LOCATION: MARICOPA ASSOCIATIONS OF GOVERNMENTS SAGUARO ROOM, SECOND FLOOR, 302 N 1ST AVE #300, PHOENIX, AZ 85003
Age Friendly Arizona and Northern Arizona Council of Governments were selected to host a free statewide technology summit with the National Center for Applied Transit Technology (N-CATT). This summit aims to help healthcare and transportation providers in Arizona identify and support technology projects to improve access to healthcare.
In this first event, transportation and healthcare providers from across Arizona were presented with case studies from around the nation on how these two sectors worked together to improve healthcare access. The Arizona group then held a wide-ranging conversation about healthcare access in Arizona, the challenges faced by both transportation and healthcare providers, and current initiatives to address these challenges.
Throughout these conversations, two general themes were identified as building blocks for additional summit events.
There is a need for enhanced collaboration across multiple sectors across the state:
- There are opportunities to combine and/or align many statewide efforts that can improve patient care and improve efficiencies for transportation providers.
- Through ongoing coordination, there is a great opportunity to build meaningful and mutually beneficial partnerships between healthcare and transportation providers.
There is a great opportunity to pilot projects at the local or regional level and demonstrate replicable success at statewide level:
- By making strategic connections, we can align statewide initiatives with local resources.
- There appears to be interest from diverse funders to support pilots and expansion projects to improve AZ’s healthcare access.
To build off of these themes we are inviting you to attend an in-person workshop on May 9 to dive deeper into the areas below (lunch and free parking will be provided):
- Development of Healthcare and Transportation Statewide Taskforce.
- Build upon efforts to establish Telemedicine Hubs supported by Healthcare Navigators.
- Explore opportunities to better link Healthcare and Transportation communication platforms.
- Identify additional new areas where technology can support healthcare access.
PLEASE REGISTER HERE TO JOIN US IN EXPLORING THESE AREAS ON MAY 9, 2023.
The Arizona Department of Health Services is inviting members of the Arizona Emergency Medical Services and Trauma System community to provide comments on its draft trauma center rules. To view the rulemaking process, proposed rule changes and take the online survey, click here.
Harvard Law School and Policy Clinic: Issue Brief on 2021 State Policy Trends in Cottage Food & Home Kitchen Legislation
Abstract: The issue brief details trends across the 51 unique pieces of legislation introduced in 31 states and the District of Columbia that aimed to expand opportunities for cottage food producers and home cooks in 2021.
Trends include expanding the list of allowable foods produced at home, raising or lifting gross sales caps for home-produced goods, ensuring local governments allow home food production, and expanding sales and delivery venues for foods produced at home.
There is a wide variety of cottage food and home kitchen laws across the country. Despite this variety, the trend in new state legislation is quite clear. Whether allowing more categories of foods, raising sales caps, preempting local regulation, or expanding sales and delivery venues, states have been steadily broadening their cottage food and home kitchen allowances.
Growing markets for cottage foods and other home-produced foods has led to economic development and rising numbers of consumers and home cooks able to advocate for these laws. The beneficiaries of these laws are largely women, immigrants, and people of color.
The Relationship Between Cottage Food Laws & Business Outcomes: A quantitative study of cottage food producers in the U.S.
Abstract: The increasing popularity of cottage foods in the United States requires that state laws regulating the industry be given careful consideration. This article discusses results from the first comprehensive survey of cottage food producers in the United States.
Linear and logistic regression analyses of survey responses from 775 cottage food producers and aspects of state cottage food laws suggest restrictive state laws may hinder entrepreneurship in rural communities.
These results suggest policymakers should consider reducing restrictions on the cottage food industry to promote small-business creation and growth, especially among women and rural populations.
Unless you’ve been on vacation, you’ve heard the drama surrounding House Bill 2509 – affectionately known as the “tamale bill”. It would have expanded the kinds of homemade foods Arizonans can sell and provided a way for families to help ends meet while building safeguards against foodborne illness.
HB2509 breezed through the legislature with bipartisan support, passing with a 45-11 majority in the House & 26-4 in the Senate. The bill was vetoed by the Governor last week.
This isn’t the first time there’s been drama about home-prepared food offered for sale in Arizona. The public policy question regarding who should be able to sell what kind of food to who goes back a couple decades.
Let’s walk through the policy history of cottage industry food products and discover why HB2509 would have been a good thing for public health.
Note: This blog post represents the opinion of Will Humble. The AzPHA Board of Directors voted to take no position on HB2509 on April 21, 2023.
If you’ve been to a farmers’ market in Arizona you’ve undoubtedly seen cottage food industry products being sold by happy vendors to smiling customers. You’ve seen all kinds of breads, sweets, fruits, jams and jellies and a lot more. It wasn’t always that way.
Prior to 2011, selling food not made in a licensed commercial kitchen was illegal and subject to citation by environmental health inspectors.
Everything changed in 2011 with the passage of a law that let people make baked and confectionery foods at home and sell them, as long as the food didn’t facilitate the growth of bacteria.
Some in the environmental health community (including the director of Maricopa County Environmental Services at the time) vigorously opposed the passage of Arizona’s cottage industry food law. Fortunately, the 2011-era Arizona Department of Health Services supported the bill. Their leadership recognized the beneficial public health impact the law would have by helping people make supplemental income. It passed with bipartisan support and was signed by Governor Brewer.
Some in the environmental health world thought the sky would fall when the 2011 law passed. It did not. The program has been wildly successful and a big public health benefit. It helps families earn extra income and improves the social determinants of health.
Under the current law, only foods that don’t require time and temperature controls qualify for sale. They need to have a label stating the food preparer’s name and registration number, a listing of the ingredients, and the production date. Chefs need to complete a food handler training course and register with ADHS. Food preparers need to display their cottage industry food registration certificate at their point of sale.
How HB2509 Worked & Why I Think it Was Good
In a nutshell, HB2509 would have expanded the current cottage industry food law to include some foods that require time or temperature control for safety. The big public health bonus was that families would have been able to legally earn additional income to help ends meet by preparing a wider variety of foods.
While it’s true the bill would increase the number of folks selling potentially hazardous foods made in unlicensed kitchens, it would also build a number of safeguards into the system that don’t currently exist.
Drinks, fish & shellfish products wouldn’t qualify. Foods with meat or poultry could qualify if allowed under federal law. For example, for a recipe to include chicken, it would need to have been raised in accordance with the 1,000-bird federal exemption & inspected in accordance with federal standards. Meat can be in the recipe if it’s from an inspected source in accordance with federal regulations.
There are other safeguards built into House Bill 2509. Foods that have dairy, meat, or poultry must be sold directly by the food preparer in person or remotely (no middleman) and delivered to the consumer in person. Every food that needs time and temperature controls has to be maintained at the right temperature during transport, can’t be transported for more than 2 hours, and can’t be transported more than once.
Everything would need to be labeled with who made the food and where they made it so there’s a way to conduct foodborne illness investigations.
ADHS would be responsible for writing the regulations including procedures for suspending or revoking a producer’s registration when people don’t comply with all the requirements.
The reality is that all kinds of home-cooked foods that require time and temperature controls like burritos, tamales etc. are already being sold in parking lots all over Arizona. The vendors operate in the shadows, aren’t registered, may or may not have completed a food safety course, and generally don’t label their products… meaning tracing is difficult if there’s a foodborne illness outbreak.
House Bill 2509 would fix that by requiring registration, production and time & temperature controls, education courses, registration, and appropriate labeling.
The big public health dividend would be an improvement in the social determinants of health by expanding opportunities for folks to supplement their income, improving their ability to make ends meet, and generally make for happier families. The public would benefit by having more access to more diverse, creative, and tasty cottage industry foods.
The full disclosure provisions of the law mean customers would be buying the food with their eyes wide open, knowing full-well that the food wasn’t prepared in a commercial kitchen. Why not give them that choice?
The Speaker of the House & president of the Senate intend to bring House Bill 2509 to the floor to override the Governor’s veto Tuesday. It’s been more than 40 years since the state legislature has overridden a veto. Will it happen on Tuesday? We shall see.
Note: This blog post represents the opinion of Will Humble. The AzPHA Board of Directors voted to take no position on HB2509 on April 21, 2023.
I’m still getting caught up after a pretty long vacation. I just went through all the bills we’ve taken positions on and updated our ‘evergreen’ PowerPoint with all the bills.
- Lots of bad bills have died in either the original or sister chamber. A couple bad bills have been vetoed.
- A few good bills are still alive, and a couple have been signed (Good Samaritan).
- Lots of bills – good & bad – are languishing in the House & Senate Rules Committees.
The state legislature is on a 2-week vacation that they’re calling ‘Spring Break’ providing a respite from tracking bills – and also giving Senate and House leadership a chance to negotiate with Team Hobbs on the state budget. Here’s Our PowerPoint with summary of bills as of “Spring Break”
The real reason for the break is fill the House spot formally filled by Rep. Liz Harris (who was expelled from the chamber). Republican Precinct Committeepersons from that district (Chandler/Gilbert) will send the Maricopa County Board of Supervisors 3 candidates to select from to fill the post. I’m not sure what would happen if the PC’s send the Board 3 election deniers.
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.
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.
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.