Very Brief Blog: David Filmore Discussing CMS NCDs, RAPID, Outlook

Healthcare journalist David filmore (MedTech Strategist) has some interesting articles at Linked In on current CMS ideas for NCD coverage - namely, the "RAPID" program.   

Find his article here:

https://www.linkedin.com/posts/david-filmore-medtech_medtech-fda-cms-share-7506362779092819968-GgRQ/

It leads also to his subscription-only article here.

See his 3-months-earlier article at Linked In here.

### AI Summary:

David Filmore’s two reports examine RAPID’s central promise: designing pivotal device trials early enough with FDA and CMS that one study can support both regulatory authorization and Medicare coverage.

In the earlier report, Filmore highlights a debate held in Dublin last spring between entrepreneur Josh Makower and former CMS official Steven Farmer. Makower sees an opportunity to accelerate market access through a trial serving both agencies. Farmer questions whether high-risk device studies can realistically satisfy both standards—and whether CMS can commit scarce resources so early, before a product’s commercial prospects are clear. RAPID’s proposed advantage over TCET is earlier engagement, before pivotal trial design is settled.

The newer report finds continued enthusiasm alongside familiar doubts. Former CMS coverage director Tamara Syrek Jensen welcomes early benefit-category decisions and written commitments concerning a proposed national coverage determination. Farmer warns that earlier coordination could bring heavier premarket evidence requirements. Makower urges CMS to adopt a “least burdensome” approach, while Scott Whittaker at AdvaMed considers RAPID a step forward with insufficient scope. 

Filmore’s reporting underscores the unresolved tradeoff: earlier coverage certainty may require more evidence upfront, while industry continues seeking legislation offering broader, more automatic coverage and better resources for CMS.

LegislationWatch: ASAP (Alzheimer Tests), MAIA, PACA, PPA (all for Medicare Advantage Claims)

 ALZHEIMER ON THE HILL

On September 16, 2026, the House Ways and Means committee advanced a bipartisan Alzheimer bill, "Alzheimer's Screening and Prevention Act ASAP."

See a dedicated website: https://alzimpact.org/ASAP_Act   

It's numbered as, H.R. 6130 / S. 3267.  

###

MEDICARE ADVANTAGE CLAIMS - ON THE HILL

Tired of Medicare Advantage payment nightmares?  Congress would like to help.   See Medicare Advantange Improvement Act of 2026, and Medicare Advantage Prompt Pay Act, and the Protecting Approved Care Act.

Read about MAIA-2026 here.  It's numbered as, HR 8375/S 4384. 

For the Prompt Pay Act PPA-2026, see HR5454 here.

Read about Medicare Advamtage "Protecting Approved Care Act" PACA here and here.  See the langhage here.  (It was just announced and may not be numbered yet.)

##

ALL ABOUT ALZHEIMER (ASAP)

Alzheimer’s Blood Tests: Congress Moves Toward Screening Coverage as Diagnostics Expand Access

The Alzheimer’s Screening and Prevention (ASAP) Act has advanced unanimously through the House Ways and Means Committee, highlighting a growing policy question: how should Medicare accommodate blood tests that can identify Alzheimer’s pathology earlier? Alongside the legislation, increasingly accessible diagnostic platforms could help more patients reach evaluation and treatment. These developments reinforce one another, but an important distinction remains: diagnosing patients with cognitive symptoms and screening people without symptoms involve different clinical evidence and coverage questions.

On September 16, the Ways and Means Committee voted 40–0 to advance H.R. 6130, the ASAP Act. The bipartisan legislation has a Senate counterpart, S. 3267. This is a significant committee milestone, although the legislation has not become law.

The introduced version would establish Medicare coverage for Alzheimer’s disease and related dementias early-detection screening tests furnished beginning January 1, 2028. It expressly includes detection at the presymptomatic and early stages, requires FDA clearance, classification, or approval, and adds the tests to Medicare’s clinical laboratory payment provision. An important version caveat: the supplied Congress.gov page records approval of a committee substitute, but the displayed legislative text is still the November 2025 introduced bill. These details therefore describe that version.

For diagnostics readers, the drafting is striking. Although promoted as a blood-test bill, it begins with a “genomic sequencing blood or blood product test,” then allows other equivalent technologies—including single-analyte tests and protein expression—as the Secretary determines appropriate. The list even includes medical imaging. The proposed statutory category is considerably broader than a single Alzheimer’s blood biomarker, although its sequencing-first structure is an unusual starting point for a field where protein biomarkers such as pTau217 are attracting attention.

The Alzheimer’s Impact Movement describes this as a “mammogram moment”: a chance for Medicare policy to accelerate adoption of earlier detection. That is an effective advocacy frame. However, the analogy expresses an aspiration; it does not itself establish that screening asymptomatic people for Alzheimer’s will produce benefits comparable to mammography. The clinical question remains what happens after detection—and whether that sequence of care improves outcomes.

A complementary commercial perspective comes from Yiqi Seow’s commentary on Roche and Lilly’s pTau217 collaboration. Seow argues that diagnostics can expand access to a therapeutic market by overcoming the difficulty of identifying eligible patients. When evaluation depends on PET imaging or lumbar puncture, diagnostic capacity can constrain treatment access. A blood assay deployed on widely installed laboratory instruments could ease that constraint. The contrast with oncology is not absolute, but the central insight is useful: diagnostic infrastructure can be essential to realizing a drug’s clinical and commercial potential.

Roche and Lilly’s Elecsys pTau217 test received FDA clearance in August for people aged 55 and older with cognitive decline. It helps assess Alzheimer’s-related pathology and must be interpreted with other clinical information; it is not a standalone diagnosis. That symptomatic population should not be conflated with population screening before symptoms appear. (reuters.com)

Taken together, these developments show Alzheimer’s diagnostics advancing on two fronts: the practical capacity to test more patients and the proposed Medicare authority to cover screening earlier in disease. Their convergence could reshape access. The policy challenge is to connect each testing use to a clearly defined population, a meaningful next clinical step, and evidence that earlier knowledge improves care.

ASAP Act: Congress.gov

###

###

ALL ABOUT MEDICARE ADVANTAGE

Three Medicare Advantage Reform Proposals: Faster Decisions, Reliable Approvals, and Timely Payment

[For links see top of blog].

Three legislative proposals address different parts of the same Medicare Advantage problem: obtaining authorization, relying on that authorization once care is delivered, and getting paid afterward. The Medicare Advantage Prompt Pay Act focuses on payment deadlines. The Protecting Approved Care Act targets retrospective denials and payment reductions. The broader Medicare Advantage Improvement Act combines administrative reforms with coverage standards and financial accountability. Together, they would make plans more accountable for how coverage works in practice.

The discussion below reflects the supplied legislative versions: two introduced bills and an unnumbered September 2026 draft of the Protecting Approved Care Act. Their proposed requirements should not be mistaken for current law.

The Prompt Pay Act: Put a clock on payment. H.R. 5454, introduced by Representatives Jodey Arrington and Linda Sánchez, would require Medicare Advantage organizations to pay at least 95% of clean claims within specified deadlines, covering both contracted and noncontracted providers. Electronic claims from contracted providers would have a 14-calendar-day deadline; other claims would have a 30-calendar-day deadline.

The bill also defines a clean claim through standardized billing-data requirements, establishes presumptions for when a claim was received, requires interest on late payments, and authorizes civil monetary penalties of up to $25,000 per determination of noncompliance. Reporting would disclose payment timeliness and interest paid. Its proposed effective date is January 1, 2027. The central idea is straightforward: make timely payment a measurable federal obligation across provider relationships.

The Protecting Approved Care Act: Make coverage decisions dependable. The supplied Landsman draft would restrict retrospective medical-necessity denials, reopening of coverage or payment determinations, and downcoding that reduces payment. It preserves specified exceptions for reopening and downcoding, including regulatory “good cause” and reliable evidence of fraud or similar fault. Its proposed requirements begin with 2028 plan years.

One especially consequential provision extends protections to covered services for which the plan requires no authorization. That reaches beyond the familiar argument that a plan should honor its prior approval: it would also limit retrospective challenges when the plan did not require an approval process in the first place. A drafting detail merits attention—the definition includes prior and concurrent authorizations, while the operative approval clause refers to authorization made “during” receipt of care. That wording warrants clarification before assuming every preservice approval receives identical protection.

The Medicare Advantage Improvement Act: Connect access, payment, and enforcement. H.R. 8375, led by Representative John Joyce with bipartisan cosponsors, is the most comprehensive proposal. Its principal reforms, generally beginning in 2028, include:

• Faster authorization: generally 72 hours for standard requests and 24 hours for expedited requests, with specified extensions and timing qualifications.

• Less repetitive administration: real-time authorization capabilities for designated services and restrictions on requiring another authorization for clinically necessary changes to approved care.

• Stronger payment protections: qualifying claims documenting authorization would be deemed clean, with a 100% prompt-payment standard, alongside restrictions on retrospective denials, downcoding, and third-party reviews.

• Coverage accountability: medical-necessity criteria no more restrictive than traditional Medicare’s, public criteria where Medicare guidance is absent, and additional hospital and post-acute-care protections.

Its enforcement provisions are particularly notable. A new compliance score would trigger 1%, 1.5%, or 2% reductions in plan payments for progressively lower performance below a score of 90. A separate compliance and coverage-protection domain would enter Star Ratings, with its measures weighted more heavily than those in other domains. Administrative behavior would therefore affect the plan’s own revenue.

Very Brief Blog: John Warren Highlights "Genealogy of Pricing" as Key to Crosswalks

In an excellent Linked In posting, CMS consultant John Warren emphasizes that you can't do crosswalks and gapfill decisions any more, without understand the genealogy of how your comparable codes were priced by CMS.   Was it by gapfill?  By PAMA?  By a crosswalk?  If a crosswalk, what's happening to the crosswalk code?   

Sounds like a hall of mirrors, but it's facts you gotta track today.

Find the posting here:

https://www.linkedin.com/posts/john-f-warren_when-the-right-clfs-crosswalk-isnt-enough-ugcPost-7508980228946382849-ZNm_/

Cheat Sheet: The Six Publications About GRAIL (Released Concurrent with FDA Ad Comm)

We just had the Ad Comm for GRAIL - whose stock nearly doubled from 9/17 to 9/24.  Market cap rising from $2.5B to $5.5B.  

You'll be excused for not keeping this week's six publications straight in your head.  See an article and op ed in NEJM, plus two articles and op ed in Nature Medicine, and finally a concensus publication by Etzioni in Cancer on late-stage-cancer as a screening endpoint.

##

Article by Chat GPT 6.

##

GRAIL’s Publication Wave: A Guide to Six Papers

Around GRAIL’s FDA review, readers encountered six related publications addressing different questions: Can Galleri find cancers? Does screening reduce advanced disease? What evidence should justify adoption? The essential distinction is that these are three research reports from two clinical studies, two commentaries, and one consensus statement. In particular, the Sasieni and Neal papers describe different aspects of the same NHS-Galleri trial, not independent trials.

1. Sasieni et al., NEJM: The randomized trial’s clinical results

In England, 142,250 participants were randomized to usual care with or without Galleri screening across three annual rounds. The trial missed its primary endpoint: reducing the incidence of stage III and IV cancers combined across 12 prespecified cancer types.

Stage IV incidence alone was approximately 14% lower with screening, suggesting possible benefit. However, because the primary endpoint failed, the prespecified statistical testing sequence did not permit formal significance testing of secondary endpoints. Longer follow-up will help determine whether this encouraging signal develops into established benefit.

Reference: Sasieni P, Johnson P, Round T, et al. “Effect of Screening with Multicancer Early-Detection Test on Late-Stage Cancer Diagnosis.” New England Journal of Medicine. Published September 22, 2026. Read article — DOI: 10.1056/NEJMoa2505723.

2. Hunter, NEJM: Op Ed, A clear “not yet” on population screening

Hunter praises the trial’s scale, rigor, and socioeconomic representation, but concludes that Galleri is not yet ready for population-wide screening. Its limited sensitivity for early-stage cancers remains a central weakness; detecting cancer at stage III rather than IV is valuable, but generally less valuable than finding it at stage I or II.

His conclusion is not “never.” Better early-stage sensitivity, further follow-up, and rigorous cost–benefit assessment could change the judgment.

Reference: Hunter DJ. “A Step in the Search for the Elusive Holy Grail of Early Detection of Cancer.” New England Journal of Medicine. Published September 22, 2026. Read editorial — DOI: 10.1056/NEJMe2611312.

______________________________

3. Neal et al., Nature Medicine: How the test performed within NHS-Galleri

This companion report examines test performance in the trial’s screened participants. Specificity remained approximately 99.5–99.6%, and cancer-origin predictions were correct in approximately 91–94% of cases.

However, positive predictive value declined from 58% to 50% to 46% across screening rounds. Sensitivity for all cancers diagnosed within the relevant 12-month periods ranged from approximately 27–37%. These findings characterize detection performance; they do not independently establish improved health outcomes.

Reference: Neal RD, Dolly S, Johnson P, et al. “Performance of a multi-cancer early detection test in the randomized controlled NHS-Galleri trial.” Nature Medicine. 2026. Read article — DOI: 10.1038/s41591-026-04652-8.

4. Nabavizadeh et al., Nature Medicine:

PATHFINDER 2’s U.S. performance and safety results

This separate, prospective U.S. study enrolled approximately 35,900 participants; approximately 32,000 were evaluable for performance. Galleri detected cancer in 0.54%, with 60.3% positive predictive value, 99.64% specificity, and 39.3% sensitivity for cancers diagnosed within 12 months.

No serious study-related adverse events were reported at this analysis. The study supports feasibility and provides reassuring short-term safety findings, but its nonrandomized design cannot establish that screening reduces advanced cancers or deaths.

Reference: Nabavizadeh N, McDonnell C, Kurbegov D, et al. “Performance and safety of a multi-cancer early detection test: the PATHFINDER 2 study.” Nature Medicine. 2026. Read article — DOI: 10.1038/s41591-026-04618-w.

5. Marinac et al., Nature Medicine:

Detection is progressing; population benefit remains unresolved

This commentary connects the three research reports. The authors see stronger evidence that MCED testing can find cancers outside existing screening programs, while emphasizing that finding more cancers does not yet establish population-level benefit.

They also stress context: some additional early-stage detection involved colorectal cancer, so Galleri’s incremental value may differ between health systems with different existing screening practices. Their tone is more exploratory than Hunter’s, but both identify an incomplete case for population screening.

Reference: Marinac CR, Rebbeck TR, O’Donnell EK. “Some answers, more questions for multi-cancer early detection tests.” Nature Medicine. 2026. Read commentary — DOI: 10.1038/s41591-026-04688-w.

__________________________

6. Etzioni et al., Cancer: What should count as persuasive evidence?

The American Cancer Society workshop’s Peachtree Consensus addresses trial design rather than reporting another Galleri study. It supports considering late-stage incidence as a primary endpoint, while acknowledging that it is not a universally validated substitute for cancer mortality.

Recommendations include cancer-specific definitions of “late stage,” comparable staging across trial arms, adequate follow-up, and reporting absolute as well as relative effects. A significant, clinically meaningful late-stage reduction could justify implementation-focused demonstration studies while mortality follow-up continues—not automatic population-wide adoption.

Reference: Etzioni R, Kessler L, Schrag D, et al. “Recommendations of the American Cancer Society workshop on design, conduct, analysis, and reporting of multicancer early detection trials with late-stage incidence end points and post-trial ongoing evaluation—The Peachtree Consensus.” Cancer. 2026;e70628. Read consensus statement — DOI: 10.1002/cncr.70628.

History Corner: The Origins of the Mismatched -26 and -TC Modifiers

Part 1

Why Is the Professional Component “26,”
but the Technical Component “TC”? 

A Little CPT Archaeology

[Article by: Chat GPT 6]

[Part 1 of this article - top - on the origins of -26 and TC.   Part 2 of this article - bottom - on the earliest history of two-digit modifiers.]

 For anyone who works regularly with pathology and laboratory billing, modifier 26 and modifier TC seem like a natural pair. A pathology or radiology service may be billed globally, or it may be divided into its professional and technical components. The professional component gets -26; the technical component gets -TC.

But stop and look at that for a moment.

Why is one half of this seemingly symmetrical pair a number, while the other is a pair of letters? Why didn't we end up with PC and TC—or perhaps 26 and 27?

It is one of those small peculiarities of medical coding that becomes puzzling only after someone actually notices it. The answer appears to be historical: 26 and TC weren't originally created as a matched pair. They come from different coding traditions that were subsequently joined together.

Modifier 26 Came From AMA CPT

BCBS, NYT: Hospital AI Bills Battle Payer AI Denials!

The headline was inevitable.  Hospital AI pumps out bigger better invoices.   Health insurer AI rolls up its sleeves and pumps out denials.

The story in the NYT is here.  It's based on a new report issued by the BCBS Association here, here.

Here's a short quote from NYT:

• Using codes for various medical conditions, hospitals submitted claims for tens of thousands of patients that described their illnesses as more complex in 2024 and 2025 than in 2023. 
• Despite the added conditions, there was no evidence that the patients had received different treatment from the hospitals, according to the analysis by the Blue Cross Blue Shield Association, which represents state Blue Cross plans.
• Using A.I. tools, hospitals are collecting more information about their patients, and submitting bigger claims, the association said.  
• “Coding is changing because of this technology,” said Luke Chalker, a senior vice president at the association. By describing patients as having more complicated conditions and adding a secondary diagnosis, like anemia or low sodium, the hospitals were paid an average of nearly $12,000 more per case.

Here's similar text from BCBS:

• Our analysis of over 55,000 excess complex cases found that hospitals are systematically adding secondary diagnoses that bump claims into higher-severity, higher-reimbursement diagnosis-related groups (DRGs) without a corresponding increase in clinical care. 
• These shifts account for 70% of the incremental inpatient coding intensity costs to the Blue System. 

GRAIL's Day at FDA: The Most Detailed Report

GRAIL has its day at FDA on September 23, 2026, with panelists voting in favor of the effectiveness and safety of Galleri.

The FDA website is here (see a 55p PDF from FDA and a 111-page PDF from GRAIL.)  

At YouTube FDA posts a 9-hour video which includes an autotranscript.   

Numerous concise meeting reports are available at news sites on the Internet.

BUT...I gave Chat GPT Astra-6 the full transcript and asked for a detailed meeting report.  Then, in an appendix, I asked Chat GPT to asses the "competing frames" of rhetoric and emphasis, and used by both FDA and GRAIL.

(See NEJM GRAIL results, 9/22/2026, Sasieni et al. here, Hunter op ed here.) 

(See also a triplet of papers in Nature Medicine 9/22/2026, Neal here, Nabavizadeh here, Marinac here.)

See the 17-page PDF report here:

https://drive.google.com/file/d/1lt9tGMwxEPwN-Nmtpm_1j-K9dwD3KI1d/view?usp=sharing

The July 2026 RFI on Modernizing CLIA: What Do Public Comments Say??

 CMS issued a Request for Information (RFI) on modernizing CLIA in July 2026, with comments closing September 14, 2026.   See the comment search page here:

https://www.regulations.gov/document/CMS-2026-2345-0001

https://www.regulations.gov/document/CMS-2026-2345-0001/comment

>>> Article below is written by Chat GPT.

##

Pathology Groups Tell CMS How CLIA Should Enter the Digital Age

Summary— CMS and CDC’s 2026 request for information on modernizing CLIA produced substantial agreement among five pathology and laboratory organizations. All treated software, AI, bioinformatics, and clinically consequential data analysis as part of modern laboratory testing, while urging flexible, risk-based oversight rather than rigid technology-specific rules. Important differences remained: whether data-only entities need their own CLIA certificates, whether molecular pathology deserves a new specialty, how explicitly CLIA should require clinical validity, and whether physician review must remain mandatory as AI moves from assistance toward autonomous interpretation.

When Does MolDx Change Its Mind? The Prelude Papers

When does MolDx change a non-coverage proposed LCD into a coverage final LCD?

Famously, this happened once in the last few years, regarding the PRISM-RA test, which provides some help when choosing advanced medications in arthritis.  (However, MolDx remarked in the final that it still found some of the evidence marginal.)  (Draft, 9/2022).  (Final, 8/2023). 

It's an evergreen topic; for example, MolDx just proposed an LCD not covering a risk stratification test in renal cancer, but the comment period is open and the final LCD could be more positive.  

On September 2, I published an article about MolDx's decision to postpone finalizing a non-coverage proposed LCD,DL40246, on biomarker risk stratification in DCIS.   That particular saga has been going on for a while, and the September 2 article contains a number of links. Test name, DCISionRT, developed by, Prelude Dx.

##

The story continues: See a new posting at Linked In by Dan Forche, CEO of Prelude Dx ("The DCIS Testing Company.")   It links to a September 8 Forbes article by Geri Stengel that updates readers on the topic, incuding a MAC contractor advisory meeting in 2024 and a new one pending October 13.  See also Stengel at Substack on September 10.

##

I won't attempt to re-summarize everything linked back on September 2, but below Chat GPT summarizes what's new from Forche and Stengel.

##

AI CORNER

##

When Is the Evidence “Good Enough”? The DCISionRT Story Continues

CMS Posts Cy2025 Part B National Utilization Data

 CMS has posted CY 2025 National Part B utilization data as simple Excel files.  Find them here:

https://www.cms.gov/data-research/statistics-trends-and-reports/part-b-national-summary-data-file?

For example, allowed dollars for code 81479 are up to $512M (for 205,000 services).

The same data will be posted in vastly more detailed sometime around June 2027, sortable for every physician and lab using each CPT code (here).

##

Here's our analysis of the CY2024 data as written up in 9/2025.

##

For 2025, PLA codes totaled about $1.5B, with almost half going to the top 3 codes.  The top 20 PLA codes had 90% of PLA dollars.

(See brand key below).

##

For mainstream codes 81162 to 81599, there were $1.9B in payments, from which 27% or $512M going to 81479, unlisted code, used almost entirely at MolDx.

The top 20 mainstream codes had 80% of the dollars in this category.

87798

87798 (other pathogen) rapidly rose to be the highest Medicare molecular code, shooting skyward even as prior supercode 81508 ($2000, Level 9) dropped off the chart.   

• In 2024, 87798 was 12.7M services for $447M.
• In 2025, 87798 was 12.3M services for $430M.
• We hear that in 2026, at least by late spring, payments for 87798 had slowed to a trickle. 

##########

CODE NAMES - PLA

0464U, Exact Sciences, Cologuard Plus
0211U, Caris Life Sciences, MI Cancer Seek – NGS Analysis
0340U, Natera, Signatera
0326U, Guardant Health, Guardant360
0540U, CareDx, AlloSure
0242U, Guardant Health, Guardant360 CDx
0108U, Castle Biosciences/Cernostics, TissueCypher Barrett’s Esophagus Assay
0037U, Foundation Medicine, FoundationOne CDx
0537U, Guardant Health, Shield
0473U, Tempus AI, xT CDx
0345U, Myriad Genetics/Assurex Health, GeneSight Psychotropic
0485U, Caris Life Sciences, Caris Assure
0239U, Foundation Medicine, FoundationOne Liquid CDx
0315U, Castle Biosciences, DecisionDx-SCC
0026U, CBLPath/UPMC, ThyroSeq v3 Genomic Classifier
0080U, Biodesix, BDX-XL2
0047U, MDxHealth, Genomic Prostate Score (GPS) Test
0241U, Cepheid, Xpert Xpress SARS-CoV-2/Flu/RSV—All Targets [deleted code]
0356U, Naveris, NavDx 

CODE NAMES - 80,000 series

81479, Unlisted molecular pathology procedure
81542, Veracyte, Decipher Prostate
81528, Exact Sciences, Cologuard
81519, Exact Sciences/Genomic Health, Oncotype DX Breast Recurrence Score
81529, Castle Biosciences, DecisionDx-Melanoma
81456, Tumor or hematolymphoid neoplasm, RNA panel, 51 or more genes
81464, Solid-tumor liquid biopsy, comprehensive DNA/RNA genomic profiling
81419, Epilepsy genomic sequencing panel
81440, Nuclear-encoded mitochondrial-disorder panel, 100 or more genes
81459, Solid tumor, comprehensive DNA/RNA genomic profiling
81443, Severe inherited-disorder panel, 15 or more genes
81546, Veracyte, Afirma Genomic Sequencing Classifier
81518, Hologic/Biotheranostics, Breast Cancer Index
81455, Tumor or hematolymphoid neoplasm, DNA panel, 51 or more genes
81541, Myriad Genetics, Prolaris
81595, CareDx, AlloMap Heart
81307, PALB2 full-gene sequencing
81418, Pharmacogenomic panel, 6 or more genes
81249, G6PD full-gene sequencing
81238, F9 full-gene sequencing

PAMA is Brutal on Top-End Kitted MoPath Tests

 Here's a section quoted from my blog on PAMA Pricing 2027:

Lesson: PAMA is brutal on kitted molecular tests

Once again, PAMA Is brutal on kitted molecular tests.   Back around 2016, Nanostring got 510K clearance for Prosigna, essentially "Oncotype in a Box," a test which won crosswalk  pricing to Oncotype when Prosigna was new. About $3400.  

However, Prosigna got a brutally low price of $900 (!) in the 2017 cycle of PAMA, resulting in year-by-year cuts.*  (The code was deleted in the 9/2026 AMA CPT meeting.)

Past is Prologue: Prosigna to Illumina

The same story plays out for 0543U, the Illumina Trusight Oncology Comprehensive test.  It won a crosswalk price of $2989 (basically the same as 81455), but gets a PAMA price of only $1337.   Apparently labs responsible for billing payers and then reporting PAMA prices did a poor job of it, to the detriment of Illumina.  

Hold your breath: CMS doesn't post data on ILMN 0543U reported paid prices, indicating there were fewer than 10 of them in 1H2025 PAMA data.  Those were enough to tank the price by over half.

You can't help seeing the parallel between Prosigna ("Oncotype in a box") and Illumina Trusight ("FMI in a box.") Both get chopped in half and tossed out the window via PAMA.  CMS is saying, don't put your molecular IVD in a box, because you won't control billing methods (as Caris, Natera, etc, can do).

##

##

*The Prosigna story is messy because it was priced as Admin-MAAA 0008M 2016 then upgraded to Cat I 81520 during 2018, but the results are as stated here.   See AI discussion: $3443 to $900.   

Public Comments on Physician Fee Schedule Proposals for CY2027

CMS accepted comments on the proposed Physician Fee Schedule rules for 2027 until September 14, 2026.

Comments are posted and searchable here:

https://www.regulations.gov/docket/CMS-2026-2377/comments

# # #

CAP Example Search

For example, the comments by CAP are here (38pp).  After its highlights, CAP's #1 topic was revaluation of 88305 88307 (common biopsy codes) and #2 was Software as a Medical Service (SaMS).  #4 was an RFI on the AMA CPT

https://www.regulations.gov/comment/CMS-2026-2377-40551

.  

See my prior summary of OPPS comments here.  Below is a direct AI summary of six comment letters by Chat GPT.

# # #

CY 2027 PFS Comments:
SaMS, AMA CPT, and the Parallel CLIA RFI

 

Across six CY 2027 PFS comment letters, the laboratory community speaks with striking unity on SaMS: CMS should not remove algorithmic laboratory analyses from the CLFS while the agency is still deciding, through its CLIA RFI, whether data-only and software-intensive testing remains laboratory activity. All six support continued use of AMA CPT, although several seek greater transparency, laboratory representation, applicant participation, and scrutiny of licensing fees. The groups differ mainly in fallback strategy: preserve CLFS pricing, permit direct laboratory billing, avoid local contractor pricing, establish national rates, and defer implementation until CMS resolves CLIA jurisdiction, enrollment, coinsurance, and operational consequences.

CMS Posts "PAMA" Lab Fee Schedule for 2027 Forward

 CMS has posted data on PAMA pricing for laboratory tests.   The private payor payment rates, effective in 1H2025, are used to set a new clinical laboratory fee schedule for 2027 forward.  CMS posted some statistics as well.

See a Fact Sheet about the rates:

https://www.cms.gov/newsroom/fact-sheets/preliminary-calendar-year-cy-2027-medicare-clinical-laboratory-fee-schedule-payment-rates

And a press release:

https://www.cms.gov/newsroom/press-releases/cms-announces-new-preliminary-medicare-payment-rates-laboratory-services-saving-taxpayers-estimated

Find resources such as data ZIP files here:

https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule/clfs-pama-reporting-resources

There is an "all data" XLS file that unzips to about 100 mb, in giant pages of about 1M rows (999,999).  (It looks like 7 worksheets, or circa 7M lines).

One common molecular code, 81455 (51 or more tumor genes) drops 2%, from $2919 to $2861 (minus $58).

##

The raw data shows extensive price range and price distribution data.   Reporting hospital labs rose from 21 in 2017 to 875 in 2026.  Physician office labs rose from 1106 to 3262.   Independent labs were about the same (658, 775).

Data for  sole-source tests aren't provided as raw data.  For example, we don't know the price range or distribution for 81519, Oncotype Dx - it's not not in the public full data table.  The median price did not change (81519, $3873 before, $3873 after).  The 70-gene test, Mammaprint, fell from $3873 to $3075.  

##

According to the Fact Sheet, 1171 codes have a lower median, and 169 have the same median.  186 codes have a higher median than in 2026.

Major code categories - chemistry, mopath, microbiology, immunology - generally fell 15-20%.   PLA codes fell only -2%.

The easiest file to review is:

5 CY_2027_Prelim_Wgt_Meds_Pmt_Rates_2026.09.21.xlsx

##

The highest code, 0211U, Caris, $8455, was unchanged.  0067U rose from $1897 to $3330.   0084U rose from $720 to $2205.   0276U fell from $2448 to $45.     0364U fell from $2007 to $337.  0382U rose from $51 to $962.    0485U rose from $3649 to $5250.   0489U rose from $1153 to $2448.  0543U fell from $2989 to $1337.  Chat GPT rewrites...

#

The highest-priced test remained unchanged: Caris Life Sciences’ MI Cancer Seek–NGS Analysis (0211U) stayed at $8,455.

Several tests received substantial increases. Silbiotech’s BBDRisk Dx (0067U) rose from $1,897 to $3,330. Grifols Diagnostic Solutions’ BLOODchip ID CORE XT (0084U) more than tripled, from $720 to $2,205. Mayo Clinic Laboratories’ Phenylalanine and Tyrosine, Self-Collect, Blood Spot test (0382U) increased nearly nineteen-fold, from $51 to $962. Caris Life Sciences’ liquid-biopsy test, Caris Assure (0485U), rose from $3,649 to $5,250, while BillionToOne’s UNITY Fetal Risk Screen (0489U) increased from $1,153 to $2,448.

Other tests experienced dramatic reductions. Versiti Diagnostic Laboratories’ Inherited Thrombocytopenia Panel (0276U) fell from $2,448 to just $45. Adaptive Biotechnologies’ clonoSEQ Assay (0364U) dropped from $2,007 to $337. Illumina’s TruSight Oncology Comprehensive test (0543U) declined from $2,989 to $1,337.  Click to enlarge.

click to enlarge

The larger point is striking: these are not gentle market adjustments. The nearly 98% collapse for the Versiti panel and the nineteen-fold increase for Mayo’s monitoring test look much more like the consequences of sparse, unstable, or unrepresentative PAMA reporting than rational reassessments of the tests’ earlier or later costs or clinical value.

##

CMS takes comments on the data for 30 days, but doesn't have authority to do other than calculate a median and use it, so the comment period is not very stimulating.

##

PAMA is brutal on kitted molecular tests

Once again, PAMA Is brutal on kitted molecular tests.   Nanostring got 510K clearance for Prosigna, essentially "Oncotype in a Box," a test which won crosswalk to Oncotype $3443 when Prosigna was new.   However, it got a brutally low price of $900 in the 2017 cycle of PAMA, resulting in year-by-year cuts.  (The code was deleted in the 9/2026 AMA CPT meeting.) [*]

The same story plays out for 0543U, the Illumina Trusight Oncology Comprehensive test.  It won a crosswalk price of $2989 (basically the same as 81455), but gets a PAMA price of only $1337.   Apparently labs responsible for billing payers and then reporting PAMA prices did a poor job of it, to the detriment of Illumina.  CMS doesn't post data on 0543U reported prices, indicating there were fewer than 10 of them in 1H2025.

You can't help seeing the parallel between Prosigna ("oncotype in a box") and Illumina Trusight ("FMI in a box.") Both get chopped in half and tossed out the window via PAMA.

##

The Prosigna story is messy because it was priced as Admin-MAAA 0008M then upgraded to Cat I 81520, but the results are as stated here. $3443 to $900.   

Can AI Get PAMA News From Investor Calls?

I asked both CLAUDE and CHAT GPT to scan recent lab industry investor calls for PAMA news and predictions.   I include CLAUDE below; the two were similar.   I include a cloud link to Chat GPT here.

This is direct AI output, offered as-is, I have not checked against original transcripts or audio files.

##

CLAUDE Opus

##

Please research public calls like investor calls for Carius, Tempus, Guardant, Natera, GenEDx, Neogenomics, Labcorp, and Quest, for evidence of specific remarks on PAMA pricing and how it might change their Medicare pricing and financial outlook.   Use investor calls around August 1 (July 15-August 30) reflecting the quarter ending June 30, 2026.     i am interested in specific quotes, for example, I understand that CARIS made a specific quote that its ASSURE test price would rise with the current PAMA cycle.  Provide specific links and quotes.

##

PAMA on the Q2 2026 Earnings Calls:
What Eight Lab Companies Said About Medicare Pricing

The summer 2026 earnings season fell during the long-delayed PAMA private-payor data reporting cycle. The Consolidated Appropriations Act of 2026 postponed CLFS rate cuts until January 2027 and required laboratories to report first-half 2025 data during a mandatory window from May 1 to July 31, 2026. CMS will use that data to set CLFS rates for 2027–2029, with annual reductions for each test capped at 15%. No preliminary CY2027 rates appeared to be public as of mid-September.

This review covers calls for the quarter ending June 30, 2026, held between late July and early August, for Caris Life Sciences, Tempus AI, Guardant Health, Natera, GeneDx, NeoGenomics, Quest Diagnostics, and Labcorp. The companies split into three groups. Quest and Labcorp framed PAMA as a downside risk to be managed through legislation. Tempus and Guardant described Medicare price increases arriving through ADLT designation. Caris stood out as the one company projecting that the ordinary CDLT reset would raise its price. Natera and GeneDx did not address PAMA in the material reviewed.

Most full transcripts cited here are AI-generated and editor-reviewed by third-party services such as Investing.com and Benzinga. Speaker labels occasionally contain errors, and quotations should be verified against company webcast replays before further use.

Caris Life Sciences (August 5)

The most specific PAMA remark of the season came at the very end of Caris's Q&A. An analyst asked whether Caris Assure would gain more coverage as it approaches 200 million covered lives. CFO Luke Power said the company would keep pushing, noting that its code is now public on the clinical lab fee schedule, which is helping win contracts, with a strategy expected to play out into 2027. Chairman and CEO David Dean Halbert then added, per the Investing.com transcript: "We're expecting a price increase with PAMA." The sentence does not name Assure. It follows directly from the Assure discussion, but it can also be read as a company-wide statement (Investing.com transcript).

The CFO's prepared remarks were more measured. He reminded listeners that the clinical assays are billed as CDLTs and that Caris views its reimbursement position as "stable, with an expected update in September on the current PAMA reporting cycle" (StockAnalysis transcript).

The Q1 call in May supplies the background. Management explained that MI Cancer Seek was priced through crosswalk and Caris Assure through gapfill. Having not pursued ADLT status, both tests are subject to the three-year PAMA cycle. Caris submitted its data on May 1 and said it felt "very good about price stability" (Globe and Mail, Q1 transcript). Between May and August, the language moved from stability to an expected increase.

The PAMA mechanics explain why Caris would be optimistic. For a single-laboratory PLA code, the weighted median of private payor rates largely reflects that laboratory's own commercial payments. The 15% statutory limit applies only to reductions, not increases. A test initially priced by gapfill, whose commercial contracting expanded during 2025, is a plausible candidate for upward repricing.

Very Brief Blog; Convergent Genomics Exits via Veracyte Acquisition

 https://www.genomeweb.com/diagnostics/molecular/liquid-biopsy/gnw-veracyte-acquisition-convergent-genomics-20260915/

Here is the headline news:

NEW YORK – Veracyte said after the close of the market Monday that it has acquired Convergent Genomics, which has developed a urine-based DNA testing platform for cancer diagnostics.

The acquisition includes $150 million in upfront cash and up to $30 million in additional cash tied to milestones related to reimbursement efforts for the company’s UroAmp test for urothelial cancers.

Convergent has specifically validated its assay for non-muscle invasive bladder cancer (NMIBC) therapy response monitoring and post-treatment surveillance.

NMIBC is generally confined to the bladder and may shed only limited tumor DNA into the bloodstream, which can make blood-based detection challenging, Veracyte noted. Urine, by contrast, comes into direct contact with the tumor and contains urinary tumor DNA (utDNA).

UroAmp uses sequencing and machine learning to analyze 60 urothelial cancer genes while also measuring changes across the whole genome, according to the company’s website. The company has validated this approach to determine minimal residual disease (MRD) in patients with a history of bladder cancer before and after treatment to monitor therapy efficacy.