FDA approves Moderna and Pfizer-BioNTech's updated COVID-19 vaccines, and HHS announces $1.4 billion for Project NextGen.

HHS announced the formation of the Office of Long COVID Research and Practice to lead the long COVID response as EG.5 subvariant cases increase.

The rule includes changes to the calculation of Medicare disproportionate share hospital payments and payment and quality reporting provisions.

The CDC Bridge Access Program will provide no-cost COVID-19 vaccines to uninsured and underinsured adults following the end of the COVID-19 Vaccine Distribution Program; the GAO released a new report outlining recommendations for future public health emergency preparedness.

CDC reports that roughly three-fourths of all Americans aged 16 and older had contracted COVID-19 by the end of 2022; the agency also reports new data showing the disproportionate effect of COVID-19 on the lowest-income communities.

Starting Oct. 1, Medicaid and the Children’s Health Insurance Program will cover only COVID-19 vaccines that have been fully approved by the Food and Drug and Administration.

Moderna seeks FDA authorization for an updated vaccine, Invivyd announces a pathway to potential emergency use authorization for the monoclonal antibody adintrevimab, and the CDC tracks a new subvariant, EU.1.1.

The FDA's Vaccines and Related Biological Products Advisory Committee advises manufacturers to develop a monovalent vaccine targeting XBB, the globally dominant subvariant, in time for the fall.

HHS offers flexible options states can adopt to ensure smooth transitions of coverage during the Medicaid redetermination process.

A CDC study confirms that a third mRNA vaccine is safe for children; FDA grants marketing authorization for the Cue at-home COVID-19 test.

Two CDC studies indicate that adults who have not received a bivalent mRNA booster vaccine have little remaining protection against COVID-19–associated hospitalization and that half of Americans aged 16 and up have hybrid immunity against the virus.

CMS says the withdrawal of the mandate, effective immediately, aligns with the agency's approach to other infectious diseases.

The Food and Drug Administration approves Paxlovid to treat COVID-19 in adults; a National Institutes of Health study sheds new light on long COVID-19.

A World Health Organization advisory group recommends using the XBB subvariant in future vaccines; the National Institute for Occupational Safety and Health recalls eight respirators.

An HHS fact sheet details policy changes with the end of the COVID-19 public health emergency; ASPR announces Project NextGen; CDC says the Johnson & Johnson vaccine no longer is available in the United States.

The letter expressed concern with reports that HRSA no longer will allow hospitals to administer 340B drugs in offsite outpatient locations that have not yet appeared on a filed Medicare cost report.

Health care providers will be able to prescribe controlled medication without requiring an initial in-person visit through Nov. 11.

America's Essential Hospitals calls on Senate leaders to reject a House proposal to impose work requirements for Medicaid as part of negotiations to raise the nation's debt limit, saying the plan would jeopardize access to care and harm communities.

The World Health Organization has ended the COVID-19 global health emergency designation, and the CDC will use hospitalization data to track COVID-19 spread.

After receiving record comments on proposals to limit the prescription of controlled substances via telemedicine, the DEA will extend this COVID-era flexibility.

FDA amends the Pfizer vaccine authorization for immunocompromised children aged 6 months to 4 years old, while the Biden administration ends its vaccine requirement for federal employees.

The May 5 webinar will feature CMS experts sharing how the end of the PHE will affect current health care waivers and flexible policies.

House panels last week heard testimony on a variety of issues important to essential hospitals, including looming cuts to Medicaid disproportionate share hospital funding, workforce shortages and training, and the 340B Drug Pricing Program.

CDC simplifies vaccine recommendations for all age groups; a new HHS program supports COVID-19 vaccines and treatments for uninsured Americans.

The proposal includes numerous policy and payment changes to Medicare’s Inpatient Prospective Payment System for fiscal year 2024, including a 2.8 percent increase in inpatient payment rates.

Individuals ages 65 and older are eligible for a second bivalent dose; HHS will end vaccine administration flexibility granted during the public health emergency.

President Biden signs a bill ending the COVID-19 national emergency; FDA grants emergency use authorization to a vilobelimab treatment.

Both the CDC and World Health Organization now recommend just one bivalent booster dose for healthy adults and children with no immunocompromising conditions.

The upcoming end of the COVID-19 national emergency will not affect policies enacted during the public health emergency issued under a separate declaration.

FDA releases guidance on transitioning to normal operations for medical device authorization after the public health emergency ends and continues to monitor the effect of viral mutation on test performance.

FDA announces that children aged 6 months through 4 years old who completed primary monovalent COVID-19 vaccination are now eligible to receive a bivalent booster dose, while agency advisers vote in favor of full Paxlovid approval.

The report reviews how COVID-19 public health emergency policies affected hospital finances and includes state-specific projections for the Medicaid disproportionate share hospital funding cuts scheduled to take effect Oct. 1.

FDA announced March 10 that it will withdraw and revise several COVID-19 guidance documents, including emergency use authorization of surgical masks, as circumstances surrounding the virus evolve.

America's Essential Hospitals and other groups, in a letter to congressional leaders, urge lawmakers to avert an $8 billion cut Oct. 1 to Medicaid disproportionate share hospital funding. President Biden's proposed budget includes measures to protect Medicare.

A bivalent vaccine that protects against SARS-CoV-2 and influenza will not be available this year, while a CDC advisory committee says there is not enough evidence to recommend more than one annual COVID-19 booster for immunocompromised people.

Key health committees in the House and Senate issue requests for information — one on reauthorizing the Pandemic and All Hazards Preparedness Act and another to examine health care workforce shortages.

Two proposed rules would extend many flexible provisions enacted during the COVID-19 public health emergency for prescribing controlled substances.

States may start initiating Medicaid renewals between February and April and terminating enrollment for individuals who no longer qualify as early as April 1.

FDA authorizes the first at-home nasal test that detects influenza A and B as well as COVID-19; Moderna reaches a $400 million agreement with the National Institutes of Health.

National Institutes of Health research finds that Black and Hispanic Americans face greater long COVID-19 risks, the CDC says that primary series vaccination protects children ages 3–5 for four months, and Novavax will deliver an additional 1.5 million doses.

The CDC updated the 2023 immunization schedule for children and adolescents to include the COVID-19 primary vaccine series, and the FDA cleared for commercial distribution a device that detects 15 respiratory viral and bacterial infections.

The roadmap outlines which policies implemented under the COVID-19 public health emergency (PHE) will be affected when the PHE ends May 11.

The president vowed to veto attempts to roll back Inflation Reduction Act measures to reduce prescription drug prices. He also voiced his plan to make permanent pandemic-related increases to Affordable Care Act premium subsidies.

FDA no longer requires a positive COVID-19 test to receive a Paxlovid or Lagevrio prescription; CDC reports that bivalent boosters protect against XBB and XBB.1.5 SARS-Co-V-2 subvariants.

The updated fact sheets share when specific waivers will end and whether they will continue after the public health emergency's end on May 11.

The guidance informs states how to maintain the temporary increased federal medical assistance percentage while returning to normal Medicaid operations.

The Biden administration announced that the COVID-19 public health emergency, initially declared Jan. 27, 2020, will end May 11.

FDA's Vaccines and Related Biological Products Advisory Committee votes to replace the original monovalent COVID-19 vaccine, Evusheld no longer is authorized under emergency use, and the CDC launches a COVID-19 testing locator.

An FDA committee will vote on the future of the COVID-19 vaccine, while CDC unveils two trackers for COVID-19, flu, and RSV–related hospital and emergency department visits.

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.

Effective Jan. 11, Health and Human Services Secretary Xavier Becerra renewed the COVID-19 public health emergency determination.

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. 

After the omnibus bill decoupled Medicaid redeterminations from the end of the COVID-19 public health emergency, CMS updates key redetermination dates.

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.

The $1.66 trillion package would extend funding for government operations through Sept. 30, 2023, including $120.7 billion for the Department of Health and Human Services, $9.9 billion more than the FY 2022 enacted level, and numerous provisions important to essential hospitals.

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.

Hospitals that fill a safety net role need targeted funding to remain on the front lines of public health emergencies and serve the nation’s most underrepresented patients and marginalized communities.

As Congress continues to consider legislation during and after the pandemic, it should make permanent policies that allow providers to expand access to care, including telehealth and hospital-at-home, to improve the health of their communities.

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.

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 final rule reverses Medicare Part B drug payment cuts to hospitals in the 340B Drug Pricing Program, continues site-neutral payment policies, and revises the inpatient-only list, among other proposed changes.

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.

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.

The Biden administration extended the COVID-19 public health emergency (PHE) through Jan. 11, 2023, and would notify providers by Nov. 11 of ending the PHE after that date. The decision extends PHE-related waivers and policies.

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.

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 updates guidance on infection control for health care personnel and staff shortages, as well as its global pandemic response strategy.

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.

Lawmakers are working to balance Democrats' calls for more COVID-19 and Monkeypox funding under a continuing resolution with Republicans' demands for a "clean" bill to fund the government through the November midterm elections.

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

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

The Biden administration requests an additional $47 billion in emergency funding in the continuing resolution, including $22.4 billion to fight COVID-19; Congress must reauthorize the FDA user fee program by Sept. 30.

No-cost, at-home COVID-19 tests no longer will be offered through the United States Postal Service, CDC releases a fall vaccination plan, and FDA warns prescribers about Paxlovid drug interactions.

Pfizer applies for emergency use authorization for its omicron-specific booster vaccine, the National Healthcare Safety Network will take over hospital data reporting, and CMS tells hospitals to brace for the public health emergency's end.

Lawmakers return to their states and districts for August recess following last week's passage of the Inflation Reduction Act. The bill includes provisions of note for essential hospitals, including those to extend Affordable Care Act subsidies and fight climate change.

CDC updated its COVID-19 safety guidelines, FDA warned of false negative test risks, and bebtelovimab will transition to the commercial marketplace.

HHS releases two new reports on long COVID-19 research and support, while the Administration for Strategic Preparedness & Response shares guidance on Paxlovid efficacy and eligibility.

The bill, which passed by a 51-50 margin, would extend Affordable Care Act subsidies through 2025, allow Medicare to negotiate drug prices, invest in measures to mitigate climate change, and make other changes of interest to essential hospitals.

The $433 billion Inflation Reduction Act would allow Medicare to negotiate prescription drug prices and would extend expanded Affordable Care Act subsidies for three years. It also includes tax provisions and new investments related to energy and climate change.

HHS agreed to purchase 66 million Moderna bivalent COVID-19 vaccine doses, while the CDC reported fewer vaccine reactions for those older than 50 who receive a second mRNA booster shot.

Work continues on a bill to advance through the reconciliation process by a Sept. 30 deadline. America's Essential Hospitals is pressing lawmakers to include more support for essential hospitals in the final package.

CDC recommends the Novavax COVID-19 vaccine for adults and reports that additional mRNA COVID-19 vaccine booster doses increase protection against moderate and severe COVID-19.

FDA approves the Novavax COVID-19 vaccine for those 18 and older as the Biden-Harris administration releases an action plan to take on the BA.5 subvariant.

Sen. Joe Manchin (D-W.Va.) again halts Build Back Better human infrastructure package negotiations; House lawmakers will vote on a FY 2023 appropriations minibus.

Effective July 15, Health and Human Services Secretary Xavier Becerra renewed the COVID-19 public health emergency determination.

Senate Democrats work to pass a revived human infrastructure bill before the end of the fiscal year, Sept. 30. The updated legislative language includes a Medicare prescription drug pricing proposal approved by all 50 Senate Democrats.

FDA approves the Pfizer COVID-19 vaccine for use in individuals ages 12 to 15 and authorizes state-licensed pharmacists to prescribe Paxlovid.

Certain providers who returned Provider Relief Fund payments because they were unable to meet the period 1 reporting deadline can apply for reissuance of these funds.

FDA advises vaccine manufacturers to incorporate an omicron variant component into booster doses; Pfizer requests FDA approval of antiviral pill Paxlovid.

CDC recommends the Moderna vaccine for kids ages 6 to 17; an FDA committee will consider modifying COVID-19 vaccine composition to reflect virus mutations.

CDC recommends that children ages 6 months to 5 years receive a COVID-19 vaccine; Pfizer study data shows Paxlovid failed to alleviate COVID-19 symptoms.

America's Essential Hospitals commented on several policy proposals of interest to essential hospitals and responded to requests for information on maternal health, equity, and climate change.

The tool compiles existing guidance to help states prepare to return to regular Medicaid operations after the COVID-19 public health emergency ends.

CDC no longer requires a negative COVID-19 test or proof of COVID-19 recovery from travelers to the United States; an FDA advisory committee recommends the Novavax vaccine.

An FDA advisory committee deliberates the safety of Novavax's COVID-19 vaccine and will consider amendments to Pfizer's and Moderna's authorization requests later this month.

FDA extended the shelf life of select lots of bebtelovimab and updated the authorization for Evusheld to include information about hypersensitivity risks.

A new CMS resource highlights federal requirements for program renewals, verifications, applications, and oversight amid the anticipated COVID-19 public health emergency unwinding.

Congress last week passed aid for the Ukraine war effort but remains stalled on a $10 billion COVID-19 funding bill. A group of three House caucuses of Black, Hispanic, and Asian Pacific American lawmakers have introduced health equity legislation.

Pfizer and BioNTech release promising data on a three-dose COVID-19 vaccine for children six months to younger than 5; CDC expands booster shot eligibility to include everyone 5 years old and older.

HHS urges governors to start planning for the end of the COVID-19 public health emergency; FDA authorizes a Pfizer booster vaccine for children ages 5 to 11.

House and Senate lawmakers work to finalize a roughly $40 billion aid package for Ukraine but remain stalled on consideration of a COVID-19 aid package; a House panel considers two bills to reauthorize various federal health programs.

FDA limits authorized use of the Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome following vaccination; a new analysis estimates vaccines are associated with $2.6 million in savings due to a reduction in Medicare hospitalizations.

A new omicron subvariant, BA.2.12.1, constitutes more than 30 percent of U.S. genomic sequences; Moderna files for emergency use authorization for a vaccine for children younger than 6.

House and Senate lawmakers returned this week to Washington, D.C., and a full agenda, which could include renewed consideration of a $10 billion COVID-19 funding bill and work on a budget reconciliation measure.

Moderna releases promising preliminary data on its variant-specific COVID-19 booster shot; CDC launches a Center for Forecasting and Outbreak Analytics.

A federal judge in Florida ruled against the Centers for Disease Control and Prevention (CDC) travel mask requirement, ending the Transportation Security Administration's enforcement of the mandate. But the CDC continues to recommend masking during traveling.

The ability to provide hospital-level care at home has been essential to managing case surges during the COVID-19 pandemic and can improve access and equity outside of a public health crisis.

Effective April 16, Health and Human Services Secretary Xavier Becerra renewed the public health emergency determination related to the continued effects of COVID-19; the determination has been in place since Jan. 27, 2020, and has been renewed every three months.

President Joe Biden announces a national research plan on prolonged illness developed after COVID-19; FDA limits authorization of sotrovimab to treat COVID-19.

Congress began a two-week recess without passing a bipartisan, $10 billion COVID-19 relief bill. Negotiations on the bill were derailed by immigration policy changes recently announced by the White House.

CMS shares tools to mitigate an anticipated increase in Medicaid fair hearing requests and resume normal operations after the COVID-19 public health emergency ends.

Party leaders in the Senate announced a compromise package that would fund $10 billion in COVID-19 relief for therapeutics, vaccines, and pandemic prevention. Meanwhile, a House panel continues work on legislation to aid small businesses.

CDC recommends an additional COVID-19 booster for older and immunocompromised adults; COVID.gov aggregates COVID-19 prevention and treatment tools; CDC data show threats to youth mental health during the pandemic.

Congressional panels will review President Joe Biden's fiscal year 2023 budget request. Sens. Robert Casey Jr. (D-Pa.) and Ron Wyden (D-Ore.) have asked the Government Accountability Office to investigate low vaccination rates among Medicaid beneficiaries.

FDA authorizes a second vaccine booster for older and immunocompromised individuals; OSHA reopens the comment period for its emergency temporary standard.

Research shows mRNA vaccines effectively prevent ventilation and death from COVID-19; Pfizer and Moderna seek authorization for an additional booster dose.

Hopes are slim for additional COVID-19 relief this week, with the House out of session and the Senate focused on a Supreme Court confirmation. Meanwhile, bipartisan legislation would extend the Acute Hospital Care at Home waiver program for two years past the end of the public health emergency. 

Citing a depletion of funds for the HRSA COVID-19 Uninsured Program, the agency says the last day for providers to submit claims for testing and treatment is March 22 and the last day to submit vaccine administration claims is April 5.

President Joe Biden signed a $1.5 trillion fiscal year 2022 spending package; he already signed a four-day continuing resolution to provide time for the omnibus spending measure to move forward. 

Although cases are declining nationwide, safety net hospitals have not recuperated from the effects of the pandemic on their finances and still need additional resources.

The Transportation Security Administration extends to April 18 its public transit mask mandate; HHS shares a fact sheet on the COVID-19 Test-to-Treat initiative.

Ensuring a reliable safety net, one ready to meet the moment in any crisis, means robustly protecting and bolstering the mechanisms and ideals that make the safety net function.

The House-passed bill does not allocate additional COVID-19 relief for providers on the front lines of the pandemic. An initial version of the legislation included $15.6 billion in COVID-19 related spending — a scaled-back version of the $22.5 billion requested by the Biden administration.

A State Health Official letter includes guidance for states to prepare for the COVID-19 public health emergency unwinding and return to regular Medicaid program operations.

President Joe Biden unveils a new COVID-19 National Preparedness Plan; FEMA extends its 100 percent federal cost share for COVID-19 efforts.

Congress continues work on a roughly $1.5 trillion omnibus spending bill to fund the government past March 11, but outstanding issues might force lawmakers to pass another short-term funding extension to buy additional time to reach a deal.

Coupled with the $11 billion previously distributed, this brings total phase 4 payments to about $11.5 billion, leaving less than $6 billion in pledged funds. These new funds will reach more than 4,000 providers across the United States this week.

The association seeks hospital feedback on unintended cuts to disproportionate share hospital payments that resulted from Section 203 of the Consolidated Appropriations Act of 2021. President Joe Biden nominated Judge Ketanji Brown Jackson as the 116th associate justice of the Supreme Court.

CDC announces a new community-level framework that assesses COVID-19 risk; the Biden administration unveils a new COVID-19 mitigation plan for people with disabilities.

National emergency extended; new study highlights conditions and symptoms developed after COVID-19 infection; CDC updates vaccine guidance with clarifications for immunocompromised people.

President Joe Biden signed a continuing resolution to keep the government funded through March 11; Biden invited all members of Congress to attend the annual State of the Union address on March 1.

The Senate voted 50–46 to confirm Robert Califf, MD, as commissioner of the Food and Drug Administration (FDA); The FDA has not had a confirmed commissioner for more than a year. Senators continue work to pass a short-term continuing resolution to fund the government past Feb. 18.

Authorization for the Pfizer COVID-19 vaccine for children six months to four years old is delayed; FDA authorizes the monoclonal antibody bebtelovimab.

A short-term continuing resolution would maintain government funding through March 11, giving lawmakers more time to agree on a final funding bill; the measure is expected to clear both chambers. Activity on the Build Back Better Act pauses as Sen. Ben Ray Lujan (D-N.M.) recovers from a stroke.

Pfizer and BioNTech apply for emergency use authorization for their pediatric COVID-19 vaccine; CDC recommends the Moderna COVID-19 vaccine; Medicare will cover over-the-counter COVID-19 tests.

FDA approves the Moderna COVID-19 vaccine and limits a monoclonal antibody authorization; OSHA withdraws its vaccine mandate emergency temporary standard.

A bipartisan group of senators released draft legislation to improve the nation's capacity to respond to future public health crises. Supreme Court Justice Stephen Breyer announces his intent to retire. The Senate Committee on Budget considers the nomination of Shalanda Young as director of OMB.

The funds will reach more than 7,600 providers across the country this week; $6 billion in pledged phase 4 funds remain undistributed.

In separate bipartisan letters, lawmakers called on the Biden administration to help mitigate dire hospital workforce shortages, particularly among nurses, and protect the 340B Drug Pricing Program from harmful drug manufacturer actions.

The Biden administration will distribute 400 million no-cost N95 masks; CDC studies highlight the importance of boosters in protecting against COVID-19.

The U.S. Supreme Court upheld CMS' vaccine mandate but struck down the Occupational Safety and Health Administration's mandate; President Joe Biden announced new initiatives to expand testing access.

The nomination of Robert Califf, MD, as commissioner of the Food and Drug Administration advances to the Senate floor. The Republican-led Healthy Futures Task Force issues several requests for information on telehealth policies and health care affordability.

Effective Jan. 14, Health and Human Services Secretary Xavier Becerra renewed the public health emergency determination related to the continued effects of COVID-19; the determination has been in place since Jan. 27, 2020, and has been renewed every three months.

CDC shortens the time between primary vaccine series and booster shot and recommends a Pfizer booster for adolescents; the Supreme Court hears oral arguments on two vaccine mandates; HHS requires coverage of at-home COVID-19 tests, effective Jan. 15.

House lawmakers noted upcoming federal funding legislation could be an opportunity for additional COVID-19 relief. A Senate committee examines COVID-19 variants and the federal response. Both chambers released draft schedules for their 2022 work.

The guidance results in a net reduction of about 30 percent of data fields; it adds questions on pediatric data, as well as makes mandatory certain influenza fields. The HHS guidance does not satisfy the requirements of a CMS quality measure on health care personnel vaccination rates.

FDA expands authorization for the Pfizer COVID-19 booster; FDA authorizes two antiviral pills; CMS updates guidance on vaccine mandate compliance.

Congress is focused on passing the fiscal year 2022 appropriations bill before government funding expires Feb. 18. As 2021 came to a close, Sen. Joe Manchin (D-W.Va.) announced he would not support the Build Back Better Act as currently drafted, stalling the legislation.

In the new rule, the agency finalizes proposals on direct and indirect graduate medical education (GME) policies in response to the COVID-19 pandemic and solicits comments on other GME issues to inform future policymaking.

The association asked that CMS provide additional time for hospitals to comply with the requirements, especially given the uncertain outcome of pending litigation regarding the administration's vaccine mandate.

CDC recommends mRNA COVID-19 vaccines be given clinical preference over the Janssen vaccine; the CMS vaccine mandate rule is revived in 25 states.

Providers now have until Dec. 20 to report lost revenue and expense information related to the receipt of Provider Relief Fund payments.

FDA authorizes the Pfizer COVID-19 vaccine booster for individuals as young as 16; the agency also authorizes a monoclonal antibody for COVID-19 prevention.

As the omicron SARS-CoV-2 variant reaches the United States, President Joe Biden releases a new plan to combat COVID-19; CMS will not enforce its health care worker vaccine mandate amid legal challenges.

CMS released guidance to help states maintain Medicaid and Children's Health Insurance Program coverage as they return to normal operations when the COVID-19 public health emergency ends. Many strategies in the documents require support from outside organizations that work with beneficiaries.

The World Health Organization Nov. 26 classified a new COVID-19 variant, B.1.1.529, referred to as omicron. The variant was first reported in South Africa. To date, no cases have been identified in the United States.

FDA and CDC endorse expanded eligibility for Pfizer and Moderna COVID-19 booster vaccine doses; Pfizer seeks authorization for its COVID-19 antiviral pill.

Final rules for Medicare’s OPPS and PFS for CY 2022 continue Medicare Part B drug payment cuts to hospitals in the 340B Drug Pricing Program; continue site-neutral payment policies; and halt elimination of the inpatient-only (IPO) list.

CMS recently announced vaccination requirements for providers as a condition of participating in Medicare and Medicaid. Simultaneously, the Department of Labor’s Occupational Safety and Health Administration released an emergency temporary standard for employers with at least 100 employees.

The Presidential Health Equity Task Force released recommendations for equitable disbursement of COVID-19 relief funds and culturally aligned communication to people of color and other underserved populations. Meanwhile, the White House announced $785 million in new investments to improve on equity.

Pfizer and BioNTech ask the FDA to authorize their COVID-19 booster vaccine for everyone age 18 and older; FEMA COVID-19 funding will continue until April 2022.

CDC recommends the Pfizer COVID-19 vaccine for children ages 5 to 11; CMS holds a stakeholder call on its vaccine mandate for health care workers. Pfizer says its investigational novel COVID-19 oral antiviral candidate significantly reduces hospitalization and death.

CMS announced phased vaccination requirements as a condition of participating in Medicare and Medicaid; vaccination must be completed by Jan. 4, 2022. A new Occupational Safety and Health Administration emergency temporary standard promotes vaccination for businesses with 100 or more employees.

FDA authorizes the Pfizer COVID-19 vaccine for use in children ages 5 to 11 and delays approval of the Moderna vaccine in adolescents ages 12 to 17. The agency recommends providers avoid purchasing or using imported medical gloves from certain companies that might be in violation of laws and rules.

FDA and CDC recommend Moderna and Janssen booster vaccines, along with heterologous booster doses; the Biden administration releases a plan to vaccinate children.

CMS will require states to cover COVID-19 treatment with no cost-sharing for Medicaid and Children's Health Insurance Program beneficiaries. Further, states in some circumstances must cover treatments for conditions that might seriously complicate the treatment of COVID-19.

The Vaccines and Related Biological Products Advisory Committee endorses booster shots of the Moderna and Janssen COVID-19 vaccines. Meanwhile, FDA delays authorization of the Moderna COVID-19 vaccine for emergency use in adolescents ages 12 to 17 after reports of cardiac side effects.

Effective Oct. 18, Health and Human Services Secretary Xavier Becerra renewed the public health emergency (PHE) determination related to the continued effects of COVID-19. The PHE determination has been in place since Jan. 31, 2020.

A new analysis finds annual clinical labor costs in the emergency department and intensive care unit and among nursing staff increased by $24 billion due to the COVID-19 pandemic, translating to about $17 million in additional expenses for the average 500-bed facility.

An HHS report shows the COVID-19 vaccine prevented hospitalization and death in Medicare beneficiaries; Pfizer applies for emergency use authorization for its vaccine in children age 5 to 11.

HHS guidance clarifies how HIPAA applies to COVID-19 vaccination status requests; CDC urges pregnant people to get vaccinated amid a surge in hospitalizations.

Providers can simultaneously apply for Phase 4 of the Provider Relief Fund and American Rescue Plan rural payments; applications close Oct. 26. The Health Resources and Services Administration will host a series of informational webinars about the funding application portal.

The Senate remains in a stalemate over a continuing resolution to fund the federal government through Dec. 3, leaving congressional leaders little time to avoid an Oct. 1 shutdown. House debate begins on a physical infrastructure bill and work continues on "human infrastructure" legislation.

FDA on Sept. 22 authorized a third booster dose of the Pfizer-BioNTech COVID-19 vaccine for select groups. A CDC panel subsequently recommended the booster shots, and CMS announced coverage for all Medicare beneficiaries and nearly all Medicaid and Children's Health Insurance Program beneficiaries.

In a Sept. 20 letter, America's Essential Hospitals welcomes the announcement of additional COVID-19 relief funding but notes the methodology falls short of adequate support for safety net providers. The association urges HHS to issue another targeted safety net distribution, among other requests.

An FDA advisory committee recommends a Pfizer COVID-19 vaccine booster for a limited population; CDC announces $2.1 billion dedicated to infection control and prevention.

The House this week is expected to consider a continuing resolution to temporarily extend current funding levels for the federal government. House Speaker Nancy Pelosi (D-Calif.) and Senate Majority Leader Chuck Schumer (D-N.Y.) intend to suspend the debt limit as part of the resolution.

The president's newly announced "Path out of the Pandemic" plan includes action steps for increasing vaccinations, further protecting those who are vaccinated, keeping schools safely open, testing and mask requirements, and economic recovery. CDC updates its infection control guidance.

A total of $25.5 billion will be available, including $17 billion through the Provider Relief Fund and $8.5 billion in American Rescue Plan funding for providers serving rural patients. Providers can apply for the new funding Sept. 29.

An FDA committee will review Pfizer's COVID-19 vaccine booster application; Moderna is applying for booster approval. CDC data show COVID-19 hospitalizations on the rise among children.

In a letter to Democratic congressional leadership, the association urges consideration of essential hospital priorities — including funding for critical workforce and hospital infrastructure needs and protecting the 340B Drug Pricing Program — in forthcoming budget reconciliation legislation.

A CDC advisory committee voted Aug. 30 to recommend the Pfizer-BioNTech COVID-19 vaccine; the agency warns against using ivermectin to treat or prevent COVID-19.

In a letter to HHS Secretary Xavier Becerra, America's Essential Hospitals urges the agency to swiftly allocate and target remaining PRF funds, take steps to ensure adequate hospital staffing, expedite full approval of COVID-19 vaccines, and protect the nation's supply chain.

FDA approves the Pfizer-BioNTech COVID-19 vaccine. HHS plans to promote a booster shot of the mRNA vaccines beginning in September. CMS and CDC work to develop an emergency regulation requiring COVID-19 vaccination for nursing home staff.

The House pauses its August break to work on the bipartisan physical infrastructure package and $3.5 trillion fiscal year 2022 budget resolution. Speaker Nancy Pelosi (D-Calif.) aims to pass both measures by Oct. 1 but faces some opposition from moderate House Democrats.

America's Essential Hospitals outlines concerns with the timeline for implementation and the scope of the Occupational Safety and Health Administration's emergency temporary standard (ETS) for occupational exposure to COVID-19.

The rule includes numerous policy and payment changes for Medicare’s Inpatient Prospective Payment System for fiscal year 2022, including a 2.5 percent increase in inpatient payment rates.

FDA and CDC recommend a third mRNA COVID-19 vaccine dose for immunocompromised people; CDC recommends COVID-19 vaccines for pregnant and breastfeeding people.

In an Aug. 13 letter to state health officials, the Centers for Medicare & Medicaid Services updates its guidance regarding the resumption of normal state Medicaid, Children’s Health Insurance Program, and Basic Health Program operations when the COVID-19 public health emergency ends.

The Senate passed a $3.5 trillion fiscal year 2022 budget resolution with no Republican support; House leaders called members back to Capitol Hill for a brief legislative session Aug. 23. Moderate House Democrats are urging leadership to call a vote on the bipartisan physical infrastructure bill.

The White House COVID-19 Response Team will host an Aug. 23 virtual conversation on increasing vaccination in an equitable way. The event is open to health system leaders and health care providers.

The Senate voted 69–30 to advance a bipartisan physical infrastructure bill. Meanwhile, Senate Democrats released a $3.5 trillion budget resolution, the precursor to a partisan reconciliation bill on “human infrastructure” priorities. Notably, the resolution does not contain a debt limit increase.

Two CDC studies highlight the effectiveness of the COVID-19 vaccines in preventing reinfection and hospitalization; CDC extends the eviction moratorium.

CMS on Aug. 2 released its fiscal year 2022 Inpatient Prospective Payment System final rule, which includes payment and quality reporting provisions. The rule does not finalize provisions related to new residency slots, organ acquisition costs, or Section 1115 waiver days. 

The Senate released much-anticipated legislative language for a $1.2 trillion bipartisan physical infrastructure package. While the legislation includes no major health care policies, it does list several health care changes to help pay for new spending.

CDC recommends everyone, even those who are fully vaccinated, wear a mask indoors in public in areas with substantial and high COVID-19 transmission.

As COVID-19 cases rise, the association calls on members to require employee vaccination; CDC urges immunocompromised people to continue wearing masks.

Effective July 20, Health and Human Services Secretary Xavier Becerra renewed the public health emergency (PHE) determination related to the continued effects of COVID-19. The PHE determination has been in place since Jan. 31, 2020, and has been renewed every three months since.

Negotiations continue on a bipartisan physical infrastructure plan after Senate Republicans blocked a procedural vote to begin formal deliberations on the framework. Republican senators opposed the legislative text because it is not final and has no Congressional Budget Office score.

The U.S. Surgeon General issues a health misinformation advisory; CDC and the Office of Minority Health develop a Minority Health Social Vulnerability Index.

As a bipartisan group of senators crafts infrastructure legislation, Senate Democrats work to develop a human infrastructure package.

The Occupational Safety and Health Administration extends to Aug. 20 the comment period for the COVID-19 health care emergency temporary standard. The Centers for Disease Control and Prevention and the Food and Drug Administration say fully vaccinated individuals do not need COVID-19 booster shots.

The Department of Health and Human Services announced $250 million in grant awards to 73 local governments as part of a new initiative to identify and implement best practices for improving health literacy to enhance COVID-19 vaccination among underserved populations.

Providers who received Provider Relief Fund dollars and are required to document their use during reporting period 1 (April 10–June 30, 2020) have until Sept. 30 to access the portal and submit the information.

America's Essential Hospitals commented on several policy proposals of interest to essential hospitals in the Inpatient Prospective Payment System rule and responded to a request for information on closing the health equity gap in hospital quality programs.

CDC extends to July 31 the eviction moratorium to protect people unable to make rental payments due to the COVID-19 public health emergency. Distribution of bamlanivimab and etesevimab is paused after tests find they are ineffective against some COVID-19 variants.

A bipartisan group of senators reached an agreement with the White House on a $1.2 trillion physical infrastructure framework that lists extending the 2 percent Medicare sequester cut as a potential method of funding the package. Lawmakers now must turn the framework into legislation.

America's Essential Hospitals urged the agency to ensure essential hospitals receive much-needed relief and are equipped for their central role in the continued response to the pandemic, including allocating remaining Provider Relief Fund dollars and revising guidance on the use of these funds.

Senators continue efforts to build consensus on a $1.2 trillion bipartisan physical infrastructure proposal introduced last week, but Democrats are taking steps to initiate the budget reconciliation process in case those talks ultimately fall short.

The interim guidance covers physical and mental health conditions present four or more weeks after some COVID-19 infections, including by patients who initially had mild or asymptomatic acute infections.

The Department of Health and Human Services revises reporting requirements and extends the deadlines for providers to use and report on the use of Provider Relief Fund payments.

The new infrastructure deal comes after months-long negotiations between the Biden administration and Senate Republicans fell apart. It includes roughly $579 billion in new spending. However, lawmakers in both parties expressed skepticism that the plan could secure enough votes to pass the Senate.

Novavax's COVID-19 vaccine demonstrated 90.4 percent efficacy in clinical trials; CDC urges vaccination upon hospital discharge.

The new timeline for spending and reporting on Provider Relief Fund (PRF) dollars depends on when a provider received the payments. The PRF reporting portal, which so far has been open only for registration, will open July 1 for providers to begin reporting on the use of their PRF payments.

The emergency temporary standard aims to protect those working in health care settings where suspected or confirmed COVID-19 patients are treated.

President Biden announces a National Month of Action to vaccinate 70 percent of U.S. adults by July 4; Moderna applies for FDA approval of its vaccine.

WHO announces new names for SARS-CoV-2 variants of concern; two NIH studies show that mRNA vaccines are safe for pregnant people.

Republicans offer a $928 billion counterproposal to President Joe Biden's $1.7 trillion infrastructure package. Leaders of the Senate Committee on Health, Education, Labor, and Pensions and House Committee on Energy and Commerce seek information on developing a public health insurance option.

FDA lengthens the refrigerator storage time for the Pfizer COVID-19 vaccine. A new CDC site aggregates state and local COVID-19 funding opportunities. The Department of Health and Human Services allocates $4.8 billion to the HRSA COVID-19 Uninsured Program.

The Senate confirmed Chiquita Brooks-LaSure as head of the Centers for Medicare & Medicaid Services. Several Senate committees last week examined issues of importance to essential hospitals, including telehealth, hospital consolidation, and the medical supply chain.

The Kaiser Family Foundation, in collaboration with UnidosUS, launched the La Conversación campaign to ensure equitable access to the COVID-19 vaccine for Latino communities. The campaign features more than 75 videos and complements earlier resources for Black communities.

The Senate voted to advance the nomination of Chiquita Brooks-LaSure as Centers for Medicare & Medicaid Services administrator; a full Senate vote could take place this week. America's Essential Hospitals hosted a virtual Capitol Hill briefing in recognition of the association's 40th anniversary.

The Department of Treasury released an interim final rule related to the distribution and allocation of $350 billion in funding for state, local, metropolitan city, and tribal governments; the funding was included in the American Rescue Plan Act.

New CDC recommendations no longer require people who are fully vaccinated against COVID-19 to wear a mask or physically distance.

A CDC brief updates transmission methods; Pfizer applies for FDA approval of its vaccine; CMS increases the Medicare payment for monoclonal antibodies.

President Joe Biden is scheduled to meet with House and Senate lawmakers this week to discuss a bipartisan path forward on infrastructure legislation ahead of his fiscal year 2022 budget proposal. The Senate is expected to confirm Andrea Joan Palm as deputy secretary of health and human services.

New CDC guidelines walk back outdoor mask regulations for fully vaccinated people; two research studies examine adverse reactions to the Janssen COVID-19 vaccine.

The Centers for Medicare & Medicaid Services’ proposed fiscal year 2022 Inpatient Prospective Payment System rule would increase operating payment rates by 2.8 percent, repeal market-based data collection, and add 1,000 new graduate medical education teaching slots, among other provisions.

Senate Republicans release a $568 billion infrastructure framework to kickstart negotiations. House Democrats and Republicans reintroduce opposing prescription drug pricing bills. A CMS decision delays advancement of Chiquita Brooks-LaSure's nomination for CMS administrator.

CDC and FDA lift the pause on Janssen vaccine administration after blood clot reports. Data show COVID-19 patients have long-term health needs.

The COVID-19 public health emergency (PHE) determination has been renewed effective April 21. The PHE determination initially was made Jan. 31, 2020, and has been renewed a total of five times.

Everyone in the United States ages 16 and older is now eligible for a COVID-19 vaccine; CDC's advisory committee will meet April 23 to discuss the Janssen vaccine pause.

The FCC announced the filing window for the second round of applications for the COVID-19 Telehealth Program will open at noon ET on April 29. The agency plans to award funding in two phases so applicants have the opportunity to provide supplemental information if they initially are denied funding.

CDC and FDA recommend pausing Janssen COVID-19 vaccine administration after six U.S. reports of blood clots; HHS expands the Health Center Vaccine Program.

CDC Director Rochelle Walensky declared racism a serious public health threat and outlined agency efforts to mitigate the impact of racism on public health. The association applauds Walensky's clear statement on systemic racism.

HHS and CDC launch a nationwide grassroots vaccine promotion network; CDC issues new guidance on travel, cleaning, and disinfection.

In a newly issued report and order, the Federal Communications Commission provided more information on the application and evaluation process for the second round of the COVID-19 Telehealth Program. The application window will open within 30 days of the order.

President Joe Biden announced initiatives to expand COVID-19 vaccine access; a CDC study shows mRNA vaccines are highly effective in preventing SARS-CoV-2 infection.

In light of the COVID-19 public health emergency, CMS updated its guidance document to expand on best practices, lessons, and planning considerations for emerging infectious diseases. 

In a new HHS Office of Inspector General report, hospitals highlight challenges associated with the public health emergency — including barriers to care delivery and vaccination, staff burnout, supply shortages, and declining revenue — that have strained the nation's health care delivery system.

FDA alerts providers about monoclonal antibody–resistant SARS-CoV-2 variants; a new study examines vaccine rates in counties where residents experience a high number of social risk factors.

In its March report to Congress, the Medicare Payment Advisory Commission recommends payment updates in fee-for-service payment systems, including for hospital inpatient and outpatient services. The panel also outlines Medicare coverage of telehealth services during the pandemic and beyond.

The Occupational Safety and Health Administration updated its COVID-19 enforcement plan; CDC updates infection control guidance for vaccinated people in health care facilities.

The House this week will vote on legislation to extend the moratorium on a 2 percent Medicare sequester cut. House Democrats unveil an infrastructure package that prioritizes funding for construction and modernization activities to bolster public health preparedness and cyberattack prevention.

The association will convene its virtual spring Policy Assembly March 16. Whether or not you join us, these resources are available to encourage your legislators to protect access to care.

The legislation includes $8.5 billion in funding for certain rural providers that serve Medicare and Medicaid beneficiaries and a a temporary increase in Medicaid disproportionate share hospital allotments.

Essential hospitals rely heavily on a patchwork of federal financial support and resources to meet their mission. Congress must bolster the individual components that form the fabric of the health care safety net.

Essential hospitals lead the nation in the battle against COVID-19 but new challenges—including COVID variants, vaccination distribution management, and long-term hospitalizations—show more help is needed to ensure providers on the front lines can maintain access to care.

In a March 9 letter, America's Essential Hospitals asked the administration to ensure adequate vaccine supplies reach essential hospitals, emphasizing the critical role they play in vaccinating the health care workforce and the broader population.

With a 50–50 party split in the Senate, Democrats must remain united and rely on Vice President Kamala Harris' vote to confirm the nomination of California Attorney General Xavier Becerra as secretary of health and human services.

The guidance clarifies how hospitals receiving Medicaid disproportionate share hospital payments can use Provider Relief Fund general and targeted distribution payments.

The $1.9 trillion package temporarily increases Medicaid disproportionate share hospital allotments to ensure essential hospitals receive the same level of payments as they would have expected absent the pandemic. The package returns to the House for a final vote, expected as early as Tuesday.

CDC releases public health guidelines for fully vaccinated people; CMS invites hospitals to pilot a COVID-19 learning series.

In a letter, America's Essential Hospitals urges swift allocation of the remaining funds in the $178 billion Provider Relief Fund and calls for another targeted distribution to hospitals omitted from the first two safety-net distributions, among other requests.

The $1.9 trillion COVID-19 relief bill would ensure essential hospitals receive the same level of Medicaid DSH payments as they would have absent the pandemic. Xavier Becerra's nomination as secretary of health and human services is expected to reach the Senate floor as early as next week.

FDA granted an emergency use authorization for the one-dose Janssen COVID-19 vaccine and an at-home COVID test; a multi-agency FAQ document addresses COVID-19 health coverage.

A CDC report shows promising COVID-19 vaccine safety profiles; the federal COVID-19 task force expands support for vaccination and testing.

Congress races to pass COVID-19 relief through the budget reconciliation process before enhanced unemployment benefits expire March 14. Senate committees hold confirmation hearings for Xavier Becerra as secretary of health and human services.

CDC provides new vaccine demographic data and guidelines for ensuring close-fitting face masks; President Biden appoints two essential hospital leaders to a health equity task force.

America's Essential Hospitals sent a letter to President Joe Biden and his administration detailing key priorities for essential hospitals, including issues related to structural racism, COVID-19, Medicaid, the 340B Drug Pricing Program, site-neutral payment policies, immigration, and other topics.

The Joint Commission's latest Quick Safety newsletter offers recommendations to ensure equitable care during the COVID-19 pandemic.

The House is expected to vote on a compiled reconciliation bill the week of Feb. 22. The Senate for the second time has acquitted former President Donald Trump of impeachment charges. House members are circulating a bipartisan letter calling for protections to the 340B Drug Pricing Program.

Janssen applied for emergency use authorization of its COVID-19 vaccine; a CDC report shows reporting gaps in ethnic and racial data of vaccine recipients.

House and Senate committees are working on the details of COVID-19 relief under the budget reconciliation process. The impeachment trial of former President Donald Trump is underway; members of both parties have indicated they prefer a short and swift trial.

A new CDC order requires mask use on public transportation; a PREP Act amendment expands the provider groups authorized to administer vaccines.

House Speaker Nancy Pelosi and Senate Majority Leader Chuck Schumer unveiled a joint budget resolution to advance President Biden's COVID-19 relief priorities through budget reconciliation. Senate leaders have yet to agree on an organizing resolution finalizing operations for the 117th Congress.

President Biden released an executive order to strengthen Medicaid and the Affordable Care Act. The order calls for a special enrollment period on the federally facilitated exchange for uninsured or underinsured individuals — particularly those hardest hit by the COVID-19 pandemic.

In his first week in office, President Biden released multiple executive orders of note to essential hospitals, including those related to COVID-19, health equity and nondiscrimination, and immigration.

CDC requires a negative test or travel clearance from a health care professional to enter the country; President Biden issues COVID-19 national strategy and complementary executive orders.

The second Senate impeachment trial of former President Donald Trump is expected to begin in early February, with Sen. Pat Leahy (D-VT) presiding. House committees with jurisdiction over health care issues add new members to their rosters.

The new guidance and deadline apply to all provider relief fund allocations to date except the Health Resources and Services Administration uninsured program, nursing home infection control distribution, and rural health clinic testing distribution.

As a highly transmissible SARS-CoV-2 variant spreads across the country, CDC issues two new vaccination toolkits; HHS alters its Provider Relief Fund reporting timeline.

For the second time, the House has impeached Donald Trump — this time, for his role in the Jan. 6 U.S. Capitol attack. Law enforcement descends on Washington amid threats of violence surrounding the inauguration. The Biden transition team releases a $1.9 trillion COVID-19 relief plan.

CDC shares information about two highly contagious SARS-CoV-2 variants, allergic reactions in Pfizer vaccine recipients, and vaccines for pregnant people.

Health and Human Services Secretary Alex Azar extended, effective Jan. 21, the COVID-19 public health emergency (PHE) determination. The PHE determination has been in place since Jan. 31, 2020; it was set to expire Jan. 20, 2021.

CDC announces target groups for phases 1b and 1c of COVID-19 vaccine allocation; a new brief recommends strategies for building vaccine trust.

In the first week of the new Congress, lawmakers will focus on certification of Electoral College votes and a Georgia special election that will determine which party controls the Senate. Nancy Pelosi (D-CA) was re-elected speaker of the House.

The Office of Management and Budget (OMB) provides additional direction to auditors on COVID-19 payments. OMB delays by three months the deadline for single-audit reports for entities that received COVID-19 funding and had original audit report due dates from Oct. 1, 2020, to June 3, 2021.

The $2.3 trillion package to fund the government, provide new COVID-19 relief, and stimulate the economy would eliminate a $4 billion cut to Medicaid disproportionate share hospital payments and add $3 billion to the Provider Relief Fund, among numerous other changes.

FDA issues an emergency use authorization for the Moderna vaccine and an at-home antigen test; a CDC committee votes on allocation recommendations.

On Dec. 16, the Health Resources and Services Administration completed its review of Phase 3 applications for Provider Relief Fund money and will distribute $24.5 billion to more than 70,000 providers.

The continuing resolution delays until Dec. 19 a scheduled $4 billion cut to Medicaid disproportionate share hospital payments. Meanwhile, lawmakers introduce a new, two-part $908 billion legislative proposal for COVID-19 relief, as well as a deal on legislation regarding surprise medical bills.

FDA authorizes the Pfizer COVID-19 vaccine for emergency use; HHS expands hospital COVID-19 data reporting requirements to include therapeutic data.

Congress indicates plans to pursue a one-week continuing resolution to keep the government funded at current levels through Dec. 18. A group of bipartisan lawmakers introduced a framework for a $908 billion COVID-19 relief deal, reinvigorating negotiations between Republicans and Democrats.

CDC recommends groups to prioritize in vaccine distribution and revises antigen testing guidance.

Moderna applied for emergency use authorization for its COVID-19 vaccine; CDC issued ethical vaccine application principles and updated face mask guidance for health care workers.

The Centers for Medicare & Medicaid Services announced the Acute Hospital Care at Home program to further increase hospital capacity during the COVID-19 crisis, in response to a rising number of hospitalizations nationwide. The program builds on the Hospitals Without Walls initiative.

Without congressional action, the government on Dec. 12 will enter a shutdown and $4 billion will be cut from Medicaid disproportionate share hospital payments. Meanwhile, negotiations are deadlocked on additional COVID-19 relief.

FDA Commissioner Stephen Hahn, MD, says drug and biological product centers will publicly post reviews of the data and information supporting emergency use authorizations (EUAs) for all drug and biological products, including vaccines, as part of the agency's COVID-19 response.

In the lame-duck session, Congress will focus on stopping a Medicaid DSH funding cut, averting a government shutdown, and providing COVID-19 relief. The House passed bipartisan bills to enhance research on minority health disparities, address the opioid crisis, and support trauma centers.

In its first letter to President-elect Joseph Biden and his transition team, America's Essential Hospitals noted a desire to work together to stabilize the nation's health care safety net and described several administrative policy priorities and paths of partnership.

Senators re-elect their leadership teams, led by Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schumer (D-NY); the House will vote on party leadership this week. Senate Republicans introduce $1.4 trillion legislative package to fund the federal government for fiscal year 2021.

An interim analysis of Moderna Inc.'s COVID-19 vaccine shows promising results; CDC guidance highlights that wearing a mask can protect the wearer.

FDA grants emergency use authorization for an Eli Lilly antibody treatment; a Pfizer vaccine has promising early results; President-elect Biden names a COVID-19 advisory board.

Lawmakers will prioritize funding for the federal government and additional COVID-19 relief. Join America's Essential Hospitals for a Nov. 18 webinar analyzing the impact of the elections on essential hospitals and health care policy. Registration open for our postelection Policy Assembly, Dec. 8–9.

Operation Warp Speed (OWS), a joint effort by the departments of Defense and Health and Human Services, on a stakeholder call discussed principles for allocation and distribution of therapeutics, specifically monoclonal antibodies. OWS also released a draft pre-emergency use authorization playbook.