Friday, June 12, 2026

A 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)

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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 and CLIA

One of the more interesting small dramas in 2026 Medicare diagnostics policy is that two substantial bills on highly technical laboratory and coverage issues are being introduced by a member of Congress who is, in political terms, 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. 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 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. It would also create a public CMS database with key information about LDT performance specifications and validation information; clarify that LDTs include modern analyses of digital laboratory information, such as genomic data derived from previously sequenced patient samples; allow voluntary confirmation by recognized third parties that an LDT is analytically and clinically valid; and establish centralized error reporting with enhanced CMS oversight authority when credible information indicates problems with analytical or clinical validity.

That is the second surprise. 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, and clearer accountability. That makes it a kind of “enhanced CLIA” approach—an alternative to FDA device-style regulation, but not a defense of the status quo in its purest form.

The timing is important. The FDA’s attempted LDT rule had already triggered intense opposition from laboratories and trade associations, and the broader legal and policy question was whether LDTs should be treated primarily as medical devices or as clinical laboratory services. Dunn’s bill stakes out the latter view. It says, in effect, that the path forward is not to migrate LDTs into FDA device regulation, but to modernize CLIA so that CMS can supervise laboratory testing in a way that better reflects genomics, digital information, complex algorithms, and modern precision medicine.

The fact that Dunn is a physician matters. A urologist and former Army surgeon from North Florida is not the stereotypical sponsor one might imagine for molecular diagnostics and CLIA modernization. But that may actually be part of the appeal. He can speak as a clinician rather than as a pure industry proxy. His district is not Boston, San Francisco, Cambridge, or Silicon Valley. It is North Florida—Panama City, Tallahassee, and surrounding areas. That gives the bills a different political flavor: access to diagnostic innovation is framed not only as a biotech issue, but as a patient-care and physician-practice issue.

The third surprise is the late-term sponsorship. Because Dunn is retiring, the natural question is whether these bills are meant to pass, or whether they are marker bills. The realistic answer is probably “marker bills, unless something changes.” Standalone Medicare process reform and CLIA modernization are not easy lifts in a crowded election-year Congress. H.R. 8500 has bipartisan elements and could plausibly attract broader support because timeliness and transparency in Medicare coverage are difficult to oppose in principle. H.R. 8890, by contrast, sits closer to the LDT regulation wars and therefore has a more obvious coalition and opposition structure.

Still, marker bills matter. They define language, create a policy baseline, organize stakeholders, and give future sponsors 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, especially if ACLA, CAP, AMP, AdvaMed, specialty societies, and patient-access groups decide the language is worth defending and refining.

The combined Dunn bills are therefore best understood as a late-term policy intervention by a clinically credentialed member with little time left but significant issue credibility. 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. Together, they reflect a surprisingly coherent diagnostics-policy agenda: faster Medicare coverage processes, clearer laboratory oversight, more transparency, and a regulatory architecture that treats advanced diagnostics as clinical services rather than ordinary widgets.

Whether they pass is uncertain. Whether they are important is less uncertain. In Washington, a bill introduced by a retiring member can look like a farewell gesture. In this case, it may be more like a draft blueprint left on the table for the next round of the diagnostics wars.

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Key factual anchors: Dunn’s H.R. 8500 press release says the bill targets Medicare LCD delays, inconsistent standards, lack of transparency, stakeholder involvement, timely completion, and a formal reconsideration-review process. (Neal Dunn) Dunn’s H.R. 8890 press release says the Enhancing CLIA Act would update CLIA, reaffirm LDTs as CMS/CLIA-regulated professional services, create a public LDT database, include genomic/digital lab information, support voluntary third-party validity confirmation, and establish error reporting and CMS oversight authority. (Neal Dunn) ACLA publicly welcomed the CLIA bill as preserving CMS as regulator of clinical laboratories while enhancing LDT oversight and transparency. (acla.com)

Source note: Dunn announced on January 13, 2026 that he would not seek re-election after five terms; H.R. 8500 was introduced on April 27/28, 2026 with Reps. Barragán and Tenney; H.R. 8890 was introduced in May 2026 and referred to Energy & Commerce and Ways & Means. (Neal Dunn)


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

 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.

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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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



Wednesday, June 10, 2026

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.

Tuesday, June 9, 2026

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. 

AI Attempts to Classify 100 New PLA Codes (Gets Migraine)

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.

 

Monday, June 8, 2026

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.

Sunday, June 7, 2026

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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Saturday, June 6, 2026

How You Get CMS to Liberalize a Burdensome Rule (Case Study: Physical Therapy Orders)

Why You May Care...

 Many stakeholders approach CMS each year with a request to liberalize one or another rule - be it an administrative policy, an NCD, or some other problem.   While the example below is not related to molecular laboratories (my main readers), the example DOES show how multiple stakeholders coordinated - and over several years - to get  a meaningful policy change at CMS.

What's It About? Physical Therapy?

Here's the status quo before 2025.  A physician sees a patient who needs physical therapy.   The physician writes a REFERRAL or ORDER for a physical therapy evaluation.  The physical therapist spends 30 to 60 minues with the patient, doing careful tests and examples, and develops a plan of care.  The PT transmits the plan of care to the physician to countersign.   (This countersignature must be re-affirmed every 90 days).

Here's what people got.   Beginning in January 2025, the physician issues a ORDER or REFERRAL for physical therapy.  The physical therapist does the exam and prepared the report and plan of care.   It's transmitted back to the referring MD.  NEW RULE:  As long as the physician doesn't reach out and tell the P.T. there is a problem, the P.T. can ASSUME the plan of care is OK with the physician.

While that may sound like  a small change, I suspect PT stakeholders were very happy to get it.

Below I give a detailed Chat GPT summary of the rulemaking, requests, and the rationales discussed.  

Find the rulemaking at 89 Fed Reg 97710, 12/9/2024, specifically 97912ff (about eight pages).

 Take Home Lessons:  How It Worked [Chat GPT]

Wednesday, June 3, 2026

CMS Releases Data for "87798" Billing in 2024

On May 21, 2026, CMS released data by lab and by CPT code (also by physician and CPT code) for Part B payments in CY2024.

There's been a lot of discussion of changing payment policies for code 87798 in the past six months; 87798 can be use as a "probe" of the data set.

Find more about the 2024 Part B data set here:

https://www.discoveriesinhealthpolicy.com/2026/06/cms-releases-rich-cloud-database-for.html

87798

First, we searched the dataset for all providers billing 87798.  There were about 1400 total providers of 87798 services.  Payments per provider ranged from $24M down to $109.  Total payments for 87798 in all 50 states were $436,743,071.  $436M.  Of that $436M, $139M or 32% went to TX and $36M to PA, $34M to FL, $23M to NJ.  This shows strong representation of Novitas and FCSO states for 87798 payments in CY2024.

Among all codes, 87798 was $436M, 81528 Exact Cologard was $306M, and 81479 was $572M (prior blog).

Services per bene - about 20 labs billed >30 services per year per bene, including 3 that billed >60 services per year per bene (87798).

The top providers of 87798 received $24M, $21M, $12M and $8M.  

Note that this is only about 16% of all 87798 payments.  Services per patient per year ran from 9 to 20.  The four labs were in TX (2 labs) and PA and FL.  


Top Four Labs Billing 87798: Their Overall Billings

We used these four labs to go back to the database and get all the CMS payments to these labs.  

The four labs are the "new universe" of claims.  The four labs were paid $131M in total, and got half of their Part B revenue from 87798 ($65M).

After getting 50% of revenue from 87798, they got 12% for candida amp probe (87481), 4% for 3-5 Resp Virus panel (87631), and about 4% each for Strep B Amp Probe (87653) and MultiOrg Amp Probe (87801).  These five tests brought in about 74% of all the annual revenue of the 4 labs.



Special Mention to Moldx Labs

Although it's not a big lab, I feel like honorable mention should go to MolDx Labs, in North Hollywood CA, which was paid $2.7M in 2024 by Noridian and MolDx, 58% for large panels of code 87798.   

Look up the NPI - from March 2024 - it's really "MolDx Labs." 



Other Analyses

I took 15 labs - the highest-5 billing 87798, next next-highest five from Texas, and the five billing immediately under $2M (selecting mid-size labs, neither giant nor tiny).   I gave the list of 15 labs to both Claude Opus 4.8 and Chat GPT and asked it to look for:
CLIA # and date, NPI # and date, evidence of web presence, other news
Result: A substantial proportion of labs paid large amounts for 87798 were found to have NO web presence, and where found, recent NPIs.

I searched for labs paid BOTH for 87798 and 81419.  I found 22 in the US in 2024, paid a total of $21M just for these two codes (about $1M per lab).   The ratio of payments for each lab from either 87798 or 81419 was not predictable - either could be much higher than the other.   

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See a Linked In article on how to decide whether to enter or exit UTI PCR diagnostic services, here, here.


Tuesday, June 2, 2026

Predicting the Scientific Future: From UCSF's Robert Wachter

Robert Wachter of UCSF is both a medical leader and a futurist. In his newest book, A GIANT LEAP, he discusses AI in medical care.  From his early AI experiences in 2022, he extracted the following.

The story of whether AI would finally transform healthcare would mostly be about whether the healthcare system could implement these tools in ways that would produce better outcomes for patients, lower costs, and some relief for beleaguered doctors and nurses. 

And that, in turn, would be determined -- as much by history, politics, economics, pride, regulations, leadership, lawsuits, guilds, culture, workflows, inertia, greed, hubris, vibes, and zeitgeist as by graphics processing units, diffusion models, and neural networks.


Wachter, A Giant Leap, 2/2026, Preface.