News Reports Signal HHS Will Extend Covid-19 PHE Through April 2023
Several news outlets have reported that the U.S. Health and Human Services Department (HHS) intends to extend the existing Covid-19 Public Health Emergency (PHE) through April 2023.
The current PHE—which has been extended many times since 2020—is effective through Jan. 11, 2023.
FDA Announces Preliminary Assessment of Certain Naloxone Products for Over-the-Counter Use
The U.S. Food and Drug Administration (FDA) this week issued a Federal Register
notice that includes the agency’s preliminary assessment that certain naloxone drug products—up to 4 milligrams (mg) nasal spray and up to 2 mg autoinjector for intramuscular (IM) or subcutaneous (SC) use—may be approvable as safe and effective for nonprescription use.
In its
announcement about the notice, FDA said this move is “intended to facilitate both the development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone.”
The announcement also said the FDA needs additional data, such as product-specific data on the nonprescription user interface design, including packaging and labeling, before it makes its final determination.
CMS Releases Medicaid and CHIP Access Data Brief
The Centers for Medicare & Medicaid Services (CMS) this week released a data
brief that includes a snapshot of selected metrics in three essential dimensions of Medicaid and Children’s Health Insurance (CHIP) access.
Culling data from various sources, CMS developed the brief to show access to Medicaid and CHIP coverage, measured by enrollment and retention; access to services, with a focus on mental health conditions and substance use disorders; and perceived access, measured by beneficiary experiences in managed care.
SAMHSA’s GAINS Center to Host Webinar About Project ECHO and SUD on Nov. 21
The Substance Abuse and Mental Health Services Administration’s (SAMHSA) GAINS Center on Monday, Nov. 21 will host “Black Robes and White Coats: Using Project ECHO to Increase Judiciary Knowledge about Substance Use Disorder,” a webinar that will provide an overview of the pilot Project ECHO for the Judiciary.
The purpose of Project ECHO for the Judiciary is for participating judges to learn about treatments for opioid disorder and develop a better understanding of substance use disorders to help inform their decisions in the courtroom.
The webinar will begin at 2:30 p.m. ET on Monday. Click
here to register.
FDA to Host Stakeholder Call About Naloxone Access on Nov. 28
The top leaders at FDA and SAMHSA will host a stakeholder call on Monday, Nov. 28 to discuss naloxone access and harm reduction.
FDA Commissioner Robert Califf, M.D. and Marta Sokolowska, deputy center director for substance use and behavioral health in FDA’s Center for Drug Evaluation and Research, will lead the call, and SAMHSA Assistant Secretary for Mental Health and Substance Use Miriam Delphin-Rittmon, Ph.D. will participate.
“Every person who experiences an opioid overdose, whether it is with prescribed medication or an illicit drug, should have access to naloxone,” FDA said in its announcement about the call. “Entities such as harm-reduction programs help save lives by making naloxone available in underserved communities,” it continued. “The agency intends to stand by these efforts by supporting their ability to acquire FDA-approved naloxone products, and we recently issued the guidance, Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA) for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency,” it said, adding that FDA recognizes this action alone is not enough and that there is more work to do.
The hourlong Zoom call will begin at 2:30 p.m. ET. Click
here to register.
Reminder: Please Submit Data to Enhance NABH’s Managed-Care Advocacy Efforts
Thank you to all members who have already submitted your data to NABH’s denial-of-care portal. Your data will help NABH highlight problems in the field related to health plan denials and timeliness. Several policymaking entities are interested in these data, which could support advocacy for expanded access to care.
For new participants, please e-mail
Emily Wilkins, NABH’s administrative coordinator, for support.
Save the Date for the NABH 2023 Annual Meeting!
Please mark your calendars and plan to join us in Washington, DC from
June 12-14, 2023 for next year’s NABH Annual Meeting!
Fact of the Week
Demand for anxiety and depression treatment remains high for the third consecutive year, and 60% of practitioners report they no longer have openings for new patients, according to the American Psychological Association’s 2022 Covid19
Practitioner Impact Survey.
For questions or comments about this CEO Update, please contact Jessica Zigmond.
