Could labels actually matter in America’s Opioid “Emergency”?

By: B. Cameron Webb, MD, JD

LAST WEEK IN REVIEW: Monday, Oct. 23rd – Friday, Oct. 27th

Early last week, Senate Finance Committee Chairman Orrin Hatch (R-Utah) and Ways and Means Committee Chairman Kevin Brady (R-Texas) announced a bicameral agreement to pair Affordable Care Act (ACA) reforms with a temporary two-year funding extension for the health law’s cost-sharing reduction (CSR) program, which could provide Americans with more certainty and choice. This would not only delay the ACA’s individual and employee mandate, but also expand tax-free Health Savings Accounts (HSRs) to allow Americans to put aside more of their hard-earned income for health costs. With open enrollment beginning on Wednesday this week, the need for bipartisan legislation to stabilize the marketplace is higher than ever before. While it may be too late for a stabilization measure to bring down premiums in states for the 2018 coverage year, there are still hopes to add $106 million for outreach and enrollment in 2019.

In the realm of disaster relief, about 10 percent of drugs manufactured for US consumers are from Puerto Rico which has taken a hit since hurricane Maria. Healthcare systems in the US are suffering from certain drug shortages due to the aftermath of the hurricane. Also, after the Governor of California declared a public health emergency earlier this month due to the wildfires, Centers for Medicare & Medicaid Services (CMS) has also taken action. Through the public health emergency, CMS is able to waive or modify certain Medicare, Medicaid and Children’s Health Insurance Program (CHIP) requirements if necessary to provide health services.

Finally, the opioid epidemic continued to lead headlines around the country last week. Officials are cracking down on opioid prescribers for engaging in questionable practices that contribute to the widespread availability of these drugs. Local experts met at the University of Virginia to discuss the crisis, while Food and Drug Administration (FDA) Commissioner, Dr. Scott Gottlieb, called for expanded use of medication-assisted treatment for opioid addiction. But the biggest news came from the White House on Thursday, when the Trump Administration officially declared the opioid epidemic a public health emergency. This week’s Spotlight will break down the opioid epidemic and how this declaration will direct efforts to address it.

SPOTLIGHT: Could labels actually matter in America’s Opioid “Emergency”?

Last Thursday, at the instruction of President Trump, Acting Health and Human Services (HHS) Secretary Eric Hargan declared a nationwide public health emergency regarding the opioid. Around the country, responses to the announcement ranged from enthusiasm to apathy, with most curious about how the declaration would substantively impact the American opioid crisis that leads to an average of 91 deaths and over 1,000 people requiring emergency room treatment each day. While there have been some really solid reviews on the rise of the opioid epidemic (e.g., from CNN, Vox and—most recently—the New York Times), we’ll begin with a fly-over of how we got here.

Origins of an epidemic

It all began with the cultivation of opium poppy in lower Mesopotamia back in 3400 B.C. Skipping a few details, by the early 1980s, physicians were wary of using opioid derivatives (such as morphine and oxycodone) in the treatment of pain—particularly given widespread awareness of the disease of addiction and dependence that accompanied the use of these medications. In the mid 1990s, though, the focus shifted to an epidemic of untreated pain in American hospitals. Around the same time that newer, long-acting opioid formulations became available and were being aggressively marketed by drug manufacturers, various groups began championing the idea of pain as the “fifth vital sign”. New guidelines for pain management followed, and a new opioid epidemic was off to the races.

Previous federal efforts to combat the opioid epidemic

While 76 million prescriptions for opioids were written in the United States in 1991, that number had doubled by 2002 and nearly tripled 10 years later. By 2010, just over a year into his first term, President Obama released his first National Drug Control Strategy. This plan emphasized a need for action to address opioid use disorders and overdose, while still ensuring adequate treatment of individuals with pain. A year later, the Obama Administration released its national Prescription Drug Abuse Prevention Plan, outlining goals for addressing prescription drug abuse and overdose. The Administration focused on supporting and expanding community-based efforts to prevent drug use, pursuing ‘smart on crime’ approaches to drug enforcement, improving prescribing practices for pain medication, increasing access to treatment, working to reduce overdose deaths and supporting the millions of Americans in recovery.

By October 2015, the Obama Administration created its plan to combat the epidemic, focusing on prescriber training and improving access to treatment. Additionally, President Obama, himself, requested $1.1 billion in funds in his budget to combat the epidemic. Still, as the 2016 election came and went, the opioid epidemic continued onward—dramatically impacting communities across the country, with opioid overdose, abuse and dependence exerting an estimated economic burden of $78.5 billion on the United States.

Defining an opioid public health “emergency”

With opioid deaths surpassing automobile accidents as the most common cause of accidental death in the United States—and with the typical descriptors of an opioid crisis or epidemic—most Americans already perceived that “emergency” status had long since been reached. In fact, in the 2017 fiscal year (from October 1, 2016 through September 30, 2017), HHS invested almost $900 million in opioid-specific funding. This included supporting state and local governments—as well as community-based organizations—to support treatment and recovery services, to target the availability of treatment for overdose, and to train first responders.

Instead of merely signaling the obvious, the Trump Administration has stated that it is using the declaration of an emergency as a mechanism to rally additional resources and support for communities across the country that have been ravaged by addiction and abuse. By asking his Acting Secretary of HHS, Eric Hargan, to declare a public health emergency, the Trump Administration empowers HHS to act beyond last year’s $900 million investment.

Under Section 319 of the Public Health Service Act, the determination of a public health emergency permits the federal government to engage in activities such as assisting state and local governments, suspending or modifying certain legal requirements, and expending available funds to address the public health emergency. This Section 319 determination will remain in effect for 90 days, with the option to renew the determination for additional 90-day periods if the Secretary of HHS determines that the emergency persists.

Specifically, the Trump Administration notes that the declaration of a nationwide public health emergency will enable HHS to accelerate temporary appointments of specialized personnel to address the emergency, will help expand access for certain groups of patients to telemedicine for treating addition, and will provide new flexibilities in HIV/AIDS programs.

Experts have suggested that this designation could grant HHS significant latitude in addressing the epidemic. Using the example of naloxone, the reversal agent for opioid overdose, several options have been suggested regarding efforts to expand access. First, under this new emergency status, HHS could consider negotiating reduced pricing for naloxone. Additionally, the agency could facilitate equipping first responders with naloxone in public spaces with frequent overdoses. Moreover, HHS could allow pharmacies to distribute naloxone over the counter. With increased latitude in the arenas of treating opioid abuse with medication, or even addressing provider prescribing practices, the designation does widen the field with regard to federal options for impacting the epidemic.

Importantly, though, there remains the issue of money. In terms of the funds available under Section 319 of the Public Health Service Act, these typically would come from the Public Health Emergency Fund—a fund created by Congress in 1983 that was funded with as much as $45 million in 1990. Today, however, the Public Health Emergency Fund currently sits at only $57,000. Congress would need to reauthorize and fully fund the effort in order to make a meaningful impact. While some in Congress—on both sides—have requested $45 billion over the next decade, some experts have suggested that the true cost of necessary services to combat the opioid crisis would be over four times that amount: roughly $190 billion.

In conclusion…and looking forward

While much ado was made in the press over the President’s decision to ask the Secretary of HHS to declare a public health emergency under the Public Health Service Act rather than pursuing a different emergency status (e.g. under the Stafford Act), most experts agree that the use of the Section 319 of the Public Health Service Act best equips the administration to swiftly and creatively assist states and localities in curbing the opioid epidemic. The substance of such interventions, however, remains to be seen. Stay tuned this week, as the President’s Commission on Combating Drug Addiction and the Opioid Crisis—led by Governor Chris Christie—is poised to submit their final report on November 1st. This could provide some important clues on where the Trump Administration goes from here to try to address this opioid emergency.

Student Contributors on this Article:
Marissa Alvarez, Chad Fletcher, Shaina Haque