Center for Public Health Law & Policy

 

The Center for Public Health Law and Policy  is the cornerstone of the Sandra Day O’Connor College of Law’s nationally-ranked health law program. The Center brings together students, leading scholars, practitioners, and policymakers to address critical issues in law, ethics, policy, and the public’s health. The Center explores a wide range of issues, including national health care reform, communicable disease control, human subject research protection, emergency legal preparedness, obesity and injury prevention, health information privacy, and vaccination law and policy.

The Center for Public Health Law and Policy is also the home to the Western Region Office of the national Network for Public Health Law, funded in part by the Robert Wood Johnson Foundation. Led by Professor James G. Hodge, Jr., the Western Region Office provides technical assistance and other vital resources to public health practitioners, officials, attorneys, and advocates across 11 Western states and nationally. Since its inception in September of 2010, the Western Region Office has fulfilled nearly 3000 requests nationally, over 1000 of which directly aided requesters in the office’s home state of Arizona.

This fall the Network for Public Health Law is organizing the 2018 Public Health Law Conference, to be held October 4-6, in Phoenix, AZ. For more information, please visit: https://www.networkforphl.org/2018_conference/phlc18.

State Action to Stem Rising Prescription Drug Costs

By Association for State and Territorial Health Officials Staff

The high cost of prescription drugs is a persistent problem in the United States, with about 10 percent of overall health spending attributed to prescription drugs. In recent years, there has been increased interest among states to address the rising cost of prescription drugs. Just this year, 24 states passed 37 bills to stem rising drug costs. In total, state legislatures have introduced 160 bills targeting prescription drug costs in 2018.

States have pursued a wide range of strategies to tackle the high cost of prescription drugs, including policies that address drug price transparency, rate setting requirements to prevent price gouging, drug importation programs, generic drugs companies, and pharmacy benefit manager transparency.

 

Drug Price Transparency

Controlling healthcare costs is one of the three elements of the Triple Aim, along with improving population health and patient care experience. As a first step toward controlling costs, states are seeking more price transparency requirements from drug manufacturers. In 2018, six states passed legislation addressing drug price transparency. Many of these laws adopt more stringent transparency policies requiring drug manufacturers to justify price increases over certain thresholds. For example, Connecticut requires drug manufacturers to justify price increases for specific drugs if the price increases by 20 percent or more in a year or 50 percent over three years.

 

Price-Gouging and Rate Setting Requirements

Anti-price gouging and rate setting requirements use information collected from transparency laws to allow states to impose penalties for excessive drug price increases. Currently, Maryland is the only state with an anti-price gouging law. The policy allows the state Medicaid agency to notify the state’s office of the attorney general when an essential off-patent brand name drug or generic medication has an excessive price increase.

Maryland’s attorney general can then request justification from manufacturers for the price increase. If the rationale of the price increase is deemed unjustified by “the cost of producing the drug, or the cost of appropriate expansion of access to the drug to promote public health,” the state can impose civil penalties or use other mechanisms to penalize the manufacturer. However, a lawsuit has since been filed in federal court by drug manufacturers asserting violations of Constitutional law as it relates to interstate commerce. To date, twelve other anti-price gouging bills have been introduced in states, although none have been enacted.

 

Drug Importation

Earlier this year, Vermont became the first state to pass a drug importation bill, allowing the state to import wholesale prescription drugs from Canada for use by all state residents. The law requires the designation of a state agency to become a licensed drug wholesaler, or to contract with a licensed drug wholesaler. Several steps remain before Vermont’s program can go into effect, including the state health department receiving federal approval from HHS by July 2019. In addition, although the Utah legislature failed to pass a bill that would have created a program for importing drugs from Canada, the legislature requested that the Utah Department of Health conduct a feasibility study associated with drug importation.

 

Generic Drugs

Recently, Maine passed a law requiring brand name manufacturers to make samples of drugs available to generic drug manufacturers, with the intention of promoting competition by increasing access of information for companies developing lower-cost generic drugs. The law states that, “In order for there to be competition in the prescription drug market, developers of generic drugs and biosimilar biological products must be able to obtain quantities of the reference listed drug or biological product with which the generic drug or biosimilar biological product is intended to compete.”

 

Pharmacy Benefit Managers

Several states have passed bills regarding pharmacy benefit managers (PBMs), which require increased transparency and disclosure of information on drug rebates and concessions. For example, Nevada passed a law in 2017 requiring PBMs to disclose the amount of rebates received from drugs used to treat diabetes. Connecticut’s drug price transparency law also requires PBMs to provide information on rebates and other price concessions received from drug companies. Mississippi passed a law preventing PBM gag clauses, which stop pharmacists from sharing information with patients on lower-cost drug options.

 

Other State Policies

In Montana, the legislature passed a bill establishing an interagency committee to study state drug pricing and spending trends, which will make recommendations to the state legislature on drug pricing policies in late 2018. In addition, New York implemented an annual cap on drug spending in its Medicaid program. Under the law, if spending projections extend beyond the cap, the state health department must identify the costliest drugs and attempt to negotiate additional rebates with manufacturers. This law also gives the state the authority to develop an independent panel that can penalize manufacturers through various mechanisms.

 

Future Opportunities

Emerging state legislation to address the rising cost of drug prices in demonstrates potential paths forward to address drug prices at the state level. The National Academy of State Health Policy (NASHP) has developed model legislation to address drug price transparency, drug importation, rate setting, and pharmacy benefit managers. The NASHP resource includes model legislation for states, bill text from states that have already passed legislation, and relevant briefing documents.

Unique Career Opportunities in Mohave County

For those of you interested in developing and implementing public health policy at the local level- there’s nothing like running a county health department.  Especially in a rural county.  Rural counties offer a unique career experience that allows you to see all facets of public health.  Folks working in rural counties learn about all the various public health programs- providing a unique opportunity to build a career in public health.  Running a smaller rural county health department also positions you well for larger organizations later in your career.

Right now there are a couple of great career building opportunities in Mohave County including the Public Health Director and Director of Environmental Health.  Both are based in Kingman.  These kinds of jobs don’t come open very often, so take a ponder over the Labor Day weekend and think about it.  I’m not spinning this- these really are good career opportunities for ambitious public health professionals that are looking to expand their reach in developing and implementing local public health policy.

AzPHA Members Voting on New Resolutions

 

Three new Resolutions have been developed by our Resolutions Committee and have been forwarded by our Board for a vote of our Members. AzPHA Resolutions are important because our advocacy priorities are driven by Resolutions. AzPHA has dozens of Resolutions in place dating back to the 1930s. Our historic Resolutions are available on our Members Only site.  

Early resolutions focused on the importance of food safety regulations, tuberculosis prevention and treatment, tobacco control, family planning, and other contemporary public health issues. More recent Resolutions have focused on addressing the Opioid epidemic, certifying Community Health Workers, and regulating electronic cigarettes. 

Our AzPHA Members that are up to date on their dues and such are now electronically voting on the proposed Resolutions between August 28 and September 12, 2018.  Links to the proposed Resolutions are located below: 

Note: This voting is just open to AzPHA Members who are up to date with their dues.  Only members in good standing were sent the message with the voting link. Let me know if you believe that you’re an active member but didn’t get the email.  It went out on the morning of August 28 and was entitled “2018 AzPHA Election Announcement”

Congress is Back in Session: Important Bills in the Balance

Members of the U.S. House of Representatives return to Washington D.C. this week.  They’ll be discussing important public health bills including the Labor-HHS-Education appropriations bill for fiscal year 2019 and the reauthorization of the Farm Bill.

Last week the Senate passed H.R. 6157 which is the combined Defense and Labor, Health and Human Services, Education and Related Agencies appropriations bill for FY19.  This one is the eighth and ninth out of 12 spending bills to be passed by the Senate for FY19.  The legislation includes increased NIH funding and boosted resources for opioid treatment, prevention, and recovery programs.  Here’s a list of some of the adopted amendments:

  • Schumer-Collins amendment to increase funding for Lyme disease activities (3759).
  • Cortez-Masto-Ernst amendment to provide for conducting a study on the relationship between intimate partner violence and traumatic brain injury (3825).
  • Peters-Capito amendment to ensure youth are considered when the Substance Abuse and Mental Health Services Administration follows guidance on the medication-assisted treatment for prescription drug and opioid addiction program (3870).
  • Heitkamp amendment to provide funding for the SOAR (Stop, Observe, Ask, Respond) to Health and Wellness Program (3893).
  • Casey amendment to provide funding for the Secretary of Health and Human Services to establish the Advisory Council to Support Grandparents Raising Grandchildren (3875).
  • Schatz-Hirono amendment to assess the ongoing mental health impact to the children and families impacted by a volcanic eruption covered by a major disaster declared by the President in calendar year 2018 (3897).
  • Heller-Manchin amendment to provide additional funding for activities related to neonatal abstinence syndrome (3912).
  • Heitkamp-Murkowski amendment to improve obstetric care for women living in rural areas (3933).
  • Durbin-Grassley amendment to provide for the use of funds by the Secretary of Health and Human Services to issue regulations on direct-to-consumer advertising of prescription drugs and biological products (3964).

The House hasn’t adopted its FY19 Labor, Health and Human Services, and Education appropriations bill. It’s unclear how both chambers will resolve differences in funding levels between their bills. The House could work on its Labor, Health and Human Services, and Education bill or skip a floor vote and start negotiations with the Senate.  The Farm Bill, which funds WIC & SNAP also hangs in the balance. Here’s a summary of the Farm Bill.   The current legislation is scheduled to expire Sept 30th.

Bottom line: with only a few legislative days before the end of FY18, it’s likely that a continuing resolution will keep the government funded into FY19.

The APHA has several tools that you can use to get the attention of your Representative or Senator.  They’ve developed APHA’s Speak for Health advocacy resources, including state-specific fact sheets to help you be a better advocate.  They also have tools to help you meet with your members of Congress or their staff or invite them to visit you and Email or call your members of Congress using the APHA action alert as a phone script or email message. It’s quick and easy.

More States Following AZ’s Lead Establishing Overdose Review Teams

More States following AZ’s Lead to Establish Overdose Fatality Review Teams

Overdose fatality reviews allow states to better understand the circumstances surrounding fatal drug overdoses so they can design better interventions.  Review teams can uncover the individual and population factors and characteristics of potential overdose victims. Knowing the who, what, when, where, and how of fatal overdoses provides a better sense of the strategies and coordination needed to prevent future overdoses and results in the better allocation of overdose prevention resources and services.  

Nine states including AZ have set up teams so far. The Network for Public Health Law provides a good overview of the states that have review teams. Here are some of the laws [OK (HB 2798), RI (S 2577 and H 7697), and VA (SB 399)], DE (HB 211) and our own (HB 2038). The laws establishing fatal overdose reviews often include the entity authorized to create and manage the review team or committee, the membership requirements for teams or committees, the scope of work of the teams or committees, confidentiality and liability protections, and data access authorizations.

Important Notice for AzPHA Members

In advance of our Annual Meeting, AzPHA will be conducting an on-line vote in early September for:

  • The new AzPHA Officers and Board Members that are being proposed by our Board of Directors.  If approved by our AzPHA Members via the electronic vote, the new Officers and Board Members will begin their terms on October 3, 2018 (at our Annual Meeting).

  • New Resolutions that have been developed by our AzPHA Resolutions Committee and forwarded by the Board for a vote of the Members.

Many of AzPHA’s public health advocacy priorities are driven by Resolutions that are approved by our Members.  AzPHA has dozens of Resolutions in place dating back to the 1930s.  They’re posted on our Members Only site at http://www.azpha.wildapricot.org/page-1465233

Early resolutions focused on advocacy regarding food safety regulations, tuberculosis treatment and control, family planning, air quality, tobacco control and other public health issues. More recent Resolutions have focused on addressing the Opioid epidemic, certifying community health workers, and addressing electronic cigarettes.  Our Resolutions are important because they help guide our public health advocacy activities. 

AzPHA Resolutions are developed by our Resolutions Committee and are forwarded to our Board for review. The Board reviews the Resolution and forwards the Resolution to the Members for approval.  Proposed Resolutions can be voted on electronically before the Annual Meeting or they can be voted on in-person at the Annual Meeting.  This year we’re conducting the vote electronically.  

After approval of the resolutions, final copies are posted on the members only portion of our website.  Resolutions stay in place until and unless Members vote to remove or update a Resolution.

AzPHA Members – please keep an eye out for an email with the electronic ballot for the proposed new Board members and Resolutions next week in a members only email.

State Approaches to Health Equity

Several states are working to supporting health equity by addressing the root causes of persistent health inequities through public health policies, plans, initiatives, reporting, and partnerships. The Association of State and Territorial Health Officials recently summarized some examples of states working to advance health equity:

  • States are partnering with stakeholders and community residents to develop tools and resources that are community driven and developed to address health equity. The Colorado Department of Public Health and Environment, Office of Health Equity recently released the Colorado Equity Action Guide, which examines the root causes of health inequities experienced by Coloradans and provides historical context for present-day adverse health outcomes by describing the impact of structural racism and inequitable policies throughout the state’s history. The guide provides action steps, integrates community voices, and serves as a practical tool for community members, government officials, and philanthropy to work together to advance equity. 
  • States are taking the opportunity to update internal policies and plans to ensure health equity is prioritized and integrated into their operating procedures, practices, and programs, as they prepare for public health department accreditation or re-accreditation now that the revised accreditation standards and domain requirements place greater emphasis on health equity. ASTHO staff analyzed 44 state health improvement plans (SHIPs), a required document for public health accreditation. Forty-three out of forty-four state plans indicated health disparities as a general focus, with ten states explicitly identifying health equity as a priority. In Washington, D.C.’s SHIP plan, DC Healthy People 2020, an agency goal was to “achieve health equity by addressing the social determinants of health and structural/system-level inequities” impacting D.C. residents. The district developed 2020 target rates for various social and environmental conditions, such as economic food insecurity, as well as recommended strategies.
  • States are embracing a broader view on what creates health and leading efforts to include health in all policy (HiAP) considerations across all sectors. The Triple Aim for Health Equity Framework, coined by former ASTHO President Ed Ehlinger (alumnus-MN), encourages policymakers to take a HiAP approach as a means to advance health equity. ASTHO defined HiAP as a collaborative approach that integrates and articulates health considerations into policy making across all sectors and levels to improve the health of all communities and people. ASTHO’s 2018 State of Health-in-All Policies report featured nine state case studies which profiled their HiAP and health equity activities. California was the first state to formally create a HiAP Task Force in 2010. The task force has representatives from 22 diverse state agencies and has been successful in integrating health and equity in state policies. The task force recently partnered with the Government Alliance on Race and Equity to create a racial equity capacity-building pilot program for California state employees.

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.