Nerd Note: How CMS Handles Early OPPS Pricing of the Newest Cat III Codes

 In the previous blog, I noted that CMS provides proposed OPPS/APC prices of Cat III codes that won't be effective for six months...and that don't even have public final code numbers.  (The same blog shows a comment letter from Valar that includes both the placeholder codes and real codes side-by-side).

This is a Chat GPT explanation of how that particular bit of CMS magic works.

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CMS Prices New CPT Category III Codes
Before Their Final Code Numbers Are Public

Yes it does! And CMS explicitly discusses how it handles new CPT Category I and Category III codes that will take effect January 1, 2027 even though their final CPT numbers have not yet been released publicly.

The key discussion is in the CY 2027 OPPS Proposed Rule at 91 Fed. Reg. 41787–41788, Section III.A.4.b, “New CPT Codes Proposed Rule Comment Solicitation.”

CMS explains that it receives the upcoming January CPT codes from the AMA early enough to use them in the OPPS proposed rule:

“For the CY 2027 OPPS update, we received the CPT codes that will be effective January 1, 2027, from the AMA in time [by June 1?] to be included in this proposed rule [with proposed prices].”

However, because the permanent CPT numbers are not yet available for use in the proposed rule, CMS uses five-character AMA/CMS placeholder codes. Thus codes such as X568T, X569T, X614T, X623T, and X624T appear in the proposed OPPS files even though those are not the eventual CPT numbers.

CMS divides the information between two addenda.

Addendum B contains the placeholder code, a short descriptor, the proposed OPPS status indicator, APC assignment, and therefore the proposed payment.

Addendum O contains the placeholder code together with the full long CPT descriptor. CMS specifically explains:

“Therefore, we are including the 5-digit placeholder codes and the long descriptors for the new and revised CY 2027 CPT codes in Addendum O, specifically under the column labeled ‘CY 2027 OPPS/ASC Proposed Rule 5-Digit AMA/CMS Placeholder Code.’”

Nerd note:  Appendix O has nearly 200 codes of different types (Cat III, also CPT Cat I, G-code, etc) that were in some state of partial definition as the rule went to press in June. 

CMS then states that the final HCPCS/CPT code numbers will appear in the CY 2027 OPPS/ASC final rule. Thus CMS is able to propose an APC assignment—and an actual dollar payment—for a new Category III service before the public-facing permanent Category III number has appeared. 91 Fed. Reg. 41787–41788.

CMS's OPPS rule and addenda are available here:

https://www.cms.gov/medicare/payment/prospective-payment-systems/hospital-outpatient/regulations-notices

The Regulations.gov docket for the CY 2027 OPPS proposed rule is:

https://www.regulations.gov/docket/CMS-2026-2344

There is also a parallel discussion for the ASC payment system at 91 Fed. Reg. 41935–41936. There CMS again explains that it has received the January 2027 CPT codes from AMA, uses five-character placeholder codes in the proposed rule, places their complete long descriptors in Addendum O, and will substitute the final CPT numbers in the final rule.

The Valar Codes Provide a Good Example

The Valar comment supplies the subsequent permanent numbers for several of these placeholders:

X568T → 1063T — Vesta Bladder Risk Stratify
X569T → 1064T — Vesta Bladder BCGPredict
X614T → 1097T — Vitara Pancreas ChemoPredict
X623T → 1106T — H&E AI analysis, breast cancer
X624T → 1107T — H&E AI analysis, prostate cancer

Valar also reproduces the full descriptors for its three own codes.

So the somewhat counterintuitive sequence is:

AMA creates and communicates the new CPT code to CMS → CMS publishes it under an Xxxxx placeholder and proposes an APC/payment → AMA's permanent CPT number becomes available → CMS substitutes that final number in the OPPS final rule.

The particularly interesting point for the SaMS discussion is that CMS isn't merely acknowledging these unreleased codes are in play. CMS staff are already making substantive payment-policy decisions about them—including whether an algorithm gets $350.50 or $750.50—while identifying the service publicly only through its temporary AMA/CMS placeholder code.

AMA Releases Cat III Codes; CMS Prices New Digital Pathology Cat III Codes

 A lot of action on the digital pathology front.

#1
AMA RELEASES Dig Path CODES

After the equivalent of a moratorium on new digital pathology codes, AMA began adding some to the Category III code set at February 2026 and May 2026 CPT meetings.   Those codes, while not active until January 2027, were published by AMA CPT on July 10.

Find the AMA home page for Cat III here.  Jump straight to the 17-page PDF of new codes here.

Let's focus on five new digital pathology codes created since the moratorium thawed:

1063T

Oncology (bladder), augmentative algorithmic analysis of histomorphologic features in digitized slides from formalin-fixed paraffin-embedded (FFPE) bladder cancer tissue (high-grade, non-muscle invasive), with clinicopathologic variables entered by the qualified health care professional; algorithm-derived parameters reported as prognostic of recurrence and progression, including hematoxylin and eosin staining of tissue sections, and digitization of glass microscope slides, when performed.

1064T

Excellent Movie May Contain Medicare Policy Error

 I live in Hollywood; I love movies.   I've worked on CMS policy for twenty years; I love CMS policy.

Here's a potential glitch where the two coincide.

One of the top-rate films of the last couple months is TUNER, which covers romance, classical music, and ruthless dangerous criminals in one package. Plus it's set in NYC and contains several scenes in the modern underground 600-seat Zankel Hall (2003).  Starring Leo Woodall, Havana Rose Liu, and Dustin Hoffman. 95% at Rotten Tomatoes.

Dustin Hoffman is a crotchety old guy who got p*ssed off at Medicare and "stopped paying his premiums."  Due to which, he owes $36,000 to the neighborhood hospital.   (The plot requires Hoffman to have a big debt that young Woodall must respond to.)

Glitch?

Medicare Part A doesn't have any premiums, and it pays a huge proportion of hospital costs, so it would be very hard to develop $36,000 in Part A deductibles or copays.

Medicare Part B does have premiums (circa $200/month), and if you stop paying your premiums, your Part B stops and all your doctor bills accumulate.  But those are doctor bills, they wouldn't be a $36,000 hospital fee.  

So, not paying your Part B premium out of crotchety-ness wouldn't give you that $36,000 hospital debt.

An Angle?

Possibly he had $36000 of Part B hospital outpatient services (PET scans, knee surgeries) at the hospital.  Or an overnight observation (Part B) not considered an inpatient admission (Part A).

Or, see my recent experience where a $400 Medicare MRI started as a $15,000 charge (!) to me and Medicare from the hospital.  Just two of those MRI's - if charged at uninsured person rates rather than published Medicare rates - would put you into the $36,000 range.

  

Two Articles by Lennerz: (1) Fixing European IVD Regs, (2) Flexible & Agile Regulation

 One of the most reliably interesting voices on Linked In is Joe Lennerz, successively of Harvard, Boston Gene, and now Natera.  Find his home page here, his Linked In postings here.

In the last few days he's co-authored several important publications.   Kahles et al. appears in Health Policy & Technology, covers major problems arising from recent changes to IVR regulations in Europe.  Find it here.   

Pair that with Schneider et al., Npj Digital Medicine, wit the title, "Can Laws Be Flexible? Rethinking Legislation for Innovation."  Released July 22, find it here.

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AI Corner

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Two 2026 Papers on Making Diagnostics Regulation More Adaptable

Schneider et al., “Can Laws Be Flexible? Rethinking Legislation for Innovation.” This broad conceptual paper asks how legislation can remain stable and democratically legitimate while responding more intelligently to rapid technological change. The authors borrow the idea of “agility” from software development—not to advocate quick-and-loose lawmaking, but to build feedback, evidence collection, periodic review, and predefined opportunities for revision into the regulatory lifecycle. They distinguish relatively permanent normative commitments, such as fundamental rights and accountability, from technical specifications and implementation rules that may appropriately change as evidence accumulates. Their illustrations include Germany’s staged introduction of digital-health legislation, adaptive mechanisms within the EU AI Act, and the five-year congressional reauthorization cycles for FDA drug and device user fees. 

The important insight is that agile legislation is not one unusually flexible statute; it is a coordinated governance system involving legislation, delegated rulemaking, standards, guidance, enforcement, and judicial review. The authors are also alert to the danger of technocracy: elected bodies must continue to establish goals and boundaries, while expert institutions generate evidence and make only bounded, reviewable adjustments.

Kahles et al., “Reforming IVDR Article 5(5).” This shorter commentary applies much the same philosophy to a highly specific and immediate problem: the European IVDR requirements governing in-house laboratory tests. The authors argue that the European Commission’s proposed reform should be understood as regulatory recalibration, not deregulation. 

Most importantly, laboratories would no longer have to prove that no equivalent commercial CE-marked test is available before using an in-house IVD. The proposal would also permit limited transfers between health institutions for compelling public-health or patient-care reasons, reduce documentation requirements for laboratories accredited under ISO 15189, and extend the in-house exemption to certain central laboratories producing tests exclusively for clinical trials. Yet core obligations—quality management, safety and performance requirements, transparency, traceability, inspection, and incident oversight—would remain. 

The paper’s caution is that shifting responsibility from premarket gatekeeping to institutional quality systems may work unevenly, particularly for high-risk, software-intensive, or algorithmic diagnostics. Success will depend on consistent interpretation, adequate inspection capacity, and careful policing of the boundary between clinical-trial testing and routine clinical use.

Common themes and insights. Both papers include Jochen K. (“Joe”) Lennerz, identified with Natera, and they share a recognizable regulatory philosophy. Regulation should not depend exclusively on a large, static barrier erected before a technology is used. Instead, safety can be protected through a lifecycle model combining qualified institutions, explicit accountability, real-world evidence, post-market monitoring, periodic reassessment, and bounded authority to adjust technical requirements. 

In the broader paper, this becomes a general theory of “agile legislation”; in the IVDR paper, it becomes a concrete proposal to replace an overly rigid test-by-test restriction with accreditation, quality systems, traceability, and continuing oversight. 

Neither article argues that innovation should escape regulation. Their stronger and more useful claim is that regulation should be designed to learn: preserve stable principles, permit controlled implementation, observe what happens, and revise the operational rules when experience shows that the original framework is unnecessarily burdensome, ineffective, or technologically obsolete. Lennerz’s corporate affiliation supplies a diagnostics-industry connection, but both articles frame their arguments principally around institutional design, patient safety, access, and the sustainability of diagnostic innovation.

Citations

Schneider NK, Stern AD, Price WN II, Lennerz JK. Can laws be flexible? Rethinking legislation for innovation. npj Digital Medicine. 2026;9:566. doi:10.1038/s41746-026-02846-5.
https://doi.org/10.1038/s41746-026-02846-5

Kahles A, Lennerz JK, Schirmacher P, Stenzinger A. Reforming IVDR Article 5(5): Will the European Commission’s proposal reduce regulatory burden for in-house IVDs? Health Policy and Technology. 2026;15:101284. doi:10.1016/j.hlpt.2026.101284.
https://doi.org/10.1016/j.hlpt.2026.101284

WSJ Opinion Piece: "Trump's Plan to Reform the AMA"

On July 14, the Washington Post had a scoop as the physician payment rule was released: it would contain an abrasive RFI going after AMA for its payment institutions, the CPT and the RUC.  (Here, here.)

The WSJ had to take a time-out, but today we get a viewpoint (in WSJ) on Trump/RFK/AMA, and written by Kurt Miceli as an opinion piece.  Dr . Miceli is chief medical officer at the organization, "Do No Harm."  Which is, fighting "the disastrous consequences of identity politics."

https://www.wsj.com/opinion/trump-lucks-into-a-plan-to-reform-the-ama-300d7b0e

Here's what Chat GPT made of it:

Do No Harm is a physician-led advocacy organization that opposes DEI initiatives and certain gender-related policies in medicine. It operates primarily through public commentary, research reports, litigation, and policy advocacy. Dr. Kurt Miceli, its chief medical officer, is trained in internal medicine and psychiatry. (Do No Harm)

In his Wall Street Journal op-ed, Miceli combines criticism of the AMA’s policy positions with a structural argument about its role in medical coding. The AMA receives substantial licensing revenue and institutional influence from CPT, while the RUC gives organized medicine an important role in physician-payment recommendations. Miceli argues that this position makes the AMA less dependent on physician membership and therefore less accountable to the views of practicing doctors.

His implied theory is that reducing the government’s reliance on CPT or the RUC would diminish the AMA’s revenue and influence, forcing it to rely more heavily on membership support. Because he believes practicing physicians are generally more conservative than the AMA’s leadership on DEI and gender policy, he expects greater member dependence to moderate the organization’s positions.

That outcome is not automatic: changing CPT or RUC arrangements would directly affect coding, payment policy, revenue, and the size (budget) of AMA, but any resulting change in the AMA’s political orientation would be indirect and uncertain.

BQ: I would argue, contra Miceli, that some white papers somewhere on the AMA website about DEI or an Op Ed on the same in JAMA -- don't necessarily affect the national dialog on DEI very much, or even effect the AMA itself, that much.  AMA will still oppose expansion of N.P. capabilities, oppose reducing physician work via AI, insist urgently on raising RVU dollar rates, and so on.    

I would also argue it's less "Trump" (in Miceli's WSJ headline) but RFK Jr who tracks this.

See Peter Sweson's 2021 book, Disorder: A history of reform, reaction, and money in American medicine; about decades of left-wing and right-wing swings at AMA.

in 2021, I wrote about AMA's report on the burden on AMA of too many white men - here.

In 2021, I relayed news about a JAMA issue on DEi that was quickly criticized for not having BIPOS authors - here.

In 2020, TMI?  You couldn't apply for a small genomic payment (pricing) group, without submitting documentation explaining your (or the candidate's) gender psychology and racial background.  Here.

BTW - Chat GPT identified articles on my blog on [AMA+DEI] faster and better than I could.  

Very Brief Blog: Hospital Charges In Real Life: $15,417 for $446

 I had an MRI in June at a nearby hospital outpatient center.  

When I log onto Medicare.gov/my/claims, I see the MRI code the hospital charged against, and the charge; $15,417.

Medicare allowed $446.50, and Medicare Part B paid 80%, leaving $89.30 to my BCBS Medigap plan.  (Separate paperwork from them shows they paid the $89.30; I owed $0.)

So the hospital charge-to-fee schedule ratio was about 30X.

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The grammar is a little confusing.  The hospital charged $15417, and the top part of the form says Medicare approved "$15417."  However, further down, the actual payment appears, which is "Total Medicare paid the facility was $350.07" (80% of allowed.)  

Medicare shows a remaining copay of $89.30 while BCBS paperwork shows $89.30 paid (but nothing about the total amounts). 

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In round numbers, my traditional fee-for-service Medicare costs about $200 a month for Part B and another $200 a month for BCBS Medigap—roughly $4,800 a year. Apart from the annual Part B deductible, there is generally little or nothing more to pay during the year.

A Medicare Advantage plan does not eliminate the Part B premium, but it generally eliminates my $200-a-month Medigap premium, potentially saving about $2,400 a year. It may also throw in modest extras, such as a $50 eye exam and $100 toward glasses.

Less visibly, however, Medicare Advantage can bring a festival of copays throughout the year—for specialists, imaging, outpatient procedures, emergency care, hospital stays, rehabilitation, and other services. In 2026, plans may expose members to as much as $9,250 for in-network medical care, or $13,900 in combined in- and out-of-network spending under a PPO. Few members will experience such a train wreck. But by December, an MA member’s accumulated copays can easily consume much—or all—of the $2,400 initially “saved” by giving up Medigap.  One M.A. copay average was quoted at $1400/year.

 

 

How I Use AI: What Percent of CRC Stool-test Orders Get Done? What Percent of Positives Get Colonoscopy?

Header:  Chat GPT rapidly answers general medical questions, here, slippage in colon cancer screening.

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We had a screening colonoscopy in the family recently and I wondered:

1) Of stool tests ordered, what percent get completed (e.g. mailed back)?

2) Of positive stool tests, what percent get the indicated colonoscopy?

Below is the direct output from Chat GPT.  I'm not taking it as gospel truth, nor have I fact-checked it.  However, it's probably directonally correct (or better) and there aren't perfect or absolute answers, anyway.  

It's pretty good for, "almost free" and "takes a few seconds."

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Completion of Stool-Based Colorectal Cancer Screening

How often is an ordered stool test completed?

FIT, United States. FIT completion varies substantially because an “order” may involve anything from handing a kit to the patient to mailing it with reminders and navigation. A reasonable practical estimate is that approximately 35%–50% of ordered or mailed FIT kits are returned in ordinary US outreach programs. In a pragmatic federally qualified health-center program, approximately 46% of ordered FITs were completed in the first year and 41% in the second. Prior behavior strongly predicted adherence: previous completers were much more likely to complete subsequent testing than previous noncompleters (Nielson et al., 2019). Programs with minimal follow-up may achieve only about 20%–35%, whereas organized mailing, reminders, and navigation can raise completion above 50%.

Cologuard/mt-sDNA, United States. Completion of an ordered Cologuard test is generally reported at about 70% within one year. Among 368,494 Medicare beneficiaries with a valid order, 44% completed the test within 30 days, 65% within 60 days, and 71% within one year (Weiser et al., 2021). A later national analysis of approximately 1.56 million first-time users similarly reported 71.3% overall completion, although completion among Medicaid beneficiaries was only 52.0% (Le et al., 2025). These findings are consistent with the likelihood that Exact Sciences’ centralized fulfillment, patient reminders, customer assistance, and tracking infrastructure improve completion relative to low-cost FIT programs. However, these are observational studies, often using Exact Sciences laboratory data, and they do not isolate the independent effect of the company’s outreach system.

Outside the United States. Organized national and regional FIT programs usually measure participation among everyone invited rather than among patients receiving a physician order. Across European programs, average FIT participation was approximately 49.5%, with a wide range of roughly 23%–71% (Senore et al., 2019). Thus, even an organized population program typically reaches only about half of eligible invitees, although the strongest programs approach 70%.

Test and setting	Approximate completion
US FIT, ordinary ordered or mailed programs	35%–50%
US FIT, low-touch or disadvantaged settings	20%–35%
US FIT, intensive organized outreach	50%–60% or higher
US Cologuard, insured populations	About 70%
US Cologuard, Medicaid	About 50%
European organized FIT invitation	About 50% average; approximately 23%–71% range

Colonoscopy After a Positive Stool Test

United States, stool tests combined. In a large study involving nearly 33,000 patients with a positive FIT, guaiac FOBT, or mt-sDNA result across 39 US healthcare organizations, 51.4% underwent colonoscopy within six months and 56.1% within one year (Mohl et al., 2023). The relatively small increase between six and twelve months suggests that the problem is not merely delayed scheduling; many patients with positive stool tests never complete the recommended diagnostic colonoscopy.

Positive Cologuard versus positive FIT. Some US studies have reported substantially higher colonoscopy follow-up after positive mt-sDNA than after positive FIT or FOBT. In one integrated-system analysis, six-month colonoscopy completion was 84.9% after positive mt-sDNA versus 42.6% after positive FIT/FOBT (Finney Rutten et al., 2020). This comparison should be interpreted cautiously because the positive mt-sDNA and FIT groups were small and unequal, and selection, insurance, clinician behavior, and manufacturer-supported communication may have contributed to the difference. Nonetheless, the findings are consistent with the hypothesis that a centralized, trackable Cologuard system produces more persistent follow-up than decentralized FIT testing.

Outside the United States. Organized FIT programs generally achieve better follow-up. An international survey of 35 screening programs found a mean 79% colonoscopy completion rate within six months, although performance varied considerably among programs (Selby et al., 2021). European screening programs have reported average compliance with colonoscopy referral of approximately 81%, with program-level rates ranging from about 64% to 92% (Senore et al., 2019).

A large Italian organized-program study included 111,423 people with positive FIT results; approximately 79% completed colonoscopy. Patients who did not undergo colonoscopy subsequently had about twice the risk of colorectal-cancer death as those who completed the diagnostic examination, although the comparison was observational and residual differences between compliers and noncompliers may remain (Zorzi et al., 2022).

Setting after positive stool test	Colonoscopy completion
United States, stool tests combined	51% by 6 months; 56% by 12 months
United States, positive FIT in routine settings	Approximately 40%–55%
United States, positive Cologuard in selected studies	Approximately 70%–85%
Organized international FIT programs	Approximately 79%–81%
Highest-performing European programs	Approximately 90% or higher

Overall Interpretation

The literature identifies two major points of attrition. First, only about four in ten to one-half of US patients complete an ordinary FIT order, whereas approximately seven in ten complete an ordered Cologuard test. The difference likely reflects not only the test itself but also Exact Sciences’ centralized logistics, reminders, patient support, and ability to track an unreturned kit. 

Second, after a positive stool test, only about half of US patients receive colonoscopy within six to twelve months, compared with roughly four-fifths in organized non-US programs. Positive Cologuard results appear to receive better follow-up than positive FIT results in some studies, but the magnitude of that advantage remains uncertain because the available comparisons are observational and frequently involve manufacturer-generated data.

References

Nielson CM, Vollmer WM, Petrik AF, et al. Factors affecting adherence in a pragmatic trial of annual fecal immunochemical testing for colorectal cancer. Journal of General Internal Medicine. 2019;34:978–985. doi:10.1007/s11606-018-4820-0.

Weiser E, Parks PD, Swartz RK, et al. Cross-sectional adherence with the multi-target stool DNA test for colorectal cancer screening: real-world data from a large cohort of older adults. Journal of Medical Screening. 2021;28:18–24. doi:10.1177/0969141320903756.

Le QA, Greene M, Gohil S, et al. Adherence to multi-target stool DNA testing for colorectal cancer screening in the United States. International Journal of Colorectal Disease. 2025;40:16. doi:10.1007/s00384-025-04805-0.

Mohl JT, Ciemins EL, Miller-Wilson LA, et al. Rates of follow-up colonoscopy after a positive stool-based screening test result for colorectal cancer among health care organizations in the US, 2017–2020. JAMA Network Open. 2023;6:e2251384. doi:10.1001/jamanetworkopen.2022.51384.

Finney Rutten LJ, Jacobson DJ, Jenkins GD, et al. Colorectal cancer screening completion: an examination of differences by screening modality. Preventive Medicine Reports. 2020;20:101202. doi:10.1016/j.pmedr.2020.101202.

Selby K, Senore C, Wong MCS, et al. Interventions to ensure follow-up of positive fecal immunochemical tests: an international survey of screening programs. Journal of Medical Screening. 2021;28:51–53. doi:10.1177/0969141320904977.

Senore C, Basu P, Anttila A, et al. Performance of colorectal cancer screening in the European Union member states: data from the second European screening report. Gut. 2019;68:1232–1244. doi:10.1136/gutjnl-2018-317293.

Zorzi M, Battagello J, Selby K, et al. Non-compliance with colonoscopy after a positive faecal immunochemical test doubles the risk of dying from colorectal cancer. Gut. 2022;71:561–567. doi:10.1136/gutjnl-2020-322192.

More CMS Legal Cases: LCD Challenges

 Header: A dissatisfied beneficiary can appeal his denied claim, OR, challenge the offending NCD or LCD as a whole. Let's see what's current on the CMS website.

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AI CORNER

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Medicare beneficiaries may challenge an LCD as unreasonable under 42 C.F.R. Part 426, but the process is obscure and procedurally demanding.

Fifteen recent DAB cases show an active yet largely unsuccessful docket: all were dismissed, eleven for threshold or jurisdictional defects, three after withdrawal, and one after the contractor revised its policy and effectively resolved the dispute. Common failures included unclear standing, failure to identify the precise LCD provision, missing physician documentation, and inadequate scientific evidence.

The cases reveal a mismatch between beneficiary-only standing and the sophisticated evidentiary burden required. NCD challenges remain legally available but appear dormant since 2014.

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The Hidden Docket: Medicare LCD Challenges Are Alive—but Rarely Reach the Merits

Medicare beneficiaries have a little-known statutory right to challenge the validity of a Local Coverage Determination, or LCD. These cases still occur: the Departmental Appeals Board published 12 LCD-related decisions in 2024, six in 2025, and two through June 3, 2026. But they are buried in annual lists containing hundreds of unrelated HHS administrative decisions, and most end before the scientific merits are reached. (HHS.gov)

What is an LCD challenge?

An LCD challenge under 42 C.F.R. Part 426 asks whether a Medicare Administrative Contractor’s coverage policy is itself unreasonable. It is not the same as an ordinary claim appeal arguing that a contractor incorrectly applied an LCD to a particular patient.

The distinction matters:

• Claim appeal: “My service should have been covered under the existing rules.” This proceeds through redetermination, reconsideration, OMHA, and potentially the Medicare Appeals Council.

• LCD challenge: “The coverage restriction in the LCD is unreasonable.” This is heard initially by an administrative law judge in the HHS Departmental Appeals Board’s Civil Remedies Division.

Only an “aggrieved party”—generally a Medicare beneficiary who needs or received the service and whose coverage is affected by the LCD—may initiate the challenge. A laboratory, manufacturer, physician society, or other commercial organization cannot ordinarily challenge the LCD in its own name. (eCFR)

The complaint must identify the LCD and exact provision challenged, establish beneficiary standing and timeliness, include relevant treating-physician documentation, explain why the policy is unreasonable, and provide supporting clinical or scientific evidence. The ALJ ordinarily gives the complainant one opportunity to correct an unacceptable filing. Failure to cure the deficiencies produces dismissal and generally a six-month bar on refiling. (eCFR)

How to find the cases

There is no polished “LCD challenge database.” The practical route is:

1. Open the HHS Departmental Appeals Board’s Administrative Law Judge Decisions page.

2. Select a year.

3. Search the page for “LCD Complaint.”

4. Search separately among DAB Board decisions for appeals using “LCD Complaint,” the LCD number, the CR decision number, or “Part 426.”

General DAB ALJ decisions page:

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/index.html

2026 decisions:

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2026/index.html

2025 decisions:

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/index.html

2024 decisions:

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/index.html

DAB Board decisions, including appeals from LCD rulings:

https://www.hhs.gov/about/agencies/dab/decisions/board-decisions/index.html

An appeal from an LCD ALJ decision goes to the DAB Appellate Division, not to the Medicare Appeals Council. The Appeals Council reviews ordinary Medicare claim appeals; the DAB Board reviews Part 426 LCD proceedings. (HHS.gov)

Fifteen Recent LCD Challenges

The following are 15 representative published decisions from February 2024 through June 2026.

1. Gastrointestinal Pathogen Multiplex Panels

Case: In re LCD Complaint: Gastrointestinal Pathogen (GIP) Panels Utilizing Multiplex Nucleic Acid Amplification Techniques (NAATs) (L38229)
Docket: C-26-432
Decision: DAB CR6894
Date: May 13, 2026

Novitas had denied CPT 87507. The beneficiary’s underlying argument was that the LCD had been incorrectly applied to his individual claim, rather than that the LCD provision itself was unreasonable. The ALJ found no jurisdiction over that question and also concluded that the amended complaint lacked the required scientific and clinical support for an LCD challenge. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2026/alj-cr6894/index.html

2. Vitamin D Assay Testing

Case: In re CMS LCD Complaint: Vitamin D Assay Testing
Docket: C-26-368
Decision: DAB CR6909
Date: June 3, 2026

The filing did not adequately establish the complainant’s aggrieved-party status, timeliness, the exact LCD and provision challenged, or the clinical and scientific basis for alleging unreasonableness. The complainant did not respond to the ALJ’s order permitting an amended complaint, and the matter was dismissed. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2026/alj-cr6909/index.html

3. Immune Globulin for Autoimmune Encephalopathy

Case: In re LCD Complaint: Immune Globulins (L34771)
Docket: C-24-215
Decision: DAB CR6782
Date: October 17, 2025

A beneficiary with Hashimoto’s encephalopathy challenged restrictions affecting IVIG coverage. During the proceeding, WPS revised its billing article to add diagnostic codes permitting coverage for autoimmune encephalitis and encephalopathy when documentation requirements were met. The case was formally dismissed, but the contractor’s revision appears to have supplied the practical coverage relief being sought. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6782/index.html

4. Magnesium Testing

Case: In re LCD Complaint: Magnesium (L39400)
Docket: C-25-746
Decision: DAB CR6746
Date: August 11, 2025

The original complaint did not satisfy Part 426’s acceptability requirements. The complainant was offered an opportunity to amend but did not submit a corrected complaint by the deadline, requiring dismissal. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6746/index.html

5. Routine Foot Care and Mycotic Nail Debridement

Case: In re LCD Complaint: Routine Foot Care (L35138) and Debridement of Mycotic Nails (L35013)
Docket: C-25-299
Decision: DAB CR6639
Date: March 13, 2025

The beneficiary sought to reduce the required interval between covered nail-debridement services from nine weeks to six weeks. Although she supplied a podiatrist’s statement, she did not provide qualifying scientific or clinical evidence explaining why the LCD’s interval was unreasonable; a private insurer’s policy was insufficient. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6639/index.html

6. Cataract Surgery and Postoperative Toric Lenses

Case: In re LCD Complaint: Cataract Surgery in Adults (L34203)
Docket: C-24-769
Decision: DAB CR6608
Date: January 22, 2025

The complaint concerned payment for toric contact lenses reportedly needed following cataract surgery. The filing lacked several required elements and supporting evidence, and no amended complaint was submitted after the ALJ identified the deficiencies. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6608/index.html

7. B-Type Natriuretic Peptide Testing

Case: In re LCD Complaint: B-Type Natriuretic Peptide (BNP) (L33573)
Docket: C-25-91
Decision: DAB CR6606
Date: January 16, 2025

The beneficiary adequately demonstrated standing and timeliness, but the complaint did not clearly identify the challenged LCD provision, articulate why it was unreasonable, or supply supporting clinical evidence. No amended complaint followed, and the matter was dismissed. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2025/alj-cr6606/index.html

8. Cologuard Screening

Case: In re LCD Complaint: Cologuard Screening
Docket: C-25-20
Decision: DAB CR6583
Date: December 5, 2024

A nurse practitioner argued that Cologuard was medically necessary for a particular patient. The ALJ explained that beneficiary-specific medical necessity ordinarily belongs in the claim-appeal system; an LCD challenge instead requires identification of an unreasonable policy provision, appropriate authorization, proof of timeliness, physician documentation, and supporting scientific evidence. None was supplied in an acceptable amended complaint. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6583/index.html

9. Hyaluronic Acid Injections for Knee Osteoarthritis

Case: In re LCD Complaint: Hyaluronic Acid Injections for Knee Osteoarthritis
Docket: C-25-44
Decision: DAB CR6580
Date: December 3, 2024

After the ALJ found the initial complaint unacceptable and allowed amendment, the complainant withdrew the challenge. Part 426 required dismissal; a dismissal following withdrawal generally cannot be appealed and prevents refiling for six months. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6580/index.html

10. Trigger-Point Injections

Case: In re LCD Complaint: Trigger Point Injections (L34211)
Docket: C-24-458
Decision: DAB CR6512
Date: July 25, 2024

The beneficiary corrected certain physician-signature and timeliness defects but still did not identify the precise LCD provision alleged to be unreasonable or provide scientific evidence explaining why it should be invalidated. The amended filing therefore remained unacceptable. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6512/index.html

11. Surgical Treatment of Nails

Case: In re LCD Complaint: Surgical Treatment of Nails (L34887)
Docket: C-24-427
Decision: DAB CR6491
Date: June 17, 2024

The filing expressed concerns about nail-avulsion procedures but did not identify a qualifying aggrieved Medicare beneficiary, demonstrate timeliness, or satisfy the substantive complaint requirements. No acceptable amended complaint was presented. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6491/index.html

12. Pressure-Reducing Support Surfaces

Case: In re LCD Complaint: Pressure Reducing Support Surfaces—Group 1 (L33830)
Docket: C-24-371
Decision: DAB CR6463
Date: April 18, 2024

The challenge concerned coverage of a pressure-reducing support surface. The beneficiary’s representative subsequently asked that the proceeding be closed, which the ALJ treated as a withdrawal and dismissed under Part 426. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6463/index.html

13. Vitamin D Assay Testing

Case: In re LCD Complaint: Vitamin D Assay Testing (L36692)
Docket: C-24-135
Decision: DAB CR6441
Date: March 13, 2024

The complaint concerned magnesium and vitamin D testing but lacked an adequate treating-physician statement, identification of the exact LCD provisions, an explanation of their alleged unreasonableness, and supporting clinical evidence. The beneficiary did not submit a corrected complaint. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6441/index.html

14. CT of the Head

Case: In re LCD Complaint: CT of the Head (L34417)
Docket: C-24-204
Decision: DAB CR6438
Date: February 29, 2024

The filing did not adequately identify the LCD provision challenged, establish aggrieved-party status, or provide supporting medical and scientific evidence. The ALJ also questioned whether the beneficiary was actually seeking review of an individual claim denial rather than challenging the validity of the LCD itself. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6438/index.html

15. Therapeutic Shoes for Persons with Diabetes

Case: In re LCD Complaint: Therapeutic Shoes for Persons with Diabetes (L33369)
Docket: C-24-199
Decision: DAB CR6435
Date: February 26, 2024

The initial complaint was incomplete. Before the deadline for correction, the complainant voluntarily withdrew it, resulting in dismissal and the regulatory six-month restriction on refiling the same complaint. (HHS.gov)

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2024/alj-cr6435/index.html

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Sidebar: The Strange, Nearly Moribund World of NCD Challenges

National Coverage Determination challenges remain authorized under Part 426, but they follow a different route. An acceptable NCD complaint goes directly to the DAB Appellate Division, rather than first being heard by a Civil Remedies Division ALJ. (eCFR)

HHS maintains a dedicated page entitled “Acceptable National Coverage Determination Complaints.” It is less a modern docket than a static historical list:

https://www.hhs.gov/about/agencies/dab/different-appeals-at-dab/appeals-to-board/national-coverage-determination-complaints/acceptable-national-coverage-determination-complaints/index.html

The most recent accepted complaint publicly listed is a vagus-nerve-stimulation proceeding from 2014. The page also includes the celebrated 2013–2014 challenge to the national noncoverage policy for transsexual surgery, which resulted in DAB No. 2576. No accepted complaint dated after 2014 appears on the public list. (HHS.gov)

Thus, NCD review is legally alive but publicly close to moribund. The page does not prove that nobody has attempted a complaint since 2014; it shows that HHS has not publicly listed a newer complaint as acceptable. The likely explanation is structural: standing is confined to affected beneficiaries, the evidentiary burden is substantial, and CMS can reconsider, withdraw, or revise an NCD while a challenge is pending. Those features make an NCD reconsideration request or conventional claim litigation more manageable for sophisticated stakeholders, although that conclusion is an inference from the regulatory design rather than an announced CMS policy. (HHS.gov)

What the Recent LCD Cases Teach

The first conclusion is stark: none of these 15 cases produced a decision holding an LCD either reasonable or unreasonable on the scientific merits. All 15 were formally dismissed.

The dispositions break down as follows:

• 11 of 15 were dismissed at the acceptability or jurisdictional stage.

• 3 of 15 were voluntarily withdrawn.

• 1 of 15, the immune-globulin case, was dismissed after the contractor revised its policy in a way that appears to have resolved the coverage problem.

• 0 of 15 generated a completed evidentiary review of the LCD record and a merits ruling.

The recurring procedural defects were remarkably consistent: failure to identify the exact LCD provision, inadequate evidence of beneficiary standing or timeliness, absence of a treating-physician statement, and—most importantly—failure to provide scientific evidence accompanied by an explanation of why the contractor’s policy was unreasonable.

Several complainants also misunderstood the nature of the remedy. They wanted an adjudicator to decide that a service was medically necessary for one patient or that the contractor had applied the LCD incorrectly. Those are ordinary claim-appeal questions. A Part 426 case requires an attack on the validity of the policy itself, supported by evidence addressing the policy’s clinical logic.

This produces an awkward imbalance. The only parties with standing are individual beneficiaries, but the task resembles sophisticated health-policy litigation: the complainant must identify the operative language, understand the evidentiary record, marshal relevant literature, and explain why the contractor’s synthesis is unreasonable. Manufacturers and medical societies may assist, but they cannot simply substitute themselves as the complainant.

The immune-globulin case is therefore especially instructive. A formal dismissal can disguise a substantive success. Once WPS revised the associated article and permitted payment under additional diagnostic codes, there was no longer a live coverage restriction requiring adjudication. Under Part 426, a contractor revision that removes the challenged provision can carry essentially the same practical consequence for the beneficiary’s claim as a favorable invalidity decision. (eCFR)

The docket is consequently neither hidden nor dead. It is poorly indexed, procedurally unforgiving, and dominated by unsuccessful pro se complaints. The scarcity of merits decisions should not be mistaken for proof that LCDs are universally defensible. It more often shows that very few complainants survive the gateway requirements necessary to place the contractor’s scientific record genuinely at issue.

 

MolDx in Court: Scanning CMS and Federal Cases for "MolDx"

 I'm such a CMS nerd that every year or two I used to scan the CMS Office of Hearings and Appeals (OMHA) for interesting cases.  (Back-when, there were some gems involving HeartFlow).

I'm not sure if OMHA still posts as many cases.  But I asked Chat GPT to search CMS and the web for legal cases involving MolDx.  I show the results below.

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AI Corner

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The publicly available  MolDX  appeal record is limited and dominated by Agendia’s disputes over BluePrint and TargetPrint breast-cancer assays. Several OMHA ALJs initially found the tests reasonable and necessary, but the Medicare Appeals Council repeatedly reversed favorable decisions for insufficient deference to MolDX LCDs and technical assessments. Later ALJs generally upheld noncoverage, finding that physician testimony, post-service publications, or evidence of clinical benefit did not adequately establish incremental clinical utility.

Federal courts ultimately sustained the MolDX framework, rejecting challenges to LCD authority and contractor delegation. Overall, the cases show that overcoming MolDX requires a strong, beneficiary-specific evidentiary record rather than generalized scientific disagreement.

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I found 13 useful decisions: one officially published HHS LCD-challenge decision, eight claim-level ALJ/Council decisions recovered from federal-court appendices or opinions, and four federal judicial-review decisions.

A caution at the outset: HHS now publishes only selected Medicare Appeals Council decisions, and there does not appear to be a comprehensive public database of ordinary OMHA claim decisions. Accordingly, this is a substantial but not necessarily exhaustive MolDX set. (HHS.gov)

I. Published HHS ALJ decision involving a MolDX LCD

1. In re LCD Complaint: MolDX Genetic Testing for Hypercoagulability/Thrombophilia

Case: In re LCD Complaint: MolDX: Genetic Testing for Hypercoagulability/Thrombophilia (Factor V Leiden, Factor II Prothrombin, and MTHFR) (L36159)
Number: DAB CR5997; Docket No. C-22-13
Date: December 9, 2021
Created title: MolDX Thrombophilia LCD Challenge Dismissed at the Threshold

A physician attempted to challenge MolDX LCD L36159 on behalf of a Medicare beneficiary. The ALJ dismissed the complaint without reaching the scientific validity of the LCD because the complainant failed to document timeliness, representative authority, the challenged provisions, supporting evidence, and other mandatory elements after being given an opportunity to amend. (HHS.gov)

Live link:

https://www.hhs.gov/about/agencies/dab/decisions/alj-decisions/2021/alj-cr5997/index.html

From NGS MAC to WELLPOINT FEDERAL

I mentioned several weeks ago that the NGS MAC (New England, New York, and MN-WI-IL) had begun referring to itself as WELLPOINT FEDERAL.  (While using "elevance" emails.)

WELLPOINT FEDERAL is now showing up on CMS.gov websites, as below.

Earlier:

https://www.discoveriesinhealthpolicy.com/2026/06/the-mystery-of-wellpoint-federal-aka.html

CMS and Software-Intensive Lab Services: The Third Rail is "How to Enroll" after Coding and Payment

In both its OPPS proposed rules, and its PFS or Part B proposed rules, CMS has proposed to drop AI-based or software-intensive lab diagnostic tests from the Clinical Laboratory Fee Schedule.  CMS says these services are not "CLIA tests" and do not require CLIA lab status.   In both rules, CMS preserves coding and payment pathways.  In OPPS, coding is the same, payment is shifted to APCs, and in PFS, coding is the same, payment is "contractor priced."

However, CMS neglected to mention a third factor.  How would such labs enroll in Medicare?  You have to enroll as "something" - as a doctor's office, as an ambulance service, as an ASC, and so  on.

I let Chat GPT chew on this dilemma and discuss it.

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CMS has addressed coding and payment—but not the supplier enrollment pathway

The proposal exposes a third problem distinct from coverage and pricing:

1. Benefit category: Is the service a clinical diagnostic laboratory test or an “other diagnostic test”?

2. Payment system: Is it paid on the CLFS, under the PFS, or through an OPPS APC?

3. Enrollment category: What kind of Medicare supplier is legally permitted to submit the claim?

CMS addresses the first two but largely overlooks the third. It reasons that a downstream algorithmic analysis of previously generated genomic, histologic, or other laboratory data is not itself an examination of human material and therefore need not be performed by a CLIA-regulated entity.  (Some will strongly disagree.)  CMS consequently proposes to treat these analyses as “other diagnostic tests,” contractor-price them under the PFS, and place the corresponding hospital services in new-technology APCs.

But Medicare does not pay an unclassifiable commercial entity simply because its service has acquired a code and price. Under 42 CFR 424.505, a provider or supplier must be enrolled to receive Medicare payment. (eCFR)

The enrollment form is CMS-855B

The classic Part B organizational enrollment application is CMS-855B, Medicare Enrollment Application—Clinics/Group Practices and Other Suppliers. The form requires the applicant to select a supplier type. Among the choices are:

• Independent clinical laboratory

• Independent diagnostic testing facility

• Clinic/group practice

• Pharmacy

• “Other”

But “Other” is not an open-ended invitation to invent a new supplier category. The form expressly says that it may be selected only when the supplier type is already eligible to enroll and bill Medicare but is not shown on the list. An applicant uncertain whether it is eligible is directed back to its MAC. (CMS)

That is precisely where the circularity can begin.

IDTF is the apparent destination—but it is an awkward one

Once CMS calls the service an “other diagnostic test” paid under the PFS, an IDTF becomes the most obvious existing enrollment category for a freestanding, nonphysician software company. Section 410.33 says that PFS diagnostic procedures generally must be performed by a physician, physician group, certain enumerated practitioners or suppliers, or an independent diagnostic testing facility. For a corporate software vendor that is neither a medical practice nor a laboratory, IDTF may be the only plausible item on that list. (eCFR)

There is some precedent for stretching the IDTF concept toward remote services. The regulations recognize IDTFs that perform services remotely and never see beneficiaries at their premises, relieving them of requirements such as handwashing facilities and patient-privacy accommodations. (eCFR)

Nevertheless, the IDTF framework remains heavily designed around imaging and physiologic testing:

• A physical practice location

• Diagnostic equipment maintained at that location

• Equipment inventories, model numbers, and serial numbers

• Named technicians and their credentials

• An interpreting physician, when applicable

• A supervising physician proficient in each procedure

• Code-by-code approval by the MAC

• State licensing and multi-state operational requirements

• Site inspections and record-production obligations

The CMS-855B IDTF attachment requires the company to identify every CPT/HCPCS code and the associated equipment model. More pointedly, it currently instructs applicants point blank that “clinical laboratory and pathology codes should not be reported.” (CMS)  (Conversely, possibly CLIA labs are only allowed to submit CLIA codes - not surgeries or MRIs - and if CMS says the codes are CLIA codes for submission purposes but are not CLIA codes for CLFS purposes, that's a hall of mirrors.)

Therefore, merely moving 0510U, 0512U, 0418U, 0220U, and similar services from the CLFS to PFS contractor pricing does not make them readily enrollable as IDTF services. CMS would have to answer such questions as:

• May these newly reclassified codes now be entered on the IDTF attachment despite their laboratory or pathology origins?

• Is the “equipment” a server, a cloud environment, a software version, or the algorithm itself?

• Who or what is the “technician” performing an automated analysis?

• For IDTFs, physician supervision required, and at what level?  (Is he supervising a computer chip?)

• How does the MAC define the medical specialty?  Must the supervising physician be a pathologist, molecular pathologist, radiologist, oncologist?   Pathologist seems natural but contradicts the CMS position the test is not a laboratory service. 

• Where is the service furnished for place-of-service and multi-state licensing purposes?

• Can one national software center enroll once, or must it enroll separately in multiple MAC jurisdictions?

• Once the code is ejected off the CLFS, is the service technical, professional, or global?

Without national answers, the proposal could produce a service that is covered, coded, and priced—but not billable by the entity that actually performs it.

HeartFlow is the scary precedent

The early HeartFlow experience illustrates this danger almost perfectly. HeartFlow sought IDTF enrollment for its FFRct software service. Noridian denied the application partly because it concluded that the proposed code was not separately payable and partly because the proposed supervising cardiologist did not meet what Noridian viewed as the applicable radiology-supervision requirement. Noridian therefore refused to grant HeartFlow a Medicare supplier number. (HHS.gov)

The Departmental Appeals Board candidly described the circularity: HeartFlow had to meet the requirements applicable to IDTFs, but Noridian primarily denied enrollment because HeartFlow had not identified a service reimbursable under the existing payment structure. The Board observed that HeartFlow could not—and would have no reason to—enroll as an IDTF if it could not bill Medicare for its only service. (HHS.gov)

That is the danger here on a larger scale. A MAC evaluating a SaMS company’s CMS-855B application might ask:

Is this really an IDTF test? Is this code authorized for IDTF billing? Where are the equipment and technician? What supervision applies?

Meanwhile, the payment staff may respond:

The code is payable under the PFS to an eligible enrolled supplier.

Each side can point to the other, leaving the company without a PTAN.

The OPPS route is less troublesome—but only because the hospital can bill

For a hospital outpatient service assigned to an APC, the hospital is already an enrolled Medicare provider and can ordinarily purchase the algorithmic analysis under an arrangement with the vendor. The software company may not need to enroll or submit the Medicare claim itself.

That does not solve the freestanding PFS problem. CMS would effectively be creating two commercial models:

• Hospital: the hospital bills the APC and pays the software vendor contractually.

• Nonhospital: the algorithm company must either find a valid supplier category or arrange for a physician or other enrolled entity to purchase and bill the service.

The latter approach could raise additional purchased-diagnostic-test, reassignment, anti-markup, supervision, place-of-service, and claim-reporting questions. It would also mean that the proprietary test developer no longer necessarily bills Medicare directly.

What CMS should do

CMS should not finalize the payment migration without simultaneously establishing an enrollment pathway. It has at least three options:

1. Preserve laboratory enrollment for this limited purpose.
CMS could permit an entity already enrolled as an independent clinical laboratory to bill designated SaMS codes even though the codes are paid under the PFS rather than the CLFS. Fee schedule and supplier enrollment category do not inherently have to be identical. Pure software entities would still require either a special “dry laboratory” enrollment subtype or another route.

2. Establish a defined remote-SaMS IDTF pathway.
CMS could state nationally that these services are eligible IDTF diagnostic procedures and modify the CMS-855B attachment and PECOS requirements for software-based testing. It would need software-appropriate rules for equipment, personnel, supervision, locations, and code approval rather than allowing each MAC to improvise.

3. Create a separate SaMS supplier category.
A new category on CMS-855B/PECOS would be the cleanest long-term answer. It could include enrollment screening, ownership disclosure, medical-record access, ordering requirements, cybersecurity and software-version controls without forcing cloud software into rules written for imaging machines and technicians.

At minimum, CMS should grandfather existing laboratory enrollments and PTANs during the transition, synchronize enrollment implementation with the January payment change, and prohibit MACs from denying enrollment merely because the affected code was historically categorized as laboratory or pathology.

The central comment point

CMS cannot logically conclude that SaMS analyses require no CLIA-regulated entity, remove them from the CLFS, and then remain silent as to which Medicare-enrolled supplier may furnish and bill them. 

Unless CMS preserves an independent-laboratory enrollment route, expressly designates these entities as remote IDTFs, or creates a SaMS supplier category, the new proposal risks reproducing the HeartFlow problem: a separately payable diagnostic service for which the actual supplier cannot obtain Medicare billing privileges.

SIDEBAR

The CLIA number for ArteraAI (e.g.)  seems to be 10D2258449, Jacksonville, per online Report Form.

The CLIA number for Valar Labs seems to be 45D2278995, per app.Dexzcodes.com.  1200 Binz St, Houston.  NPI 1891554481 as Clin Med Lab, 1200 Binz St, Houston.

Very Brief Blog: FDA Guidance on Payor Communications

Here's one for your horizon scan.  FDA has posted draft guidance updating its policies for communications with payors, such as HEOR information.

Here's my understanding.  FDA already had a guidance that covered marketed product (drug or device) communications with payors about 'health economics' that was not misleading.  

Recall that the starting point for FDA-regulated manufactuerers is what's literally on the FDA label, where HEOR usually isn't.

The old guidance was predicated in part on 502(a) and involved communications on approved products and indications.  There was some FDA "enforcement discretion" for unapproved products (pipelines).  

A 2023 bill adds 502(gg) which specifically extends by law some protections to unapproved (pipeline) products.   

The draft was released June 3 with 60-day comment to August 3.  Think of it this way: 

• Old 2018 final guidance + 2023 new law §3630 creating 502(gg) = this 2026 new draft guidance.

The comments docket is here.  The 24-page draft is here.

_____

Any number of articles about the draft are on Google here.  For extra credit, also check out the 2025 FDA guidance on unapproved uses of approved products here.

Here's the AI White Paper on Paying for AI...Articles from STAT and PETERSON

Do payers pay for AI?   Or do they assume AI-mediated savings, and deflation of prices?  Is one clinical area totally different from another in terms of AI financing and strategies?

STAT just ran a three-part series on AI and reimbursement, with Medicare and other use cases.  Peterson Institute just released a 15pp on AI financing in healthcare.  And there are collateral sources, e.g. a PathAI webpage on the cost strucures of digital pathology.

Here's a consolidated view from Chat GPT...

This essay is also available as a PDF white paper in the cloud - here.

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Summary.

• Clinical AI is not simply another medical device awaiting a code and payment rate. It can replace human labor, operate continuously, and scale at low marginal cost, creating both opportunities for better care and risks of uncontrolled spending. 
• A useful financial architecture must therefore address six interconnected layers: investment, transactions, workflow and accountability, evidence, market integration, and dynamic governance. 
• The Peterson framework provides the central economic argument. 
• STAT, PathAI, CMS policy, and academic research then show how implementation costs, downstream utilization, platform power, weak evidence, and changing professional roles shape the result. 
• Together, they determine whether AI lowers costs or merely adds another reimbursable layer.

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AI Guest Author: A Detailed White Paper about Payors and Genomics 2017-2026

Header: An AI-generated 20-page white paper that surveys a decade of articles about payors and genomics.  

Here's another adventure in current AI thinking and writing.  Chat GPT 5.6 surveyed 15 papers on payors and genomics, and for contrast, it also read 5 papers on payors and other medical industries. 

The report provides a general overview and key conclusions.  Trends over the decade are discussed. There's a contrast-and-compare with other medical industries - from continuous glucose meters to radiation therapy.  A side bar reviews two UCSF papers (both Phillips et al...2018, 2026) on payors and genomics.

• Find the white paper in the cloud here.

Summary: 

• Over the past decade, payer–genomics literature has evolved from documenting fragmented coverage policies to examining the broader implementation system. 
• Early studies emphasized inconsistent standards, reliance on guidelines, and uncertainty about clinical utility. 
• Later work showed that coverage alone does not ensure access: prior authorization, counseling gaps, clinician hesitation, patient cost, coding, and claim denials remain substantial barriers.
• Payers increasingly appear not only as gatekeepers, but also as potential implementation partners. 
• The central lesson is that genomic progress depends on more than accurate assays. It remains to be seen how increasingly rapid and advanced genomic testing will fare in an uncertain marketplace of payers expected to reimburse it.

The LabCorp $14M Fine on Tox Testing (Humor)

 You're probably seen press releases about the recent LabCorp $14M DOJ fine related to urine tox testing.

There are some sources that go into numbing detail about the coding situations and the coding definitions and overlap.  First link is DOJ press release; second link is 11p court document.

https://www.justice.gov/opa/pr/labcorp-agrees-pay-145m-resolve-false-claims-act-allegations

https://www.justice.gov/opa/media/1452616/dl

click to enlarge