AI Corner Lauterbach at Harvard Kennedy School

 I typed some rough laptop notes with many typos during the Kennedy School talk (Lauterbach/Tripathi) on US and Germany health systems and digital advances.   I asked Chat GPT to convert the typed bullets and phrases into an essay.  2023 Sep 22.

Main blog here - https://www.discoveriesinhealthpolicy.com/2023/09/lecture-notes-german-health-ministers.html

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CHAT GPT:  CREATES A GOOD ESSAY FROM TYPOS & FRAGMENTS IN MY NOTES 

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On the 22nd of September, 2023, at the Harvard German American Club, an enlightening discussion took place on the topic of "Data and AI in Healthcare." The distinguished speakers were Dr. Lauterbach, the Health Minister of Germany, and Dr. Tripathi, the head of the Office of the National Coordinator (ONC) for US health data. The conversation, held at the Kennedy School of Government, was skillfully moderated by Dr. Agrawal of Harvard University.

Dr. Agrawal, who boasts affiliations with Heidelberg, Johns Hopkins University, and Dana Farber, opened the session by introducing the central theme - the critical role of health data in saving lives every day.

In response to the question of where the most tangible benefits of health data lie, Dr. Lauterbach underscored the need for Germany to catch up in health IT technology. He emphasized two key priorities: transitioning to fossil-free energy and fostering digital advancements, particularly in healthcare. Dr. Lauterbach outlined four forthcoming laws that would address these priorities, highlighting their collaboration with Dr. Lennerz and colleagues at Harvard.

The first set of laws pertains to two circles of data: the outer circle for Care and the inner circle for Research, both interconnected. By 2025, Germany aims to connect 70 million individuals to an Electronic Health Record (EHR), allowing for opt-out options. Within this network, 20,000 pharmacies, 1,800 hospitals, 180,000 doctors' offices, and laboratories would enable immediate EHR access to patient reports. This data can also be accessible to patients, with doctors potentially granted permission to access comprehensive medical information, including hospital and radiology reports.

The outer circle is encrypted but not anonymized, ensuring data security. 

In contrast, the inner circle can access clinical, cohort, and genomic data, residing in the Federal Research Space (FRS). The FRS is a confidential, non-encrypted research space, open for analysis, and will serve as a valuable resource for AI systems. Researchers and organizations, including pharmaceutical companies, will gain access to this data for various purposes.

Addressing the challenges of data privacy and structure, Dr. Lauterbach stressed the importance of making data accessible yet keeping it confidential. He also recognized the need to structure narrative data for retrospective analysis, possibly through partnerships like "Lewins [?]."

Dr. Tripathi, speaking on ONC priorities, expressed admiration for the top-down authority held by Dr. Lauterbach. In contrast, the United States faces fragmentation in its healthcare delivery system. Instead of a unified database, the U.S. system comprises loosely connected providers and payers, making interoperability a complex challenge.

Dr. Tripathi highlighted the significant investments made in the U.S. to lay the foundation for digital health, including incentives for Electronic Health Record adoption. He discussed the need for modern interoperability, emphasizing health equity, safety, and security. Additionally, Dr. Tripathi mentioned draft regulations regarding transparency for AI tools, ensuring data origin, uses, and potential risks are known.

The discussion delved into audience questions, with Dr. Agrawal posing inquiries to both speakers. Dr. Lauterbach detailed Germany's legislative efforts, including digitalizing bills, universal EHR implementation by 2025, and a strong focus on medical research acceleration. [for example, a goal to approve research protocols in Germany in 30 days, much faster than today.]

 Dr. Tripathi addressed the challenges of interoperability and the role of AI in closing these gaps. He also mentioned efforts to standardize data sets and promote accessibility, including through Application Programming Interfaces (APIs). [ONC rulemaking on AI here]

In closing, Dr. Agrawal touched on the importance of digital trust and transparency in AI algorithms. Dr. Lauterbach emphasized the need for transparency in AI systems and data usage.

The session concluded with brief audience questions, including inquiries about Germany's approach to health data accessibility and the challenges faced by patients in the U.S. regarding their medical records. Dr. Lauterbach highlighted Germany's granulated opt-out system and patient ownership of data, while Dr. Tripathi discussed the nuances of patient rights and data access in the U.S.

In summary, the discussion shed light on the evolving landscape of healthcare data and AI, highlighting both the progress and challenges faced by Germany and the United States in harnessing the potential of these technologies to improve healthcare outcomes.

DEX in French

 A blog from 9/19 in French (per Chat GPT)

https://www.discoveriesinhealthpolicy.com/2023/09/moldxology-dex-registry-allows.html

"Je ne suis pas sûr de quand cela a commencé, mais je suis presque certain que ce n'était pas là auparavant. Le registre en ligne MolDx Z code, DEX (qui montre tout sur un test enregistré, SAUF son véritable code Z secret) a toujours permis la recherche par nom de test et nom de laboratoire.

(Le nom du test peut être un véritable far west, et le nom du laboratoire peut même être compliqué en cas d'acquisitions et de filiales.)

Désormais, Palmetto DEX permet de rechercher selon cinq catégories différentes déroulantes. Sur le côté gauche, ce sont les maladies, le statut FDA, la spécialité médicale (par exemple, cardiologie), la méthode, et le type de test. (Le type de test est "diagnostique, confirmatoire, prédictif", etc). Trouvez DEX ici : https://app.dexzcodes.com/

Il semble y avoir une logique "et" intégrée, par exemple, ici j'ai recherché pour la catégorie Type de Test "DIAGNOSTIQUE" alors que j'avais laissé le nom de test "RaDaR" dans le champ de recherche par nom. Cela a exclu pas mal de variantes du test RaDaR, mais en montrant une qui est classée comme "diagnostique".

Le registre DEX est disponible avec une inscription par e-mail gratuite."

Comment to Novitas by Lewis Black (CHAT)

Sidebar to this blog:

https://www.discoveriesinhealthpolicy.com/2023/09/acla-others-comment-on-verbose-and.html

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So, folks, gather 'round! We've got ourselves a letter here dated September 8, 2023, and it's a doozy. The medical directors got some mail, they received a letter from a bunch of big-shot organizations, and boy, are those guys concerned!

Why, you ask? Well, it seems these "Genetic Testing for Oncology" draft policies by Novitas and First Coast Service Options (FCSO) are about as clear as mud. And, if they're actually finalized, Medicare beneficiaries with cancer might as well kiss their access to genetic testing goodbye! And who needs that when they're in the middle of a cancer diagnosis, right?

But wait, there's more! These policies apparently don't play by the Social Security Act and Medicare Program Integrity Manual's rules. Shocking, I know. They're worried about this "default" non-coverage for tests that aren't in some "knowledgebases." Sounds pretty darn vague, doesn't it? And if a test isn't covered, well, tough luck, pal.

And don't even get them started on those pesky ICD-10 codes! Some codes mysteriously disappeared from the billing articles. Poof! Gone! If your code isn't there, tough cookies, because your test won't be covered. Who needs genetic testing anyway? It's overrated!

But the fun doesn't stop there. Brace yourselves, because there's a whole bunch of issues in this draft LCD. They're worried about "Documentation Requests" and the inevitable coverage limitations because doctors and labs can't seem to share information properly. Go figure!

And here's the pièce de résistance: genetic tests for hereditary cancer syndromes are limited to once in a beneficiary's lifetime. Yep, you read that right! Even if technology improves and we learn more, tough luck, Granny!

Now, as we all know, these folks don't believe Novitas and FCSO have followed the rules for an LCD. Apparently, you need to include a summary of the evidence when you make one of these things, but who's got time for that?

So, in true bureaucratic fashion, these organizations are begging, pleading, and practically getting down on their knees, asking Novitas and FCSO to pretty please fix these policies. Because, you see, they'd like Medicare beneficiaries to have access to essential genetic tests. What a novel idea!

So there you have it, ladies and gentlemen, a whirlwind tour of bureaucratic mishaps and healthcare concerns, all wrapped up in one delightful Lewis Black-style rant! Isn't the world just a fascinating place? 

CMS and Prostate Screening Policy

 PSA testing is baked into statute as an annual covered service, but that doesn't mean CMS likes it.   Nonetheless, CMS may be anti-PSA on one day and pro-PSA on another.  Here are some materials promoting that screening PSA test to Medicare patients.

https://www.cms.gov/training-education/medicare-learning-network/newsletter/2023-09-14-mlnc#_Toc145581416

Chat Explains what a CMS "SAD" Drug List Is

 I fed Chat GPT a Self Administered Drug Exclusion List (a CMS document) and here's the answer.

https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=52800

This document appears to be an article or informational document related to the Medicare program in the United States. It provides information and guidelines regarding the coverage of outpatient prescription drugs under the Medicare program.

The document discusses the criteria used to determine whether a drug or biological is usually self-administered by patients, and if so, whether it is excluded from payment. It also outlines the evidentiary criteria and presumptions used in this determination. The document contains a list of specific drugs and their exclusion status based on these guidelines, with details such as generic and brand names, exclusion effective dates, and reasons for exclusion.

Additionally, the document discusses the use of modifiers for drugs with multiple routes of administration and provides information about coding and billing procedures related to these drugs.

Overall, this document serves as a reference for healthcare providers and contractors participating in the Medicare program to understand the coverage and payment rules for outpatient prescription drugs.

User

How many drugs are mentioned?

ChatGPT

There are a total of 142 drugs mentioned in the document. These drugs are listed with their respective codes and additional information related to their administration and coverage status.

How does Medicare decide if something belongs on this list of drugs, or not?

[WARNING: THIS IS NOT A GOOD ANSWER.  IT IS GENERAL TO "COVERED" DRUGS NOT SAD DRUGS!

ChatGPT

Medicare uses a specific process to determine which drugs are included on its list of covered drugs, known as the Medicare formulary. This process is governed by guidelines and regulations established by the Centers for Medicare & Medicaid Services (CMS). Here are the key steps in how Medicare decides if a drug belongs on its list:

FDA Approval: In most cases, for a drug to be considered for inclusion on the Medicare formulary, it must first receive approval from the U.S. Food and Drug Administration (FDA). The FDA evaluates drugs for safety and efficacy before they can be marketed in the United States.

Drug Classes and Categories: Medicare organizes drugs into classes and categories based on their therapeutic use. These categories help determine which drugs are interchangeable with each other. Within each category, Medicare looks for drugs that provide clinically significant benefits over others.

Formulary Committees: Medicare contracts with private insurance companies to administer its prescription drug plans (Part D plans). These insurance companies have Pharmacy and Therapeutics (P&T) Committees consisting of healthcare professionals, pharmacists, and other experts. These committees review and evaluate drugs within specific categories.

Clinical Guidelines and Evidence: P&T Committees consider clinical guidelines, medical literature, and scientific evidence to assess the safety and effectiveness of drugs. They may consider factors like clinical trial data, real-world outcomes, and patient preferences.

Cost Considerations: While Medicare primarily focuses on the clinical effectiveness of drugs, cost-effectiveness is also considered. Insurance companies negotiate with drug manufacturers to obtain favorable pricing for drugs that will be included on the formulary.

Patient Access and Availability: Medicare aims to ensure that beneficiaries have access to necessary medications. They consider factors like patient needs and the availability of alternative treatments.

Public Input: CMS and Part D plan sponsors often seek public input on proposed formulary changes. This can include input from healthcare professionals, patient advocacy groups, and the general public.

Periodic Reviews: Medicare conducts regular reviews of the formulary to make updates and changes as new drugs become available, clinical guidelines evolve, or when there are changes in drug pricing and market dynamics.

Exceptions and Appeals: In some cases, a beneficiary may need a drug that is not on the formulary. There is a process for requesting exceptions or appealing coverage decisions.

It's important to note that the specific criteria and processes may vary slightly among different Medicare Part D prescription drug plans, but they all adhere to the general principles outlined above. The goal of Medicare's formulary is to balance clinical effectiveness, cost-efficiency, and patient access to ensure that beneficiaries receive appropriate and affordable medications.

NOTE: THE ABOVE WAS A POOR ANSWER, ABOUT PART D NOT "SAD" LIST.

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MEDPAGE ARTICLE SUMMARY BY CHAT GPT

https://www.medpagetoday.com/special-reports/exclusives/106338

The news article highlights a specific case involving Medicare policy changes related to self-administered drugs (SADs) and their significant financial implications for patients. The key points in the article are as follows:

Patient's Situation: George Beitzel, an 84-year-old retiree with Crohn's disease and Parkinson's disease, had been receiving injections of ustekinumab (Stelara) at a clinic every 2 months for 5 years. Medicare had previously covered the cost of these injections under Part B, which covers drugs administered in medical settings.

Policy Change: On October 15, 2021, Medicare quietly changed its policy regarding Stelara. It reclassified Stelara as a "SAD" or self-administered drug, even though Beitzel was unable to self-administer due to his Parkinson's disease. This policy change meant that Medicare would no longer cover the drug when administered in an outpatient setting.

Financial Impact: Beitzel was unaware of this policy change, and he continued to receive injections at the clinic for another 7 months. As a result, he now faces a bill of $43,543.47 for each injection he received after the policy change, totaling as much as $176,000. He received numerous letters from Medicare denying his appeals.

Lack of Notice: What's particularly distressing is that Medicare did not require providers to give advance notice to beneficiaries about the change in coverage status, leaving patients to discover the change only when they received large bills months later.

Legal Action: Beitzel and another patient filed a class-action lawsuit against the U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra through the Center for Medicare Advocacy (CMA). They are seeking relief for the financial burden caused by the policy change and requesting an injunction to require proper notice and modifications to the program for those who cannot self-administer SADs.

Impact on Other Patients: The article mentions that this policy change doesn't only affect Stelara but also potentially thousands of Medicare beneficiaries who are facing similar unexpected financial burdens due to the reclassification of drugs as SADs.

Safety Concerns: Beitzel emphasizes the danger posed by Medicare's actions, as patients who cannot self-administer are left with limited options, high costs, and the risk of discontinuing necessary treatments.

This news article illustrates how changes in Medicare policy, particularly the reclassification of drugs as self-administered, can have profound and unexpected financial consequences for patients. It also highlights the importance of clear communication and notice to beneficiaries when such policy changes occur, especially when patients may not be able to self-administer due to medical conditions. The legal action taken in response to these changes underscores the potential impact on a broader group of patients facing similar challenges.

MolDx Senior Staff and Titles

 Dr. Angella Charnot-Katsikas, MD, FCAP Medical Director, MolDX Chief Medical Officer, Palmetto GBA

 

Megan Landsverk PhD, MB(ASCP) ^CM, FACMG Associate Director, MolDx

 

Dr. Magdalena Jurkiewicz, MD, PhD, MPH Medical Director, MolDX Chief Medical Officer, Palmetto GBA

AI Creates Trade Journal Article Today, About AMP Economics Summit in Two Weeks

ChatGPT creates an article as if the journalist had attended.

https://www.amp.org/advocacy/amp-molecular-pathology-economics-summit/

Medical Technology Conference Explores

Economic Challenges and Solutions in Precision Medicine

Washington, D.C., September 13, 2023 — Medical professionals, industry leaders, and patient advocates gathered at the Omni Shoreham Hotel's Empire Room for a day of insightful discussions at the Precision Medicine Economics Summit. Hosted by the AMP Economic Affairs Committee, the conference aimed to address the economic challenges faced by various stakeholders in the field of molecular diagnostics and explore potential solutions to ensure the continued advancement of precision medicine.

The conference began with a hearty breakfast and registration, setting the stage for a day of engaging conversations. Dr. Samuel Caughron, Chair of the AMP Economic Affairs Committee and a representative of the MAWD Pathology Group, P.A., welcomed attendees with opening remarks that emphasized the importance of collaboration across industries in overcoming economic obstacles in the realm of precision medicine.

The morning sessions comprised a series of "Real World Perspectives Roundtables," each focusing on a different stakeholder community. These discussions highlighted the unique challenges faced by clinical laboratories, patient advocacy groups, in vitro diagnostic manufacturers, and pharmaceutical companies. Facilitated by Dr. Clifford Goodman, these candid discussions offered attendees the chance to explore the specific economic hurdles encountered by each stakeholder group.

The first roundtable, "Clinical Laboratories," discussed the economic challenges facing molecular diagnostics from the perspective of laboratory professionals. The "Patient and Provider Community" roundtable delved into how economic issues affect patient access to advanced molecular diagnostics. The "Manufacturer Community" and "Pharmaceutical Community" roundtables explored the perspectives of IVD test manufacturers and pharmaceutical partners, respectively, shedding light on how these sectors are impacted by economic constraints.

A refreshing coffee break provided attendees the opportunity to network and exchange ideas in the Empire Foyer before the program resumed with the afternoon session. Dr. Caughron and Dr. Goodman introduced the afternoon program, setting the stage for an interactive discussion aimed at identifying solutions and action items.

During the afternoon breakout sessions, attendees were grouped into roundtables to discuss specific topics related to the challenges underlying molecular diagnostic testing. These discussions encompassed various themes, including the perception of test quality, providing feedback to private payer policies, educating payers about molecular diagnostics, and streamlining coding systems. The goal of these discussions was to formulate actionable items that could drive progress in addressing these challenges.

The facilitated discussion that followed focused on identifying the most impactful and feasible action items resulting from the earlier breakout sessions. Dr. Goodman guided attendees through prioritizing these items, ensuring that they would effectively address the economic challenges posed by precision medicine.

The conference concluded with a forward-looking discussion led by Dr. Caughron. Attendees explored the future of the Molecular Diagnostics Industry, touching on potential innovations, the role of AI, and anticipated challenges that lie ahead. With the insights gained from this discussion, attendees left the conference with a deeper understanding of the evolving landscape of precision medicine.

Dr. Caughron returned to deliver the closing remarks, expressing gratitude to all attendees for their active participation and reaffirming the commitment to addressing the economic challenges that impact the progress of precision medicine. The summit concluded on a high note, leaving attendees inspired and equipped to drive positive change in the field of molecular diagnostics and precision medicine.

For more information on the Precision Medicine Economics Summit and future updates on precision medicine advancements, visit [conference website link].

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