The roadmap implements the three pillars of the President's March 2022 Strategy to Address our National Mental Health Crisis.

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

HHS seeks input on the No Surprises Act's advanced explanation of benefits and good faith estimate requirements for insured individuals; comments are due Nov. 15.

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 encourages organizations to commit to working toward its goal of ending hunger and increasing healthy eating and physical activity by 2030.

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.

The association urged CMS to adequately reimburse off-campus, provider-based departments; refine physician quality reporting; and codify a definition of essential hospitals.

A September continuing resolution provides a potential legislative vehicle for health policy provisions. We summarize key workforce priorities and actions from Congress, the administration, and the association.

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

An Aug. 31 CMS proposed rule aims to streamline Medicaid and CHIP enrollment and ensure continuous coverage throughout the renewal process.

CMS on Aug. 29 finalized its decision to delay indefinitely implementation of the Radiation Oncology Model, which was scheduled to start Jan. 1, 2023.

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.

The Department of Homeland Security finalized a rule codifying the Deferred Action for Childhood Arrivals program with some limited changes.

The annual 340B Drug Pricing Program recertification period for hospitals began Aug. 24. Hospitals will have until Sept. 19 to complete the process.

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.

The rule finalizes disclosure requirements for the qualifying payment amount and select provisions for the related independent dispute resolution process.

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 proposed rule expands the definition of discrimination "on the basis of sex" and explicitly includes telehealth services in nondiscrimination policies.

The declaration enables HHS to modify Medicare and Medicaid program requirements and could lead to more emergency funding for virus prevention and vaccines.

Health care providers have until Aug. 30 to download their preview reports before CMS shares quality data publicly in October.

The regulation contains payment and quality reporting provisions, a new designation to identify “birthing-friendly” hospitals, and a 4.3 percent increase in operating payment rates for general acute-care hospitals, compared with a proposed 3.2 percent update.

This is the second star ratings update since the agency updated its methodology in 2020 to include the use of peer grouping.

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.

As the World Health Organization declares monkeypox a global health emergency, CDC updates clinical guidance, and HHS plans to allocate additional vaccine doses.

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.

The Aug. 22 webinar will complement other federal resources on the annual 340B Drug Pricing Program recertification period for hospitals, open from Aug. 24 to Sept. 19.

The Department seeks comment on Public Service Loan Forgiveness program eligibility policies for physicians at nonprofit hospitals.

CMS seeks feedback at a July 21 listening session on the 5 percent lump sum Alternative Payment Model Incentive Payment, set to expire at the end of 2022. 

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.

The Medicare Outpatient Prospective Payment System proposed rule for calendar year 2023 reverses cuts to 340B Drug Pricing Program hospitals and seeks comment on remedying existing cuts to 340B hospitals.

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

CMS proposes to decrease the conversion factor determining physician payment rates for specific services by $1.53. The proposed rule also includes provisions related to Medicare reimbursement of telehealth services, vaccine administration, and the Medicare Shared Savings Program.

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.

The document outlines five priority goals to improve maternal health and outcomes and, for each, actions the federal government will take.

The GAO reviewed recent and planned actions to enhance oversight of state-directed payments and found the effectiveness of these actions is unknown and information gaps remain.

The strategy aims to deploy vaccines rapidly in the most affected communities, facilitate testing, and engage stakeholders to mitigate spread.

The HHS Office of Climate Change and Health Equity announced a climate change webinar series, beginning July 14, and shared a companion resource compendium.

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.

In a resounding victory for essential hospitals, the U.S. Supreme Court unanimously ruled in favor of America’s Essential Hospitals in its years-long legal challenge to restore full Medicare payment rates for 340B Drug Pricing Program hospitals.

The order instructs the HHS Secretary to use the agency's authorities to protect LGBTQI+ individuals' access to medically necessary care.

In its June report to Congress, the Medicaid and CHIP Payment and Access Commission considers oversight of managed care directed payments and examines Medicaid's role in advancing health equity.

The commission's June report to Congress includes illustrative policies about defining and supporting Medicare safety net providers and aligning payments across outpatient settings, among other topics of interest to essential hospitals.

The Supreme Court’s dismissal of the appeal does not touch on the legality of the public charge rule but only on the ability of the 13 states to intervene in defense of the rule.

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.

The National Steering Committee for Patient Safety calls on health care providers to put its 2020 Action Plan into practice.

Hospitals have until June 16 to preview their Overall Hospital Quality Star Rating, measure group score, and individual measure results, along with peer grouping.

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.

The agency's strategy to strengthen behavioral health care focuses on improving access, equity, quality, and data integration.

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

CMS on May 25 approved proposals in four states to extend postpartum Medicaid coverage from 60 days to one year after birth.

A new advisory from U.S. Surgeon General Vivek Murthy, MD, MBA, calls for a whole-of-society approach to protect and support health workers facing burnout.

The webpage includes renewal instructions for eligible beneficiaries and guidance for ineligible beneficiaries to secure insurance through the marketplaces.

CDC is tracking monkeypox, a virus endemic to west and central Africa, after confirming a case in a Massachusetts resident who recently traveled to Canada.

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

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.

The current National Suicide Prevention Lifeline number, 1.800.273.8255, will transition to 988 on all devices on July 16.

The association urged HHS to provide funding, educate stakeholders, and build capacity to execute the 2022 Environmental Justice Strategy and Implementation Plan.

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.

New HHS initiatives focus on climate change, health equity, and the role health care stakeholders can play in promoting climate resilience.

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.

The association thanked the administration for taking steps to reverse the damaging 2019 broadened definition of public charge and made recommendations for developing and implementing a new definition.

The final rule raises the essential community provider threshold from 20 to 35 percent and uses wait time standards to evaluate qualified health plans for network adequacy.

In a white paper, the association encourages CMS to develop policies that reduce disparities and incorporate equity into waiver approval and evaluation processes.

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

The Accreditation Council for Graduate Medical Education introduced two rural track program designations to accredited residency programs and seeks members for an advisory group on health care access for medically underserved areas and populations.

Hospitals and other industry stakeholders are invited to pledge by June 3 to reduce greenhouse gas emissions and increase their climate resilience.

America's Essential Hospitals generally supports the tool, as it will direct investments to target several social determinants of health, but recommended the tool show aggregate data at the state and county levels.

The action plan includes goals to close gaps in health care access, quality, and outcomes through data collection, outreach, and community engagement.

The proposed fiscal year 2023 Inpatient Prospective Payment System rule would increase operating payment rates by 3.2 percent and make other changes to Medicare payment and quality reporting policies. CMS is accepting comments on the proposed rule until June 17.

The independent dispute resolution process can be initiated to resolve payment disputes between health care providers and issuers.

The association made recommendations on payment rates, workforce development, eligibility and enrollment policies, and measuring access to hospital services.

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.

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.

Two new documents provide guidance for health care providers on No Surprises Act compliance and good faith estimates for uninsured or self-pay patients.

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.

Recommendations for Medicare and Medicaid equity measures under development focus on standardized data collection and opportunities for testing and feedback.

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.

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.

In its March report to Congress, the Medicaid and CHIP Payment and Access Commission examines the relationship between Medicaid disproportionate share hospital (DSH) allotments, uncompensated care costs, and services for low-income, uninsured populations.

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.

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.

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.

The court ruled the qualifying payment amount should not be the main factor in determining payment for out-of-network services in independent dispute resolution.

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

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.

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.

The Centers for Medicare & Medicaid Services outlines the application process for 1,000 new graduate medical education slots created by the Consolidated Appropriations Act of 2021. Applications for the first round of slots are due March 31, 2022, and CMS intends to award slots July 1, 2023.

The Center for Medicare & Medicaid Innovation will release a request for applications for the Realizing Equity, Access, and Community Health accountable care organization model, which will focus on promoting health equity and mitigating health disparities for underserved communities.

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

Through a request for information, the Centers for Medicare & Medicaid Services hopes to better understand enrollees' barriers to coverage and access to care to inform future policies and regulatory actions. A 60-day public comment period began Feb. 17.

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

Due to a calculation error in measure results used for calendar year 2021 public reporting, the Centers for Medicare & Medicaid Services has delayed until July the overall hospital star ratings update originally scheduled for April.

The Department of Health and Human Services will distribute $19.2 million in American Rescue Plan Act funds to help train primary care residents to provide quality care to diverse populations and communities, particularly in underserved and rural areas.

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.

An estimated 5.8 million people newly gained coverage during this open enrollment period; 32 percent of consumers using the federal marketplace selected a plan that costs them $10 or less per month. Enrollment remains open through Jan. 31 in five states and the District of Columbia.

Each awardee will receive up to $1.5 million for a three-year period to reduce the number of uninsured children by advancing Medicaid and Children's Health Insurance Program enrollment and retention. Grant applications are due March 28.

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

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

HHS awarded $103 million to improve health care worker retention by reducing staff burnout and promoting mental wellness. Several essential hospitals were among the awardees, including the University of New Mexico, Virginia Commonwealth University, and the University of Utah.

In response to the proposed rule for the 2023 plan year, the association urged the Department of Health and Human Services to ensure equitable access, finalize nondiscrimination policies, standardize collection of Z codes, and prorate premiums and advanced premium tax credits.

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.

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.

The Centers for Medicare & Medicaid Services released guidance and example templates for good faith estimates and the surprise billing patient-provider dispute resolution process.

The Medicare Part B drug model, also known as the most favored nation model, would have phased-in reduced payment rates for 50 Part B drugs over four years. America's Essential Hospitals previously called on CMS to withdraw the model.

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.

New guidance from the Centers for Medicare & Medicaid Services reviews the timeline for open negotiations and initiating the federal independent dispute resolution process under the No Surprises Act.

The new document explains various provisions under part II surprise billing regulations, including that all financial assistance should be reflected in the good faith estimate regardless of the amount or type of discount. The new regulations take effect Jan. 1, 2022.

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.

In a new white paper, America's Essential Hospitals discusses essential hospitals' role in value-based payment models and makes recommendations to the Center for Medicare and Medicaid Innovation on improving equity through broader model participation.

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.

A Centers for Medicare & Medicaid Services letter to state Medicaid directors outlines new supplemental payment reporting and Medicaid disproportionate share hospital requirements under the Consolidated Appropriations Act.

The Substance Abuse and Mental Health Services Administration will ask grant recipients to develop or expand evidence-based services that may include the provision of sterile syringes, safe-sex kits, prevention education, overdose prevention kits, and more. Applications are due Feb. 7, 2022.

The advisory aims to combat the youth mental health crisis that worsened due to the COVID-19 pandemic. Specifically, the surgeon general recommends health care professionals focus on prevention and trauma-informed care principles, routinely screen children for mental health risk factors, and more.

In its comments to the Agency for Healthcare Research and Quality, the association stressed the importance of considering hospital physical infrastructure and financial status in developing research and practice improvement strategies.

As part of Vice President Kamala Harris' call to reduce maternal mortality and morbidity, a Department of Health and Human Services report highlights the impact of extending postpartum Medicaid coverage. In addition, CMS intends to propose a "Birthing-Friendly" hospital designation.

Vice President Kamala Harris hosted the first federal Maternal Health Day of Action. Coinciding with the event, America's Essential Hospitals announced 12 member hospitals will participate in a new CVS Health Foundation–funded learning collaborative to improve maternal health.

America’s Essential Hospitals commented on the second interim final rule implementing the No Surprises Act. The association urged HHS to revise good faith estimate requirements and create an IDR process that does not favor payers over providers.

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.

A new Department of Health and Human Services report finds the share of Medicare visits conducted via telehealth increased from about 840,000 in 2019 to 52.7 million in 2020. In particular, telehealth was helpful in offsetting potential foregone behavioral health care during the COVID-19 pandemic.

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.

The Department of Health and Human Services announced a $1.5 billion investment to help grow and diversify the nation's health care workforce through loan repayment and scholarship programs.

The proposed rule aims to strengthen and preserve the Deferred Action for Childhood Arrivals policy, which is critical to the nation's health care workforce. The association urges the Department of Homeland Security to formally add the policy through the notice-and-comment rulemaking process.

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

The Department of Health and Human Services released a fourth interim final rule to implement the No Surprises Act. The agency aims to enhance transparency and provide insight into how prescription drugs contribute to the growth of health care spending and the cost of health coverage.

CMS released final guidance for compliance with Medicare conditions of participation related to co-location, which occurs when two Medicare-certified hospitals or a Medicare-certified hospital and another health care entity are on the same campus or in the same building and share resources.

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.

The letter from America’s Essential Hospitals to the Senate Committee on Finance responded to the panel’s request for information on improving access to and enhancing mental and behavioral health care.

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.

The rule adjusts the conversion factor used to determine physician payment rates and includes provisions related to appropriate use criteria, Medicare reimbursement for telehealth services, vaccine payment rates, the Quality Payment Program, and the Medicare Shared Savings Program.

The Medicare Outpatient Prospective Payment System final rule for calendar year 2022 continues cuts to hospitals in the 340B Drug Pricing Program and pauses elimination of the inpatient-only list. The rule also includes provisions on price transparency, rural emergency hospitals, and health equity.

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.

The new strategy from the Department of Health and Human Services expands the scope of crisis response beyond opioids to include other substances often involved in overdoses. It focuses on four priority areas: primary prevention, harm reduction, evidence-based treatment, and recovery support.

The plan — required by the Coronavirus Aid, Relief, and Economic Security Act — focuses on increasing the health workforce in rural and underserved areas and better preparing for the health care needs of the future. HHS will issue a report to Congress on implementation.

Consumers now can preview health plans and prices on healthcare.gov ahead of open enrollment, which runs Nov. 1, 2020, through Jan. 15, 2021.

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

America's Essential Hospitals submitted comments on the Department of Homeland Security advanced notice of proposed rulemaking on the public charge ground of inadmissibility. Following feedback, the agency plans to engage in the rulemaking process to issue an updated public charge regulation.

America's Essential Hospitals urged CMS to finalize withdrawal of the Trump administration's Most Favored Nation Model, citing procedural deficiencies, ongoing legal challenges, and significant reduction in provider payment rates.

A new Center for Medicare and Medicaid Innovation white paper outlines a strategy to advance health system transformation. The goal is to achieve equitable outcomes by driving accountable care, advancing health equity, supporting innovation, addressing affordability, and creating partnerships.

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.

In a letter to congressional leaders, America's Essential Hospitals advocates for strengthening the health care workforce in the wake of COVID-19, including through more funding in public health emergencies, prioritized visas for foreign clinicians, and increased graduate medical education slots.

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.

Money from the American Rescue Plan will fund up to 50 awards through the Health Resources and Services Administration's State Loan Repayment Program for state-run programs that support, recruit, and retain primary care clinicians who work in underserved communities.

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.

The Department of Homeland Security will use the notice-and-comment rulemaking process to codify the Deferred Action for Childhood Arrivals program.

HHS released a Spanish version of QuestionBuilder, an app that helps patients and caregivers prepare for their in-person or telehealth appointments, along with a report on Latino patients' access to care.

The use of Z codes to document social determinants of health in Medicare fee-for-service beneficiaries increased slightly from 2017 to 2019 but remains low.

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.

The departments of Health and Human Services (HHS), Treasury, and Labor and the Office of Personnel Management issued Part II of the No Surprises Act interim final rule with comment period.

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 rule, released by the Department of Health and Human Service and the Department of Treasury, extends open enrollment, adds a new special enrollment period, expands navigator responsibilities, and modifies Section 1332 innovation waivers.

The calendar year 2022 Physician Fee Schedule proposed rule includes provisions on Medicare payment for telehealth services, the Quality Payment Program, and more. The association also responded to a request for information on improving health equity through data collection.

In response to the calendar year 2022 Outpatient Prospective Payment System proposed rule, America's Essential Hospitals urged CMS to halt elimination of the inpatient-only list and to restore adequate payment to hospitals in the 340B program and to off-campus provider-based departments.

In this first white paper of a new series, America's Essential Hospitals discusses the chronic underfunding of Medicaid as a form of structural racism and provides recommendations to ensure the program is an effective tool to improve equity.

The comprehensive plan includes potential legislative and administrative actions that could be used to lower drug prices. The plan also notes the importance of the 340B Drug Pricing Program and its role in supporting the health care safety net.

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.

Hospitals have until Sept. 13 to complete 340B Drug Pricing Program recertification through the Office of Pharmacy Affairs Information System.

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 the Centers for Medicare & Medicaid Services, America's Essential Hospitals commented on the first interim final rule implementing the No Surprises Act. The association urged HHS to delay implementation until after the COVID-19 public health emergency, among other requests.

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.

The Department of Homeland Security released an advance notice of proposed rulemaking to gather data and feedback on the public charge ground of inadmissibility. Public comments are due Oct. 22; DHS will host public listening sessions on Sept. 14 and Oct. 5.

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 Office of the National Coordinator for Health Information Technology will host a series of webinars to discuss information sharing requirements finalized in a 2020 rule. The first webinar, focused on clinicians, will be Sept. 14, from 1–2 pm ET. 

America's Essential Hospitals sent CMS recommendations for implementing the new Medicaid supplemental payment reporting system under the Consolidated Appropriations Act of 2020. The association noted the importance of accuracy and avoiding duplicate data collection.

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.

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 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.

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

CMS proposes to rescind the Trump administration’s Most Favored Nation model interim final rule, which aimed to reduce payment for 50 Medicare Part B drugs. America’s Essential Hospitals previously urged the agency to withdraw the model due to substantive and procedural issues.

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 annual 340B Drug Pricing Program recertification period for hospitals will begin Aug. 16. Hospitals will have until Sept. 13 to complete the process.

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

Effective Jan. 1, 2021, hospitals are required to publish standard charges, including negotiated rates, for all services in a machine-readable format. The Centers for Medicare & Medicaid Services will host a webinar on Aug. 11 for hospitals to learn about posting standard charge information.

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

CMS released an advisory alerting certain qualifying participants in alternative payment models that the agency does not have billing information needed to disburse incentive payments. Participants who anticipated but have not received an incentive payment should submit the necessary form by Nov. 1.

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.

The administration has created a new website, StopRansomware.gov, to help government agencies and the private sector understand the threat of ransomware, mitigate risk, and learn how to respond to a ransomware attack.

A bulletin from the Center for Medicaid and CHIP Services notes the withdrawal of the 2019 public charge rule and addresses states' role in safeguarding applicant and beneficiary information. The public charge rule was vacated and is no longer in effect, retroactive to March 2, 2021.

The OPPS proposed rule would continue cuts to hospitals in the 340B Drug Pricing Program and off-campus provider-based departments, pause the elimination of the inpatient-only list, and increase penalties for failing to report standard charges.

HRSA announced $103 million in American Rescue Plan funding over three years to help reduce burnout and promote mental health among the health care workforce.

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

CMS announces $15 million for state Medicaid agencies to launch mobile crisis intervention services, as authorized by the American Rescue Plan.

The rule includes provisions related to telehealth, vaccine payment rates, the Quality Payment Program, and the Medicare Shared Savings Program; comments are due to CMS by Sept. 13.

The Aug. 11 webinar will complement other federal resources on the annual 340B Drug Pricing Program recertification period for hospitals, which is scheduled to start Aug. 16. Hospitals will have until Sept. 13 to complete the process.

Notable to essential hospitals, the Biden administration's July 9 executive order includes health care items related to prescription drugs, price transparency, hospital consolidation, and health insurance.

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.

On July 1, the Biden administration released part 1 of the No Surprises Act interim final rule. Passed as part of the Consolidated Appropriations Act of 2021, the rule establishes new patient protections from balanced billing and excessive cost-sharing, known as surprise billing.

The Supreme Court’s decision to review the case marks a significant step in the association’s efforts to overturn harmful Medicare Part B cuts to hospitals in the 340B Drug Pricing Program. The Supreme Court will hear oral arguments in the case in its next term, with a decision likely in 2022.

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.

The departments of the Treasury and Health and Human Services proposed extending open enrollment in the Affordable Care Act marketplaces, adding a new special enrollment period, expanding navigator responsibilities, and modifying Section 1332 innovation waivers.

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.

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.

In its June report to Congress, the Medicare Payment Advisory Commission issues recommendations on issues of importance to essential hospitals, including payment for Part B drugs, alternative payment models, indirect medical education payments, and Medicare coverage of vaccines, among other topics.

The Biden administration proposes to rescind a Trump-era final rule requiring federally qualified health centers to charge certain low-income patients no more than the 340B Drug Pricing Program price for insulin and injectable epinephrine. Comments on the proposed rule are due July 16.

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 lawsuit, brought by individual plaintiffs and 18 Republican-led states, argued the ACA’s individual mandate was unconstitutional and that the entire ACA had to be dismantled as a result. The court's decision was made on procedural grounds and did not rule on the underlying merits of the case.

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.

America's Essential Hospitals and 11 additional national groups sent a letter to the Centers for Medicare & Medicaid Services urging the agency to partner with stakeholders who can offer technical expertise and context in developing the supplemental payment reporting system.

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

The Centers for Medicare & Medicaid Services is issuing $80 million in grant funding for navigators in states using the federal insurance marketplace for the 2022 plan year.

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.

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 interpretive guidance includes information on hospital admission, discharge, and transfer notification requirements outlined in CMS' May 2020 interoperability and patient access final rule.

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.

HHS will interpret and enforce the Affordable Care Act's prohibition on discrimination "on the basis of sex" to include sexual orientation and gender identity. The change comes in response to a Trump administration rule in June 2020 that removed protections for transgender and LGBTQ individuals.

The agency seeks input, information, and recommendations from stakeholders on equity assessments and strategies, barrier and burden reduction, procurement and contracting processes, financial assistance, and stakeholder and community engagement.

In a letter to the HHS Office of Civil Rights (OCR), America's Essential Hospitals responds to proposed changes to privacy rules under the Health Insurance Portability and Accountability Act. OCR outlined the changes in a Jan. 21 proposed rule aiming to improve the transition to value-based care.

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

In a new interim final rule with comment period, the Centers for Medicare & Medicaid Services revises the rules for certain hospitals seeking a wage index reclassification with the Medicare Geographic Classification Review Board.

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 Office of Minority Health page includes tools for data collection and analysis, developing language access plans, and strategic plan creation.

The Centers for Medicare & Medicaid Services published updated overall hospital quality star ratings on its Care Compare website; the ratings were last updated in January 2020. America's Essential Hospitals has expressed continued concern about the fairness and reliability of the ratings.

Effective April 28, HHS expanded the group of providers eligible to prescribe buprenorphine, a drug used to treat opioid use disorder, and removed some barriers to its use.

The Department of Health and Human Services announced $80 million in grants to increase access to marketplace enrollment assistance for consumers. The agency's 2021 open enrollment report shows more than 12 million consumers selected a marketplace plan during the 2021 open enrollment period.

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.

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.

The waiver makes Illinois the first state to provide continuity of full Medicaid benefit coverage for mothers by extending eligibility during the entire first year after delivery.

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.

The Office of National Drug Control Policy outlines the Biden administration's drug policy priorities for 2021, including expanding access to evidence-based treatment and prevention services, advancing racial equity, reducing supply of illicit substances, and advancing recovery-ready workplaces.

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.

The Centers for Medicare & Medicaid Services is extending until Aug. 15 the special enrollment period for 36 states using the federal health insurance marketplace, giving consumers more time to view new options under the American Rescue Plan, including lower premiums and plan upgrades.

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 an annual report to Congress, the Medicaid and CHIP Payment and Access Commission finds an increase from 2018 to 2019 in the number of uninsured and in charity care and bad debt. The report includes state-specific projections of the Medicaid disproportionate share hospital allotment.

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.

In response to an executive order, a new issue brief reviews four policy areas under Section 1115 demonstrations and their impact on Medicaid coverage and access to care. The brief notes all examined areas create barriers to enrollment and reduce coverage, leading to adverse health effects.

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 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.

In accordance with the presidential regulatory freeze, HHS proposes to further delay until July 20 a final rule requiring federally qualified health centers to charge certain low-income patients no more than the 340B Drug Pricing Program price for insulin and injectable epinephrine. 

A new White House Gender Policy Council, established via executive order, will coordinate efforts to advance gender equity and equality across executive departments and agencies.

A federal court vacated several policies in the Trump Administration’s 2019 health insurance marketplace rule for violating federal law, including provisions related to review of network adequacy, standardized options, income verification requirements, and reducing medical loss ratio rebates.

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.

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.

CDC warns health care providers to stay vigilant amid Ebola outbreaks in the Democratic Republic of the Congo and Guinea.

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.

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.

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 special enrollment period, intended to ensure access to health coverage amid the the COVID-19 pandemic, will continue through May 15. The enrollment period applies to consumers in the 36 states that use the federal marketplace platform.

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

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.

A new executive order calls on agencies to review public charge rules enacted under the Trump administration. Two other executive orders establish an interagency task force to reunite immigrant families and create a comprehensive regional framework to address the causes of migration.

Hospitals have 30 days to review their reports before public reporting to Care Compare.

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

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.

The regulatory freeze could affect rules directing health clinics to pass certain drug discounts on to patients, establishing minimum standards in Medicaid state drug utilization review, and modifying Health Insurance Portability and Accountability Act privacy arrangements.

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 document outlines acceptable approaches to calculate and report median payer-specific negotiated charges by Medicare Severity Diagnosis Related Group for reporting periods ending on or after Jan. 1, 2021.

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.

The Centers for Medicare & Medicaid Services will begin reprocessing outpatient claims to excepted off-campus provider-based departments at the lower site neutral payment rate it established in the calendar year 2019 Outpatient Prospective Payment System final rule.

The website contains FAQs on the administrative dispute resolution (ADR) panel and board, the monetary threshold for filing an ADR claim, the types of documentation stakeholders must provide as part of the ADR process, and other information.

A new notice encourages states to improve health outcomes, reduce disparities, and lower costs within Medicaid and the Children's Health Insurance Program. It describes how states might address social determinants of health using flexibility available under current law.

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

Managed care organizations can participate in direct contracting for their populations dually eligible for Medicare and Medicaid. The model builds on direct contracting opportunities that test risk-sharing arrangements to reduce Medicare expenditures while preserving or enhancing quality of care.

A new Centers for Medicare & Medicaid Services final rule addresses minimum standards in Medicaid State Drug Utilization Review, creates value-based purchasing arrangements with manufacturers, and outlines minimum standards to reduce opioid prescribing–related fraud and abuse.

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.

The rule, currently on hold due to a regulatory freeze, requires federally qualified health centers to pass 340B Drug Pricing Program discounts on to certain low-income patients as a condition of receiving federal grant funding; it applies to insulin and injectable epinephrine.

The proposed rule builds on a CMS final rule on interoperability and patient access; it would leverage application programming interfaces to improve patients’ access to their electronic health information and reduce burden on providers related to prior authorization.

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

Two federal courts halted implementation of the Centers for Medicare & Medicaid Services' most favored nation model interim final rule. The seven-year model was set to begin Jan. 1, 2021, phasing in a reduced payment rate for 50 Medicare Part B drugs.

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 next phase of the Maternal and Infant Health Initiative (MIHI) includes a new focus on postpartum care visits, well-child visits, and decreasing rates of cesarean-section births in low-risk pregnancies. A work group developed a set of recommendations and a report on next steps for the MIHI.

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.

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

The Department of Health and Human Services’ Office of Civil Rights proposed modifications to the Health Insurance Portability and Accountability Act privacy rule as part of the agency's regulatory sprint to coordinated care.

The Health Resources and Services Administration finalized a rule creating a 340B Drug Pricing Program administrative dispute resolution process for covered entities and drug manufacturers; the rule marks a long-delayed implementation of an Affordable Care Act requirement.

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

The Department of Health and Human Services released a detailed action plan on maternal health and announced a public-private partnership to reduce maternal mortality and morbidity. The surgeon general simultaneously announced a call to action to improve maternal health, complementing HHS' plan.

The Medicare Outpatient Prospective Payment System final rule for calendar year 2021 continues cuts to hospitals in the 340B Drug Pricing Program and off-campus provider-based departments, and updates the overall hospital star ratings methodology.

CMS establishes a conversion factor of $32.41 — a decrease of $3.68 from CY 2020. The final rule also includes provisions related to Medicare reimbursement for telehealth services, the Quality Payment Program, and the Medicare Shared Savings Program.

In a notice of proposed information collection, the Centers for Medicare & Medicaid Services announced its intention to make changes to the Medicare cost report and accompanying instructions.

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.

The Dec. 8 webcast will offer hospitals information and resources to prepare for publishing standard charges, including negotiated rates, for all services in a machine-readable format and display prices of shoppable services in a consumer-friendly format.

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.

The Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) finalized rules in conjunction with HHS' regulatory sprint to coordinated care. The OIG rule modifies safe harbor protections; CMS’ rule targets undue burden of the physician self-referral law, or Stark law.

In an interim final rule with comment period, CMS announces a seven-year mandatory payment model set to go into effect Jan. 1. The Most Favored Nation rule builds on an International Pricing Index model; by issuing an interim final rule, the agency bypasses releasing a proposed rule.

The Centers for Medicare & Medicaid Services (CMS) on Dec. 1 will retire its original Hospital Compare tools, encouraging users to visit Medicare.gov’s new Care Compare tool to find and compare health care providers. CMS will not update the overall hospital quality star ratings in January 2021.

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.

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

The Medicaid and Children's Health Insurance Plan managed care final rule includes provisions to help reach Medicaid goals, increase network adequacy for managed care plans, and align quality rating approaches.

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.

In mid-September, CMS Administrator Seema Verma withdrew the Medicaid Fiscal Accountability Regulation (MFAR) via a tweet, citing stakeholder concerns. America's Essential Hospitals asserts formally withdrawing MFAR would be the best course of action both for CMS and stakeholders.

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.

The decision of the U.S. District Court for the Northern District of Illinois marks the first time a court ruled in favor of the plaintiffs on the merits of the legal challenges to the public charge rule. DHS immediately appealed the case, allowing continued enforcement while the appeal is pending.

The rule sets content elements a plan or issuer must disclose for a covered item or service. The rule also finalizes changes to the medical loss ratio program to allow issuers offering group or individual health coverage to receive credit for certain savings they share with enrollees.

In a letter to the Department of Homeland Security, America’s Essential Hospitals called on the department to withdraw a proposal that could affect the ability of essential hospitals to hire and retain international medical graduates in residency programs.

The threat involved malicious actors using Trickbot malware to compromise information technology systems, including by engaging in ransomware attacks, data theft, and the disruption of health care services.

The Office of the National Coordinator for Health Information Technology has pushed back the starting date for compliance with information blocking provisions from Nov. 2, 2020, to April 5, 2021.

The new FAQs specify that a provider may use PRF payments to cover the distribution of a COVID-19 vaccine licensed by the Food and Drug Administration. Providers also may use PRF funds to prepare for the distribution of a vaccine before it becomes available.

The Centers for Disease Control and Prevention has updated guidance for mask use on public transportation; the Food and Drug Administration has expanded its list of approved remote patient monitoring devices during the pandemic.

In Nov. 2 comments on the interim final rule, America's Essential Hospitals strongly opposed new hospital conditions of participation related to reporting COVID-19 data and urged the Centers for Medicare & Medicaid Services to withdraw these requirements.

In a response to Republican leaders of House and Senate committees with jurisdiction over the 340B Drug Pricing Program, America's Essential Hospitals said the program needs no fundamental reforms and continues to provide vital support to essential hospitals.

The interim final rule targets future vaccine costs, price transparency for COVID-19 tests, and enhanced Medicare payments for new COVID-19 treatments.

New email inboxes set up by the Department of Health and Human Services (HHS) and Centers for Medicare & Medicaid Services (CMS) will take questions about the updated guidance for hospital COVID-19 data reporting requirements as part of Medicare conditions of participation.

Hospital COVID-19 data is public on HHS Protect; FDA approves first treatment for hospitalized COVID-19 patients; CDC redefines "close contact."

International Infection Prevention Week, Oct. 18–24, highlights the role of infection preventionists in protecting health care workers and patients from COVID-19.

The Centers for Medicare & Medicaid Services added 11 new telehealth services to the list of Medicare services reimbursable during the COVID-19 public health emergency. The agency also published resources on Medicaid and Children’s Health Insurance Program coverage of telehealth services.

The Centers for Disease Control and Prevention created a vaccines web resource with helpful COVID-19 information. The Centers for Medicare & Medicaid Services announced new actions to pay for expedited COVID-19 test results.

The change would require certain visa holders completing medical education or training to proactively apply for an extension of status toward the end of their authorized period of stay.

Following the Supreme Court's denial of hospitals’ appeal petition, the D.C. Circuit’s decision upholding CMS' third-party payer final rule will stand. This allows CMS to require the offset of third-party payments in calculating the hospital-specific disproportionate share hospital payment limit.

The webinar series for hospitals and other stakeholders will review new requirements for reporting COVID-19 data as a Medicare condition of participation and feature administration subject matter experts.

NIH will study experimental COVID-19 treatments and support the development of six new testing technologies; FDA's vaccine committee will meet Oct. 22.

The proposed rules would deepen Medicare Part B cuts to hospitals in the 340B Drug Pricing Program, continue site-neutral payment policies, and revise the overall hospital star rating methodology. The association urged CMS to protect funding for essential hospitals and access to care.

An upcoming webinar and stakeholder toolkit support the new $20 billion general distribution of the Provider Relief Fund; the application period runs through Nov. 6.

America’s Essential Hospitals requested that HHS withdraw its recent Provider Relief Fund post-payment reporting guidance, as the agency's new definitions of the terms "lost revenue" and "expense" contradict its previous definitions and could have adverse consequences for essential hospitals.

CMS shares new guidance and FAQs on implementation of an interim final rule requiring COVID-19 data reporting as a Medicare condition of participation. The agency on Oct. 7 began sending letters regarding compliance status; hospitals that do not comply face termination from the Medicare program.

CDC reports that airborne transmission is rare but possible; a framework includes recommendations for equitable vaccine allocation.

The webpage includes checklists, step-by-step instructions, and FAQs to help hospitals comply with the Hospital Price Transparency Rule, effective Jan. 1, 2021. It also offers information to help consumers use the data.

Effective Oct. 23, Health and Human Services Secretary Alex Azar issued a renewal of determination that a public health emergency exists as a result of the continued effects of COVID-19.

A new $20 billion distribution of the Provider Relief Fund is open to eligible providers on the front lines of the pandemic, including those who already received PRF payments and need additional support, certain previously ineligible providers, and an expanded group of behavioral health providers.

CMS released a guide and online payment option for laboratories seeking approval to test for COVID-19; CDC studies COVID-19 in health care workers.

In a Sept. 25 letter to Congress, America’s Essential Hospitals urged lawmakers to include policies that bolster the health care safety net as part of legislative efforts to help rectify the unconscionable health inequities among vulnerable populations across the country.

House Democrats released a continuing resolution to maintain government funding through Dec. 11. The legislation would delay a $4 billion cut to Medicaid disproportionate share hospital funding and change the recoupment and repayment terms for the Medicare Accelerated and Advance Payment Program.

The Centers for Disease Control and Prevention reverses guidance that asymptomatic patients do not need to be tested. The agency also announced a new semiweekly publication summarizing COVID-19 studies.

In a letter to state Medicaid directors, CMS outlines lessons learned from previous initiatives, offers a comprehensive toolkit and examples of value-based care models, and highlights changes to existing flexibility.

An Operation Warp Speed strategy summarizes the federal government's plan for distributing and administering a COVID-19 vaccine.

More than 40 percent of U.S. adults report delaying or avoiding care due to COVID-19 fears; FDA shares vaccine development updates.

Nearly 250 members of Congress sent a bipartisan letter to Health and Human Services Secretary Alex Azar expressing concerns about recent actions by several drug manufacturers to impose policy changes that would undermine the 340B Drug Pricing Program.

Care Compare merges the agency's eight health care provider comparison tools into one interface; price and provider data are now available through an application programming interface.

The National Academies of Sciences, Engineering and Medicine released a preliminary framework for equitable allocations of a COVID-19 vaccine that rests on foundational principles, including maximizing benefits, fairness, mitigating health inequities, equal regard, evidence-based work, and transparency.

HHS announced that assisted living facilities can now apply for a relief fund payment from the second-phase general allocation. The agency also released information on how it will determine incentive payments under the nursing home allocation.

The finalized fiscal year 2021 Inpatient Prospective Payment System rule includes payment and quality reporting provisions. The rule goes into effect Oct. 1; CMS has waived the 60-day delay in effective date due to the COVID-19 public health emergency.

In a Sept. 1 letter, America's Essential Hospitals urged HHS to prioritize remaining Provider Relief Fund dollars for hospitals still in need, especially those that have yet to receive a payment from any targeted allocation, such as the safety-net and high-impact distributions.

CDC no longer encourages asymptomatic people to get tested; FDA expands its remdesivir emergency use authorization and authorizes a new antigen test with instant results.

The new frequently asked questions address how to report provider relief payments on cost reports, charges reimbursed through the Provider Relief Fund uninsured program, and Small Business Administration loan forgiveness amounts.

America's Essential Hospitals urges HHS to prevent drug manufacturers from restricting access to life-saving drugs in the 340B Drug Pricing Program. Manufacturers recently notified covered entities that the companies will cease shipping 340B-priced drugs to some pharmacies; other manufacturers are requiring biweekly data on all contract pharmacy claims.

Hospitals have until Sept. 14 to complete the 340B Drug Pricing Program recertification process. Covered entities that fail to create OPAIS accounts and conduct recertification will be removed from the program.

The Centers for Medicare & Medicaid Services in an interim final rule announced new Medicare condition of participation requirements for hospitals to report COVID-19 cases and related data to the Department of Health and Human Services.

Providers now have until Sept. 13 to apply for additional payment from the general allocation of the Provider Relief Fund. The initial deadline was Aug. 28.

Positive tests must be demonstrated using only the results of viral testing (i.e., molecular or antigen), consistent with CDC guidelines. The test may be performed either during or prior to the hospital admission.

CMS issued an information bulletin outlining two approaches for states to reflect third-party payer payments in calculations of uncompensated care costs used to determine hospital-specific Medicaid disproportionate share hospital limits.

FDA issued an emergency use authorization for convalescent plasma treatment of COVID-19 patients, along with guidance for pooled testing and screening.

HHS announces $6.5 million in testing investments; CDC issues antigen testing guidance; HHS partners with Moderna to manufacture and deliver its vaccine.

The agency announced that Medicare Part C enrollee days, otherwise known as Medicare Advantage days, would be included in the calculation of the Medicare fraction used to determine Medicare disproportionate share hospital payments for years prior to fiscal year 2014.

The Department of Health and Human Services will distribute $1.4 billion in Provider Relief Fund payments to nearly 80 free-standing children's hospitals.

The decision limits a block on implementation and enforcement of the Department of Homeland Security public charge rule to only three states: Connecticut, New York, and Vermont. The nationwide injunction on the Department of State's public charge rule is still in effect.

Medicare providers that did not receive payment from the $20 billion distribution from the general allocation can apply for additional funding through the portal; applications are due Aug. 28. HHS also announced a $5 billion allocation for nursing homes and long term–care facilities.

A new report, from a National Quality Forum (NQF) 25-person technical expert panel, provides insight on how quality measures can be combined in a system to improve health outcomes and drive high-value care for all.

The agency is using its discretion to allow premium credits to support continuity of coverage for individuals and families impacted by the COVID-19 public health emergency and facing difficulties paying premiums.

CDC onboards health departments to conduct electronic data reporting; HHS awards funding to Johnson & Johnson for vaccine manufacturing and delivery.

America's Essential Hospitals, along with five other national associations, calls for withdrawal of the proposed Medicaid Fiscal Accountability Regulation. In a letter, the groups note that the rule, if finalized, would exacerbate public health and economic uncertainty resulting from the pandemic.

The Medicare Outpatient Prospective Payment System proposed rule for calendar year 2021 would deepen cuts to hospitals in the 340B Drug Pricing Program, continue cuts to off-campus provider-based departments, and update the overall hospital star ratings methodology.

CMS proposes to decrease the conversion factor determining physician payment rates for specific services by $3.83. The proposed rule also includes provisions related to Medicare reimbursement of telehealth services, the Quality Payment Program, and the Medicare Shared Savings Program.

Health systems can add CDC's Coronavirus Self-Checker to their own website; HHS updates COVID-19 data reporting FAQs; CDC shares guidance on pooling tests.

The Health Resources and Services Administration Office of Pharmacy Affairs will hold an Aug. 12 webinar on the 2020 340B Drug Pricing Program recertification process. Hospitals must complete the recertification process by Sept. 14 to remain in the program.

The Department of Health and Human Services will extend the application deadline for Provider Relief Fund payments for eligible Medicaid and Children's Health Insurance Program providers, and will reopen the portal for Medicare providers to apply for additional payments from the general allocation.

A federal district court blocked for the duration of the public health emergency the nationwide implementation, application, and enforcement of a Department of Homeland Security rule expanding the types of public benefits immigration officials consider in making a public charge determination.

CDC releases a COVID-19 health equity strategy, and FDA shares options for screening substitutions amid supply issues.

The executive orders aim to end retrospective rebates to Medicare Part D pharmacy benefit managers; allow patients of federally qualified health centers to purchase certain drugs at 340B discounted prices; and tie Medicare Part B payment to international drug prices, among other provisions.

The COVID-19 pandemic has demonstrated the efficacy of telehealth. America's Essential Hospitals asked the administration to permanently expand the list of Medicare reimbursable telehealth services and allow reimbursement of certain services using audio-only technology.

Effective July 25, Health and Human Services Secretary Alex Azar issued a renewal of determination that a public health emergency exists due to COVID-19.

The annual 340B Drug Pricing Program recertification period for hospitals will run from Aug. 17 to Sept. 14. Covered entities that fail to recertify will be removed from the program.

The HHS Coronavirus Data Hub goes live; CDC guidance recommends a symptom-based strategy for COVID-19 patients. CMS data show an increase in telehealth use among Medicare beneficiaries. The IRS extends the deadline for tax-exempt hospitals to conduct a community health needs assessment.

HHS will pay $50,000 per eligible admission to hospitals with more than 161 COVID-19 admissions from Jan. 1 to June 10. The agency will account for funding received by hospitals in a May disbursement of high-impact funds in determining the amount facilities receive in this round.

HHS issues updated guidance on COVID-19 data reporting; an updated toolkit provides new guidance for alternate care sites to manage patient surge.

The changes aim to remove barriers to care coordination and allow additional information sharing for providers treating patients with substance use disorder.

A new members-only resource tracks relevant expiration dates for additional authority and flexibility options provided during the COVID-19 pandemic.

CMS announces the end of the blanket Extraordinary Circumstances Exception for quality reporting and value-based purchasing programs. HHS issues a remdesivir allocation fact sheet, and FDA approves a third influenza and COVID-19 combination diagnostic test.

In a July 6 letter, the association urged HHS to use a refined methodology that directs a portion of the remaining dollars in the Provider Relief Fund to hospitals filling a safety-net role that did not receive payment in the initial safety-net allocation.

In this second report on the topic, the agency describes three findings: there is no systematic or standard collection of social risk data; dual enrollment in Medicare and Medicaid remains a predictor of poor outcomes; and there are limited efforts to identify effective and scalable interventions.

The proclamation pauses the issuance of new non-immigrant employment-based visas until Dec. 31, 2020. The suspension excludes individuals whose entry is deemed in the national interest, including those providing care to hospitalized COVID-19 patients or conducting research on the pandemic.

HHS has acquired additional remdesivir to be sold at wholesale allocation price; CDC reports declining emergency department use during the pandemic and updates its list of conditions that increase risk of serious illness from COVID-19.