May 2025 – Page 2 – AZ Public Health Association

May 20, 2025May 20, 2025

Kennedy’s War on Vaccination: FDA to Suspend Approval of Updated COVID Boosters Except for Seniors & Folks w/ High Risk Factors

In a major and dangerous policy shift, the FDA announced in a New England Journal of Medicine article that updated COVID-19 vaccines will now require randomized, controlled trials for approval in healthy individuals aged 6 months to 64 years.

This marks a departure from previous decades long practice where annual updates were approved based on immune response data, similar to the approach for influenza vaccines.

Under the new guidelines, only older adults and people with high-risk medical conditions will have access to updated COVID-19 vaccines – a change that will affect vaccine for more than 100 million Americans.

Kennedy’s Not-So-Silent War On Vaccination – AZ Public Health Association

This new dangerous policy shift is 100% in line with Kennedy’s longstanding anti vaccine outlook.

Requiring full-scale clinical trials for each updated vaccine variant is logistically impossible, not financially feasible (ROI) and will lead to preventable deaths and hospitalizations. Furthermore, conducting placebo-controlled trials when effective vaccines already exist is ethically questionable.

The FDA’s new policy is likely the first major assault in a long war that Kennedy will be undertaking over the next few years to reduce vaccine accessibility and public health preparedness.

For now, I really don’t have a call to action to stop this harmful decision – although I’ll keep thinking about it.

Note: The CDC’s advisory panel (ACIP) will be voting on this policy shift in June – and may rubber stamp of the FDA’s policy article – which will lead to the CDC no longer recommending the booster to those under 65. Health plans would then stop paying for the vaccine for those populations. ACIP members who vote against the new recommendations will likely be dismissed by Kennedy.

In Below is an excerpt from the NEJM article from this week:

“Moving forward, the FDA will adopt the following Covid-19 vaccination regulatory framework: On the basis of immunogenicity — proof that a vaccine can generate antibody titers in people — the FDA anticipates that it will be able to make favorable benefit–risk findings for adults over the age of 65 years and for all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes, as described by the CDC.”

“For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted. Insofar as possible, when approving a Covid-19 vaccine for high-risk groups, the FDA will encourage manufacturers to conduct randomized, controlled trials in the population of healthy adults as part of their post marketing commitment.”

May 19, 2025May 19, 2025

Will Humble Federal Budget, Social Determinants, Wills Blog

A Familiar Idea Returns: Will ‘Most Favored Nation’ Drug Pricing Survive This Time?

Americans continue to pay more for prescription drugs than anyone else in the world. This has been a long-standing and well-documented problem. A key driver isn’t just what patients pay out of pocket—it’s the actual list prices of the drugs themselves. These prices inflate private insurance premiums, drain the Medicare trust fund, and strain household budgets across the country – damaging the social determinants of health.

One of the key reasons for this price disparity has been Medicare’s historic inability to negotiate prices directly with drug manufacturers. This changed modestly with the 2022 Inflation Reduction Act, which gave Medicare limited authority to negotiate the prices of a small number of high-cost drugs.

It was a step forward, but really a C-. By contrast, a more aggressive bill—H.R. 3, the Lower Drug Costs Now Act—would have required the Medicare to negotiate prices for hundreds of drugs. That bill did not pass in large part because Senator Sinema cut a deal with big pharma to sabotage HR3.

‘Inflation Reduction Act of 2022’ Gets a C- for Cutting Prescription Drug Prices – AZ Public Health Association

This week the Trump administration block, copied, and pasted the executive order from his first term to use ‘international reference pricing’ to cap what Medicare pays for some Part B (physician administered) drugs.

This “Most Favored Nation” approach would tie Medicare payments for physician-administered drugs (Part B Drugs) to the lowest price paid by similar wealthy nations. On paper, it’s an appealing proposal. After all, why do we pay two to four times what other countries pay for the same meds?

Note: The EO only applies to Part B Drugs administered by physicians – not Part D drugs (the lion’s share of medications). Medicare spends about $150B on Part D drugs vs. just $50B on Part B drugs – so this proposal doesn’t include the majority of meds and none of the drugs one gets at the pharmacy.

During Trump’s first term his HHS Secretary finished a rule to apply MFN pricing to 50 high-cost drugs, but the rule was blocked by the courts before it could take effect.

Pharma’s Big Con: Keep the Scam Going by Confusing Prescription Drug Prices with Out-of-Pocket Costs – AZ Public Health Association

Fast forward to the 2.0 drug EO this week: The administration has issued a new executive order trying the same thing again. The language and structure are almost identical to the earlier version that was struck down. And so, the question looms—will the courts allow it this time?

Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients – The White House

There’s reason to be skeptical. If the new version doesn’t address the legal shortcomings of the earlier rule it’s likely to also crash and burn.

Still, it’s not meaningless. It keeps the conversation alive and signals – for the first time – bipartisan frustration with drug pricing in the U.S.

Whether through MFN pricing, more aggressive negotiation powers for Medicare, or robust patent reform, meaningful change is still both necessary but elusive because of the chokehold big pharma has on Congress.

For now, the new executive order is worth a try—but don’t hold your breath. And remember, HR3 would have been an ironclad solution.

‘Inflation Reduction Act of 2022’ Gets a C- for Cutting Prescription Drug Prices – AZ Public Health Association

May 17, 2025May 17, 2025

Will Humble Public Health, Wills Blog

A Breath of Fresh Air: Sheila Sjolander Named Interim ADHS Director

We’re delighted to share that Sheila Sjolander has been appointed as the interim director of ADHS! This is good news for public health in Arizona—and a breath of fresh air for county health departments across the state.

Sheila is no stranger to public health and ADHS. She’s been shaping public health policy and strategy in Arizona for more than two decades. Most recently, she served as Deputy Director for Public Health Services, overseeing a team of over 700 public health professionals across the divisions of Prevention, Preparedness, and Licensing.

Before stepping into the deputy director role, Sheila worked for more than 10 years as Assistant Director for Prevention Services – including areas like maternal and child health, WIC, physical activity and nutrition etc.

She’s also been on the front lines of health improvement, strategic planning. Her efforts have earned her well-deserved recognition, including the Outstanding Achievement in Rural Women’s Health award in 2016 and the CHW Champion Award in 2017.

Sheila’s commitment to helping Arizona’s county health departments is steadfast and consistent.

Sheila earned a Master of Social Work from Temple University, and brings a unique blend of compassion, experience, and strategic vision to her new role.

As ADHS enters this new chapter, Sheila’s appointment feels like the good fit. We look forward to seeing how her leadership uplifts ADHS’ mission.

P.S. I’ve been trying to confirm who is the interim director at AHCCCS but haven’t been able to independently identify who it is – all I have right now is grapevine stuff.

May 15, 2025May 12, 2025

Will Humble Public Health, Wills Blog

The Science & Community Impacts Mapping Project

Science transforms our world but doing science and the impacts of scientific research are often hidden from view. Not anymore.

That’s because the Science & Community Impacts Mapping Project now allows folks to explore how science and health fuels the economy, supports jobs and improves health outcomes.

The White House and Secretary Kennedy have ordered large cuts to federal funding for scientific research. These changes include a proposal to reduce support for all health-related research nationwide, and cancellations of many grants for specific research projects.

We encourage you to contact your local elected officials and representatives in Congress to share your opinion and call attention to these funding cuts. Click here to find contact information for your representatives. Here are some facts to keep in mind:

Less than 1% of the federal budget goes to NIH, but this investment has a big impact.
Federally funded scientific and medical research improves health, drives innovation, creates jobs, and grows the economy.
Every dollar invested in scientific research through NIH produces, on average, $2.56 of economic activity in return – over 250% gain.
NIH research supports over 400,000 jobs across the U.S.
Reducing indirect cost rates to 15% would undermine the ability of universities, hospitals, and research institutes to conduct lifesaving, medical research.

May 15, 2025May 16, 2025

Will Humble Medicaid, Public Health, Wills Blog

Congress’ Proposed Medicaid Cuts & Kennedy’s Separate IED: How Arizona Could Lose AHCCCS Coverage for 600,000 Residents

The U.S. House of Representatives’ Energy and Commerce Committee just passed a budget bill along party lines (30-24) that proposes $715B in federal Medicaid spending cuts over the next decade.

While the bill includes several overt measures to reduce spending (and throw people off Medicaid), less conspicuous provisions in the bill and a separate CMS regulation change being proposed by Secretary Kennedy and CMS Administrator Oz poses a big threat to Medicaid coverage for hundreds of thousands of Arizonans.

Key Provisions Limiting Access to Care

The bill introduces several measures that could restrict or end access to care for millions:

Altering and freezing ‘provider taxes’: Prohibits states from setting up any new provider taxes or increasing the rates of existing taxes. Revises how states can use ‘provider taxes’ to pay for the state part of Medicaid financing (this is super important in Arizona as we raise nearly $1B by assessing hospitals a fee to pay the state part to cover 600,000 Arizonans).
Work Requirements: Starting January 1, 2029, Medicaid members aged 19-64 would be required to complete 80 hours of work or approved activities monthly to keep coverage. Note: AHCCCS is already about to start work or community engagement requirements for ‘able bodied adults’ pending Dr. Oz’ certain approval – see: AHCCCS Asks Permission to Implement Work Requirements & Five-Year Benefit Limit
Increased Eligibility Redeterminations: The frequency of eligibility checks would double from once to twice a year, increasing administrative burdens and the likelihood of disenrollment due to procedural issues.
Freezing Medicaid Provider Taxes: This provision would cap a key funding mechanism for states to increase provider payments. This freeze would effectively limit states’ ability to raise Medicaid reimbursement rates over the next decade, potentially impacting provider payments as healthcare costs rise.
Defunding Planned Parenthood: The bill would block all Medicaid funding for Planned Parenthood, affecting access to preventive care, birth control, cancer screenings, and other services for Medicaid enrollees who rely on these clinics.

Kennedy’s “Improvised Explosive Device”: Changes to Provider Taxes

Beyond the legislative provisions, a separate proposal from HHS Secretary Kennedy aims to set a new statistical test to decide whether state-based fees (assessments) are acceptable to fund the state part of Medicaid. Their proposed rule change (this is over and above what congress is proposing) will use a new statistical ‘test’ to decide whether “non-uniform or non-broad-based” health care-related taxes are “generally redistributive.”

See Kennedy’s Proposed Rule Change for Hospital Assessments

In Arizona, the Medicaid program (AHCCCS) relies heavily on provider taxes to fund its share of Medicaid expansion costs (to the tune of $1B). If the new statistical test considers Arizona’s provider tax structure non-compliant, CMS could withdraw approval and end AHCCCS coverage for 600,000 Arizonans covered under Medicaid expansion – especially adults without dependents and those earning between 100% and 138% of the federal poverty level.

Note: Arizona assesses hospitals $682M to draw down $5.3B to cover the “prop 204 population” and overall assesses hospitals $1.5B to draw down over $8B in federal funds. Both Kennedy’s rule change (CMS) and the bill passed this week jeopardize both of those funding sources putting at risk the federal draw-down which would be absolutely catastrophic for AZ.

Conclusion

While the budget bill passed today by the Energy and Commerce Committee didn’t have the initial existential threat to AHCCCS in it: namely changing the formula for how much states need to pay for Medicaid (the FMAP rate) or per-capita caps, the less visible regulatory change regarding provider taxes poses a significant threat to Medicaid coverage in Arizona.

Secretary Kennedy’s independent plan to change the way they decide whether and how states can use a provider tax to pay the state part of Medicaid costs is the IED that could independently sink Arizona’s Medicaid ship and coverage for more than 600,000 Arizonans.

U.S. House panel passes GOP plan that cuts Medicaid by $625B, adds work requirement | Arizona Mirror

Hobbs, Democrats condemn GOP’s ‘disastrous’ proposed Medicaid cuts

May 14, 2025May 12, 2025

Will Humble Professional Development, Public Health, Wills Blog

AI & Public Health Practice: MEZCOPH Summer School

The Public Health & AI Summer School at the Mel and Enid Zuckerman College of Public Health is offering an immersive, direct educational experience designed to equip graduate students, research staff, faculty, and public health professionals with essential skills in AI and digital public health.

Participants will explore foundational and advanced topics such as Digital Epidemiology, AI and Machine Learning fundamentals, generative AI applications, digital biomarkers, ethical considerations, and precision public health.

Registration for County Health Department Staff is just $150!

Beyond technical skills, the program emphasizes critical thinking, responsible AI governance and ethical implications of AI integration in public health. Participants will engage directly with industry leaders and renowned instructors, enhancing their ability to lead and innovate in an AI-driven landscape.

Public Health & AI Summer School Registration, Tucson | Eventbrite

May 13, 2025May 12, 2025

Will Humble Vaccination, Wills Blog

Kennedy’s Not-So-Silent War On Vaccination

In what may be an early warning of a public health crisis, Secretary Kennedy is imposing new clinical trial requirements on the Novavax COVID-19 vaccine for each updated variant.

This marks a departure from the streamlined approval process that previously allowed updated vaccines tweaked to focus on new antigens.

According to a recent NBC News report, FDA appears to be slow-walking vaccine approvals this bureaucratic slowdown could be the tip of the iceberg. If these new hurdles become the standard, Pfizer and Moderna’s mRNA vaccines may soon face the same impossible demands: full-scale clinical trials for every tweaked version tailored to emerging variants.

Kennedy may even apply the same ‘logic’ to the seasonal flu vaccine, which is reformulated each year based on evolving strains.

It’s logistically impossible to conduct full clinical trials in time for each flu or COVID variant. If the FDA (Kennedy) insists on this standard, it could lead to the effective de-authorization of all COVID and flu vaccines.

As Politico reported, RFK Jr. eyes reversing CDC’s Covid-19 vaccine recommendation for children Kennedy is already planning to pull COVID vaccine recommendations for kids.

If he follows through, it’s a man-made disaster. Tens or even hundreds of thousands of preventable deaths annually, and a healthcare system overwhelmed by millions of unnecessary hospitalizations.

I know I keep writing gloom and doom stuff – and it is probably making you sad and overwhelmed – but it’s times like these when we need to use our collective professionalism, education, experience and ethics in motion to pushback however we can – even if it’s just writing this blog.

If we don’t act now, we may soon find ourselves unarmed in the fight against both seasonal and pandemic diseases—with devastating consequences.

Note: Next week I’ll cover the legal interventions to some of Kennedy’s decisions that have been taken by APHA. If you feel powerless and want to do something about all this damage to public health – one thing you can do is simply join APHA.

May 12, 2025May 13, 2025

Will Humble Medicaid, Wills Blog

AHCCCS Asks Permission to Implement Work Requirements & Five-Year Benefit Limit

AHCCCS just turned in their waiver request to the CMS asking permission to implement work reporting requirements and establish a five-year lifetime limit on Medicaid benefits for certain adults.

The proposal aligns with Senate Bill 1092 (enacted in 2015) which requires AHCCCS to annually ask CMS permission to implement a work requirement & 5-year lifetime benefit cap for able bodied adults.

See the Final Submitted Waiver Request

As you might expect – the real key in the waiver is the definition of who is ‘able bodied.’

AHCCCS’ proposal has a long list of categories of adults that are exempted because they’re not considered ‘able bodied.’ More on that in a bit.

Once approved by CMS (which will happen unless they think AHCCCS was too generous with excluding populations), “able-bodied adults” aged 19 to 55 would need to engage in at least 20 hours per week of qualifying activities like a job, school attendance or participation in “Employment Support and Development” programs in order to keep their Medicaid coverage.

There will also be a 5-year lifetime limit for Medicaid enrollment in AZ for “able-bodied adults”.

Exempt Populations:

People who are at least 56 years old;
Those who qualify for services through the Indian Health Service or Tribally-Operated Health Facilities;
Native Americans;
Women up to the end of the 12-month postpartum;
Former Arizona foster youth up to age 26;
People determined to have a serious mental illness or who have have a qualifying SMI diagnosis;
Those in active treatment with respect to a substance use disorder;
People receiving temporary or permanent long-term disability benefits from a private insurer or the government;
Individuals who are receiving Supplemental Nutrition Assistance Program, Cash Assistance, or Unemployment Insurance income benefits;
People who are exempt from ADES’ SNAP Work Requirement programs;
Individuals who are determined to be medically frail;
Individuals who have an acute medical condition (physical and/or behavioral) that would prevent them from following the requirements;
Full-time high school students who are older than 18 years old;
Full-time trade school, college, or graduate students;
Victims of domestic violence;
People taking part in AHCCCS Works;
Individuals who are homeless or who were recently homeless for up to six months post-housing;
Individuals who have recently been directly affected by a catastrophic event such as a natural disaster;
Parents, caretaker relatives, foster parents, and legal guardians, and caregivers of individuals diagnosed with SMI;
Caregivers of a family member who is enrolled in the Arizona Long-Term Care System (ALTCS);
Individuals who were incarcerated within the last six months; or
Veterans regardless of the discharge status.

Effective implementation will depend on AHCCCS’s ability to cross-reference databases to find exempt individuals, collaborating with agencies like ADES, Social Security etc. for data sharing.

Additionally, it’ll be super important to set up user-friendly systems for “able-bodied” members to report their work, school attendance, or ESD program participation is crucial to prevent unnecessary loss of coverage due to documentation challenges.

I expect the work program and the 5-year benefit limit for able bodied adults to begin October 1, 2025.

See the Final Submitted Waiver Request

AHCCCS Seeks Public Input on Proposed Medicaid Work Requirements & 5-Year Lifetime Limit on Benefits – AZ Public Health Association

May 12, 2025May 12, 2025

Will Humble Medicaid, Wills Blog

Congressional Budget Office Scores Various Medicaid Cut Impacts

The Congressional Budget Office was established by congress in 1974 to give congress objective, nonpartisan information to help them make decisions about budget and economic policies.

The CBO is part of the Legislative Branch – and is supposed to provide nonpartisan alternatives to the information from the Office of Management and Budget – which is part of the Executive Branch.

This week the CBO scored the financial and health insurance impacts (loss of health insurance coverage) of various options for cutting Medicaid beging considered in congress right now.

Rather than give a breakdown I thought I’d just link to the CBO Letter to Wyden-Pallone Letter -Medicaid and you can read it for yourself. It’s only 8 pages long.

Jan Brewer: Scaling back AHCCCS hurts all of Arizona | Opinion

May 11, 2025May 12, 2025