An AI Query About the PRA

What is known about the Patients Rights Advocate organization PRA, such as how old is it, where does funding come from, who is the leadership, what do data like IRS 990 say...

Master article about PRA-AMA-CPT is here.

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Yes. There is a reasonably clear picture in the public record, and it makes PatientRightsAdvocate.org (PRA) more interesting than I had appreciated from the lawsuit alone. It is not an old-line patient membership organization. It is a fairly young, founder-driven, philanthropy-funded policy and advocacy organization, with substantial money behind it despite a remarkably small visible governance and staff structure.

How old is it?

PRA was formed in 2017 and received its IRS 501(c)(3) determination in January 2018. Its EIN is 82-3586244. The filings through 2024 list Newton, Massachusetts as its principal location; interestingly, the new AMA complaint says PRA is in the process of moving its incorporation and operations to Florida. (ProPublica)

Its stated activity is unusually focused: research whether hospitals, insurers and other healthcare organizations comply with federal price-transparency requirements, and advocate for consumers, businesses and taxpayers through transparency and competition. 

In other words, it is fundamentally a health-policy advocacy and research shop, not an organization principally providing individual patient services. (Inspiring Generosity)

Who runs it?

The central figure is Cynthia A. Fisher, founder and chairman. She is a life-sciences entrepreneur who founded ViaCord and co-founded ViaCell, later sold to PerkinElmer; she is also a Boston Beer Company director. Boston Beer's SEC filing identifies her as the spouse of Boston Beer founder C. James “Jim” Koch. She receives $0 compensation from PRA according to the recent 990s. (PatientRightsAdvocate.org)

The organization's website currently identifies Linda Bent as President and Ilaria Santangelo as Director of Research. Bent is described as a manager at a Boston-area family office. 

• The 2024 Form 990 lists Santangelo at $189,006, 
• research/communications manager Julia Havlak at $129,704 and 
• Marie Larobareier at $115,006. 
• Fisher and Bent are listed at zero compensation on that filing. (PatientRightsAdvocate.org)

The 990s tell a striking financial story

PRA went from tiny to very large very quickly. In 2017 it reported only $210,000 of revenue. By 2020 it was receiving $8.6 million; in 2021, $23.2 million; and in 2022, $19.0 million. Nearly all of that early growth was charitable contributions: $8.53M in 2020, $21.36M in 2021 and $16.76M in 2022. (ProPublica)

Then it began spending down that capital aggressively. In 2023, PRA had only $1.88M revenue but spent $13.91M, reducing net assets to $6.97M. In 2024, it received $7.79M but spent $12.09M, leaving $2.67M in year-end net assets. Of 2024 revenue, $5.34M was contributions; another $2.35M was net proceeds from sales of assets. (ProPublica)

I summed the IRS figures from 2017 through 2024: PRA received about $63.0 million in total revenue and spent about $60.3 million. Roughly $54.7 million—87% of all revenue—was reported as contributions. So this is emphatically not an earned-revenue nonprofit. It has had essentially no program-service revenue. (ProPublica)

Where did all those contributions come from?

Here there is an important limitation. PRA's public Form 990 tells us how much it receives in contributions, but generally not who the donors are. The IRS specifically exempts the names and addresses of donors to ordinary public charities from public disclosure. Private foundations are different: their 990-PFs are public, so sometimes the donor can be identified from the donor's return rather than PRA's. (IRS)

And there is one very large clue. A grant database constructed from 990-PF filings identifies the Fisher Koch Family Foundation as having awarded PRA $27.4 million in 2021, for the purpose “support the organization.” The Fisher Koch Family Foundation's IRS records list Cynthia A. Fisher as a director; that foundation made $28.3M in total charitable disbursements in its fiscal 2021. (Granted AI)

I would put a small asterisk beside the exact $27.4M until looking directly at the underlying grant schedule—the grant database is secondary, and foundation and recipient fiscal years need not align. But the evidence is strong that Fisher-family philanthropy was a very important, probably dominant source of PRA's extraordinary early capitalization.

PRA itself gives a lot of money away

This is another feature I had not expected. PRA is not merely spending its money on its own reports and lobbying/advocacy. Its 990 schedules show 28 grants totaling $16.2 million during 2020–2024. Recipients have included Power to the Patients ($4.74M in 2022 and $2.025M in 2023), Families USA, Johns Hopkins, Bentley University, Brown University, U.S. PIRG Education Fund—and also ideologically conservative organizations including ALEC, America First Policy Institute, AMAC Action and Young Americans for Liberty. (Inspiring Generosity)

That mix is actually revealing. It looks less like a conventional partisan advocacy organization than a well-funded campaign organized around the particular economic doctrine of healthcare price transparency, willing to fund allies on both the left and right when they advance that objective.

One eyebrow-raising governance feature

The 2024 990 reports just two voting members of the governing body, of whom only one is independent. It also answers “No” to having a conflict-of-interest policy, whistleblower policy, document-retention policy, and independent review of top-official compensation. Those are disclosures, not evidence of wrongdoing, but they are notably sparse governance arrangements for an organization that has moved more than $60 million through its books. (Inspiring Generosity)

Charity Navigator currently gives PRA 65%, two stars. The rating appears substantially affected by these accountability/governance issues: Charity Navigator notes no independently audited financial statements, no audit-oversight committee, and no records-retention policy. It also notes positively that PRA reports no material diversion of assets or insider loans. So the two-star rating should not be read as an allegation of financial misconduct. (Charity Navigator)

My read (AI)

The shortest characterization would be:

PRA is an eight-to-nine-year-old, Cynthia Fisher-founded healthcare policy nonprofit that was capitalized with tens of millions of philanthropic dollars, apparently including very substantial Fisher-Koch family funding, and has used that capital unusually aggressively for research, publicity, coalition-building, grants, price-transparency advocacy—and now litigation.

That context makes the AMA case more intelligible. This is not a small consumer group that suddenly decided to challenge CPT. It is a comparatively small organization institutionally, but it has had the financial resources to mount sustained national policy campaigns and litigate against major healthcare trade associations.

I think the next worthwhile exercise would be to trace PRA's funding year-by-year from the donor side—searching private-foundation 990-PFs for its EIN, and then mapping its own $16.2M in outgoing grants. That could tell us much more precisely who built PRA financially and where PRA has deployed the money.

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OK

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Yes. I traced both directions, and the result is fairly revealing. There is also one qualification to my earlier answer: the Fisher-Koch funding is clearly substantial, but its precise year-by-year accounting is less clean than I initially implied.

1. What PRA itself reports receiving

PRA's Form 990s show a dramatic capitalization beginning in 2020. Its reported contributions and grants total about $54.72 million from 2017 through 2024:

PRA fiscal year	Contributions/grants reported by PRA
2017	$210,172
2018	$335,056
2019	$1,923,818
2020	$8,528,246
2021	$21,363,091
2022	$16,760,000
2023	$260,000
2024	$5,337,500
Total	$54,717,883

The figures come directly from the IRS-derived 990 data. The extraordinary period was 2020–2022: about $46.65 million in contributions in three years. (ProPublica) Earlier years were much smaller, while 2023 saw contributions collapse to $260,000 before rebounding to $5.34 million in 2024. (ProPublica)

2. Can we identify who gave the money?

Only partly—and there is a structural reason.

Ordinary 501(c)(3) public charities do not have to make the names and addresses on their donor Schedule B publicly available. Private foundations are different, because their grantmaking is publicly disclosed; public charities that make grants also leave a donor-side trail. Thus we can search other organizations' filings for PRA's EIN, but there will always be holes. The IRS explicitly confirms this disclosure rule. (IRS)

A donor-side IRS database finds three identifiable grants to PRA in 2022–2023:

Donor-side record	Year	Amount
Donor Advised Charitable Giving	2022	$16,500,000
Corporate Creations Foundation	2022	$10,000
Apex Foundation	2023	$10,000

That $16.5 million item is the striking one. (Inspiring Generosity)

Donor Advised Charitable Giving, EIN 31-1640316, is the entity associated with Schwab Charitable—now branded DAFgiving360. Its IRS filing describes its mission as administering a donor-advised giving program and lists schwabcharitable.org as its website. (Inspiring Generosity) The current DAFgiving360 site confirms that it operates donor-advised fund accounts. (Schwab Brokerage)

So in 2022 we can say something quite precise:

PRA reported $16.76 million in total contributions, and $16.5 million—98.4% of that amount—is identifiable as coming through a Schwab donor-advised fund sponsor.

But we cannot identify from that public record who the underlying donor-adviser was. That's precisely one of the opacity features of DAFs: the recipient's record says Schwab Charitable, not necessarily the person or family whose DAF recommended the grant.

3. And then there is the Fisher Koch Family Foundation

This is the other major trail.

A grant database built from private-foundation 990-PF filings identifies a $27.4 million grant from the Fisher Koch Family Foundation to PatientRightsAdvocate.org, classified in 2021 and described simply as “SUPPORT THE ORGANIZATION.” (Granted AI)

The underlying Fisher Koch Foundation IRS record makes the scale plausible: for its fiscal year ending October 2021, it reported $28.30 million in charitable disbursements altogether. Its directors included Cynthia A. Fisher, Elizabeth F. Koch and Emily F. Koch. (ProPublica)

And a useful point about the name: this Fisher-Koch family connection is Cynthia Fisher and Boston Beer founder C. James “Jim” Koch, her spouse. An SEC filing identifies Fisher simultaneously as founder/chairman of PRA and spouse of Boston Beer founder C. James Koch. (SEC)

However, here is the accounting wrinkle. PRA itself reported only $21.36 million of contributions in calendar 2021, whereas the donor database attributes $27.4 million to Fisher Koch in the foundation's fiscal 2021. (ProPublica)

Those numbers do not reconcile as a simple same-year cash transfer. The foundation's fiscal year ends in October, PRA's ends in December, and there can be differences in payment versus recognition, grant installments, or database aggregation. I therefore would revise my earlier characterization slightly:

The public evidence strongly supports Fisher-family philanthropy as a major source of PRA's early capitalization, but I would not present “$27.4M received by PRA in calendar 2021” as an audited fact without inspecting the underlying grant schedule and accounting dates.

It may well span PRA's 2020 and 2021 receipt periods: PRA reported $8.53M plus $21.36M in contributions across those two calendar years, or $29.89M. But that is an observation about the numbers, not proof of how the Fisher Koch grant was booked. (ProPublica)

4. Where did PRA send its own grants?

Here the public record is remarkably complete. PRA reported 28 grants totaling $16.24 million from 2020 through 2024. The annual map is:

Year	Grants paid	Major recipients
2020	$53,500	Independent Women's Voice $53.5K
2021	$5.36M	Power to the Patients $5.05M; 1065 Institute $250K; Independent Women's Forum $50K; American Research & Policy Institute $10K
2022	$6.865M	Power to the Patients $4.74M; 1065 Institute $1M; Families USA $500K; RAND $250K; IWF $250K; ALEC $50K; Johns Hopkins $45K; American Transparency $30K
2023	$2.998M	Power to the Patients $2.025M; Families USA $500K; AMAC Action $150K; Johns Hopkins $135K; One Fact Foundation $100K; U.S. PIRG Education Fund $87.5K
2024	$960,850	Bentley $250K; ALEC $230K; Brown $150K; U.S. PIRG $100.85K; America First Policy Institute $100K; Johns Hopkins $90K; Dollar For $20K; Young Americans for Liberty $10K; Power to the Patients $10K

These amounts are extracted from PRA's IRS Schedule I filings. (Inspiring Generosity)

There are two big conclusions.

5. Nearly three-quarters went to one organization: Power to the Patients

Across the five years, Power to the Patients received $11.825 million—about 73% of every dollar PRA granted to another organization.

And Power to the Patients is not an unrelated outside grantee.

Cynthia Fisher is its co-founder and chairman, while also being founder and chairman of PRA. The 2024 Power to the Patients 990 lists Cynthia Fisher as a board member and Linda Bent as treasurer; Bent is also president/board member of PRA. (SEC)

Power to the Patients was founded in 2021, exactly when the large PRA grants to it began. Its purpose is more overtly public-facing advocacy: the SEC biography describes it as generating public awareness about how upfront health prices can reduce costs and overcharges. (SEC)

So the organizational picture looks something like:

PRA = research, policy, legal work, transparency reports and advocacy
↓ approximately $11.8M
Power to the Patients = mass-market public-awareness/advocacy campaign

The organizations overlap substantially at the leadership level. That fact by itself says nothing improper about the grants, but it is important when describing where PRA's philanthropic capital went. This is much closer to funding a sister advocacy vehicle than to a conventional foundation making independent charitable grants.

6. The remaining grant portfolio is strikingly bipartisan

After Power to the Patients, PRA's grants are quite eclectic.

On one side are Families USA and U.S. PIRG. There are major academic/research organizations—RAND, Johns Hopkins, Brown and Bentley. And there is a substantial cluster of organizations more commonly associated with conservative or free-market policy advocacy—ALEC, Independent Women's Forum, Independent Women's Voice, AMAC Action, America First Policy Institute and Young Americans for Liberty. (Inspiring Generosity)

That fits PRA's own characterization of itself as nonpartisan and suggests something more interesting than an ordinary ideological funding network: price transparency has been deliberately built as a cross-partisan coalition issue. PRA has funded organizations from quite different parts of the political spectrum when they can carry the transparency message to different constituencies.

The $1 million to Families USA and $280,000 to ALEC are a nice illustration of how unusual that coalition is. (Inspiring Generosity)

7. PRA itself is not primarily a grantmaking pass-through

The $16.24M of grants is only about 30% of PRA's $54.72M cumulative contributions. The rest did not simply sit there or get re-granted.

The 2024 filing is particularly informative. PRA spent $12.1M that year, including roughly $4.5M in other professional/service fees, $2.6M in advertising and promotion, and $1.3M in legal fees, while direct grants were about $962K. Its largest listed contractors included Outdoor Solutions for public awareness, CRC Advisors for communications/public affairs, and Crowell & Moring for legal services. (Inspiring Generosity)

That is a useful lens on the AMA lawsuit. PRA has evolved into an organization spending serious money on communications, public campaigns and law, rather than simply commissioning academic reports about hospital prices.

What I think we can now say with confidence

The financial biography is becoming pretty clear.

PRA appears to have been created as a comparatively small Fisher-led advocacy organization, then very heavily capitalized beginning around 2020. Fisher-family philanthropy appears to have been a major component of that capitalization. In 2022, almost the entire year's $16.76M of contributions can be traced publicly to a single $16.5M grant routed through Schwab's donor-advised fund system, although the actual donor behind that DAF is not publicly identified.

PRA then deployed the capital in two ways. It built its own national research/legal/communications operation, and it re-granted $16.24M, nearly three-quarters of which went to the closely affiliated Power to the Patients public-awareness organization. The rest went to an unusually broad coalition spanning academic research institutions, mainstream consumer organizations, and conservative/free-market advocacy groups.

That makes PRA somewhat different from the image created by the phrase “patient advocacy group sues AMA.” It is better understood as a well-capitalized, founder-driven health-policy campaign organization with a deliberate research + litigation + media + coalition strategy.

And one unanswered question is now especially conspicuous: who recommended the $16.5 million Schwab DAF grant in 2022? The public tax record takes us right up to that door and then stops. If that donor could be independently identified, we would have a nearly complete financial origin story for PRA.

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Viacord?

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Yes—ViaCord was Cynthia Fisher’s original biotech company, and it explains where much of her healthcare-industry background came from.

She founded ViaCord in 1993 as an early private umbilical-cord-blood banking company. The business collected cord blood at birth, processed and cryopreserved the hematopoietic stem cells, and stored them for possible future therapeutic use. She served as founder and CEO. (ONC)

In 2000, Fisher co-founded ViaCell, a broader cellular-medicine company, and ViaCord became a division of ViaCell. ViaCell went public in 2005 and was acquired by PerkinElmer in 2007 for about $300 million, largely for the ViaCord business. (Wikipedia)

So Fisher was not simply a wealthy philanthropist who later became interested in healthcare policy. She was an actual healthcare entrepreneur, fairly early in the commercial stem-cell field. That history also makes her later emphasis on health-price transparency somewhat more intelligible: she had spent years inside a consumer-facing medical service business.

One small wrinkle: sources differ on whether ViaCord was technically founded in 1992 or 1993; Boston Beer’s current biography says 1992, while federal and other biographies say 1993. (The Boston Beer Company - IR Site)

And ViaCord still exists as a cord-blood banking brand, though it long ago ceased being Fisher's independent company. (National Park Foundation)

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What is known about the law firm hired for this lawsuit of PRA vs AMA?

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Yes. The law firm is quite notable, and the relationship with PRA substantially predates the AMA/CPT lawsuit.

The August 12 complaint is signed by Consovoy McCarthy PLLC of Arlington, Virginia: partners Jeffrey M. Harris and Cameron T. Norris, plus associates Ryan M. Proctor and Nicholas (Nick) Venable. 

This is a small, elite constitutional/appellate litigation boutique founded in 2014 by William Consovoy and Thomas McCarthy. Reuters has described it as a central player in the contemporary conservative legal movement. 

Its best-known achievement is probably representing Students for Fair Admissions in the successful Supreme Court cases ending race-conscious admissions at Harvard and UNC. 

They have also represented Donald Trump, the RNC, Republican officials and plaintiffs in other major constitutional and administrative-law cases. (Reuters)

The most important lawyer here appears to be Jeffrey Harris. He is not merely somebody brought in to devise the CPT lawsuit. Harris has worked with PatientRightsAdvocate.org since at least 2019. When the American Hospital Association sued to block the Trump administration's hospital price-transparency rule in December 2019, PRA was already putting Harris forward as its lawyer and spokesman. In 2020, Harris prepared and filed PRA's amicus briefs supporting HHS's transparency regulation in AHA v. Azar. (PatientRightsAdvocate.org)

So there is a seven-year PRA–Consovoy relationship, not a brand-new alliance.

Harris is an unusually credentialed regulatory litigator. 

• He graduated from Harvard Law School, 
• clerked for Chief Justice John Roberts 
• and two D.C. Circuit judges.
• He later served as the No. 2 official at the White House Office of Information and Regulatory Affairs (OIRA), the office that reviews major federal regulations. 
• He has argued before the Supreme Court and eight federal circuits. (Consovoy McCarthy Park PLLC) 
• Particularly relevant here, Harris has developed genuine health-policy specialization: in 2022 he published a 20-page article, “Using ERISA to Ensure Transparent Health Care Prices,” in the ABA Journal of Labor & Employment Law. (JSTOR)

Cameron Norris is another heavyweight. He is a partner, Vanderbilt Law graduate, former clerk to Justice Clarence Thomas, Judge William Pryor and Judge Karen Henderson. He has argued twice in the Supreme Court; one of those arguments was the Harvard affirmative-action case. His firm biography says he has represented states, prominent nonprofits, the Republican Party and the President of the United States. (Consovoy McCarthy Park PLLC)

Ryan Proctor is younger but comes from the same appellate pipeline: Yale, Harvard Law cum laude, editor-in-chief of the Harvard Journal of Law & Public Policy, followed by clerkships for Judges Joan Larsen and Gregory Katsas and then Justice Clarence Thomas. (Consovoy McCarthy Park PLLC)

Nick Venable is also academically unusual: Yale, a Ph.D. in Classics from Chicago, Stanford Law, and a clerkship with Sixth Circuit Chief Judge Jeffrey Sutton before appellate practice. (Consovoy McCarthy Park PLLC)

There is an even more revealing connection. Harris, Norris and Proctor are already representing PRA in the parallel AHA litigation over the UB-04 hospital billing manual. In that case, AHA sued PRA after PRA announced that it wanted to make the copyrighted UB-04 manual freely available—the same basic “privately copyrighted rules incorporated into mandatory healthcare billing” theory now being deployed against CPT. 

• A May 2026 filing lists Harris, Norris and Proctor as PRA's counsel. (Litigation Tracker) Venable appears to have joined that core team for the new AMA case.

That changes how I would characterize the CPT lawsuit. It looks much less like PRA suddenly found a clever copyright theory and much more like an emerging litigation program. Consovoy McCarthy and PRA first spent years litigating and writing about healthcare price transparency; then PRA deliberately challenged the proprietary UB-04 billing manual; now the same lawyers have escalated the strategy to the vastly more consequential CPT system.

There is even a fascinating detail from the UB-04 case. AHA alleges that an associate at Consovoy McCarthy bought a copy of the UB-04 manual in July 2025 using a personal Gmail account, before PRA sent AHA its formal demand asserting the right to publish it. That allegation is AHA's—not an established fact—but it reinforces how deliberately this litigation strategy appears to have been developed. (CCH Business)

So I would describe the team as very serious Supreme Court-caliber conservative/public-law litigators with a longstanding relationship to PRA and a growing specialization in healthcare transparency. The ideological pedigree is unmistakably conservative, but the CPT suit itself is not conventional partisan litigation; its legal theories draw heavily on public-access, fair-use and “no one owns the law” precedents that have attracted support across ideological lines.

The particularly interesting discovery is that the AMA lawsuit is essentially the second installment of the UB-04 strategy, with nearly the identical legal team. That might deserve a paragraph in the blog, because it makes the CPT case look considerably less spontaneous—and considerably more strategic—than the news stories convey.

David Clark on NHS and Digital Pathology Saga

David Clark - Nottingham  - hematopathologist - Nottingham NHS Trust

https://www.linkedin.com/in/david-clark-61a79a23b/

He's written a series on faulty plans for NHS investments in digital pathology.

Entry point here:

https://www.linkedin.com/feed/update/urn:li:activity:7491025358016888833/

It matches to a four-part series he wrote at Pathology News;

https://www.pathologynews.com/the-masterbuilders-path-to-recovery/

Use the National Denial File to Assess "Claim by Claim" Coding of PLA Codes

 While some PLA codes have high dollar volumes and specific coverage under LCD or NCD, most of the 600 PLA codes do not have policies - so they are under "claim by claim" review, as CMS says.  Let's cal lit CbC.

I think that CbC review usually means either (A) autopay or (B) autodenial, with relatively few codes getting true manual review of actual medical records.

Let's test it with the Denials Database (here).

I filtered 2024 for codes ending in "U" - PLA codes.

This gave about 3400 lines downloaded into XLS.  (Be sure to convert from csv to xls soon.)

Column i (eye) is submitted claims, column L is denied claims.  I mean a new row "S" which is denied/submitted.

Because CMS shows 0 denied by "*", the percent denied when zero comes ot as "value!" rather than "0".

ZERO DENIALS

About 2700 lines had 0 denied (suggesting autopay).

I deleted claims with 0-10 claims (CMS had already deleted all of those that were not 0,)

This left 541 lines. About 83 lines had >100 claims, up to 629.

 Total services were 31,017 and total payments were $13M, average $419.

10-20% DENIALS

About 132 lines had 10-20% denials.

Total services were 75,660 and total payments were $27M, average $363.

45-55% DENIALS

Only 25 lines had 45-55% denials.

Total services were 2961 and total payments were $452,000, average $153.

80-90% DENIALS

Only 20 lines had 80-90% denials.

Total services for these persistent hopeful labs were 5015 and payments $130,000, at $26.

100% DENIALS

Here, we pop up to about 245 lines with 100% denials.

Total services for these scalawags were 22,730. 

Actually, they're not scalawags, because about 80% of these submitted with the GZ modifier, which expects "denial." In the other groups, nearly nobody used GZ modifier.

We have no payments, but charges were $35M, so under normal circumstances, payments might have been in the $15M range.  If so, implied average payment per service for the 22,000 services might have been $650 each.  (But again, these were 100% denials, no payments).

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100% Denials - Deeper Dive - What Codes?

Here's a look at some of the highest-volume services in the 0 payment, 100% denial filter.

Some may have been submissions of known-to-deny claims, such as for appeal rights.

Others likely represent tiny percentage of all claims for large test,where the code may have had many payable lines, but here we see one odd line with 0% payments.  

01106T - exclusive or inclusive algorithm text

 

1106T  Oncology (breast), augmentative algorithmic analysis of histomorphologic features in digitized hematoxylin and eosin stained slides from formalin-fixed paraffin-embedded (FFPE) breast cancer tissue, algorithm-derived parameters reported as 5-year and 10-year risks of distant metastasis, including digitization of glass microscope slides and hematoxylin and eosin staining of tissue sections, when performed.

This CPT code is silent as to whether the algorithm EXCLUDES a test which uses both histomorphology and cliniccal features like "tumor size".   Does it imply only "histomorphologic" algorithms be coded here, or can algorithms with also clinical features be aloud on the groounds they are not excluded and merely silent.   PS _ i read the question as difficult and perhaps splitting experts.

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CHAT GPT

I agree this is a difficult coding interpretation. It is exactly the sort of question that reasonable CPT experts could disagree about because the descriptor does not expressly answer it.

Here's how I would analyze it.

The descriptor

"Augmentative algorithmic analysis of histomorphologic features in digitized H&E slides..."

The object of the algorithm is stated to be histomorphologic features. It does not say:

• histomorphologic and clinical features,

• multivariable prediction model,

• clinicopathologic model,

• or "using all available patient information."

That tends to favor a narrow reading.

But it does not say "only"

On the other hand, CPT descriptors often describe the principal work without attempting to enumerate every internal computational step.

Suppose an algorithm:

• extracts hundreds of image-derived features from H&E,

• then combines them with

  • age,

  • tumor size,

  • nodal status,

  • ER status,

before generating the final risk score.

Nothing in the descriptor explicitly says this is prohibited.

Arguments for inclusion

Someone favoring use of 1106T would probably argue:

• The service remains an algorithmic analysis of histomorphologic features.

• Clinical variables merely calibrate or refine the prediction.

• The dominant source of information remains the digital pathology algorithm.

• CPT descriptors generally do not police internal mathematical architecture unless they specifically do so.

This is actually common in laboratory medicine. Many genomic algorithms incorporate age or sex without changing the CPT code.

Arguments against inclusion

The opposing argument is also strong.

One could say:

The descriptor intentionally identifies the analyte as histomorphologic features.

If the reported risk is materially generated from a clinicopathologic model rather than image analysis alone, then the reported result is no longer simply an algorithmic analysis of histomorphology.

The service has become a different category of test.

That argument gains force because the CPT Editorial Panel has recently become much more concerned about distinguishing:

• laboratory measurements,

• algorithmic analyses,

• software-only analyses,

• multicomponent predictive models.

Analogies

This resembles other CPT interpretation problems.

For example:

• A genomic assay does not stop being a genomic assay merely because age is incorporated into the report.

• Conversely, if an algorithm combines genomic data with imaging, laboratory values, and EHR variables into a single integrated prediction, many CPT experts would hesitate to call it solely a genomic test.

Where that line falls is often judgment rather than explicit CPT instruction.

My reading

If I were asked to interpret the descriptor without additional AMA guidance, I would probably adopt this principle:

The algorithm may incorporate limited ancillary clinical variables, provided the essential analytical work remains the extraction and interpretation of histomorphologic features from the digital slides.

However,

if the clinical variables materially contribute to the prediction such that the result is better characterized as a clinicopathologic prediction model than as histomorphologic analysis, then the fit with 1106T becomes questionable.

Confidence

I would characterize this as roughly:

• 40%: descriptor should be read narrowly—image-derived features only.

• 60%: limited clinical covariates are permissible if the algorithm remains fundamentally a histomorphology algorithm.

The real answer would likely depend less on the wording of the descriptor itself than on the CPT Editorial Panel's intent, which might be reflected in:

• the original Category III application,

• CPT Assistant commentary,

• Editorial Panel discussion minutes,

• or future coding guidance.

So I think your instinct is right: this is not a question with an obvious textual answer, and it is one that could legitimately split experienced CPT coding experts.

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CLAUDE

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Short answer: experts are likely to differ — but I'd put it 70/30 against, and the strongest evidence is sitting in the same tab.

The decisive point isn't abstract canon-of-construction reasoning; it's internal to the code family. The bladder codes released alongside 1106T read "augmentative algorithmic analysis of histomorphologic features in digitized slides from FFPE bladder cancer tissue (high-grade, non-muscle invasive), with clinicopathologic variables entered by the qualified health care professional." The Panel demonstrably had the vocabulary, understood the distinction, and deployed it where it applied. Its absence from 1106T is therefore not innocent silence — it is an omission made against a live, adjacent alternative that the drafters were staring at the same afternoon. That's about as clean an expressio unius setup as CPT ever gives you.

The second-order support is the placement of "when performed." The descriptor flags optionality exactly once, and it attaches to digitization and H&E staining — the workflow envelope — not to the analytic inputs. The drafters showed you where they meant to leave slack, and it isn't in the algorithm.

Third, note that "tumor size" almost certainly isn't a histomorphologic feature under the Panel's own working vocabulary. Grade, mitotic index, tubule formation, stromal TIL density — those are histomorphologic. Size and nodal status are precisely what the bladder descriptor calls clinicopathologic. The taxonomy is right there in the family.

Now the case for the permissive reading, which is not frivolous. The descriptor lacks any restrictive limiter — no "solely," no "alone," no "without." CPT descriptors are definitions, not exclusion lists, and elsewhere in the code set additional work not named in the descriptor doesn't disqualify the code; it's just uncompensated. A multimodal breast test genuinely does everything 1106T recites: digitizes the slide, runs an augmentative algorithm over histomorphologic features, and reports 5- and 10-year distant-metastasis risk. On that view the clinical variables are a refinement, not a different service. And the alternative — 88399 or 81599 unlisted — is commercially close to a death sentence, which supplies considerable motivated-reasoning pressure toward "not excluded, therefore allowed."

The rebuttal is that for algorithmic codes the algorithm is the service. In surgery, an extra maneuver is incidental to a described procedure; here, changing the input set changes the intellectual content of the reported output. That's the organizing logic of MAAA coding and Appendix O generally: test identity is defined by what goes in, not merely what comes out. Two tests reporting the same endpoint from different input sets are two services.

Where this actually gets resolved, though, is not textual. Under MolDX the Z-code/DEX registration does the discriminating work, and a contractor can perfectly well pay 1106T-plus-Z-code for a multimodal test without ever adjudicating the descriptor question — the code becomes a container and the registry becomes the definition. So "correct coding" and "what gets paid" can diverge here for years without anyone forcing the issue. Meanwhile the AMA's own answer, if you put it to CPT Network, would almost certainly be: the descriptor describes analysis of histomorphologic features; if your test requires entry of clinical variables, file a code change application — and here is the bladder code proving we'll write one for you.

Which is the real tell. The permissive reading isn't wrong because it's illogical; it's weak because the Panel has already shown, in the same release, exactly how it says the thing 1106T doesn't say.

WAIT

I agree with you, but I think the question is subtlely different. it is not whether the drafters had a habit of including those variables, when they were aware of them. The question is whether this code can be used with a est that includes tumor size as an (unstated0 input. Perhaps we could think of a lot of unstated inputs necessary to run a test or do a procedure.

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You're right, and the reframing is the better question. Drafting habit tells you what the Panel would have written; it doesn't tell you whether an unnamed input is disqualifying. And you're correct that every code is silent about a great many things: 81519 doesn't mention reference genes, a colonoscopy code doesn't mention insufflation, 88360 doesn't mention that someone had to pick the field. Silence about inputs is the normal condition of CPT, not an anomaly demanding explanation.

So the real test isn't stated-vs-unstated. It's enabling versus constitutive — and I'd put three axes under that.

First, does varying it change the reported number? Hold the slide fixed and change the input. Scanner model, stain lot, nuclei count, tumor area annotation, QC thresholds — the answer doesn't move, or moves as noise. Tumor size in a Cox-type model moves the 10-year risk materially and monotonically. An input that is patient-specific, independently prognostic, not derivable from the slide, and additive in the model is a determinant of the answer, not a means of obtaining it. That's the category the descriptor is defining when it names "histomorphologic features" as the object of analysis.

Second, gating versus weighting. This is where a lot of the intuitive force of your point lives. A lab needs ER and HER2 status to know the patient is even eligible for the test; it needs specimen adequacy, fixation time, block selection. Those are unstated inputs genuinely necessary to run the test, and nobody thinks they belong in a descriptor. But they gate — they don't weight. They select who gets the analysis; they don't enter the computation. Tumor size as a model term weights.

Third — and this is the strongest argument for your permissive reading, better than anything I gave you last round — upstream input versus downstream calibration. The descriptor demands output "reported as 5-year and 10-year risks of distant metastasis." Not a score. Not a stratum. Absolute, time-indexed risk. You cannot get absolute risk out of morphology alone; you need a baseline hazard, and a baseline hazard implies a population anchoring that in practice usually means age, at minimum, and often nodal and endocrine-therapy context. The descriptor's own output specification arguably presupposes clinical inputs. If a test's algorithmic analysis is purely histomorphologic and clinical variables are applied only afterward to convert a morphologic score into an absolute risk, an expert could say — quite defensibly — that the algorithmic analysis of histomorphologic features is exactly what the code describes, and the calibration step is the unremarkable arithmetic of turning a hazard ratio into a percentage.

That's a real carve-out, and it's narrower than "tumor size is fine because nobody excluded it." A test that runs a multivariable model with size as a coefficient sits outside; a test whose morphologic classifier is calibrated to absolute risk using age plausibly sits inside.

So I'd revise my verdict this way: experts will still differ, but the disagreement should be about whether the clinical variable is constitutive of the risk estimate or ancillary to producing it — not about whether silence implies permission. Which also happens to be the fight that CPT Assistant or a code change application could actually settle, and the one a lab's coding memo should be arguing on the merits rather than on the absence of the word "solely."

Tracking Abrupt Changes to Remote Monitoring and its Software

 Here's a linked in post from Kelli Stovall RPh on the pharmacy angle:

https://www.linkedin.com/feed/update/urn:li:activity:7488560277790253056/

But see also connection to Nixon Peabody 6pp memo:

Homepage:

https://www.nixonpeabody.com/insights/alerts/2026/07/22/medicare-proposes-changes-to-remote-patient-monitoring-and-remote-therapeutic-monitoring-services

And as 6pp pdf:

https://www.nixonpeabody.com/-/media/files/alerts/2026/07/medicare_proposes_changes_to_remote_monitoring_services.pdf

Here, memo from ATA on RTM cutbacks:

https://www.americantelemed.org/press-releases/ata-action-sounds-alarm-as-cms-pfs-proposed-rule-threatens-to-reverse-bipartisan-congressional-gains-on-remote-patient-monitoring/

##

Don't forget the July 2026 proposals aren't in a vacuum.  

See supposed risks and drawbacks of RTM from my May 2025 blog:

https://www.discoveriesinhealthpolicy.com/2025/05/remote-monitoring-peterson-center-oig.html

Note: I also have some private notes and assisted searches also from earlier in March 2026:

https://www.blogger.com/blog/post/edit/8334321271827217759/6434864259285744275

Handy Citations on Screening - Not Saving Costs

 Here's a tag at Linked In from Jeff Levin-Scherz, around August 1, 2026:

https://www.linkedin.com/posts/jlevinscherz_how-should-we-think-about-the-cost-of-cancer-share-7485631887173001216-_KsM/ 

It pulls up a Substack article, July 26, 2026, by Levin-Scherz, "How should we think about the cost of cancer screening?"

https://employercoverage.substack.com/p/how-should-we-think-about-the-cost-d49?triedRedirect=true

Which kicks off, in part, from a Ann Intern Med article,  The Annual Cost of Cancer Screening in the United States, Halpern et al.

https://www.acpjournals.org/doi/epdf/10.7326/M24-0375

Toward the end see a callback to Levin-Scherz on Substack, from July 2024, on "fallacy of cost savings" -

https://employercoverage.substack.com/p/the-fallacy-of-future-cost-savings

See the home page for his Substack here:

https://employercoverage.substack.com/

SIDEBAR: Valar Comment on Digital Pathology OPPS Pricing (As Sidebar)

 SIDEBAR to July 28 blog

Yes. The interesting thing about the Valar Labs comment is that it is not attacking CMS’s new SaMS framework at all. It embraces the framework and argues that CMS applied it inconsistently to Valar’s two bladder tests.

What is Valar’s pricing problem?

Valar has three new H&E/AI oncology services:

Valar test	2027 CPT	CMS proposed APC	Proposed payment	Valar asks
Vesta Bladder Risk Stratify	1063T / X568T	1542	$350.50	APC 1509, $750.50
Vesta Bladder BCGPredict	1064T / X569T	1542	$350.50	APC 1509, $750.50
Vitara Pancreas ChemoPredict	1097T / X614T	1509	$750.50	Keep $750.50

So the practical request is quite simple: more than double payment for each of the two bladder tests, from $350.50 to $750.50. The pancreas test is already where Valar wants it.

Valar thinks CMS has somehow treated the two bladder codes as related/similar procedures and effectively subjected them to a roughly 50% reduction. The letter says this appears to reflect a misunderstanding because the two tests are separately ordered, produce separate reports, and answer different clinical questions: one is prognostic for recurrence/progression and surgical decisions; the other predicts response to BCG.

What rules does Valar say should apply?

Valar's argument is essentially four layers.

First, O1 separate payment. Valar strongly supports CMS's proposed new status indicator O1, with payment specifications like status indicator S: SaMS gets a separate APC payment, rather than being packaged. That is particularly important because these tests are performed after the hospital encounter and their results affect later oncology management.

Second, New Technology APCs are the right interim home. Valar accepts CMS's premise that ordinary clinical APCs don't fit algorithm-driven services very well. New Technology APCs are therefore a reasonable bridge while CMS collects claims/cost information and develops a permanent SaMS methodology. That tracks CMS's own stated transitional approach.

Third, comparability should drive the APC assignment. Valar doesn't have an established CLFS price for these brand-new Category III codes. So it says CMS should look to similar H&E AI oncology services, particularly 0220U, 0376U, 0414U, 0418U, 0512U and 0513U—all of which CMS proposes to put in APC 1509 at $750.50. It gives especially strong weight to new Category III codes 1106T/X623T and 1107T/X624T, whose descriptors are almost twins of Valar's bladder codes except for tumor site and clinical endpoint; CMS also put those at $750.50.

Fourth, don't apply a multiple-procedure-type discount to the two bladder tests. This is a particularly good argument under CMS's own proposed architecture. CMS defines O1 as “separate APC payment.” Valar's point is that 1063T and 1064T are independently useful tests rather than two components of one procedure. CMS itself proposes O1 as the separately payable SaMS indicator.

There is also an older packaging argument: Valar cites CMS's prior rationale for separately paying some cancer algorithm tests because they are relatively disconnected from the encounter where the specimen was obtained and inform subsequent treatment.

And yes—the tables are unusually useful

Pages 5–7 are probably the most reusable part of the comment. Valar essentially builds a mini-reference table for H&E computational pathology reimbursement.

For each service it supplies:

code/test/company → specimen → workflow/resources → algorithm methodology → proposed APC/SI/payment.

It covers six existing PLA H&E-AI services:

0220U PreciseDx Breast; 0376U ArteraAI Prostate; 0414U LungOI; 0418U PreciseDx Breast Biopsy; 0512U Tempus p-MSI; and 0513U Tempus p-Prostate.

Then it adds Valar's three tests and the two very similar new Category III breast/prostate codes 1106T and 1107T. That's an 11-row comparison table, and it is much richer than CMS's table because Valar has supplied the operational details—accessioning, QC, pathologist review, WSI digitization, image transfer/storage, GPU inference, report generation, etc.

For digital-pathology work, that table is quite valuable independent of Valar's lobbying position.

Does Valar call out CMS's strange Table 62?

Surprisingly, essentially no.

CMS's actual Table 62 contains exactly 10 codes, not eleven. CMS says it selected them according to a purportedly simple rule: if the descriptor contained no laboratory method and only algorithmic analysis, CMS classified it as a SaMS laboratory analysis.

But the table itself is rather obviously troublesome. Among the ten are:

• 0511U, whose descriptor actually says “tumor cell culture in 3d microenvironment”—rather hard to characterize as having no laboratory method.

• 0208U, which expressly describes mRNA gene-expression analysis of 108 genes from an FNA specimen.

• 81416, which is sequence analysis of a comparator exome—again, rather conspicuously a sequencing code rather than merely an algorithm running on previously generated data.

That seems internally inconsistent with CMS's own sentence immediately preceding the table: no laboratory methods in the descriptor; only algorithmic analysis. CMS also inexplicably puts 81416 in APC 1575, $10,001–$15,000, while the genuine H&E-AI codes cluster at APC 1509.

Valar does not take CMS to task for any of that. Nor does it point out the rule text's erroneous reference to 42 CFR 493.21 in defining the underlying CLIA concept. Instead, Valar very sensibly cherry-picks the part of Table 62 that helps its case—the H&E AI comparators—and leaves the rest alone.

Its only mild comment about Table 62 is that Valar assumes its own codes weren't in the published Table 62 because the final Category III CPT numbers weren't yet available when CMS prepared the proposed rule.

So I would characterize the comment this way:

Valar accepts CMS's SaMS theory, accepts O1, accepts New Technology APCs, and even uses CMS's Table 62 as precedent. Its dispute is narrowly about horizontal equity: if substantially similar H&E-AI oncology tests get APC 1509/$750.50, Valar's two bladder tests should too. It does not challenge the much more fundamental oddities in CMS's selection of the ten “lab SaMS” codes.

And in the process, Valar has inadvertently given everybody else a very nice little comparative inventory of the emerging H&E-AI CPT/PLA universe and its proposed Medicare pricing.

##

##

Valar's argument is logical and well-crafted.   Yet, it may represent the very problem CMS alluded to in the original OPPS pages about CLFS and digital.  CMS may worry we image a $10 H&E slide once, and every ten seconds run a new algorithm in memory - $750, $1500, $2250, $3000, etc.

##

Yes. Valar is a very well-written illustration of the exact economic problem CMS says it is trying to solve.

CMS says rather candidly that OPPS was built to pay for things whose costs are largely material resources, whereas SaMS may derive its value from proprietary algorithms and “scalable, non-material costs.” CMS then adds that the cost-based system may provide limited transparency and “may not effectively constrain pricing.” It separately flags subscription, license, and per-use or “per-click” fees as raising program-integrity concerns.

Now put Valar into that framework.

A patient already has an FFPE block. You make an H&E slide; perhaps the slide costs tens of dollars. You digitize it once. Thereafter, the same WSI data file can potentially support:

• Risk Stratify → $750.50

• BCGPredict → another $750.50

• conceivably some future biomarker/prediction algorithm → another $750.50

• and so forth.

The marginal physical resource cost of the second and third analyses may be dramatically lower than the first. I would not assert that they literally take only seconds without Valar-specific evidence—there may be QC, data handling, pathologist oversight, computing, report production, etc.—but economically the important point survives: the cost of running another trained algorithm against an already-created digital image is unlikely to resemble the resource structure of repeating a $750 physical medical procedure.

And Valar's particular request almost highlights the issue. It says its two bladder tests are genuinely different clinical services, which is perfectly plausible: one predicts recurrence/progression and one predicts BCG response. Therefore, Valar says, pay each one separately at $750.50.

That is a sound coding/clinical-distinctness argument, but it does not answer the CMS policymaker's payment-economics question:

If two different answers are generated from the same slide and substantially the same digital infrastructure, should Medicare pay 2 × $750 merely because there are two separately coded outputs?

Indeed, CMS seems to have anticipated almost exactly this problem. Its proposed O1 status indicator would initially work like status indicator S—separate payment without a multiple-procedure reduction. But CMS specifically asks whether SaMS should instead get a status indicator functioning like T, so that multiple-procedure discounting would apply, expressly mentioning program-integrity concerns.

That makes Valar's situation a nearly textbook example:

Valar's position:
“These are two separate clinically meaningful tests, therefore don't discount either one.”

CMS's problem:
“Fine—but if both are software analyses of the same previously created image, paying the full standalone price every time may wildly overpay the incremental resource cost and create an incentive to proliferate separately coded algorithms.”

There is an even deeper problem. A 50% multiple-procedure reduction is itself borrowed from a world of procedures and may be economically arbitrary for software. If the first algorithm costs $750 and the incremental computational/reporting cost of the second is, hypothetically, $30 or $100, then paying the second one $375 still doesn't solve the problem. Conversely, some software may entail significant licensing, human review, cloud infrastructure, validation and ongoing development costs that make a pure marginal-compute-cost price too low.

So CMS really needs something more sophisticated than either:

$750 + $750 + $750, or
$750 + $375 + $375.

The long-term answer could be some combination of a base payment plus incremental-analysis payment, episode bundling, multiple-SaMS packaging, capped payment per underlying dataset/image, or a valuation methodology that recognizes both fixed intellectual-property costs and very low marginal production costs.

And this is why I think the Valar comment is unusually instructive. Valar may be entirely right under the payment rules CMS has proposed, while simultaneously demonstrating why CMS believes those rules cannot be the permanent answer. The company's excellent tables actually make the policy problem more visible: once H&E becomes a reusable digital substrate, an unlimited number of separately coded algorithms can potentially sit on top of it.

That, much more than whether this bladder algorithm deserves $350 or $750, is the elephant in CMS's SaMS discussion.