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.

CMS and CDC Open a Broad CLIA Inquiry

On July 16, 2026, the Centers for Medicare & Medicaid Services and Centers for Disease Control and Prevention published a request for information on possible modernization of the Clinical Laboratory Improvement Amendments regulations. The agencies noted that laboratory technology has advanced substantially since the regulations were implemented in 1992.

The RFI was not itself a proposed rule. Rather, CMS and CDC solicited information that could inform future regulations or guidance. Questions covered pathology-block retention, specimen preparation, suboptimal specimens, test validation, artificial intelligence, data-only facilities, remote competency assessment, emergency preparedness, cybersecurity, and laboratory specialties.

Five organizations—the Association for Molecular Pathology, College of American Pathologists, Coalition for 21st Century Medicine, California Clinical Laboratory Association, and Digital Pathology Association—submitted particularly relevant responses.

A Strong Common Theme: The Test Does Not End at the Wet Bench

Across the five letters, the clearest common position was that modern laboratory testing cannot be divided neatly between physical specimen processing and subsequent computational work. Bioinformatics, image analysis, risk calculations, AI interpretation, and report generation may be integral parts of the test itself.

The organizations generally rejected the idea that analysis becomes something other than laboratory testing merely because it occurs after a slide is scanned, sequencing is completed, or data are transferred to another computer or organization. When software converts specimen-derived information into a clinically actionable result, it remains part of the total testing process.

They also agreed that CLIA modernization should preserve flexibility. Detailed requirements written around today’s technologies could quickly become obsolete. Most favored a framework built around clinical risk, intended use, laboratory-director accountability, end-to-end validation, and professional standards that can evolve more rapidly than federal regulations.

Association for Molecular Pathology:
Bring the Entire Diagnostic Procedure Under CLIA

AMP presented the broadest argument for strengthening CLIA as the principal federal framework for laboratory-developed procedures. It urged CMS to recognize expressly that CLIA is responsible for the quality of all laboratory-developed procedures and to require laboratories to establish their clinical validity.

AMP proposed that clinical validity could be supported through multiple forms of evidence, including peer-reviewed literature, clinical guidelines, case-control studies, registries, real-world data, postmarket evidence, and clinical trials. This would codify an activity that AMP believes responsible laboratory professionals already perform, without importing a single FDA-style approval pathway.

For software and AI, AMP argued that algorithms, machine learning, mathematical formulas, clinical calculations, risk models, and decision-support tools fall within CLIA when they generate, interpret, or materially affect a reportable laboratory result. AMP specifically included SaMS—Software as a Medical Service—within this continuous diagnostic-testing process.

AMP took the clearest position on data-only facilities: a facility receiving specimen-derived data for analysis and generating a reportable clinical result should itself be CLIA-certified. It recommended expanding the regulatory definition of laboratory to cover facilities that examine data, produce interpretations, or summarize information derived from human specimens.

AMP nevertheless opposed highly prescriptive rules. It recommended continued laboratory discretion in validating tests, modifying FDA-authorized assays, preparing reagents, and deciding whether clinically necessary testing can be performed on suboptimal specimens. It also called for new CLIA specialties or subspecialties for molecular, genetic, genomic, and flow-cytometric testing.

College of American Pathologists:
Preserve Pathologist Leadership and Technology-Neutral Rules

CAP’s 25-page response was the most comprehensive. CAP characterized CLIA as an adequate baseline and emphasized the role of accreditation requirements, professional guidelines, and laboratory-director judgment in keeping practice current when federal regulations lag behind technology.

CAP opposed writing rules around specific technologies. In its view, CLIA should regulate quality and accountability through existing specialties, while organizations such as CAP update detailed accreditation checklists and practice guidelines as science changes. Consistent with that philosophy, CAP opposed creating additional CLIA specialties, including a separate molecular pathology specialty.

On artificial intelligence, CAP drew a firm boundary. AI may assist and augment pathologists, identify regions of interest, quantify biomarkers, estimate tumor cellularity, detect mitoses or metastases, integrate molecular and morphologic findings, and generate prognostic or predictive assessments. However, CAP stated that AI systems cannot provide the medical diagnosis or assume responsibility for patient-care decisions. Physician review and approval remain necessary: AI can make predictions, but pathologists make diagnoses.

CAP also placed data-only facilities within CLIA when they generate information used in a final clinical laboratory result. Such activities can include sequence alignment, variant calling, annotation, image analysis, or other processing that directly affects patient-specific findings. Purely administrative, storage, transmission, or other ancillary functions may fall outside the testing process.

Elsewhere, CAP supported considering a longer pathology-block retention requirement but opposed anything beyond ten years, its own accreditation standard. It favored continued exemption of tissue processing and slide preparation from CLIA personnel regulation; laboratory-director discretion for suboptimal specimens; remote competency observation under specified safeguards; and alternative quality procedures for factory-calibrated instruments that users cannot recalibrate.

CAP urged CMS not to create laboratory-specific emergency, biosafety, or cybersecurity mandates where responsibility is shared across hospitals, health systems, vendors, and other healthcare entities. It similarly argued that blood-culture contamination is primarily a preanalytic collection problem that laboratories can monitor but often cannot directly control.

Coalition for 21st Century Medicine:
Risk-Based Reform for Advanced Diagnostics

C21 described molecular testing, distributed testing, dry laboratories, and remote test performance as major gaps in the existing regulations. It supported reasonable, risk-based reform while keeping CLIA the principal quality framework for advanced diagnostic services.

C21 supported longer retention of clinically valuable pathology blocks, noting that many laboratories already retain blocks for ten years or more. It nevertheless recommended considering the specimen type, diagnosis, intended use, and probability of future testing rather than imposing one undifferentiated requirement.

For NGS and other molecular tests, C21 identified performance measures such as limit of detection, variant-class accuracy, depth and uniformity of coverage, precision, specificity, reportable range, and bioinformatics-pipeline performance. It recommended test-specific standards informed by CAP, AMP, ACMG, and similar organizations rather than universal requirements.

C21 viewed algorithms as longstanding components of laboratory testing, not an entirely new phenomenon. Laboratories already use them to analyze digital slides, identify variants, process gene-expression data, and produce proprietary risk scores. It therefore saw no need for a separate AI-specific regulatory regime.

Unlike CAP, C21 cautioned against automatically requiring human review of every software-generated result. Some AI outputs cannot be reproduced or verified visually by a human—for example, an H&E-based prediction of recurrence or molecular status. Their reliability must instead be established through appropriately designed validation studies.

C21 supported bringing clinically actionable data-only work within CLIA. However, it proposed a carve-out for facilities providing only ancillary information that a CLIA-certified laboratory subsequently incorporates, validates, and assumes responsibility for in the final report. It also favored a new, tiered molecular pathology specialty reflecting the large difference between a single-gene PCR assay and a complex NGS test with bioinformatics and AI-assisted interpretation.

California Clinical Laboratory Association:
A Focused Version of the Advanced-Laboratory Position

CCLA’s comments closely paralleled several C21 positions. It emphasized laboratory-director discretion, flexible validation requirements, and recognition that computational interpretation is often inseparable from the laboratory service.

CCLA opposed universal NGS requirements and FDA-style clinical-validity demands that smaller laboratories could not realistically meet. It suggested that CAP and New York State standards could supply practical models without freezing rapidly changing technical details into federal regulation.

CCLA also opposed a separate AI regulatory system. Software used to interpret sequencing data, digital pathology images, or gene-expression results should be validated as part of the complete end-to-end laboratory workflow.

For data-only facilities, CCLA drew the regulatory line at clinical actionability. A facility producing a prognostic, diagnostic, or treatment-related result from an H&E image or sequencing file should fall within CLIA. A facility supplying ancillary information to a CLIA laboratory that validates the input and accepts responsibility for the final result need not necessarily be treated the same way.

Like C21 and AMP, CCLA supported creation of a molecular pathology specialty, potentially divided into tiers based on methodology and complexity. It also called for more consistent national public-health reporting requirements following the fragmented experience of COVID-19.

Digital Pathology Association:
Regulate the Function, Risk, and Degree of Autonomy

DPA concentrated on digital pathology, AI, data-only services, and remote competency assessment. Its central argument was that software is increasingly the mechanism by which a scanned slide becomes a clinically meaningful result.

DPA described three distinct AI roles:

• A sole interpreter, producing a result with no human-perceptible equivalent, such as a multimodal recurrence score or inference of molecular status from H&E morphology.

• A real-time assistant, directing attention, displaying heat maps, quantifying biomarkers, or triaging cases while the pathologist reviews them.

• An independent second reader, comparing its conclusion with the pathologist’s initial interpretation and flagging disagreements.

DPA argued that oversight should depend on which role software actually performs—not merely on the algorithm’s theoretical capabilities. It proposed a tiered system in which requirements increase with clinical consequence and interpretive autonomy.

It also distinguished locked algorithms from adaptive or continuously learning models. Locked products can generally be managed through initial validation and revalidation after material changes. Adaptive systems require ongoing drift monitoring, version control, audit trails, and clear revalidation triggers.

On data-only services, DPA emphasized function rather than physical location or corporate identity. Digitizing a slide is another transformation in the testing continuum, comparable to fixation, sectioning, or staining. An algorithm performs the same clinical function whether it runs inside the originating laboratory or on an outside platform.

DPA stopped short, however, of saying that every organization touching laboratory data should obtain a separate CLIA certificate. It favored having quality expectations follow the interpretive activity across the total testing process, while avoiding indiscriminate expansion of site-based certification.

The Important Areas of Disagreement

The letters revealed four meaningful policy divisions.

First, AMP favored CLIA certification for data-only facilities generating reportable results. C21 and CCLA focused on whether the output is independently actionable, with an ancillary-services exception. DPA focused more heavily on the regulated function than on separate certification of every site. CAP said clinically consequential data-only work should be part of the CLIA-regulated test system but did not fully resolve the certificate mechanics.

Second, AMP, C21, and CCLA supported new molecular or genomic specialties. CAP argued that existing specialties remain adequate and that creating technology-specific categories would make CLIA less adaptable.

Third, CAP insisted on physician review and approval of AI-generated information used in diagnosis. C21 warned against permanently mandating human intervention, while DPA explicitly contemplated systems functioning as sole interpreters or eventually as autonomous diagnostic tools.

Fourth, AMP recommended an explicit CLIA clinical-validity requirement. C21 and CCLA accepted the importance of clinical validity but cautioned strongly against requirements resembling FDA product-approval studies.

Bottom Line

Taken together, the five letters largely rejected a sharp boundary between the physical laboratory and the computational interpretation of laboratory-derived data. They treated digital pathology, bioinformatics, AI, and clinically meaningful data analysis as components of the total testing process—not as unrelated services that begin after laboratory testing ends.

The remaining debate is therefore less about whether these functions require quality oversight than about how CLIA should attach that oversight: to a certified facility, to the laboratory issuing the final report, to the clinical function wherever it occurs, or to some combination of the three. That question is likely to become central to the next generation of CLIA policy.

Source: Public comments submitted in docket CMS-2026-2345, Request for Information; Clinical Laboratory Improvement Amendments of 1988 Regulations.

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

When does MolDX turn a proposed noncoverage LCD into a positive final LCD?

It can happen. A recent example was the PrismRA test, which helps guide selection of advanced therapies in rheumatoid arthritis. MolDX proposed noncoverage in September 2022 but issued a favorable final LCD in August 2023—although the final policy still described portions of the evidence as marginal.

The question is evergreen. MolDX has just proposed noncoverage of a risk-stratification test in renal cancer, for example, and that comment period remains open.

The Back Story in Brief

On September 2, I discussed MolDX’s still-unfinished LCD for biomarker risk stratification in ductal carcinoma in situ, or DCIS. The policy is particularly important for PreludeDx and its DCISionRT test.

MolDX issued proposed LCD DL40246 in July 2025. The draft would deny coverage for biomarker tests intended to estimate DCIS recurrence risk and predict the benefit of radiation therapy.

Ordinarily, the next step would be a final LCD. Instead, in July 2026, the MolDX contractors announced that they were delaying finalization “given the impact of this determination.” They promised additional information in the coming months.

That was unusual. Now we know at least part of what comes next: MolDX has scheduled another Contractor Advisory Committee meeting for October 13.

Two New Articles by Geri Stengel

Geri Stengel has now examined the controversy in two closely related—but distinct—articles.

Her September 8 Forbes article, “Medicare Will Pay for Radiation. Will It Pay to Know Who Needs It?”, tells the story primarily from the patient and clinical perspective.

DCISionRT combines tumor biology with clinical and pathological factors to estimate recurrence risk and potential radiation benefit. The central point is not simply that the test reduces radiation use. In a 2024 clinical-utility study involving 2,007 women at 63 sites, DCISionRT changed physicians’ radiation recommendations in 38% of cases. Some women initially headed toward radiation were advised to avoid it, while some initially thought unlikely to need radiation were advised to receive it.

Thus, the test can move treatment in either direction. The goal is neither more treatment nor less treatment, but better-directed treatment.

Stengel also highlights MolDX’s central objection. Changing a physician’s recommendation is not necessarily the same as proving that the resulting decision improves patient outcomes. MolDX argues that the evidence has not yet shown convincingly enough that biomarker testing adds value beyond conventional clinicopathologic factors and freely available risk tools.

Her September 10 Substack essay, “Who Decides When the Medical Evidence Is Good Enough?”, goes more deeply into that evidence dispute and its business implications.

Stengel begins with a striking fact from the July 2024 MolDX advisory meeting: six of seven breast surgeons and radiation oncologists believed that sufficient evidence supported biomarker testing to help determine which women with DCIS could forgo radiation. Nonetheless, MolDX subsequently proposed noncoverage.

The Substack article also explores several layers of “proof” that are too often blended together: analytical validity, clinical validity, clinical utility, prediction of radiation benefit, and superiority to existing clinical tools. It discusses MolDX’s concern about analyses using Decision Score thresholds of 3.0 and greater than 2.8, as well as PreludeDx’s response that its reported clinical cutoff did not change.

Most importantly, Stengel identifies the commercial bind created when the evidentiary bar remains uncertain. Evidence affects reimbursement; reimbursement affects adoption; adoption affects further evidence generation; and all three affect financing. PreludeDx says it submitted its MolDX technical assessment in 2020. Six years later, the coverage question remains unresolved.

Forche: Why Another Advisory Panel?

On September 21, PreludeDx President and CEO Dan Forche highlighted Stengel’s reporting in a LinkedIn post.

Forche focuses on the disconnect between the July 2024 advisory panel and the subsequent draft LCD. If six of seven physician experts found the evidence sufficient, he asks, why was that strong consensus not reflected in the proposed policy? And why is MolDX convening a second CAC?

The LinkedIn post does not introduce a new clinical study. Rather, it sharpens the procedural and governance questions raised by the two Stengel articles. Who decides what evidence is sufficient? How transparent is the standard? And can a diagnostic developer know the standard early enough to design the studies that will eventually be demanded?

The Next Date to Watch

The next major event is the October 13 CAC meeting.

A second advisory panel does not guarantee that MolDX will reverse the proposed noncoverage policy. Nor does a favorable expert vote bind the contractors. But reconvening a CAC after the draft LCD, public comments, new publications, and the earlier 6–1 vote is plainly significant.

The dispute is no longer about whether DCISionRT has evidence. It clearly does. The dispute is about what kind of evidence MolDX will accept, how much incremental value must be demonstrated over conventional tools, and whether the evidentiary finish line has been defined clearly enough for innovators, physicians, patients—and investors—to see it.

# # #

SIDEBAR:
Advocates Dive Deeper Into the World of Evidence Appraisal

The new advocacy does something unusual: it ventures well beyond familiar arguments about patient access, innovation, and the harms of noncoverage. The Stengel essays and Forche’s response engage directly with the machinery of scientific evidence appraisal.

The dispute is not simply whether DCISionRT has published evidence. It plainly does. The harder questions are how different forms of evidence should be assessed and weighted. How much weight belongs on clinical validity, treatment-decision impact, prediction of radiation benefit, and long-term patient outcomes? Must a test merely add useful biological information, or must it demonstrate superiority to every available clinicopathologic model? How should retrospective analyses of randomized trial specimens be valued? And when an analysis performs differently at cutoffs of 3.0 and 2.8, is that evidence of a moving threshold—or a legitimate effort to understand where predictive information is strongest?

These are questions of scientific judgment, not simple boxes that can be checked mechanically.

The essays also expose the distinction between evidence appraisal and coverage policy. MolDX can reasonably acknowledge that a test is informative while concluding that it has not demonstrated enough incremental value to merit Medicare payment. Conversely, physicians may reasonably believe that evidence capable of changing treatment in both directions has substantial clinical utility, even before a new prospective randomized trial reports long-term outcomes.

Ultimately, “sufficient evidence” is not a self-defining scientific fact. It is a policy judgment produced by selecting endpoints, ranking study designs, weighing uncertainty, choosing comparators, and deciding how much residual risk Medicare will tolerate.

That is why the 6–1 vote at the 2024 advisory panel matters. It does not dictate the correct coverage decision, but it demonstrates that experienced clinicians can examine the evidence and reach a markedly different judgment from MolDX. The question for October 13 is therefore not merely whether more evidence exists. It is how MolDX will weight the evidence already in hand—and whether it can explain clearly where the threshold for “good enough” actually lies.  

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.

Watchdog Releases Documentation of WISER Prior Auth Problems; How to Upgrade FOIA to Lawsuit

The watchdog EFF Electronic Frontier Foundation has released 1000 pages of CMS documents, which in part lay out problems with launcher WiSER, Medicare's attempt to bring Ai and Prior Auth together into the rickety fee for service claims processing system.

There are a number of open access news stories, and you can link directly to the "treasure trove" of FOIA documents.  One tip - they didn't just file a plain-jane FOIA request, they got a first-class upgrade into a FOIA lawsuit.

• Here's a long September 6 blog at EFF itself - here.
• Here's what appears to be an EFF home page for the FOIA project - here.
• Here's news at STAT - here.
• Open access news at Fierce Healthcare here.

##

One often hears FOIA requests takes years; EFF filed a legal complaint with a judge in late March (10pp) here.  I asked Chat GPT how the 10 page legal complaint differs from a "normal" FOIA request.

Very Brief Blog: CMS Updates NCD Wait List

CMS has provided a September 2026 update of its "wait list" for future NCDs.   CMS also flags recently completed NCDs.

Find it here:

https://www.cms.gov/files/document/ncddashboard.pdf

Genomeweb: Alarm Over CMS Rule on Lab Algorithms

 

See a subscription article at Genomeweb about "algorithm only testts." By Adam Bonislawski, 9/11/26, here:

https://www.genomeweb.com/business-news/reimbursement/gnw-cms-acla-ai-reimbursement-20260910/

I covered the comments of the top organizations in a September 2 blog:

https://www.discoveriesinhealthpolicy.com/2026/09/opps-rule-ditching-digital-pathology.html

##

##

Genomeweb cites public comments (as did my blog) as wel as a Nex Gen Summit panel in DC in late August.

I don't want to squeeze their copyright but a mini summary of Genomeweb is here, encouraging you to see the original:

• CMS proposes moving “algorithm-only” laboratory tests from the CLFS into a new Software as a Medical Service category paid under OPPS. Clinical labs warn the shift could bring 20% patient coinsurance, budget-neutral payment pressure, billing complications, and removal from CLIA oversight. 
• Industry groups argue these services remain part of the diagnostic laboratory process and suggest CMS modernize CLIA rather than separate software analysis from laboratory testing.

The first comment deadline (OPPS) is past but the PFS comments go to 9/14.   

Do Current Fraud Press Releases Flag the Pending CRUSH Regulation?

 Last winter, CMS introduced the CRUSH anti-fraud program, with an RFI in the Federal Register.  Since August 2026, that has matured to a proposed regulation that is percolating in review at OMB/WH.   But we just saw a flurry of CRUSH-CRIME press releases from CMS.   Do those press releases flag themes we'll be reading soon in CRUSH?   Let's look into it.

UPDATE:

This blog focuses on two CMS press releases about DME and LAB fraud, that HHS can use as fuel for its campaign to push through new CRUSH legal authorities.

Let's add an OIG report about bad goings-on in the DME world, HHS will also use this August 2026 OIG report (23pp) as additional fuel for the CRUSH fire, when the proposed regulations are released.

https://oig.hhs.gov/reports/all/2026/the-nations-challenge-to-combat-durable-medical-equipment-fraud-in-medicare/

Here's a Linked In article on the CMS Lab payment walls - here.

##

AI CORNER
##

Reading CRUSH Before It Arrives: What CMS’s Recent Fraud Announcements May Signal—and Why Legitimate Molecular Laboratories Should Care

CMS’s proposed Comprehensive Regulations to Uncover Suspicious Healthcare (CRUSH) rule remains under review at the Office of Management and Budget. CMS transmitted the proposed rule on August 7; OIRA lists it as a proposed rule, with no statutory deadline and without an “economically significant” designation. (RegInfo)

The Evergreen HHS Press Release: Recyling Rural Health Investment News

Header: In July 2025, Congress passed a huge tax bill that included $billions in spending for rural health, especially rural health technology.   We show how HHS keeps the "news" surprisingly evergreen, including a flood of recent press releases.

###

 

The Evergreen Press Release:
How One Rural Health Appropriation Keeps Becoming New News

The money is real. The projects are real. But many of the “new” investments trace back to one congressional appropriation enacted more than a year ago.

Anyone following CMS press releases in late August and early September 2026 may have noticed an unusual rhythm.

The Trump Administration announces $149.3 million for rural health in Arkansas. Then $58 million for Hawaii. Then $120 million for Indiana. Then $76 million for New York. Michigan gets $25 million for technology, telehealth and broadband. West Virginia gets another announcement for $4.8 million.

The announcements are coming fast enough to resemble a campaign itinerary conducted by press release.

There is nothing fictitious about the projects. Ambulances really may be purchased. Rural hospitals really may install better technology. Telehealth networks, workforce programs, maternal health initiatives and remote patient monitoring really may expand.

But there is an important piece of context: much of this money was not newly created when these press releases appeared.

It might be called press-release evergreening.

AMA CPT Asks Weird Social Equity Questions; RFK Jr Goes on Attack

It's no secret that AMA CPT applications are full of now-sounds-dated language about whether an applicant's CPT code "perpetuates social bias" (? structural racism) and (even worse) "propagates" it.  (No, sir, I'm just measuring potassium).   

Now RFK Jr has launched a direct attack on AMA CPT as a "Monopoly" which favors "special interests" and he asks the American Public to comment to his RFI by September 14.  Transcript below.

Find the three-minute  HHS video here:

https://www.youtube.com/watch?v=Gam-7T9KnV8

Find coverage at Medical Economics here:

https://www.medicaleconomics.com/view/kennedy-asks-the-public-to-weigh-in-on-the-ama-s-control-of-cpt-codes-by-sept-14 

Here's a transcript:

Hi, I'm Robert F. Kennedy, Jr., your HHS secretary.

Every time that you receive a medical bill, you pay for more than your care. You also pay for a billing system that most Americans have never heard of. Today, we're taking the first step toward changing that.

The Trump administration has launched a formal request for information on the future of medical coding and billing. We want to hear from patients, doctors, nurses, hospitals, the innovators, and every American who believes that healthcare should serve patients, and not special interests.

Here's the problem. Every time your doctor bills your insurance company, or a federal program like Medicare or Medicaid, that claim includes medical billing codes called Current Procedural Terminology, or CPT codes. These CPT codes identify the tests, the procedures, the evaluations, and services that you receive.

CPT codes are owned exclusively by the American Medical Association, the AMA. Despite its name, only about 20 percent of America's physicians belong to the AMA. Decades ago, Congress gave the AMA a de facto monopoly over these codes to help manage our national healthcare billing system.

Today, the AMA licenses those codes and collects hundreds of millions of dollars in royalty payments every year from healthcare providers, insurers, and health IT companies that rely upon them. Last year alone, organizations across all of our healthcare systems paid the AMA more than $300 million just to use those CPT codes.

Those costs don't disappear. Healthcare providers, and insurers, and employers pass them on to their patients. Every American pays the price.

• Washington created a system that put special interests ahead of the American people. 
• President Trump is changing all of that. 
• Now we need your help.

Visit the Federal Register, or click the link on this video's caption, and tell us how we can build a simpler, more transparent, and more affordable medical billing system.

We're cutting red tape. We're breaking the grip of special interests. 

And we're putting money back into Americans' pockets.

That's how we make America healthy and affordable again. Thank you.

#

#

See a long form essay by Chat GPT here.

#

#

Sidebar:  Regarding the lawsuits and RFIs against AMA - RFK Jr may not be going anywhere.  It's entirely possible we'll have another Republican administration - imagine a national playoff between VP Vance and AOC - and RFK Jr could stay on as HHS leader.   He comments carry a lot of weight and attention as Secretary of Health - he knows that.  And he can probably manage his personal workstyle and workload enough to run into a second term without burnout.

You Better Learn the Biggest Myth About Payor Coverage of Diagnostics

 

"The Coverage Myth in Diagnostics"

In an interview, I was asked, "What's the biggest myth you hear repeated?'  

That led to the (AI assisted) essay below.  

For representative entry points, here, here, here, here.  Traditional view of "the payer mind" here and here (both POC).  ADVI, on need for integrated reimbursement planning here. 

So I maintain that the rare case is:

A specialty lab meets with a payor, and, the payor listens carefully, and the lab "wins" unexpected coverage for that one test, for that one payor. 

I'd say: it's a myth, don't hold your breath for that day.  \

But of course, there are exceptions.  For example, UHC comes out early for doverage of Guardant Shield here.   Anthem just opened up coverage for Tau 217 ... here. (Note, this carried along the C2N multi-test including Tau 217, but Anthem woulda covered 217 alone.)

+++++++

The Biggest Single Coverage Myth in Diagnostics

There is a comforting myth in diagnostics reimbursement: that coverage is a rational contest, occuring in real time, conducted by serious people, in which the best evidence wins. 

In this myth, the startup starts by publishing several good papers, then it writes a strong PowerPoint deck, and secures a payer medical-director meeting.  The startup brings along one or two respected KOLs, and the payer (who asked several thoughtful questions during the PowerPoint) thoughtfully concludes that the test is clinically valuable and should be covered.

That world may exist in every pitch deck. It rarely exists in real reimbursement.

The reality is far more institutional, slower, and far less responsive to scientific persuasion than investors want to believe. 

In molecular diagnostics, the practical route to coverage usually requires one of two things: either the lab benefit manager decides to approve the test, or major clinical guidelines make the test effectively required. Both pathways are very slow. Both are opaque. Neither is well suited to a startup running on a finite cash runway.

The problem is not that evidence does not matter. Evidence matters a great deal. But evidence is not self-executing. A publication does not automatically become a policy. A favorable KOL quote does not become a claims edit. A well-designed clinical utility study does not force a lab benefit manager, or MolDx, or any MAC, a commercial payer committee, or a guideline panel to move on a venture-backed timeline.

This is where investors often misprice diagnostics. They build reimbursement timelines as if each step takes six months: six months for coding, six months for evidence, six months for payer engagement, six months for coverage. But novelty does not move through the system like a Gantt chart. Novelty gets bogged down. Two or three years is not for the diasaster cases where everything went wrong.   It may be the optimistic scenario. Five years is not unheard of. For some technologies, the system simply times-out again and again.

Examples are everywhere. 

• I saw an improved imaging test for osteoporosis and bone-density screening became tangled in CMS processes for years. 
• National coverage decisions can sit for three, four, or more years. 
• MolDx and other MAC processes, including Noridian, can take years to resolve novel technologies. 
• The automated retinal imaging code 92229 illustrates the same pattern: coding arrived in 2019, publication followed in early 2021, but payment and RVU issues dragged on because software novelty did not fit comfortably into existing physician-fee-schedule machinery. 
• By 2024 - there were 5000 Medicare sales for $200,000 ($40/each).
• The test may be useful, the clinical logic may be strong, and the code may exist — yet the reimbursement system can still stall.

The same warning now applies to computational pathology. For stakeholders in this vibrant new field, AMA CPT appeared to impose what felt like a moratorium on new codes for two years or more. Then, instead of continuing the earlier PLA-code pathway used by some whole-slide imaging and digital pathology tests, CPT shifted new computational pathology services into Category III codes. That may be defensible as coding policy, but from a business-planning perspective it leaves companies in limbo. CMS pricing is still up in the air: will these services be paid on the Clinical Lab Fee Schedule, through physician-fee-schedule RVUs, through contractor pricing, or through some future software-specific payment system? For a startup, that uncertainty is not an academic detail. It can determine whether the product is commercially viable.

The Deeper Lesson

The deeper lesson is that coverage is not merely an evidence review. It is an operating system. It includes coding, payment, benefit-category logic, medical-necessity language, claims edits, utilization management, guideline incorporation, payer committee cycles, lab benefit managers, MAC jurisdictional variation, and sometimes CMS national policy. Any one of those components can delay or defeat a test.

Don't Use "A Fairy Tale" for Planning

This makes the standard market-access fairy tale dangerous. It encourages startups to believe that if they are scientifically right, the system will eventually recognize them in time. But “eventually” is not a business model. A company with $10 million, or even $30 million, may not have enough runway to survive a multi-year reimbursement slog, especially if the product requires continued evidence generation, field sales, KOL cultivation, coding work, payer engagement, and operational claims support.

The most important reimbursement question for a diagnostics investor is therefore not simply, “Is the test good?” It is: “Who has to say yes, through what mechanism, on what timeline, and can the company survive until then?”

In diagnostics, the best test does not always win. The test that wins is the one that becomes operationally unavoidable — through guidelines, through lab benefit manager approval, through entrenched clinical workflow, or through a payer system that finally knows how to pay for it.

___

tagmyth