.

CMMI ACCESS Program: Can Well-Intentioned Goals Conceal Adverse Incentives?

Header:  CMMI produces a JAMA Op Ed on its "ACCESS" technology and chronic care program.  I used an AI-generated essay to explain, then critique the program in some detail.

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This week, JAMA publishes an important paper from CMMI, which appeared online May 11.  See:

• Outcome-Aligned Payments for Technology-Enabled Care—A New CMS Approach to Paying for Chronic Disease Care in Medicare.  
• (2026)  Shiff J & Sutton A.  JAMA 335:1932-34.
• Online here.
• Clinician-facing ACCESS page.
• See an essay about possible trade-offs by Liao here.
• See an article on ACCESS for Medicaid here.

I've been experimenting with longer-form AI-mediated writing, and I respond to Shiff & Sutton with a 10-page, 5000-word AI essay.

The ten-page essay is in the Google cloud as a PDF here.

The Essay Summary is here:

• CMS’s ACCESS model is a serious attempt to modernize Medicare payment for technology-enabled chronic care. Rather than paying for visits, devices, app clicks, or care-management minutes, ACCESS pays organizations for measurable improvement in chronic disease outcomes — an elegant and potentially important idea. 
• But it also exposes a deeper CMMI paradox: under-managed Medicare patients may need more care, not less. Better management can mean more drugs, physical therapy, behavioral health, monitoring, labs, and specialist follow-up. Judged too narrowly on savings, ACCESS may reward low-cost "metric improvement" while discouraging the costly care activation patients actually need. 

I asked Claude Opus and Chat GPT to make a classification system for the 102 PLA codes being considered for this summer's Annual Lab Meeting, which will price the 102 tests by the crosswalk or gapfill methods between now and November.

I noted that one approach is repeated binary decisions (human vs microbial; then microbial as pathogen panels vs other; and so on), but I emphasized that other classification schemes were possible.    

• Here is a cloud zip file with (1) the original CMS excel, (2) the Claude excel, (3) the Chat GPT excel: 3 files 1 zip.
• Note that both AI's produced complex Excels with many rows, columns, and tabs.  Chat GPT even included a bar chart.

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AI Attempts to Classify 100 New PLA Codes — Gets Migraine

The AMA CPT Editorial Panel creates special proprietary lab codes called PLA codes, or “Proprietary Laboratory Analyses.” In many cases, these describe tests unique to one laboratory, although some are FDA-approved, kit-distributed tests. There are now roughly 700 PLA codes, but no stable public classification system for them.

For the June 10, 2026 CMS Annual Laboratory Meeting, CMS posted a list of 102 new PLA codes to be priced by crosswalk or gapfill between now and November. The CMS spreadsheet includes a “Category” column, but it has not yet been populated. Public presentations proceed code by code, but by the July expert advisory meeting, CMS will impose some kind of category structure on the group.

So I asked two AI systems — Claude Opus and ChatGPT — to classify the 102 codes using the long descriptor column. As a starting point, I suggested one possible approach: repeated binary decisions, such as human versus microbial; then microbial as pathogen panel versus other; and so on. But I also emphasized that other classification patterns might work better. The challenge will be that PLA codes are not just “oncology” or “infectious disease.” They mix analyte, technology, clinical intent, specimen type, and algorithmic output in ways that do not fit neatly into one tree.

 

News Summary: WaPo: HHS Wants to Bring Physicians and AI Together

 

On June 4, 2026, Washington Post has a lead aritlce, "Push to bring AI doctors into American medicine," by Elizabeth Dwoskin.

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Chat GPT summarizes;

The Washington Post article is worth reading because it shows how quickly AI medicine is moving from speculative futurism into federal and state policy. The main story is not just that chatbots may help patients, but that some officials and entrepreneurs are now openly contemplating AI systems that diagnose, triage, refill prescriptions, and eventually practice medicine with limited human oversight.

The article centers on Amy Gleason, now advising HHS on AI, and describes a broader Trump administration push to integrate AI into health care through 

• prescription-refill pilots, 
• cardiovascular triage research, 
• FDA digital-health fast tracks, 
• Medicaid reimbursement for AI wellness tools, and 
• possible future regulation of “independent AI doctors.” 

The article also gives WaPo readers the essential counterweight: physicians, researchers, and licensing boards warning that chatbots still make diagnostic errors, perform unevenly in real-world patient conversations, and may blur the line between advice and unauthorized medical practice.

For readers interested in FDA policy, digital health, medical liability, access to care, or reimbursement, this is an early map of a major coming policy battlefield.

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Chat GPT also researched Amy Gleason's background, as follows:

Amy Gleason began in nursing, including emergency-room nursing, then moved into health-care technology, especially electronic medical records, practice-management systems, interoperability, and patient access to data. An archived White House profile from the Obama-era Precision Medicine Initiative says she “began her career in nursing” and then spent years building and implementing EMR and practice-management technologies.

Her personal story is central to her public identity. Her daughter Morgan developed a rare autoimmune disease, often described as juvenile dermatomyositis / juvenile myositis, and Gleason became intensely focused on the failures of fragmented medical records and data access. The WaPo article says Morgan later uploaded years of medical records into ChatGPT, leading to a different diagnostic framing and trial eligibility.

Professionally, she co-founded or helped lead CareSync, a health-care coordination / records company, and later worked in digital-health roles including Russell Street Ventures, Main Street Health, and CareBridge.

In government, she worked with the U.S. Digital Service [bringing tech experts and government together, under Obama), including health-data modernization projects. She is now described as Acting Administrator of the U.S. DOGE Service, and Strategic Advisor to CMS, focused on modernization, interoperability, and AI/data systems in health care.

So, in one sentence: Amy Gleason is a former nurse turned health-tech executive and patient-data advocate whose personal experience with her daughter’s rare disease pushed her toward interoperability, federal digital services, and now AI-driven health-system modernization.

AMA's New Digital Pathology Codes in "Category III": What If They're Not on the CLFS?

Key Lesson:

In 2026, AMA CPT began assigning whole-slide-imaging digital pathology codes to Category III, rather than the PLA pathway used for earlier WSI codes. That matters because PLA lab codes can move onto the Clinical Laboratory Fee Schedule and be priced by crosswalk or gapfill, while Category III codes are usually not nationally priced by CMS. 

If software-intensive WSI services instead fall into the Medicare RVU/practice-expense system, they face a known trap: CMS may count only technician time and tiny amortized equipment costs, while rejecting per-use software fees. CPT 92229, autonomous retinal imaging, is the warning case.  In the past, CMS has elected to leave such codes "carrier priced" rather than underprice them by 80% - but this does nothing to fix the underlying problems for software-intensive services.

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