Will Humble Return on Investment, Tobacco, Wills Blog

FDA Finally Proposes Updated Cigarette Warning Labels

In 2009 the Congress directed the FDA to create more graphic warning labels and mandate them on packs of cigarettes. In 2012, the FDA proposed 9 new more graphic labels. The tobacco industry sued the FDA arguing that the proposed new warning labels violated their 1st Amendment rights to free speech. Astonishingly, a 3 judge panel agreed because the propoised labels were crafted to evoke a strong emotional response rather than to educate consumers.

So it was back to the drawing board. Over the next few years the FDA didn’t propose new labels, so some health groups sued the FDA in 2016 because they still hadn’t complied with the 2009 law (now 10 years old). The health groups won, and the court ordered the FDA to come out with new draft warning labels by August with final ones in March of 2020.

You can read more about the new labels and look at them on the FDA website. Perhaps the new labels will be finally on packs of cigarettes next spring- more than 10 years after the law was passed and signed.

Will Humble Family Planning, Social Determinants, Wills Blog

National Family Planning Program in for a Major Shake-Up

Title X is a super important public health program that provides folks with comprehensive family planning and related preventive health services. It’s designed to prioritize the needs of low-income families or uninsured people. The overall purpose is to promote positive birth outcomes and healthy families by allowing individuals to decide the number and spacing of children.

The services provided by Title X grantees (the funding comes from the federal government) include family planning and contraception, education and counseling, breast and pelvic exams, breast and cervical cancer screening, screenings and treatment for sexually transmitted infections and HIV.  It also focuses on counseling, referrals to other health care resources, pregnancy diagnosis, and pregnancy counseling. Title X funding does not pay for abortions.

Back in March of this year, the US Department of Health & Human Services published in the Federal Register a final rule making changes to the federal regulations governing the Title X national family planning program. The final rules dramatically change the existing Title X family planning program nationally and in AZ.  The changes include:

  • Eliminating Title X’s long-standing legal and ethical requirement for non-directive pregnancy options counseling; and

  • Requiring a “bright line” of physical and financial separation between the provision of family planning and abortion services.

Numerous provider groups, state attorneys general and non-profit organizations sought an injunction after the new Rules were announced (seeking an injunction to stop the rule from taking effect while the courts decide the legality of the rule). 

Legal History of the Case

Multiple federal district court judges blocked the new restrictive rules from going into effect. On June 20, 2019, a three-judge panel of the 9th Circuit Court of Appeals granted the Administration’s request to lift the preliminary injunctions, allowing the new Title X rules to be enforced. In early July, the 9th Circuit court ordered the cases be reheard en banc (meaning by all the judges on the 9th circuit versus a three-judge panel).

On July 11, the en banc court refused to block the new Title X rules from taking effect.

So, what’s the bottom line then?  For now- the new April Title X Rules that eliminate Title X’s long-standing model of offering non-directive pregnancy options counseling, and requiring a “bright line” of physical and financial separation between the provision of family planning and abortion services stand. 

Title X grantees including the Arizona Family Health partnership received notice from HHS that they must certify that they comply with the new regulations by September 18.  The plans for how they intend to comply were due Friday August 18.

What remains to be seen is what happens to the family planning network after September 18.  If Planned Parenthood decides to no longer provide Title X because of the new Rules, there would be a big gap in the network and folks that usually get their family planning services via Title X would need to find other places to go for these services. Since other providers are likely booked up- that means there cojld be some pretty significant delays in getting appointments for family planning services.

Will Humble EMS, Public Health, Public Health Law, Wills Blog

A Primer: How Arizona’s Ambulance Licensing System Works

The Basics

Arizona uses a Certificate of Necessity (CON) system to regulate ground ambulance service.  The overall idea is to have a regulatory system that optimally allocates resources, makes sure every place in the State has adequate emergency medical services, and that reduces rates to the extent possible.  

Any entity that wants to run an ambulance service needs to get a CON from the ADHS. It’s basically a license to run an ambulance service. The CON describes the geographic service area, level of service (advanced life support or basic life support), hours of operation, response times, effective date, expiration date for emergency medical services in the specific geographic area.  

An ambulance service that gets a CON is supposed to stick with the criteria on their certificate and operate in accordance to the statutes and rules by which it’s governed. 

A common misconception is that Arizona’s CON system is designed to limit the number of ambulance services in Arizona. That’s not the case.  Parts of the State (especially areas with high populations lots of transports) have multiple providers and overlapping service areas where more than one ambulance company can provide services. 

The Statutes and Rules require that people who want to start an ambulance service have to demonstrate that there’s “a public necessity” for the proposed service. There are detailed statutes that define what the words “public necessity” mean for the purposes of providing direction to the ADHS Director when she or he decides whether to approve a CON application.  There’s also a guidance document that outlines what the words “other things as determined by the Director” means.

How it Works

When someone wants to get a CON they apply to the ADHS. There are usually competitors that don’t want the applicant to get it (because the new applicant will be taking some of their cheese).  When someone challenges an application (called an intervenor) a hearing is scheduled with the Office of Administrative Hearings (in the ADOA).

A new statute limits that hearing to 10 days of testimony (a big improvement because these hearings used to go on for weeks or even months). The Hearing Officer listens to the testimony and documents and issues an “Order” with their opinion whether the Director should issue the CON. 

The ADHS can take or not take the Hearing Officer’s opinion. She or he can approve the CON, deny it, or approve it with some modifications.  There’s a lot of interest among the parties when these CON applications are being considered – mostly because there’s a bunch of money at stake. CON applications are quite litigious.

Here’s a couple of recent cases that illustrate recent urban and rural CON applications. 

The Case of Community Ambulance (Urban)

An outfit called Community Ambulance applied for a CON to be able to do inter-facility transports (no 911 service) in Maricopa County. The goal was to have a CON that would provide inter-facility service between the Dignity Health facilities in Central AZ.  Dignity Health was supportive of the application because they believe contracting with Community Ambulance would help them more efficiently transport their patients between facilities- improving patient care and reducing costs. 

While the current providers (AMR and a couple others) can and do provide inter-facility transports in Maricopa County, the applicant and their supporters believe that a specific service dedicated strictly to interfacility would improve efficiency (Dignity would have contracted with Community Ambulance for this specific service). 

After reviewing the application and documents, a Hearing Officer at the Office of Administrative Hearings recommended that the ADHS deny the application. Here’s that Opinion. Upon review of the Hearing Officer’s opinion, the ADHS Director agreed with the hearing officer opinion and denied the CON. 

There’s an opportunity to appeal, and Community Ambulance filed a Motion for Review with the Director. The ADHS Director can review the case and change her mind or stay with the initial decision. If the CON remains denied, Community Ambulance can appeal to Maricopa County Superior Court.

The Case of Timber Mesa (Rural)

Back in 2017, an outfit called the Timber Mesa Fire District applied to extend the boundaries of their CON to include the city of Show Low.  An existing CON was in place in Show Low (Show Low EMS- now called Arrowhead Mobile Healthcare).

After hearing the evidence- the Hearing Officer recommended that the ADHS deny the CON application because: 1) Timber Mesa didn’t show that more resources were needed in the service area; 2) the reduction in call volume for Show Low EMS would make Show Low EMS unable to meet their current obligations; and 3) Timber Mesa didn’t prove that Show Low EMS has engaged in substandard performance in either 911 or interfacility service.

The ADHS Director didn’t agree with the Hearing Officer’s recommendation and approved Timber Mesa’s CON boundary expansion into Show Low. 

Show Low EMS (now Arrowhead Mobile Healthcare) appealed the ADHS Director’s decision in Superior Court.  Last week, the Superior Court judge in the case agreed with Arrowhead that “the Director exceeded her statutory authority when she “sua sponte” amended CON 111 to include the Expanded Service Area”.  It’s now the ADHS’ job to read the Judge’s decision and figure out what to do next.

Editorial Note: When I was in the Director position, I was reluctant to issue additional CONs in rural areas because adding too many providers in rural areas can jeopardize overall service and increase costs. That’s because when transports are spread “too thin”, one or both ambulance service providers may not be able cover their expenses – which can cause them to ask for rate increases or neglect underpopulated areas which jeopardizes response times.  

In urban and suburban urban areas, I was more inclined to approve CONs that met the basic statutory requirements because there are usually plenty of transports around to ensure that ambulance providers can meet their expenses…  and increasing the number of providers can safely increase competition. In urban and suburban areas there’s a lot less risk that adding additional resources will cause rate increases or result in providers neglecting the less populated parts of the service area.

This primer is just a short summary of the CON system and how it works in Arizona. One can spend an entire career on this subject and still learn something every day- so take this for what it’s intended- a small window into the complicated world of Ambulance service Certificates of Necessity in Arizona.

Will Humble Oral Health, Wills Blog

Recent Oral Health Research

Ending the neglect of global oral health: time for radical action

Richard G Watt, Blánaid Daly, Paul Allison, Lorna M D Macpherson, Renato Venturelli, Stefan Listl, and others

The Lancet, Vol. 394, No. 10194, p261–272

Published: July 20, 2019

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Oral diseases: a global public health challenge

Marco A Peres, Lorna M D Macpherson, Robert J Weyant, Blánaid Daly, Renato Venturelli, Manu R Mathur, and others

The Lancet, Vol. 394, No. 10194, p249–260

Published: July 20, 2019

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Conflicts of interest between the sugary food and beverage industry and dental research organisations: time for reform

Cristin E Kearns, Lisa A Bero

The Lancet, Vol. 394, No. 10194, p194–196

Published: July 20, 2019

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Richard Watt: time to tackle oral diseases

Rachael Davies

The Lancet, Vol. 394, No. 10194, p209

Published: July 20, 2019

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Promoting radical action for global oral health: integration or independence?

Rob H Beaglehole, Robert Beaglehole

The Lancet, Vol. 394, No. 10194, p196–198

Published: July 20, 2019

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Oral health at a tipping point

The Lancet

The Lancet, Vol. 394, No. 10194, p188

Published: July 20, 2019

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Will Humble Medicaid, Opioids, Wills Blog

Arizona Scores $10.5M to Boost Medication Assisted Treatment for Opioid Use Disorder 

On Friday the US Substance Abuse and Mental Health Services Administration announced the release of an additional $10.5M in State Opioid Response funds for Arizona (AHCCCS) to supplement 1st year funding.

SAMHSA expects to also release additional 2nd year continuation awards later this year. The objective of the grant is to expand access to evidence based treatment…  especially to medication-assisted treatment (MAT) with social supports.  There are three medications commonly used to treat opioid addiction:

  • Methadone – clinic-based opioid agonist that does not block other narcotics while preventing withdrawal while taking it; daily liquid dispensed only in specialty regulated clinics

  • Naltrexone – office-based non-addictive opioid antagonist that blocks the effects of other narcotics; daily pill or monthly injection

  • Buprenorphine – office-based opioid agonist/ antagonist that blocks other narcotics while reducing withdrawal risk; daily dissolving tablet, cheek film, or 6-month implant under the skin

Reducing the public health impact from the opioid epidemic will take a combination of evidence based interventions including continued reforming of prescribing practices, increasing treatment options and access, additional community based interventions including syringe access services, increasing access to rescue medications and interventions by law enforcement and the criminal justice system.

This new supplemental award as well as the upcoming 2nd year funding will provide important new opportunities to make additional progress.

Will Humble Behavioral Health, Medical Marijuana, Social Determinants, Wills Blog

Retail Marijuana Voter Initiative In the Works

A group of Medical Marijuana Dispensary operators have completed statutory language for a retail marijuana and marijuana law criminal justice reform voter initiative. The Initiative isn’t posted on the Secretary of State’s website yet but I was able to get the text of the Initiative. The statutory language is 16 pages long- and there are a lot of provisions…  but here’s a review of some of the highlights:

The existing medical-marijuana dispensaries would be allowed to apply to the ADHS for a license to run a retail marijuana storein early 2021. It’s possible that there could be a few more stores that open eventually, but not many, because the total number is limited to about 130 total (10% of the number of pharmacies in AZ). Existing medical marijuana dispensaries, with a handful of exceptions, would essentially be the only stores that exist. ADHS would regulate the program.

There would be no criminal penalty for people 21 or over to have 28 grams (one ounce) or less of marijuana or 5 grams of extract. Minor penalties and low grade misdemeanors are outlined for people 21 and over that give or sell marijuana to people under 21.

People under 21 that possess marijuana would be subject to a $100 fine for the 1st offense, a petty offense the 2nd time, and a Class 1 Misdemeanor for the 3rd offense.

People previously convicted of possessing less than 28 grams of marijuana can petition to have their record expunged. The petitions must be granted unless law enforcement provides clear and convincing evidence the person isn’t eligible.

Adults 21 and over could grow 6 plants at home with a maximum of 12 per house.

A 16% excise tax would be placed on marijuana products. Money from the excise tax would fund the various state agencies such as ADHS and Department of Public Safety for expenses related to the act. Other entities that will get excise tax funds are the community colleges (31%); police, fire and sheriff’s departments (31%) and a highway fund (30%). There’s also a one-time distribution ($10M) the ADHS from the existing medical marijuana fund for public health stuff.

Employers can have drug-free workplace policies and can restrict marijuana use by staff.

Driving while impaired (to the slightest degree) by marijuana would still be illegal.

The folks running the campaign still need almost 238,000 valid signatures by July 2, 2020 to get on the ballot- no easy feat given the recent new requirements passed by the Legislature and signed by the Governor which make getting things on the ballot harder.

We’ll continue to review the language and evaluate whether basic public health principles related to our Retail Marijuana Resolution before taking any position.

Will Humble Uncategorized, Wills Blog

Cannabis Communications Toolkit for State and Local Health Departments

The CDC & the CDC Foundation Foundation have developed have developed a Communications Toolkit to help communications staff and program managers in states and local health departments communicate effectively about cannabis to providers and the public. The toolkit also summarizes the health of effects of marijuana for youth and pregnant women and has summary findings around mental health effects of cannabis. Access the toolkit here and hover over “toolkits.”

Will Humble Uncategorized, Wills Blog

APHA Opens Access to American Journal of Public Health Firearm Research 

The American Public Health Association has opened up public access to all of their research papers and analytic essays on public health and firearms.  

Research is available now available to everybody (including non-members) regarding the effect of state legislation on firearm homicide, interventions to improve safe firearm storage, employer firearm policies and workplace homicide, public opinion on carry laws.

Also included is research on role firearms play in establishing homicide as a leading cause of death for pregnant and postpartum women, the urban-rural differences in firearm suicides, how law enforcement and firearm retailers can serve as partners in suicide prevention, loaded handgun carrying, the financial cost of firearm injury, among other subjects.

Perhaps our elected officials will examine the public health evidence and consider some evidence-based interventions in state law to curb the increasingly devastating impact of firearm violence.

Will Humble Uncategorized, Wills Blog

Several Bills to Address Firearm Violence Failed Last Legislative Session 

Actually, They Weren’t Even Heard

Several bills that addressed various aspects of firearm violence were proposed last legislative session. None were successful. In fact, a quick perusal of the bills will reveal to you that none were even given a hearing. Sad state of affairs, don’t you think?

SB 1219 Domestic Violence Offenses & Firearm Transfer (Carter)

Persons that have been adjudicated and the court rules that they may not possess a firearm must surrender their firearms to a law enforcement agency.  The law enforcement agency may then dispose of the firearm(s) in accordance with law.  People that have an Order of Protection against them must also surrender their firearms, although the law enforcement agency must return the firearm when the Order expires (after a background check).

HB 2247 Bump Stocks (Friese)

This bill would outlaw the sale of bump stocks on firearms.

HB 2248 Firearm Sales (Friese)

This bill would require a background check for all sales at gun shows.

HB 2161 Order of Protection (Hernandez)

A person who is at least 18 years of age and who is either a law enforcement officer, a “family or household member” (defined), a school administrator or teacher or a licensed behavioral health professional who has personal knowledge that the respondent is a danger to self or others is permitted to file a verified petition in the superior court for a one-year Severe Threat Order of Protection (STOP order), which prohibits the respondent from owning, purchasing, possessing or receiving or having in the respondent’s custody or control a firearm or ammunition for up to one year.

HB 2249  Mental Health and Firearm Possession (Friese)

An immediate family member or a peace officer is authorized to file a verified petition with a magistrate, justice of the peace or superior court judge for an injunction that prohibits a person from possessing, controlling, owning or receiving a firearm. Any court may issue or enforce a mental health injunction against firearm possession, regardless of the location of the person. Information that must be included in the petition is specified. If the court finds that there is clear and convincing evidence to issue a mental health injunction against firearm possession, the court must issue the injunction. Information that must be included in the injunction is specified.

Will Humble Uncategorized, Wills Blog

Arizona Area Health Education Center System in Transition

Arizona and 47 other states have programs called Area Health Education Centers that focus on enhancing access to quality healthcare (especially particularly primary and preventive care) by improving the supply and distribution of healthcare professionals through academic-community educational partnerships in rural and urban medically underserved areas.

Arizona’s state Area Health Education Center (AzAHEC) is housed at the University of Arizona.  Like the AHECs in most other states, Arizona’s statewide AzAHEC focuses on developing health professions workforce education programs that emphasize primary care and increasing access to care in rural and underserved communities.  Many of the strategies to accomplish this include improving the supply, quality, diversity and distribution of the health professions workforce.

The state AHEC program at the UA works in collaboration with the 5 statewide Arizona AHEC regional centers which are independent non-profit organizations that work in coordination with the state program:

The 5 regional centers each have their own unique strategies to improving the supply, quality, diversity and distribution of the health professions workforce.  Many of the regional strategies include strategies to develop health professions students and health professions workforce, recruiting and retaining a health professions workforce, and inter-professional training.  The regional centers also support many health careers programs including students in medicine, nursing, pharmacy, public health, dentistry, and allied health.

As of July 1, 2019 the Central Arizona Health Education Center took over as the Area Health Education Center for Central AZ.  For many years, Empowerment Systems dba the Greater Valley Area Health Education Center had been the Central Regional AHEC.  Sean Clendaniel is busy getting the business model and systems up and running as you read this. I’ll be updating the happenings in the Central AHEC in the coming months.

The combined work of the 5 regional centers and the state program are far too wide-ranging to capture here- but you can get an idea of the particulars by reading the state program Annual Report which includes summaries of the priority programs at the state program (UA) as well as the regional AHECs.

How it’s Funded

Funding for Arizona’s AzAHEC system is voter protected. The statute authorizing and funding the state system was approved by Arizona voters as Proposition 203 (in 1996) (aka Healthy Arizona 1) which required the Arizona State Lottery to allocate funds including the state AzAHEC programs [A.R.S. §5-522(E)] when annual Lottery revenues reach a specified threshold.

The system really matured in 2000 when voters passed Proposition 204 (aka Healthy Arizona 2) which expanded eligibility for the AHCCCS to 100% of the federal poverty level guidelines…  but also included a directive to distribute $4M annually to the AzAHEC system. 

It’s rare to have a state program that has a guaranteed source of income that doesn’t require an appropriation authorization from the state legislature, which is a real source of strength and stability. Also, because the funds are voter protected, if money is still available at the end of the fiscal year the reserves aren’t swept (like they are in most other state government programs).  As a result, the system has accumulated some carry-forward funds that are available for use in future years.  FY 2016 began with an effective carry-forward balance of approximately $7.5M.  Annual reports after 2016 didn’t disclose carry forward balances- so I’m not sure what the current carry forward is.

Leadership Change at the State Level & Moving Forward

Earlier this month, Dr. Sally Reel decided to step down from her role as the head of the AzAHEC system. Dan Derksen, MD, has agreed to serve as acting director as the U of A conducts a search for a successor.  As is the case with any leadership change- this will provide an opportunity to take a fresh look at the direction and priorities of the AzAHEC system including mission priorities and allocation of the funds.

With this leadership change, the state program moved out of the administrative control of the College of Nursing where it has been for many years to the office of the Senior Vice President for Health Sciences at the UA.  This administrative change will also provide some additional opportunities to better develop cross program inter-professional training opportunities.

Another opportunity for the state AzAHEC system is the implementation of new budget items that were in this year’s state budget- especially the addition of $12.5M more for Graduate Medical Education ($7M rural and $4.5M urban) in the coming year.  Graduate Medical Education is important because Residency programs have a huge impact on retaining primary care physicians and other allied health professionals- a big leverage point for driving healthcare professionals toward rural and underserved areas of AZ.

While Arizona has some pretty robust Medicaid GME spending already, those residencies are generally distributed in urban areas.  That’s because the money used to draw down the federal matching funds comes mostly from urban area hospitals – and the residencies go to those areas.  Also, those residency slots are generally for subspecialists – not primary care (which has the greatest need).

The new state AzAHEC program will now be in a position to influence the decisions to allocate the new $12.5M in Graduate Medical Education funding- that’s great because of the expertise within the program and at the AZ Center for Rural Health at the UA.

Other opportunities for program include soliciting input from regional AzAHEC office which could result in new innovative strategies that could be implemented either by the regional AHEC offices of the statewide AzAHEC.  Perhaps this could best be accomplished by convening a statewide primary care workforce forum to get input from a cross section of Arizona Stakeholders regarding strategic planning options and use of state AzAHEC funds.  An independent entity such as AzPHA could convene the forum, which would solicit ideas presented by participants including local AzAHEC programs.

More to come.

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