Tuesday, March 5, 2024

Very Brief Blog: AMA Confirms New Alzheimer CPT Codes

At the February 2024 CPT meeting, AMA considered several CPT codes for neurologic disease.  Three out of four passed.   These are CPT codes for Amyloid (40,42) and CPT code for Phospho-Tau and for Tau-Total.   A fourth ALZ code, for neurofilament, was withdrawn but has appeared already on the May 2024 agenda.

The new Neuro codes (including the May neurofilament one) will be priced by CMS in Summer 2024 and active beginning January 2025.

The Panel Actions page is here:

https://www.ama-assn.org/about/cpt-editorial-panel/summary-panel-actions

The February 2024 PDF (9pp) is here:

https://www.ama-assn.org/system/files/february-2024-cpt-summary-of-panel-actions.pdf

Statistics

Of 45 code agenda proposals, 16 were withdrawn and 4 were rejected, totalling 20, or nearly half.  Codes are usually withdrawn if the sponsor realizes they will be rejected.






Monday, March 4, 2024

Nerd Note: Medicare Law Remarks on Costs of Quality Measures, CPT Codes

Header.  Congress renews funding for a quality measures institute.  From that springboard, we discuss pricing and cost policy for both quality measures and the CPT.


##

As discussed in this blog in August 2023, HHS transferred the longstanding quality measures contract from National Qualify Forum (NQF) to Battelle, where it is now titled, the PQP Partnership for Quality Measurement.

https://www.discoveriesinhealthpolicy.com/2023/08/nqf-loses-national-contract-february.html

Here's some trivia on the topic.

Where's the Quality Institute in Statute?

The relevant part of the Medicare statute is SSA 1890, "Contract with Consensus Based Entity."

https://www.ssa.gov/OP_Home/ssact/title18/1890.htm

Do Quality Forums Report Have to Congress and Public?

NQF's last report to Congress (for CY2022) weighed in at 92 pages and appeared in March 2023, here:

https://www.qualityforum.org/Publications/2023/03/2022_Annual_Report_to_Congress-2147351060.aspx

I would guess the quality report to Congress for March or April 2024, representing CY2023, will probably come from Battelle/PQP.

Funding for Quality Measures?

In the March 2024 bill to keep the government running, PQP was given $20M for one period and $9M for another period.

https://docs.house.gov/billsthisweek/20240304/HMS31169.PDF


So NQF/PQP have a funded monopoly on quality measures.   In contrast, the AMA has a "monopoly" so to speak on CPT coding for physician, imaging, and lab services, but it is not funded (it is self-funded through sales). It's at 45 CFR 161.1002.   

Costs and Pricing of Quality Measures and Codes - Compared

Regarding the quality forum costs, SSA 1890(c)(7) remarks,

  • Membership fees.—If the entity requires a membership fee for participation in the functions of the entity, such fees shall be reasonable and adjusted based on the capacity of the potential member to pay the fee. In no case shall membership fees pose a barrier to the participation of individuals or groups with low or nominal resources to participate in the functions of the entity.

Regarding costs of coding entities like the CPT, the language isn't in statute (162.1000ff) but it was included in the original rulemaking on August 17, 2000 (65 FR 50324):

  • Under HIPAA, the Secretary has the authority to select existing code sets developed by either private or public entities and is not precluded from selecting proprietary code sets. The Secretary is required to ensure that all standard code sets are updated as needed and that there are efficient, low cost mechanisms for distribution (including electronic distribution) of the code sets and their updates. 
  • Free distribution of standard code sets is not required by the statute. 
  • We have obtained some clarification from the developers of these code sets about the pricing structure and mechanisms for publishing the pricing structure that will be in place when the initial standards are implemented. 
  • The existence of efficient, low-cost distribution mechanisms will affect future decisions regarding changes or additions to the code sets designated as standards/



Sunday, March 3, 2024

Literary Note: Dr Abraham Verghese Discusses Life, Career

HEADER: I rarely mention literatry events but here is one.  Dr. Abraham Verghese, clinician and novelist, in a 45 minute interview on C-Span.

##
Dr Abraham Verghese was raised in Ethiopia, where he started medical school until a revolution closed it. (One of his classmates become a guerrila and eventually prime minister).

Verghese finished medical school in India and has had most of his career in the United States, currently as a professor at Stanford.

He's written many notable essays and two memoirs and two novels (one of which was a NY Times bestseller for months).  Online biography here.

###

VIDEO

See him discuss his wide-ranging global life on CSpan/BookTV, a 45 minute interview from January 2024.

https://www.c-span.org/video/?533287-2/abraham-verghese-life-work

###

He also mentions an autobiographical essay from 1997 in New Yorker; a summary is online at the link and the full essay is back of a paywall.

https://www.newyorker.com/magazine/1997/06/23/the-cowpath-to-america



##

AI Corner

The autobiographical New Yorker essay, 1997, is available as a non-character-based image PDF.  Chat GPT was able to read it instantly and summarize it in 10 bullet points.

Chat GPT writes,

I've reviewed the document, and here's a summary of the main points:

  1. The narrative is a detailed account of the experiences of Abraham Verghese, a physician from Ethiopia of Indian descent, as he navigates his life and career in the United States.
  2. It explores the cultural and professional challenges he faces transitioning from Ethiopia to a small town in Tennessee, highlighting the differences in medical practices and societal norms.
  3. Verghese’s journey is marked by his passion for medicine and his commitment to providing compassionate care to his patients, particularly those suffering from AIDS.
  4. The story delves into the complexities of the AIDS epidemic in America during the 1980s, reflecting on the stigma, fear, and lack of understanding surrounding the disease at the time.
  5. Verghese's personal life, including his marriage and family, is intricately woven into his professional experiences, showcasing the personal sacrifices and emotional toll of his career.
  6. The narrative also touches on themes of identity, belonging, and the search for home, as Verghese navigates his multicultural identity in a predominantly white, rural American setting.
  7. His interactions with patients and the community provide insight into the human side of medicine, emphasizing the importance of empathy, understanding, and personal connection in healthcare.
  8. The document highlights the challenges of medical education and the journey of becoming a doctor in a foreign country, including the rigorous training and exams required for foreign medical graduates in the US.
  9. Verghese's experiences with his patients and in his personal life lead to a deeper understanding of life, death, and the value of human connection.
  10. The story concludes with reflections on the meaning of success, the impact of one's work on others, and the continuous journey of learning and growth in both personal and professional life.

This summary captures the essence of Abraham Verghese's narrative, focusing on his professional journey, personal growth, and the profound impact of his experiences on his understanding of medicine and humanity.

##

 

Saturday, March 2, 2024

NOTEWORTHY: FDA Sends Final LDT Rule to White House

Header: FDA Sends Finalized LDT Rule to White House OMB/OIRA

##

Moving at a fast pace, FDA has finalized its review of comments on the LDT regulation, and the final regulation was logged at the White House on March 1, 2024.   Specifically, the rule is at the Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs (OIRA).

https://www.reginfo.gov/public/do/eoDetails?rrid=431763


OIRA Meetings

The OIRA page logs all official meetings on the rule, called EO-12866 meetings.  Find them here:

https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=&rin=0910-AI85&viewRule=true

Nine meetings were logged, the first on August 4 (Cara Tenenbaum and Center for Science in the Public Interest, which submitted a 4-page letter demanding LDT regulation in May 2023).  (See also ProPublica June 14). 

The last one was September 26 (William Signer of Carmen Group and ACELT, Academic Coalition for Effecitve Laboratory Tests). ACELT brought speakers from U Chicago, U Colorado, Harvard, Yale, and Wash U. Each of the meetings shows cloud copies of any documents presented. For example, ACELT included a 25-page legal memo against the FDA's authority to regulate LDTs.


##

The rule's page when it was a draft rule is here.


##

Update.  As of 3/18, OMB had scheduled5 new meetings:

3/18, Assoc for Dx and Lab Med
3/19, AMP
3/20, ARUP
3/21, ACMG
3/22, Childrens Hospital Association






Friday, March 1, 2024

SCISPACE: An AI tool for biomedical paper research

Like SCITE, "SCISPACE" is a sort of PubMed on AI steroids.  You'll get AI-driven bells and whistles, compared to a plain-jane PubMed search.

## 

On February 22, 2024, I highlighted SCITE, a tool for studying who's cited a key biomedical paper, how they've cited it, and seeing related papers. 

Here, a few words about another tool in this space, SCISPACE. Find it here:  https://typeset.io/search  [*]   

You can ask SCISPACE a biomedical question, and it comes back with five or six AI sentences with citations.  It also comes back with bibliographies of topical papers, and you can filture for features like "Top tier papers" or "Open access."

It does more, but that's a thumbnail sketch.

##

I asked it a topical question, "What is the evidence for the clinical utility of minimal residual disease (MRD) monitoring in cancer management?"

It came back instantly with this "Insight from Top 5 Papers."

  • Minimal residual disease (MRD) detection has shown clinical utility in cancer management. MRD monitoring is a powerful predictor of disease-free and overall survival, particularly in acute lymphoblastic leukemia (ALL) [1]. Different methods, such as polymerase chain reaction (PCR) and droplet digital PCR (ddPCR), have been used for MRD detection with high sensitivity and precision [2] [3]. MRD detection using ddPCR has been shown to detect micro-residual disease missed by PCR in one patient [4]. In non-small cell lung cancer (NSCLC), ultrasensitive fragmentomic assays using whole-genome sequencing (WGS) have demonstrated the ability to detect MRD and predict recurrence with high sensitivity [5]. In breast cancer, circulating tumor DNA (ctDNA) assays have allowed for the detection of molecular residual disease (MRD) prior to clinical evidence of recurrence, providing a lead time for intervention . MRD detection using ctDNA has shown promise in guiding therapy escalation in ongoing clinical trials . In colorectal cancer, tumor-informed ctDNA testing has been used to detect and quantify MRD, with higher rates of detection in liver metastasis . These findings highlight the clinical utility of MRD detection in cancer management, including early intervention and guiding treatment decisions.

###

It may not escape attention that the above instantly-created paragraph about MRD could be nearly cut-and-pasted for various purposes that are not super-demanding.  

###

In addition, SCISPACE came back with 10 papers by name, with links and PDFs if available.  

It also instantly provided a one sentence summary of each paper. Click below to see the top of this ten-row table.


Check YouTube for training and review videos for SciSpace or register with email for some entry level features.  More by subscription.

##

I asked the question again but specified I wanted results in lung cancer.

  • MRD detection has shown to be useful in lung cancer management. Studies have demonstrated that the traditional circulating tumor DNA mutation-based approach has limited performance in MRD detection, especially for early-stage cancer after surgery [1] [2]. However, a cfDNA fragmentomics-based method using whole-genome sequencing has shown great sensitivity in predicting prognosis and detecting patients with a high risk of recurrence [3] [4]. This method has been found to be more sensitive in predicting patient recurrence compared to the traditional circulating mutation approach [5] . Additionally, longitudinal MRD detection using circulating tumor DNA has shown high sensitivity and can potentially identify patients who may benefit from consolidation therapy . These findings highlight the potential of MRD detection in guiding adjuvant therapeutics and improving outcomes in lung cancer patients .

When I filtered in my query for "top tier papers," it came back in a couple seconds with an updated 10-paper list and again a write-up of first 5 papers.

  • Molecular residual disease (MRD) detection has shown promise in the management of lung cancer. Studies have demonstrated that circulating tumor DNA (ctDNA) analysis can be used to detect MRD in non-small cell lung cancer (NSCLC) patients after surgery or radiotherapy [1] [2]. Longitudinal surveillance of ctDNA has been found to be effective in predicting relapse and guiding adjuvant therapy decisions [3]. The sensitivity and specificity of ctDNA MRD detection have been shown to be high, making it a promising biomarker for relapse prediction [4]. Additionally, ctDNA analysis has been used to identify patients with MRD who may benefit from targeted therapies or chemotherapy [5]. These findings suggest that MRD detection using ctDNA analysis can play a valuable role in the management of lung cancer, allowing for early detection of relapse and personalized treatment strategies.

##

SCITE versus SCISPACE?  I haven't used each enough to give a masterful comparison.  But, on the surface, SCISPACE is designed to be driven by questions, as in the examples above, give you 10 citations, sort them by "open access" if you want, and give you a paragraph summary of the field driven by the top citations, as well as one-sentence summaries-at-a-glance of all the papers it pulled.

SCITE works better if you already know a key paper.  It gives you every paper that has cited it, which you could get elsewhere, but it shows you HOW each citing paper has cited your index paper.   That can be pretty darn powerful and it's  available in a second or two.  

SCITE pretty much depends on a subscription, as I recall.  SCISPACE has a free tier that is pretty good, but will cut you off after a limited number of queries.   The upgrade at SCISPACE is $12/mo but sold as $120/yr.   

##

Other resources of potential interest are Semantic Scholar, and Google Biomed Explorer. They're both free.
See also the general AI  sources Perplexity.ai and You.com.  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.
##

* At some point the address will be Scispace.com.






Webinar March 7; Telehealth, Genetics, Precision Medicine. Now with e-Summary of Deck.

 See a webinar on March 7, 2024, sponsored by the California Telehealth Resource Center:

"Success and Sustainability: Digitally-provided Genetic Services Overcome Obstacles to Patient Access to Precision Medicine."

Find more info here:

https://caltrc.org/events/success-and-sustainability-digitally-provided-genetic-services-overcome-obstacles-to-patient-access-to-precision-medicine/

See 49 slide deck, and summary below (AI Corner).

https://caltrc.org/wp-content/uploads/2024/03/TeleGenetics.2024.pdf

Thanks for Sylvia Trujillo for highlighting on LinkedIn.  It's 12 pacific on a Thursday.


##

AI CORNER

With e-summary of deck.

The webinar focused on the expansion and sustainability of genetic services through digital means, emphasizing telemedicine's potential to improve access to precision medicine. Here's a summary of the main points and key takeaways:

Webinar Summary

Genetic Services and Precision Medicine:

Genetics and genomics are increasingly crucial in healthcare, with a rising demand for services.
Implementing precision medicine is a challenge due to a knowledge gap among physicians, despite their recognition of its impact.

Workforce and Demand:

The genetic workforce in the US is limited, highlighting a significant demand for genetic services that outpaces supply.

Cleveland Clinic's Approach:

Cleveland Clinic's Center for Personalized Genetic Healthcare (CPGH) is a leading provider of genetic services, constantly facing unmet demand.
The vision for increased access involves digital tools to ensure the right service is provided in the right way and at the right time.

Digital Innovations:

Telemedicine, eConsults, and chatbots are pivotal in expanding access and allowing providers to practice at the top of their license.
A shift to virtual services was successfully made during the pandemic, with a hybrid model enhancing team retention and service delivery.

Chatbots in Genetic Counseling:

Chatbots serve various roles, from pre-test counseling to facilitating cascade testing, improving efficiency and patient satisfaction.

Future Directions:

The webinar underscores the ongoing development of chatbots for different genetic services, highlighting the importance of innovation in predicting and shaping the future of genetics healthcare.

10 Key Takeaways

  1. Growing Importance of Genetics: Genetics is becoming integral to healthcare, driving a need for more accessible services.
  2. Precision Medicine Implementation Gap: There's a significant gap between the perceived impact of genomics and physicians' readiness to implement it.
  3. Limited Genetic Workforce: With only around 6,600 genetics professionals in the US, the demand far exceeds the supply.
  4. Digital Expansion: Digital tools like telemedicine, eConsults, and chatbots are essential for expanding access to genetic services.
  5. Telemedicine Success: Telemedicine has proven effective in delivering genetic services, particularly during the COVID-19 pandemic.
  6. eConsults Utilization: eConsults provide a streamlined way for providers to consult genetics experts, enhancing service efficiency.
  7. Chatbots for Education and Triage: Chatbots are used for pre-test education, risk assessment, and improving patient engagement.
  8. High Patient Satisfaction: Early implementations of chatbots in pharmacogenomics have shown high patient satisfaction and completion rates.
  9. Future Chatbot Applications: Continued development and deployment of chatbots for various genetic counseling aspects are anticipated.
  10. Innovation and Regulation: The future of genetic services relies on innovation, with a need to navigate regulations carefully.
This comprehensive approach to integrating digital tools in genetic services not only caters to the current demand but also paves the way for future expansions and improvements in precision medicine delivery

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:

https://www.360dx.com/reimbursement-news/cms-clarifies-billing-article-revisions-organ-transplant-rejection-testing



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:

https://www.ama-assn.org/system/files/2021-01/image-bundling-decision-tree.pdf


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:

https://www.natera.com/company/news/medicare-extends-coverage-of-nateras-signatera-mrd-test-to-ovarian-cancer-and-neoadjuvant-breast-cancer/

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



More  

See open access coverage at Genomeweb here;

https://www.360dx.com/molecular-diagnostics/natera-signatera-mrd-test-nabs-medicare-coverage-ovarian-neoadjuvant-breast




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.

             Abstract

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.

###

AI CORNER

I ran the PDF through Perplexity.ai.  (More on Perplexity).

Summary?

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:

https://www.ama-assn.org/about/events/cpt-editorial-panel-meeting#agenda

https://www.ama-assn.org/system/files/may-2024-lab-mopath-agenda.pdf

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.

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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.

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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.
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Other resources of potential interest are Semantic Scholar, Google Biomed Explorer.  See also the general AI  sources Perplexity.ai and You.com.  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.

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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.

https://www.cms.gov/files/document/mm13485-appropriate-use-criteria-advanced-diagnostic-imaging-cy-2024-update.pdf

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.   

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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.

https://searchlf.ama-assn.org/letter/documentDownload?uri=%2Funstructured%2Fbinary%2Fletter%2FLETTERS%2F2021-3-1-Signed-On-Letter-to-Richter-re-RO-Model-Stakeholder.pdf

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,  https://www.astro.org/Daily-Practice/QPP/Alternative-Payment-for-RO   

See also Fierce Healthcare on the same topic, https://www.fiercehealthcare.com/providers/cms-indefinitely-delays-controversial-radiation-oncology-model


AI Corner

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