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Maryellen Guinan

Principal Policy Analyst

Maryellen Guinan is a principal policy analyst at America's Essential Hospitals.

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.

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

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

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

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

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

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

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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.

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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.

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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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