As part of the U.S. Food and Drug Administration’s continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products’ safety. Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.

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The 117th Congress is underway and the first legislative issue the new Congress and Administration plan to take up is additional COVID-19 relief. At this time, it is unclear what the relief package will include, or what the method for passage will be.

On Jan. 19, the U.S. Department of Human Health Services (HHS) released its Vaccines National Strategic Plan: 2021–2025 that is focused on protection across the lifespan. View the plan here.

Pfizer and Moderna currently have the market on COVID-19 vaccination, but if all goes well, that won’t be true much longer. COVID-19 has existed for barely more than a year, but 64 vaccines are in clinical development and another 173 in preclinical development worldwide, according to the World Health Organization. Dozens of hopefuls are in clinical trials in the U.S. The two inching closest to the finish line here—by Oxford-AstraZeneca and Johnson & Johnson—although behind original schedules, could win emergency use authorization from the U.S. Food and Drug Administration as soon as this spring. Unfortunately, this week Merck announced it has halted development of two potential vaccines for the coronavirus, citing data that showed a lack of immune response.

The Centers for Disease Control and Prevention (CDC) quietly changed its guidance on COVID-19 vaccinations, saying it is okay to mix use of Pfizer’s and Moderna vaccine for first and second doses in “exceptional situations” and that it’s also fine to wait up to six weeks to get the second shot of either company’s two-dose immunization. While Pfizer’s and Moderna’s vaccines, which both use messenger RNA technology, were authorized to be given 21 and 28 days apart, respectively, the CDC now says you can receive either shot so long as they are given at least 28 days apart, according to new guidance posted Thursday on its website. Read more.

The Pennsylvania Department of Human Services (DHS), Office of Medical Assistance Programs has issued a new bulletin. The purpose of this bulletin is to inform Medical Assistance (MA) providers about updates related to billing and payment for the administration of the novel coronavirus (SARSCoV-2) vaccines, effective Dec. 1, 2020. MAB 01-20-59 advised providers that the administration fee for first and second doses was $10.00. The new administration fee, going back to Dec. 1, 2020, is now $16.94 for the first dose and $28.39 for the second dose. The new fees are based on what Medicare is paying for first and second dose administration and publication of the bulletin indicates DHS received approval from the Centers for Medicare and Medicaid Services (CMS) to pay at Medicare rates. DHS will also pay FQHCs/RHCs for COVID-19 vaccination not affiliated with an FQHC/RHC encounter at Medicare rates, but has not yet published the MA Bulletin affirming this.

The Biden Administration sent a letter to the nation’s Governors signaling its intent to renew the COVID-19 Public Health Emergency (PHE) throughout 2021. Further, the letter indicates that the U.S. Department of Health and Human Services will provide states with 60 days’ notice prior to terminating the PHE or allowing it to expire. Statute requires the PHE to be renewed every 90 days.

By Eyal Kedar
“The message of this essay is simple. It is a call for awareness and for larger and more concerted action. It is a call to eliminate a longstanding double standard in American medicine.”
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The Centers for Disease Control and Prevention (CDC) provides information about local health departments, along with questions and answers for health care workers and consumers about the COVID-19 vaccination.

This tool from CMS is a resource to assist states and territories in their planning efforts to restore regular Medicaid and Children’s Health Insurance Program (CHIP) operations after the COVID-19 public health emergency (PHE).