The AMA last week urged the nation’s naloxone manufacturers to immediately submit applications to remove prescription status for the life-saving opioid overdose reversal agent. “At this stage in the nation’s drug overdose epidemic, there is no valid clinical, public policy, or ethical reason for drug manufacturers to delay OTC (over-the-counter) applications,” wrote AMA Executive Vice President and CEO James L. Madara, MD, to Akorn, Inc. (PDF), Adamis Pharmaceuticals Corporation (PDF), Emergent BioSolutions (PDF), Kaléo Inc. (PDF), Pfizer Inc. (PDF), Teva Pharmaceuticals USA, Inc. (PDF), and Hikma Specialty USA, Inc. (PDF).
“The nation’s drug-related overdose and death epidemic is being fueled by increasing levels of illicit fentanyl, fentanyl analogs, and drugs contaminated with illicit fentanyl,” wrote Dr. Madara. “Naloxone has proven its efficacy in saving lives from opioid-related overdose. Without this medication, it is likely that tens of thousands more Americans would be dead from an opioid-related overdose.”
To help encourage manufacturers, the AMA also is urging a wide cross-section of national stakeholders to encourage manufacturers to submit OTC applications. Letters (PDF) were sent to the National Governors Association, National Conference of State Legislatures, National Council of Insurance Legislators, National Association of Insurance Commissioners, National Association of Attorneys General, Federation of State Medical Boards, National Association of Boards of Pharmacy, Association of State and Territorial Health Officials, National Association of City and County Health Officials, National Association of Medicaid Directors, American Pharmacists Association, National Community Pharmacists Association, PhRMA and America’s Health Insurance Plans.
In addition to making popular formulations of prescription naloxone OTC, including nasal sprays and intramuscular auto injectors, read why (PDF) the nation’s harm reduction organizations also strongly support OTC, or “no-prescription” status for naloxone.
On Oct. 27, New Jersey received federal approval of a demonstration waiver to extend pregnancy-related Medicaid eligibility for 12 months following childbirth. Virginia received similar approval on Nov. 18. Virginia’s waiver extends coverage under the Children’s Health Insurance Program (CHIP) as well as Medicaid. Prior to the waiver approvals, pregnancy-related coverage in both states terminated after a 60-day postpartum period. The waivers are expected to cover an additional 8,700 women in New Jersey and an additional 6,000 women in Virginia. With this coverage, women will gain access to additional care to help prevent and treat postpartum-related complications, illness and death.
Both state waivers align with the American Rescue Plan, which gives states the option to extend coverage for 12 months following childbirth via a state plan amendment beginning on April 1. To date, five states have received federal approval to extend postpartum coverage via waivers.
The AMA adopted policy in June 2019 advocating for the extension of Medicaid coverage to 12 months postpartum. During the 2021 Special Meeting of the House of Delegates in November, the policy was amended to support 12-months of CHIP coverage after the end of pregnancy as well.
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