Thursday, February 29, 2024

CMS Update Notice - MolDx Updates a Major Transplant Article, CMS Highlights in New Press Release

 I've had a number of questions about the February 22 WSJ Op Ed about Medicare and CareDx, and I've been putting together notes for an essay.


UPDATE - On February 29, 2024, see


For some CareDx news from the day before, Feb 28, see my blog here.

See also coverage of these events at Genomeweb:

Wednesday, February 28, 2024

Brief Blog: CareDx and Medicare; 4Q2023 10-K Cites "Medicare" 215 Times. CMS Updates Press Release.

I've had a number of questions about the February 22 WSJ Op Ed about Medicare and CareDx, and I've been putting together notes for an essay.


UPDATE - On February 29, see

updated press release from CMS 

and updated billing article A58019 from MolDx.


But meanwhile, on February 28, CareDx held its 4Q-2023 investor call, and issued its updated SEC 10-K form.

Hint:  The 10-K report uses the term "Medicare" 215 times.  ("Coverage" appears 166 times, MolDx appears 82 times, Palmetto 16).

I fed the 10K and the WSJ into GPT4 and asked, what did it make of it?  It popped back with this illustration:

AI Corner

Besides the photo illustration, I asked GPT4 to "read" the 10-k and WSJ and write up an AI summary of them.   Find it here.  

In an auto transcript of the 50 minute investor call, 8500 words, we tallied "coverage" 35 times, "Medicare" 22 times, and "LCD" 4 times.  ("Capitol Hill" once.)  

In discussing operating expenses, CareDx remarked for the winter quarter, "The sales and marketing spend increased $1.6 million, primarily related to our targeted policy efforts to restore Medicare coverage." (That's about $100K a week for 12 weeks).

Between the 10-k report and 50-minute discussion, terms I've cited like "Medicare" and "Coverage" occurred some 540 times.

For comparison, Natera's Feb 28 10k mentions Medicare 52 times and the transcript, mentions Medicare 6 times.  

Out of curiousity I generated these pie and bar charts inside GPT4 rather than in Excel or PPT.

Nerd Note: AMA Explains "Image Bundling"

Coding in AMA CPT may include optional language, such as "Sequencing, including duplication-deletion analysis if performed."

One area of healthcare where separate coding, add-on coding, and bundled coding may fly together is imaging plus procedures.  The term of art is "image bundling" and it is an area of advanced policy at AMA CPT.

See their entertaining flow chart and instructions:

A JPEG is not as good as the PDF link above, but I include a JPEG also:

click to enlarge

Let's ask artificial intelligence (Chat GPT4) to have a crack at it for us:

Monday, February 26, 2024

Very Brief Blog: Natera Wins MolDx Coverage for MRD in Neoadjuvant Breast Cancer and in Ovarian Cancer

Header:  Natera, which provides the bespoke (patient-tailored) Signtera test for minimal residual disease, wins MolDx coverage for breast and ovarian cancer.


Natera's Signatera test, which screens for minimal residual disease with a bespoke test that is custom-tuned to each patient's prior tumor exome or large panel, adds more Medicare coverage from MolDx.

Coverage is for use in neoadjuvant breast cancer therapy (chemotherapy given prior to the initial lumpectomy), the first coverage of this category for MolDx.   In another first, Natera also announced coverage for MRD in ovarian cancer.

See the press release here:

The Natera Press Release - Structure and Function

In January, I wrote a blog article about how the Natera CEO presentation at JP Morgan was richly infused with facts and capabilities about their reimbursement expertise and tactics (here).  

Natera's new press release, just cited, is worth studying for its use of carefully footnoted facts, call-outs to guidelines, and links to key supporting publications (#4, #7).  The press release even includes selected citations to the size of population studied, number of unique biosamples, and some statistics.  The study cites pivotal publications in 2022 and 2023, which is related to MolDx reliance on published trials, and MolDx timeline (counted in quarters) for review of new indications not covered before.

Both key publications (Hou 2022 in ovarian and Magbanua 2023 in breast) are open access.  Example of the data power are shown in Hou 2022, Fig 3, where ctDNA+ relapse rate was 13%, vs 75% in ctDNA+.  Although the "N" gets smaller +20 months, relapse rate for ctDNA- remains low.

Hou 2022; Ovarian; Click to enlarge

The Magbanua paper includes online supplemental data such as patient-level Excel charts.

Magbanua 2023; open access patient level data in Excel


See open access coverage at Genomeweb here;

Friday, February 23, 2024

Journal Club: Peabody's 2021 Paper on Success and Failure in Diagnostic Startups

Header:  John Peabody founded the medical consultancy QURE.  In 2021, they published a paper on diagnostic startups, successes and failures, in "BMJ Innovations."


John Peabody MD founded the consultancy QURE (later acquired, still active).   

I stumbled across an interesting 2021 paper of his - find the article online here.  (Firewall).  For the BMJ Innovations journal home page - here.  

I clip the title and abstract below.   One of the coauthors,  Mickey Urdea, revisited in 2023.  See a 45 minute vlog.


Postmortems on diagnostic testing start-ups: 

Reports of commercial successes and failures and the case of the Zombie life science company.


Background From 2014 to 2017, more than 1000 diagnostic companies were launched, securing more than US$10 billion in investment.

Methods We performed an in-depth exploration of 28 diagnostic companies to differentiate successful and failed startups, plus a third ‘Zombie’ state where companies have achieved financial solvency but without long-term viability.

Results From these data, we created a five-phase, 13-item framework indicating the corporate health of a diagnostic company as it progresses from conception to commercialisation. We found 6 successful companies, 14 failures and 8 Zombies. On a scale of 0–26 points (two points per item), successful companies averaged 24.5 points (range 22–26), failures averaged 4.5 (range 0–16) and Zombies averaged 12.3 (range 3–23) (p<0.001).

To determine if there was any predictivity to this framework, we looked at only the first two phases (concept and feasibility/planning) of progress and found a distinct gradient in success potential based solely on these first two phases.

Conclusion Our five-phase framework generated a score that could predict diagnostic companies more likely to successfully and sustainably enter the market from those more likely to fail.


Take-home lesson, reading the business features left to right across the five columns, successes had mostly "green lights" as seen in the top rows. Failures had lots of "red lights" (bottom rows).


Not too surprisingly, QURE, which focused on helping startups with early commercial planning, found that higher quality early commercial planning was important.  (I focus on some of the same in a 2024 white paper on valuation and due diligence for genomics, here).

I also looked up the QURE paper at Semantic Scholar, a free resource..  This provides an interesting feature for every article - TLDR - which means "Too Long Didn't Read," essentially a 1-sentence summary of every paper it hits.  The webpage at Semantic Scholar for the paper should be here. And this is the automatic TLDR:

  • TLDR- "An in-depth exploration of 28 diagnostic companies to differentiate successful and failed startups, plus a third ‘Zombie’ state where companies have achieved financial solvency but without long-term viability. Generated a five-phase, 13-item framework indicating the corporate health of a diagnostic company as it progresses from conception to commercialisation."

Semantic Scholar lets you save the hit in a private library, get code to input into reference managers, etc.



I ran the PDF through  (More on Perplexity).


The paper titled "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) explores the outcomes of 28 diagnostic companies, categorizing them as successful, failed, or in a 'Zombie' state. The study presents a five-phase framework to assess the corporate health of diagnostic companies from conception to commercialization. Successful companies scored high across all phases, while failures lacked in meeting key criteria. Notably, failures often stemmed from issues like inadequate market understanding, technical barriers, or lack of clinical utility evidence. The study emphasizes the importance of thorough planning, market understanding, and meeting clinical requirements for successful diagnostic startups

Main Argument?

The main argument of the paper "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) is to present a comprehensive framework consisting of five phases and 13 items to evaluate the corporate health of diagnostic companies from inception to commercialization. The study aims to differentiate successful companies, failed startups, and those in a 'Zombie' state, where companies achieve financial solvency but lack long-term viability. By analyzing 28 diagnostic companies, the paper demonstrates that successful companies scored significantly higher across all phases compared to failures and Zombies. The framework developed in the study can predict which diagnostic companies are more likely to enter the market successfully and sustainably, highlighting the importance of strategic planning, market understanding, and meeting clinical requirements for the success of diagnostic startups

Key Findings?

The key findings of the paper "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) are as follows:

  1. The study analyzed 28 diagnostic companies and categorized them into successful companies, failed startups, and those in a 'Zombie' state.
  2. A five-phase, 13-item framework was developed to assess the corporate health of diagnostic companies from conception to commercialization.
  3. Successful companies scored significantly higher across all phases compared to failures and Zombies, with an average score of 24.5 out of 26.
  4. Failures often stemmed from issues such as inadequate market understanding, technical barriers, or lack of clinical utility evidence.

The framework created in the study could predict which diagnostic companies are more likely to enter the market successfully and sustainably, emphasizing the importance of strategic planning, market understanding, and meeting clinical requirements for the success of diagnostic startups

Weaknesses? Next steps?

The weaknesses of the paper "Postmortems on diagnostic testing start-ups: reports of commercial successes and failures and the case of the Zombie life science company" by Peabody et al. (2021) include:

  1. The study's sample size is relatively small, analyzing only 28 diagnostic companies, which may limit the generalizability of the findings.
  2. The paper does not provide detailed information on the specific characteristics or profiles of the companies analyzed, which could enhance the depth of the analysis.
  3. The study focuses on diagnostic companies in a specific timeframe (2014-2017), potentially limiting its relevance to current or future trends in the industry.

Good next steps for this research could involve:

  1. Conducting a larger-scale study involving a more extensive sample of diagnostic companies to increase the robustness and generalizability of the findings.
  2. Including more detailed case studies or profiles of the companies analyzed to provide a richer understanding of the factors contributing to success, failure, or 'Zombie' states.
  3. Extending the analysis to include diagnostic companies from a broader timeframe to capture evolving trends and dynamics in the industry.

These steps could further enhance the insights provided by the study and offer a more comprehensive understanding of the factors influencing the success or failure of diagnostic startups

As a Haiku?

Diagnostic startups,
Success, failure, Zombie states,
Framework predicts fate.

Thursday, February 22, 2024

AMA Posts Lab Test Agenda for May 2024 CPT Meeting

Header:  Months ahead of each CPT meeting, AMA publishes for comment the lab test agenda.


Months ahead of each CPT meeting, and before other codes, AMA publishes for comment the lab test agenda.  Find it here:

If you want to comment:

Read the PDF.  You must request a code of interest by February 29, and submit your comment by March 4.

In brief, lab codes are:

  1. MAAA code / bacterial vaginosis.
  2. CPT code - Neurofilament light chain
  3. CPT code - Pneumocyst. Jirovecii PCR
  4. CPT code - Optical genome mapping OGM
  5. CPT code - Cell enrichment by beads (for FISH)
  6. 0500T > CPT Code - HPV genotyping
  7. CPT code - Strep Ab
  8. CPT code - cytokine panel
  9. CPT code - Revise carrier genetic testing (81412, 81433)
  10. CPT code - Revise cancer risk panels (81432, 81435, others)
Under #10, there are current cancer risk panels for HBOC (e.g. BRCA et al.) and Lynch (most often colorectal risk).  Those panels look to be revised, plus a new pan cancer panel 81X01.

The OGM code should help Bionano, which has had growing revenues but just laid off 30% of staff.

The meeting will be May 9-11, 2024, in Chicago, both in person and virtual.  It looks like regular (non lab) CPT codes open for comment on March 1, 2024.  "Summary of Panel Actions" from the prior meeting a few weeks ago in San Diego, should appear by early March, but here.

AMA CPT comment portal:

AI Corner: SCITE, A Subscription Tool for Science & Policy Writing

Header:  SCITE is a subscription tool that supercharges your ability to instantly see and evaluate citations to an index paper.  In a few seconds, you get "the buzz" of what a dozen later papers think of your index paper.


There are coming to be hundreds of special AI tools, and a whole YouTube genre of reviewing them.  One that I've found useful a number of times is SCITE.   You give it an index paper, and it shows you all the papers that cite it.  But that's not what's new.  

SCITE also shows you the context in which each paper cites your index paper.  And that is truly a new capability.  Instead of finding and downloading a dozen PDFs known to cite your index paper, on one screen in a few seconds you can see the context of their remarks on your index paper.


Take an example. You figured out that the go-to paper on the fizzle of the CMS Oncology Care Model is JAMA, 2021, Keating.   Here it is highlighed as a key paper in SCITE.

One of the articles that cites KEATING, is BROOKS 2022.  OK, now in Brooks 2022, Keating is reference #13.   And SCITE will show you all 6 places where Brooks refers to Keating 2021, and the context, like a half paragraph.

One more example.  Landom 2023 also Keating multiple times,  But in Landom 2023, the Keating article is "Ref #7".  So here, SCITE pulls up the places where Landom cites to Landom's Ref 7 which is Keating 2021.

There are many more bells and whistles in SCITE but this a key capability.
Other resources of potential interest are Semantic Scholar, Google Biomed Explorer.  See also the general AI  sources and  The latter 2 are both general AI's, with a free tier, but which are especially adept with citations.  I showed an example of drafting a footnoted article with Perplexity in an earlier blog.

See my mini review of SCISPACE, which is different but complemntary to SCITE.  

Nerd Note: CMS DeepSixes the Advanced Imaging "Appropriate Use Criteria" that Congress Gave It

Header:  The Lab Industry remembers PAMA 2014 for lab pricing law, but it also created Appropriate Use Criteria (AUC) for Imaging.  It's fallen down, as did a Radiation Oncology payment model.


PAMA #1 - Lab Price

PAMA, the Protecting Access to Medicare Act, in the lab industry is shorthand for a major new lab test repricing law, based on median community pricing of lab tests.  PAMA has been on hold and in limbo from 2020 to at least 2025.

PAMA #2, #3 - RVU Rules and AUC Project

Two other initiatives from PAMA were a section that gave CMS much more authority to set and revise RVU values, and a section that created mandatory "Appropriate Use Criteria" for advanced imaging (e.g. MRI).

The Advanced Imaging AUC Project

The AUC proceded in fits and starts and has finally been put on hold indefinitely, as per a recent notice to contractors from CMS.   More details could be found by perusing 8 years of Federal Register annual rulemakings on the topic.

Tie In to Genomics

I thought the AUC was worth watching becaise" if you could apply required AUC to orders for $600 MRI tests why not also apply required AUC rules to $3000 genomic tests.   


BTW - RO Model Also Deep Six'ed

Speaking of radiology, another issue was radiotherapy, where CMS proposed an unpopular Radiation Oncology bundled price model that was "modality agnostic."  This was extremely unpopular in the clinical community and was even delayed sometimes by an act of Congress.   See an extensive, 6-page letter on perceived severe problems with RO MODEL, written by numerous stakeholders to CMS in 2021.

See a 2021 article on RO MODEL by Milliman here.

In 2022, the RO MODEL was delayed or suspended to cancel a prior go live date in 2023, and stop or delay out to a future date "to be determined." 

See ASTRO,   

See also Fierce Healthcare on the same topic,

AI Corner

Perplexity discusses the 7-page ASTRO and multi stakeholder complaint to CMS, here.

Wednesday, February 21, 2024

A Different AI: "" Talks About Value-Based Care in Oncology

Header:  In a few seconds, an alternative, open-access AI (Perplexity) generates several short essays about the outlook for value-based oncology.


A few weeks ago, this blog highlighted a new article by two oncologists, Klein & Kolodziej, here.  Their new article is a look-back and look-forward relative to their ten-year-old forecast for value based care and value based payment in oncology.


Fast forward.  This week, I've had several sessions playing with the free level of   In the example below, I asked it three questions about value based care in oncology.  1) What's a general overview; 2) What's the main barriers, and 3) What's the five year outlook?   

In each case, Perplexity combines very rapid internet research and a strong general knowledge database (as in "regular" AI like Chat GPT).  

Perplexity also extensively footnotes its reports.   One of the big concerns of 2023, that AI's would not give sources and would make things up, is largely left in the rear view mirror, when you use Perplexity.   

Except for the text in red, everything below was written in a few seconds by Perplexity.   Some of it is sharp; some of it is harmless general prose.   It would certainly jump-start someone who had to think about this topic and didn't have a starting place.


Unfortunately, I couldn't get the Perplexity report to word-wrap correctly on this blog, so to read the report with the important web links, I'll need to send you either to Plexplexity (in open access mode) or to Google Doc, below.




All the text below, except that in red, were generated in a few seconds by Perplexity. To click on links, use the cloud based document resources above, not the passage below.


Part 1 - 

Overview of a Report on Value-Based Oncology

To write a comprehensive report on value-based oncology care, focusing on patient outcomes, cost-effectiveness, provider incentives, and challenges, it's essential to integrate findings from recent studies and analyses. Here's a structured approach to crafting your report:


Begin with an overview of value-based care in oncology, emphasizing the shift from volume-based to value-based models. Highlight the global need for affordable, accessible cancer care that produces optimal patient outcomes1.

Patient Outcomes

Discuss how value-based care aims to improve patient outcomes by focusing on the quality rather than the quantity of care. Mention the lack of standardization in measuring long-term patient outcomes and the need for universal clinical and patient-reported outcome measures (PROMs)1. Also, address the challenges in implementing these measures, especially in less developed countries1.


Examine the financial aspects of value-based care, including the rising cost of cancer care and the financial toxicity associated with it2. Discuss strategies to improve cost-effectiveness, such as using composite tools to assess the value of drugs and increasing cost communication between patients and oncologists2. Highlight the importance of frameworks like the ASCO Value Framework and the ESMO Magnitude of Clinical Benefit Scale in assessing the value of clinical interventions2.

Provider Incentives

Explore how reimbursement incentives influence physician practice in oncology. Mention that value-based reimbursement policies may align physician incentives with patient needs more effectively3. However, also note the skepticism among physicians regarding the impact of financial incentives on their practice3.


Identify the primary challenges in implementing value-based care models, such as navigating the payer landscape, identifying cost-reduction opportunities4, and accounting for patient and disease complexity5. Highlight specific examples where value-based models like the Oncology Care Model failed to account for these complexities, leading to financial losses5.


Conclude by emphasizing the potential of value-based care in oncology to align healthcare delivery with patient needs, improve outcomes, and manage costs. However, also acknowledge the significant challenges that need to be addressed, including standardizing outcome measures, ensuring cost-effectiveness, aligning provider incentives, and overcoming implementation barriers.

Throughout the report, use examples from the provided studies to illustrate both successful implementations and areas where value-based care models have fallen short. This balanced approach will provide a comprehensive view of the current state of value-based oncology care, its potential benefits, and the obstacles that must be overcome.

Part 2 - 

What are the key challenges to implementing value-based care in oncology?

The main challenges and hurdles that have impeded the development of value-based oncology payments include:

  1. Lack of Standardization in Measuring Performance: It is difficult to measure performance from clinic to clinic, cancer site to cancer site, or physician to physician. This lack of standardization makes it challenging to define value in cancer care3.
  2. Difficulty in Defining Value in Cancer Care: There is no unanimous agreement on what "value" means in cancer care, making it challenging to establish value-based payment models3.
  3. Application of Quality Measures: The main challenge of value-based cancer care for payers and providers is the application of quality measures. There is a big push to use pathways and guidelines in the entire oncology arena, but putting these pathways into place is a challenge3.
  4. Problems with Benchmarks: It's hard to get into a value-based care contract if there is no historical data to show how a provider performs. Additionally, benchmarks can be problematic if something changes in the regular treatment of a disease4.
  5. Reporting Burden: The amount of data that needs to be reported to take part in value-based care programs is substantial, and it can be challenging to capture all the necessary data4.
  6. Difficulty in Defining "Value": It is difficult to define value-based care in any area, particularly in cancer care. There are challenges in defining the value of a life and determining the point of diminishing returns for certain therapies3.
  7. Financial Toxicity for Patients: The financial fallout of a cancer diagnosis can play a significant role in patients' outcomes, leading to severe financial toxicity for many patients5.

These challenges have contributed to the complexity and slow progress of implementing effective value-based oncology payment models. Overcoming these hurdles will be essential for the successful development and implementation of value-based care in oncology.

Part 3 - 
What is the 5 year outlook? 
You are chief commercial officer, for biotech, precision oncology, and genomics.

The five-year outlook for value-based care in oncology presents a landscape of both potential growth and persistent challenges. Specialists are expected to accelerate the adoption of value-based care models, leading to increased effectiveness and scalability, particularly in fields like nephrology and oncology2. However, the transition to value-based care in oncology is not without its hurdles. 

The Oncology Care Model (OCM), a major attempt to introduce value-based care into oncology, faced difficulties, with the successor model, Oncology Care First, now in doubt5. The OCM demonstrated challenges in managing the cost of new and expensive cancer therapies, impacting the ability to achieve cost savings5. Despite these obstacles, the potential for growth in value-based care remains significant, with the landscape evolving to address issues of quality, outcomes, and cost management2.

In the next five years, the value-based care market could reach a valuation of $1 trillion, driven by increased adoption and enhanced capabilities across providers, employers, and other healthcare stakeholders2. The continued traction in the value-based care market is expected to lead to improved quality of care and outcomes while providing benefits for patients, clinicians, and investors2. However, it's crucial to address the challenges related to cost management, equity issues, and the development of effective payment models to ensure the success of value-based care in oncology5.

In summary, the five-year outlook for value-based care in oncology presents a landscape of potential growth and continued challenges. While the adoption of value-based care models is expected to accelerate, addressing issues related to cost management and equity will be crucial for its long-term success. The evolving landscape of value-based care in oncology holds significant potential for improving patient outcomes and delivering benefits across the healthcare ecosystem.

click to enlarge

Separately, Perplexity discusses a 7-page letter that stakeholders sent to CMS in 2021 opposing a radiation oncology value based purchasing proposal, here.

 (More on Perplexity).  (Here too.)

Tuesday, February 20, 2024

Medicare to Tighten Access to Research Data; Some Are Upset

Header: Some groups are quite upset at CMS proposals to close or tighten access to research data.


CMS has very extensive public data resources as well as massive data resources available through agreements and contracting.

According to several recent news sources, CMS plans to make the data access harder, to say the least.   See an article at Forbes here:

At Medriva here:


See a CMS announcement that the news articles are building on:


See recent articles about how $2B in Medicare fraud was picked up by outside parties (like ACO's) through their access to relevant CMS data - here.

I don't believe this affects currently open access data such as, "Medicare Physician & Other Practitioners by Provider and Service."  What does that mean?  Physician by Provider - doctor by doctor name.  By Service - by CPT code.  Each doctor and each paid CPT code he got, by year.   Here.

Monday, February 19, 2024

Decibio: Vision of the Future under FDA LDT Regulation (White Paper)

Header:  Decibio has released a 15-page white paper that assumes the FDA LDT regulation will go forward, more or less just as proposed, and then taking a wide view of the strategic implications.


The FDA's proposal to regulate LDTs, rolling out reviews or test withdrawals within a few years, has triggered many responses.   Some organizations are strongly supportive, others are strongly opposed (for the downsides, see exhibits like the ACLA comment letter and the Hyman Phelps comment letter).  For the FDA's plans (full steam ahead) see links and quotes from FDA, here.

The Decibio White Paper on FDA LDT

The consultancy Decibio has released an important 15-page white paper that takes a distinctive posture.  The white paper assumes the FDA LDT regulation will proceed, more or less as proposed, and then takes an elaborate and wide-ranging view of what that means for stakeholder strategies.

Find it here:

Worthwhile reading.  


I've mostly had a different entry point - that the costs and man-years of labor both at FDA and outside it make the plan unfeasable at anything like its current form/  Nobody has $50B to spend on a couple years on regulatory labor, nor does the labor even exist, if the money appeared.

Plus, tie-ups in court could last several years (see ACLA and Hyman Phelps earlier). Under the resulting mess, alternatives like VALID could resurface, not now, but in 4-5 years...  By which time the US would also incorporate what would be several years of European experience with the LDT lessons from the imminent IVDR.    

AI Corner.

This is how Chat GPT spontaneously intepreted the white paper (click to enlarge).
clilck to enlarge

Thursday, February 15, 2024

Fortune Mag: Venture Capital, from Age of Unicorns to Age of Unicorpses

You haven't seen much about Theranos or WeWork or Bird or other venture capital "unicorns" (valued over $1B) a few years ago.

Here's how Fortune magazine captures the shift in venture funding from left to right:

Mintz Summarizes Really Important New Rule on "Algorithms" in US Health Systems, Effective Soon

In December 2023, HHS released a major, very important rule about AI and Predictive Algorithms (broadly defined) in EHRs. See press release. See fact summary. See Federal Register. See PDF, 247pp (Dense!) here.  Jump to pagea 1245-46 for an idea of what's in and what's out.  (They're only able to give a probabiiltic, not a  clean, answer when asked if the BMI algorithm is in and out.  "Likely" not in, but don't pin us down...)  

i can't do justice to the complexity of this rule, but the Mintz law firm can. Here is a go-to detailed article on the requirements:

VERY worth while reading.  By attorney Pat Oullette.  The actual 247 page rule is very dense, and in some parts, scary.  Regarding overlap with FDA regulations for software and  SAMD, they remark helpfully that if you've made it through FDA, you likely have much of the data required by THIS separate complex rule.  But no guarantees.  


AI Corner.

While I can't recommend the Mintz article highly enough, and it's quite detailed, as an experiment I asked the AI resource Perplexity to summarize the rule, too.

Wednesday, February 14, 2024

LA Times on New Alzheimer Biomarkers: What Would Chat GPT Say?

On February 14, 2024, LA TIMES published a lengthy and mostly negative article about in-process new guidelines for Alzheimer biomarker testing.

This was a cover stody at LATimes on Sunday, February 18.   See a coincidental Op Ed on prodromal diagnostics, at JAMA NEUROL by Erickson here.


I asked Chat GPT for a review and "critique" ... to see what would happen.


Since the whole point of the experiment is to see what Chat GPT would make of this, pro and con, I've put the Chat-generated article over here.  

It's about Chat GPT.  It's done as an experiment in what AI could write, not claiming to be the "correct" assessment of the LAT article as it lays out pro's and con's.

The Future of Medicare: the Bipartisan Policy Center Weighs In (December 2023)

In December 2023, the Bipartisan Policy Center released an 85-page report on the future of Medicare.  See the press release and the PDF here:

The BPC's comprehensive report outlines urgent reforms needed to sustain Medicare, focusing on immediate restructuring to ensure affordability and the program's long-term viability. It proposes consolidated deductibles, an out-of-pocket spending cap, and adjustments in Medicare Advantage payments, emphasizing the need for bipartisan support to enact these critical changes.



AI Corner

Executive Summary

More than 65 million older Americans and those with disabilities rely on Medicare for health care, but as the population rapidly ages, the program faces increasingly urgent financial challenges. Indeed, expenditures in recent years have consistently outpaced dedicated revenue streams. With Medicare’s Hospital Insurance (HI) Trust Fund facing insolvency by 2031, and with beneficiaries and taxpayers frustrated by the lack of progress in ensuring greater affordability, policymakers must overcome their political fears of addressing the problems and focus on reforms that will sustain and improve Medicare in the coming years.

Central to ensuring Medicare’s long-term survival is for Congress to address the program’s core financial issue—the gap between rising spending and lagging revenue. Medicare now covers nearly 20% of the U.S. population, and total expenditures for benefits are projected to exceed $1 trillion this year, up from $580 billion only 10 years ago. The number of workers who help finance the program through payroll taxes relative to the number of beneficiaries is declining. There were about four workers for every beneficiary from 1980-2008; by 2022, the number had dropped to about 2.9, and by 2030 it is expected to be 2.5.

Congress also needs to examine a second significant problem: how Medicare can better meet the needs of enrollees. Beneficiaries, many of whom are retirees on fixed incomes, are struggling to pay their share of expenses and navigate a complex Medicare system to find the right coverage and benefits. Health care advocates question the program’s fairness, too, as some enrollees get benefits that others do not, depending on which coverage options they select.

In this report, the Bipartisan Policy Center issues recommendations for Congress to improve the program—both its financing and the benefits it provides. BPC’s 2021 report, The Cost of Waiting to Act on Medicare’s Hospital Insurance Trust Fund, points to recurring examples of policymakers’ hesitancy to address reform, analyzes various reform proposals, and demonstrates that waiting only increases the price of action.

Congress has been reluctant to address Medicare’s long-term solvency, due largely to the scale of the financial adjustments required and aversion to the political risks involved. Reforming Medicare undoubtedly will invite political opposition: Older Americans turn out for key elections in disproportionately high numbers. Earlier in 2023, when some in Congress suggested restraining Medicare spending as part of a deal to raise the debt ceiling limit, others strongly opposed the move. In his State of the Union address in February 2023, President Biden urged both parties to commit to keeping Medicare benefits unchanged. In a rare demonstration of unity, both Democrats and Republicans stood and applauded. Without a politically viable path toward bipartisan compromise, Congress took Medicare changes off the table and raised the debt ceiling in May without addressing the challenges facing the program when it passed the Fiscal Responsibility Act of 2023.

That said, a politically viable path forward is possible, and this report outlines how. It is not without precedent for Congress to act on a bipartisan basis to address Medicare’s cost and solvency issues. Examples include but are not limited to the Social Security Act Amendments of 1983, which established a new prospective payment system for inpatient hospital services, and the Balanced Budget Act of 1997, which established both a prospective payment system for outpatient services and Medicare Part C. Both examples occurred when divided government existed, which is to say different parties held the White House and at least one chamber of Congress. Indeed, the political divide is virtually a prerequisite to avoid the temptation to politicize any effort to improve Medicare. These previous accomplishments demonstrate policymakers’ ability to come together when the need arises and leaders of the two parties lead.

This report creates a road map for bipartisan action that Congress should pursue in a two-step process. The changes in the first step would secure meaningful improvements that would make Medicare more affordable for the federal government, taxpayers, and beneficiaries. It also lays the foundation for a second set of fundamental reforms that build upon the first step’s goals by ensuring further simplification for beneficiaries and promoting competition within the program.

The road map’s first step, outlined in Phase 1 below, calls on Congress to immediately address the HI Trust Fund’s impending insolvency and affordability challenges for beneficiaries by slowing spending increases and raising revenues. At the same time, policymakers would enhance Traditional Medicare (TM) by improving benefits, reducing costs, and simplifying the program for easier access.

Phase 1 also addresses enforcement of past triggers that Congress has instituted—but ignored—to force action when federal spending on Medicare dangerously exceeds revenues. To be sure, important new prescription drugs and devices are contributing to Medicare’s increased spending, and that should be a factor for policymakers to consider as they make decisions about appropriate levels of spending. Nevertheless, it will be important to fix the current general revenue trigger so that it more effectively pressures Congress and the administration to take corrective steps as appropriate to ensure the program’s financial sustainability.

The recommendations in the second step, outlined in Phase 2, would create apples-to-apples competition between Traditional Medicare and Medicare Advantage (MA), allowing beneficiaries to easily compare these coverage options based on a standard set of benefits.

It is crucial for Congress to embrace both parts of this road map; rationalizing and improving how MA plans and TM fairly compete within an improved competitive policy will not in and of itself address all solvency and affordability issues facing the program. Because of demographics, Medicare’s costs will increase regardless of how efficient the program becomes; enhanced revenues and payment reforms, as a result, will have to be part of any bipartisan compromise that thoughtfully deals with solvency.

Public Trustees: Dysfunctional Nominations

BPC also encourages the Senate to swiftly engage in full, fair, and prompt consideration of the Social Security and Medicare public trustees. The Senate Finance Committee approved two nominees on November 2, 2023, but a full Senate vote is required, and at the time of publication, the Senate had not moved forward. In addition to the four trustees who are members of the administration, the two public trustees serve as objective experts who report on the status of the trust funds to Congress and the American people; they also provide credibility for the annual reports. Since 2015, these two positions have been vacant due to Senate inaction. Congress should ensure that these positions are consistently filled moving forward


10 Key Takeaways from the Bipartisan Policy Center's Medicare Report

  1. Immediate Reform Needed: The BPC emphasizes urgent reforms to prevent Medicare's financial insolvency by 2031, ensuring sustainability for future generations.
  2. Consolidated Deductibles: Proposes merging Medicare Parts A and B deductibles to simplify costs for beneficiaries.
  3. Out-of-Pocket Limits: Introduces an annual out-of-pocket spending cap to protect beneficiaries from catastrophic healthcare expenses.
  4. Medigap Revisions: Recommends changes to Medigap policies to better align with the restructured Medicare benefits, promoting efficiency and cost-effectiveness.
  5. Provider Payment Adjustments: Suggests adjustments in provider payments to control Medicare costs without compromising care quality.
  6. Medicare Advantage Reforms: Advocates for revising payment formulas for Medicare Advantage and Part D to ensure program affordability and value.
  7. Fair Competition: Aims to level the playing field between Traditional Medicare and Medicare Advantage by standardizing benefits for easier comparison.
  8. Bipartisan Support Essential: Highlights the necessity of bipartisan efforts to enact meaningful Medicare reforms, drawing on past successes for future progress.
  9. Enhanced Affordability and Value: Focuses on improving Medicare's affordability for beneficiaries and its value for taxpayers.
  10. Comprehensive Strategy: Outlines a phased approach to reform, combining short-term fixes with long-term strategies to ensure Medicare's endurance and effectiveness.

FDA and CMS Collaboration: The Bipartisan Policy Center Weighs In (Jan 2024)

In January 2024, the Bipartisan Policy Center (BPC) issued a 34-page white paper, Strengthening  Regulatory Collaboration Between FDA and CMS.  Find it here:

The recommendations aim to improve information sharing between FDA and CMS to foster collaboration, without changing their statutory roles or current processes.  Most of the report (not indicated in the title) is about drug approvals and coverage.

Key proposals are for FDA to regularly share information on upcoming drug reviews and approvals with CMS, for Congress to increase CAG funding and review FDA-CMS MOUs, for AHRQ to analyze CMS real-world evidence on drugs, for CMS to engage with sponsors of accelerated approval drugs, for an NIH/CMS/FDA working group on surrogate endpoints, for FDA training of state Medicaid staff on the drug approval process, and for cross-agency training programs. The goal is to ensure CMS has timely drug information for coverage and payment decisions.

  • BPC recommends an increase in funding of $10M for the Coverage & Analysis Group at CMS.
  • Last December, BPC wrote an 85-page report on the future of Medicare - here.


AI Corner

Top Line:
The Bipartisan Policy Center's recent report on the collaboration between the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) underscores a critical step towards enhancing the efficiency and effectiveness of healthcare service delivery in the United States. The document outlines pragmatic recommendations aimed at fostering better coordination and information sharing between these two pivotal agencies within the Department of Health and Human Services (HHS). This collaboration is essential for ensuring that beneficiaries have timely access to safe and effective therapies, while still adhering to CMS' statutory requirements for coverage and payment decisions.

Deeper Dive
In an era of rapid scientific advancement, the collaboration between the FDA and CMS is more crucial than ever. The FDA, responsible for ensuring the safety and efficacy of drugs and biologics, and CMS, which oversees Medicare and Medicaid coverage and payment, operate within distinct mandates but share a common goal: to deliver safe, effective, and affordable healthcare. The Bipartisan Policy Center's report offers a roadmap for bridging information gaps and enhancing cooperation without necessitating legislative changes. By implementing practical, bipartisan recommendations, the agencies can improve their workflow and decision-making processes, ultimately benefiting patients and the healthcare system at large.

The report on FDA-CMS collaboration fully discusses the necessity for these two agencies to work hand in hand to improve health policy implementation. Such a collaboration is pivotal in ensuring that innovative treatments become accessible to beneficiaries in a timely manner, all while navigating the regulatory landscape that demands both safety and economic viability. The recommendations put forth are designed to create a more dynamic, information-rich environment between the FDA and CMS, which is crucial for addressing the challenges presented by fast-paced advancements in medical science and healthcare technologies. 

In short, these proposed steps, and their rationales, are a proactive approach to not only enhancing patient care but also streamlining the regulatory approval and reimbursement processes that can often slow the availability of new therapies. The detailed expansion of this collaboration aims at a more integrated health policy framework that benefits all stakeholders, particularly patients who stand to gain from faster access to cutting-edge medical treatments.

10 Key Takeaways  

1) Prompt Access to Therapies

The initiative seeks to ensure beneficiaries gain swift access to safe and effective treatments, aligning with CMS' coverage and payment requirements.

2) Balanced Information Flow

Establishing a consistent and balanced exchange of information between the FDA and CMS is crucial for enhancing collaboration and decision-making.

3) Legislative Independence

The majority of the suggested policy enhancements do not depend on new legislation, allowing for smoother and more immediate implementation.

4) Data Sharing and Coordination

Improved coordination and sharing of critical data, including drug approvals and surveillance information, between FDA and CMS are essential for informed decision-making.

5) Quarterly Updates

The FDA is encouraged to provide CMS with quarterly updates on new drug entities and those undergoing accelerated approval pathways.

6) CMS Capacity Expansion

Proposals include additional funding for CMS to bolster its capacity for coverage analysis and decision-making.

7) AHRQ Annual Review

An annual assessment by the Agency for Healthcare Research and Quality on the utilization of real-world evidence is recommended to inform coverage decisions.

8) Early CMS Engagement

Early involvement of CMS in the drug approval process is advised, especially for drugs under accelerated approval, to streamline coverage and payment determinations.

9) Biomarker Research Collaboration

The establishment of a working group involving NIH, CMS, and FDA to prioritize biomarker research and its implications for treatment efficacy and safety.

10) Cross-Agency Training

Initiatives for cross-agency training and information sharing are suggested to ensure that both agencies are aligned and informed in their regulatory and coverage decisions.

These elaborated points emphasize the importance of a cohesive approach between the FDA and CMS in advancing healthcare policy, aiming to achieve a balance between innovation, safety, and affordability.

AI Corner: Interacting with AI

I had the impression the report focused mostly on drug policy amongst all the health tech handled by CMS and FDA.  Yet, nearly always, drugs are covered by CMS if FDA approved, so what's the fuss?    Please help me understand if I've misunderstood or I'm missing something, or validate if I have a good point and I am appropriately puzzled.

Your observation about the focus of the report on drug policy and the seeming automatic coverage by CMS of FDA-approved drugs highlights a nuanced issue within the healthcare regulatory framework. While it's generally true that drugs approved by the FDA are often covered by CMS, the "fuss" arises from several key areas where the process is not as straightforward as it might seem. Here are some points that address this complexity and validate the concerns raised by the report:

Coverage with Evidence Development (CED): CMS may use CED for certain FDA-approved drugs where additional evidence is needed to determine their effectiveness in the broader Medicare population. This approach allows CMS to provide coverage while gathering more data on a drug's real-world effectiveness and safety.

Accelerated Approval Pathway: Drugs approved via the FDA's Accelerated Approval Pathway often require further evidence post-market to confirm their clinical benefit. CMS's coverage decisions for these drugs can be complicated, as they must balance immediate access to promising therapies against the need for conclusive evidence of benefit.

National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs): CMS makes coverage decisions through NCDs and LCDs, which can involve complex evaluations of a drug's clinical utility and cost-effectiveness. These determinations can lead to nuanced coverage decisions that are not directly tied to FDA approval status.

Diverse Medicare Population: CMS must consider the specific needs and characteristics of the Medicare population, which may not have been fully represented in clinical trials leading to FDA approval. This can lead to additional scrutiny and requirements for coverage.

Off-Label Use: CMS has the flexibility to cover off-label uses of FDA-approved drugs in certain circumstances, especially in oncology, where off-label prescribing is common. This requires CMS to evaluate evidence beyond the initial FDA approval.

Economic Considerations: While the FDA does not consider cost in its approval decisions, CMS must take into account the economic implications of covering new drugs, including negotiations around pricing and reimbursement levels.

Policy and Pricing Models: Discussions around drug approval pathways, coverage policies, and pricing models are ongoing, especially in light of high-profile cases where the FDA's approval of a drug has led to debates over CMS coverage decisions.

Information Asymmetry: The report emphasizes the need to address information gaps between FDA and CMS to ensure timely and informed coverage decisions. Enhanced collaboration and information sharing are seen as key to improving this aspect.

Your point is well taken that there might seem to be a straightforward path from FDA approval to CMS coverage, but the reality is far more complex due to the factors mentioned above. The report’s emphasis on improving FDA-CMS collaboration is aimed at addressing these challenges to ensure that Medicare and Medicaid beneficiaries have access to safe, effective, and reasonably necessary treatments without undue delay or uncertainty.

It's still true that to date, while CMS could apply "CED" or even "noncoverage" this has almost never happened, out of 100's of drugs, there are the 1 or 2 rare exceptions that "prove the rule" but they are still rare indeed.

You raise a valid point about the rarity of CMS applying "Coverage with Evidence Development" (CED) or choosing not to cover FDA-approved drugs. Indeed, the vast majority of drugs approved by the FDA are covered by CMS, making instances where CMS applies CED or opts for non-coverage appear as exceptions rather than the rule. However, there are several factors and nuances to consider which can explain why these mechanisms, despite their rarity, are significant and why the report might emphasize improving collaboration between FDA and CMS.

Complexity and Rapid Pace of Medical Innovation: The healthcare landscape is evolving rapidly, with new drugs and therapies being developed at a pace that challenges the existing regulatory and reimbursement frameworks. The complexity of new treatments, especially those approved under the FDA's Accelerated Approval Program, can necessitate further evidence to assess their real-world effectiveness and cost-effectiveness for broader populations, including the Medicare population.

Targeted Use of CED: While indeed rare, the use of CED reflects CMS's cautious approach in specific, often high-stake situations. For example, the document mentions that CMS has used a national coverage determination with CED for one category of on-label use of FDA-approved drugs—monoclonal antibodies for Alzheimer’s treatment. This targeted use underscores the mechanism’s role in ensuring that coverage decisions are based on sufficient evidence of benefit for Medicare beneficiaries.

The Importance of Post-Market Data: The report highlights the importance of collecting and analyzing post-market data to inform coverage decisions. Even when drugs are FDA-approved and covered by CMS, there's an ongoing need to assess their performance in the real-world, broader population. This is particularly crucial for drugs approved via accelerated pathways, where confirmatory trials are expected to verify the anticipated clinical benefits.

Potential for Future Applications of CED: The discussions and recommendations in the report suggest a recognition of the potential for expanding the use of CED or similar mechanisms as the healthcare system continues to grapple with the introduction of innovative, yet highly expensive, therapies. This foresight is about preparing the regulatory and reimbursement framework to more effectively handle such challenges, ensuring that Medicare and Medicaid beneficiaries have access to effective treatments without unwarranted delays or financial burdens on the system.

Enhancing Collaboration for Better Decision-Making: The emphasis on improving FDA-CMS collaboration reflects an understanding that more seamless and informed decision-making processes can better address the nuances of drug approval and coverage. This is especially relevant in a healthcare environment where precision medicine and personalized treatments are becoming more common, requiring a more nuanced approach to coverage decisions.

In summary, while the application of CED and instances of non-coverage by CMS for FDA-approved drugs are indeed rare, the report's focus on these areas highlights the need for a more adaptable, evidence-based approach to coverage decisions. This approach is particularly pertinent in an era of rapid medical innovation, where ensuring access to safe and effective therapies in a cost-effective manner remains a paramount concern.

While the focus is drugs, does the bipartisan report give much specific space and discussion to other things like (1) medical devices or (2) diagnostic tests.


The Bipartisan Policy Center's report, while primarily focused on drug-related policy recommendations, does acknowledge the collaboration between CMS and FDA on medical devices. This aspect, albeit not the main focus, is significant and incorporates several key areas of interaction that could potentially serve as models for drug policy as well​​.

Investigational Device Exemption Studies: The report mentions the cooperation between CMS and FDA in the context of investigational device exemption studies. This collaboration facilitates device payment within clinical trials, highlighting a structured approach towards supporting the development and evaluation of medical devices.

Parallel Review: Introduced in 2010, the parallel review program represents a collaborative effort to evaluate certain medical devices concurrently. This initiative aims to serve the public interest by reducing the time between FDA's marketing approval or clearance decisions and CMS's national coverage determinations​​. The parallel review program underscores the agencies' commitment to streamlining the approval and coverage process for medical devices, although it has been applied to a limited number of devices so far.

Transitional Coverage for Emerging Technologies (TCET): CMS proposed a new coverage pathway, the TCET, for breakthrough devices in June 2023, after repealing the “Medicare Coverage of Innovative Technology” final rule due to concerns about patient safety and benefit category designations​​. This move signifies an effort to facilitate rapid access to new technologies by offering a defined pathway for Medicare coverage of medical devices granted breakthrough status.

Regarding diagnostic tests, the parallel review program's mention indicates that diagnostic devices are also considered within the scope of FDA and CMS collaboration. For instance, the program facilitated the approval and coverage of a colon cancer test and a companion diagnostic for the safe and effective use of a drug, illustrating the application of collaborative efforts beyond medical devices to include diagnostics​​.

In summary, while the report's main emphasis is on drug policy, it does provide specific discussion and examples of collaboration on medical devices and diagnostic tests. These examples demonstrate the agencies' broader efforts to improve healthcare innovation access through regulatory and coverage decision alignment, even though they constitute a smaller portion of the report's overall focus.