Knowledge Base Article

This week we highlight key updates spanning from May 4th through May 10th, 2021.

May 3, 2021: New COVID-19 Coverage Assistance Fund: Paying for COVID-19 Vaccine Administration

HHS posted a Press Release (link) announcing the new COVID-19 Coverage Assistance Fund (CAF). This program will cover the cost of administering a COVID-19 vaccine for individuals enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing.

May 4, 2021: Funding to Increase COVID-19 Vaccinations in Underserved & Rural Communities

HHS announced (link) the availability of $250 million, through the American Rescue Plan, “to develop and support a community-based workforce who will serve as trusted voices sharing information about vaccines, increase COVID-19 vaccine confidence, and address any barriers to vaccination for individuals living in vulnerable and medically underserved communities.”

In addition to underserved communities, HHS announced (link) the availability of nearly $1 billion to increase vaccination efforts in rural communities.

May 5, 2021: FDA Issues Roadmap for FDA Inspectional Oversight

The FDA has issued a new report titled “Resiliency Roadmap for FDA Inspectional Oversight” (link). This report outlines their “inspectional activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.”

At the onset of the pandemic, FDA inspections began to be reserved for what they describe as “mission-critical issues” based on the following four factors:

• Product received breakthrough therapy or regenerative medicine advanced therapy designation,
• Product is used to treat a serious disease or medical condition and there is no substitute,
• Product required follow-up due to recall, or there is evidence of serious adverse events or outbreaks of a foodborne illness, and
• Product is related to FDA’s COVID-19 response (e.g., drug shortages).

May 6, 2021: Increased Payment for COVID-19 Monoclonal Antibody Infusions & Two New HCPCS Codes

CMS announced (link) an increase in the national average payment rate, for administering monoclonal antibodies to treat COVID-19, from $310 to $450 for most health care settings. Further, “in support of providers’ efforts to prevent the spread of COVID-19, CMS will also establish a higher national payment rate of $750 when monoclonal antibodies are administered in the beneficiary’s home, including the beneficiary’s permanent residence or temporary lodging (e.g., hotel/motel, cruise ship, hostel, or homeless shelter.)” CMS has updated the COVID-19 Vaccines and Monoclonal Antibodies webpage (link) to reflect the payment updates.

Along with CMS establishing a higher national payment rate for monoclonal antibodies in the beneficiary’s home, CMS has added two new HCPCS codes for the administration of the monoclonal antibodies infusion in the home (M0244 and M0246). Note, these will be paid in the same manner as HCPCS codes, M0243 and M0245.

May 7, 2021: CDC Updates SARS-CoV-2 Mode of Transmission

The CDC had updated their Scientific Brief: SARS-CoV-2 Transmission (link). Recent updates to this brief includes:

• Updates have been made to reflect current knowledge about SARS-CoV-2 transmission,
• “Modes of SARS-CoV-2 transmission are now categorized as inhalation of virus, deposition of virus on exposed mucous membranes, and touching mucous membranes with soiled hands contaminated with virus.
• Although how we understand transmission occurs has shifted, the ways to prevent infection with this virus have not. All prevention measures that CDC recommends remain effective for these forms of transmission.”

May 10, 2021: EUA Expanded for Pfizer-BioNTech COVID-19 Vaccine

The FDA announced (link) the expansion of the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age. “The most commonly reported side effects in the adolescent clinical trial participants, which typically lasted 1-3 days, were pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain. With the exception of pain at the injection site, more adolescents reported these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.”