For the summer Annual Lab Meeting, CMS has published an expanded code list, with 91 action items.
Go to this site and scroll down for Meeting Notice - Agenda, and find "Code List v.2 5 28 2025."
In the expanded list (released May 28) CMS adds codes confirmed by AMA in early May 2025.
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For full background on this public meeting (June 27) and the Expert Panel Meeting (July 23-24), see my original blog:
The interesting news site Endpoints News has an article on Illumina and the sequencing ecosystem, by editor Jared Whitlock. Find it here:
https://endpts.com/how-illuminas-ex-employees-became-its-customers-and-competitors/
Chat GPT summarizes,
AdvaMed has a new posting on Linked In, highlighting a recent panel in which HHS leadership voiced a commitment to Breakthrough Device coverage.
Find the posting here, including a video clip:
Here's part of what AdvaMed writes:
It's about 60 days since a Texas federal court tossed out the FDA LDT regulation. Recall the government had 60 days to file an appeal. If it doesn't, FDA might issue some other kind of information, like an administrator's blog or a press release on the topic.
Along the way, New England Journal has published a 3-page article on the FDA decision. (Spoiler alert - the authors wish the FDA would have won). Find Sachs, Sharfstein & Zettler online here:
https://www.nejm.org/doi/full/10.1056/NEJMp2504926
In a previous blog, I noted that CMS had released CY2023 Part B claims (by doctor or by lab) for CY2023. I showed the top ten billing labs for 81479, molecular unlisted code, for which the total dollar volume was nearly half a billion dollars ($488M) in 2023.
Here, I went back to the cloud database and extracted all the molecular codes (811 series to 815 series), plus PLA codes ending in U, plus microbiology molecular codes (87468-87999).
The database has 130,000 lines, and weighs about 30 MB after I had done some different sorting options.
Total molecular dollar volume in 2023 was $3.4B, of which 14% or $488M went to 81479.
After that, $300M or 9% went to 81528 (Cologuard / Exact Sciences) and $288M or 8% to 87798 (other infectious agent probe). The next two positions were 3% for $118M for 81455 (any lab, heme CGP) and 3% $104M to 0242U Guardant FDA LBx CGP test.
The top 15 codes had 57% of all dollar volume. Click to enlarge.
PLA CODES
CMS logged sales for 82 of the approximately 400 PLA codes at the time. Total sales for PLA codes were $519M. The top 10 PLA codes got 80% of the PLA code dollar volume (of all 400 PLA codes). The top 4 PLA codes (or 400 PLA codes) had half the dollar volume. Click to enlarge.
See It Yourself
I posted the 30 mb Excel file as a Cloud resource in Google Drive. It's open access but you may need a google account to see and download it.
Some More Examples from the Data:
87798
87798 was a very widely used code in 2019-2020-2021, including in MolDx states. Then MolDx brought out an LCD, or revised one, that made it very hard to use 87798 (other molecular probe, pathogen). The top 20 labs biling 87798 by 2023 were almost all in non-MolDx states.
While it doesn't address "standing orders," a separate topic, recall there's a major MolDx article from 2024 which deals with "pathologist-originated orders," and that under appropriate circumstances, these orders can definitely be for genomic tests (not just special stains). Here.
If you follow this area, track a whistleblower settlement in which Agenda pays $3.2M or more regarding "standing or automatic orders" for molecular tests.
The case also makes reference to "honoraria, gift cards, and payments per referral." See a 360Dx article on May 22, 2025, here. For more details see the full DOJ press release, dated May 21, here.
Regarding "settlements" - The claims resolved by the settlement are allegations only and there has been no determination of liability.
While most stakeholders assume payers cover what is considered “standard of care,” the article explains that payers often base decisions on stricter, formalized evidence hierarchies. This disconnect leads to denials of common tests even when supported by consensus guidelines or typical specialist practice. For lab leaders, this is a reminder that payers may not follow clinical logic—and labs must bridge the gap through clear documentation and advocacy.
Generic CPT codes like 81479 (genetic testing) and 83520 (immunoassays) allow very different tests to be billed under a single code, making payer adjudication inconsistent. The article stresses how vague codes increase denials, slow claims, and limit coverage decisions, reinforcing the need for labs to support PLA code development or utilize DEX Z-codes for more transparent claims.
Astion skewers the notion of “free testing” from outside labs. Even when the assay itself is gratis (e.g., sponsored research or pharma partnerships), there are internal costs—tubes, logistics, IT, result reconciliation, and clinician education. These costs are real and recurring, and labs need to quantify and communicate them when asked to permit out-of-network or ad hoc ordering.
The “burnt toast” metaphor is apt: labs and providers are stuck doing time-consuming appeals (grievances) that could often be avoided by front-end ICD-10 coding accuracy and improved EMR documentation. The article encourages labs to focus stewardship not just on test utilization, but on pre-adjudication readiness—ensuring orders are defensible before submission.
Astion highlights wasteful practices (e.g., duplicate testing, overly bundled panels, obsolete assays like CK-MB), citing Choosing Wisely. Payers view these as signposts for poor stewardship. Labs that fail to police this waste risk tighter controls, lower fee schedules, and greater scrutiny. The article indirectly calls for labs to proactively deimplement low-value tests as a strategy for payer trust.
While the cost of out-of-network testing is well known, the article notes that payers also worry about data opacity, variable test quality, and patient dissatisfaction. By aligning test menus, utilization policies, and education with payer goals, labs can position themselves as preferred in-network providers—an increasingly strategic distinction as payers steer patients more aggressively.
Most weeks, New England Journal includes a section called Case Records of MGH, a detailed presentation of a puzzling case. A visiting clinician (who didn't know the patient, only the records) reasons through the case and tries to puzzle it out.
Case 13-2025 has a typical title - "A 70-Year-Old Man with Weight Loss..." but the discussant, MGH's Matthew Gartland MD, gives us something extra in his discussion and reasoning.
He shows a four-part framework for putting the numerous puzzle pieces together, which he calls Unboxing, Corners and Edges, Landmarks, and Bridging. Click on the pic to enlarge:
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| click to enlarge |
Dr. Matthew G. Gartland: This 70-year-old man
presented with subacute progressive anorexia, weight loss, and headache.
Shortly after admission to this hospital, fulminant encephalopathy
developed in the patient.
This case requires iterative clinical reasoning with synthesis of multiple pivot points to arrive at a diagnosis.
The process of clinical reasoning often unfolds much like the way we approach a jigsaw puzzle. Thus, I will apply a framework I will call “jigsaw heuristics” to approach this complex case.
·
I will use a similar strategy to develop a
differential diagnosis for this patient.
After unboxing, I often focus on assembling the corners and edges to identify the boundaries of the puzzle. This patient’s presentation contains two discrete timelines that serve as the boundaries of the case, which can be described with time-bound semantic qualifiers. This patient had a subacute-to-chronic syndrome that began at least 6 weeks before hospitalization, with features that include the findings on initial physical examination, such as bruising and thinning skin, as well as the abnormal laboratory test results and radiographic findings on admission. In the hospital, a second process unfolded with fulminant, progressive encephalopathy that may have had a subacute onset. Pertinent findings for this process include intermittent headache, an abnormal CSF profile, multifocal lacunar infarcts, and abnormal results on electroencephalography. At this point, it is unclear where the patient’s weight loss will fit.
Lastly, I shift to “bridging,” which is the process of
methodically completing homogeneous areas of a puzzle by using the shades and
shapes of the pieces.
Cushing’s
syndrome…
Candida meningitis…
Cryptococcal
meningitis…
Hot off the press at NATURE MEDICINE:
Find it here (subscription):
https://www.nature.com/articles/s41591-025-03711-w
At Linked In, the prolific Denis Horgan gives a detailed open-access summary of the paper's key points:
It looks like Horgan includes a downloadable version of the 3-page PDF within his Linked In article.
The paper is focused on systematic issues for implementation in the European Union, and one of three key issues is diagnostic fragmentation.
The authors write,
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AI CORNER
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Summarize the several paragraphs about diagnostics.
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Key Points on Genomics in European Cancer Care – What Needs to Change [Subbiah et al]
Start Molecular Testing Early:
The paper urges comprehensive molecular profiling at diagnosis, not just at disease progression. Early testing enables more effective targeted and immunotherapies before tumors evolve resistance, and supports better trial enrollment and long-term tracking.
Adopt Universal Testing:
For real progress in cancer care, the authors advocate for routine somatic and germline testing in all cancer patients—highlighting the need for investment in infrastructure, cost coverage, and clinical decision tools.
Support Tumor-Agnostic Therapies:
Europe lags behind the U.S. in approving biomarker-based, tumor-agnostic therapies. The authors call for a strategic framework (like ESMO's ETAC) to evaluate and enable approvals based on molecular alterations rather than tumor histology.
Coordinate Multi-Stakeholder Action:
Achieving these goals will require coordinated action across regulators, industry, clinicians, and patient groups—particularly to overcome barriers in rare cancers where large RCTs are infeasible.
In sum, the paper pushes for earlier, broader, and smarter molecular diagnostics in cancer care, with updated regulatory and clinical strategies to match.
For a long time, blogger and scientist Derek Lowe has been putting out interesting essays. For several years, he's been hosted by SCIENCE.
Here's one. His May 21 blog at "In the Pipeline" (at SCIENCE) looks into the cash-for-papers industry. It's not new, but it's probably accelerated by AI. Derek gives a lengthy summary at his blog, and for more details, refers readers to an earlier online article by Leonid Schneider at a website called, "For Better Science."
Find Derek Lowe here:
https://www.science.org/content/blog-post/inside-scientific-paper-mill
He's summarizing from Leonid Schneider [46pp]:
https://forbetterscience.com/2025/05/19/a-sting-inside-a-papermill/
By sides the summary by Lowe and the long-format article by Schneider, see also March 2025 book, Columbia University Press, by Swiss scientist Csaba Szabo, "Unreliable: Bias, Fraud and the Reproducibility Crisis in Biomedical Research."
Regarding paper mills, quoting from Lowe:
Over at For Better Science, Leonid Schneider has a fascinating look into the papers-for-cash schemes that have been going on for years now in the scientific literature. A pharmacology professor at Univ. Fribourg in Switzerland, Csaba Szabo, was contacted by one of these shady outfits with an offer, or rather, a whole selection of offers. "Ms. Kristen" from the "Alliance Academy of Science" (whatever the hell that is) wrote Prof. Szabo in2023 with an "invitation for potential cooperation", and he was able to [include that in his new book.]
...he needed more clarification ... and what emerged was a detailed schedule of potential payouts that depended on the amount of "cooperation" and the impact factors of the journals where the resulting articles would appear, as well as the speed of acceptance at the journals themselves. It was a long list of variations on the themes of ghostwriting, authorship manipulation, and outright bribery to get things published in actual journals. These things, depressingly, have been going on for a long time now...
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AI CORNER
Here's a summary of the 46-page Schneider article via Chat GPT.
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Here is a concise summary you can adapt for your blog, highlighting Leonid Schneider's and Csaba Szabo’s investigation into papermills, and how Szabo’s sting operation helped expose their mechanics:
In a riveting exposé on For Better Science, investigative journalist Leonid Schneider and pharmacologist Csaba Szabo team up to illuminate the inner workings of academic papermills — shadowy networks that churn out fake scientific publications for a price.
Szabo, a senior scientist at the University of Fribourg, was approached by a Chinese papermill offering cash (up to $5000) for either ghostwriting papers or using his editorial influence to secure their publication. Instead of complying, he collaborated with Schneider to stage a sting operation — posing as a willing participant to gather inside information.
Over a 72-hour WhatsApp exchange with contacts named “Julia” and “Ariana,” Szabo was offered various shady "cooperation modes": he could ghostwrite papers, sell authorship slots, or manipulate journal acceptances as an editor. He was even sent a complete manuscript — later traced to authors with a history of suspicious publications and PubPeer complaints. The paper was typical of papermill output: scientifically superficial, full of recycled tropes (like lncRNA in cancer), and padded with suspect references.
The investigation revealed that the Anzen Academy of Science, which contacted Szabo, is not a real entity. Payments were offered via crypto and obscure platforms like Perfect Money, and names of supposed collaborators were withheld — classic red flags of an international fraud scheme.
Schneider's detailed analysis and Szabo’s undercover work expose a billion-dollar industry undermining scientific integrity. Their findings confirm that papermills exploit weak editorial systems, hijack peer review (often via fake email accounts), and profit from academia’s publish-or-perish culture. This sting also complements Szabo’s broader critique in his recent book, Unreliable, which examines bias and fraud in biomedical research.
Recently, the ACLA submitted a public letter to the Trump administration requesting improvements in laboratory policy. See entry point here.
The ACLA prominently cites a MolDx article from twelve months ago, about pathologist test orders and about information already included in the medical record via a TRF - a test requisition form. See entry point here.
In its letter to HHS and OMB, page 4-5, ACLA specifically cites the MolDx article, and asks that it be made effective nationwide via additional guidance from CMS itself.
In the next section of the letter ACLA asks for fixes to the cumbersome 14-day rule.
On May 14, 2025, AHRQ released a 140-page review of the field of Multi Cancer Early Detection tests. The systematic review focused on 20 studies to date, 7 of which it found were higher quality. They report only one study had enough assessment of harms; therefore, it was too early to do a risk-benefit calculation of harms.
Find the report here:
https://effectivehealthcare.ahrq.gov/products/cell-free-dna/research
Update - See data on top codes, top PLA codes, in a later blog:
https://www.discoveriesinhealthpolicy.com/2025/05/cms-2023-lab-data-part-b-highest-dollar.html
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Each year, CMS releases a cloud database of provider and CPT code utilization for the calendar year about 18 months earlier - e.g. CY2023 data released around May-June 2025. CMS released data for CY2023 on April 24, 2025.
Find the entry point here:
https://data.cms.gov/provider-summary-by-type-of-service/medicare-physician-other-practitioners
For example, you can enter this database:
Physician and Other Practitioners [& Labs] - By Provider and Service. If you enter the NPI for, for example, Neogenomics (100325317) you get all the 2023 Part B payments to that lab by CPT code.
The database requires a little time to understand, but basically you use options under the button FILTER and when satisfied, you click EXPORT and get a CVS (comma) file which I recommend you immediately open and re-save as an XLS file.
The full cloud database you are searching has about 9.6 million rows of data. (Whereas, for example, if you filter on the NPI for Neogenomics, you get 274 rows).
I Was Not Sure This Would Happen
For about a decade, CMS has been releasing this doctor-specific (or lab-specific) payment data, based on a legacy of federal court cases on whether they were private or releasable. Frankly…I couldn't have guaranteed they would be released under the current new administration - but here they are.
81479 in 2023
If you search on the molecular unlisted code 81479, you get 80 rows. The payments for 81479 tally to $488,385,801 in total. That is, despite the explosion of 500-plus PLA codes, nearly half a billion dollars goes out via 81479.
The top 8 payments for 81479, totalling about 90% of payments, are all in MolDx states. Click to enlarge:
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| Click to enlarge |
Dollarized, that’s $297,378, and $593,548, and $39,922,313 (0.7%, 1.5%, 97.8%).
81408 "Fraudomatic Code"
Wild use of code 81408 led to around a billion dollars of payments around 2018-2021. Utilization in 2023 was essentially zero (11 uses).
Download Yourself
I posted the 30mb of data for all molecular lab codes in a cloud file. You might need a google account but otherwise it is open access.
Today's news includes, per Reuters and WSJ, that United Healthcare may be under criminal investigation relative to Medicare Advantage programs.
There's also a important and informative article by Cornell authors about Medicare Advantage and how it "traps" patients who can't return to fee for service Medicare. Find it here (subscription).
Over on the fee for service side, for a premium of about $200 a month, you get Part A and Part B, and for another circa $200 a moth, you get Medigap, which covers nearly all copays (so your out of pocket may approach $0.)
The problem is that once you are in Medicare Advantage, you can switch back to FFS Part B, but you probably can't get a MediGap plan, without which, the 20% copays can risk being highly onerous.
And, you may find if you are trapped in Medicare Advantage, narrow networks or copays or denials might worsen over time.
The Casalino et al. article runs through a range of pro's and con's and in's and out's of the system as it exists.
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See also a Health Affairs article on how we could clarify the nature of supplemental benefits for enrollees - here.
While there is an RFI for deregulatory ideas to CMS, and for deregulatory ideas to all of HHS (open to June 10 and July 10, respectively) - AHA and OMB have already submitted deregulatory ideas to OMB.
AHA here. ACLA here. 18pp and 12pp, respectively.
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I asked for a Chat GPT comparison.
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Here is a detailed comparative analysis of the American Clinical Laboratory Association (ACLA) and the American Hospital Association (AHA) submissions in response to the Administration’s deregulatory RFI (2025), with an emphasis on the ACLA letter and then a structured contrast with AHA’s approach.
The ACLA letter is a highly focused, technically detailed, and policy-savvy document aimed squarely at regulatory barriers unique to clinical laboratories. It speaks the language of CMS rulemaking and OMB cost-benefit review, while laying out eight specific deregulatory proposals, most of which are highly actionable within current agency authority.
PAMA Reform (CLFS Rates):
ACLA sharply critiques CMS’s implementation of PAMA Section 216 and calls for rate freezes and updated data collection windows.
It frames the issue using statutory interpretation (e.g., CMS may reduce but not must reduce) and budgetary facts (CLFS cuts already exceeded CBO projections by $1.5B in just 3 years).
Medical Necessity Documentation:
Urges CMS to formally recognize test requisition forms (TRFs) as valid documentation — citing inconsistency among MACs and referencing MolDX precedent.
Prior Authorization and Date of Service:
Focuses on misuses of CMS’s “date of service” rule as a denial tactic.
Seeks amendments to 42 CFR §§ 414.510 and 422.122 to clarify payment pathways and prevent retroactive denials.
National Coverage Determinations (NCDs):
Proposes a streamlined process for NCD reconsiderations that expand (rather than narrow) coverage — aimed at unlocking innovation backlog.
Coding and NCCI Manual Conflicts:
Calls for deletion of several burdensome and contradictory clauses in the NCCI Policy Manual that conflict with AMA CPT guidance.
Seeks to align CMS with the official HIPAA code set source (CPT), asserting that CMS edits that deviate from CPT guidance should not stand.
Electronic Signatures:
Proposes a modernization of signature policy, arguing that HL7v2-based lab orders from EHRs inherently reflect physician intent.
ICD-10 Excludes Notes:
Argues that these create systematic denials of legitimate claims, especially when multiple ICD-10 codes apply.
CPT Licensing Fees:
Raises a broader issue of monopolistic pricing — that CMS mandates CPT codes but does not regulate AMA’s licensing fees — a rare deregulatory push on public-private cost imposition under HIPAA.
By contrast, the AHA submitted an expansive and multi-faceted 100-point deregulatory agenda, organized into four domains: Billing/Admin, Quality, Telehealth, and Workforce.
Breadth Over Depth: The AHA letter is sweeping, aimed at reducing system-wide friction across all sectors of hospital operations — billing, regulation, safety, staffing, etc.
Pragmatic Framing: Focuses on financial instability (40% hospitals with negative margins) and massive admin overhead ($1T/year) to justify relief.
Policy Recommendations Include:
Repeal of CMMI Mandatory Models like TEAM and IOTA.
Rollback of CMS’s 2024 Information Blocking Disincentive Rule.
Codification and rapid implementation of Interoperability and Prior Auth Rule (CMS-0057-F).
Elimination of duplicative and outdated reporting (e.g., sepsis bundle, COVID-19 vax stats, 42 CFR Part 2 behavioral health privacy).
CMS survey reform, including virtual low-risk complaint surveys.
Major telehealth expansions including origin site, modality, and provider type.
HIPAA updates, such as removing breach notices for events under 500 persons.
| Theme | ACLA Approach | AHA Approach |
|---|---|---|
| Tone & Style | Technical, regulatory detail, aimed at CMS/OMB staffers | Advocacy-forward, sweeping, politically inflected |
| Focus | Lab-specific deregulatory pain points, especially CLFS and coverage coding | Entire hospital ecosystem: payment, surveys, workforce, quality, IT |
| Primary Regulatory Targets | CMS (CLFS, NCDs, PAMA, NCCI), HHS (HIPAA) | CMS, HHS, CMMI, OSHA, FTC, EPA |
| Use of Executive Order 14219 Framework | Strong alignment: cites each action under EO-defined categories like “not based on best reading of statute” or “excessive cost” | Implicit use; themes align but less explicitly cited |
| Actionability | Focused, rule-by-rule roadmap of actionable CMS revisions | Big-picture policy wishlist — some requiring Congress, many needing interagency coordination |
| Innovation Framing | Emphasizes how flawed regulation suppresses diagnostics R&D and precision medicine | Innovation cited more generally, especially in payment models and digital care delivery |
Criticism of Prior Authorization Abuse: Both criticize MA plans for using prior auth to obstruct care, especially retroactive denials.
Telehealth Support: Both want telehealth regulations updated to reflect post-pandemic realities (origin site, behavioral health, hospice, etc.).
Regulatory Overhead: Both highlight administrative burden detracting from patient care.
Lab-Centric Issues: ACLA uniquely targets CPT license fees, Excludes Notes logic errors, and the misalignment of NCCI with CPT — none of which appear in AHA’s list.
Payment Models: AHA squarely attacks mandatory CMMI bundles (TEAM, IOTA); ACLA does not engage payment reform beyond CLFS.
Workforce & Accreditation: AHA’s list is heavy on workforce de-bureaucratization (e.g., NPs, surveys, OSHA), not relevant to ACLA’s world.
For a lab industry audience, the ACLA letter provides a precise deregulatory roadmap tailored to actual operational friction points in laboratory medicine — from pricing mechanisms (PAMA) to coding conflicts (NCCI/CPT), to coverage hurdles (prior auth). It is tightly written, strategically framed in EO 14219 language, and well-suited to OMB deliberations.
In contrast, AHA’s letter serves as a maximalist deregulatory manifesto, collecting long-standing frustrations across a fragmented hospital landscape into a single political and economic narrative. While both documents seek relief from regulatory burdens, ACLA is surgical, AHA is systemic.
Let me know if you’d like a one-page version, a chart-only summary, or a redline to use in briefings.