Wednesday, July 15, 2026

AI Finds and Assesses a New Alzheimer Risk Study (Buckley 2026)

We recently reported the news that Anthem would soon be covering FDA approved pTau217 blood tests, with conditions, as part of dementia work-ups in the clinic.

And today, I saw headline news at CNN that there's a new study, pTau217 is a strong marker of 5-year risk of developing MCI or dementia in healthy elders.   The CNN article said that high pTau217 matched a 38% increased risk of dementia.   I thought this sounded misleading; do I care if my ten year dementia risk is 10 chances ini 100 or 13.8 chances in 100?  It turns out the CNN piece was misquoting, and pTau217 is actually a much stronger predictor (from 12% to 38% absolute risk or 3X relative risk).

Here's a dialog with Chat GPT to puzzle it out.

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Can you find this paper? There is recent evidence that p-tau171 can be a marker for elevated dementia risk in “healthy elders,” somewhat as high blood pressure is a risk factor for stroke. I had seen a five-year figure of 38% and a ten-year figure of 78%. However, relative-risk numbers can be misleading: if my underlying chance were one in ten, a 38% increase would raise it only to about 1.38 in ten. The information may have come from a recent news report or perhaps an abstract at the upcoming international Alzheimer’s meeting.

Chat GPT

The paper can indeed be found, although the biomarker is p-tau217, not p-tau171. It is:

Buckley RF, Townsend DL, Birkenbihl CJ, et al. “Prognostic Value of Blood-Based P-Tau217 Levels for Progression to Cognitive Impairment.” JAMA. Published online July 14, 2026. doi:10.1001/jama.2026.12556.

The paper was published in conjunction with its presentation on July 15 at the 2026 Alzheimer’s Association International Conference in London. It pooled 2,684 people who were cognitively unimpaired at baseline across six longitudinal research cohorts. Their median age was 69.6 years, and median follow-up was 5.4 years. During follow-up, 478 participants reached the study’s composite endpoint of cognitive impairment. (JAMA Network)

The CNN sentence gets the central statistic wrong

My initial impression came from a CNN report by Sandee LaMotte, which said that cognitively healthy people with high p-tau217 had an “estimated 38% greater chance” of developing early signs of dementia over five years. As written, that is not what the study found. (Facebook)

The study found that people in the very-high p-tau217 group had an estimated 38% absolute probability of progressing to cognitive impairment within five years. It did not find merely that their risk was 38% higher than that of some comparison group.

That distinction is substantial. The estimated five-year risk in the low p-tau217 group was 12%, while the estimate in the very-high group was 38%. Therefore:

  • The absolute increase was 38% minus 12%, or 26 percentage points.

  • The risk ratio was 38 divided by 12, or approximately 3.2 times the risk.

  • Expressed as a relative increase, the very-high group’s risk was about 217% higher than the low group’s risk.

By contrast, a “38% greater chance” applied to a baseline risk of 12% would produce a risk of only about 16.6%:

12% × 1.38 = 16.6%.

Thus, the CNN wording does not merely simplify the result. It transforms a 38% absolute risk into an apparent 38% relative increase, which is a very different and much smaller effect.

There may be an identifiable source for the mix-up. The paper separately reports that each one-standard-deviation increase in p-tau217 was associated with a hazard ratio of 1.38 for progression. That means a 38% increase in the instantaneous event rate per standard-deviation increase, within the time-to-event model. It is not the same thing as saying that people with very high p-tau217 had a 38% increase in their five-year probability. The paper’s HR of 1.38 and its five-year absolute risk of 38% happen to contain the same digits, but they answer different statistical questions. (JAMA Network)

The complete risk table—and how many people were in each group

The study divided participants into four p-tau217 categories. These were not quartiles. The investigators standardized p-tau217 measurements within each cohort and chose thresholds corresponding approximately to biologically meaningful amyloid-PET Centiloid levels: 10, 25, and 60 Centiloids. Consequently, the four groups were unequal in size. (JAMA Network)

Baseline p-tau217 categoryApproximate amyloid-PET correspondenceParticipants, N (%)5-year absolute risk10-year absolute risk
Low: <−0.5 SD<10 Centiloids516 (19.2%)12% (95% CI, 9%–15%)40% (31%–49%)
Intermediate: −0.5 to <1.1 SD10–24 Centiloids1,087 (40.5%)15% (12%–17%)45% (37%–52%)
High: 1.1 to <2.5 SD25–60 Centiloids598 (22.3%)24% (20%–28%)62% (52%–69%)
Very high: ≥2.5 SD>60 Centiloids483 (18.0%)38% (33%–43%)78% (69%–84%)

The group sizes are important. The 38% estimate did not arise from a handful of extreme outliers: the very-high category initially included 483 participants. At the same time, the fact that 18% of this particular study population fell into the very-high category should not be interpreted as showing that 18% of ordinary cognitively healthy older Americans have such levels. These were selected Alzheimer’s research cohorts, not a representative population sample. (JAMA Network)

The table also clarifies another ambiguity in the CNN account. The formal high group had a five-year risk of 24%, twice the 12% risk in the low group. The 38% estimate belonged specifically to the very-high group. Referring simply to participants with “high levels” collapses two distinct categories.

At two years, the modeled absolute risks remained low in all four groups, ranging from approximately 1% to 4%. The sharper separation appeared over five years, and still more dramatically in the ten-year projections. (JAMA Network)

The endpoint was not dementia alone

The study’s outcome was broader than “developing dementia.” Participants were counted as having progressed if they developed any one of the following:

  1. Mild cognitive impairment;

  2. Dementia; or

  3. Two consecutive global Clinical Dementia Rating scores of 0.5 or greater.

Therefore, “progression to cognitive impairment” is the accurate description. CNN’s phrase “early signs of dementia” is understandable as popular shorthand, but it blurs the distinction between MCI, a low CDR score, and established dementia. The reported 38% should not be presented as a five-year probability of receiving a dementia diagnosis. (JAMA Network)

The secondary cognitive analysis told a consistent story. Over five years, modeled cognitive performance was relatively stable in the low and intermediate groups, while the high and especially the very-high groups showed greater decline on the harmonized Preclinical Alzheimer Cognitive Composite. (JAMA Network)

Why the ten-year number is less secure

The 78% ten-year estimate is striking, but it is much less firmly supported than the five-year result. Only 139 participants—about 5% of the entire sample—had at least ten years of clinical follow-up, and most of the long-term information came from one cohort. (JAMA Network)

The survival figure shows how sparse the tail became. Of the 483 participants who began in the very-high group, 425 were still under observation and event-free at two years, 285 at four years, 143 at six years, 27 at eight years, and only 11 at ten years. The corresponding numbers at ten years were also small in the other groups: 19 low, 65 intermediate, and 16 high.

The 78% figure is therefore a model-based extrapolation informed by a dwindling number of long-observed participants. Its reported confidence interval—69% to 84%—does not fully communicate every source of uncertainty, including reliance on selected cohorts and the scarcity of ten-year observations.

The models also did not explicitly treat death as a competing risk because mortality information was not consistently available. Someone who died or left the study without developing cognitive impairment was censored. In an older population, failing to model death as a competing event may make long-range disease probabilities appear somewhat higher than the probability a living person would actually experience before death. (JAMA Network)

“Healthy elders” were cognitively healthy, but not necessarily population-typical

The participants were cognitively unimpaired at enrollment, but “healthy elders” can give an overly broad impression. The pooled population was assembled from six observational studies and clinical-trial cohorts. One component was the 952-person A4 prevention trial, which required participants to be amyloid-positive. Overall, 43% of the pooled study population was amyloid-positive at baseline. (JAMA Network)

That enrichment was useful scientifically because it provided enough people with substantial Alzheimer-related pathology to study subsequent progression. It also means the observed distribution of low, intermediate, high, and very-high p-tau217 should not be treated as a prevalence survey of the general older population.

The accompanying JAMA editorial noted additional limitations: the cohorts were generally highly educated and had limited racial, ethnic, and socioeconomic diversity. Medical conditions that can affect measured p-tau217 concentrations, including chronic kidney disease, were not incorporated fully into the prognostic estimates. Cognitive impairment could also arise from vascular disease, other neurodegenerative conditions, or mixed pathology rather than Alzheimer disease alone. (JAMA Network)

Is p-tau217 analogous to blood pressure?

The blood-pressure analogy is useful in one limited respect: both measurements may help stratify the future probability of a clinically important outcome in a person who currently has no symptoms.

But biologically they are not quite equivalent. High blood pressure is itself a causal and modifiable contributor to stroke risk. Elevated p-tau217 is better viewed primarily as an indicator that an Alzheimer-related pathological process—particularly amyloid-associated tau biology—may already be advancing. It is closer to a measure of underlying disease burden or disease stage than to a stand-alone risk factor imposed upon an otherwise pathology-free brain. The study found that p-tau217 retained prognostic information even after accounting for amyloid PET, suggesting that it captures an integrated aspect of advancing Alzheimer-related pathology. (JAMA Network)

For now, the most defensible application is research: identifying cognitively normal individuals at sufficiently high near-term risk to make Alzheimer prevention trials feasible. The authors and editorialists caution that the estimates are not yet precise or generalizable enough to tell an individual cognitively healthy person, based on a commercial blood result, that his or her personal five- or ten-year risk is a particular percentage. Current guidance continues to recommend against routine p-tau217 testing of cognitively unimpaired people outside research studies or clinical trials. (JAMA Network)

The bottom line is therefore considerably more dramatic—and more nuanced—than the CNN sentence. The study did not find a mere 38% relative increase. It estimated a 38% five-year absolute risk of broadly defined cognitive impairment in the very-high p-tau217 category, compared with 12% in the low category: a 26-percentage-point difference and roughly a threefold risk ratio. That is a substantial prognostic signal. But it was derived from selected, pathology-enriched research cohorts, the endpoint was broader than dementia, and the ten-year estimate rests on comparatively sparse follow-up.

Primary paper: Buckley et al., JAMA, July 14, 2026

Accompanying editorial: Schindler SE, Wolk DA. “Predicting Risk of Cognitive Impairment With Alzheimer Disease Blood Biomarkers.” JAMA. Published online July 14, 2026. doi:10.1001/jama.2026.13322.

Tuesday, July 14, 2026

WaPo Jumps on CMS RFI Against AMA CPT, RUC

Header: WaPo Slams AMA Hard, Lands Punches Early


On Tuesday, July 14, the Washington Post had a headline article ready to run, featuring a lot of information from the RFK Jr HHS.  Here. The article describes the Administration's new healthcare target: the AMA CPT and AMA RUC.   Appearing so fast after the proposal came out in an obscure place, this likely indicates it was placed in the WaPo by the administration to get a headstart on the messaging.

Another clue that this was hand-delivered from HHS to WaPo - even by midnight, no other media captured on Google, other than WaPo, had even mentioned the story.

The WaPo highlighted this as a goal of RFK Jr within weeks of the November 2024 election - here. (Both today's article and he 2024 one were written by Dan Diamond).   (More on the journalist and the context here.)

The WaPo writes,

  • Health Secretary Robert F. Kennedy Jr. and his aides have spent about two years privately discussing plans for shifting away from the current system, a move cheered by some public health advocates who agree [w RFK] that the current system is flawed. 
  • [But] efforts at change have met fierce resistance from lobbyists.
  • Financial incentives are different in other countries, where more physicians go into primary care and health outcomes are better.
  • “White House aides are interested in what alternatives we have to this monopoly,” said one White House official, speaking on the condition of anonymity to preview internal plans.
The article also quotes Miriam Laugesen, who I've mentioned many times in this blog, including her book, "Fixing Medical Prices."  [Note - I had the chance to meet Laugesen this spring.]

Not surprisingly, given the likely-unexpected maneuver to everyone but HHS and the Washington Post, "AMA did not respond to questions."  

The article then adds, "The AMA also collects millions of dollars from...training, selling books, and charging royalties" to submit healthcare claims.

WaPo interest in the topic goes back to at least 2013, with a headline, "Secretive Panel...Distorts Doctor's Pay."  The Wall Street Journal has also had a number of detailed articles on the AMA CPT & RUC. See WSJ, 2010, here.  Last fall, WSJ had some early inside-track news on Sen. Cassidy's maneuvers against AMA, here

Larry Levitt, an EVP at Kaiser KFF, said the proposal was one of just handful of areas where the Trump administration is pursuing changes.

# # #
My blog about the RFI - here.





CMS Releases Physician Fee Schedule Rule - Proposals for 2027

On July 14, 2026, CMS released the Physician Fee Schedule (aka Part B rule) as proposals for 2027.  

Find the early release version here (a typescript of 1500 pages).

Wait for the Federal Register version here on July 16.

See the FACT SHEET here.  (Shared Savings programs get their own Fact Sheet here.)

See the PRESS RELEASE here.  

See rapid coverage of the CMS RFI at WaPo here (7 pm).  My coverage of WaPo here (10 pm).

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Included are reforms to practice expense (will you miss IPCI?), an RFI about the big world of CPT and RUC, special rules on remote monitoring (some restrictive), and more about Software as a Medical Service, which was introduced at lengnth (both for general services and specifically for lab services) a couple weeks ago in the OPPS rule (here).  They also worry about duplicate testing, an area where PET scans inflict a lot more financial damage than hematocrits.

Comment to September 14; the listed manager for CLFS topics is Patrick Sartini.

Things AI Can Do: Analyzing Trends in Today's CMS Lab Experts Meeting

Today, July 14, CMS held its annual experts advisory committee for the 100-odd codes it is pricing for CY2027.

In a previous blog, I showed how AI could quickly make a structured complete transcript of the day, including features like writing the code descriptor just before each discussion. Here.

In this blog I took the whole transcript of the day - 82 pages and 32,000 words - and I asked Chat GPT to analyze it via several questions.

  • (AI can make mistakes so take these as directional or first-pass only.  Also, some of the questions, two human raters might tally different numbers againts the 82 page transcript.)

Things AI Can Do - Builds Structured/Merged Transcript of CMS Lab Pricing Meeting - in Minutes

Header: AI Makes Super-Notes from a Federal Meeting.

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Today, CMS held its professional advisory panel for pricing of new lab tests for 2027.  The meeting was broadcast by Zoom.

Here's what AI can do.

1.  I ran an audio auto record during the Zoom broadcast.

2.  Otter.ai made an auto transcript (somewhat rough, not great formatting).

3.  I gave two documents to Chat GPT.  (1) The CMS PDF agenda for the meeting, 110 entries in a table.  (2) The autotranscript.

I asked CMS to clean up and format the entire autotranscript.  Add, break it into sections for each agenda item   

For each agenda item, report from the PDF, the FACA PANEL item number, the agenda number from the June public comment meeting ALM, the code, and also the long descriptor.  THEN print the transcript from that minute's discussion.

Chat GPT chugged away for about 15 minutes and then delivered the output (for the morning session) in about twenty minutes as a Word doc (as I'd requested)

Prompt at bottom.

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Screen shots of the auto transcript, the agenda, and the output below.  (Click to enlarge.)

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# # #

# # #

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Prompt

This is an autotranscript of the morning session of the summer Medicare pricing meeting for new lab tests. This is the session where a panel of experts comments on the pricing of each new code.

You have (1) the raw autotranscript and (2) the meeting agenda pdf. 

Please edit the transcript for clarity, but preserve it as basically a transcript. For example, adding or deleting individual words or rearranging grammar is fine, but deleting one and more sentences would go too far.

Start each new code with a new section. Use the PDF agenda to provide the FACA Panel # in sequential order, the ALM Code #, the Current Code, and the Final Code, which is often TBD. Then insert the full long code descriptor, followed by the edited and cleaned transcript text.

Please export the result as a Word document, if possible. If not, choose another appropriate format.

Flurry of News for Alzheimer Diagnostics


 A flurry of news for Alzheimer diagnostics, and we're closing in on the international Alzheimer conference in Toronto, AAIC-26.   

Two longstanding organizations, the Michael J Fox Foundation [Parkinson's] and te Alzheimer Drug Discovery Foundation, ADDF, are partnering, initially with $5M, to develop noninvasive testing.  This $5M is part of a broader $50M effort of the ADDF to advance "next generation tests."  360Dx here on the $5M project, Precision Medicine Online here in March on the $50M project. 

See an article in Science, 12 May 2026, writing

  • Most dementia patients have multiple brain diseases
    • How should they be treated?  
    • Growing awareness of “copathology” inspires new diagnostic tests and clinical trials.
    • See SIDEBAR 2, below.

Amprion Dx receives funding from Decathlon Partners as growth capital for both Parkinson's and Alzheimer's biomarkers.  Here.

Anthem issues coverage for C2N multimodal PrecivityAD2 blood test.   Press.   

See the actual Anthem policy, Testing for biochemical markers in Alzheimer's disease, here: LAB.00046.  Anthem provides policy for more general coverage for FDA-approved p217 tau tests.  See SIDEBAR 1 below.  It looks like the effective date for new Alzheimer coverage is October 1

Three open access reviews, discusssed as SIDEBAR 3 below. See a 2025 narrative review of the field by Scholl here.  See a 2025 Viewpoint from Wisch & Ances here.  See a 2025 specific to plasma pTau by Teunissen et al here.

Monday, July 13, 2026

AI Guest Author; CMS TAVR Proposed Revisions & TAVR History at CMS

In July 2026, CMS released a proposed revision of its coverage policy for TAVR - Trans-vascular aortic valve replacement. The proposal and rationale are at link.   

See also this news story : https://www.scai.org/media-center/news-and-articles/proposed-tavr-ncd-released-key-changes-and-next-steps   

Please review the history and rationales of CMS NCD coverage of TAVR discuss the proposal for a new coverage rules set, including more MAC discretion. summarize with a view of the process and what's likely to happen next. How could the proposed decision be improved in the final NCD in a few months? (Eg what would you comment to CMS?)

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CMS’s 2026 TAVR Proposal:
From National Managed Entry
to a Federal Floor

Bottom line

CMS’s proposed decision—posted June 15, 2026, with comments due July 15, 2026—would fundamentally recast the TAVR National Coverage Determination, or NCD. Symptomatic severe aortic stenosis would become ordinary nationally covered care under Social Security Act §1862(a)(1)(A), no longer Coverage with Evidence Development, or CED. Asymptomatic severe aortic stenosis would remain under a narrower, targeted CED pathway.

CMS would also eliminate mandatory hospital procedure-volume thresholds, mandatory TVT Registry participation, and the requirement that a surgeon and interventional cardiologist jointly perform every procedure. It would retain a heart-team structure, onsite cardiac surgery and intensive-care capabilities, and a minimum operator-level experience requirement. [1]

Conceptually, that is a defensible transition. TAVR has moved from a novel, high-risk technology needing nationally managed entry to a mature standard of care for symptomatic severe aortic stenosis. But CMS is simultaneously removing several mutually reinforcing quality controls. The proposal therefore needs stronger, more explicit outcome surveillance and considerably clearer limits on Medicare Administrative Contractor, or MAC, discretion.

AI Guest Author: History of CMS Coverage of Amyloid PET Scans

News today of Anthem covering blood-based Alzheimer tests (here, here, policy here) reminded me of the tortured history of CMS and amyloid PET scans, plus the fact that no MACs have yet brought out any Alzheimer test policies (neither for serum tau nor PET).

I asked Chat GPT to research and write up the history of CMS coverage of Amyloid PET.   (Prompt at bottom).

# # #

 

Amyloid PET in Medicare:
From Extreme Control to Near–Auto-Payment

Research found one variance from your request.  IDEAS produced a conspicuously split result. It was strongly positive on a comparatively soft physician-behavior endpoint and negative on its harder health-care utilization endpoint. Much of the favorable publicity blurred that distinction.

Medicare's coverage of amyloid PET imaging has undergone a remarkable reversal over the past decade. 

In 2013, CMS adopted one of its most restrictive diagnostic imaging policies, limiting coverage almost exclusively to Coverage with Evidence Development studies because evidence that amyloid PET improved patient outcomes was lacking. The resulting IDEAS study showed that PET scans frequently changed physicians' diagnoses and management plans but failed to demonstrate reductions in hospitalizations or emergency department visits, despite promotional messaging that often emphasized the management findings. A second study, New IDEAS, largely confirmed the management-change results in a more diverse population without establishing improved clinical outcomes. 

By 2023, however, the emergence of anti-amyloid therapies fundamentally changed the policy landscape. CMS withdrew its National Coverage Determination entirely, leaving coverage decisions to Medicare Administrative Contractors. 

Ironically, this shifted Medicare from one of its most tightly controlled diagnostic policies to a largely permissive system with few published contractor coverage policies and substantial reliance on routine claims processing.


1. The original CMS decision was unusually restrictive

The commercial amyloid PET tracer era began with FDA approval of florbetapir in 2012, followed by additional tracers in 2013 and 2014.

In September 2013, CMS concluded that the evidence did not adequately show that amyloid PET improved meaningful health outcomes, or that management guided by amyloid PET improved such outcomes. Medicare therefore covered essentially one amyloid PET scan per beneficiary only through Coverage with Evidence Development, principally in approved studies addressing difficult differential diagnoses or clinical-trial selection. [1]

That decision was stringent, but it was intellectually coherent.

Thursday, July 9, 2026

MolDx Finalizes LCD: Liver Disease Risk Stratification

MolDx MACs finalize an LCD, proposed last summer, on "Biomarker Testing for Risk Stratification in Metabolic Dysfunction-Associated Steatotic Liver Disease and Metabolic Dysfunction-Associated Steatohepatitis."

See draft DL40187 here.   See final L40187 here.   

See request letter #1 9/19/2023 here.  #2 7/1/2024 here.   Posted as MA Connelly and H Imai, respectively; the latter on Siemens letterhead.

# # #

1. Request letter 1

Letter 1 is a Labcorp request, dated September 18, 2023, asking MolDX/Palmetto for a new LCD for NIS4, described as a non-invasive blood test to identify at-risk NASH in patients with features of metabolic syndrome. The letter frames the request as a Medicare Part B diagnostic clinical laboratory test and argues that access would improve treatment decisions and outcomes.

Tuesday, July 7, 2026

AI Reports as Part of Thinking? The Falling Friction of Knowledge Work

Header: AI is making analytical reports cheap enough that they become tools for thinking, not just finished products.

(Note - this essay generated by Chat GPT 5.5; fifth draft; substantial prompting.)
(This essay began in April, when Stephane Budel/Decibio showed me a 10-page multi-part Claude Opus report.)

 

When Reports Become Part of Thinking

Patterns from Index Medicus to ChatGPT Reveals the Falling Friction of Knowledge Work


I have lived through two revolutions in knowledge work. The first unfolded over several decades. The second seems to be unfolding in just a few years. Although separated by forty years, I think they are fundamentally the same story.

As an MD-PhD student in the early 1980s, performing a comprehensive medical literature search was a significant undertaking. Younger physicians and scientists may find it difficult to imagine how much effort it required.

In 1980, the standard tool for a student was Index Medicus: rows of encyclopedia-sized volumes that occupied many linear feet of library shelves, printed in extraordinarily fine type. A serious literature review meant you sat for hours in front of them.  You  searched these indexes by hand, copying references to ink and paper, and then locating the bound journals themselves, up and down the levels of the library and back and forth to a slow xerox machine.

By the mid-1980s, technology had advanced, but the process remained cumbersome. The National Library of Medicine maintained the MEDLINE database, but few investigators searched it directly. Instead, one met with a medical librarian, described the project, and the librarian formulated and executed the search. Several days later, after a charge of perhaps $50 to a research grant, a stack of paper arrived containing titles and abstracts (probably from a dot-matrix printer.) It was a new generation of service, but it was also slow, expensive, and infrequent.

Then came the Internet. 

CHAT GPT Tries to Understand All 600 PLA Codes

Here's another exercise where we give Chat GPT the ~600 current PLA codes and we ask it to find rhyme or reason in their multitudes.  The text and the analysis below are entirely machine-written with minimal instructions from me.

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Here are AMA CPT PLA codes up to code 0659U. Some codes have been deleted, so the active file contains 583 lines rather than 659 separate items.

Study them and discuss them for my blog readers. Then assess the codes in categorized groups, using categories that seem reasonable to you. I suggest using no more than ten categories, including an “Other” category. Some codes may fit more than one category; in those cases, use a “best fit” principle.

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Bruce, Here’s a blog-ready version based on the uploaded workbook. I also created an annotated workbook with the added category column and a summary sheet:
PLA codes categorized summary [not a live link]

(BQ: See tables in Google Cloud here.  Note that there are 2 tabs.)


A Field Guide to the PLA Code Universe:
0001U Through 0659U

The AMA’s PLA code series has become a kind of public fossil record of modern proprietary diagnostics. The file reviewed here runs through code 0659U. Although the numerical series reaches 659, the active workbook contains 583 rows and 581 unique HCPCS codes. Two rows, 0563U and 0564U, appear twice in the file. Thus, 78 code numbers in the 0001U–0659U range are absent from this active list, presumably because of deletions or gaps.

CMS Publishes Federal Register Rules for Software as a Medical Service (Incl Lab Tests)

 A few days ago, this blog flagged that CMS was proposed to take software-intensive lab tests OFF the clinical lab fee schedule (at least in the hospital outpatient setting.)  Here.   We flagged that this is not a lab-only policy but a whole new field of CMS policy for "software as a medical service" or SaMS.  Here.

 "SaMS" occurs 91 times in the outpatient rule.

On July 7, CMS published the Federal Register rulemaking for both (1) SaMS in general AND for (2) SaMS applied to software-intensive lab tests.  Find it here:

https://www.govinfo.gov/content/pkg/FR-2026-07-07/pdf/2026-13656.pdf

Comments due August 31, 2026; starting point here.

Pagination of New Rules

  • CMS overviews SaMS on page 41803.
  • Note that references to new SaMS concepts occur througout the New Tech applications; e.g. 41804 including footnote column 3.
  • The discussion of general SaMS starts on page 41918 to 41920 (plus tables 41921-41925.
  • The discussion of LABORATORY SaMS starts on 41925 and runs to 41926, plus table 41927.  
  • Discussion of new SaMS modifier O1 on page 41929, table 63.

Monday, July 6, 2026

Example of AI Company Research; What's up with Mdxhealth?

 I saw a headline that Mdxhealth received a NASDAQ minimum price warning.  July 2.  

https://mdxhealth.com/press_release/mdxhealth-announces-receipt-of-nasdaq-notification-regarding-minimum-bid-price-deficiency/

I had recently seen it had closed an infectious molecular testing line of business, perhaps related to numerous payor cutbacks in 87798 payments.

I asked Chat GPT for a quick debrief. The text is entirely machine written, including the table, with minimal up-front guidance from me.

##

Mdxhealth is a real operating prostate/urology diagnostics company, but it has a weak public-market situation. The Nasdaq notice means its share price has been below $1.00 for 30 consecutive business days, triggering a minimum-bid deficiency notice. It does not immediately delist the company; Mdxhealth has until December 28, 2026 to regain compliance by closing at $1.00+ for at least 10 consecutive business days. The company also said it may consider a reverse share split if needed. (mdxhealth)

The likely investor concern is not “they only have 87798 microbiology.” It is more like:

  1. They had a reimbursement blowup in Resolve mdx, the UTI/STI infectious-disease business. Novitas issued a roughly $10.4M recoupment decision related to historical Resolve claims, which Mdxhealth says it is contesting. (mdxhealth)

  2. They then decided to exit Resolve mdx and shut down the Plano, Texas lab, leaving restructuring/write-down costs to be recognized later. (mdxhealth)

  3. Their remaining/core business is prostate/urology oncology, not microbiology: Exo mdx, Confirm mdx, and GPS mdx are the current prostate-cancer-oriented lines highlighted on the company site. The company describes itself as focused on “prostate cancer and other urologic diseases.” (mdxhealth)

  4. Financially, they are still losing money. In Q1 2026, revenue was $27.4M, but operating loss was $7.3M, net loss $8.9M, and adjusted EBITDA was negative $4.3M. Cash was $43.2M at March 31, but pro forma for a $15M Exact Sciences earnout payment, cash would have been $28.2M. (mdxhealth)

So a revised capsule would be:

Mdxhealth is not primarily an 87798 microbiology lab. It is a prostate/urologic molecular diagnostics company that bought or built a set of prostate assays, but it also had a Resolve mdx infectious-disease business that became a reimbursement liability. The Nasdaq issue reflects share-price/capital-market distress, probably driven by losses, dilution/cash concerns, and the Resolve/Novitas overhang — not by the absence of a prostate business.

##

I asked about recent acquisitions.

##

Yes. Mdxhealth has been assembling a prostate/urology diagnostics portfolio by acquisition. The two big ones are:

YearSeller / sourceTest / businessComment
2022Exact Sciences / Genomic Health legacyOncotype DX Genomic Prostate Score / GPSMdxhealth bought Exact’s Oncotype DX GPS prostate cancer business for up to $100M, including $25M cash upfront plus stock and earnout structure. This was the old Genomic Health prostate assay, since Exact had acquired Genomic Health in 2019. (mdxhealth)
2025Bio-Techne / Exosome DiagnosticsExoDx Prostate / EPIMdxhealth acquired Exosome Diagnostics from Bio-Techne, including the ExoDx Prostate test, CLIA lab, and related assets, for total consideration of about $15M. The acquisition closed in September 2025. (mdxhealth)  Related fact: BioTechne had paid $250M for Exosome in 2018.
2015NovioGendixSelectMDxOlder acquisition: Mdxhealth acquired NovioGendix, giving it the urine-based SelectMDx prostate cancer liquid-biopsy test. (mdxhealth)

So your memory is right: GPS came from Exact Sciences/Genomic Health, and ExoDx came from Bio-Techne/Exosome Diagnostics. Alongside legacy ConfirmMDx, that gives them a prostate-testing stack: pre-biopsy risk assessment, post-negative-biopsy risk assessment, and localized prostate cancer prognosis/treatment guidance.

The confusing part is that Resolve mdx, the UTI/STI infectious-disease business using codes like 87798, became the recent reimbursement problem and was discontinued. But that was not the whole company. The surviving strategic story is more like: a financially stressed prostate molecular-diagnostics roll-up that also had a failed/discontinued UTI line.

AMA Posts PLA Applications for July-August Cycle

 AMA has posted applications (for public comment) for the July-August application cycle.  

Find them here:

https://www.ama-assn.org/system/files/aug-2026-pla-public-agenda.pdf

Comment via the indicated portal, by deadline July 20.  (I'm not sure the deadline but I'd suggest noon central.)

Palmetto MolDx Shows Up in National News (DCIS)

Palmetto MolDx and its pending decision on DCIS test coverage has made national news on NBC.  The news includes a detailed article as well as video stories. This article quotes Linkd-In, quotes an NBC video, and abstracts points from a long NBC article.


See an article on Linked In by Dan Forche, CEO at PreludeDX.  Prelude makes the "DCISionRT' test to help make decisions about RT (radiotherapy) in DCIS patients.

He links to a firewalled NBC article by Gretchen Morgenstern. Headlining:

"Millions of women may lose Medicare coverage for a breast cancer test hailed by doctors. A private company advising the agency that oversees Medicare has recommended against reimbursing for the biomarker tests, sparking a backlash from cancer specialists."

See the firewalled article here:

And there's a five minute video version:

https://www.nbcnews.com/video/millions-may-lose-medicare-coverage-for-breast-cancer-test-hailed-by-doctors-265914437537

Or at YouTube:

The  5-minute video transcript is here: