COVID-19 Updates and Developments
- January 08, 2021
Department of Health and Human Services (HHS)
January 6—States, territories, and local governments will receive more than $22 billion in funding to expand testing and vaccination distribution for COVID-19, HHS announced. The funding will be provided before January 19, HHS said. More than $19 million is allocated to support testing and contract tracing to mitigate the spread of COVID-19, while over $3 billion is being distributed to aid in vaccination-related activities.
December 23—The federal government will pay Merck roughly $356 million to support development and manufacturing of the company’s investigational therapeutic MK-7110, which helps moderate the immune response in hospitalized patients with severe or critical COVID-19, HHS announced. Interim analysis of an ongoing Phase 3 clinical trial in September 2020 indicated that patients receiving a single dose of MK-7110 had a 60% greater chance of recovery than those receiving a placebo. Under the agreement, Merck will deliver up to 100,000 doses of the therapeutic by June 30 if it receives an Emergency Use Authorization (EUA)
December 23—The federal government is purchasing 100 million additional doses of Pfizer Inc. and BioNTech’s COVID-19 vaccine, which the Food and Drug Administration authorized for emergency use on December 11, 2020, the agency said. The agreement doubles the number of doses the government has purchased of the vaccine. The agreement requires Pfizer to deliver at least 70 million doses to government-designated locations by June 30, with the balance due no later than the end of July, according to a press release.
Office for Civil Rights (OCR)
December 18—OCR issued guidance on when the Health Insurance Portability and Accountability Act allows covered entities and their business associates to disclose protected health information (PHI) to health information exchanges (HIEs) for reporting to a public health authority (PHA) conducting public health activities. The guidance indicates disclosures are permissible without individual authorizations when the disclosure is required by law; when an HIE is a business associate of the covered entity (or of another business associate) that wishes to provide PHI to a PHA for public health purposes; and when an HIE is acting under a grant of authority or contract with a PHA for a public health activity. The guidance also notes that a covered entity can rely on a PHA’s request to disclose a summary record to a PHA or HIE as being the minimum necessary PHI needed to accomplish the public health purpose of the disclosure. In addition, a covered entity doesn’t need a direct request from a PHA to disclose PHI to a PHA through an HIE.
Other Developments
January 7—The American Hospital Association (AHA) called on HHS to take steps to speed up the administration of COVID-19 vaccines. In a January 7 letter to HHS Secretary Alex Azar, the group said initial excitement about the availability of a vaccine has now turned to concern about the slow pace of the vaccine roll out. The letter outlines several “barriers” that hospitals have witnessed first-hand as they work to administer the vaccine, including a lack of transparency about the administration's goals and expectations and how to achieve them. The letter also called for ongoing support at the federal level to guide vaccination efforts, including tracking progress toward vaccination goals at the state and local level and sharing effective approaches and lessons learned.