HHS Secretary Xavier Becerra will release an amendment to the declaration in the coming weeks.
Pharmacists can continue to enjoy the extended authorities granted by the Public Readiness and Emergency Preparedness (PREP) Act through December 2024, according to a news release published by the Department of Health and Human Services (HHS).1 The announcement comes just one month before the COVID-19 Public Health Emergency is due to expire.
“Over the past 3 years, the PREP Act declaration has provided liability protection to manufacturers, distributors, and other organizations conducting countermeasure programs and providers administering COVID-19 countermeasures,” an HHS news release explained.
In the coming weeks, HHS Secretary Xavier Becerra plans to release an amendment to the declaration, which will extend coverage for administration of COVID-19 tests and vaccines, as well as seasonal influenza vaccines, to pharmacists, pharmacy interns, and pharmacy technicians through the end of 2024. Under the amendment, these providers may continue to administer vaccines (“to those individuals 3 and over, consistent with other requirements”) regardless of any government agreements or emergency declarations.
The amendment will end the ability of pharmacists and pharmacy interns to vaccinate against COVID-19 across state lines, and will no longer extend coverage to all routine childhood vaccinations by pharmacists, pharmacy interns, and pharmacy technicians.
Additionally, the HHS press release outlined some key features that will not change under the amended PREP Act declaration, including continued liability immunity for pharmacists, pharmacy interns, and pharmacy technicians prescribing or dispensing oral antiviral COVID-19 treatments and continued coverage of the Test to Treat program.
The National Community Pharmacists Association (NCPA), the American Society of Health-System Pharmacists (ASHP), the American Pharmacists Association (APhA), and the National Association of Chain Drug Stores (NACDS) are applauding the move, which will continue to provide Americans with access to care at pharmacy locations across the country.
“Pharmacy teams and those throughout the supply chain worked hard to make the federal vaccine program a success, and succeed it has,” said NCPA CEO B. Douglas Hoey, in a news release.2 “Countless lives have been saved because of these efforts. Ensuring patients can keep accessing these and other important health care services at their local community pharmacy is critical for millions of Americans. We’re grateful to Secretary Becerra and the Biden administration for recognizing this.”
In an ASHP news release,3 vice president of government relations Tom Kraus expressed the organization’s appreciation of “HHS’s recognition of the key role the pharmacy workforce plays in protecting our nation’s public health. We look forward to continuing to work with them through the public health emergency wind down, and into the future, to empower pharmacists to better serve our patients.”
While APhA4 and NACDS5 commended the actions of HHS and the Biden administration, both organizations also called on Congress to pass H.R. 1770, the Equitable Community Access to Pharmacist Services Act (ECAPS).
“NACDS continues to urge the U.S. Congress to address another missing link: establishing the reliable Medicare payment mechanisms that are part of the necessary infrastructure for pharmacy services,” said NACDS President and CEO Steven C. Anderson. “It is critical that Congress pass and enact [H.R. 1770]—bipartisan legislation backed by nearly 200 groups representing patients, seniors, rural Americans, hospitals, health systems, pharmacists, and pharmacies.”
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
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