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.

A report highlights hospitalization risk factors for COVID-19, and GAO evaluates the National Disaster Medical System. FDA revokes emergency use authorizations for chloroquine phosphate and hydroxychloroquine sulfate.

In a closely split decision, the Supreme Court ruled the Trump administration unlawfully terminated the Deferred Action for Childhood Arrivals program. The decision allows an opportunity to rescind the program if the administration follows appropriate procedures.

HHS made public the 2018 Medicare cost report data sources used to determine eligibility for the $10 billion targeted safety-net allocation from the Provider Relief Fund. Hospitals had to meet three metrics to be eligible; 761 hospitals received payment.

Under the Federal Reserve Board proposal, certain hospitals and other nonprofits "of sound financial condition" prior to the public health emergency could be eligible to receive loans to help alleviate financial burden due to COVID-19.

The Department of Health and Human Services finalized a rule overhauling parts of the Affordable Care Act to remove nondiscrimination protections for transgender individuals and certain language access requirements for providing health care services to people with limited English proficiency.

New CDC guidance offers best practices to safely venture outside and begin to resume daily activities amid the COVID-19 pandemic, as well as information on using telehealth to expand access. CMS releases recommendations for non-emergent care in areas that are in Phase II of recovery.

Hospitals in the 340B Drug Pricing Program may begin using 340B drugs for patients seen at off-site locations before the hospitals officially register these clinics in the Office of Pharmacy Affairs Information System. This guidance is intended to last beyond the COVID-19 public health emergency.

HHS identified hospitals eligible for part of a $10 billion Provider Relief Fund allocation to aid safety-net providers. The agency also made public a list of total payments by state, including the number of hospitals in each state receiving a payment in this distribution.

In a letter to Senate leaders, America's Essential Hospitals outlines key legislative priorities to assist essential hospitals in the ongoing response to the COVID-19 public health emergency as Congress considers another supplemental bill.

New guidance provides details on COVID-19 lab test data reporting and flexible options for states implementing a Medicaid group for testing the uninsured.

The new options are detailed in a comprehensive table for each payment model. Notably, CMS will extend the Next Generation Accountable Care Organization model through December 2021.

CMS has issued blanket waivers and flexible options to increase hospital capacity, expand access to COVID-19 testing, promote telehealth, and augment the health care workforce. CMS is clarifying what requires usage of modifier “CR” or condition code “DR” when submitting claims to Medicare.

The Joint Commission will resume regular surveys of health care facilities; Gilead Sciences Inc. donates a second round of remdesivir to treat severe COVID-19 cases; CDC issues antibody testing guidelines.

CMS updates Medicare payment information to capture two new testing codes; FDA updates testing FAQs; CDC issues resources for reopening businesses and organizations.

The Department of Health and Human Services announced two distributions from the Public Health and Social Services Emergency Fund, known as the Provider Relief Fund: $4.9 billion for skilled nursing facilities and $500 million for Indian Health Service providers.

The president encouraged agency leaders to rescind, modify, waive, or provide exemptions from regulations and other requirements that could inhibit economic recovery in the aftermath of the COVID-19 public health crisis.

Providers have until June 3 to accept terms and conditions and submit necessary documentation to receive additional payments from the Provider Relief Fund to support providers incurring health care–​related expenses and lost revenue from response to the COVID-19 pandemic.

Early survey results from the Kaiser Family Foundation show implications of the unexpected pandemic upended previous budget projections as Medicaid enrollment is shown to grow rapidly during economic downturns and uncertainty.

CDC warns of an inflammatory syndrome in children with COVID-19. The agency also shares its serology surveillance strategy and guidance for resuming care unrelated to COVID-19.

The House approved the HEROES Act by a narrow margin. While the bill will not become law, it contains a number of provisions important to essential hospitals and for which the association will advocate in any final COVID-19 supplemental legislation.

The Centers for Medicare & Medicaid Services released its proposed fiscal year 2021 Inpatient Prospective Payment System rule, which includes payment and quality reporting provisions.

Hospitals interested in administering the donated experimental drug should contact their state health department.

HHS clarifies HIPAA rules for media; FDA tightens antibody testing rules and approves a home saliva test; the Missouri Hospital Association studies COVID-19 and race in St. Louis.

CMS issued the 2021 final notice of benefit and payment parameters rule and letter to issuers updating regulatory and financial standards for plans offered on the health insurance marketplaces. CMS provides detailed options for issuers to adopt value-based designs for marketplace plans.

Providers now have 45 days, increased from 30 days, to attest and accept the terms and conditions for payments from the Provider Relief Fund to support providers incurring health care–​related expenses and lost revenue from response to the COVID-19 pandemic.

America's Essential Hospitals expressed deep concern with the agency's ill-timed launch of the 340B Drug Pricing Program acquisition cost survey during this public health emergency.

CMS has updated its Medicaid and CHIP COVID-19 frequently asked questions (FAQ) document, which has been reorganized for greater usability. The new FAQs offer guidance on adjusting upper payment limit demonstrations, supplemental payments, and more to reflect pandemic response.

In a letter, America's Essential Hospitals urged the agency to reopen the comment period for the Medicaid Fiscal Accountability Regulation to allow stakeholders to address the proposed rule's impact, as the COVID-19 pandemic has fundamentally altered the health care and economic landscapes.

America's Essential Hospitals in a May 5 letter urged the Department of Health and Human Services to allocate $20 billion specifically to essential hospitals that serve large Medicaid and low-income patient populations, to ensure the stability of the nation’s health care safety net.

America's Essential Hospitals calls on the Health Resources and Services Administration to allow newly eligible entities and sites to immediately register and begin purchasing 340B drugs, suspend program audits, and disregard DSH payment adjustment percentage changes during the COVID-19 emergency.

A new study highlights racial disparities among COVID-19 patients; CDC updates testing and isolation guidelines and releases National Healthcare Safety Network data.

The rule requiring hospital-specific Medicaid DSH limit calculations to include payments from Medicare and commercial payers now is valid nationwide, with lower courts determining the effective date. Plaintiff hospitals filed a petition to appeal the decision to the United States Supreme Court.

This targeted allocation distributes $12 billion to 395 hospitals that provided inpatient care for 100 or more COVID-19 patients through April 10. Of that total, $2 billion is allocated to hospitals based on Medicare and Medicaid disproportionate share hospital (DSH) and uncompensated care payments.

CDC revised its testing guidance to reflect six new COVID-19 symptoms: chills, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell. HHS released a Workforce Virtual Toolkit, and CMS released a State Medicaid and CHIP Telehealth Toolkit.

Hospitals can now register as participating providers to receive reimbursement for COVID-19 testing and treatment services furnished to uninsured patients on or after Feb. 4. Participating providers can begin submitting claims May 6.

The survey will run April 24 to May 15 and requests drug acquisition costs from all hospitals participating in the 340B Drug Pricing Program, except critical access hospitals. CMS might use data collected through the survey to determine Medicare Part B drug reimbursement rates.

HHS opened the verification portal for providers to submit patient revenue data for payments from the general allocation of the COVID-19 provider relief fund. The agency also answered frequently asked questions and posted a fact sheet to aid providers requesting and attesting to receipt of payments.

The bipartisan legislation provides $484 billion in resources across the Department of Health and Human Services and the Small Business Administration, including an additional $75 billion for the Public Health and Social Services Emergency Fund for providers.

The Department of Health and Human Services announced April 22 how it will allocate more than $70 billion in COVID-19 provider relief under the CARES Act, including targeted aid for hospitals and other providers on the front lines of the pandemic.

Hospitals now have until April 25 at 3 pm ET to submit data to HHS that will inform how the agency will allocate $10 billion in COVID-19 provider relief funds in areas most impacted by the pandemic.

HHS announced additional detail on how the agency intends to distribute the COVID-19 relief fund to hospitals and other providers. HHS will allocate funds through a general approach and use a targeted approach for certain hospitals, rural providers, and Indian Health Services.

The agency provides recommendations for resuming non-essential care for services that cannot be virtually delivered and for health care systems and facilities in regions with low incidence of COVID-19.

CMS announced waivers for IPPS and long-term care hospitals; Medicare will nearly double payment for select COVID-19 tests; CDC developed a new National Healthcare Safety Network COVID-19 module.

CMS released new COVID-19 FAQs for state Medicaid and CHIP agencies, providing additional guidance on Medicaid provisions in the Families First Coronavirus Response Act and the Coronavirus Aid, Relief, and Economic Security (CARES) Act. 

Congress should increase emergency funding for hospitals on the front lines of the COVID-19 epidemic, target hospitals in greatest need, adjust Medicaid to help essential hospitals, and provide other financial and regulatory relief.

HHS has distributed $30 billion of the COVID-19 provider relief fund. Providers have 30 days from receipt of their payment to complete attestation and agree to terms and services or return the payment.

New CDC guidance requires face coverings for all who enter a health care facility. HHS Secretary Azar issues FAQs on testing and reporting requirements. Federal agencies warn about scams related to COVID-19.

In an April 10 letter, America's Essential Hospitals urged the agency to target critical relief to essential hospitals, expressed concern about disbursements based on Medicare payments, and offered general metrics to identify and support providers serving Medicaid and low-income patients.

To ensure essential hospitals have proper resources to respond to the COVID-19 pandemic, America's Essential Hospitals asked the Department of Labor to clarify the emergency exception under the Fair Labor Standards Act and the 500-employee threshold of the Families First Coronavirus Response Act.

The fund, authorized by the CARES Act, intends to support providers incurring health care–related expenses and lost revenue from COVID-19 pandemic response.

Eligible health care providers now can apply for funding for information services, telecommunications services, and devices to provide telehealth during the COVID-19 pandemic.

Providers will receive direct deposits of their share of the $30 billion based on 2019 Medicare fee-for-service payments.

HHS sends rapid tests to public health labs and issues a HIPAA enforcement notice; CDC recommends cloth masks; a new OIG report details hospital challenges amid the pandemic.

The short-term COVID-19 Telehealth Program will offer $200 million in immediate relief to providers to purchase technology and device, and the three-year Connect Care Pilot Program will provide $100 million to support connected health services and technology for eligible providers.

The Centers for Medicare & Medicaid Services issued various waivers to increase hospital capacity, expand the health care workforce, eliminate certain paperwork requirements, and further promote telehealth.

America's Essential Hospitals distills recent CMS guidance on enhanced Medicaid funding for essential hospitals during the COVID-19 pandemic.

Secretary Azar requested governors allow health care providers to practice across state lines and relax scope of practice requirements.

FDA will not object to the use of improvised face masks; a CDC tool helps health care providers estimate their personal protective equipment supply.

CMS releases guidance for hospitals in quality reporting programs; CDC updates guidelines for testing and handling COVID-19 specimens.

The new waivers and flexible options are designed to increase hospital capacity, rapidly expand the health care workforce, temporarily eliminate certain paperwork requirements, and promote telehealth in Medicare.

The association calls on HHS to design a mechanism to distribute funds made available by the Coronavirus Aid, Relief, and Economic Security Act to hospitals serving vulnerable communities and complex patients and facing other challenges during this public health emergency.

The administration has issued guidance making policy changes related to Medicare payment, mandated paid leave, and hospital reporting requirements related to COVID-19.

President Trump has signed a $2 trillion package of COVID-19 aid that provides $100 billion to hospitals and other providers, averts cuts to Medicaid disproportionate share hospital (DSH) payments, suspends Medicare sequester cuts, and includes numerous other relief measures.

CMS issued a frequently asked questions document on how the agency will implement enhanced Medicaid funding to states to support COVID-19 response. The 6.2 percent increase in the Federal Medical Assistance Percentage was included in the Families First Coronavirus Response Act, made law on March 19.

As the Senate continues work on a third legislative package to address public health and economic needs during the COVID-19 crisis, House Democrats introduced an alternative that includes provisions important to essential hospitals and key changes absent in the Senate bill.

The March 20 letter details additional action needed to support essential hospitals as they respond to the pandemic. The letter also explains how essential hospitals face significant financial challenges as they work on the front lines of public health threats.

CDC recommends shelters plan for higher usage during the outbreak and consult with community leaders, local public health departments, and faith-based organizations about places to refer clients if a shelter space is full.

HHS announced new flexibility to increase coverage of Medicare telehealth services during the COVID-19 crisis. In separate guidance, HHS’ Office of Inspector General will allow providers to use a variety of audio and video communication platforms without incurring penalties under HIPAA.

CMS issues elective surgery guidance, telehealth toolkits, and information on quality reporting flexibility amid the COVID-19 pandemic; The Joint Commission suspends regular surveys.

The Health Resources and Services Administration (HRSA) has created a webpage with COVID-19 resources for providers participating in the 340B Drug Pricing Program. HRSA acknowledges 340B covered entities will need additional flexibility pertaining to program compliance during the COVID-19 crisis.

CMS issued several checklists and templates for state Medicaid and the Children's Health Insurance Program agencies to request regulatory relief and flexibility to respond to the COVID-19 outbreak.

An alert from U.S. Citizenship and Immigration Services clarifies testing, treatment, and preventive care — including a vaccine, if one becomes available — related to COVID-19 will not be considered as part of a public charge inadmissibility determination.

President Trump declared a national emergency as the number of confirmed COVID-19 cases in the U.S. nears 3,500. CMS responds to concerns about complying with Emergency Medical Treatment and Labor Act requirements and CDC released updated infection control guidance for health care providers.

America's Essential Hospitals expressed concern that a proposed drug acquisition cost survey exceeds CMS authority under Medicare statute and would impose excessive burden on hospitals in the 340B Drug Pricing Program.

The rules, intended to increase interoperability and improve patients’ access to their health information, finalize provisions related to the MyHealthEData initiative and implement provisions of the 21st Century Cures Act.

As U.S. cases of the new coronavirus rise to more than 400, the agency updates guidelines for testing patients and for health care workers exposed to COVID-19.

The new code applies to tests conducted outside CDC laboratories; CMS also issued frequently asked questions and fact sheets about COVID-19–related billing.

In a memo to state survey agencies and accrediting organizations, CMS announced it will focus survey activities solely on infection control until further notice and provided guidance for patient triage and nursing homes.

This decision is the latest of several court cases invalidating work requirements policies in Medicaid; Utah now is the only state with these requirements in effect. It is unknown at this time if Michigan or the Department of Health and Human Services will appeal the decision.

The report, mandated by the 21st Century Cures Act, highlights issues and challenges pertaining to the use of health information technology and electronic health records (EHRs) in four categories: clinical documentation; usability and the user experience; EHR reporting; and public health reporting.

These cases bring the total number of COVID-19 cases detected and confirmed in the United States to 16. The Centers for Disease Control and Prevention and the Food and Drug Administration have issued new guidance and resources to prevent the spread of the virus and improve testing.

The Supreme Court announced it will review the court decision finding the Affordable Care Act’s individual mandate unconstitutional. The case, now expected to be heard this fall with a decision likely in 2021, will determine the fate of the law.

The agency announced it will count patients repatriated by the Department of State separately from other cases. Additionally, the World Health Organization developed an emergency ICD-10 code for COVID-19.

A new proposed rule would extend the Comprehensive Care for Joint Replacement (CJR) model by three years and add outpatient knee and hip replacement to the definition of a CJR episode. Comments are due to CMS by April 24.

The Department of Homeland Security will implement its expanded definition of public charge nationwide until five district courts decide on the lawfulness of change. Meanwhile, the Department of State also will begin using the expanded definition for those seeking visas.

In a new Modern Healthcare commentary, association President and CEO Bruce Siegel explains that the proposed Medicaid Fiscal Accountability Regulation would do more to shrink Medicaid than to contribute to program integrity and transparency.

In the unanimous decision, the United States Court of Appeals for the District of Columbia Circuit found that the Department of Health and Human Services failed to adequately assess the potential impact of work requirements on coverage under Arkansas' Section 1115 demonstration waiver.

Administrator Verma writes that provisions of the Medicaid Fiscal Accountability Regulation are meant to ensure transparent and lawful use of taxpayer resources to fund Medicaid. She contends that nothing in the proposal is meant to reduce Medicaid funding or prohibit supplemental payments.

The new coronavirus — now officially called COVID-19 — has infected 15 people in the United States. The Centers for Disease Control and Prevention released new guidance for health care providers to help with risk assessment, monitoring, and work restriction decisions.

Comments on a proposed acquisition cost survey to inform Outpatient Prospective Payment System payment rates for 340B drugs are due March 9.

The proposal calls for $920 billion in cuts to Medicaid funding, including a call to finalize the Medicaid Fiscal Accountability Regulation.

The new authorization allows any CDC-qualified laboratory to use the 2019-nCoV diagnostic test. Each test kit can evaluate up to 800 patient samples.

A new rule allows CDC to require that airlines collect and provide data on passengers and crew arriving from foreign countries for health education, treatment, prophylaxis, or other public health interventions.

GAO found that state Medicaid programs did not always have written procedures to identify 340B drugs and prevent duplicate discounts. Even when states have written policies and procedures, GAO found they were not always adequate to prevent duplicate discounts.

CMS issued the 2021 notice of benefit and payment parameters proposed rule and draft letter to issuers updating regulatory and financial standards for plans offered on the health insurance marketplaces. CMS is not proposing any changes to network adequacy standards.

The agency reports that cybercriminals could send "phishing" emails purporting to include infection prevention information related to the new coronavirus (2019-nCOV) outbreak.

The Department of Homeland Security will evaluate applications for immigration benefits postmarked or submitted electronically on or after Feb. 24. The agency will not consider any newly added public benefit categories that the applicant received before Feb. 24.

CMS issued guidance outlining how states can receive a block grant or per-capita cap in exchange for additional administrative flexibility. Through a Section 1115 demonstration waiver, these new financing arrangements would apply to coverage of optional Medicaid patient populations.

In response to a joint proposal, America’s Essential Hospitals expressed concern about mandating the public posting of payer-specific negotiated rates and urged the departments of Labor, Treasury, and Health and Human Services to seek alternatives that better serve consumers.

In its submitted comments, the association outlines overarching and specific problems that necessitate withdrawal of the rule to protect the stability and viability of the Medicaid program.

CMS plans to transition to a unified Medicare Care Compare portal this spring that will combine and standardize the eight existing tools and allow a single point of entry for quality information.

This month’s data refresh is based on the existing, flawed methodology used during the last update of star ratings in February 2019.

Five cases of the coronavirus have been reported in the United States; CDC will host a Jan. 31 call for clinicians to share updated guidance about the virus.

DHS now can enforce the public charge rule everywhere but Illinois. The stay on the injunction will remain in place until the Court of Appeals for the Second Circuit makes a final decision on the merits of the government’s appeal.

Despite a growing awareness of the impact of social determinants of health on patient health outcomes, the CMS study found challenges to consistent data collection, including a lack of standardized screening tools and inconsistent use of electronic health record codes.

CMS issued a request for information seeking input on coordinating care from out-of-state providers for medically complex children who are eligible for Medicaid coverage. The agency will use the information collected to produce guidance to state Medicaid directors.

The issues are related to the validation process for Windows Elliptic Curve Cryptography certificates and the Windows remote desktop client. The Department of Health and Human Services is urging health care providers to install patches to minimize their risk.

In an amicus brief, America's Essential Hospitals joined other national hospital associations in calling for an expedited Supreme Court review of a case that will determine the future of the Affordable Care Act. The court on Tuesday denied the expedited schedule.

A panel convened by the National Institutes of Health culminated in an evidence report that includes 26 recommendations for improving implementation of proven services to reduce disparities in preventable conditions.

The statutorily required report reviews rules and oversight for institutions for mental disease in seven states. Meanwhile, CMS announced it will integrate the psychiatric hospital program survey into its larger survey to determine compliance with Medicare conditions of participation.

The recommendations come after a GAO review of more than 250 nongovernmental hospitals found several issues with how the Health Resources and Services Administrative oversees 340B program compliance.

In an informational bulletin to state Medicaid agencies, CMS provides best practices to avoid duplicate discounts on drugs purchased through the 340B Drug Pricing Program.

The new guidelines reflect revised conditions of participation in the September 2019 discharge planning and burden reduction final rules.

CMS granted a 15-day comment period extension for the Medicaid Fiscal Accountability Regulation. Comments are now due to the agency on Feb. 1, 2020.

America’s Essential Hospitals said the federal Anti-Kickback Statute and Physician Self-Referral Law should be modified to remove barriers to coordinating care for the complex patients essential hospitals serve.

Congress approved and the president signed a fiscal year 2020 spending package that delays through May 22, 2020, a $4 billion cut to Medicaid disproportionate share hospital payments.

A U.S. Court of Appeals panel upheld a ruling on the constitutionality of the individual mandate but returned the case to a lower court to decide whether that nullifies the entire law.

The agency announced awardees for two new models that seek to improve care coordination for children and for mothers with opioid use disorder.

The report is based on feedback gathered during a September listening session, in which more than 300 stakeholders shared recommendations for improving predictability, stability, and relevance of star ratings.

Through this newly approved Section 1115 demonstration waiver, South Carolina becomes the first state to apply work requirements primarily to parents and caregivers.

Beginning Jan. 1, 2020, CMS will start to adjust claims that were paid at the reduced rate. The agency also filed a notice appealing its case to the U.S. Court of Appeals for the District of Columbia Circuit.

America’s Essential Hospitals expressed concern that a proposed drug acquisition cost survey would impose excessive burden on hospitals and raise many operational challenges.

In a letter to the Department of State, America’s Essential Hospitals expressed concern that broadening the definition of public charge would harm the nation’s health care system, vulnerable patients, and state and local economies.

The agency published new requirements for hospitals to publicly post standard charges, including information based on rates negotiated with third-party payers. 

The agency proposes to increase transparency in Medicaid supplemental payments and impose more stringent requirements on those payments and their financing for states and providers.

This year’s update contains new quality and accountability measures and new national context data.

A new brief summarizes program recommendations from an expert panel, which included America's Essential Hospitals staff.

The move aims to give researchers a better understanding of key Medicaid and Children's Health Insurance Program information, including on utilization and spending under Medicaid managed care.

CMS also approved a unique behavioral health transformation waiver for the District of Columbia that targets beneficiaries with serious mental illness or serious emotional disturbance.

Health care providers have until Dec. 3 to download their preview reports, which include overall hospital quality star ratings.

The final rule includes provisions related to the Quality Payment Program, evaluation and management services, telehealth services, and the Medicare Shared Savings Program.

In a separate, forthcoming final rule, the Centers for Medicare & Medicaid Services will summarize and respond to the more than 1,400 public comments it received about proposed requirements for hospitals to make public their standard charges.