Busy Day at MOLDX: New Draft LCD for Prostate GEP Tests; For Lung Nodules; For Thyroid Nodules; New Final LCD For R.A. Biomarkers

Busy day at MOLDX with three new draft LCDs and one new final LCD.

NEW DRAFT LCDS

DRAFT - ADVANCED PROSTATE

See DL39636, Gene expression profile (GEP) tests for decision making in castration resistant and metastatic prostate cancers.  

MolDx has a long history of LCDs for prostate cancer prognostic tests, this appears to be a new version (not style as a revision).   Prior versions focused on early diagnosis and management.  This LCD is based on a February 2022 letter from Dr Davincioni of Decipher/Veracyte.  MolDx publishes only the cover letter of the request.

The LCD notes it does not deal with CGP (e.g Foundation Medicine type tests) or "single biomarker" tests.  Patients must be facing multiple therapy optoins of variable severity and the test will help make that choice.

The LCD does not named covered or non covered tests but the LCD has an associated billing article DA59462.  This lists only 81479 as a potentially covered code, so that's kind of a dead end for policy wonks trying to determine  or understand coverage (e.g. by doing studies on payer coverage and publishing them.)

On a commerical note, the Decipher Veracyte prostate GEP test has been taking a larger share of a market that once was divided in thirds (Veracyte, Genomic Health, Myriad).  A Veracyte Decipher collaboration with Duke was just covered in Genomeweb based on a publication in JCO Precision Oncology by Bitting et al. 

DRAFT LUNG NODULES

DL39654, Molecular biomarkers for risk stratification of indeterminate pulmonary nodules following bronchoscopy. 

Note that this isn't framed as a policy for imaging-based nodules, but for nodules "following bronchoscopy."  While this sounds like, for example, a Veracyte Percepta test, the LCD is framed as "internally initiated."  The rules confirm this is for post bronchoscopy patients.  The LCD separately discusses "first generation" and "second generation" Percepta tests.  

The billing article DA59476 again presents itself as "information that complements the LCD" but simply lists 81479 as a possible billing code. 

For the use case you might have thought of - a mystery small nodule on low dose CT screening or an incidental small lung nodule - and it's before bronchoscopy or PET - Medicare has an LCD for "XL2" test from Biodesix, here. 

DRAFT THYROID NODULES

LCD DL39646 is "Risk Stratification for Thyroid Nodules" and is based on a letter from Veracyte (Dr Gerrard)  from January 2022.  The letter notes that coverage was previously requested for "Veracyte MTC" and that the January 2022 update restyles the request in the format of a foundational (pan-product) LCD.  Coverage is valid for a patient with an indeterminate nodule Bethesda III or IV, or else, a nodule Bethesda V "for which molecular testing may aid in further decision making."

The LCD concludes, Given the cost and risks associated with thyroid surgery, the clinical decision making that goes into the extent of surgery, additional follow up management, and published guidelines, this contractor finds that molecular tests that aid in medical decision making for thyroid nodules of Bethesda Categories III-V are reasonable and necessary. Specifically, this contractor recognizes improved outcomes by safely precluding unnecessary surgical procedures with these services as well as better selecting patients who may benefit from such procedures. 

Reference to specific tests in this document does not imply coverage by this contractor.

Readers unfamiliar with "foundational LCDs" may be puzzled by the remark that evaluation of a specific test in an LCD "does not imply coverage."

A billing article is provided, DA59470.  Potentially covered codes include 81479, again, as well as specific code 81546.  Veracyte GSC Genomic Sequencing Classifier. 

NEW FINAL LCD: FLIP TO COVERAGE

FINAL RHEUMATOID ARTHRITIS

LCD L39424.  This is based on a letter from SCIPHER, making PRISM-RA,   The request letter is undated and the PDF has a document creation of 7/2022, so it might have been the date preceding the October 2022 draft LCD.  While it's an inferenec, SCIPHER's approach for an LCD likely preceded the CAC in December 2021.

The original Draft LCD position on non coverage, in October 2022, was curt. It followed a CAC meeting in December 2021.

• "Current molecular biomarker tests to guide targeted therapy selection in Rheumatoid Arthritis (RA) are non-covered by this contractor."

Champagne corks are popping somewhere because the final LCD provides "limited coverage" based on "new evidence" and following 12 rules.   The patient has a history of failure or contraindication to at least one first line DMARD and is considering a range of alternate therapies (TNF, JAK, etc).  And MolDx has determined the test to be appropriately validated and designed, etc.

The billing article - again - simply points to a possible unlisted code, in this case, 81599, other MAAA test.  See A59529.    

With the flip in coverage status, there is a lengthy "response to comments" document A59519. I extract and highlight the specific rationale for the favorable policy change, and critiques of the field that MolDx still feels are valid.  Sidebar here.  (There, I also ask ChatGPT for its opinion on the policy flip.)

MY COMMENT

IImproved Coordination & Timing for Comment

This crop of LCDs, draft and final, had better coordination of posting, with the same timing at the several MolDx MACs - which will help speed up finalization of those in draft.   Draft LCD have comment from August 31 to October 14.

For two dated LCD request letters, the time from letter to a draft LCD was 6-9 months.  The time from draft to final LCD, for the one final LCD, was 10 months.

Convergent Evolution of LCD Text

The LCDs for indeterminate nodules (lung, thyroid, etc) tend to consolidate toward very similar language in terms of coverage and performance rules.  Eg. rules on the lines of, "the test must be appropriate designed for the population."

Stymies Academics and Publications

There's been excellent work in recent years documenting and publishing the nature of  payor policies, but policy experts with be stymied by the lack of specific coverage details either in LCDs or articles.  To some extent, the DEX database run by Palmetto can back fill this, but includes no coverage dates and no archival form (DEX lives in the eternal present moment only).   This limits the abilities of academic experts, or consultancies, to tabulate coverage issues, even if they are on grants commissioned by HHS.  See eg Trosman et al. 2020 PMID 32389219.

PAMA Thwarted?

The widespread use of "unlisted codes" puts whole fields of genomics outside the elaborately designed CMS and Congressional PAMA pricing system, even as genomics grows as a proportion of lab spending.

AI Corner

Chat GPT 3.5 rewrites this article to 650 words, shortened from 1050.

Here.

I ask GPT 3.5 about the R.A. policy flip [lower part of the linked page]. Here.

GPT 3.5 summarizes the 4600 word R.A. LCD in 600 words.  Here.

MolDx Covers Another Transplant Rejection Test; This One Digital PCR (Oncocyte VitaGraft)

MolDx has issued coverage for the Oncocyte VitaGraft renal rejection test, per a press release here and brief coverage at 360DX here,   

The relevant organ rejection LCD is a broad, or foundational LCD, that allows the potential for future coverage of molecular testing for graft rejection in any organ.   Actual coverage issued has included tests using donor DNA detection, from CareDx and Natera.  There have been some kerfuffles about the LCD, its textual analysis, and revisions.  

Price Pending

As of August 29, the Palmetto "DEX" database did not yet list the Vitagraft test as covered, and, it had no Medicare price list.   Updates will likely appear online over a week or two.

The DEX database refers to the "Allaro" Kidney test, whose description then calls itself the VitaGraft test [?].  One year share price is down from $18 to $3.50.  Market cap is $30M.  For 2022, "full-year 2022 revenues were $5.6 million, down 27 percent from the prior year.  Net loss for the year was $72.9 million." The company has bounced in and out of Nasdaq compliance.  The company has immuno-oncology test assets that are not yet covered by MolDx (Determa IO).  

ddPCR and MolDx

Although examples are still not too common, digital PCR has potential applications in graft rejection and minimal recurrent disease detection in oncology.  

click to enlarge

Large Health System Sues Anthem; Lawsuit PDF Provided

According to a colorful article in MedCityNews here, Bon Secours Mercy Health Virginia (BSMH Virginia) has filed a lawsuit against Anthem Health Plans of Virginia for over $93 million in unpaid and underpaid health claims. 

BSMH Virginia alleges that Anthem engages in delaying and denying payment tactics, impacting patient care. Anthem claims BSMH is using the lawsuit to distract from leaving Anthem's provider network.

MedCity provides a PDF of a 25 page legal filing with more colorful details.  Here.

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AI Corner.  

ChatGPT provides Haiku Summaries:

Unpaid claims in court,
Anthem and BSMH clash,
Healthcare payments strained.

Lawsuit's bitter fight,
Anthem's tactics under fire,
Patients caught between.

Money owed, care stalled,
Legal clash of health titans,
Healing at a cost.

September 27: Roche Webinar on New Rules for Her2 Staining

 I recently ran a blog about new rules for "low Her2 staining," based in part on a long article in CAP TODAY, and on several Op Eds that were published along with the new rules.

On September 27, 2023, at 11 pacific 2 eastern, attend a webinar sponsored by ROCHE on the new rules.  Find more info here:

https://mailchi.mp/uscap/register-now-her2-ihc-testing-in-the-wake-of-the-2023-her2-breast-guideline-update?e=fdf9fc4ebd

Novitas MAC Publishes Article on "T Codes" for Slides Digitization

Header:  Novitas has published guidelines on the new AMA Category III codes for digitizing medical slides, stipulating special situations where they may be payable.  But I see a few policy bugs in the water.

For subscribers to Genomeweb, see a deep-dive article by Greg Cima on the same topic (including private payers and lab consultant interviews), August 29, 2023, here.

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Last January, AMA CPT brought out about a dozen Category III codes, unpriced, for digitizing slides for medical purposes (not teaching or team conferences).  And there's more.  For January 2024, AMA has announced a few dozen more.  They are add-on codes that will eventually pair to nearly any code that generates a glass slide.

CMS has put the codes on "bundled/not separately paid" status for the OPPS setting. Ouch!  See my article about the nonpayment edits here.   (To my surprise, there wasn't even a short paragraph on this topic for these new codes in the July 2023 OPPS proposed rule.)

Novitas Article

Novitas publishes the first article about the codes.  It says that they are potentially payable IF REASONABLE AND NECESSARY.  They describe this pretty narrowly, giving the example of a glass slide that is unique and risky to mail, so it needs to be digitized and sent as whole slide imaging.  Another example is an emergency where sending the slide digitally is faster than Fed Ex.

Find the article here, and I'll clip it at the bottom of this blog as well.

https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00278110   

Two Dilemmas for BQ

I see two "nerd dilemmas."  

One, while I'm an advocate of digital pathology, from a neutral view, it's not entirely clear why, if CMS would not pay $30 for Fed Ex, CMS would potentially pay $30 (or some other fee) for WSI.   One way out of this corner, is to point out that Fed Ex is not an FDA-approved device, whereas a WSI scanner is.

The other dilemma is that both clin chem and pathology have CMS dates of service rules that fix the DOS for 14 or 30 days as the date of specimen collection.  If that's in a hospital (inpatient or outpatient) the bundling rule against these codes may apply.   For example, with a hospital outpatient office visit, routine clin lab tests (but not genetics) are bundled, and they're bundled whether or not the clin chem is done at the hospital or off site.   By analogy, I think the OPPS no-pay bundle rule for the Cat III codes might apply even if the slide is coming from elsewhere as long as the date of service rule ties it to an inpatient or outpatient event.   Novitas' text doesn't dwell on this.  It focuses on a Pt B 1500 claim, not a hospital 1450 claim, but the bundle rules are established by specimen origin location and timing, not by the choice of claim form (wouldn't that be nice).   Avoiding the OPPS non payment policy, the Novitas article would be a good fit (for example) for an private office-based skin biopsy processed in a Part B lab. 

Actually, a bonus, third dilemma, is that these are styled as "add on codes," so they have to be on the same claim form on same day of service as the parent code (e.g. 88305).  That limits the usefulness, even under Novitas' own rules, when the special consult might come up a couple weeks after the 88305 event.

NOVITAS - June 29, 2023

Billing for digitization of glass microscope slides, CPT codes 0751T-0763T

Digital pathology is a practice in which glass microscope slides are digitally scanned by clinical staff. The digitized images are saved to a computer or cloud-based system, where they can further be viewed, analyzed, and shared with other providers. Providers can remotely access digitized pathological images and data for review and diagnostics. Digital pathology can enhance diagnostic efficiency, prognosis, and prediction of illness. These codes are used to report additional staff work and resource needs associated with the process of scanning and digitizing pathology content.

Effective for claims received on or after August 5, 2023

Providers shall provide a statement on Item 19 of the CMS-1500 claim form, or the electronic equivalent, to document how the digitization of glass microscope slides is medically reasonable and necessary. An example of a potentially reasonable and necessary service includes if a slide requires an outside consultation that would normally require mailing of the slide, digitization could potentially be medically reasonable and necessary if either the slide represents the only slide demonstrating the pathology of interest (and loss of the slide would mean loss of irreplaceable material) or the consultation is required urgently and mailing a slide would take too much time and the delay would put the patient's health at risk.

Failure to prove a statement on Item 19 of the CMS-1500 claim to document the need for the digitization of glass microscope slides may result in claims rejected as unprocessable.

##

Some MACs publish pricing for codes not priced by CMS.   I spotchecked this at Novitas and the Dig Path code I looked up was still $0, at least today.

NY Times Opinion Piece Antagonistic to Precision Oncology; PMC Responds

On Saturday, August 5, 2023, the New York Times published an opinion piece which is antagonistic to precision oncology, raising concerns about how effect precision drugs are and raising questions of cost and value.  The piece also notes that minority and other underserved populations are less likely to get genomic testing, an equity issue.  

The piece is by Prof. James Tabery, Philosophy, University of Utah.   The Op Ed is paired with his newly released book 'Tyranny of the Gene," (August 2023, Knopf.)  One of Tabery's main points seems to be that green space, anti-smoking and anti-asbestos programs, and social equity are more important goals than molecular medicine.

The President of the Personalied Medicine Coalition, PMC, responds with a detailed rebuttal on PMC's web site.  Ed Abrahams remarks,

As Tabery notes, personalized medicines come with high price tags, in part because they must recoup research and development costs from limited markets, sometimes as small as a single patient, and because they are hard to discover and develop. But personalized medicines also promise to reduce the overall costs of health care because one-size-fits-all medicines are also expensive for patients and health systems, mainly because they are prescribed to everyone whether they work or not. It is difficult to envision a future in which it will make sense to forego the sophisticated efficiencies of personalized medicine in favor of wasteful trial-and-error approaches that leave too many patients sick for too long.

LINKS

• New York Times here.
• Tabery Book here.
• PMC Response here.

AI Corner

Chat GPT3.5 reads both articles, summarizes.

More Updates on Low Her2 in Breast Pathology: Feisty Debate

Updated 2023 guideline for low HER2 staining for new breast cancer drugs.  Op Ed says AI holds promise.

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Big news last year was that a new class of breast cancer drugs was indicated for Her2 1+ cases, a big change because previous drugs were not used in 1+ cases.   1+ cases are borderline and difficult to call. 

One of my biggest blogs during 2022 was whether low Her2 diagnosis might be a "killer app" for digital pathology or AI pathology - something that digital might do better than people.  (By which I mean, the digital scores might correlate r=0.8 with drug response while visual scores correlated r=0.7 - just a hypothetical).

Archives of Pathology and Lab Medicine have now published a new nine page article on how to rate 1+ cases, Wolff et al., and it comes with an op ed by Schnitt et al.   (And if these are of interest, see also a new review in the same journal by Sun et al. of IHC uses in breast cancer more generally - here.)

There's also a detailed review of Wolff et al., with comments by other experts, in CAP TODAY this month - by Karen Titus; find it here.  CAP TODAY doesn't shy away from pretty sharp differences of opinion among the experts interviewed.  

See also an additional, unrelated article on trends in Her2 in Genomeweb this month by Alison Kanski.

Register for a ROCHE seminar on Her2 on September 27 here.

See a JAMA Oncology letter on the topic, Robbins et al, July 2023, here.

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Schnitt et al. close their op ed with a remark akin to my June 2022 speculation - 

• While the guideline update also does not endorse the use of newer methods to quantify HER2 protein levels at the present time, newer technology such as quantitative immunofluorescence assays and the use of artificial intelligence algorithms applied to digitized slides may be particularly well suited for HER2 quantification in a consistent and reproducible manner if a clinical need persists.

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Like some of the experts in CAP Today, I find the positioning of Wolff et al a little perplexing.   (Basically, it's like, Her2 negative (0,1+) now includes Her2 low (1+).)  See also a second op ed in APLM by Jaffer on the "perplexingness" of the field.  

I extract a summary from Wolff et al here:

"While it is premature to change reporting terminology for lower levels of HER2 IHC expression (eg, HER2-Low), pathology labs should include a footnote in their HER2 testing reports (IHC and in situ hybridization [ISH]) with the following recommended comment:

• “Patients with breast cancers that are HER2 IHC 3þor IHC 2þ/ISH amplified may be eligible for several therapies that disrupt HER2 signaling pathways. Invasive breast cancers that test ‘HER2-negative’ (IHC 0, 1þor 2þ/ISH not-amplified) are more specifically considered ‘HER2-negative for protein overexpression/gene amplification’ since non-overexpressed levels of the HER2 protein may be present in these cases. Patients with breast cancers that are HER2 IHC 1þor IHC 2þ/ISH not amplified may be eligible for a treatment that targets non-amplified/non-overexpressed levels of HER2 expression for cytotoxic drug delivery (IHC 0 results do not result in eligibility currently).”

• HER2 IHC 1+ or 0 results are still both interpreted as HER2-negative (HER2 is not overexpressed) using the previously recommended scoring criteria (Figure). Importantly, the semiquantitative IHC score [bq range 0 to 3] must always be reported as well to ensure patients who meet eligibility criteria for trastuzumab deruxtecan [bq 1,2,3] can be identified. 

Example: HER2-negative for protein overexpression (1+staining present)."

###

AI Corner.  

The Schnitt Op Ed doesn't have an abstract, and I've clipped a GPT4 summary here:

The editorial by Schnitt et al. delves into the challenges faced by pathologists in identifying HER2-low breast cancers. These challenges emerged following the publication of the DESTINY-Breast04 (DB-04) phase 3 trial in June 2022, which indicated the efficacy of trastuzumab-deruxtecan (T-DXd), an anti-HER2 antibody-drug conjugate (ADC), in treating patients with HER2-low metastatic breast cancer.

Historically, pathology communities utilized IHC assays to detect tumors with high HER2 protein overexpression. These assays, however, were not designed to discern tumors with low HER2 protein levels. The three previous versions of the ASCO-CAP HER2 guidelines did provide a distinction between HER2=0  and  HER2=1+ cases. Still, this differentiation was deemed clinically irrelevant --  until the revelation of the DB-04 results.

The identification of HER2-low breast cancers is made more complex due to several factors:

• Preanalytic and analytic variables such as cold ischemic time, fixation time, decalcification procedures, epitope retrieval protocols, and more.
• High interobserver variability when differentiating between HER2 0 and 1+ cases.
• Variability in the HER2-low phenotype over time within patients, with roughly 40% of cases showing conversions between primary tumors and subsequent recurrences.

Furthermore, uncertainty remains about the response of HER2 0 tumor patients to ADCs like T-DXd, as these patients were not part of the DB-04 trial.

In response to these challenges, the ASCO-CAP 2023 guideline update offers best practices for pathologists, which include adhering to the 2018 ASCO-CAP guidelines and considering the review of a second pathologist for borderline cases. However, the guidelines do not advise adopting the "HER2-low" terminology, cautioning against its potential misapplication.

In the face of these challenges, emerging technologies such as quantitative immunofluorescence assays and artificial intelligence algorithms applied to digitized slides hold promise for a more consistent and reproducible assessment of HER2 levels in the future.

##

The Jaffer Op Ed also refers to progress in Her2 automated image analysis. and in her CAP interview, she discusses this as promising, as does Yale's Dr. Rimm.

See a ChatGPT analysis of the CAP Today article here, including, asking it to highlight expert disagreements, and, to pull out info about AI.  See a ChatGPT summary of Jaffer here.

 

Meeting Note: Digital Pathology Association, October 29-31, 2023, Orlando

See an updated review with detailed AI descriptions of the meeting.

https://www.discoveriesinhealthpolicy.com/2023/09/ai-corner-digital-pathology-orlando.html

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ORIGINAL BLOG:

Quoting,

The Digital Pathology Association annual meeting, Pathology Visions 2023, will take place Oct. 29–31 in Orlando, Fla. This year’s theme is “Igniting Digital Pathology Transformation.”

Pathology Visions brings together hundreds of experts and peers across the field of digital pathology to address real-world, practical applications of digital pathology and artificial intelligence as well as new technologies and developments. Attendees have access to more than 50 presenters and 70 poster presentations, nearly 50 vendors showcasing the latest innovations, and more.

More information about the meeting and how to register can be found below.

On PubMed, citations for "digital pathology" have been running about 500 a year and will be 600-plus in 2023.

500 per year in 2021, 2022

LINKS

https://digitalpathologyassociation.org/

https://digitalpathologyassociation.org/pathology-visions-conference

I asked Chat GPT 3.5 to summarize the conference, and at first, it basically just summarized the literal agenda.  I include that deeper below.

I then asked Chat GPT to summarize the conference in the voice of a med tech journalist who has already attended it.  That was more fun.

Title: Unveiling the Future of Digital Pathology: Insights from the Cutting-Edge Conference

By [Journalist Name Here], MedTech Correspondent

The realm of digital pathology has experienced a seismic shift, as innovators and experts converged at a recent conference to unveil the latest strides and future directions of the field. Hosted by the Digital Pathology Association (DPA), the event saw luminaries from the medical technology industry, pioneering clinicians, and data scientists take center stage to explore the intersection of technology and healthcare.

Charting New Avenues with AI

At the heart of the conference was the exploration of how artificial intelligence (AI) is shaping the landscape of healthcare. In a captivating keynote address, Dr. Anthony Chang, a luminary at CHOC and AIMed, shared his reflections as a clinician-data scientist. He discussed the successes, disappointments, and forthcoming possibilities of AI in healthcare. Dr. Chang's insights illuminated the delicate balance between human expertise and technological prowess.

Dr. Rama Gullapalli from the University of New Mexico and Dr. Ehsan Ullah from Health New Zealand, Auckland, delved into the remarkable potential of large language models in diagnostic pathology. The duo explored the intricate opportunities, formidable challenges, and ethical dimensions posed by these models, igniting intense discussions among the attendees.

Calculating the Cost of Progress

Unveiling the enigma of cost in the digital pathology landscape, Dr. Orly Ardon of Memorial Sloan Kettering Cancer Center introduced a dynamic cost calculator that empowers informed decision-making. This groundbreaking tool offers insights into the investment required for implementing digital pathology solutions, laying the foundation for strategic planning.

Practical Insights into Implementation

While the discussions revolved around the theoretical possibilities, the conference also brought forth practical case studies. Dr. Harshwardhan Thaker from the University of Texas Medical Branch presented the journey of digital primary diagnosis at a mid-sized Pathology Department. The university's experience illuminated the transformational impact of embracing digital pathology, underscoring the potential to enhance patient care.

AI's Evolution in Cancer Diagnosis

Pathology's critical role in cancer diagnosis and treatment was a recurrent theme. Dr. Nghia Nguyen from the University of Texas-Houston Medical School shared groundbreaking research on predicting breast cancer metastasis using artificial intelligence. This AI-powered approach holds the promise to revolutionize prognostic strategies and enable earlier interventions.

Balancing Technological Growth with Ethical Considerations

Amid the excitement surrounding technological advancements, the conference acknowledged the ethical quandaries intertwined with AI and digital pathology. Presenters, including Dr. David Brettle from Leeds Teaching Hospitals NHS, discussed considerations for digital pathology displays, emphasizing the importance of maintaining accuracy and integrity while harnessing technology's potential.

A Glimpse into the Future

The conference also provided a glimpse into the future with presentations on cloud-based digital pathology repositories, advanced image analysis, and immediate image-based molecular profiling. Experts painted a vivid picture of a healthcare landscape where AI not only augments clinical decision-making but also enables real-time molecular insights.

Reflections and Networking

The two-day conference wrapped up with a networking reception, allowing attendees to engage in thought-provoking discussions and build lasting connections. As journalists, we left with a deepened understanding of the transformative power of digital pathology, AI's evolving role, and the need for a balanced approach that prioritizes patient care and ethical considerations.

In an ever-evolving med tech landscape, the conference stood as a testament to the relentless pursuit of innovation, the collaborative spirit of experts, and the potential for technology to reshape the healthcare ecosystem. The future of digital pathology holds immense promise, and the insights shared at this event will undoubtedly drive the field's evolution in the years to come.

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The upcoming digital pathology conference is set to cover a wide range of topics related to the integration of digital technology and artificial intelligence (AI) in the field of pathology. The agenda includes keynote addresses, presentations, workshops, and discussions led by experts in the field. Here is a summarized overview of the conference agenda:

Day 1: Monday, October 30

9:30 AM - 9:45 AM

• Welcome & Opening Remarks
  • Dr. Liron Pantanowitz, MD, PhD, UPMC; DPA President

9:45 AM - 10:45 AM

• DPA Foundation Remarks
  • Michael Rivers, Roche; DPAF President

10:45 AM - 11:15 AM

• KEYNOTE ADDRESS
  • Reflections of a Clinician-Data Scientist: Successes, Disappointments, and Future Directions of AI in Healthcare
  • Dr. Anthony Chang, MD, MBA, MPH, MS; CHOC, AIMed

11:15 AM - 11:45 AM

• Large Language Models in Diagnostic Pathology – Opportunities, Challenges, and Ethical Considerations
  • Dr. Rama Gullapalli, MD, PhD; University of New Mexico
  • Dr. Ehsan Ullah, MBBS, MPhil, PhD; Health New Zealand, Auckland

11:45 AM - 12:45 PM

• The Cost of Digital Pathology: A Dynamic Customizable Cost Calculator for Informed Decision-making
  • Dr. Orly Ardon, PhD, MBA; Memorial Sloan Kettering Cancer Center

12:45 PM - 1:05 PM

• Lunch & Visit with Exhibitors

1:10 PM - 2:45 PM

• TRACK 1 (Windermere Y)
  • Presentation on Digital Primary Diagnosis at a mid-sized Pathology Department
  • Reports from the University of Texas Medical Branch
• TRACK 2 (Windermere Z)
  • Presentation on A Scalable, Standardized, and Responsible Framework for Clinical AI Models
  • Mayo Clinic's perspective by Dr. David McClintock and Dr. Chris Garcia

3:30 PM - 3:50 PM

• Refreshment Break & Visit with Exhibitors

3:55 PM - 5:30 PM

• TRACK 1 (Windermere Y)
  • Presentations on Digital Pathology Implementation in Asia and Europe
  • Image Analysis Comparisons and AI in Education
• TRACK 2 (Windermere Z)
  • Presentations on Predicting Breast Cancer Metastasis and Domain-Specific Pre-trained Models
  • Building Accessible Datasets for Cancer Research

5:30 PM - 7:00 PM

• Networking Reception

7:00 PM - 8:00 PM

• Philips Dinner Workshop

Day 2: Tuesday, October 31

7:00 AM - 3:30 PM

• Conference Registration

7:30 AM - 8:30 AM

• Iron Mountain Breakfast Workshop

9:00 AM - 10:45 AM

• PLENARY ADDRESS
  • Twenty Years of Digital Pathology: Lessons Learned
  • Dr. Sylvia Asa, MD, PhD, University Hospitals Cleveland
• Interoperability, Regulatory & Standards Updates

11:30 AM - 12:30 PM

• Lunch & Visit with Exhibitors

12:55 PM - 3:15 PM

• TRACK 1 (Windermere Y)
  • AI in the Pathologist's Daily Workflow and Future Possibilities
  • AI-Empowered Digital Workflow for Prostate Pathology
  • AI-Supported Primary Diagnosis of Gastric Biopsies
  • DeepHeme: A Bone Marrow Classifier
  • Comparison between Glass Slides and Digital Slides for Thyroid Cytology
• TRACK 2 (Windermere Z)
  • Clinical Validation of Primary Diagnosis and Molecular Profiling
  • Mayo Atlas, European Bigpicture Project Updates
  • Immediate Image-Based Molecular Profiling
  • Improved Statistical Benchmarking of Digital Pathology Models

3:15 PM - 3:30 PM

• Poster Awards

This conference covers a comprehensive range of topics, including AI applications in digital pathology, the challenges of implementation, cost considerations, ethical concerns, regulatory updates, and interoperability issues. Attendees will benefit from the insights and experiences shared by experts in the field of digital pathology.

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