Will Humble, Author at AZ Public Health Association

June 26, 2023June 26, 2023

Will Humble Reproductive Health, Wills Blog

Governor Hobbs Issues Reproductive Rights Executive Order

Governor Hobbs issued an executive order last week which gives Attorney General Kris Mayes prosecutorial authority over any abortion prosecutions in Arizona – removing that authority from the various county attorneys in AZ.

The Executive Order states that the AG “… shall assume duties with regard to any criminal prosecution of a medical provider or other entity or individual that is pending or brought in the future by the county attorney of any county” that is related to abortion care.

The order also prohibits state agencies (mostly ADHS and various Boards) from “... participating in or assisting an investigation of unlawful abortion procedures” (unless required by a court order) and states that Arizona won’t extradite anyone charged with abortion-related crimes in another state.

The Order also creates a new committee to study abortion access and provide recommendations to the governor. Here’s where you can read the Executive Order.

Note: This action will no doubt be court.

June 20, 2023June 20, 2023

Will Humble Healthcare, Wills Blog

New Alzheimer’s Drug Provides Hope for Patients… but the Costs to Medicare Would be Extreme

There’s a fair amount of chatter in families who have a family member with Alzheimer’s now that a about a new (monoclonal antibody) drug developed by Eisai Co., Ltd. & Biogen Inc. An Advisory Committee to the Food and Drug Administration (FDA) unanimously endorsed the efficacy and clinical benefit of their drug, called lecanemab (Leqembi™, Eisai). The committee decision makes it very likely FDA will give full approval for the drug (a monoclonal antibody treatment) later this summer.

At that point, a huge debate will ignite about whether Medicare will cover the treatment and for whom.

For families and patients, the drug may slow progression of the disease in early-stage patients. However, this drug is not a cure, and it doesn’t make people get better, but it may slow down progression in very mild disease patients. Leqembi can cause swelling or bleeding in the brain, which means patients must receive periodic brain scans after starting treatment. The monoclonal antibodies are given intravenously every other week to remove amyloid from the brain. Amyloid plaques are a hallmark of Alzheimer’s, though many earlier drugs that targeted amyloid failed to slow down patients’ loss of mental abilities.

The stakes are high for everyone who pays Medicare payroll taxes and especially persons who already participate in Medicare, as the drug is so expensive. The potential number of patients so also large, meaning covering the drug could result in large premium increases for all Medicare patients and potentially even require a Medicare payroll tax increase.

The exact number of Medicare beneficiaries who meet the prescribing requirements for Leqembi is unknown and the take-up rate among eligible individuals is difficult to estimate. But, if 5% of the 6.7 adults in the US with Alzheimer’s disease take Leqembi at the annual list price of $26,500 it would cost Medicare Part B $8.9 billion to Medicare Part B every year. A 10% take-up rate would amount to $17.8 billion in higher spending.

From KFF: “Spending on Leqembi would be roughly equal to spending on the top 3 Part B drugs combined in 2021 based on the 5% take-up rate. At the 10% take-up rate, projected spending on this one drug alone would exceed spending on the top 10 Part B drugs in 2021 and would represent close to half of the $40 billion spent in total on the 600+ Part B covered drugs in 2021.”

New Alzheimer’s Drugs Spark Hope for Patients and Cost Concerns for Medicare | KFF

Higher Medicare Part B spending would likely lead to higher Medicare Part B premiums, which are set to cover roughly 25 percent of program costs. In the case of Aduhelm, the anticipation of substantially higher Medicare Part B spending due to coverage of that drug contributed to a 15% jump in the Part B premium between 2021 and 2022, an increase substantially above the norm. Medicare’s subsequent decision to limit coverage of Aduhelm contributed to a modest (3%) decline in the Part B premium for 2023.

At Leqembi’s current $26,500 list price, Medicare patients administered the drug would be responsible for more than $5,000 out of pocket each year, based on a 20% coinsurance requirement in traditional Medicare.

To address concerns about the effect of high-priced drugs on Medicare program spending, the Inflation Reduction Act requires Medicare to negotiate the price of top spending drugs, but manufacturers of biologic drug products like Leqembi would be exempt from having CMS-negotiated prices take effect for 13 years from the drug’s licensure date.

Assuming Leqembi receives full approval in July 2023 and Medicare coverage expands shortly thereafter, the drug’s manufacturers will have between now and 2036 to recoup investments in research and development and earn revenue from Medicare before possibly having negotiated pricing take effect.

While broader access to Leqembi could provide modest clinical benefits to older adults with mild cognitive impairment and mild dementia stage of Alzheimer’s disease, a significant increase in Medicare spending and premiums is a distinct possibility, and one that Medicare, patients, and taxpayers are likely to confront in the not-too-distant future.

Editorial Note: The issue with the price to Medicare for this drug highlights what will be an increasing problem for Medicare. The cost of new drugs times the number of people that will want them is becoming increasingly untenable under the current fiscal framework.

If you listen to the media and some politicians, you may have been led to believe the Medicare negotiation component of the Inflation Reduction Act took care of this problem IT DID NOT.

While earlier proposals (H.R. 3 and even the initial proposal in the IRA) did give good negotiating authority to Medicare the final version only gives very modest and delayed negotiating authority to Medicare. Senator Sinema was instrumental in stripping out the more meaningful parts of the bill, just sayin’.

See: More Meaningful Prescription Drug Price Reform That Could Have Been

June 19, 2023June 19, 2023

Will Humble Public Health, Wills Blog

Public Health Journalism this Week

Mayes: Ruling dropping preventive drugs from insurance would be devastating

Arizona opioid settlement announced

Nearly 150,000 Arizonans have lost Medicaid coverage since April

How fentanyl is driving Arizona’s increase in opioid overdose deaths

Shortage of cancer drugs carboplatin and cisplatin continues to strain care

Governor Hobbs’ veto threat ends effort to change State Hospital oversight

June 18, 2023June 19, 2023

Will Humble Opioids, Wills Blog

More Opioid Settlement Money on the Way

Plans to Use the Funds Underway in Some Counties: Little Action at the State Level

Arizona Attorney General Mayes announced this week that Arizona will be getting an added $380 million from a national opioid settlement with drug makers Teva and Allergan, as well as CVS and Walgreens pharmacies. This is on top of the $542M AZ is set to receive over the next 18 years to combat the ongoing opioid epidemic.

This new money ($380M) will arrive over the next 15 years, with $213 million going to local governments and $167 million dedicated to the state level. The tap on the new money is supposed to turn by the end of 2023. The new bolus brings Arizona’s share of money to about $1 billion.

Because the new settlement is so fresh, there’s not much detail about how and when that will be disbursed. However, the earlier settlement ($542M) is going out to all the 90 AZ cities and towns and all 15 counties who signed on to a framework called the One Arizona Memorandum of Understanding (One Arizona Plan).

The One Arizona Plan provides funding for programs to address and ameliorate opioid abuse, and includes reporting requirements for greater transparency of how money is used:

56% of the first settlement is going to local governments for opioid mitigation programs.
44% of the total settlement goes to a State for yet to be determined interventions.
Funds must be spent following approved, nationally recognized strategies to pay for future costs incurred by the State and local governments to address the opioid epidemic.

The state opioid funds went to the Attorney General’s Office and neither AHCCCS nor ADHS have received any of the funds. The Attorney General’s Office has suggested legislative appropriation is necessary to spend the state portion of the funds.

The funds are in some ways restricted in that they are supposed to go directly to relief and resources related to opioids, including to diversion programs to prevent people from going to prison for an addiction or substance-use disorder. Arizona is one of 15 states who’ve agreed to make settlement expenditures public: https://www.opioidsettlementtracker.com/publicreporting/#promises

There still isn’t a lot of granularity about how the state and local jurisdictions intend to invest the funds… but county staff is certainly undergoing planning to make sure that they wisely use the funds. A priority for Pima County is to make sure they get input from the community before making decisions- always a good idea.

County health departments apparently don’t need appropriation authority from the legislature and are well into their planning. Here’s a link to what Maricopa has going: Opioid Settlement Planning | Maricopa County, AZ. Pima County has already begun to spend some of their funds, with their Board of Supervisors allocating $180,000 for the immediate purchase and distribution of Narcan (this is a very small portion of what Pima is allocated so you can think of this as an initial down payment on interventions): Opioid mitigation efforts underway in Pima County – AZPM. Next fiscal year, the health department plans to hire staff to oversee community outreach efforts addressing mental health and substance misuse throughout the county.

Arizona Opioid Settlement | Arizona Attorney General (azag.gov)

June 14, 2023June 15, 2023

Will Humble Assurance & Licensure, Behavioral Health, Suicide Prevention, Wills Blog

Governance Reform of the Arizona State Hospital Goes Up in a Puff of Smoke

The two-year effort to improve care at the Arizona State Hospital by building a more accountable and unconflicted governance structure went up in a puff of smoke this week. Senate Bill 1710 – which would have corrected major governance flaws that led to terrible unmitigated outcomes during the Ducey administration vaporized. More on how it happened in a bit.

AZPHA and other stakeholders interested in improving care at ADHS’ Arizona State Hospital have been trying to extricate ASH from the ADHS to remove the conflict of interest that impaired care during the Ducey administration. Rather than being housed within ADHS, the ASH Superintendent would have reported to an independent appointed governing board instead of the ADHS Director, removing the conflict of interest wherein the ADHS is responsible for both running and regulating ASH.

The lack of independent regulation & oversight of the Arizona State Hospital results in poor accountability and can lead to unchecked substandard care when the ADHS Director soft-pedals regulatory oversight to give the appearance that the facilities are providing care that meets standards.

There’s evidence that this occurred during the Ducey Administration. For example, ADHS’ licensing division investigated multiple suicides and a homicide over the last couple of years and concluded that no significant operating deficiencies led to those deaths and no enforcement actions were advanced. Suicides and homicides only occur in the presence of significant deficient practices that would normally result in enforcement actions.

See: Fixing the Governance Flaw at Our Arizona State Hospital: A Primer

Here’s what went down this week to stop this important governance and accountability reform.

As you’ll recall, SB1710 passed the Senate with wide bipartisan support with a vote of 27-2. The bill got unanimous support in the House Health Committee and passed the Rules Committee. That’s when things got sticky.

Last week, the Governor’s team started expressing ‘deep concern about the civil rights implications of the bill’ (I still don’t know what those civil rights concerns are). That, and the fact that ADHS had signed up against the bill, sent the message to the bill’s sponsor (Senator Gowan) that if SB1710 reached her desk she’d veto it (state agencies never oppose a bill unless directed to by a governor’s team).

I’m reading between the lines here… but I’m guessing at this point Senator Gowan was thinking “I wonder if I can get at least something out of the bill if I have it amended to become a completely different bill”. Along comes Representative Montenegro in the House Committee of the Whole on Monday with an amendment to SB1710 that strips out 100% of the language that built more accountability and governance. He then inserts language that would allow some physician assistants to help psychiatrists with certain kinds of assessments – something totally unrelated to the original bill.

The amended version – which does nothing to reform ASH or ADHS – then passes the full House on Tuesday, passes the Senate again in its new trivial form, and is sent to the governor for her certain signature. The title of the bill that she’ll be signing is still called SB1710 State Hospital; Governing Board; Governance… but the bill has absolutely NOTHING to do with the State Hospital or ADHS.

Editorial Note: As a result of the sad turn of events this week, the fox will continue to watch the henhouse. Under some administrations, the fox (the ADHS Director) can be trusted. In other administrations they absolutely cannot, as we observed during the Ducey administration. Whether we’ll be able to trust ADHS to honestly regulate ASH during this administration remains to be seen.

We won’t know the answer until ADHS finally has a permanent agency director and we observe how she or he behaves vis a vis their responsibilities to honestly regulate the Arizona State Hospital. In the mean-time, patients and their families will need to continue to wait for meaningful structural reform.

See: AZ Capitol Times YELLOW SHEET REPORT June 13

June 13, 2023June 12, 2023

Will Humble Affordable Care Act, Public Health Law, Wills Blog

ACA’s Preventive Services Requirements are the Next Target for Opponents of the Affordable Care Act: Braidwood Management v. Becerra

One of the pillars of the Affordable Care Act is the requirement that most private insurance plans cover preventive health services without any patient cost-sharing. The Act is specific about what preventive health services include (e.g., a range of services including screening tests, immunizations, behavioral counseling, and certain medications).

The ACA started with the preventive health services that were recommended in 2010 (when the law passed). As new preventive services are added by the U.S. Preventive Services Task Force (USPSTF), Advisory Committee on Immunization Practices (ACIP), or (HRSA), private health plans need to add them w no cost sharing. As previous recommendations change or are modified, private health plans need to cover those services in the next plan year.

The Plaintiffs in the Braidwood v. Bererra case are trying to get rid of no co-pay coverage for preventive services. Their argument is that those task forces and committees don’t have the ability to make policies like that because they violate the Appointments Clause of the US Constitution.

Specifically, they’re arguing that only “officers of the United States” can make decisions and they must be appointed by the president and senate confirmed. The judge U.S District Judge Reed O’Connor in Texas (the go-to judge to file challenges to the ACA & women’s reproductive rights) agreed with the Plaintiffs that members of USPSTF, ACIP and HRSA are “officers of the United States”, weren’t appointed by the President (they’re appointed by the HHS Secretary) and therefore their decisions can’t be implemented as policy under the ACA.

Plaintiffs make another argument that the USPHTF recommendation for certain populations to prevent HIV violates their religious freedom. The judge took that bait too.

On March 30, 2023, District Court Judge O’Connor issued a ruling, striking down the ACA’s coverage requirement for preventive services. That ruling blocks the federal government from requiring health plans to cover services recommended or updated by the U.S. Preventive Services Task Force (USPSTF) on or after March 2010.

There are 53 Preventive Health Services with an A or B rating by the USPHTF (A & B Recommendations). All but two of these recommendations have been updated or are new since 2010.

See: Mayes: Ruling dropping preventive drugs from insurance would be devastating | Arizona Capitol Times

HHS appealed the ruling to the United States Court of Appeals for the 5^th Circuit. A couple of weeks ago the Circuit Court of Appeals stayed the district court’s ruling, meaning HHS can continue enforcing the preventive services requirement while the case proceeds through the courts.

What If the Courts Ultimately Uphold O’Connor’s Decision?

If the Texas District Court ruling ultimately holds, private health plans would still have to cover no cost-share coverage of preventive health services as they existed in 2010. Private health plans would no longer be required to cover any preventive service identified after 2010 (for example screening for major depressive disorder in adolescents 12-18 y.o.). Basically, it would stop the clinical practice clock in 2010.

For services recommended before 2010, HHS could only hold health plans accountable for covering services as they existed in 2010. For example, prior to 2010 colorectal screening was recommended for people 50 – 75 years old. Based on clinical evidence, that has since been changed to 45-75 y.o.

That would mean required coverage would be limited to clinical practice standards as they existed 13 years ago.

Medicine and public health are iterative disciplines. Best practice standards shift over time as we learn more from evidence and studies. Freezing clinical and public health practice in the year 2010 makes no sense.

In any event, it will be several months if not years before we know the fate of preventive health services coverage in the ACA. The decision will most likely be made by the U.S. Supreme Court.

Note: (Credit to KFF): “Overturning the preventive services requirement broadly would have significant implications for coverage of a broad range of clinical preventive services. Should the final decision for this case be found in favor of the plaintiffs, and applied nationwide, then millions of people may be vulnerable to loss of guaranteed coverage of preventive services without cost sharing. It will again be at the discretion of plans and employers to determine what preventive services will be covered and whether they will charge cost-sharing, lowering premiums in some cases, but likely creating a patchwork of coverage for these services.”

The Secretary of HHS has the authority to determine coverage for preventive services for Medicare beneficiaries. The ACA eliminated Medicare cost sharing, including coinsurance and deductibles, for most preventive benefits that are rated A or B by the USPSTF, beginning in 2011, and authorized the Secretary of HHS to add coverage for new preventive services.

Coverage under Medicare for several preventive services, including some rated A or B by the USPSTF, predated the ACA and is specified in statute, and therefore would not be affected by any ruling on the current litigation.

See: Mayes: Ruling dropping preventive drugs from insurance would be devastating | Arizona Capitol Times

June 10, 2023June 30, 2023

Will Humble Assurance & Licensure, Behavioral Health, Emergency Management, Wills Blog

Legislative Session Update: Week of June 12

Both the House & Senate will be back in session for a couple days or so this week. Two important bills will be debated in the Committees of the Whole this week. Both may roll over to Third Read votes (final floor voting).

The House is considering SB1710 – an effort to correct the governance flaw at our Arizona State Hospital. Since 1974 ADHS has been responsible for both running & regulating ASH, obviously a conflict-of-interest reminiscent of the old saying: “The fox is watching the henhouse.”

Under some ADHS directors the system worked OK and ADHS’ licensing division did an honest job regulating ASH.

However, as we observed during the Ducey administration, sometimes that’s not the case and the lack of independent regulation & oversight results in unchecked substandard care because ADHS leadership (the Director) soft-pedals regulatory oversight to give the appearance that the facilities are providing care that meets standards to ‘keep things quiet’.

See: Fixing the Governance Flaw at Our Arizona State Hospital: A Primer

SB1710 would provide checks and balances in the system by having the Superintendent of ASH report to an independent 5-member Board beginning 1/1/25. The ADHS licensing division would then be able to regulate the hospitals without a conflict of interest – reducing the chances that what happened during the Ducey administration would be repeated. See: SB1710 Fact Sheet

Senate COW will debate HCR2039 – a resolution that would limit all emergency declarations to just 30 days. The legislature would need to approve 30-day extensions.

Because this would change the constitution, it would need to be approved by the voters. If it passes the Senate this week, it’ll go directly to the 2024 ballot. If the voters end up approving it, the Recovery phase of emergencies would evaporate.

2023 AZ’s 2023 Legislative Session: The Good, The Bad, The Close Calls, & The Missed Opportunities

View Our Webinar Summarizing the 2023 Legislative Session: https://us06web.zoom.us/rec/share/vEOWDWlR3BW1D3gaJBRsH4AhduOLA83IuSD_byKYHmBPMulwKmLQJN3D3D7z_4Ed.Ih7vqw7INNyYNtTI Passcode: 5=5FjjNC

Passcode: 5=5FjjNC

See: Ballot Referral Could Dismantle Arizona’s Emergency Management System

June 9, 2023June 12, 2023

Will Humble Professional Development, Wills Blog

What’s the Solution to AZ’s Doctor Shortage? More Medical Students or More Residencies?

It’s no secret that Arizona has a physician shortage that’s getting worse, not better. The shortage is most acute in rural Arizona and worse in the key specialty areas that do the most to improve community health: primary care, family medicine and a very few specialties like obstetrics. According to research by the UA Center for Rural Health, Arizona has a shortage of 560 primary care physicians right now and 1,941 more will be needed by 2030 because of retirements, population increases, higher rates of chronic disease and an aging population.

At first glance most folks might think the solution is simple… just expand the number of medical schools and the sizes of the enrollment per school in Arizona. Makes intuitive sense, right?

Mostly wrong.

The bottleneck in getting more physicians practicing in the field in AZ isn’t the number of medical school students in the pipeline… it’s mostly the number of residency slots that are available in AZ & geographic and specialty distribution of those residencies.

Nationally, about 42,000 students finish allopathic (MD) medical school each year (2022 data) but the number of residencies available for medical school graduates hasn’t kept pace with the increase in students, meaning that a bit over 20% (8,400) of medical school graduates are left out – unable to get the residency slot they need to complete their training so they can practice.

In 2022 about 80% of the total 42,549 applicants were matched with a residency program. Match rates weren’t equal across the board. 93% of U.S. allopathic (MD) medical students were matched but only 61% of international medical graduates 58% of non-U.S. citizens matched. Doctors of osteopathy (DO) had lower match rates than MD students.

The lowest hanging fruit for getting more of the right kinds of doctors into the field (and in the right places) is building more residency slots in Arizona (especially in things like family medicine, primary care, and obstetrics etc.)… not necessarily graduating more AZ medical students. Placing those primary care residency slots in rural community-based settings is crucial.

Why? Because physicians are likely to practice near where they complete their residency (not where they finish medical school).

We need to expand the number of medical residency training programs in rural areas to fill gaps in care – doctors tend to settle within 100 miles of where they do their residency (especially family medicine specialists).

What Are Some Solutions?

Building teaching health centers at rural federally qualified health centers in collaboration with a rural hospital is a terrific tool for building and retaining a primary care workforce like the Teaching Health Centers at North Country Healthcare and El Rio Community Health Center:

El Rio Health is helping to create a new model of medical education in what is known as a Teaching Health Center. This concept emphasizes multidisciplinary, inter-professional educational opportunities within community health centers. This allows students and residents with a passion for community medicine to obtain their training directly within the community health center environment.

Dr. Doug Spegman, El Rio’s Chief Clinical Officer:

These residencies provide traditional, clinical training in acute and chronic care management and also emphasize preventive care and wellness. This includes a comprehensive approach to understanding healthcare disparities and social determinants of health that are often overlooked barriers to care and patient wellness.

Arizona’s budget agreement this year allocated $5M to the AZ AHEC program to specifically get the pieces together for more teaching health center collaborations like El Rio and North Country going.

“One-Two” residency programs—one year in an urban, academic hospital followed by two years in a rural area are effective in rural recruitment, while providing the amenities of academic residency programs centered around large, academic hospitals.

Other effective strategies are loan repayment programs like Arizona has, and the National Health Service Corps (NHSC says 81% of recent participants remained in rural areas after completion of their service agreements).

There are several pieces that need to come together to get more residency sites up and running. Among the most important are funding the startup costs at new clinical training sites and recruiting qualified primary care and key specialty preceptors.

Focusing solely on getting more medical students to study in AZ and thinking that alone will build more in-state practitioners is off target. Let’s hope public resources go to residency development and not just more medical students.

Arizona State University announces plans to create medical school

What does a new medical school mean for Arizona State University?

ASU will open its first medical school to address health care shortage

What ASU’s new medical school means for Arizona’s health care industry | KJZZ

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