On November 16, 2021, 12 states—Montana, Alabama, Arizona, Georgia, Idaho, Indiana, Louisiana, Mississippi, Oklahoma, South Carolina, Utah and West Virginia—filed a complaint in the US District Court for the Western District of Louisiana requesting that the Interim Final Rule with comment period (IFR) that put in place the vaccination mandate applicable to certain covered healthcare facilities and staff be declared arbitrary and capricious, contrary to law and in excess of the Centers for Medicare and Medicaid Services’ (CMS) statutory authority. CMS published an IFR on November 5, 2021, that implements the Biden administration’s previously announced vaccine mandate for healthcare facilities. The expansive IFR applies to more than a dozen types of healthcare providers and suppliers (facilities), affects more than 10 million healthcare staff and carries an anticipated potential price tag in excess of $1.3 billion dollars for the first year of implementation.
UPDATE: CMS Issues COVID-19 Vaccination Interim Final Rule for Healthcare Facilities
Tags: 42 U.S.C. § 1302, 42 U.S.C. § 1395z, Administrative Procedure Act, Biden administration, CMS, COVID-19, Emergency Temporary Standard, ETS, healthcare facilities, Interim Final Rule with comment period, Medicaid, Medicare, OSHA, The Centers for Medicare and Medicaid Services, the Occupational Safety and Health Administration, US District Court for the Eastern District of Missouri, US District Court for the Western District of Louisiana, vaccine
Sandra M. DiVarco
Sandra (Sandy) M. DiVarco focuses her practice on the representation of hospitals and health systems. She has counseled health care facility and system clients regarding all aspects of health law transactions and health system restructurings. Read Sandra DiVarco's full bio.
Gregory Fosheim
Gregory E. Fosheim provides counsel on a wide array of corporate, transactional and regulatory compliance matters across the healthcare and life sciences industry. Drawing on his extensive laboratory and public health background and insight, he regularly advises on clinical and diagnostic laboratory matters, anatomic pathology and fertility laboratory compliance. Greg also represents hospitals, health systems and physician practice management companies in all aspects of transactional and operational matters, particularly those with regulatory, licensing, accreditation and policy considerations, and he has negotiated several acquisitions and sales of proton therapy centers. Read Gregory Fosheim’s full bio.
Lauren Knizner
Lauren leverages her health-related legal background to advise clients on regulatory matters impacting the health care industry. Her work focuses on helping clients successfully engage in the federal regulatory process to advance health policy advocacy efforts, including engaging in federal agency rulemaking processes and working with agency officials to develop and improve agency guidance. Lauren works with a wide variety of clients in the health care industry, including hospitals and health systems, trade and professional associations, pharmaceutical and medical device manufacturers, and health information and technology companies. Lauren’s work focuses on several areas, including Medicare reimbursement issues, Medicare value based care models, and Medicare telehealth policy. Read Lauren Knizner's full bio.
Kristen O'Brien
Kristen O’Brien is an accomplished healthcare executive with a deep understanding of regulatory advocacy and healthcare policy efforts. Kristen offers a strong background and a keen eye for solutions to barriers and challenges impacting healthcare clients. With more than 10 years of experience, her work focuses on implementing new laws through the rulemaking process, as well as working with relevant agency officials to develop and improve agency guidance. Read Kristen O’Brien's full bio.
Sandra (Sandy) M. DiVarco focuses her practice on the representation of hospitals and health systems. She has counseled health care facility and system clients regarding all aspects of health law transactions and health system restructurings. Read Sandra DiVarco's full bio.
Gregory Fosheim
Gregory E. Fosheim provides counsel on a wide array of corporate, transactional and regulatory compliance matters across the healthcare and life sciences industry. Drawing on his extensive laboratory and public health background and insight, he regularly advises on clinical and diagnostic laboratory matters, anatomic pathology and fertility laboratory compliance. Greg also represents hospitals, health systems and physician practice management companies in all aspects of transactional and operational matters, particularly those with regulatory, licensing, accreditation and policy considerations, and he has negotiated several acquisitions and sales of proton therapy centers. Read Gregory Fosheim’s full bio.
Lauren Knizner
Lauren leverages her health-related legal background to advise clients on regulatory matters impacting the health care industry. Her work focuses on helping clients successfully engage in the federal regulatory process to advance health policy advocacy efforts, including engaging in federal agency rulemaking processes and working with agency officials to develop and improve agency guidance. Lauren works with a wide variety of clients in the health care industry, including hospitals and health systems, trade and professional associations, pharmaceutical and medical device manufacturers, and health information and technology companies. Lauren’s work focuses on several areas, including Medicare reimbursement issues, Medicare value based care models, and Medicare telehealth policy. Read Lauren Knizner's full bio.
Kristen O'Brien
Kristen O’Brien is an accomplished healthcare executive with a deep understanding of regulatory advocacy and healthcare policy efforts. Kristen offers a strong background and a keen eye for solutions to barriers and challenges impacting healthcare clients. With more than 10 years of experience, her work focuses on implementing new laws through the rulemaking process, as well as working with relevant agency officials to develop and improve agency guidance. Read Kristen O’Brien's full bio.