News & Analysis as of

Rulemaking Process Executive Orders Coronavirus/COVID-19

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Benesch

November Ends With Flurry of Litigation Regarding Various COVID Vaccine Mandates

Benesch on

As November came to an end, federal courts across the country continue to examine and issue preliminary rulings on challenges to various COVID vaccine mandates put in place by the Biden Administration. At the beginning of...more

Foley & Lardner LLP

CMS Requires COVID-19 Vaccination for Health Care Facility Staff

Foley & Lardner LLP on

On November 4, 2021, the Centers for Medicare & Medicaid Services (CMS) issued an interim final rule that requires most Medicare and Medicaid certified providers and suppliers to vaccinate staff members within 60 days. The...more

Womble Bond Dickinson

The Biden Administration Expands Staff Vaccination Requirement to All Medicare & Medicaid Participating Providers/Suppliers.

Womble Bond Dickinson on

The Biden Administration, through the Centers for Medicare and Medicaid Services (“CMS”) and via Interim Final Rulemaking (“IFR”), has expanded vaccination requirements in many health care settings. Effective November 5,...more

Benesch

OSHA to Develop Rule Requiring All Employers with 100+ Employees to Implement Vaccine Mandate

Benesch on

On September 9, 2021, President Biden announced his administration’s “action plan” for finding a “path out of the pandemic.” President Biden has directed OSHA to develop a rule that will require all employers with 100 or more...more

Ruder Ware

Supreme Court of Wisconsin Ends State Mask Mandate on March 31

Ruder Ware on

Yesterday, March 31, 2021, the Supreme Court of Wisconsin ended the state-wide mask mandate after finding Executive Order (EO) #105 to be unlawful, ending it immediately.  Governor Tony Evers issued EO #105 shortly after the...more

K&L Gates LLP

Health Care Triage: What AMCs May Expect in Health Care Policy Priorities from the New Congress and the Biden Administration

K&L Gates LLP on

In this episode, Health Care partner Rebecca Schaefer interviews Karishma Page, partner of the firm’s Public Policy and Law practice group, on what is likely to be coming down the pike in the health care policy landscape of...more

Bradley Arant Boult Cummings LLP

New Administration, New DOL Approach: Department Pulls Back Trump Rulemaking Limitations

With the new Biden administration now in place, the Department of Labor (DOL) has withdrawn a Trump era measure on guidance documents. Following a recent Executive Order, the DOL issued a final rule on January 27 to rescind...more

Snell & Wilmer

President Biden Focuses on Strengthening COVID-19 Workplace Compliance

Snell & Wilmer on

Occupational Safety & Health Administration (OSHA) issues and proposed actions took center stage in the first week of the Biden Administration. The President called for greater enforcement by OSHA of more stringent worker...more

Sheppard Mullin Richter & Hampton LLP

Permanent Expansion of Medicare Telehealth Services

On December 1, 2020, the Centers for Medicare and Medicaid Services (“CMS”) released the annual Physician Fee Schedule final rule (“Final Rule”) which, among other things, aimed to further President Trump’s October 3, 2019...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Wisconsin Supreme Court Invalidates State’s ‘Safer at Home’ Order

On May 13, 2020, the Wisconsin Supreme Court issued its decision in Wisconsin Legislature v. Secretary-Designee Andrea Palm, et al. and declared the state’s Safer at Home Order unlawful, invalid, and unenforceable, creating a...more

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