Tuesday, March 25, 2025

FDA and Lab-developed Collection Kits: Law Firm Article

I am a reimbursement expert, not an FDA expert, but I will point out to clients who ship proprietary (non-FDA) collection kits, the FDA has sometimes been adverse to those.  (Not commonly.)

Zegarelli and Hawana of the Mintz law firm post an article about collection kits - titled, "FDA's Backup LDT Enforcement."

Find it here:

https://natlawreview.com/article/fdas-backup-ldt-enforcement-method-specimen-collection-kits

Pointed out by Heather Thompson at Linked In (here).


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AI CORNER

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AI summary.

TL;DR – Careful Summary of “FDA’s Backup LDT Enforcement Method: Specimen Collection Kits” (Mintz, March 13, 2025)

Even as FDA’s new rule to regulate laboratory-developed tests (LDTs) faces legal challenges, the agency has another powerful enforcement pathway: specimen collection devices and kits. These are separately regulated medical devices under existing FDA rules, even when used with LDTs.

Key Points:

  • Specimen collection devices and kits (e.g., saliva tubes, lancets, dried blood spot cards) are considered in vitro diagnostic (IVD) medical devices, regulated independently of the LDTs they support.

  • When multiple collection components are assembled and sold together (e.g., a branded home saliva kit), FDA considers this a “convenience kit” subject to device regulations, including establishment registration, labeling, quality systems, and sometimes 510(k) clearance.

  • For at-home collection kits, FDA requires human factors data showing safe use by laypersons, often a high regulatory hurdle.

  • Some labs and kit providers mistakenly assume these kits fall under LDT enforcement discretion—they don’t. FDA can target these kits even if LDT oversight is blocked or delayed.

  • Noncompliant kits—such as those marketed for unauthorized uses or directly to consumers without clearance—are at high risk of enforcement, especially if tied to serious health conditions like cancer or infectious diseases.

  • Clinical labs may face a Catch-22: to get a collection kit cleared, they must show it's safe with their specific LDT, but can't collect data without clearance—potentially exposing the LDT to FDA scrutiny.

Strategic Implication:

Regardless of what happens to the LDT final rule, the FDA can still enforce compliance by focusing on collection kits. Labs must ensure the kits they develop or distribute meet all applicable FDA device regulations—or obtain them from compliant third-party manufacturers. State agencies like New York CLEP are also emphasizing this requirement.

Bottom Line:

Specimen collection kits are a regulatory choke point for LDTs. Even if broader LDT regulation is stalled, FDA oversight of these kits is real, expanding, and enforceable now. Labs using or distributing them need a clear compliance strategy—or risk enforcement.

Monday, March 24, 2025

Nerd Note: MAC Contacts Table at CMS Database

 Are you looking for names and emails of CMS medical directors?   There's a report for that.

Go to the Medicare Coverage Database and click on REPORTS.   Under "Local Coverage" find the "MAC Contacts Report."    (Prior, there often had been a PDF of MAC contacts buried somewhere on the CMS website.)


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AI CORNER

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Chat GPT writes an excited article about the big news.

Nerd Note: 

How to Find CMS MAC Medical Directors 

(the Easy Way)

Are you on the hunt for CMS medical director names and emails like a hound dog sniffing out a scent trail? You’re in luck.

For years, Medicare stakeholders played “Where’s Waldo?” when trying to find who was in charge at their local MAC. If you were lucky, you stumbled across a crusty old PDF on the CMS website listing contact points—usually two versions out of date.

No more. CMS has given us a grown-up toy train set: a live, sortable MAC Contacts Report on the Medicare Coverage Database. This is your one-stop-shop for finding out who’s who at each MAC—from CGS to Noridian to Palmetto and beyond. Medical directors, emails, contracts, coverage areas—you name it, it’s here.

๐Ÿ‘‰ Head over to the CMS Medicare Coverage Database Reports page.
๐Ÿ‘‰ Click on “MAC Contacts Report” under the “Local Coverage” section.
๐Ÿ‘‰ Or go directly to the MAC Contacts Report here.

You’ll see contacts like:

  • Meredith Loveless, MD, Chief Medical Officer for CGS Part A and Part B (covering Kentucky and Ohio)

  • Neil Sandler, MD, leading CGS’s HHH MAC work across states from Colorado to Virginia

It’s all in there. You can even download the Excel file (the highlight of our week!) and nerd out on the full list, like any self-respecting policy wonk with a thing for coverage logic, LCDs, and email addresses ending in @cgsadmin.com.

So go ahead, bookmark it, share it, and bask in the glow of government transparency—one Excel file at a time.



Friday, March 21, 2025

AI in the Office: Chat GPT Reads NEJM Article on Burnout, Summarizes, Provides Infographic

 Interesting title in NEJM this week:

Evidence-Based Work Design — Bridging the Divide, by by Burden and Dirbye, 392:1044.

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Chat GPT provides a simple "infographic," then a short summary, then answers a question about what might actually be envisioned.

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AI CORNER

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AI Infographic

Evidence-Based Work Design — Bridging the Divide (NEJM, March 2025)

The article by Burden and Dyrbye argues that corporatization and financially driven decisions in health care are fueling burnout, moral injury, and inefficiencies among health care workers (HCWs). Much of the harm comes from modifiable but poorly designed work structures, which the authors label as “administrative harm.”

They call for a shift to evidence-based work design, using data-driven and iterative methods — similar to clinical evidence-based practice — to align job demands and resources for better outcomes. This includes using EHR metadata, AI tools, and predictive analytics to monitor and improve workload and team structures.

They advocate for interdisciplinary collaboration and innovative research (e.g., simulations, rapid trials) to guide best practices. The ultimate goal is to support health systems in achieving the quadruple aim: better health outcomes, improved patient experience, lower costs, and enhanced HCW well-being.

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Can you give some more specific examples?

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Great question — you're right that the article lays out a compelling framework but remains high-level on specifics. Based on the text and its implications, here are some specific changes that the authors likely envision as part of implementing evidence-based work design:


๐Ÿ”ง 1. Redesigning Staffing Models

  • Shifting from RVU-based productivity metrics to evidence-based staffing thresholds (e.g., optimal patient load per hospitalist or per nurse).
  • More thoughtful deployment of team members (e.g., when to use MDs vs. nurse practitioners vs. both) based on empirical outcomes rather than cost or habit.
  • Flexible team structures based on case complexity, not flat headcount.

๐Ÿ•’ 2. Monitoring and Adjusting Workload in Real Time

  • Use of EHR metadata (e.g., message volume, after-hours charting, click fatigue) to trigger automated flags when workload is approaching burnout thresholds.
  • Early-warning systems for unsafe staffing levels, akin to patient deterioration alerts.

๐Ÿ“Š 3. Embedding Simulation or AI-Based Planning Tools

  • Simulation models to predict the downstream effects of staffing cuts (e.g., how reducing a unit’s nurse coverage increases falls or LOS).
  • AI-powered planning tools to optimize shift design, break timing, or patient handoff processes.

๐Ÿ’ฐ 4. Reframing Financial Incentives

  • Moving from short-term cost-cutting to total cost of care modeling (e.g., recognizing that fewer doctors per shift may lead to higher readmission rates or burnout-driven turnover costs).
  • Payer or CMS pilot programs that reimburse based on staff well-being metrics or organizational sustainability.

๐Ÿ“‰ 5. Incorporating Work Design into Safety & Quality Dashboards

  • Adding workforce strain indicators to existing quality dashboards (e.g., ratio of in-basket messages per hour; % of after-hours charting).
  • Tracking clinician attrition and burnout as key organizational metrics, not just HR stats.

๐Ÿงช 6. Redefining What Gets Studied in Health Services Research

  • RCTs or robust observational studies comparing, say, 10 vs. 15 patient loads per hospitalist in terms of safety, satisfaction, and discharge efficiency.
  • Studies assessing which team configurations (e.g., solo NP vs. NP + MD) yield better chronic disease outcomes or fewer ED visits.

๐Ÿฅ 7. Co-Designing Workflows with Frontline Staff

  • Including clinicians in administrative design decisions through structured “co-design” processes.
  • For example, redesigning the inbox triage system with those who use it daily, not just IT or finance staff.

๐Ÿšจ 8. Guardrails on AI Implementation

  • Requiring evidence of time savings and safety outcomes before rolling out AI tools that increase clinician responsibilities (like documentation).
  • Avoiding the trap of offsetting AI efficiency gains by increasing visit volume quotas.

These would represent a paradigm shift: from reactive, finance-first staffing to a data-informed, adaptive, and humane approach to organizing clinical work. It’s an attempt to bring the same level of rigor to workflow design that we expect in prescribing a medication or evaluating a clinical intervention.

Want a summary of this list in a visual format (like a table or infographic)?


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WSJ: Doctors are as upset as patients.  Here.

Why AI-driven productivity is hard to measure in general.  Here.  Same topic but, why healthcare AI productivity is hard to measure.  Here.



Thursday, March 20, 2025

CMS Updates NCD Coverage for Cologuard, Guardant Shield, Illumina Trusight, Caris

CMS regularly publishes updates to its coding and coverage instructions for NCDs.   Find them here:

https://www.cms.gov/medicare/regulations-guidance/transmittals/2025-transmittals

On March 20, 2025, CMS released CR 13939 (T13097) updating its colorectal screening NCD and its NGS-tumor NCD.

https://www.cms.gov/medicare/regulations-guidance/transmittals/2025-transmittals/r13097otn

Bonus

At least when this PDF was released, the CMS reference to a cloud instructions file was a "dead link." ("Please follow the link below for the NCD spreadsheets ...")  This is a cloud copy I received (note it has many tabs).

https://docs.google.com/spreadsheets/d/1iYzETIFix-HfzHYxaTlU7QTdqNm9hTGc/edit?usp=sharing&ouid=110053226805181888143&rtpof=true&sd=true

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NCD 90.2 (NGS in Cancer) is updated for:

0448U, Pillar Oncoreveal Lung/Colon (Delete)
0523U, Pillar Oncoreveal CDx. (Start)

These are a little quirky because a recent AMA PLA update (Jan 1 2025) deleted 0448U effective January 1.  That AMA PLA update also made 0523U (22 genes FFPE) effective January 1, 2025.

ILMN Trusight Comprehensive, under code 81455 from August 21 2024 and under code 0543U effective April 1, 2025.    

Caris MI Cancer Seek 0211U, effective November 5, 2024.

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NCD 210.3 CRC Screening is also updated.

Add 74263, screening CT colonography.
Add Cologuard Plus 0464U (October 3, 2024)
Add 0537U CRC Guardant SHIELD (July 26, 2024)

There is also a comment, "remove stool-based language from policy to all for all non invasive CRC screening tests" (e.g. apparently stool or other media).  There is also a comment, "Subsequent omnibus CR with additional editing for expansion of colorectal cancer screening policy."  To me, these dangling comments are just cryptic.  NCD 210.3 actual text would be updated here.

There is a link to what I suspect should be a giant excel file, but for me today it's a dead link.

https://www.cms.gov/Medicare/Coverage/DeterminationProcess/downloads/CR13939.zip




Wednesday, March 19, 2025

The Year in AI: A Special Issue of "Sensitive and Specific" Newsletter

The newsletter "Sensitive and Specific" is worth tracking for frequent lab industry updates and insights.

I especially enjoyed their new issue, "AI Year in Review," covering a wide range of topics in the clinical lab, imaging, and beyond.

Find it here:

https://sensitiveandspecific.substack.com/p/sensitive-and-specific-the-year-in

It seemed appropriate to try an AI review of the special issue.



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AI Corner

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The 2024 AI Explosion in Diagnostics: Hype, Hope, and Hard Questions

The latest issue of Sensitive and Specific is a fitting encapsulation of 2024—a year in which AI didn’t just enter the diagnostic landscape; it steamrolled through it. The sheer breadth of developments covered in this special issue reinforces a point many in the molecular and diagnostic industries have sensed for some time: AI is not a tool of the future; it is the present.

While AI has already transformed radiology and imaging, the newsletter rightly highlights how digital pathology and patient-reported data analysis are rapidly gaining traction. The next challenge isn’t technical capability—it’s proving scalability, achieving physician buy-in, and navigating the regulatory maze. The comparison to the early days of genomic testing is apt. AI’s biggest barrier isn’t whether it works (it does); it’s whether clinicians trust it enough to change their workflows and decision-making.

AI Across Diagnostics: A Tipping Point?

The special issue lays out an impressive collection of real-world AI applications, from predicting pancreatic cancer 475 days before diagnosis to guiding ultrasound exams for non-specialists with expert-level accuracy. Some highlights:

  • Cancer detection: AI-assisted colonoscopy improved polyp detection by 40%, and AI-enhanced CT scans identified pancreatic tumors over a year earlier than standard screening.
  • Cardiology: Deep learning models can now diagnose coronary artery disease from retinal images—a development that could shift how we think about non-invasive screening.
  • Mental health & neurology: AI-based speech analysis is making strides in depression diagnosis, and machine learning models are showing promise in Alzheimer’s prediction.

And yet, the issue also captures AI’s limitations—notably, that AI doesn’t always improve radiology accuracy and that many AI-powered diagnostic tools remain uncovered by insurance.

Beyond the Hype: The Policy and Adoption Questions

The special issue smartly recognizes that AI’s greatest challenge is no longer whether it works—it’s how we integrate it responsibly into healthcare. The final section highlights:

  • Regulatory shifts: HHS now requires AI vendors to disclose training data—a crucial move for transparency and bias reduction.
  • Liability and reimbursement: Who is responsible when an AI-assisted diagnosis goes wrong? Will insurers pay for AI-enhanced diagnostics? These questions remain unanswered.

The Genie is Out of the Bottle

Perhaps the most important takeaway from this issue is that AI’s role in diagnostics is no longer theoretical. From early cancer detection to AI-driven sepsis prediction, 2024 cemented AI as an indispensable part of the diagnostic ecosystem. The wait-and-see approach that once applied to genomics is now being tested again, this time with AI. If history is any guide, those who embrace AI early will define the future of diagnostics.

For molecular and diagnostics professionals, this issue of Sensitive and Specific is required reading—not just to understand AI’s current capabilities, but to prepare for the seismic changes still to come.

Tuesday, March 18, 2025

AdvaMed Strongly Supports Dr. Oz for CMS; Wins Favorable Remarks; Lessons for AMA?

 In November 2024, AdvaMed's CEO rapidly released a favorable statement about the nomination of Dr. Oz to lead CMS.    Press release, news coverage:

https://www.advamed.org/industry-updates/news/advamed-statement-on-president-elect-trumps-intent-to-nominate-dr-oz-to-lead-cms/

https://www.medtechdive.com/news/Advamed-Dr-Oz-Trump-pick-CMS/733486/

At the CMS Senate hearing last Friday, Dr. Oz promptly featured his interest in rapid coverage for new technologies at Medicare.   The exchange was prompted by Sen. Daines (R-MT).

https://www.medtechdive.com/news/dr-oz-tcet-medicare-coverage-medical-devices/742611/

The sequence is, AdvaMed strongly supports the Republican nominee; then the Republican nominee gives a presentation where he in turn prioritizes a goal of AdvaMed. 

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This contrasts with a crisis brewing at AMA, where for several years, and worst this year 2025, physician payments for services have badly lagged inflation.    

https://www.ama-assn.org/system/files/2025-medicare-updates-inflation-chart.pdf

For nearly the first time in history, physician pay cuts continue, and were not fixed by a Congressional budgeting process.   This is a major hit for physicians and all services valued in RVUs (e.g. non-hospital-based MRI).

It's difficult to know how much a role AMA and JAMA positions constantly disagreeing with the administration played into the pay cuts.   But, a minimalist political argument would just point to the lack of AMA and JAMA positions supporting the administration.   For example, the AMA's journal JAMA Forum currently writes, "President Trump nominated Robert F. Kennedy Jr, an advocate known for false and misleading statements..." without qualifying the assertion.   That's their business, but it must make it harder for AMA to then negotiate sitting next to the same RFK Jr a few weeks later.  

And it's not just RVU's; UCSF's Vinay Prasad asserts the HHS is looking at AMA's "monopoly" on coding, a major source of revenue for AMA:



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3/20: Dr Oz in Charge of Medicare and Medicaid.

https://www.washingtonpost.com/opinions/2025/03/20/mehmet-oz-cms-medicare-trump/

3/20:  Dr Oz, the Grown-Up in the Room

https://www.theatlantic.com/health/archive/2025/03/dr-oz-senate-hearing/682102/



Chat GPT Answers a Question about U.S. ICD-10-CM

 I can't guarantee the precision of this AI answer but I believe it's directionally correct.

QUESTION

ICD-10 is the "international" classification of disease.   But it is also maintained by CDC and CMS, and edited and updated by them regularly.  Do what extent is our ICD-10 CM in the US "international" and to what extent "local" due to these CDC CMS updates?

### Chat GPT 4o:

ICD-10-CM (Clinical Modification) in the U.S. is both international and local due to how it is derived from and modified from the global ICD-10 standard.

International Aspects

  1. Core Structure from WHO – The ICD-10 system itself is maintained by the World Health Organization (WHO) as an international standard for disease classification.
  2. Fundamental Coding Categories – The broad chapters, category structures, and many codes remain consistent with WHO’s ICD-10 to ensure international comparability.
  3. Crosswalks with Global Systems – Because it is derived from ICD-10, ICD-10-CM maintains alignment for global epidemiological and statistical tracking.

Local (U.S.-Specific) Aspects

  1. Expanded Clinical Modification (CM) – The U.S. CDC and CMS developed ICD-10-CM to significantly expand ICD-10, adding thousands of additional diagnosis codes tailored to U.S. clinical and billing needs.
  2. Annual Updates by U.S. Agencies – Unlike the WHO version of ICD-10, which is updated less frequently, ICD-10-CM is updated annually by CDC and CMS based on U.S. healthcare policy, reimbursement needs, and clinical practice changes.
  3. U.S.-Specific Codes – Many codes are unique to ICD-10-CM and do not exist in the WHO’s ICD-10, such as codes for:
    • Specific social determinants of health (e.g., Z codes for housing or food insecurity)
    • U.S.-centric diseases and conditions (e.g., opioid epidemic-related codes)
    • Greater specificity for certain conditions to align with U.S. billing and compliance needs.
  4. CMS Influence on Coding Rules – The Medicare & Medicaid Services (CMS) define how ICD-10-CM codes are used for reimbursement, which adds an additional layer of U.S.-specific coding guidance that differs from how ICD-10 is used globally.

Conclusion

While ICD-10-CM is rooted in the WHO’s ICD-10, it has evolved into a heavily modified version tailored to U.S. healthcare, reimbursement, and public health tracking. This means international comparisons remain possible at the broader category level, but at the specific code level, ICD-10-CM is highly localized.





Monday, March 17, 2025

CMS Hasn't Released CY2023 Summary Part B Data (?)

 In my experience, dating back years, CMS releases Part B data by CPT code in two tranches.

In November, they release excel spreadsheets of national CPT usage and payment data, for the prior calendar year.   These go on a page called, "Part B National Summary Data File."   

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

In around June, they release very detailed data by lab and/or physician, in a cloud database.  This is data for the year 18 months prior.

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

Specifically, "Medicare physician and other practitioners by provider and service."

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

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However, right now in March 2025, the most recent data I can find is for CY2022 (which is available for both types of data above, the national Excel and the cloud physician- or lab-level data).    So what is missing is, the CY2023 data that should have appeared in November 2024 at the first link shown above (National summary data file) but has not appeared.

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There is one CMS cloud database that IS updated to 2023, which is "Physician Supplier Procedure Summary." [Link below.]  However, I haven't been able to sort and filter this 14M line database in a way that rolls up the data usefully without breaking each CPT code into too many lines.   

So I haven't published my normal Autumn summary of prior-year national data, such as fall 2024 report for CY2023.  For example, we'd ask what proportion of 2023 lab claims were under 81479, and other topics.

 https://data.cms.gov/summary-statistics-on-use-and-payments/physiciansupplier-procedure-summary/data


Sunday, March 16, 2025

CMS Releases NCD Proposals with CED; Calls it TCET; Relevant Article by Hernรกn et al

Background

Last year the Biden administration released a roadmap for coverage with evidence development (CED) called TCET - Transitional Coverage for Emerging Technologies.   The administration proposed 5 NCDs of this type per year, with review of each 2 years out.   At scale, this means 10 NCD reviews per year under TCET.   How CMS will pull this off has puzzled me, since CMS only does 2-3 NCDs per year.

Some initial data has emerged.   CMS has recently released 3 CED proposals that refer to TCET.  One is  for trans-vascular cardiac valves, a topic where CMS has done numerous CED NCDs for a decade.  In short, some types projects already being done under NCD-CED will now be tallied in the TCET column.

  • See CED for renal denervation, proposed 1-14-2025, CED for cardiac contractility, proposed 1-10-2025, CED for transcatheter tricuspid valve, proposed 12-19-2024.   
  • These all have CED, and all refer to TCET.
  • For example, we read, "CMS received a complete, formal request to provide coverage for the EVOQUE tricuspid valve replacement system (EVOQUE system). This is a Transitional Coverage of Emerging Technology (TCET) pilot. The manufacturer of this device tested the processes and concepts of TCET."
    • (CMS also proposed, on March 11, an NCD for home ventilation, a DME-like product, with no CED.)   
    • (CMS also finalized, on February 11, an NCD on pulmonary heart failure centers, that has CED, but doesn't mention TCET).

? Structure for CED:

See Hernรกn et al, 2025, "The Target Trial Framework for Causal Inference From Observational Data: Why and When Is It Helpful?"



While it's subscription-based at Annals of Internal Medicine, I was struck by the high-quality thinking in Hernรกn et al. (here).  Most CED studies have been based on registries, rather than detailed RCT's.   Hernan et al. describe an important approach to thinking about observational studies.    You should first lay out, in detail, a randomized controlled trial that answers the question that must be answered.    (This is the "Target Trial.")   Once you have done that, look closely at whether observational data (including a de factor control or comparison) can address the underlying question.    Hernan et al. argue that when this is done, and successfully, the observational data is very likely to be valid.   When the observational power falls short of key findings that an RCT would have provided, conclusions (if any) from the observational data are likely to be lacking or not be confirmable.   That's a summary; the full article lays out the logic and uses many examples.

For my money, the level of thinking in Hernรกn et al. goes beyond the level of logic brought to most discussions of CED.

Diagnostic Tests

Hernรกn et al. focus on interventional trials with therapies - you get a drug or placebo; you get a surgery or you don't.   With diagnostic tests, we more likely have accuracy data, clinical context, superiority to standard of care diagnostics, and decision impact.   You don't, for example, take a woman with a very low Oncotype score and give her chemotherapy, or a woman with a very high Oncotype score, and deny her chemotherapy.   

I've argued for years that simply evaluating diagnostics under the rubric "analytical validity, clinical validity, and clinical utility" is too vague, and more logic is required.   (It might be assumed that all the thinking and logic is just recreated for each new test assessment, pegged to AV, CV, CU).   In 2014, Frueh and I (here) wrote a paper on "defining clinical utility" where we argued that about six or seven questions are enough.   (One is too few - "do you have clinical utility" and 30 or 40 questions is too many).   These involved:

  1. What is the population?
  2. What is the standard of care test?
  3. What is the new test?
  4. What is the improvement obtained with the new test (e.g. #3 minus #2 = delta).   
  5. How much COULD that improvement affect clinical outcomes?
  6. How much DOES that improvement affect clinical outcomes?
  7.  Some measure of cost effectiveness or efficiency.
While we published this in 2014, and it's sometimes quoted, my experience remains if you badly fail some of these questions, a T.A. probably won't go well, regardless of exactly what method the T.A. uses.  If you can give a tight, logical answer in 2-3 sentences to all the questions, you'll probably do OK.

Similarly, for therapeutic questions and with observational data to look at, Hernรกn et al. provide a logical framework which should give decision-makers a lot of traction.

While I'm not at the level of Hernรกn et al., both their article and mine on diagnostics aimed to shine a light on ways of making data plans more sound and logical.

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Hernรกn et al., Abstract

When randomized trials are not available to answer a causal question about the comparative effectiveness or safety of interventions, causal inferences are drawn using observational data. 

A helpful 2-step framework for causal inference from observational data is 1) specifying the protocol of the hypothetical randomized pragmatic trial that would answer the causal question of interest (the target trial), and 2) using the observational data to attempt to emulate that trial. The target trial framework can improve the quality of observational analyses by preventing some common biases. 

In this article, we discuss the utility and scope of applications of the framework. We clarify that target trial emulation resolves problems related to incorrect design but not those related to data limitations. [BQ - And it highlights which is which.]  

We also describe some settings in which adopting this approach is advantageous to generate effect estimates that can close the gaps that randomized trials have not filled. In these settings, the target trial framework helps reduce the ambiguity of causal questions.

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AI CORNER
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See a Chat GPT 4o summary of the article.

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Final point.  This article discusses CED going forward as part of NCDs.  However, during the first Trump admininstration, HHS General Counsel took the position, CMS should not be doing CED at all, for legal reasons.   Here, here (Charrow 2021).

See an update 2025 on CMS coverage, Tunis et al.


Saturday, March 15, 2025

Chat GPT Finds Five Humorous Moments in Dr. Oz Senate Hearing

On Friday, March 14, 2025, Dr. Mehmet Oz met with the Senate Finance Committee, which reviewed his nomination for administrator of CMS.

For an AI-generated article based on the auto-transcript, here.

In this blog, I asked Chat GPT to find "moments of humor" in the transcript.  While these are hardly worthy of Mark Twain, the point is that Chat GPT understood the request, and, read through the three-hour transcript to retrieve five exact quotes that were in the ballpark of "humor."   

This would have taken a human much longer than three seconds.

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AI Corner, Chat GPT 4o

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Here are five moments of wit, irony, or comic timing from Dr. Oz’s hearing, using direct quotes from the transcript:


1. On His Marriage and Decision-Making

Dr. Oz: "My wife, Lisa, right there—I should point out, I married her in the wisest decision of my life, 40 years ago. And if I can just come close to being that insightful when I'm administering Medicare, confirmed by this committee, then I think it at least begins to battle some of the challenges we will face."
๐Ÿ“Œ Why it's witty: Oz humorously suggests that if he can make decisions at CMS as well as he did in choosing his spouse, everything will turn out fine.


2. On the Bureaucratic Nightmare of Medicare Mailings

Dr. Oz: "Has anyone ever read their Medicare mail? It's just not riveting reading."
๐Ÿ“Œ Why it's ironic: This is a deadpan critique of CMS’s own communication strategy, highlighting the unreadability of Medicare’s dense paperwork while subtly implying it needs fixing.


3. On Senator Wyden’s Jump Shot

Sen. Wyden: "I'd like to invite you this morning to come visit Malheur County if you're confirmed and see what this really means to rural communities."
Dr. Oz: "If confirmed, I commit to visiting with you—if you'll teach me your jump shot."
๐Ÿ“Œ Why it's witty: Oz sidesteps a tough policy question with a friendly quip, showing his TV-host instincts for banter.


4. On a “New Sheriff in Town” at CMS

Dr. Oz: "Part of this is just recognizing there's a new sheriff in town. We actually have to go after places and areas where we're not managing the American people's money well."
๐Ÿ“Œ Why it's ironic: He presents himself as a no-nonsense reformer, subtly calling out inefficiencies in CMS while playing on a Western-movie trope.


5. On His Senate Office “Thrashing”

Sen. Whitehouse (angrily pressing about Rhode Island’s Medicare payments): "CMS has sat idly by, looked at that payment differential and said, 'Oh, what a pity. Too bad. We're not going to do anything about it.'"
Dr. Oz: "Well, I did a little homework after the office visit—the thrashing that I experienced."
๐Ÿ“Œ Why it's funny: Oz lightly pokes fun at himself and acknowledges Whitehouse’s aggressive questioning, diffusing the tension.


These quotes show Dr. Oz using humor strategically—sometimes self-deprecating, sometimes sharp, but always aimed at lightening the room while keeping control of the conversation. Let me know if you’d like more examples or analysis!

Friday, March 14, 2025

Chat GPT Reviews Dr Oz Senate Hearing

Dr Mehmet Oz was the subject of a Senate Finance Committee hearing on March 14, 2025, to determine his nomination for administrator of CMS.

See extensive real-time updates captured at Healthcare Dive:

https://www.fiercehealthcare.com/payers/live-updates-dr-oz-senate-confirmation-hearing

See an article on Oz, the hearing, and coverage of new technology:

https://www.healthcaredive.com/news/dr-oz-tcet-medicare-coverage-medical-devices/742645/

The article below is written by Chat GPT, based on an Otter.ai transcript of the livestream [28,000 words].

https://www.youtube.com/watch?v=XWl2ms0lYgE



MAIN ARTICLE

   APPENDIX A:  PRIOR AUTHORIZATION REMARKS
   APPENDIX B:  DR OZ REGARDING EFFICIENCY
   APPENDIX C:  A "POLICY MEMO" ON A MORE EFFICIENT CMS

 Humorous Moments- here.




* MAIN AI ARTICLE*

Dr. Mehmet Oz Faces Intense Scrutiny in Senate Finance Committee Hearing for CMS Administrator Role

March 14, 2025 | Washington, D.C. (Chat GPT 4o)  — The Senate Finance Committee convened today for the confirmation hearing of Dr. Mehmet Oz, President Trump’s nominee for Administrator of the Centers for Medicare & Medicaid Services (CMS). The hearing, which spanned several hours, underscored the stark divide over Oz’s qualifications, policy stances, and past professional endeavors, setting the stage for what could be one of the most contentious CMS confirmations in recent memory.

A Nominee at the Crossroads of Medicine, Media, and Politics

Dr. Oz, a cardiothoracic surgeon and former television personality, presented himself as a reformer uniquely positioned to modernize CMS, citing his decades of clinical experience, academic research, and work in public health outreach through his syndicated television show. "All great societies protect their most vulnerable," Oz stated in his opening remarks, emphasizing his commitment to safeguarding Medicare, Medicaid, and the Children's Health Insurance Program (CHIP).

However, Democratic committee members, led by Ranking Member Ron Wyden (D-OR), painted a very different picture, raising concerns over Oz’s history of promoting dubious health products, alleged tax avoidance, and deep ties to for-profit insurance companies. Wyden accused the nominee of personally benefiting from Medicare and Social Security tax loopholes to the tune of $440,000 over three years, a charge Oz did not directly rebut.

Policy Battles: Medicare Advantage, Medicaid Cuts, and PBM Reform

A key point of contention was Oz’s stance on Medicare Advantage (MA). While the nominee lauded the program as a “market-driven benefit structure” that should serve as a model for CMS reform, Wyden and other Democrats expressed deep concern about its high costs and predatory marketing practices.

"Dr. Oz has made a lucrative career advertising for-profit insurance options targeting seniors," Wyden charged. "He even signed up to be an insurance salesman himself."

Senator Michael Bennet (D-CO) pressed Oz on whether he would support cuts to Medicaid, which many in the administration have floated. Oz sidestepped a direct answer, stating only that he “cherishes” Medicaid and wants to ensure its sustainability. When asked by Sen. Maggie Hassan (D-NH) how many children losing health coverage would be “acceptable,” Oz simply replied, “I don’t want children losing health insurance.”

Republican members, by contrast, praised Oz’s focus on chronic disease prevention and transparency initiatives. Committee Chair Mike Crapo (R-ID) highlighted Oz’s background in clinical innovation, particularly his advocacy for preventive health measures and nutrition-based interventions. “We need a CMS Administrator who understands the intersection of policy and real-world patient care,” Crapo stated, lauding Oz’s emphasis on “empowering beneficiaries” with information and AI-driven decision-making tools.

Oz, for his part, leaned heavily into technological modernization proposals, advocating for AI integration to streamline physician workflows and improve fraud detection mechanisms within CMS.

Pharmacy Benefit Managers (PBMs) and Preauthorization Reform

Oz faced bipartisan scrutiny over the role of pharmacy benefit managers (PBMs). Senator Chuck Grassley (R-IA), a longtime PBM critic, warned that CMS must hold these "powerful drug middlemen" accountable. Oz signaled alignment with the growing push for PBM reform, noting that “pricing spread” and lack of transparency in rebates contribute to rising drug costs. He vowed to pursue "radical transparency" in the drug pricing pipeline.

Preauthorization processes also emerged as a central focus, with Senator Bill Cassidy (R-LA) noting that cumbersome MA preauthorization requirements were delaying care and driving up costs. Oz agreed, proposing a more automated system that would limit preauthorization requirements to a select number of procedures, allowing real-time adjudication similar to a credit card transaction.

Medicare Funding and Fraud: Navigating the Fiscal Crisis

With the Medicare Trust Fund projected to become insolvent within the decade, fiscal concerns loomed large. Oz identified CMS’s ballooning expenditures—driven largely by chronic disease management—as a key area for reform. “We spend 12% of CMS’s budget on administrative costs,” he stated, suggesting that AI and automation could reduce bureaucratic waste.

Senator Sheldon Whitehouse (D-RI), however, redirected the conversation to payment disparities affecting Rhode Island hospitals, which he said are underpaid by 20-28% relative to neighboring Connecticut and Massachusetts. “CMS has sat idly by while Rhode Island hospitals hemorrhage funding,” Whitehouse fumed. “We are sick of it.”

Oz acknowledged the disparities but suggested that statutory changes would be required to fix them. Whitehouse vowed to keep pressure on the nominee should he be confirmed.

Controversial Past and Ethical Concerns

Several senators grilled Oz about his history of promoting questionable medical products on his television show. Hassan asked whether he stood by past endorsements of green coffee extract and raspberry ketones as “miracle” weight loss solutions. “I take great pride in the research we did at the time,” Oz responded, without fully disavowing his previous claims.

Hassan was unimpressed. “You are still unwilling to take accountability for your promotion of unproven snake oil remedies,” she concluded.

Senator Steve Daines (R-MT) shifted the conversation to abortion funding under Medicaid, asking Oz if he would commit to upholding the Hyde Amendment. “Yes,” Oz responded unequivocally, earning praise from conservative members.

The Road Ahead

Despite the sharp partisan divide, Oz’s confirmation remains likely, given the Republican majority in the Senate. However, he will face an uphill battle in gaining the trust of CMS career professionals, particularly as he navigates competing pressures from the administration, Congress, and stakeholders in the health insurance and provider sectors.

For CMS insiders, the hearing revealed critical early indicators of how Oz might govern. His commitment to modernization and fraud prevention resonated with many, but his reluctance to provide clear answers on Medicaid funding and Medicare Advantage oversight raised red flags. The fate of his nomination—and the direction of CMS under his leadership—will be closely watched in the weeks ahead.


 


APPENDIX A:  PRIOR AUTH



MORE ABOUT PRIOR AUTHORIZATION

Certainly! Based on the transcript, prior authorization (PA) issues were a major point of discussion, with Senator Bill Cassidy (R-LA) and Dr. Oz delving into its impact on Medicare Advantage (MA), physician burden, and inefficiencies within the CMS system. Below is a deeper dive into the key themes and proposals raised:


The Burden of Prior Authorization in Medicare Advantage

Senator Cassidy framed prior authorization as a mechanism that frequently results in delayed or denied care, emphasizing that such delays can lead to worsened health outcomes and higher overall costs. Cassidy provided an example from his discussions with a surgeon in Florida, who argued that if prior authorization had been granted more quickly, a patient's surgery would have been cheaper, the rehabilitation period shorter, and the overall outcome better.

This reflects a widespread concern among providers that prior authorization is used more as a cost-containment tool by insurers and Medicare Advantage (MA) plans rather than as a legitimate gatekeeping mechanism to ensure medical necessity.

Dr. Oz’s Perspective and Reform Proposals

Dr. Oz largely agreed with Cassidy’s critique, stating that prior authorization is a "pox" on the system and highlighting that CMS administrative costs consume 12% of its budget, much of which is attributed to bureaucratic processes like PA.

Oz acknowledged that preauthorization is necessary in some cases to prevent unnecessary procedures, but argued that it is being misused in ways that stall treatment, frustrate physicians, and drive up costs. He outlined several specific reform ideas:

  1. Reducing the Number of Procedures Subject to Prior Authorization:

    • Currently, there are approximately 15,000 procedures that go through some form of prior authorization in the U.S. healthcare system.
    • Insurance companies, in aggregate, list around 5,500 of these for preauthorization, but Oz suggested that the actual number needed may be far lower, around 1,000.
    • His argument: If the high-cost, high-risk procedures could be narrowly defined and standardized, much of the administrative burden could be eliminated.
  2. Establishing Clear and Immediate Criteria for Authorization:

    • Oz suggested a real-time adjudication system, comparing it to a credit card approval process, where decisions would be made nearly instantaneously based on pre-set clinical criteria.
    • Example: If a patient requires a knee replacement, and the criteria say that "if the knee can bend more than 120 degrees, the surgery isn't necessary," then approval or denial could be instant—eliminating the weeks or months of back-and-forth between doctors and insurers.
    • Such automation would also remove the opaque, shifting justifications that currently allow insurers to deny claims for inconsistent reasons.
  3. Minimizing Step Therapy Redundancies (aka "Fail First" Requirements):

    • Senator Cassidy raised step therapy as a related concern, noting that patients often must reattempt previously failed treatments when switching insurers—even when there is clear documentation that the previous treatments didn’t work.
    • Cassidy’s example: A patient with chronic pain or autoimmune disease may have already tried and failed multiple medications, but a new insurer forces them to "start over" with treatments that are ineffective before granting approval for the medication they actually need.
    • Oz agreed that this was a major problem, stating that CMS should be able to track past authorizations and use AI-supported tools to automatically recognize when a patient has already met criteria for an exception.
    • This could prevent patients from having to suffer through ineffective treatments again and reduce redundant paperwork for physicians.
  4. Addressing Upcoding and Overuse of Preauthorization:

    • Oz referenced systemic upcoding issues in Medicare Advantage, where some insurers push for inflated patient risk scores to increase reimbursement.
    • He implied that some prior authorization requirements may be tied to insurers’ financial incentives rather than patient outcomes, and that better oversight could help streamline the process.

Wider Implications for CMS Reform

The discussion of prior authorization underscored a broader philosophical divide about the role of CMS oversight vs. market-driven efficiency:

  • Democrats like Wyden and Hassan focused on preventing abuse by for-profit insurers that use PA as a cost-cutting measure that denies necessary care.
  • Republicans like Cassidy and Grassley argued for reducing bureaucratic hurdles that make it harder for doctors to practice medicine efficiently.
  • Dr. Oz positioned himself as an advocate for transparency and automation, suggesting that CMS could leverage AI and other tech solutions to standardize and expedite preauthorization, eliminate waste, and reduce frustration for both physicians and patients.

Next Steps and Challenges

While Oz’s proposals are ambitious and largely aligned with bipartisan frustrations, implementing them would require:

  • Regulatory clarity: Determining which 1,000 procedures truly require prior authorization and how automated adjudication would be structured.
  • Interoperability mandates: Ensuring that prior authorization histories follow patients across insurers to eliminate step therapy redundancies.
  • Stakeholder buy-in: Gaining support from both private insurers and provider groups, who may have competing interests in maintaining (or eliminating) preauthorization barriers.

Conclusion

The hearing made clear that prior authorization remains one of the most dysfunctional aspects of Medicare Advantage and private insurance alike. While Oz’s AI-driven solutions and real-time adjudication models may sound promising, the practical realities of CMS bureaucracy, insurer pushback, and provider resistance to automation could make reform a heavy lift.

However, if confirmed, Oz will likely face continued pressure from both Senator Cassidy’s camp (demanding faster approvals and physician autonomy) and Senator Wyden’s camp (ensuring insurers do not exploit preauthorization for cost-cutting at the expense of patient care).


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APPENDIX B:  EFFICIENCY

MORE ABOUT DR OZ AND MEDICAL EFFICIENCY

Yes, Dr. Oz raised multiple ideas in the hearing about how to make healthcare more efficient and reduce the administrative burden on physicians, who he acknowledged are "drowning in paperwork." While some of his proposals were broad, he repeatedly emphasized modernization, automation, and AI-driven efficiencies as key solutions.


Dr. Oz’s Vision for a More Efficient Healthcare System

During the hearing, Dr. Oz framed inefficiencies in the healthcare system as one of the biggest barriers to quality care, arguing that the current system is too focused on administrative processes rather than improving patient outcomes. He cited multiple statistics and examples to highlight the unsustainable administrative costs in CMS:

  • 12% of CMS’s total budget goes toward administrative processes rather than direct patient care.
  • Doctors and nurses spend as much time on paperwork as they do seeing patients.
  • Preauthorization, coding complexities, and fragmented communication lead to wasted time and money.

His core argument was that CMS must transition from an outdated, manual bureaucracy into a tech-enabled, real-time decision-making system that removes friction for physicians and patients.


Specific Proposals for Reducing Bureaucracy and Increasing Physician Efficiency

1. Reducing the Time Physicians Spend on Preauthorization and Insurance Hassles

  • Oz highlighted that doctors are forced to deal with preauthorization requests for thousands of procedures, many of which should be approved instantly.
  • His proposal: Limit prior authorization requirements to only the most complex, high-risk procedures—reducing thousands of hours of administrative back-and-forth.
  • He also suggested automating preauthorization approvals in real time, so that doctors receive instant decisions, much like credit card transactions.

2. Using AI to Automate Paperwork and Reduce Physician Burden

  • Oz made a strong case for leveraging AI and automation to handle billing, documentation, and prior authorization more efficiently.
  • He argued that physicians should spend more time with patients, not filling out forms and that AI can handle repetitive tasks like coding and claim submissions.
  • His vision is for real-time, AI-driven decision support tools that help doctors document care faster and get paid faster without jumping through bureaucratic hoops.

3. Real-Time Physician Feedback & Decision Support

  • Oz suggested that CMS should provide real-time insights to doctors within their workflow.
  • Instead of relying on after-the-fact audits and documentation reviews, physicians would receive immediate alerts and suggestions—allowing them to adjust treatment decisions in real time based on CMS guidelines.

4. Cutting Down CMS’s Own Inefficiencies & Making Rules More Transparent

  • He criticized the current CMS approach of mailing out hundreds of millions of dollars worth of paper notifications that few people read.
  • He proposed digital-first communication that would make it easier for providers and beneficiaries to understand new rules, payment policies, and coverage changes.
  • He also called for more transparency in CMS’s internal decision-making, so that doctors and hospitals aren’t caught off guard by new policies or denied claims.

5. Reforming Medicare Advantage (MA) Payment Models to Reward Efficiency

  • Oz acknowledged concerns about upcoding and excess costs in Medicare Advantage, but rather than scrapping the program, he suggested making payments more value-based.
  • He proposed tying MA payments to physician efficiency metrics, rewarding doctors who reduce unnecessary procedures and streamline patient care.

Physician Burnout: A Major Concern for CMS Policy

Oz’s comments reflected a recognition of the burnout crisis among U.S. physicians. His main focus was on how CMS policies contribute to physician frustration, particularly:

  • Long preauthorization delays
  • Complicated reimbursement rules
  • Excessive documentation and audits
  • Fragmented communication between insurers, providers, and government payers

His core argument was that these inefficiencies increase costs, delay care, and demoralize the medical workforce, ultimately making healthcare worse for both doctors and patients.


The Challenge of Implementation

While Oz’s vision of automation and AI-driven efficiency sounds compelling, his testimony lacked specific implementation details. The big questions left unanswered:

  • What specific AI tools would be used to streamline documentation?
  • How would CMS enforce real-time preauthorization decisions?
  • What safeguards would prevent AI from denying necessary care?
  • How would CMS ensure insurers comply with efficiency mandates?

If confirmed, Oz would face significant bureaucratic resistance from CMS career officials, private insurers, and even some physician organizations, which may resist AI-driven oversight of clinical decision-making.


Conclusion: Can Oz Deliver on His Efficiency Promises?

Dr. Oz clearly understands that administrative complexity is one of CMS’s biggest problems and that physicians are fed up with drowning in paperwork. His testimony indicates he would prioritize cutting red tape, modernizing CMS operations, and making Medicare payments more transparent.

However, the lack of concrete details on execution raises serious questions about how much of this agenda can realistically be implemented. CMS reform is notoriously slow-moving, and AI-driven automation of medical decision-making is a deeply controversial topic in healthcare policy.

If confirmed, Dr. Oz will likely need to show rapid progress in small, tangible areas—such as simplifying preauthorization for a subset of high-impact procedures or piloting AI-driven administrative tools in select hospital systems—before tackling larger system-wide changes.

Key Takeaways for CMS Experts

  • Oz wants to cut bureaucratic inefficiencies and make healthcare more tech-driven.
  • He envisions AI replacing many administrative tasks currently burdening physicians.
  • Preauthorization reform is a priority, with an emphasis on instant approvals for common procedures.
  • He wants CMS to be more transparent and communicative with providers and beneficiaries.
  • The biggest challenge will be turning these ideas into actionable policies without creating unintended consequences.

Would you like me to draft a follow-up CMS policy roadmap for these proposed reforms? That could outline how these ideas could actually be implemented in practice.


[Note to reader - Chat GPT formatted the above as a "policy memo," except added a lot of general ideas about CMS efficiency, whether they were mentioned by Dr Oz or not.  I had to ask it to rewrite, using only Dr Oz's testimony on 3/14.]




APPENDIX C:  

EFFICIENCY, WRITTEN AS A POLICY MEMO



Got it! Here's a tighter version of the policy memo, and this time, strictly based on what Dr. Oz actually said during the hearing, without additional extrapolation.


Here is the policy memo rewritten in paragraph form, maintaining clarity while selectively using structure for readability.


CMS Modernization and Efficiency Plan

Key Takeaways from Dr. Mehmet Oz’s Senate Hearing

A Policy Overview Based on Dr. Oz’s Testimony
March 14, 2025 | Senate Finance Committee Hearing on CMS Administrator Nomination

Introduction

During his confirmation hearing before the Senate Finance Committee, Dr. Mehmet Oz outlined his priorities for modernizing the Centers for Medicare & Medicaid Services (CMS), improving physician efficiency, and reducing bureaucratic waste. He emphasized that physicians are overburdened with administrative tasks and that CMS should adopt technological and structural reforms to streamline processes. His vision for reform centered on modernization, automation, and eliminating inefficiencies that delay care and drive up costs. This memo summarizes the specific reforms he discussed and how they align with current CMS challenges.

Prior Authorization Reform

A central theme of Dr. Oz’s testimony was the overuse of prior authorization (PA) in Medicare Advantage (MA) and the resulting delays in necessary care. He criticized current CMS policies that require preauthorization for thousands of procedures, many of which could be automatically approved based on established medical guidelines. He pointed out that physicians are wasting time on unnecessary denials and repeated approvals for treatments that should already be covered.

To address these inefficiencies, Dr. Oz suggested that CMS should reduce the number of procedures requiring PA. He noted that many of the 5,500 procedures currently subject to PA could be limited to a much smaller list of truly high-risk procedures. While he did not outline a specific methodology for determining which procedures should remain under PA, his comments imply that CMS should revise its guidelines to eliminate PA requirements for low-risk, routine services. Additionally, he advocated for real-time adjudication of PA requests, comparing the process to a credit card transaction, where instant approval should be possible for requests that meet clear-cut medical criteria.

Another key issue Oz addressed was step therapy and repeat authorizations, arguing that patients should not be forced to restart treatments that have already failed simply because they switch insurance plans. His remarks suggest support for a CMS tracking system that retains prior authorization approvals across insurers, ensuring that once a treatment pathway has been approved, patients are not subjected to unnecessary delays when moving between plans.

Reducing Physician Administrative Burden

Dr. Oz repeatedly emphasized the need to reduce the paperwork burden on physicians, arguing that doctors spend too much time on administrative tasks instead of patient care. He suggested that CMS should leverage AI and automation to streamline documentation and reduce excessive compliance requirements. While he did not propose specific AI tools, he stressed that automation could be used to reduce redundant data entry in electronic health records (EHRs), simplify billing, and eliminate unnecessary preauthorization requests. His broader argument was that technology should assist, not hinder, clinical decision-making.

Oz also highlighted the financial inefficiencies within CMS, citing that administrative overhead accounts for 12% of the total Medicare budget. While he did not provide a specific cost-reduction plan, his comments suggest that CMS should identify bureaucratic processes that can be streamlined or eliminated to free up resources for patient care. Additionally, he criticized Medicare’s complex audit and compliance rules, implying that CMS should reduce redundant documentation requirements and simplify Medicare billing to decrease the rate of technical claim denials. His overall stance suggests a desire for a system that rewards efficiency rather than punishing providers with excessive paperwork.

Transparency and Communication Improvements at CMS

Dr. Oz also focused on the need for greater transparency and clearer communication between CMS and healthcare providers. He noted that CMS policy changes are often unclear, making it difficult for physicians and hospitals to keep up with evolving Medicare and Medicaid regulations. He suggested that CMS should move away from dense, paper-based rulebooks [NOTE*] and transition to digital, interactive formats that are easier to navigate.

While Oz did not propose a specific new rulebook format, his remarks imply that CMS could develop simplified online tools to help physicians understand and comply with billing and compliance requirements. Additionally, he emphasized the importance of direct physician engagement in CMS rulemaking, though he did not outline a specific advisory structure. His testimony supports the idea that CMS should establish a more systematic approach for gathering physician feedback on regulatory changes, ensuring that new policies are informed by real-world clinical experience.

Conclusion: Dr. Oz’s CMS Vision

Dr. Oz’s testimony focused on three core efficiency goals for CMS: reducing unnecessary prior authorization to speed up care approvals, cutting down on administrative paperwork to allow physicians more time with patients, and improving CMS communication and transparency to make regulations clearer for providers. While his testimony provided broad principles rather than specific implementation plans, his statements indicate a strong push for modernization, AI-driven efficiencies, and reduced bureaucratic hurdles.

If confirmed, Oz will need to turn these ideas into actionable CMS policy changes. Some of the next steps for CMS should include:

  • Clarifying specific AI and automation initiatives that CMS should pursue.
  • Identifying which Medicare procedures can have PA removed or auto-approved.
  • Developing a clear plan for reducing CMS’s administrative overhead.
  • Improving CMS’s communication and rule-making transparency.

Although his confirmation remains uncertain, Oz’s emphasis on efficiency and modernization signals potentially significant changes for CMS operations. His proposals align with longstanding frustrations within the provider community regarding bureaucratic inefficiencies, prior authorization delays, and excessive administrative burdens, making these areas likely focal points for reform if he is confirmed as CMS Administrator.


This version maintains a professional policy memo format, while shifting to paragraph form for readability. Selective bullet points help clarify key takeaways, but the main structure is narrative-driven. Let me know if you'd like further refinements!


 

NOTE [*]  CMS may not use "paper based" rules but the point stands.  Federal Register and CMS policies are voluminous and are PDF-based, "as if" they were paper, and why not envision a portal-like, machine-friendly, AI-friendly approach to rules. 


 

Nerd Note: CMS 2025 CLFS Code List Includes Codes Deleted by AMA CPT

I'm willing to be proven wrong, but there seem to be some weird typos in the CMS Clinical Lab Fee Schedule published for 2025.   It seems to include a few codes deleted by AMA, and to ignore revised AMA CPT text for other codes.


What It Was Like

The mopath codes have long included 81432 (breast cancer gene panel) and 81433 (add on dup del studies).   And 81435 (Lynch syndrome gene panel) and 81436 (add on dup del studies.)

What Happened

AMA heavily revised these gene panel codes, 81432 and 81435.   At the same time, AMA deleted the dup del codes (deleted 81433 81436).

There was debate at CMS about how to price the new 81432 and 81435, but CMS settled on $1303, a PLA price used for a gene panel at Ambry (0129U).

What It's Like Now

Look up the CMS 2025 Excel spreadsheet, the standard reference for CMS's Clinical Laboratory Fee Schedule.  (Links below.)

81432 is there, with the correct new price $1303.    But the text shown is the old 2024 text.  And 81433 is still there, even though it's been deleted by AMA CPT (book, page 669).

Similarly, 81435 is there, with the correct new price $1303.  But the text is the old 2024 text.  And 81436 (deleted dup del code) is still there at CMS.

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What's Next?

CMS has just released Transmittal 13966, March 13, effective April 1, making these corrections.

https://www.cms.gov/files/document/r13104cp.pdf

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CMS 2025 spreadsheet

https://www.cms.gov/medicare/payment/fee-schedules/clinical-laboratory-fee-schedule-clfs/files/25clabq1

CMS new prices

https://www.cms.gov/files/document/r12992cp.pdf

Quest has updated its coding to reflect the new, more flexible ranges for 81432 and 81435 as revised by AMA.

https://www.questdiagnostics.com/content/dam/corporate/restricted/documents/icd-10-codes/CPT_-2025_-client-letter-v1-final-(002).pdf


81432 (AMA 2025 book)

Hereditary breast cancer related disorders (eg hereditary breast cancer, hereditary ovarian cancer, hereditary endometrial cancer, hereditary pancreatic cancer, hereditary prostate cancer), genomic sequence analysis panel, 5 or more genes, interrogation for sequence variants and copy number variants.  

Do not report with 81435, 81437

81433 has been deleted.  

To report dup/del only, 81479.

81435 (AMA 2025 book)

81435 (AMA 2025 code book)

Hereditary colon cancer related disorders (eg Lynch syndrome, PTEN hamartoma syndrome, Cowden syndrome, familiar adenopolyposis), genomic sequence analysis panel, 5 or more genes, interrogation for sequence variants and copy number variants

Do not report with 81432, 81437.

81436 has been deleted.  

To report dup/del only, 81479.


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PS  There seem to be some PLA codes released effective January 1, 2025, that are missing from this "January 1, 2025" excel, as well.