65th Edition of the A.I. Healthcare Report

65th Edition of the A.I. Healthcare Report

Important Announcements

Well, we did it, everyone! Sixty-five editions of the A.I. Healthcare Report. Thank you for reading. If you find one thing interesting in each newsletter, that is a success in my book!

My goal has always been constant. It is to challenge the conventional coverage and access arguments we hear in healthcare.

I want to take this time to note that I will now be offering consulting services exclusively in A.I. healthcare for clients. I figured after 60+ editions that now is the time to start monetizing my knowledge. Do not worry the newsletter will remain free. Please direct message me for more information.

Also please follow the AI Healthcare Podcast LinkedIn Page here: https://www.dhirubhai.net/company/ai-healthcare-podcast/


Main Ideas

  • The Congressional Budget Office recently released a report that explores the impacts of Medicare covering anti-obesity medications and how it would affect the federal budget.
  • XtalPi and Janssen Biotech team up on biologics.
  • The Centers for Medicare and Medicare Services (CMS) is publishing final guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturing of the maximum fair price in 2026 and 2027 regarding the Inflation Reduction Act (IRA).
  • Rep. Jill Tokuda [D-HI-2] is the latest cosponsor of H.R. 8144.
  • Rep. Doris Matsui [D-CA-07] introduces legislation that would amend the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes.
  • Plano-based NTT DATA North America teams up with Duke Health and Ellipsis Health to bring automation and generative AI to in-home care.


This Week on The A.I. Healthcare Report

Welcome to the Sixty-Fifth of the AI Healthcare Report!

Welcome to the Sixty-Fifth Edition of the A.I. Healthcare Report! The Longhorns routed the Sooners 34-3 at the annual Red River Rivalry in Dallas and sit on top of the rankings at number 1 and the Aggies are now 14. The Longhorns will face the Georgia Dawgs next week in Austin. The Aggies will face the Mississippi State Bulldogs next in Starkville. A lot of exciting things happening in College Football. Not to mention we are in the middle of an exciting baseball playoffs season!


Weekly Question

The Congressional Budget Office recently released a report that explores the impacts of Medicare covering anti-obesity medications and how it would affect the federal budget.

Do you think Medicare should cover anti-obesity medications? How would you improve patient outcomes while reducing federal spending?

For more information, please click here .


Healthcare Market Watch

XtalPi’s AI biologics discovery platform licensed to Janssen Biotech

KeyBioscience and Eli Lilly extend partnership for obesity treatments

Booster Therapeutics to develop proteasome activator medicines

Roche burnishes breast cancer portfolio with FDA approval for Itovebi, a threat to Novartis and AZ

Lilly's manufacturing splurge continues with $200M expansion in China


Healthcare Policy Watch

1.Veterans Rural Health Advisory Committee, Amended, Notice of Meeting

The Veterans Rural Health Advisory Committee will hold its in-person meeting.

The purpose of the meeting is to advise the Secretary of VA on rural health issues impacting veterans and examine policies and procedures that impact and improve healthcare delivery to the respective population.

The agenda will include updates from the Executive Director, VA Office of Rural Health; the Committee Chair, and other experts.

The meeting is open to the public and will be broadcast virtually for those who cannot be in person. More information is below:

Location: American Legion Build, 1608 K St. NW, Washington, DC 20006

Date: Thursday, October 24, 2024.

Time: 8:00 a.m. til 4:30 p.m. EST


2.Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program Final Guidance

The Centers for Medicare and Medicare Services (CMS) is publishing final guidance for the second cycle of the Medicare Drug Price Negotiation Program and manufacturing of the maximum fair price in 2026 and 2027 regarding the Inflation Reduction Act (IRA).

Please send emails regarding the final guidance to [email protected] with the subject line “Medicare Drug Price Negotiation Program Final Guidance.”


3.Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2026; and Basic Health Program

CMS has published a proposed rule that mentions payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) and the 2026 benefit user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs).

The proposed rule also impacts the calculations for the Basic Health Program (BHP) payment the Initial Validation Audit (IVA) sampling approach, and the Second Validation Audit (SVA) for HHS-RADV.

Other areas that are impacted range from HHS authority of compliance reviews and actions against insurance violations for HHS Exchange standards and requirements to proposed visions of the medical loss ratio reporting (MLR) system and rebates.

Please submit comments by November 12, 2024.


4.Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2025 Proposed Guidance Development

The FDA has announced the publication of two guidance documents that the Center for Devices and Radiological Health (CDRH) will publish in FY25.

The agency has established a docket where key stakeholders can comment on any proposed draft language, suggestions, and other feedback.

Please submit comments by December 10, 2024.


5.Medical Devices; Quality System Regulation Amendments; Correction

The FDA will correct a final rule that first appeared in the Federal Register on February 2, 2024.

The final rule amended current good manufacturing practice (CGMP) requirements of the Quality System (QS).

The original final rule failed to mention a particular definition.

The final rule will now be effective February 2, 2026.


Congressional Updates

H.R. 8144 Bill Update

Rep. Jill Tokuda [D-HI-2] is the latest cosponsor of the bill.

For more information, please click here .


H.R. 9497 Bill Update

Reps. Dean Phillips [D-MN-3] and Alexandria Ocasio-Cortez [D-NY-14] are the latest cosponsors of the bill.

For more information, please click here .


S.5150 Bill Update

The legislation now has bill text.

For more information, please click here .


S.5152 Bill Update

The legislation now has bill text.

For more information, please click here.


S.5170 Bill Update

The legislation now has bill text.

For more information, please click here .


S.5182 Bill Update

The legislation now has bill text.

For more information, please click here .


New Bills

H.R.9979 - To amend the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes.

Sponsor: Rep. Doris Matsui [D-CA-07]

Cosponsor: Rep. Gus Bilirakis [R-FL-12]

The bill amends the Federal Food, Drug, and Cosmetic Act to establish a process for externally led, science-focused drug development meetings, and for other purposes.

The legislation has been referred to the House Energy and Commerce Committee.

For more information, please click here .


State Updates

Texas 2036 Newsletter Signup

North Texas’ NTT DATA Partners with Duke?Health to Bring Automation and Gen?AI to?In?Home Care

Plano-based NTT DATA North America (part of Tokyo-based NTT Group, John Frownfelter, MD, FACP, lead for Data-Driven Health at NTT DATA said the following:

“Today’s models for care at home continue to limp along with insufficient resources and piecemeal technologies. We are taking today’s best practices to the next level with the power of automation and generative AI.”

Mainul Mondal, founder and CEO of Ellipsis Health, talked about the business ramifications of the mentioned partnership:

"By integrating our AI virtual agent with NTT DATA’s solution, we enhance patient access to holistic, personalized care, empowering families and caregivers with vital data and insights while reducing the burden on healthcare professionals. This initiative offers significant support for our loved ones during their healthcare journeys, ensuring that compassionate, efficient, and comprehensive care is accessible to everyone, right in the comfort of home.”

Emily Norboge, Chief Research Informatics Officer of Duke Cancer Institute also applauded the partnership by stating the following:

“This partnership is focused on using advanced digital technology to address a broad range of patient needs efficiently and cost-effectively,”


Coming up

No pertinent hearings this week


What I Am Reading

Stanford Human-Centered Artificial Intelligence is a great resource for diving deeper into AI and Healthcare. I have provided the signup page for their free newsletter here .

Fathom.org is also a great newsletter for AI news.

I am currently reading Thinking, Fast and Slow by Daniel Kahneman.

For the physical book, click here .


Projects

Below are a few writing projects I have done.


Follow Me

Below are my social channels to read the AI Healthcare Report/listen to the AI HealthcarePodcast


All podcast episodes can be found on Apple Podcasts and Spotify too.




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