• 11/01 - Orange County ZOOM Table - Discussion Topic: "Five Ways to Expand from Your Core Business" - Featuring Nicholas Focil, CEO of FOMAT Medical Research


• 11/16 - Bay Area ZOOM Table - Discussion Topic: "What Do Employees Want Now?" - Featuring Cecile Currier, CEO of Concern Health + VP of Corporate & Community Health Services at El Camino Health


• 11/17 - Los Angeles ZOOM Table - Discussion Topic: "Ways You've Expanded from Your Core Business" - Featuring Nicholas Focil, CEO of FOMAT Medical Research


• 11/14 - Membership-wide IN-PERSON AI EVENT (in Orange County): Supercharging Your Company's AI Game
  - to Surf Instead of Sink in Today's AI Growth Wave - with AI and other related tools. You can listen, discuss, and meet with a great panel of speakers - and others who'll be with us for this special event; also featuring lunch and a Round Table. 9:30 am to 3 pm. OC location to be provided to those Members who RSVP Yes. So RSVP today!

PANEL OF SPEAKERS:
ALI PAYANI, founder of Payani Group, on using AI for growth marketing;
GREG LEBSACK, on Using AI for Exponential Business Growth;
THOMAS LEFFLER, President of Project Insight, on sharing his "AI-in-Healthtech" Project Management perspective;
SATNAM GAMBHIR, CEO of Envision Financial Systems, on AI for Initial Issues Management;
MARISA BRUTOCO, Sheppard Mullin Partner (formerly in-house counsel at Google, Amazon and Apple) and Member of SM's Technology Transactions Team, on how AI is transforming Content, Technology, and Related Legal Issues;
and ABL's BOB KELLEY making the Positioning Presentation and Panel Moderator.

• Addiction Research Institute (Gene Barduson) Offers New Podcast Episode: Is There a Cure?
• Alegre Home Care (Charles Symes) Earns Green Business Certification
• AlzWell (Nick Focil) Wins Innovation Award
• Catalight (Susan Armiger) Provides 5 Key Takeaways from Recent Webinar + Launches Career Advancement Services for Neurodiverse Candidates
• Choice in Aging (Debbie Toth) Takes Part in Solano County's "Master Plan for Aging" Event + Spotlighted in Feature Article
• Donor Network West (Janice Whaley) Celebrates Signing of AB 1268 Into Law
• Eitan Medical (Roger Massengale) Wins Health Tech Home Care Award
• El Camino Health (Cecile Currier) Earns HeartCARE Center Designation & Named One of the Nation's Top Hospitals
• Illumination Foundation's (Pooja Bhalla, DNP) Partnership with CalOptima & OC Health Care Agency is Highlighted in Recent Webinar
• Kaiser Permanente (Marcos Vasconcelos) Adds Digital Services to Assist Patients
• Life Adjustment Team (Cynthia Sampson) Examines Exercise as Medicine & Life Skills Training as Part of Psychosocial Rehab
• MedWand (Bob Rose) Debuts REACH: Rapid Electronic Assessment for Community Health
• Nelson Hardiman (Harry Nelson, JD) Examines California's Office of Health Care Affordability & Implications of New Reproductive Health Laws
• On Lok (Grace Li) PACE Removes Barriers for Seniors Facing Isolation and Loneliness
• Onward (Steve Grau) Recognized in Digital Health Hub Foundation Awards
• PreludeDx (Dan Forche) Featured in DocWire News Interview
• Providence Digital Innovation Group (Marcee Chmait) Unveils Praia Health, Its 4th Incubated Technology
• Pulse Healthcare Marketing's Robin Raff Certified in AI Business Strategies & Applications
• Sheppard Mullin (Linda Igarashi) Examines New M&A Safe Harbor Policy & Pillars of Due Diligence
• WestFax (Barry Clark) "Leads the Pack" Among HIPAA-Compliant Fax Providers
• Wipfli (Jeff Johnson) to Present Healthcare-Focused Webinar on Nov. 21

• Eckert & Ziegler (Frank Yeager) Signs Supply Agreements
• GIDEON Informatics (Uri Blackman) on: Successful Mass Vaccination Programs

Eckert & Ziegler AG (EZ) has signed a reservation agreement for the supply of the therapeutic radioisotope Actinium-225, used as an active substance in cancer treatment, whereby PharmaLogic Holdings Corp will have access to EZ's high-purity, non-carrier-added Ac-225 for the labeling of radiopharmaceuticals for R&D work and commercial use.
PLUS, EZ signed an agreement with POINT Biopharma Global for the supply of carrier-free lutetium-177. POINT's pipeline has multiple lutetium 177-based clinical candidates including for the treatment of metastatic castration-resistant prostate cancer. (LA)

In Successful Mass Vaccination Programs: From Smallpox to COVID-19, GIDEON Informatics shares that the World Health Organization (WHO) has just approved a second vaccine to prevent malaria, an important milestone in the fight against this highly contagious disease. An effective mass vaccination campaign is desperately needed since there is no effective treatment for malaria. GIDEON notes that such programs helped us eradicate smallpox, significantly reduce polio cases, and lower the number of deaths, severe diseases, and hospitalizations from diphtheria, cholera, tetanus, influenza, rubella, measles, and more. GIDEON goes on to look at three notable mass immunization campaigns, starting with COVID-19.
MEANWHILE, GIDEON recently announced that its ebook on infectious diseases in Israel, the West Bank, and Gaza would be free for 30 days. This data can help frontline relief efforts. (LA)

On October 13, 2023, California Governor Newsom signed California Senate Bill No. 525 into law, which gradually raises the minimum wage to $25 for California health care workers. Beginning June 1, 2024, SB 525 requires most health care facilities to raise minimum wages for their employees, with the rate of the wage increases depending on the type of facility. Unless expressly exempted, facilities providing health care services must comply with the minimum wage increases under SB 525. The term "health care services" is defined broadly to mean "patient care-related services including nursing; caregiving; services provided by medical residents, interns, or fellows; technical and ancillary services; janitorial work; housekeeping; groundskeeping; guard duties; business office clerical work; food services; laundry; medical coding and billing; call center and warehouse work; scheduling; and gift shop work; but only where such services support patient care." (https://www.kslaw.com/news-and-insights/health-headlines-october-23-2023)

Consumers rate their satisfaction with health insurers higher than with hospitals, according to the American Customer Satisfaction Index. The index scored overall satisfaction with health insurers at 76 out of 100, the highest the industry has ever received, according to an Oct. 17 news release. Hospitals were rated at 74 out of 100. According to the Satisfaction Index, consumers report much higher levels of satisfaction with outpatient care, which received a score of 81 out of 100. The index is based on interviews with 12,849 customers conducted between October 2022 and September 2023. (https://www.beckerspayer.com/payer/consumers-are-happier-with-health-insurers-than-hospitals.html)

As health care costs continue to rise, more than half of working-age Americans said they've struggled to afford care this year, according to a new Commonwealth Fund survey. Nearly a third of adults reported having medical or dental debt, and nearly half of them said it's at least $2,000. Other results included: 57% said at least one-tenth of their monthly budget goes toward health care. 43% of those in employer-sponsored health insurance, which is the largest source of insurance coverage in the U.S., said they had difficulty affording care. Almost 40% of adults reported skipping or putting off health care in the past year because they couldn't afford it. Of this group, 57% said their health worsened as a result. About 33% adults said health care costs made it harder to pay for food and utilities, regardless of their coverage status. (https://www.axios.com/2023/10/26/health-care-unaffordable-insurance)

The dean of Stanford University's medical school, Dr. Lloyd Minor, thinks artificial intelligence will transform the medicines you take, the care you get and the training of doctors. Dr. Minor has teamed up with Fei-Fei Li, co-director of the Stanford Institute for Human-Centered Artificial Intelligence, to launch an initiative called Responsible AI for Safe and Equitable Health, or Raise-Health, which the two groups are funding together. It aims to serve as a repository for key research, to gather experts to discuss AI and to tackle ethical concerns in its application. Dr. Minor spoke with the Wall Street Journal about how he expects AI to change medicine: https://www.wsj.com/tech/ai/artificial-intelligence-medicine-innovation-6739b4f8?mod=hp_lista_pos3

The COVID-19 pandemic posed unprecedented challenges to the health care system, especially for patients who rely on controlled medications for their treatment. In response, the Drug Enforcement Administration issued several waivers and temporary rules to facilitate the practice of telemedicine and allow for the prescription of controlled medications via online platforms. The most recent extension, announced on October 6, 2023, prolongs these flexibilities until December 31, 2024, providing telemedicine providers a longer runway and more time to develop competitive strategies befitting the post-pandemic healthcare economy. Read Nelson Hardiman's Regulatory Update on the topic: One More Lifeline for Telemedicine: DEA Again Extends Flexibilities for Prescription of Controlled Medications. (https://www.nelsonhardiman.com/dea-again-extends-flexibilities-for-prescription-of-controlled-medications/)

The Food & Drug Administration recently published a long-awaited proposed rule on laboratory developed tests - showing that FDA is still asserting that it has statutory authority over all laboratory developed tests and has not significantly changed its thinking on laboratory developed tests since it issued draft guidance on the topic in 2014. The proposed rule is open for public comment through December 2, 2023. (https://kslawemail.com/128/10749/uploads/ca-(1).pdf)

On October 27, 2023, the Departments of HHS, Labor, and Treasury and the Office of Personnel Management released a proposed rule updating the payor-provider dispute resolution process under the federal No Surprises Act. The proposed rule (the IDR Operations Proposed Rule) focuses on the operations of the independent dispute resolution (IDR) process and does not address the controversial dispute resolution criteria. If finalized, the IDR Operations Proposed Rule would modify the requirements for pre-dispute negotiation communications between plans and providers, expand upon the pre-dispute eligibility determination processes, and change the administrative fee structure. The IDR Operations Proposed Rule also provides new batching provisions. The IDR Portal opened for disputes on April 15, 2022. The Departments reported that 489,000+ disputes were submitted between April 2022 and July 2023, and that as a result of this unexpected high volume the dispute resolution process is taking longer than required under prior rulemaking. (https://kslawemail.com/128/10770/pages/art1.asp?sid=a0584477-26cc-45d7-927b-4d37da9d9c38)

CMS issued a final rule on October 27, 2023, that updates payment rates and policies under the end-stage renal disease (ESRD) prospective payment system (PPS) for renal dialysis services provided to Medicare beneficiaries on or after January 1, 2024. The changes to the ESRD PPS will provide a bundled, per-treatment payment to ESRD facilities that covers all renal analysis services provided for outpatient maintenance dialysis, including drugs, biological products, and other items and services that were previously separately payable. The final rule also includes several changes to the payment policies, such as reporting requirements for discarded dialysis drugs and biological products. (https://www.cms.gov/newsroom/fact-sheets/calendar-year-2024-end-stage-renal-disease-esrd-prospective-payment-system-pps-final-rule-cms-1782-f)

U.S. health officials are warning consumers to stop using more than two dozen over-the-counter eye drop products due to the potential risk of eye infection that could lead to vision loss. The FDA recently issued the alert for 26 products from the following brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up and Velocity Pharma. The agency said it recommended the manufacturers to recall the subject products, after FDA investigators found bacterial contamination in critical drug production areas of a manufacturing facility. None of the products have caused adverse effects in consumers yet (as of article publication). (https://www.npr.org/2023/10/29/1209279307/fda-eyedrops-contamination)

The Cybersecurity and Infrastructure Security Agency (CISA) and the Department of Health and Human Services (HHS) recently co-hosted a roundtable discussion on the cybersecurity challenges that the U.S. healthcare and public health sector system faces, and how government and industry can work together to close the gaps in resources and cyber capabilities. Ahead of the roundtable, CISA and HHS released a cybersecurity tool kit that includes resources tailored for the healthcare and public health sector. This toolkit is at www.CISA.gov/healthcare and consolidates resources like: CISA's Cyber Hygiene Services; HHS's Health Industry Cybersecurity Practices; and HHS and the HSCC's HPH Sector Cybersecurity Framework Implementation Guide.  (https://www.hhs.gov/about/news/2023/10/25/cisa-hhs-release-collaborative-cybersecurity-healthcare-toolkit.html)

The Advanced Research Projects Agency for Health (ARPA-H), an agency within HHS, recently announced a series of research projects totaling over $330 million that will support biomedical health breakthroughs aimed at improving health solutions and health care for the American public. ARPA-H makes pivotal investments in breakthrough technologies and broadly applicable platforms, capabilities, resources, and solutions with the potential to transform important areas of medicine and health that cannot readily be accomplished through traditional research or commercial activity. Last year, President Biden worked with Democrats and Republicans in Congress to establish and fund ARPA-H to drive breakthroughs to prevent, detect, and treat cancer and other diseases. ARPA-H is now moving aggressively to advance the goals of the Biden Cancer Moonshot and the President's Unity Agenda, among other initiatives.
Initiatives include:
>> Up to $50M in funding for six contract awards through the Digital Health Security project, to protect the U.S. health care system's electronic infrastructure.
>> Up to $26M for a newly funded project that aims to lay the groundwork for the development of 3D printed, fully-functional human organs.
>> Up to $37M in project funding to restore function to the thymus, an organ responsible for supporting normal immune cell development, and potentially restore immune system function as people age.
>> A new project to combat the growing threat of antibiotic-resistant bacteria.
>> 3 major projects for radical new ways to detect and treat cancer.
>> The launch of ARPANET-H, a nationwide health innovation network. (https://www.hhs.gov/about/news/2023/09/29/biden-harris-admin-announces-over-330-mil-dollars-in-new-funding-to-advance-biden-cancer-moonshot-initiative-improve-health-care-research-treatment-and-outcomes.html)

The California Office of Healthcare Affordability (OHCA) recently released updated regulations pertaining to the healthcare transaction notice requirements that will apply to transactions that close on or after April 1, 2024. On June 30, 2022, the Health Care Quality and Affordability Act (SB 184) was signed into law in California. The new law established OHCA and set forth that OHCA would be tasked with overseeing and containing healthcare spending in California. As part of that responsibility, OHCA would review certain proposed healthcare transactions in the state. Earlier this year, OHCA published proposed regulations to govern the review of proposed healthcare transactions that close on or after April 1, 2024. Beginning on April 1, 2024, a "health care entity" is required to provide written notice to OHCA at least 90 days prior to entering into a covered agreement or transaction. Within 60 days, OHCA will advise the entity whether OHCA will conduct a cost and market impact review (CMIR) or provide a written waiver. OHCA must conduct a CMIR if the proposed transaction is "likely to have a risk of a significant impact on market competition, the state's ability to meet cost targets, or costs for purchasers and consumers." OHCA may not block a transaction, but the review could take longer than the 90-day notice period and should be factored into a transaction's closing timeline. https://www.kslaw.com/news-and-insights/health-headlines-october-23-2023

Across all industries, 164 CEOs left their posts in September, according to the most recent report from Challenger, Gray & Christmas (CGC), an executive outplacement firm that tracks turnover month to month. That's the highest total on record for the third quarter. The problem persists in healthcare; hospitals and health systems, all of which reported 125 CEO changes in the first nine months of the year, up 67% from the same time period in 2022. Fortune recently described CEO turnover as a "Great Resignation" of its own. CGC data shows that most companies are vague about CEO departures. Although 22% of exits can be attributed to retirements, and 17% stepped down into other C-level, advisory or board roles, the uncertain economy might also be playing a role. (https://www.beckershospitalreview.com/hospital-management-administration/ceos-great-resignation.html)

A new feature in Apple Watch Series 6 and later versions uses the device's ambient light sensor, GPS and motion sensors to track the amount of time the wearer spends outdoors. Too much exposure to the sun without protection is detrimental to human health, but too little sun exposure and time indoors is also detrimental, and Apple says the Time in Daylight feature can encourage people to spend more time outdoors. (https://www.washingtonpost.com/wellness/2023/10/11/apple-watch-health-daylight-tracker/)

LA's Cedars-Sinai has launched a 24/7 virtual care app that uses artificial intelligence to evaluate patients. Cedars-Sinai Connect offers virtual urgent care around the clock and same-day primary care appointments. The health system developed the platform as a joint venture with digital health company K Health, which uses AI for clinical intake and data entry to speed up appointments. When patients log into Cedars-Sinai Connect, an AI chatbot collects health details and symptoms and then generates a summary for the virtual clinicians. The app, which is integrated with Cedars-Sinai's EHR, is available for California patients and accepts any insurance that the health system takes. (https://www.beckershospitalreview.com/digital-health/cedars-sinai-launches-virtual-care-app-with-ai-chatbot.html)

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