UPDATE: CMS Issues COVID-19 Vaccination Interim Final Rule for Healthcare Facilities

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.

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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 advises healthcare and life sciences clients across a variety of corporate, transactional and regulatory compliance matters. Working with hospitals, physician practice groups, clinical research programs, pharmaceutical companies, device manufacturers and others, Greg provides counsel on healthcare fraud and abuse risks, Medicare, Medicaid, and private payor billing, and clinical research and laboratory compliance in connection with federal grants, among other issues. Greg also provides regulatory due diligence support on healthcare transactions and collaborations, helping his clients drive innovation and expand their businesses. Read Gregory Fosheim’s full bio.


Jason Caron
Jason B. Caron provides strategic advice to healthcare and life sciences organizations, primarily focusing on regulatory, reimbursement and policy matters. He has extensive experience navigating coding, coverage, payment, medical necessity, clinical documentation, comparative research, certification, enrollment, and other payer participation and reimbursement issues, particularly in light of ongoing health reforms.Read Jason B. Caron'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.

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