FDA Approves Generic Epi Pen

 

“Epi Pens” swiftly and safely deliver life-saving epinephrine for folks with a food or other allergies.  Schools routinely stock them so that the medication is swiftly available in an emergency, as do health care facilities and EMS services.  A recent problem has been that the manufacturer (Mylan) raised the price substantially to $600 for a two-dose pack (after successfully lobbying state governments to mandate the stocking of EpiPens in schools).

Now there’s some financial relief on the way for schools and other facilities that will need to replace their existing stock.  Last week the FDA approved a generic product manufactured by Teva Pharmaceuticals that will be available for purchase shortly.  Here’s the FDA’s Media Release.

Conflicting Rulings on Voter Initiative “Strict Compliance Standard”

107 years ago, Arizona’s founders protected ordinary voters with a state constitution that guaranteed AZ residents the power of referendum, recall and initiatives.  Many of the bold moves to improve public health policy have come via citizens initiatives. A few examples are:

  • The Smoke Free Arizona Act;
  • The TRUST Commission for tobacco education and prevention;
  • First Things First;
  • Establishment and funding of the Area Health Education Center programs; and
  • Proposition 204 (from 2000) which extended Medicaid eligibility to 100% of federal poverty.

In 2017 the State Legislature passed and Ducey signed HB2244 which changed the citizen’s initiative compliance standard from “substantial compliance” to “strict compliance” for putting initiatives on the ballot. This law made it easier to reject petitions if there are any errors on the document, making it more difficult to put measures on the ballot in the future that are good for public health.

Last week there were conflicting court rulings regarding whether the standard set in  HB2244 is constitutional.  Maricopa County Superior Court Judge James Smith ruled that the Strict Compliance standard imposed by HB2244 is not constitutional (this was a case related to the ballot measure to fund schools).  However, in the very same day, Maricopa County Superior Court Judge James Kiley reached the opposite conclusion (on the clean energy initiative). 

Last week’s conflicting rulings mean that the AZ Supreme Court will likely need to settle the matter (and soon).  The result will have a big impact on voter’s ability to put future measures to voters to improve public health.

Webinar: Complying with Arizona’s Opioid Related Licensing Requirements

AzHHA Webinar: Creating an AZ Opioid Compliance Program to Meet Licensing Regulations

Keep current with the AZ changes related to opioid prescribing, ordering and administration requirements in the hospital and outpatient clinic settings. AzHHA recently released the Arizona Opioid Compliance Toolkits for Hospitals and Outpatient Clinics. On Tuesday, September 18th, Coppersmith Brockelman, LLC, will present a webinar to review the new legal requirements and recommendations for structuring an opioid compliance program. 

For more information and to register, click here.

Leveraging Doulas to Improve Birth Outcomes

Doulas are professionals who provides physical, emotional, and informational support to a woman throughout pregnancy, childbirth, and postpartum. Doula’s act as a facilitator between the laboring women and her physician by ensuring that mom and dad get the information they need in a way that they understand so they can make informed decisions. 

A growing body of evidence suggests that continuous support from doulas or other non-clinical labor support can improve birth outcomes for both mothers and infants, fewer preterm and low-birth weight infants, and reductions in cesarean sections. In fact, when doula services are included throughout the pregnancy and birth process, births cost less. A recent study found that when a doula is included in the process births cost an average of $986 less – including the doula service fee.

Currently, Minnesota and Oregon take advantage of the fact that doulas can reduce healthcare costs while improving outcomes in their state Medicaid programs. In the 2018 budget, Minnesota increased the reimbursement rates for doulas.  The new law also requires Oregon’s coordinated care organizations (which deliver Medicaid services) to provide information about how to access doula services online and through any printed explanations of benefits. The law tasked Oregon Medicaid with facilitating direct payments to doulas, which was addressed through rulemaking.  

Several organizations, such as DONA International, provide doula training and certification. Women can also choose to become certified as community-based doulas through HealthConnect One. This community-based doula program model, which has been replicated nationwide to serve unique populations, trains doulas to provide culturally sensitive pregnancy and childbirth education to underserved women in their own community. While all doula services can be beneficial, creating a standard for the training and certification of doulas may improve understanding and acceptance of doula care.

Looking for more info? Access this UA Issue Brief on Doula Coverage to Help Minimize Arizona’s Birth Woes

Who’s a Doula?

By AzPHA Member Prashanthinie (Prashi) Mohan, MBA

Over the last few years, there has been more and more focus on the triple aim – improving patient experience, reducing costs, and improving population health. Accomplishing these goals requires the system to be creative and actively look for new approaches to lowering costs while improving outcomes.

Doulas are increasingly being recognized as a professional that can do just that. 

Several studies have shown that moms who have doula services during their pregnancy and delivery have fewer cesarean sections and epidurals, reduced premature births, higher rates and a longer duration of breastfeeding. In March 2014, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal medicine issued a consensus statement which explicitly stated that published data has indicated better labor and delivery outcomes when continuous support personnel such as doulas are used.

So, we’ve got better outcomes covered, what about lower costs?

Recent evidence on the return on investment for doulas is encouraging. In addition to improving birth outcomes, doula coverage can also be cost effective (if not cost saving) to Medicaid programs. Doula coverage can help reduce costs by lowering the rate of pre-term and cesarean deliveries. One study conducted across 10 states computed an average savings of $986 per doula supported birth.

Despite the evidence on doula-supported births, only 6% of U.S. women who give birth are estimated to have doula support. Low income women and women of color, who are the most likely groups to want doula services, may not be able to afford doula services, which can cost $500 to $750 per birth in Arizona.  Because few health plans currently reimburse for doula services, most women are unable to take advantage of the improved outcomes and enhanced birth experience that doulas provide.

Licensed and culturally trained doulas who are from the minority communities can not only provide emotional support during the prenatal period and the delivery process, but can also help facilitate key communication between the mother and her care providers.

The question is, what are we waiting for? Doulas have proven to be effective in improving birth outcomes cost effectively in other states in the U.S. It’s time Arizonans start looking into how doula services can be efficiently reimbursed for the mothers in our state.

Take Your Understanding of Health Policy Beyond the Classroom

ASU’s College of Nursing and Health Innovation is excited to announce our new  Health Policy Academy.  It’s a 4-week program designed for new and transitioning professionals interested in the policy, politics and advocacy affecting public health today.  There is 3 weeks of intensive online training and three days of in-person experience at the Arizona State Capitol, and participants will receive practical tools to better navigate and impact the world of health policy.  This inaugural cohort will take place from September 10 – October 4, 2018. 

The Health Policy Academy is now accepting applications and the deadline for applying is Friday, August 31, 2018. Come join this talented group and develop the skills and connections to effect meaningful change!   Learn More about the Health Policy Academy

Program Particulars:

  • September 10-30, 2018 – Online Self-Guided Modules
  • October 2-4, 2018 – In-person Workshop at Arizona State Capitol
  • Price: $550  Apply Here

Federal Policy Decisions Eroding Health Insurance Stability

It’s been a few weeks since I’ve written about what’s happening with the Affordable Care Act- and there’s been some recent action- so here goes.

First of all, there’s good evidence that stable health insurance coverage helps people get preventive and primary care services that improve outcomes and downstream healthcare spending.  The Affordable Care Act included several provisions that helps people get these kinds of preventive services.  One of the primary goals of the ACA was to create broad access to robust health insurance coverage through: 

  • Employer mandated coverage for large employers;
  • An mandate to be insured or face a tax penalty to encourage full participation;
  • Subsidies and out-of-pocket protections for purchasing in the individual federal marketplaces;
  • Guaranteed issue and community rating of premiums;
  • Expansion of Medicaid to low-income adults; and
  • Ten essential health benefits for all marketplace insurance sold on the individual federal marketplaces, which includes requirements to cover services for mental health, substance abuse, and reproductive health.

It’s been working.  In the last several years the percentage of uninsured working-age adults decreased from 20% in 2013 to 12% by 2016 (nationally).  It would have been an even bigger decrease if all states had expanded Medicaid.  This  coverage expansion has led to increased access to preventive services, higher rates of having a usual source of primary care and increased affordability of care. 

However, progress is now stalling because of policy changes that have been made by the President like:

Cost Sharing Reduction Payments Stopped

In October 2017, the President announced that he was ending cost-sharing reduction payments (a program that previously reimbursed health insurance companies for the out-of-pocket protections available to some individuals who purchased coverage on the individual marketplaces). This caused higher premium rates in the individual marketplaces this year. 

Short Term Health Plans

The President also issued Executive Order 13813, which expanded “association health plans” and short-term, limited duration insurance. These plans create parallel markets in which healthier individuals move to cheaper plans that offer barebones coverage, destabilizing the marketplace.

Last week HHS and the US Department of Treasury followed through on the EO and issued a final rule that will allow consumers to buy short-term health plans to provide coverage for up to 36 months. These plans don’t need to comply with ACA requirements like covering essential health benefits, pre-existing conditions or the requirement to sell to any consumer regardless of health status.

These plans will likely attract younger, healthier and drive them out of the risk pool, which will increase costs in the ACA compliant plans.  It’s estimated that about 600,000 Americans will enroll in these short-term health plans, increasing federal spending on marketplace subsidies by $200M in 2019 and $28B over ten years.

Individual Mandate Effectively Expiring

As part of the new federal tax law, the individual mandate tax penalties will be $0 starting on January 2019, which will further erode the goal of increasing coverage and stabilizing insurance markets. In July 2018, the Commonwealth Fund predicted that eliminating the tax penalty will result in at least 2.8 million fewer Americans with coverage.  The nonpartisan Congressional Budget Office estimates that the number of people with health insurance will decrease 4M by 2019 and 13M by 2027.   CMS also cut funding for the federally-facilitated Exchange Navigator Program which will also contribute to decreased enrollment rates.

Risk Adjustment Payments

CMS announced in July that it would freeze $10.4B in 2017 risk adjustment payments. Luckily CMS released a final rule a couple of weeks ago to reinstate payments, so that’s an additional destabilizing thing that thankfully won’t happen at least for now.

Everyone benefits from access to primary and preventive services (including behavioral and reproductive health services), specialty care, and culturally appropriate care. If the individual insurance market continues to destabilize or doesn’t include affordable plans that offer comprehensive services, consumers may face expensive and inaccessible healthcare options. 

Many of the decisions that the President has been making make that outcome more likely in my opinion.

Loneliness as a Public Health Threat

I was surprised to learn this week that loneliness raises the risk of premature death by up to 50 percent-that makes loneliness a public health hazard on the scale of smoking and alcohol. Yet many medical and public health professionals haven’t heard about how many risks it poses.

Loneliness means that a person has a small support network and minimal interpersonal contact, and it becomes more common with age.  When a person’s children move or a spouse dies many people find it harder to engage in social activities. Seniors in rural areas are particularly susceptible. Geographic isolation and lack of public transportation combine to keep them alone.

Lack of human contact has serious physiological consequences. Studies show that without human contact our risk of functional decline increases as does our risk of mobility loss. The risk of clinical dementia goes up by 64%.   These health problems further isolate those suffering from social isolation, threatening a vicious cycle of physical, emotional, and psychological decline.

Better support access to existing services is a good start as an intervention.  For example, programs like Meals on Wheels can identify isolated seniors and connect them with resources to reduce loneliness. Other places like churches and city senior centers also serve as important community connectors and potential evaluation and intervention points for lonesome people.

Medicare could prioritize coverage for programs like SilverSneakers which keeps seniors active and creates opportunities for social connections through group exercise.  The Welcome to Medicare and annual Medicare exams could provide opportunities for screening and interventions.  

Medicare Advantage plans could cover benefits to address social isolation.  With an ROI analysis, interventions to reduce isolation could reducing health care costs (the triple aim) while improving outcomes. Developing a reliable tool to screen seniors for social isolation would help as well. 

There’s Hope for More Valley Fever Research Funds

Representatives Kyrsten Sinema and David Schweikert introduced a bill last week that, if it passes, will increase the funding that’s available for valley fever research.  The bill supports new research and incentivizes the development of innovative treatments to fight the disease. The bill would:

  • Provide incentives to researchers working to find new treatments for Valley Fever;
  • Streamline the approval and review process for new treatments of the disease;
  • Direct HHS to conduct research on Valley Fever and sets up a Valley Fever Advisory Committee to oversee the work; and
  • Establish a grant program to facilitate Valley Fever research by universities, hospitals, and non-profits.

Valley fever (Coccidiomycosis) treatment research funds are extremely limited, in part, because it’s a regional illness (unique to the desert southwest).  If the entire country were susceptible to the illness, there would probably be more private research funds invested because there would be a large commercial market for a treatment. 

Basically, that’s why we need an investment of federal funds and policy, because the return on the research investment for valley fever isn’t adequate to recoup costs of developing a treatment because not enough people are susceptible to the illness (because it’s limited to the desert southwest).

Can Medical Marijuana Card Fees Pay for Drug Treatment in AZ?

This week AZ Attorney General Brnovich wrote an Opinion stating that state lawmakers (or presumably the ADHS) can use qualified medical marijuana patient card fees to operate programs to help get people off of other drugs. The Arizona Medical Marijuana Fund (administered by the ADHS) contains more than $44M right now (the fund consists of fees paid by patients for cards, other card fees like dispensary agent cards, and dispensary application fees). 

Here’s a simple Q & A from this week’s Opinion:

Q. Could the Legislature, through the budget process, direct the ADHS Director to appropriate some of the Fund monies to help people addicted to drugs?

A. Yes.  The Legislature may direct the ADHS Director to spend Fund monies for programs to help people addicted to drugs if: (1) the appropriation is passed with a three-fourths vote of each legislative chamber; (2) the appropriation does not deplete the Fund and leave insufficient revenues to cover the immediate and future costs of the initiative; and (3) the appropriation furthers the purpose of the AMMA, i.e., it relates, in some way, to medical marijuana.

The AG Opinion states that:

“The Legislature may direct the ADHS Director to expend monies from the Fund for programs to help people addicted to drugs if: 1) the appropriation is passed with a three-fourths vote of each house; 2) the appropriation does not deplete the Fund and leave insufficient revenues to cover the immediate and future costs of the initiative; and 3) the appropriation furthers the purpose of the AMMA.  

To that end, an appropriation for activities related to distinguishing between medical and nonmedical uses of marijuana, protecting patients and providers from criminal prosecution, or carrying out, implementing, or administering the AMMA would meet this criterion.  If these requirements are met, it is not necessary to submit an appropriation request to Arizona’s voters.