North America

Supreme Court Blocks OSHA Vax-or-Test ETS for Large Employers, Allows CMS Health Care Vax Rule

As explained in greater detail by our colleague Stuart M. Gerson, the Supreme Court of the United States handed down two major, and quickly decided, rulings on January 13, 2022. After hearing oral arguments only six days earlier, the Court issued two unsigned decisions per curiam. A 5-4 decision in Biden v. Missouri dissolved a preliminary injunction against enforcement of an interim final rule (“Rule”) promulgated by the Centers for Medicare & Medicaid Services (CMS), requiring recipients of federal Medicare and Medicaid funding to ensure that their employees are vaccinated against COVID-19.

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Supreme Court gives go ahead to healthcare workers vaccine mandate

The vaccine mandate covering healthcare workers took the same journey to the Supreme Court as the broader OSHA ETS, but ended with a much different outcome. In a 5-4 decision, the Supreme Court lifted the injunctions blocking the Centers for Medicare & Medicaid Services’ (CMS) vaccine mandate for healthcare workers opening the way for enforcement at healthcare facilities across the country. Read more…

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Guidance for employers following Supreme Court rulings on OSHA ETS and vaccine mandate for healthcare workers

Supreme Court stays the OSHA ETS

Now that the Supreme Court has reinstated a stay on the OSHA Emergency Temporary Standard that required employers of 100 or more employees to implement a “vaccine or test” policy, employers must decide how to proceed – with policies they may have already rolled out, with confidential medical information they may have already collected, and with expectations from employees on both sides of the COVID-19 vaccine divide. McDonald Hopkins’ Labor and Employment team has prepared guidance for employers on how to move forward with a continued focus on workplace safety and compliance.

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Podcast: No Surprises Act: New Rules and Guidance for Stakeholders (Part 2) – Diagnosing Health Care

In this episode of the Diagnosing Health Care Podcast:  The Biden administration has released a series of rules and guidance to implement the No Surprises Act, which went into effect on January 1. All providers and facilities must now provide a good faith estimate to uninsured and self-pay patients scheduling appointments for services or upon request.

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A Year in Review: Top 10 Privacy, Cybersecurity & Data Asset Management Issues in 2021

Throughout 2021, we closely monitored the latest privacy laws and a surge of privacy, cybersecurity, and data asset management risks that affect organizations, small and large. As these laws continue to evolve, it is important for companies to be aware and compliant. We will continue to monitor these trends for 2022.

The attorneys of the Privacy, Cybersecurity & Data Asset Management group have written on a wide range of notable developments and trends that affect employers and health care providers. In case you missed any, we have assembled a recap of our top 10 blog posts of 2021, with links to each, below:

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CMS “Splits the Baby” on Aduhelm—Medicare Coverage But Only with Evidence Development for Now

On January 11, 2022, the Centers for Medicare and Medicaid Services (“CMS”) published an anticipated proposed National Coverage Determination (“NCD”) decision memorandum that begins the process of determining whether the Medicare program will cover FDA-approved monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s Disease. (

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Plan Coverage of At-Home COVID-19 Testing

The Departments of Labor, Health and Human Services and the Treasury issued joint guidance mandating plan coverage of FDA-approved over-the-counter at-home COVID-19 diagnostic tests beginning January 15, 2022. The joint guidance was issued on January 10, 2022 in the form of FAQs.

Background of At-Home TestingUnder the Families First Coronavirus Response Act (FFCRA) and the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), group health plans and issuers must cover approved COVID-19 diagnostic testing without any cost-sharing requirements, prior authorizations, or other medical management requirements. Read more…

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Five Fast Facts on Boston’s Indoor Vaccine Mandate

Ready for the “new normal”? Starting January 15, 2022, Boston’s “B-Together” Vaccine Mandate (“the mandate”) will require certain indoor establishments to require proof of COVID-19 vaccination for entry from employees, contractors, and customers.

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Keep on Masking: NY Governor Extends Mask Mandate Through February 1, 2022

As we previously reported, in December New York Governor Kathy Hochul issued a mandate requiring that masks be worn in all indoor public places, unless the business or venue requires proof of vaccination for entry.  As part of the state’s “Winter Surge Plan 2.0”, the mandate, which was initially set to expire on January 15, has now been extended for an additional two weeks, through February 1, 2022.

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Unpacking Averages: Likelihood of FDA Medical Device Inspections

It is common for FDA and others to show a map of the United States with the states color-coded by intensity to showcase the total number of inspections done in that state.  Indeed, FDA includes such a map in its newly released dashboard for FDA inspections.  In reviewing that map with the U.S. map color-coded to reflect where medical device establishments are located, do you notice anything?  Not to destroy the suspense for you, but it turns out that FDA tends to inspect where medical device inspection facilities are located.  Really.

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