White House Announces DACA Recipients May Eventually Qualify for ACA Marketplace Insurance & Medicaid

A fact sheet published by the White House today announced an initiative that would eventually allow DACA recipients to apply for Medicaid benefits and buy health insurance & qualify for subsidized Marketplace insurance.

The fact sheet says the president is directing the US Department of Health and Human Services to propose a rule amending the definition of ‘lawful presence’ for purposes of Medicaid and ACA Marketplace coverage, so it includes DACA recipients. The change in definition is what would trigger the potential benefit for DACA recipients.

DACA is an initiative of the Obama Administration that lets people who were brought into the country illegally as children avoid deportation. About 580,000 people are eligible for DACA and about 34% of them are uninsured according to an HHS estimate.

This initiative won’t take place immediately… HHS still needs to write the regulation and promulgate the rule in accordance with the Administrative Procedures Act. Also, because Medicaid is a shared program between the state & federal government, states would presumably need to elect to cover this population.

In Arizona, I think that would mean AHCCCS would need to apply for an 1115 Waiver or a State Plan Amendment first. I don’t know whether AHCCCS would need authorization from the state legislature or not.

What’s the Backstory on the Mifeprestone Rulings Last Week?

The availability of a medication that safely and effectively terminates pregnancies (Mifeprex) has become a central battle line over access to abortion services ever since the June 2022 Dobbs ruling by the US Supreme Court overturning the constitutional right to abortion care.

Several lawsuits have been filed challenging various aspects of FDA’s approval of the drug Mifeprex in 2000 and subsequent changes to the limitations in the packet insert that the FDA approved in 2016, 2021 and 2023.

At the heart of these cases is the FDA’s authority to approve drugs, whether the FDA followed the statutory authority Congress have the agency, whether FDA followed the Administrative Procedures Act as they made their decisions, whether courts can reverse the FDA’s decisions, and whether states can impose additional restrictions beyond what the FDA requires.

Q & A: Implications of Two Conflicting Federal Court Rulings on the Availability of Medication Abortion and the FDA’s Authority to Regulate Drugs

The core case, which was decided in favor of the Plaintiffs in a Texas Federal District Court last week in Alliance for Hippocratic Medicine (AHM) v. FDA challenged FDA’s decision to approve mifepristone (Mifeprex). Plaintiffs argued that the FDA didn’t follow Congress’ guidelines for approving the drug and contending FDA didn’t promptly respond to petitions to review the approval as required by the Administrative Procedures Act.

The plaintiffs also argue that FDA’s April 2021 decision to exercise ‘enforcement discretion’ regarding the dispensing of Mifeprex through the mail is illegal because mailing the drug is in violation of the 1873 “Comstock Act”, which prohibits the mailing of any medication used for abortion (the Comstock Act has never been repealed and is still on the books).

Mifeprex Regulatory Timeline
  • September 2000: FDA approved Mifeprex for the medical termination of pregnancy through 49 days’ gestation. FDA imposed conditions on the use of the drug that healthcare providers needed to follow to prescribe the drug and restricted how it could be distributed.
  • August 2002: The “American Association of Pro-Life Obstetricians and Gynecologists” and “Christian Medical& Dental Associations and Concerned Women for America” submitted a petition requesting FDA revoke approval of Mifeprex.
  • March 2016: The FDA denied the 2002 AAPLOG petition requesting to revoke approval of Mifeprex. Note: The Administrative Procedures ACT requires FDA to respond to petitions in 365 days.
  • March 2016: FDA updated and approved a new evidence-based regimen and drug label, which guides current clinical practice, approving the drug for medical abortions for up to 10 weeks of pregnancy.
  • March 2019: AAPLOG and ACOP submitted a petition to FDA asking the agency to “restore and strengthen elements of the Mifeprex regimen and prescriber requirements approved in 2000,” and “retain the Mifeprex [REMS], and continue limiting the dispensing of Mifeprex to patients in clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.” 
  • April 2020: The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) sent a letter urging FDA to suspend enforcement of the in-person dispensing requirements of the Mifeprex.
  • April 2021: FDA responded to the letter from ACOG and SMFM, stating that (during the COVID-19 public health emergency) they “would exercise enforcement discretion with regard to dispensing of Mifeprex . . . through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber.
  • In December 2021 the FDA denied their request to restore the prescribing requirements approved in 2000 and to limit dispensing (for both Mifepristone and Misoprostol) in person.
  • January 2023: FDA removed the in-person dispensing requirement for Mifepristone.

Texas Case Ruling

By now you know by now that the judge in the Texas case ruled in favor of the plaintiffs and found that Mifeprex was improperly approved stating: 

Accordingly, the Court hereby STAYS the effective date of FDA’s September 28, 2000, approval of mifepristone and all subsequent challenged actions related to that approval — i.e., the 2016 Changes, the 2019 Generic Approval, and the 2021 Actions.”

The ruling is over 100 pages long and there are many aspects to it, but at the core the judge stayed the 2000 approval of Mifeprex because he believes the FDA:

  • Ignored the petition to review the 2000 approval of the drug for over sixteen years, even though the law requires an agency response within 180 days;
  • Inappropriately approved the drug under an emergency provision called Subsection H, an accelerated approval process for drugs to treat serious or life-threatening illnesses that provide therapeutic benefit over existing treatments (e.g., ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy)”; and
  • Didn’t follow proper procedures and properly consider safety evidence when they changed the label and other prescribing and use criteria in 2016.

The court also said FDA’s decision to:

“… exercise enforcement discretion with regard to dispensing of Mifeprex through the mail either by or under the supervision of a certified prescriber, or through a mail-order pharmacy when such dispensing is done under the supervision of a certified prescriber” because that decision is in violation of the 1873 “Comstock Act”.

That would mean the drug could not be mailed to patients seeking a medication abortion in areas without access to that care.

Washington State Case Ruling

Later in the week, the State of Washington Circuit Court issued a conflicting opinion shortly after Kacsmaryk’s decision with a completely opposite opinion:

“Pursuant to Federal Rule of Civil Procedure 65(a), irrespective of the Northern District of Texas Court ruling or the Fifth Circuit’s anticipated ruling, Defendants and their officers, agents, servants, employees, attorneys, and any person in active concert or participation, are PRELIMINARILY ENJOINED from altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States and the District of Columbia.”

U.S. Supreme Court Stay

The week closed out with the U.S. Supreme Court put a hold on the Texas case ruling through next Wednesday. It’s unclear what will happen next, but the conflicting opinions put FDA in an untenable position – increasing the likelihood that the US Supreme Court will accept this case on an expedited bases to resolve the conflict.

See: Texas Judge in Abortion Pill Case Was Shaped by Conservative Causes – The New York Times

Do Red Light Cameras Save Lives? The Evidence Says YES.

Let’s face it. Getting a ticket in the mail for speeding or running a red light is no fun.  But the evidence suggests that photo enforcement of red lights and speed is an effective public health intervention, which is why we’re against SB1234 – which will be up for a final vote in the House this week. It would prohibit any jurisdiction from using photo enforcement technology to enforce speeding or red light running.

Many state and local governments in AZ have turned to photo enforcement of speeding and running red lights promote public safety (and some would say to raise revenue). The theory is that drivers will pay more attention to their speed and red lights when they know they’re at risk for getting a ticket. It stands to reason that cameras would keep drivers’ speeds in check and prevent serious injuries from high-speed crashes. But do they?

A landmark study for photo enforcement was done by Retting et.al. and published in the American Journal of Public Health examining the impact that photo enforcement had in Oxnard CA after they implemented their photo enforcement program.

Intersections that had red light cameras installed had a 29% reduction in injury crashes.  Right-angle crashes (which often happen because of red light running) were reduced by 32% and right-angle crashes involving injuries were reduced by 68%.  Overall accidents at the intersections were reduced by 7%.

In 2008, an Arizona established a statewide photo speed enforcement program on interstate highways. DPS contracted with a private company to install the cameras (along with signage to alert drivers), and they began operating that fall. Vehicles that were clocked going 11 miles per hour or more over the speed limit got tickets in the mail.  The system was in use until 2010 when the contract expired, and the cameras were removed.  Did their presence influence public safety?

Last year, a research team that included Dr. Chengcheng Hu, director of biostatistics for the Phoenix campus of the UA Mel and Enid Zuckerman College of Public Health, Dr. Steven Vanhoy, a recent graduate of the UA College of Medicine – Phoenix, and several colleagues from Banner – University Medical Center Phoenix, offers some insight.

The researchers examined crash data along a 26-mile segment of Interstate-10 in Phoenix where speed cameras had been placed every 2 miles as well as a 14-mile control segment where no cameras had been deployed. They compared crash data from Jan. 1 to Dec. 31, 2009 (when cameras were in place) to data from Jan. 1 to Dec. 31, 2011 (after the cameras had been removed).  They found that the removal of the photo radar cameras was associated with a two-fold increase in admissions to Level 1 Trauma Centers from car crashes in the areas where the cameras were removed.

Nobody likes getting a traffic ticket, but we believe that photo enforcement of reasonable traffic laws can significantly reduce severe injuries.   Believe me, I’m no evangelist for every single speed limit in my part of town nor the placement of some of the cameras and vans- but moving to eliminate this option for local communities would cause public health harm.  That’s why we’re against SB1234.

 Striker Bill Targets Eliminating Public Health Emergency Authority

April is often sneaky season for bills – when legislators bring out their ammunition for things they’ve wanted to get done but knew they would go down in flames if they expose the bill too fast or they try to resurrect earlier bad bills and propose them again – but under a deceptive name.

Those are called Strike All Amendments – AKA Striker Bills. A doozie came out of the woodwork this week called HB2545 from Jake Hoffman (Senate). The label on that bill says “Legislators; Unpaid leave of absence”. Sounds boring and unrelated to public health, right?

Wrong.

Despite its fake name, the bill would limit Governors to declaring a public health emergency for only 7 days. To extend the public health emergency declaration, the governor would need to get a supermajority of the legislature (2/3) to extend it – and then only in one-week increments. Each week after that the Governor would need to get another 1-week extension!

Ridiculous, I know. There are other ridiculous limitations in there too: HB2545 Striker Memo.  Why doesn’t he just run a bill to get rid of all public health emergency authority?

This striker bill naturally cleared Hoffman’s Senate Government Committee yesterday. It still needs to pass the full Senate and then succeed in a House committee and then pass the House. If it made it that far, it would meet a sure veto stamp.

Because of the certain veto, the bill really doesn’t post a public health threat. It looks a lot more like a vehicle for Senator Hoffman to build his brand.

UPDATE: HB2545 is up for a final floor vote in the Senate on Tuesday, April 10. Because it’s a strike all amendment it’ll still need to pass the House before it would get to the Governor’s desk – where it would face a certain veto,

Ballot Referral Could Dismantle Arizona’s Emergency Management System

HCR2039 governor; state of emergency is a House Resolution that’s an existential threat to emergency management in Arizona. It poses a huge potential threat to not just public health emergency responses – but to overall emergency management. See: Scottsdale lawmakers want more legislative oversight over emergency declarations.

It would end Governor-proclaimed states of emergency after 30 days (including public health emergencies) unless extended by the Legislature in 30-day increments. It would impact all declared emergencies like floods, fires, chemical spills, and other kinds of disasters – not just public health emergencies.

Here’s why it’s so bad for emergency management:

The 4 pillars of Emergency Management are Mitigation, Preparedness, Response and Recovery. The Response part of many if not most state-declared emergencies (think wildfires) often last more than a month. If this becomes law, all of them would expire after 30 days unless the legislature acts (whether they’re in session or not). If the legislature doesn’t extend the authority, the response would just end. Money flows would likely stop and the people impacted would be out of luck.

The Recovery portion of Arizona emergency responses would be damaged the most. The Recovery phase always lasts a lot longer than the response. The response part of a flood disaster includes things like rescuing people, cleaning up the roads, moving earth and the like. The Recovery phase includes fixing the drainage culverts, roads, and the uphill hazards like loose uphill boulders.

If HCR2039 ends up on the ballot and passes, the Recovery phase of emergency response would basically not happen. The flow of money and authority to do the recovery work would have ended. There is no way to get a quorum & a majority of legislators to keep reauthorizing emergencies – especially when they’re not in session.

Because HCR2039 would change the state constitution, it would need to be approved by the voters at the November 2024 election to be effective. It has already passed the full House (31-28) & the Senate Government Committee. All that remains is the Senate Rules committee and then the full Senate, where it’s likely to pass on a party line vote.

It will then go on the November 2024 ballot (it doesn’t need Hobbs’ signature to get on the ballot).

Would voters put in the time to understand how this would impact emergency management and vote it down? Maybe… but there are also bad actors that might intentionally confuse folks into changing our constitution in a way the permanently disables emergency management in Arizona.

Let’s hope at least one Republican Senator is paying attention and either votes no or ‘takes a walk’ and sinks this before it gets to the ballot.

The Lancet: Arizona Had the Highest Per-capita Standardized COVID-19 Death Rate in the U.S between January 2020 & July 2022

Assessing COVID-19 pandemic policies and economic trade-offs across US: Jan 1, 2020, to July 31, 2022

“Standardized cumulative COVID-19 death rates for the period from Jan 1, 2020, to July 31, 2022 varied across the USA (national rate 372 deaths per 100 000 population, with the lowest standardized rates in Hawaii and the highest in Arizona (581 per 100 000).”

Note: This study adjusts for each state’s age profile and the prevalence of chronic health conditions that put people at higher risk of death from COVID-19 like COPD, diabetes, BMI, and cancer and smoking rates… meaning it more directly measures the quality of a state’s response because it factors out age and health factors outside of a governor or health department director’s control.

“State governments’ uses of protective mandates were associated with lower infection rates, as were mask use, and higher vaccination rate.” 

“US states that mitigated those structural inequalities, deployed science-based interventions such as vaccination and targeted vaccine mandates and promoted their adoption across society were able to match the best-performing nations in minimizing COVID-19 death rates.”

Note: If Arizona were a country, our crude COVID-19 mortality rate would rank among the worst in the world, similar to Russia, Romania, and Belarus and just behind Peru.

Bill Separating the Arizona State Hospital from the ADHS Likely to Get Final House Floor Vote this Week

The needs of patients at ASH can be complex and the patients are vulnerable, so it’s critical to ensure the facility uses best practice treatment and is following a rigorous set of regulations. To achieve fidelity to best practice standards, it’s critical that the governance structure ensures accountability and is free from conflicts of interest.

The existing governance structure is insufficient to ensure quality care is provided at ASH. The fundamental flaw is that ADHS both runs & regulates ASH.

The lack of independent regulation of ASH results in poor accountability and can lead to unchecked substandard care when ADHS leadership soft-pedals oversight to give the impression that the facilities are providing care that meets standards.

SB1710 reforms of the governance structure by removing ASH from ADHS, separating ADHS’ operational and regulatory responsibilities re ASH by creating two separate entities (ASH would no longer be a part of ADHS). 

A 5-member State Hospital Governing Board would be responsible for the oversight of ASH. The Superintendent would report to the Board rather than the ADHS Director. ADHS would then regulate the hospital without an institutional conflict of interest.

I’ve written a summary of how ASH is currently governed and why I believe SB1710 is so important. Here is that summary: Fixing the Governance Flaw at Our Arizona State Hospital: A Primer

I’m confident SB1710 will have the needed votes in the House this week…  but whether the Governor will sign it is an unknown. There are no doubt forces within the executive branch that will do a full court press to urge her to veto this important intervention. Let’s hope commonsense & reason prevail!

Do You Have Events Planned for National Public Health Week?

Many of our members are excited to celebrate National Public Health Week April 3-9, 2023. This year’s theme is “Centering and Celebrating Cultures in Health”. You can find lots of tools to help you commemorate the week on APHA’s NPHW Website!

 The American Public Health Association wants to promote events happening during NPHW. If your organization is planning any events during NPHW, contact our APHA representative to the governing council, Rebecca Nevedale, at [email protected].

Rebecca will collect some information from you and provide to APHA so that they can promote your event too. You can also submit an event to be included on the NPHW website by clicking here.

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

The Arizona State Hospital is located on a 260 bed 93-acre campus in Phoenix providing inpatient psychiatric care to people with mental illnesses who are under court order for treatment.  Treatment at ASH is considered “the highest and most restrictive” level of care in the state. Patients are admitted because of an inability to be treated in a community facility or because of their legal status.

The Civil portion of the hospital provides services to people civilly committed as a danger to self, danger to others, gravely disabled and/or persistently and acutely disabled. Forensic patients are court-ordered for pre- or post-trial treatment because of involvement with the criminal justice system due to a mental health issue.

The needs of patients at ASH can be complex and the patients are vulnerable, so it’s critical to ensure the facility uses best practice treatment and is following a rigorous set of regulations. To achieve fidelity to best practice standards, it’s critical that the governance structure ensures accountability and is free from conflicts of interests.

The Problem

The existing governance structure is insufficient to ensure quality care is provided at ASH. The fundamental flaw is that ADHS both runs & regulates ASH.

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

There is evidence that this occurred during the Ducey Administration.  For example, in 2021, ADHS’ licensing division investigated multiple suicides and a homicide and concluded that no operating deficiencies led to those deaths. Suicides and homicides only occur when there are deficient practices.

For context read this article by Amy Silverman: Patient deaths at Arizona State Hospital raise questions about staffing levels, lack of oversight and this piece by Mary Jo Pitzl at the Arizona Republic

The Solution

AzPHA is a supporter of SB1710 because it is a commonsense solution to governance problem that’s jeopardizing care at ASH by separating the operational functions of running ASH from the regulation of ASH by creating two separate entities (ASH would no longer be a part of ADHS).

The bill would establish a 5-member State Hospital Governing Board and transfer operational responsibilities to the Board. Members of the governing board would be appointed by the governor. The ASH Superintendent would report to the governing board rather than the ADHS Director. ADHS would then regulate the facility without an institutional conflict of interest.

[SB1710 passed the full Senate with a vote of 27-2 and has passed all assigned committees in the House. It awaits a final floor vote in the AZ House of Representatives. If it isn’t amended on the House floor and passes, it would go to Governor Hobbs’ desk for a signature.]

ADHS leadership has suggested that there is sufficient independent oversight of ASH, an oft told and misleading statement designed to give the impression that separating ASH from ADHS is unnecessary. To clear things up, we prepared this review of how the Arizona State Hospital is ‘regulated’ under the current model and why SB1710 is so important.

Civil Hospital

The ASH Civil Hospital provides treatment and care for persons that are court ordered to the facility for psychiatric care.  The Civil Hospital at ASH is run and regulated by the Arizona Department of Health Services (ADHS). ADHS’ Licensing Division is responsible for regulating the Civil Hospital which the ASH Superintendent is responsible for its operation.

State law allows healthcare institutions like ASH’ Civil Hospital to enjoy a Deemed Status license from the ADHS. That means that the Civil Hospital can hire an accrediting body to accredit the Civil Hospital. Once accredited, the Civil Hospital turns in the accrediting report to the ADHS Licensing division, and the ASH Civil Hospital receives a License from the ADHS – even though the ADHS doesn’t do an inspection of the facility before issuing the license.

ADHS pays The Joint Commission to accredit the Civil Hospital, which gives the facility a deemed-status license from ADHS. ASH Civil started hiring TJC to do that work when I was Director. I think we paid TJC something like $10K for that service. Here’s a link to the deemed status licensing information about the Civil Hospital: Licensing Statement of Deficiencies.  ADHS accepts the accreditation in lieu of an inspection and issues the state license to operate on that basis.

ADHS doesn’t do any annual inspections of the Civil Unit to ensure compliance with state licensing criteria because of its ‘Deemed Status’.  ADHS’ Licensing division can send out surveyors to investigate complaints about the care at the Civil Hospital when they receive them. If the complaint is substantiated, the ADHS Licensing Division can require corrective action and has some enforcement authority like issuing civil money penalties or placing the facility on a provisional license or even seeking revocation.

During the Ducey administration, ADHS ‘complaint investigations’ seldom substantiated the complaints they receive and seldom find deficiencies (with a few exceptions), even after suicides. Here’s the recent compliance record: Licensing Services Facilities Report

Because Medicare and Medicaid (AHCCCS in Arizona) pay for some of the services at the ASH Civil Hospital, CMS requires ASH’ Civil Hospital to be Certified to their certification standards. However, CMS doesn’t do their own certifications. They contract with the ADHS Licensing staff to conduct the certification surveys.

ADHS licensing staff go out and check at the ADHS ASH Civil Units to see if they’re adhering to CMS’ certification standards (which are a little different from the actual ADHS healthcare Institution regulations). ADHS Licensure then sends their report to CMS Region IX in San Francisco and the report is blocked, copied, pasted, and is sent back to ADHS and ASH on CMS letterhead.

ADHS both runs and regulates the ASH Civil Hospital. ADHS leadership often suggest that there are checks and balances in the regulatory system to send the message that the monitoring of care is rigorous. CMS Certification is not an independent review of care at the Civil Hospital because the work is conducted by ADHS Licensing staff.

While it’s true that The Joint Commission accreditation is separate from ADHS, the agency pays TJC for the accreditation surveys. TJC views ADHS as a customer/client. It is not a regulatory body, and they have no enforcement authority. TJC Accreditation inspections that document deficiencies can sometimes jeopardize their contract with their customer, having a chilling effect on documenting deficient practices.

Forensic Hospital

ASH’ Forensic Hospital provides care for patients that are determined by the courts to be “Guilty Except Insane” or “Not Guilty by Reason of Insanity”.  The Forensic Hospital is also both run and ‘regulated’ by ADHS.

State law allows ASH’ Forensic Hospital to enjoy a Deemed Status license from the ADHS. That means the Forensic Hospital can also hire an accrediting body to accredit the Forensic Hospital. Once accredited, the Forensic Hospital turns in the accrediting report to the ADHS Licensing division and receives a License from the ADHS – even though the ADHS doesn’t do an actual inspection of the facility. ADHS also pays the Joint Commission to accredit the Forensic Hospital.

When ADHS’ Licensing division receives complaints about care at the Forensic Hospital they can send out surveyors to investigate those complaints. If the complaint is substantiated, the ADHS Licensing Division can require corrective action and has some enforcement authority like issuing civil money penalties or placing the facility on a provisional license or even seeking revocation.

During the Ducey administration, ADHS ‘complaint investigations’ seldom substantiated the complaints or identified deficiencies (with some exceptions). Here’s the recent compliance record: Licensing Services Facilities Report (azdhs.gov)

Conclusion

The current governance structure for operating and regulating the Arizona State Hospital is fundamentally flawed because the ADHS both runs and regulates the hospital. The lack of independent regulation and oversight results in poor accountability and can lead to unchecked substandard care when ADHS leadership soft-pedals regulatory oversight to give the appearance that the facilities are providing care that meets standards. There is evidence that this occurred during the Ducey Administration.

SB1710 reforms of the governance structure by removing ASH from ADHS. It would separate the operational functions of ASH from the regulatory responsibilities by creating two separate entities (ASH would no longer be a part of ADHS). A 5-member State Hospital Governing Board would be responsible for the oversight of ASH and the Superintendent would report to the Board rather than the ADHS Director. ADHS would then regulate the hospital without an institutional conflict of interest.

ADHS Justice Reinvestment Grant Applications Open

In November 2020, Arizona voters approved the Smart and Safe Arizona Act legalizing retail marijuana and establishing a Justice Reinvestment Fund for grants to qualified nonprofit organizations that provide justice reinvestment programs in Arizona. 

Last week ADHS opened up the application period for the first set of Justice Reinvestment Grants. The RFGA will remain open and accept applications for the next 6 weeks. Pre-application conferences are being held over the next couple of weeks for folks interested in applying.