Knowledge Base Article

This week we highlight key updates spanning from February 16th through February 22nd, 2021.

Resource Spotlight: CMS Memorandum – Hospital Survey Priorities Revised

On February 18, 2021, CMS published a revised version of a January 20, 2021 Memorandum regarding Hospital Survey Priorities. This memorandum clarifies expectations of State Survey Agencies and Accrediting Organizations as “CMS is committed to taking critical steps to protect vulnerable individuals to ensure America’s health care facilities are prepared to respond to the Coronavirus Disease 2019 (COVID-19) Public Health Emergency PHE.” Specifically, CMS is extending the hospital survey limitations for an additional 30 days from the date of the revised memo (March 22, 2021).

February 16, 2021: Moderna Press Release – U.S. COVID-19 Vaccine Supply Update

Moderna, Inc.’s press release opened with the following numbers:

• 4 million – the number of doses the company has supplied to the U.S. Government to date,
• 5 million – the number of doses that have been administered in the U.S. as communicated by the CDC,
• 2 million – The number of additional doses that have been produced and are filled in vials and in the final stages of final production and testing before release,
• 100 million – the number of doses the company expected to deliver to the U.S. Government by the end of March 2021, and
• 100 million – the number of additional doses the company expects to deliver by the end of May 2021 followed by another 100 million by the end of July 2021.

The Press Release goes on to provide information about the Moderna COVID-19 vaccine and important safety information.

February 17, 2021: Actions to Expand COVID-19 Testing

HHS announced new actions to expand COVID-19 testing capacity nationwide. They go on to note in the Press Release that “these actions will improve the availability of tests, including for schools and underserved populations; increase domestic manufacturing of tests and testing supplies; and better prepare the nation for the threat of variants by rapidly increasing virus genome sequencing.” Three specific actions outlined includes:

• Expansion of COVID-19 testing for schools and underserved populations,
• Increase domestic manufacturing of testing supplies and materials to address testing shortages, and
• Having the CDC “rapidly increase genomic sequencing of the virus to better prepare for the treat of variants and slow the spread of the disease.”

February 18, 2021: CMS MLN Connects News – Further Steps to Provide Wide Access to COVID-19 Antibody Treatment

As reported in last week’s article, the FDA issued an emergency use authorization (EUA) for bamlanivimab and etesevimab being administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients at risk for progressing to severe COVID-19. Later in the week, CMS published the following information regarding this EUA in the February 18, 2021 edition of MLN Connects:

“The U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) for the investigational monoclonal antibody therapy, bamlanivimab and etesevimab, administered together, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive COVID-19 test results who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab, administered together, may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the Emergency Medical System (EMS), as necessary. Review the Fact Sheet for Health Care Providers EUA of Bamlanivimab and Etesevimab regarding the limitations of authorized use when administered together.

During the COVID-19 Public Health Emergency (PHE), Medicare will cover and pay for these infusions the same way it covers and pays for COVID-19 vaccines (when furnished consistent with the EUA).

CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment: Eli Lilly and Company’s Antibody Bamlanivimab and Etesevimab, (ZIP) EUA effective February 9, 2021:

Q0245:

• Long descriptor: Injection, bamlanivimab and etesevimab, 2100 mg
• Short descriptor: bamlanivimab and etesevima

M0245:

• Long Descriptor: intravenous infusion, bamlanivimab and etesevimab, includes infusion and post administration monitoring
• Short Descriptor: bamlan and etesev infusion”

February 18, 2021 FDA Bulletin: COVID-19 Transmission is not through Food or Food Packaging

In a Bulletin attributed to Acting USDA Secretary Kevin Shea and Acting FDA Commissioner Janet Woodcock, M.D., the authors indicate that “considering the more than 100 million cases of COVID-19, we have not seen epidemiological evidence of food or food packaging as the source of SARS-CoV-2 transmission to humans. Furthermore, transmission has not been attributed to food products or packaging through national and international surveillance systems. Food business operations continue to produce a steady supply of safe food following current Good Manufacturing Practices and preventive controls, focusing on good hygiene practices and keeping workers safe.”

February 19, 2021: CDC Morbidity and Mortality Weekly Report (MMWR): COVID-19 Vaccine Safety Monitoring

This CDC MMWR provides insight into the first month (December 14, 2020 – January 13, 2021) of COVID-19 vaccine safety monitoring in the United States. 13.8 million Doses of the Pfizer-BioNTech and Moderna COVID-19 vaccines were administered to the U.S. population in this first month. The most frequently reported symptoms by those vaccinated includes headache, fatigue, dizziness, chills and nausea. The authors of this article (Gee J, Marquez P, Su J, et al.) note in their summary that “monitoring, conducted as part of the U.S. vaccination program, indicates reassuring safety profiles for COVID-19 vaccines. Local and systemic reactions were common; rare reports of anaphylaxis were received. No unusual or unexpected reporting patterns were detected.”

CDC COVID Data Tracker – United States COVID-19 Cases