The MAHA Report and AI Used Dumbly

By now, you've probably heard that the May 22 version of the Make America Healthy Again report had many errors due to AI-created false citations.   

This blog points out that problem was COMPLETELY unnecessary and could have been avoided with easily available better choices.

##

• See May 22 article at NYT here.  See 68-page version archived at NYT here.
• Original article at "NOTUS" exploring errors - May 29 here.
• Washington Post updates on errors; May 30 here.
• I used Draftable.com online to compare the 68-page May 22 version (NYT) and the current May 31 73-page version at Whitehouse.   
• You have to click on little red triangles to see changes.  At the google cloud pdf upload by me, here.

Rather than belabor problems in the original manuscript, I'd make the point, it didn't have to be that way.  

#1

For example, even in Chat GPT, you have an option to send it to the internet for sources which it will retain as links; this at least eliminates the risk of non-existent sources.

#2

Another method - and I'm sure there are others - is to use the science research tool Scite.ai.  I don't use Scite often, but I've had a subscription for a year or two.  

For me, it has two main modes.  One does elaborate research on index publications - find out what papers cite the publication, and, see a clip of the sentences that make the citation.  For example, Lubarski 2008 cites 76 papers, and see what sentence in Lubarski cites which paper in the bibliography.  Since 2008, 60 newer papers have cited Lubarski, and you instantly see the sentence or two that each newer paper used to make the citations to Lubarski.

The second SCITE mode is a writing mode, where you offer a question (a prompt) and it responds in a couple minutes with an assay based on PubMed citations.  This would have helped MAHA. 

Now, OK, it may not have the best citations, or cite every article exactly correctly.   However, you WILL avoid the MAHA problem of literally fictitious citations and global humiliation.   And Scite's about $20 a month.

##

I give an extremely simplistic example below.   It took me five or ten seconds to ask for and a minute in creation by Scite.  That is, this is a "no effort" example.

• Cite recent sources in the last 3 years that document an increase in chronic disease in children such as asthma, autism, autoimmune diseases, obesity, etc.

##  Scite writes, and cites:

The prevalence of chronic diseases among children, including obesity, asthma, autism, and autoimmune diseases, has shown a marked increase in recent years, as evidenced by numerous studies conducted globally.

Obesity rates in children have been documented to rise sharply. A systematic review highlighted that the prevalence of childhood obesity in Spain has escalated substantially over the past decade, necessitating urgent policy measures to address this growing epidemic (Bravo-Saquicela et al., 2022). Furthermore, a nationwide observational study in Japan revealed similar trends, indicating that childhood obesity has increased consistently from 2012 to 2021 (Fujiwara et al., 2023). This escalation in obesity prevalence is further illustrated by various studies indicating a rise in overweight and obesity rates among children in different regions, including Geneva Narvaez et al. (2024) and Brazil, where obesity prevalence displayed wide regional variations, underscoring the urgency for preventive strategies (Santos et al., 2023).

The association of childhood obesity with other chronic conditions, particularly the link between obesity and autoimmune diseases, has become a focal point in recent research. For instance, a study examining antibody-mediated autoimmune diseases in children found a gradual rise in incidence, suggesting a concerning pattern that may be correlated with the increased rate of obesity (Kang et al., 2023). Additionally, chronic conditions such as atopic dermatitis have also seen a rise, and while it is suggested that genetic and environmental influences play a role, the classification of these diseases as autoimmune is still debated (Floca et al., 2022).

Asthma prevalence has not remained static either. Research has indicated that chronic childhood asthma symptoms fluctuate with environmental changes, and there is ongoing concern that the prevalence of asthma among children has been exacerbated by factors such as exposure to passive smoking during childhood (Jaakkola et al., 2021). This suggests a complex interplay between environmental conditions and the manifestation of chronic respiratory conditions in children.

Moreover, the COVID-19 pandemic has adversely affected the prevalence of childhood obesity. Studies indicate that a deterioration in behavioral and environmental factors during the pandemic has led to an increase in obesity rates among children (Emiroğlu et al., 2024). Particularly, the socioeconomic status of families has been shown to correlate strongly with higher rates of childhood obesity and associated health problems, which may exacerbate overall health disparities within populations (Batioja et al., 2024; ,Sritart et al., 2022).

The multifactorial nature of these chronic diseases amongst children encompasses not only environmental and genetic components but also socio-economic elements that can influence health outcomes. As research continues to reveal interconnections between various chronic conditions and emerging trends in obesity, these findings highlight the need for comprehensive public health strategies that address the multifaceted factors contributing to chronic diseases in children today.

[End scite auto generated text]

References:

Batioja, K., Elenwo, C., Hendrix‐Dicken, A., Ali, L., Wetherill, M., & Hartwell, M. (2024). Associations of social determinants of health and childhood obesity: a cross-sectional analysis of the 2021 national survey of children’s health. Journal of Osteopathic Medicine, 124(5), 231-239. https://doi.org/10.1515/jom-2023-0239
Bravo-Saquicela, D., Sabag, A., Rezende, L., & Rey-López, J. (2022). Has the prevalence of childhood obesity in spain plateaued? a systematic review and meta-analysis. International Journal of Environmental Research and Public Health, 19(9), 5240. https://doi.org/10.3390/ijerph19095240
Emiroğlu, P., Taneri, P., & Güner, A. (2024). Impact of the covid-19 pandemic on childhood obesity prevalence. Bagcilar Medical Bulletin. https://doi.org/10.4274/bmb.galenos.2024.2024-02-0183
Floca, E., Gaga, R., Sur, G., Lupan, I., Armat, I., Samaşcă, G., … & Sur, L. (2022). A new autoimmune disease: atopic dermatitis in children. Allergologia Et Immunopathologia, 50(6), 17-21. https://doi.org/10.15586/aei.v50i6.655
Fujiwara, S., Harada, K., Hagiya, H., Koyama, T., Hasegawa, K., Tsukahara, H., … & Otsuka, F. (2023). Trends in childhood obesity in japan: a nationwide observational study from 2012 to 2021. Clinical Obesity, 14(2). https://doi.org/10.1111/cob.12636
Jaakkola, J., Rovio, S., Pahkala, K., Viikari, J., Rönnemaa, T., Jula, A., … & Raitakari, O. (2021). Childhood exposure to parental smoking and life-course overweight and central obesity. Annals of Medicine, 53(1), 208-216. https://doi.org/10.1080/07853890.2020.1853215
Kang, Q., Liao, H., Yang, L., Fang, H., Ning, Z., Liao, C., … & Wu, L. (2023). Clinical analysis of 173 pediatric patients with antibody-mediated autoimmune diseases of the central nervous system: a single-center cohort study. Frontiers in Immunology, 14. https://doi.org/10.3389/fimmu.2023.1140872
Narvaez, L., Mahler, P., Baratti-Mayer, D., & Jeannot, É. (2024). Changes in body weight and risk factors for overweight and obesity in 5–6-year-old children attending school in geneva. Children, 11(5), 529. https://doi.org/10.3390/children11050529
Santos, F., Silva, E., Baêta, C., Campos, F., & Campos, H. (2023). Prevalence of childhood obesity in brazil: a systematic review. Journal of Tropical Pediatrics, 69(2). https://doi.org/10.1093/tropej/fmad017
Sritart, H., Taertulakarn, S., & Miyazaki, H. (2022). Disparities in childhood obesity prevalence and spatial clustering related to socioeconomic factors in isaan, thailand. International Journal of Environmental Research and Public Health, 20(1), 626. https://doi.org/10.3390/ijerph20010626

CMS Publishes Updated Code List for Summer Lab Pricing Meetings

For the summer Annual Lab Meeting, CMS has published an expanded code list, with 91 action items.   

Go to this site and scroll down for Meeting Notice - Agenda, and find "Code List v.2 5 28 2025."

• https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/annual-public-meetings

In the expanded list (released May 28) CMS adds codes confirmed by AMA in early May 2025.

##

For full background on this public meeting (June 27) and the Expert Panel Meeting (July 23-24), see my original blog:  

• https://www.discoveriesinhealthpolicy.com/2025/04/cms-announces-summer-2025-lab-pricing.html

(From Endpoints): Illumina's Diaspora, Customers and Competitors

The interesting news site Endpoints News has an article on Illumina and the sequencing ecosystem, by editor Jared Whitlock.   Find it here:

https://endpts.com/how-illuminas-ex-employees-became-its-customers-and-competitors/

Endpoints is switching to a new "dot-news" website June 1:

https://endpoints.news/

Chat GPT summarizes,

• In a sweeping feature for Endpoints News, Jared Whitlock explores how Illumina — the DNA sequencing giant that helped democratize genomics — has paradoxically seeded a wave of competition from within. Over 70 companies have been founded by former Illumina employees, forming a "diaspora" that’s both reliant on and rival to their former employer. While some of these spinouts, like Element Biosciences, have become fierce competitors, many still use Illumina sequencers or complement its tech. 
• The article details how Illumina, grappling with the results of its Grail acquisition, is now expanding beyond DNA into multiomics — often into the same markets its alumni now occupy. 
• For readers tracking the genomics industry's evolution, this piece is a fascinating look at innovation, spinout culture, and corporate strategy in real time.

AdvaMed Says: CMS, FDA Leadership Care About Breakthrough Device Coverage

AdvaMed has a new posting on Linked In, highlighting a recent panel in which HHS leadership voiced a commitment to Breakthrough Device coverage.

Find the posting here, including a video clip:

https://www.linkedin.com/posts/advamed_medtech-breakthroughdevices-activity-7333871545150320640-aeui/

Here's part of what AdvaMed writes:

• When the FDA deems breakthrough medtech safe and effective, there shouldn’t be duplicative, years-long reviews that delay patient access to lifesaving innovations. 
• In a recent FOX interview, Dr. Makary shared that [FDA] and Dr. Mehmet Oz are working on “a way Medicare can pay for something the second the FDA approves a breakthrough device, so they don’t have to go through their own repeat, duplicative approval process for a year.” 
• This effort aligns with the recent introduction of bipartisan legislation by U.S. Senators Todd Young (R-Ind.) and Alex Padilla (D-Calif.) aimed at improving this process and expediting coverage for FDA-designated breakthrough medical technologies. House legislation is expected soon. If enacted, this reform will accelerate patient access, improve efficiency, and ensure smarter use of taxpayer dollars.

I've pointed out as far back as March that AdvaMed has strongly supported HHS appointments like Dr. Oz:

https://www.discoveriesinhealthpolicy.com/2025/03/advamed-strongly-supports-dr-oz-for-cms.html

...Whereas AMA, JAMA, NEJM, etc, have been consistently highly negative about the administration.  NEJM, etc, have gotten "vaguely threatening prosecutor's letters."  AMA got a pay cut for physicians.  This week's news is that RFK Jr would like to block NIH from publishing in journals like JAMA and NEJM.    

NEJM Covers the FDA LDT Legal Decision

It's about 60 days since a Texas federal court tossed out the FDA LDT regulation.   Recall the government had 60 days to file an appeal.   If it doesn't, FDA might issue some other kind of information, like an administrator's blog or a press release on the topic.

Along the way, New England Journal has published a 3-page article on the FDA decision.   (Spoiler alert - the authors wish the FDA would have won).    Find Sachs, Sharfstein & Zettler online here:

https://www.nejm.org/doi/full/10.1056/NEJMp2504926

One lingering question for me, as a non-attorney.  The decision clearly means that FDA can't mandate lab-developed procedures to undergo FDA review as devices.    But does this also mean the FDA is barred from review of LDTs that labs bring to the FDA voluntarily?   A lab might want its LDT to be FDA-approved in order to get some other benefit, like CMS coverage under an NCD or special CMS pricing as an ADLT (advanced diagnostic laboratory test).   But could FDA review it, voluntarily, if the FDA is generally precluded from reviewing lab procedures because they are not "devices" and not within FDA scope?   

CMS 2023 Lab Data Part B - HIghest Dollar Volume Codes

 In a previous blog, I noted that CMS had released CY2023 Part B claims (by doctor or by lab) for CY2023.   I showed the top ten billing labs for 81479, molecular unlisted code, for which the total dollar volume was nearly half a billion dollars ($488M) in 2023.

Here, I went back to the cloud database and extracted all the molecular codes (811 series to 815 series), plus PLA codes ending in U, plus microbiology molecular codes (87468-87999).    

The database has 130,000 lines, and weighs about 30 MB after I had done some different sorting options.

Total molecular dollar volume in 2023 was $3.4B, of which 14% or $488M went to 81479.   

After that, $300M or 9% went to 81528 (Cologuard / Exact Sciences) and $288M or 8% to 87798 (other infectious agent probe).   The next two positions were 3% for $118M for 81455 (any lab, heme CGP) and 3% $104M to 0242U Guardant FDA LBx CGP test.

The top 15 codes had 57% of all dollar volume. Click to enlarge.

Breaking out 81479, "Code #1," these were top-paid labs:

PLA CODES

CMS logged sales for 82 of the approximately 400 PLA codes at the time.   Total sales for PLA codes were $519M.   The top 10 PLA codes got 80% of the PLA code dollar volume (of all 400 PLA codes).  The top 4 PLA codes (or 400 PLA codes) had half the dollar volume.  Click to enlarge.

About half the PLA codes, that logged any Part B sales, logged less than $100,000.  About a quarter of the PLA codes, that logged any Part B sales, logged less than $10,000.  About 3/4 of the 400 PLA codes for 2023 logged 0 sales at CMS.

See It Yourself

I posted the 30 mb Excel file as a Cloud resource in Google Drive.  It's open access but you may need a google account to see and download it.

https://docs.google.com/spreadsheets/d/1a1cQNKUdB5pmcOnJDqZF8EgtPD6EYiRH/edit?usp=sharing&ouid=110053226805181888143&rtpof=true&sd=true

Some More Examples from the Data:

87798

87798 was a very widely used code in 2019-2020-2021, including in MolDx states.  Then MolDx brought out an LCD, or revised one, that made it very hard to use 87798 (other molecular probe, pathogen).   The top 20 labs biling 87798 by 2023 were almost all in non-MolDx states.  

MolDx vs Other MACs on 81455 (81456)

MolDx rarely allows labs to use the code for 50+ tumor genes (81455, about $2850).  Instead, MolDx asks labs to code 81479 instead of 81455 (see e.g. Caris billing pattern, 84% 81479).   In Illinois, conventional codes are accepted by the NGS MAC, such as from Tempus.  (81455 for DNA or for DNA and RNA analysis; 81456 for RNA analysis).  Click to enlarge:

DOJ Acts Against "Standing Orders" for Molecular Tests

While it doesn't address "standing orders," a separate topic, recall there's a major MolDx article from 2024 which deals with "pathologist-originated orders," and that under appropriate circumstances, these orders can definitely be for genomic tests (not just special stains).  Here.

If you follow this area, track a whistleblower settlement in which Agenda pays $3.2M or more regarding "standing or automatic orders" for molecular tests.  

The case also makes reference to "honoraria, gift cards, and payments per referral."  See a 360Dx article on May 22, 2025, here.  For more details see the full DOJ press release, dated May 21, here.

Regarding "settlements" - The claims resolved by the settlement are allegations only and there has been no determination of liability.

##

The two qui tam cases are captioned U.S. ex rel. Raymond Brig, M.D. v. Agendia, Inc. et al., Case No. 3:21-CV-286 (E.D. Tenn.) and U.S. ex rel. Lance Albertson v. Agendia, Inc., Case No. 3:23-CV-289 (E.D. Tenn.).  The relators will receive $296,725 of the proceeds from the settlement and may eventually receive as much as $921,725.

Labs vs Payer Industry: A New Paper by Astion & Baird

 

In the past couple years, I've heard some excellent talks on the lab, hospital, and payer industries from Michael Astion MD of Seattle.   Here, we get some of this thinking distilled in an article, by Astion & Baird, 2025.   The title is, "Payer Perspectives on Laboratory Stewardship," find it here at J Appl Lab Med.

I'll quote the abstract in full:

Background: The US healthcare system is complex and includes a number of entities and systems that provide services to patients and to pay for them. While improving health and well-being are accepted goals of healthcare, the 3 stakeholder groups relevant to healthcare—patients, providers, and payers—often have different perspectives on how care should be utilized, performed, and paid for. These differing perspectives are discussed as they relate to clinical laboratory testing.

Content: Patients expect that the laboratory tests performed on them are necessary and covered by their insurance. Providers expect that they will be able to carry out what they believe to be the standard of care for their patients, and they furthermore expect that the systems in place from laboratories and payers will support their efforts without exposing their patients or their practice to financial toxicity. Payers, finally, desire to meet the needs of their customers, who are both patients as well as employers, by providing access to necessary healthcare services at a fair cost. Aligning these desires and perspectives is challenging in a fragmented healthcare system, and in the face of substantial opportunities for secondary gain from disreputable practices such as fraud, waste, and abuse.

Summary: Within the constraints of a US healthcare system based on competition and susceptible to misalignment, opportunities nonetheless exit for all relevant stakeholders in the laboratory testing space (patients, providers, and payers) to align and agree on practices that provide reasonably priced, fairly distributed, and medically necessary healthcare.

###
AI CORNER

###

I asked Chat GPT to provide six take-aways that went beyond the title and abstract content.

1. Medical Necessity ≠ Standard of Care

While most stakeholders assume payers cover what is considered “standard of care,” the article explains that payers often base decisions on stricter, formalized evidence hierarchies. This disconnect leads to denials of common tests even when supported by consensus guidelines or typical specialist practice. For lab leaders, this is a reminder that payers may not follow clinical logic—and labs must bridge the gap through clear documentation and advocacy.

---

2. Poor CPT Specificity Undermines Claims Accuracy

Generic CPT codes like 81479 (genetic testing) and 83520 (immunoassays) allow very different tests to be billed under a single code, making payer adjudication inconsistent. The article stresses how vague codes increase denials, slow claims, and limit coverage decisions, reinforcing the need for labs to support PLA code development or utilize DEX Z-codes for more transparent claims.

---

3. Laboratories Often Incur Hidden Costs from “Free Testing”

Astion skewers the notion of “free testing” from outside labs. Even when the assay itself is gratis (e.g., sponsored research or pharma partnerships), there are internal costs—tubes, logistics, IT, result reconciliation, and clinician education. These costs are real and recurring, and labs need to quantify and communicate them when asked to permit out-of-network or ad hoc ordering.

---

4. Grievances are Toast: Prevention Beats Scraping

The “burnt toast” metaphor is apt: labs and providers are stuck doing time-consuming appeals (grievances) that could often be avoided by front-end ICD-10 coding accuracy and improved EMR documentation. The article encourages labs to focus stewardship not just on test utilization, but on pre-adjudication readiness—ensuring orders are defensible before submission.

---

5. Lab Test Waste is a Payer Red Flag

Astion highlights wasteful practices (e.g., duplicate testing, overly bundled panels, obsolete assays like CK-MB), citing Choosing Wisely. Payers view these as signposts for poor stewardship. Labs that fail to police this waste risk tighter controls, lower fee schedules, and greater scrutiny. The article indirectly calls for labs to proactively deimplement low-value tests as a strategy for payer trust.

---

6. Payers Prefer In-Network Labs Not Only for Cost, But Quality

While the cost of out-of-network testing is well known, the article notes that payers also worry about data opacity, variable test quality, and patient dissatisfaction. By aligning test menus, utilization policies, and education with payer goals, labs can position themselves as preferred in-network providers—an increasingly strategic distinction as payers steer patients more aggressively.

A mental template for diagnostic medical puzzles: From NEJM Case Records

Most weeks, New England Journal includes a section called Case Records of MGH, a detailed presentation of a puzzling case.  A visiting clinician (who didn't know the patient, only the records) reasons through the case and tries to puzzle it out.

Case 13-2025 has a typical title - "A 70-Year-Old Man with Weight Loss..." but the discussant, MGH's  Matthew Gartland MD, gives us something extra in his discussion and reasoning.  

He shows a four-part framework for putting the numerous puzzle pieces together, which he calls Unboxing, Corners and Edges, Landmarks, and Bridging.   Click on the pic to enlarge:

click to enlarge

Extracts from Discussion - 

Dr. Matthew G. Gartland: This 70-year-old man presented with subacute progressive anorexia, weight loss, and headache. Shortly after admission to this hospital, fulminant encephalopathy developed in the patient.

This case requires iterative clinical reasoning with synthesis of multiple pivot points to arrive at a diagnosis.

The process of clinical reasoning often unfolds much like the way we approach a jigsaw puzzle. Thus, I will apply a framework I will call “jigsaw heuristics” to approach this complex case.

 There are several stages of assembling a jigsaw puzzle, including

·        unboxing the pieces,
·        identifying the corners and edges,
·        assembling landmarks, and
·        bridging across the more homogeneous parts of the puzzle (Figure 2).

·        I will use a similar strategy to develop a differential diagnosis for this patient.

 

 Unboxing

 To start assembling a puzzle, I first empty the box and place all the different pieces right side up. Similarly, in this patient’s case, I begin by laying out the raw data to generate a comprehensive list of problems. The patient’s clinical history is sparse and has several common features, including anorexia, progressive weight loss, and fatigue. Headache and dysgeusia are useful differentiating features, along with abnormalities involving vital signs such as hypertension, findings on physical examination such as scattered bruises and thinning skin, and subsequent laboratory and radiographic findings, including an adrenal nodule, hypokalemia, and hyperglycemia. After he was admitted to this hospital, progressive encephalopathy developed, acute multifocal lacunar infarcts were noted, and the results of CSF analysis were markedly abnormal.

 Corners and Edges

 After unboxing, I often focus on assembling the corners and edges to identify the boundaries of the puzzle. This patient’s presentation contains two discrete timelines that serve as the boundaries of the case, which can be described with time-bound semantic qualifiers. This patient had a subacute-to-chronic syndrome that began at least 6 weeks before hospitalization, with features that include the findings on initial physical examination, such as bruising and thinning skin, as well as the abnormal laboratory test results and radiographic findings on admission. In the hospital, a second process unfolded with fulminant, progressive encephalopathy that may have had a subacute onset. Pertinent findings for this process include intermittent headache, an abnormal CSF profile, multifocal lacunar infarcts, and abnormal results on electroencephalography. At this point, it is unclear where the patient’s weight loss will fit.

 Landmarks

 Once the boundaries of the puzzle are established, we can focus on landmarks by piecing together well-defined shapes. In clinical reasoning, we often search for pivot points — discrete syndromes or findings with a limited differential diagnosis that can be used as a fulcrum for diagnostic thinking.  Potential frameworks around which we can organize our thoughts in this patient’s case include altered mental status, weight loss, and micronutrient deficiency after gastric bypass; however, the patient’s nonspecific clinical presentation lacks differentiating features for these pivot points. We have more pertinent findings that suggest an endocrine disorder, such as Cushing’s syndrome, which would fit within the timeline for a subacute-to-chronic syndrome, followed by encephalopathy with a markedly abnormal CSF profile. These findings are suggestive of a second acute-to-subacute process.

 Bridging

Lastly, I shift to “bridging,” which is the process of methodically completing homogeneous areas of a puzzle by using the shades and shapes of the pieces.

   Cushing’s syndrome…

   Candida meningitis…

   Cryptococcal meningitis… 

Journal Club: "Nature Medicine: Cancer Treatment Paradigms in the Precision Medicine Era"

Hot off the press at NATURE MEDICINE:

Subbiah et al., 2025, Cancer Treatment Paradigms in the Precision Medicine Era.

Find it here (subscription):

https://www.nature.com/articles/s41591-025-03711-w

At Linked In, the prolific Denis Horgan gives a detailed open-access summary of the paper's key points:

https://www.linkedin.com/posts/denis-horgan-ph-d-92b25118_cancer-treatment-paradigm-in-precision-medicine-activity-7330880001317253120-_C5r/ 

It looks like Horgan includes a downloadable version of the 3-page PDF within his Linked In article.

The paper is focused on systematic issues for implementation in the European Union, and one of three key issues is diagnostic fragmentation.

The authors write,

• To fully harness precision medicine and transform cancer care for the better will require a strategic shift to highly personalized interventions that embrace innovation and adaptability....

##

AI CORNER

##

Summarize the several paragraphs about diagnostics.

##

Key Points on Genomics in European Cancer Care – What Needs to Change [Subbiah et al]

1. Start Molecular Testing Early:
   The paper urges comprehensive molecular profiling at diagnosis, not just at disease progression. Early testing enables more effective targeted and immunotherapies before tumors evolve resistance, and supports better trial enrollment and long-term tracking.

2. Adopt Universal Testing:
   For real progress in cancer care, the authors advocate for routine somatic and germline testing in all cancer patients—highlighting the need for investment in infrastructure, cost coverage, and clinical decision tools.

3. Support Tumor-Agnostic Therapies:
   Europe lags behind the U.S. in approving biomarker-based, tumor-agnostic therapies. The authors call for a strategic framework (like ESMO's ETAC) to evaluate and enable approvals based on molecular alterations rather than tumor histology.

4. Coordinate Multi-Stakeholder Action:
   Achieving these goals will require coordinated action across regulators, industry, clinicians, and patient groups—particularly to overcome barriers in rare cancers where large RCTs are infeasible.

In sum, the paper pushes for earlier, broader, and smarter molecular diagnostics in cancer care, with updated regulatory and clinical strategies to match.

From Derek Lowe: "INSIDE A PAPER MILL"

For a long time, blogger and scientist Derek Lowe has been putting out interesting essays.  For several years, he's been hosted by SCIENCE.   

Here's one.  His May 21 blog at "In the Pipeline" (at SCIENCE) looks into the cash-for-papers industry.  It's not new, but it's probably accelerated by AI.   Derek gives a lengthy summary at his blog, and for more details, refers readers to an earlier online article by Leonid Schneider at a website called, "For Better Science."

Find Derek Lowe here:

https://www.science.org/content/blog-post/inside-scientific-paper-mill

He's summarizing from Leonid Schneider [46pp]:

https://forbetterscience.com/2025/05/19/a-sting-inside-a-papermill/

By sides the summary by Lowe and the long-format article by Schneider, see also March 2025 book, Columbia University Press, by Swiss scientist Csaba Szabo, "Unreliable: Bias, Fraud and the Reproducibility Crisis in Biomedical Research."

Regarding paper mills, quoting from Lowe:

Over at For Better Science, Leonid Schneider has a fascinating look into the papers-for-cash schemes that have been going on for years now in the scientific literature. A pharmacology professor at Univ. Fribourg in Switzerland, Csaba Szabo, was contacted by one of these shady outfits with an offer, or rather, a whole selection of offers. "Ms. Kristen" from the "Alliance Academy of Science" (whatever the hell that is) wrote Prof. Szabo in2023 with an "invitation for potential cooperation", and he was able to [include that in his new book.]   

...he needed more clarification ... and what emerged was a detailed schedule of potential payouts that depended on the amount of "cooperation" and the impact factors of the journals where the resulting articles would appear, as well as the speed of acceptance at the journals themselves. It was a long list of variations on the themes of ghostwriting, authorship manipulation, and outright bribery to get things published in actual journals. These things, depressingly, have been going on for a long time now...

###

AI CORNER

Here's a summary of the 46-page Schneider article via Chat GPT.

###

Here is a concise summary you can adapt for your blog, highlighting Leonid Schneider's and Csaba Szabo’s investigation into papermills, and how Szabo’s sting operation helped expose their mechanics:

---

Inside the Academic Papermill: 

Schneider and Szabo Unmask the Market for Fraudulent Science

In a riveting exposé on For Better Science, investigative journalist Leonid Schneider and pharmacologist Csaba Szabo team up to illuminate the inner workings of academic papermills — shadowy networks that churn out fake scientific publications for a price.

Szabo, a senior scientist at the University of Fribourg, was approached by a Chinese papermill offering cash (up to $5000) for either ghostwriting papers or using his editorial influence to secure their publication. Instead of complying, he collaborated with Schneider to stage a sting operation — posing as a willing participant to gather inside information.

Over a 72-hour WhatsApp exchange with contacts named “Julia” and “Ariana,” Szabo was offered various shady "cooperation modes": he could ghostwrite papers, sell authorship slots, or manipulate journal acceptances as an editor. He was even sent a complete manuscript — later traced to authors with a history of suspicious publications and PubPeer complaints. The paper was typical of papermill output: scientifically superficial, full of recycled tropes (like lncRNA in cancer), and padded with suspect references.

The investigation revealed that the Anzen Academy of Science, which contacted Szabo, is not a real entity. Payments were offered via crypto and obscure platforms like Perfect Money, and names of supposed collaborators were withheld — classic red flags of an international fraud scheme.

Schneider's detailed analysis and Szabo’s undercover work expose a billion-dollar industry undermining scientific integrity. Their findings confirm that papermills exploit weak editorial systems, hijack peer review (often via fake email accounts), and profit from academia’s publish-or-perish culture. This sting also complements Szabo’s broader critique in his recent book, Unreliable, which examines bias and fraud in biomedical research.

---

 

ACLA Federal Comment Cites MOLDX Rule Regarding Test Requests, Audits

 Recently, the ACLA submitted a public letter to the Trump administration requesting  improvements in laboratory policy.  See entry point here.

The ACLA prominently cites a MolDx article from twelve months ago, about pathologist test orders and about information already included in the medical record via a TRF - a test requisition form.  See entry point here.

In its letter to HHS and OMB, page 4-5, ACLA specifically cites the MolDx article, and asks that it be made effective nationwide via additional guidance from CMS itself.

In the next section of the letter ACLA asks for fixes to the cumbersome 14-day rule.

Brief Blog: AHRQ Releases Report on MCED Evidence to Date

 On May 14, 2025, AHRQ released a 140-page review of the field of Multi Cancer Early Detection tests.   The systematic review focused on 20 studies to date, 7 of which it found were higher quality.   They report only one study had enough assessment of harms; therefore, it was too early to do a risk-benefit calculation of harms.

Find the report here:

https://effectivehealthcare.ahrq.gov/products/cell-free-dna/research

CMS Releases 2023 Part B Utilization by CPT Code, Lab or Physician

Update - See data on top codes, top PLA codes, in a later blog:

https://www.discoveriesinhealthpolicy.com/2025/05/cms-2023-lab-data-part-b-highest-dollar.html

###

Each year, CMS releases a cloud database of provider and CPT code utilization for the calendar year about 18 months earlier - e.g. CY2023 data released around May-June 2025.   CMS released data for CY2023 on April 24, 2025.

Find the entry point here:

https://data.cms.gov/provider-summary-by-type-of-service/medicare-physician-other-practitioners

For example, you can enter this database:

https://data.cms.gov/provider-summary-by-type-of-service/medicare-physician-other-practitioners/medicare-physician-other-practitioners-by-provider-and-service/data

Physician and Other Practitioners [& Labs] - By Provider and Service.   If you enter the NPI for, for example, Neogenomics (100325317) you get all the 2023 Part B payments to that lab by CPT code.

The database requires a little time to understand, but basically you use options under the button FILTER and when satisfied, you click EXPORT and get a CVS (comma) file which I recommend you immediately open and re-save as an XLS file.   

The full cloud database you are searching has about 9.6 million rows of data.  (Whereas, for example, if you filter on the NPI for Neogenomics, you get 274 rows).   

I Was Not Sure This Would Happen

For about a decade, CMS has been releasing this doctor-specific (or lab-specific) payment data, based on a legacy of federal court cases on whether they were private or releasable.   Frankly…I couldn't have guaranteed they would be released under the current new administration - but here they are.

81479 in 2023

If you search on the molecular unlisted code 81479, you get 80 rows.  The payments for 81479 tally to $488,385,801 in total.  That is, despite the explosion of 500-plus PLA codes, nearly half a billion dollars goes out via 81479.   

The top 8 payments for 81479, totalling about 90% of payments, are all in MolDx states.  Click to enlarge:

Click to enlarge

Searching on Ambry Genetics, you get 174 services for 0101U, 466 services for 0129U, and a whopping 22,503 services for 81479.   

Dollarized, that’s $297,378, and $593,548, and $39,922,313 (0.7%, 1.5%, 97.8%).

The wide use of 81479 in MolDx's coding instructions to labs means that huge amounts of genomics payments fall under 81479 and public health data researchers can't tell what is actually being tested and used by doctors and patients.  (MolDx knows, because each of those 81479 uses is paired with a Z code).

In addition, all those 81479 payments fall outside of PAMA data collection or application.   

Broader Filters

You can do broader filters, such as "starts with 81" to get molecular codes and then quickly manually truncate (erase) the results above code 81599.   You can search with "ends with U" to get PLA codes - et cetera.

81408 "Fraudomatic Code"

Wild use of code 81408 led to around a billion dollars of payments around 2018-2021.   Utilization in 2023 was essentially zero (11 uses).   

Download Yourself

I posted the 30mb of data for all molecular lab codes in a cloud file.  You might need a google account but otherwise it is open access.

https://docs.google.com/spreadsheets/d/1a1cQNKUdB5pmcOnJDqZF8EgtPD6EYiRH/edit?usp=sharing&ouid=110053226805181888143&rtpof=true&sd=true

Cornell Authors on Medicare Advantage "Trap"

 Today's news includes, per Reuters and WSJ, that United Healthcare may be under criminal investigation relative to Medicare Advantage programs.

There's also a important and informative article by Cornell authors about Medicare Advantage and how it "traps" patients who can't return to fee for service Medicare.   Find it here (subscription).

Basically, each you a patient is free to flip-flop between Traditional Medicare and Medicare Advantage.  Over half of patients are in Medicare Advantage, which may offer discounts, dental care, and other advantages.   However, Medicare Advantage may subject you to unexpected denials, prior authorization hassles, narrow networks (even nearly-unavailable services).

Over on the fee for service side, for a premium of about $200 a month, you get Part A and Part B, and for another circa $200 a moth, you get Medigap, which covers nearly all copays (so your out of pocket may approach $0.)   

The problem is that once you are in Medicare Advantage, you can switch back to FFS Part B, but you probably can't get a MediGap plan, without which, the 20% copays can risk being highly onerous.

And, you may find if you are trapped in Medicare Advantage, narrow networks or copays or denials might worsen over time.   

The Casalino et al. article runs through a range of pro's and con's and in's and out's of the system as it exists.   

Deregulatory Ideas from AHA and ACLA to OMB (April/May 2025)

 While there is an RFI for deregulatory ideas to CMS, and for deregulatory ideas to all of HHS (open to June 10 and July 10, respectively) - AHA and OMB have already submitted deregulatory ideas to OMB.

AHA here.  ACLA here.  18pp and 12pp, respectively.

##

I asked for a Chat GPT comparison.

##

Here is a detailed comparative analysis of the American Clinical Laboratory Association (ACLA) and the American Hospital Association (AHA) submissions in response to the Administration’s deregulatory RFI (2025), with an emphasis on the ACLA letter and then a structured contrast with AHA’s approach.

---

ACLA: Focused, Targeted Deregulation in Laboratory Policy

The ACLA letter is a highly focused, technically detailed, and policy-savvy document aimed squarely at regulatory barriers unique to clinical laboratories. It speaks the language of CMS rulemaking and OMB cost-benefit review, while laying out eight specific deregulatory proposals, most of which are highly actionable within current agency authority.

Core Themes of ACLA’s Strategy:

1. PAMA Reform (CLFS Rates):

   • ACLA sharply critiques CMS’s implementation of PAMA Section 216 and calls for rate freezes and updated data collection windows.

   • It frames the issue using statutory interpretation (e.g., CMS may reduce but not must reduce) and budgetary facts (CLFS cuts already exceeded CBO projections by $1.5B in just 3 years).

2. Medical Necessity Documentation:

   • Urges CMS to formally recognize test requisition forms (TRFs) as valid documentation — citing inconsistency among MACs and referencing MolDX precedent.

3. Prior Authorization and Date of Service:

   • Focuses on misuses of CMS’s “date of service” rule as a denial tactic.

   • Seeks amendments to 42 CFR §§ 414.510 and 422.122 to clarify payment pathways and prevent retroactive denials.

4. National Coverage Determinations (NCDs):

   • Proposes a streamlined process for NCD reconsiderations that expand (rather than narrow) coverage — aimed at unlocking innovation backlog.

5. Coding and NCCI Manual Conflicts:

   • Calls for deletion of several burdensome and contradictory clauses in the NCCI Policy Manual that conflict with AMA CPT guidance.

   • Seeks to align CMS with the official HIPAA code set source (CPT), asserting that CMS edits that deviate from CPT guidance should not stand.

6. Electronic Signatures:

   • Proposes a modernization of signature policy, arguing that HL7v2-based lab orders from EHRs inherently reflect physician intent.

7. ICD-10 Excludes Notes:

   • Argues that these create systematic denials of legitimate claims, especially when multiple ICD-10 codes apply.

8. CPT Licensing Fees:

   • Raises a broader issue of monopolistic pricing — that CMS mandates CPT codes but does not regulate AMA’s licensing fees — a rare deregulatory push on public-private cost imposition under HIPAA.

---

AHA: Broad, Systems-Level Deregulatory Agenda

By contrast, the AHA submitted an expansive and multi-faceted 100-point deregulatory agenda, organized into four domains: Billing/Admin, Quality, Telehealth, and Workforce.

Key Characteristics of the AHA Letter:

• Breadth Over Depth: The AHA letter is sweeping, aimed at reducing system-wide friction across all sectors of hospital operations — billing, regulation, safety, staffing, etc.

• Pragmatic Framing: Focuses on financial instability (40% hospitals with negative margins) and massive admin overhead ($1T/year) to justify relief.

• Policy Recommendations Include:

  • Repeal of CMMI Mandatory Models like TEAM and IOTA.

  • Rollback of CMS’s 2024 Information Blocking Disincentive Rule.

  • Codification and rapid implementation of Interoperability and Prior Auth Rule (CMS-0057-F).

  • Elimination of duplicative and outdated reporting (e.g., sepsis bundle, COVID-19 vax stats, 42 CFR Part 2 behavioral health privacy).

  • CMS survey reform, including virtual low-risk complaint surveys.

  • Major telehealth expansions including origin site, modality, and provider type.

  • HIPAA updates, such as removing breach notices for events under 500 persons.

---

Comparative Insights: ACLA vs. AHA Approaches

Theme	ACLA Approach	AHA Approach
Tone & Style	Technical, regulatory detail, aimed at CMS/OMB staffers	Advocacy-forward, sweeping, politically inflected
Focus	Lab-specific deregulatory pain points, especially CLFS and coverage coding	Entire hospital ecosystem: payment, surveys, workforce, quality, IT
Primary Regulatory Targets	CMS (CLFS, NCDs, PAMA, NCCI), HHS (HIPAA)	CMS, HHS, CMMI, OSHA, FTC, EPA
Use of Executive Order 14219 Framework	Strong alignment: cites each action under EO-defined categories like “not based on best reading of statute” or “excessive cost”	Implicit use; themes align but less explicitly cited
Actionability	Focused, rule-by-rule roadmap of actionable CMS revisions	Big-picture policy wishlist — some requiring Congress, many needing interagency coordination
Innovation Framing	Emphasizes how flawed regulation suppresses diagnostics R&D and precision medicine	Innovation cited more generally, especially in payment models and digital care delivery

---

Shared Ground and Divergence

Shared Ground:

• Criticism of Prior Authorization Abuse: Both criticize MA plans for using prior auth to obstruct care, especially retroactive denials.

• Telehealth Support: Both want telehealth regulations updated to reflect post-pandemic realities (origin site, behavioral health, hospice, etc.).

• Regulatory Overhead: Both highlight administrative burden detracting from patient care.

Divergence:

• Lab-Centric Issues: ACLA uniquely targets CPT license fees, Excludes Notes logic errors, and the misalignment of NCCI with CPT — none of which appear in AHA’s list.

• Payment Models: AHA squarely attacks mandatory CMMI bundles (TEAM, IOTA); ACLA does not engage payment reform beyond CLFS.

• Workforce & Accreditation: AHA’s list is heavy on workforce de-bureaucratization (e.g., NPs, surveys, OSHA), not relevant to ACLA’s world.

---

Conclusion

For a lab industry audience, the ACLA letter provides a precise deregulatory roadmap tailored to actual operational friction points in laboratory medicine — from pricing mechanisms (PAMA) to coding conflicts (NCCI/CPT), to coverage hurdles (prior auth). It is tightly written, strategically framed in EO 14219 language, and well-suited to OMB deliberations.

In contrast, AHA’s letter serves as a maximalist deregulatory manifesto, collecting long-standing frustrations across a fragmented hospital landscape into a single political and economic narrative. While both documents seek relief from regulatory burdens, ACLA is surgical, AHA is systemic.

Let me know if you’d like a one-page version, a chart-only summary, or a redline to use in briefings.

HHS Advice on De-regulation: Now Comment on Deregulation Ideas Across the HHS

 A few weeks ago, Medicare issued a call for ideas on how Medicare can  rapidly decrease regulatory burdens.  The input is open until June 10.

This week, all of HHS asks for about the same thing - how any part of HHS can kill burdensome regulations.

• Article at Fierce Healthcare here.   Article AHA here - Amer Hosp Assoc.
• See home article at HHS news room - here.
• See the new, May 14, 2025 request at 90 Fed Reg 20478, May 14, 2025.  Comments to July 14.
• Home page: https://www.federalregister.gov/documents/2025/05/14/2025-08384/request-for-information-rfi-ensuring-lawful-regulation-and-unleashing-innovation-to-make-american 
• PDF: https://www.govinfo.gov/content/pkg/FR-2025-05-14/pdf/2025-08384.pdf

###

There are some special webpages for deregulation like here and here.   

For example, AHA has already submitted 100 ways to deregulate on May 12 - here.

ACLA submitted deregulatory ideas to OMB, April 10, 12 pp.  here.

##

See an RFI for "the market for digital health products for Medicare beneficiaries."

https://public-inspection.federalregister.gov/2025-08701.pdf   (click link at top after 5/16).

See the Medicare simplification request, from April 22, open til June 10.

https://www.discoveriesinhealthpolicy.com/2025/04/cms-asks-for-ways-to-simplify-its.html

Although it goes in a different direction, you might also like to see this week's announcement of new directions and goals for CMMI - here.

###

Here's an AI take on the HHS-wide deregualtory request from May 14.

##

AI CLIENT MEMORANDUM
TO: Health Industry Clients
FROM: [Your Law Firm], Senior Partner, Healthcare Regulatory Practice
RE: HHS Request for Public Comment on Massive Deregulatory Initiative under Executive Orders 14192 and 14219
DATE: May 15, 2025

---

Overview

On May 14, 2025, the U.S. Department of Health and Human Services (HHS), under Secretary Robert F. Kennedy Jr., issued a sweeping Request for Information (RFI) as part of what is described as the largest deregulatory effort in the Department’s history. The initiative is aligned with President Trump’s Executive Orders 14192 (“Unleashing Prosperity Through Deregulation”) and 14219 (“Ensuring Lawful Regulation and Implementing the President’s Department of Government Efficiency Deregulatory Agenda”).

The RFI invites all stakeholders—including healthcare providers, payers, state agencies, technology firms, and patient advocates—to submit proposals to eliminate, streamline, or radically modify HHS regulations, policies, guidance documents, and reporting requirements.

Deadline for submissions: July 14, 2025, 11:59 PM ET

---

Context and Legal Basis

Executive Order 14192 mandates a “10-for-1” deregulatory model—for every new regulation issued, at least 10 existing regulations must be repealed, and the net cost of all new regulations must be significantly less than zero.

Executive Order 14219 compels agencies to identify regulations that are:

• Unconstitutional or legally dubious,

• Rooted in unlawful legislative delegation,

• Inconsistent with statutory authority,

• Imposing unjustified economic burdens,

• Stifling innovation or small business,

• Or otherwise exceeding executive power.

These actions are being coordinated through OIRA (Office of Information and Regulatory Affairs) and integrated into a new Unified Regulatory Agenda.

---

What HHS Is Asking From You

HHS seeks detailed stakeholder input on how specific regulations should be:

• Modified, rescinded, or repealed;

• Replaced with less burdensome alternatives (state or private-sector analogs encouraged);

• Updated to reflect technological advancement or better regulatory alignment.

Submissions should ideally include:

• Regulation citation or title;

• Responsible HHS office or program;

• Statutory authority for proposed changes;

• Detailed cost-benefit analysis (preferably consistent with OMB Circular A-4 and HHS economic guidance);

• Real-world implementation examples or data.

---

Questions HHS Wants Addressed

1. Which HHS rules are unconstitutional, unauthorized, or overly burdensome under E.O. 14219?

2. What rules interfere with reversing chronic disease trends (E.O. 14212)?

3. Which regulations are confusing, outdated, technologically obsolete, or duplicative?

4. Are there less burdensome alternatives used by states or the private sector?

5. Are any HHS rules inconsistent with other executive orders (e.g., E.O. 14151, 14154)?

6. What are the estimated cost savings of proposed repeals?

---

Strategic Considerations for Industry Clients

• This is a real opportunity to influence policy rollback. The Kennedy-led HHS appears serious about publishing stakeholder proposals directly into the Federal Register as draft rules or notices.

• Target regulations that impede innovation, such as legacy reporting requirements, burdensome IT documentation standards, or overlapping state/federal licensure rules.

• Use economic data and clinical case studies to frame deregulatory asks. The more “shovel-ready” your proposal, the better.

• If your organization operates under both CLIA and FDA, this is an ideal forum to challenge overlapping regulatory burdens on lab-developed tests or RUO products.

• Be aware: this is not a grant solicitation or funding opportunity, and HHS disclaims any obligation to respond individually.

---

Next Steps for Clients

1. Identify top 3–5 HHS regulations that are costly, obsolete, or duplicative for your organization.

2. Work with counsel or your compliance office to articulate statutory authority and suggest precise modifications or repeal language.

3. Submit your proposal before July 14 at www.regulations.gov/deregulation, under docket AHRQ–2025–0001.

4. Consider whether you want your organization’s name to appear on the record or to submit anonymously.

---

Conclusion

This RFI opens a window into the new regulatory strategy of the Trump Administration and Secretary Kennedy’s HHS. It is designed to rapidly unwind large portions of the administrative state—and healthcare stakeholders who submit thoughtfully supported proposals could have an outsized role in shaping which regulations survive and which do not.

We strongly encourage your compliance, legal, and policy teams to participate.

Let us know if you would like our firm’s assistance in developing or reviewing your submission.

---

Prepared by:
[Name]
Senior Partner, Healthcare Regulatory Practice
[Your Law Firm]

###

I also asked Chat GPT to directly compare the April CMS regulation RFI with the brand new HHS-wide deregulation RFI.

 ##

CLIENT MEMORANDUM
TO: Health Industry Clients
FROM: [Your Law Firm], Senior Partner – Healthcare Regulatory Practice
RE: Comparison of April 15 and May 14, 2025 Federal Deregulatory RFIs from CMS and HHS
DATE: May 15, 2025

---

Overview

In April and May 2025, two significant deregulation Requests for Information (RFIs) were issued by the Department of Health and Human Services (HHS). While both respond to Executive Order 14192, “Unleashing Prosperity Through Deregulation,” they differ in scope, target agencies, policy rationale, and deregulatory ambition. This memo compares:

• April 15 CMS RFI: Focused solely on Medicare-related regulations.

• May 14 HHS-wide RFI: Broad call to deregulate all HHS divisions, including FDA, CDC, NIH, and CMS.

---

Key Differences

Category	April 15 CMS RFI	May 14 HHS-Wide RFI
Issuing Agency	Centers for Medicare & Medicaid Services (CMS)	Department of Health and Human Services (HHS)
Target Scope	Only Medicare program regulations	Entire HHS portfolio (CMS, FDA, NIH, CDC, AHRQ, etc.)
Deadline	June 10, 2025	July 14, 2025
Submission Portal	cms.gov/medicare-regulatory-relief-rfi	regulations.gov/deregulation
Legal Authority Cited	EO 14192 (10-for-1 repeal of regulations)	EO 14192 and EO 14219 (lawful regulation mandate); references also EO 14212 (chronic disease), 14151, 14154, 14168, 14213
Tone and Framing	Efficiency, administrative simplification, provider relief	Sweeping deconstruction of the administrative state, restoring constitutional authority, and “Making America Healthy Again”
Stakeholder Targets	Medicare providers, Medicare Advantage plans, Part D plans, suppliers	Entire U.S. public: health plans, providers, state and local agencies, faith-based orgs, researchers, food producers, technology companies, etc.
Topics of Inquiry	Specific burdens in Medicare rules: reporting, documentation, duplicative requirements, cross-agency conflicts	Entire HHS regulation universe: unconstitutional rules, burdensome mandates, outdated tech, conflicting EO alignment, innovation barriers
Preferred Submission Format	CMS Form #s and OMB Control #s requested for clarity	Legal citations, economic estimates, and pre-drafted NPRM/DFR content encouraged
Deregulatory Metric	10 regulations repealed for every new one proposed; net cost of all new regs < $0	Same 10-for-1 repeal rule, but also a constitutional test, national interest test, and innovation test for all HHS rules

---

Strategic Insights

1. CMS RFI = Practical, Bottom-Up
   The April 15 CMS RFI is a relatively conventional deregulatory effort. It encourages providers and plans to highlight inefficiencies in Medicare’s Conditions of Participation, reporting rules, and documentation burdens. It focuses on administrative simplification and Medicare-specific cost relief.

2. HHS RFI = Ideological, Top-Down
   The May 14 RFI goes much further. It frames federal regulation as constitutionally suspect and economically harmful, and openly aims to dismantle major portions of the administrative state. It invites public participation in rewriting the regulatory role of HHS itself—from the FDA’s drug and device policies to NIH research protections and beyond.

3. Cross-Submission Opportunity
   Stakeholders with concerns that span both Medicare and other programs (e.g., Medicaid, FDA clinical trial requirements, LDTs, digital health tools) may submit parallel comments to both RFIs. HHS encourages submissions that can be directly adopted into the Federal Register.

4. Political Climate Caution
   The May 14 RFI’s constitutional language (e.g., “unlawful delegations of power,” “deconstructing the administrative state”) is ideologically charged and could face resistance in courts, Congress, or the next administration. Submissions should be grounded in cost-benefit analysis and statutory clarity, regardless of tone.

---

Recommendations for Clients

• Medicare-Only Clients: Focus your resources on the April 15 CMS RFI. Identify specific Medicare reporting/documentation rules that duplicate private payer policies or state mandates.

• Broad-Scope Clients (e.g., diagnostics, life sciences, health tech): Prepare submissions for the May 14 HHS RFI. Address overlapping FDA/CLIA/LDT burdens, 21st Century Cures Act conflicts, or outdated regulatory assumptions.

• Format Matters: Wherever possible, cite OMB Control Numbers (CMS RFI) or propose draft regulatory language (HHS RFI). Quantify burdens and potential savings.

• Review Past Submissions: Both RFIs build on Trump-era 2020 RFIs. Review past deregulatory ideas and update them for 2025.

---

Please let us know if you would like assistance drafting or reviewing RFI submissions or identifying high-impact regulatory targets.