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Paxlovid Access and Education: Hennepin Healthcare’s Approach

Hennepin Healthcare, in Minneapolis, ensured optimal Paxlovid access by utilizing a local courier service and taking a proactive approach to medication safety.

COVID-19: Long COVID-19 Action Plan, ASPR Paxlovid Resource

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.

COVID-19: Adolescent Vaccine Approved, Pharmacists May Prescribe Paxlovid

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

COVID-19: FDA Recommends Omicron-Specific Booster, Pfizer Seeks Paxlovid Approval

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

COVID-19: Post-PHE Planning; Pediatric Booster Authorized

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.

COVID-19: Second Booster Authorized for Older, Immunocompromised People

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

COVID-19: Pediatric Vaccine Delayed; Bebtelovimab Authorized

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

COVID-19: Virus Transmission; Pfizer Vaccine Authorized for Ages 12–15

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

COVID-19: No-Cost, At-Home Tests to End, CDC Fall Vaccination Plan

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.

CMS Issues FY 2023 IPPS Final Rule

The rule from the Centers for Medicare & Medicaid Services includes numerous policy and payment changes important to essential hospitals, including a 4.3 percent increase in inpatient payment rates for fiscal year 2023.

CMS Issues FY 2023 IPPS Final Rule

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.

On the Hill: Senate Works to Finish Reconciliation before Recess

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

COVID-19: HHS Secures Moderna Bivalent Vaccine Doses, CDC Releases Booster Safety Update 

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.

COVID-19: FDA Committee to Deliberate Vaccine Composition

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.

COVID-19: CDC Recommends Moderna, Pfizer Vaccines for Children

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.

Florida Declines to Preorder COVID-19 Vaccines for Young Children

The Florida Department of Health does not recommend COVID-19 vaccines for “healthy children” and will not facilitate statewide vaccine distribution; health care providers still may order vaccines directly from the federal government.

COVID-19: FDA Committee to Review Vaccine Authorization Requests

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.

COVID-19: FDA Revises Treatment EUAs, Issues Fraud Warning

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

COVID-19: Pfizer Pediatric Vaccine Data; Booster Eligibility Expanded

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.

COVID-19: Janssen Limits, Vaccines Linked to Medicare Savings

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.

CMS Issues FY 2023 IPPS Proposed Rule

The proposed rule includes numerous policy and payment changes for Medicare’s Inpatient Prospective Payment System for fiscal year 2023, including a 3.2 percent increase in inpatient payment rates.

COVID-19: New Subvariant on Rise, Moderna Seeks Pediatric EUA

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.

COVID-19: Moderna Bivalent Booster, CDC Forecasting Center

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

CMS Releases FY 2023 IPPS Proposed Rule

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.

COVID-19: Long COVID-19 Initiative; Sotrovimab Authorization Limited

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

COVID-19: New Booster Recommendations, Site

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

COVID-19: Vaccine Effectiveness; Pfizer, Moderna Request EUA for Fourth Shot

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

COVID-19: Public Transit Mask Mandate, Test-to-Treat FAQs

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.

COVID-19: Community Levels Framework; Accessibility Plan

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.

Premier Health Partners with Professional Society for Vaccine Equity

The Dayton, Ohio, health system has built a valuable partnership with a community organization of Black health care professionals to confront disparities.

COVID-19: National Emergency Extended; Post-Infection Conditions

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

COVID-19: Pediatric Vaccine Application; Medicare Coverage of Testing

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.

COVID-19: Moderna Vaccine Approved; Omicron Variant Strains Health Systems

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

COVID-19: N95 Mask Distribution, Vaccine Studies

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

COVID-19: Vaccine Mandate Ruling; Testing and Therapeutics Access

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.

COVID-19: Revised Booster Guidance, Supreme Court Vaccine Mandate Arguments

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.

COVID-19: Guidance Updates, Authorization of Antiviral Pills

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

COVID-19: Pfizer Booster Expanded; FDA Authorizes Preventive Monoclonal Antibodies

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.

SAMHSA to Issue $30M in Harm Reduction Grants

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.

COVID-19: Omicron Variant Reaches U.S.; Vaccine Mandate on Hold

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.

States Respond to COVID-19: N.Y. Declares Disaster Emergency

New York is experiencing a surge in COVID-19 transmission rates. An executive order from the governor authorizes all state agencies to take appropriate action to assist local governments and individuals in combating COVID-19, including delaying non-essential elective procedures, until Jan. 15, 2022.

COVID-19: Vaccine Booster Eligibility, Oral Antiviral Medication

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

COVID-19: CDC Recommends Pfizer Vaccine for Children

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.

COVID-19: FDA, CDC Recommend Boosters; Plan to Vaccinate Children

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

COVID-19: FDA Panel Endorses Moderna, Janssen Boosters

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.

COVID-19: FDA, CDC Recommend Pfizer Booster Shot

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.

COVID-19: FDA Votes on Boosters, CDC Infection Control Funding

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.

COVID-19: CDC Recommends Pfizer Vaccine, Warns Against Ivermectin

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.

CMS Grant Opportunity for Crisis Care

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

Administration Releases First Phase of Surprise Billing Regulations

The rule, released by the departments of Health and Human Services, the Treasury, and Labor and the Office of Personnel Management, bars health care insurers, carriers, and providers from billing patients more than in-network cost sharing amounts in certain circumstances.

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