Of these public health emergencies, it is also unclear when the opioid emergency will terminate or expire, with several health experts questioning whether the government’s response
Public health emergencies (PHE) can be declared by the secretary of the U.S. Department of Health and Human Services (HHS) any time a disease or disorder exists that either presents some type of emergent risk to public health or includes a significant infectious disease outbreak or bioterrorist attack. Declaring a PHE enables the secretary to take certain actions in response, such as temporarily waiving or revising federal healthcare requirements.
As of April 13, 2022, the HHS reports that there are two active national PHE declarations. One is in reference to the COVID-19 pandemic. The other addresses the opioid crisis.
COVID-19 PHE declaration
The first public health emergency regarding the coronavirus was declared on January 27, 2020, and has been renewed every three months since, with the most recent renewal being issued on January 14, 2022.
One of the responses provided under a PHE declaration is emergency use authorization (EUA) of products that have either not yet been approved by the Food and Drug Administration (FDA) or have been previously approved but not for the specific use intended under the PHE.
In response to the coronavirus pandemic, EUA has been provided for vaccines, drugs used to treat the virus, and a variety of medical devices, some of which include blood purification devices, decontamination systems for personal protective equipment (PPE), remote or wearable patient monitoring devices, and ventilators and ventilator accessories.
Another response provided under the COVID-19 PHE declaration is a blanket waiver for health care providers concerning federal insurance programs such as Medicaid and the Children’s Health Insurance Program (CHIP).
The Centers for Medicare & Medicaid Services (CMS) shares that one of the changes under this waiver is regard to telemedicine, enabling patients enrolled in these programs to engage in health visits virtually with greater ease while also allowing providers to be reimbursed at the same rate as when meeting with patients in-person. It also waives the face-to-face requirement for replacing durable medical equipment, prosthetics, orthotics, and supplies.
Opioid crisis declaration
The other PHE that is currently active addresses the opioid crisis. The opioid PHE was originally declared on Oct. 26, 2017, and was most recently renewed on April 4, 2022.
The CMS shares that several factors contributed to the original declaration. Among them was the fact that the number of opioid-related overdose deaths had quadrupled since 1999, more than six in 10 drug overdose deaths involved an opioid, and over half a million people died from an opioid overdose between 2000-15, equating to 91 opioid overdose deaths per day.
One of the remedies provided by this PHE is a waiver of the requirements as set forth under the Paperwork Reduction Act. This PHE also enabled the National Institutes of Health (NIH) to fund research related to opioid use disorder, overdose, and treatment under its Helping to End Addiction Long-term (HEAL) Initiative at an accelerated rate. On Sept. 26, 2019, the NIH reported that the monies provided for this initiative totaled $945 million and included 375 awards in 41 states.
The future of these two public health emergencies
On Jan. 21, 2021, the Secretary of HHS issued a letter to governors that states would receive 60 days notice before the termination of the COVID-19 PHE declaration. Therefore, it is likely that this declaration will be renewed until at least July of 2022, if not extending beyond that date, with agencies such as the American Society of Health-System Pharmacies calling for the flexibilities under the COVID-19 PHE to remain permanent.
Of these public health emergencies, it is also unclear when the opioid emergency will terminate or expire, with several health experts questioning whether the government’s response has even been effective. One such example is an article published by the AMA Journal of Ethics in August 2020, in which the author states that the PHE doesn’t address the role that healthcare provider ethics plays in the prescription of opioid medications. The author further suggests that the response strategy “neglects the need for public health interventions and policy.”
There are also questions as to whether one PHE has impacted the other. A 2022 study in the JAMA Health Forum indicates that the answer is yes, citing that while the COVID-19 PHE didn’t interrupt access to a drug used to treat opioid use disorder (buprenorphine), it did interrupt access to urine drug testing and opioid program services.
