The National Institutes of Health launches the Home Test to Treat program; FDA and CDC report a COVID-19 vaccine safety concern for those ages 65 and older.

FDA and CDC say Evusheld is unlikely to neutralize the XBB.1.5 subvariant, and a CDC report indicates COVID-19 vaccination in children and adolescents is highest among Asian and Hispanic youth. 

FDA approves the use of Actemra, a monoclonal antibody treatment, as COVID-19 cases caused by the XBB.1.5 subvariant of SARS-CoV-2 spike.

Americans again can request four no-cost, at-home COVID-⁠19 tests per address; FDA's vaccine committee will meet in January to develop a long-term strategy.

CDC expands its recommendation for bivalent COVID-19 vaccines for children ages 6 months to 5 years old as health agencies confront low vaccination rates among children.

FDA pauses its emergency use authorization of bebtelovimab, which does not protect against prevalent SARS-CoV-2 subvariants; CDC updates its guidance for managing COVID-19 in congregate living settings to align with previous guidance.

New COVID-19 vaccine initiatives seek to address access inequalities, and NIH launches a website where Americans can self-report COVID-19 test results anonymously to provide data to public health departments.

Pfizer-BioNTech and Moderna data indicate that bivalent vaccines provide greater protection than the original monovalent vaccine against the emerging BQ.1.1 omicron subvariant, while the CDC reports low COVID-19 vaccination numbers among children.

The agency shared three sample formats to help hospital staff build machine readable files to comply with the Hospital Price Transparency Rule.

A JAMA Network open study highlights disparities in access to Test-to-Treat sites; the Biden administration holds a White House COVID-19 Equity Summit.

The CMS Innovation Center shares a progress report on its 10-year strategy and a blog post announcing plans to improve integrated specialty care.

A new report from the Department of Veterans Affairs indicates that Paxlovid can reduce risk of long COVID-19; new data show Pfizer bivalent COVID-19 booster vaccines substantially increase immune responses compared with monovalent vaccines.

The rule finalizes the conversion factor and includes reimbursement provisions for telehealth and behavioral health services, the Quality Payment Program, and the Medicare Shared Savings Program.

President Joe Biden urges Americans to get their updated COVID-19 vaccine, which protects against the original SARS-CoV-2 variant and BA.4 and BA.5 subvariants.

A CDC committee recommends the inclusion of COVID-19 vaccines in the 2023 immunization schedule; the administration releases a biodefense strategy.

CDC recommends for younger age groups updated Pfizer and Moderna COVID-19 booster vaccines that target the BA.4 and BA.5 subvariants of SARS-CoV-2.

CMS extends for two years the Bundled Payments for Care Improvement Advanced Model and alters the accounting process for beneficiaries with COVID-19.

Effective Oct. 13, Health and Human Services Secretary Xavier Becerra renewed the COVID-19 public health emergency determination.

HHS links COVID-19 vaccinations to fewer COVID-19 hospitalizations and deaths, and NIH details its plan to study long COVID-19 effects.

CDC issued a health advisory reminding health care providers to remain aware of a patient’s international travel history.

FDA now urges COVID-19 test developers to take traditional premarket review pathways, and HHS will cover the cost of 60,000 bebtelovimab doses.

CDC reports lower in-hospital mortality rates from the omicron variant, providers have until Sept. 30 to report period 3 Provider Relief Fund spending.

America's Essential Hospitals urges CMS to swiftly restore full Medicare Part B drug payment rates for hospitals in the 340B Drug Pricing Program and define a select group of hospitals with a safety net mission.

The Biden administration's fall plan to manage the COVID-19 pandemic includes securing millions of updated vaccines and additional at-home, rapid tests; ensuring vaccine access for higher-risk Americans; and fostering community conversations about updated vaccines.

The agency requests information on health care access and equity, provider experiences, and the effect of policies introduced in response to COVID-19.