Healthcare Law Blog

Shaping the World of Healthcare Law

On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs) or were subject to relaxed enforcement policies during the COVID-19 pandemic. Acknowledging that the COVID-19 emergency will not last forever, the FDA’s recent draft guidances propose a 180-day transition path

On January 6, 2022, the Centers for Medicare and Medicaid Services (“CMS”) issued the proposed rule on  Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the “Proposed Rule”).  Per CMS, the Proposed Rule will reduce out-of-pocket prescription drug costs, improve price transparency and market competition

In its December Hospital Flash Report, Kaufman Hall identified and reviewed the continued, negative impact of COVID-19 on hospital operating margins. After a dramatic drop in hospital margins during the height of the pandemic in 2020 and early 2021, hospitals experienced a fluctuation of decreasing and increasing margins in the latter-half of the year.

Scope of practice expansion has been a hot-button issue within medical communities and state legislatures for more than thirty years. The debate is centered on what services advanced practice providers (“APPs”) who hold Master’s Degrees (e.g., Physician Assistants, Nurse Practitioners, Pharmacists, Dental Hygienists, etc.) should or should not be able to furnish in their professional

Physicians and other providers can take a deep breath as Congress has acted to prevent the trio of Medicare payment cuts that were set to take effect at the beginning of 2022—a 3.75% cut due to scheduled changes in the Medicare Physician Fee Schedule (“PFS”), a 2% cut for Medicare sequestration, and a 4% Statutory

On December 2, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a memorandum (the “CMS Memo”) addressing survey and enforcement of the COVID-19 vaccine requirement applicable to Medicare and Medicaid participating healthcare providers and suppliers and their staff. The CMS Memo was issued in response to preliminary injunctions against the implementation and enforcement

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will be taking actions to advance its strategic commitment to drive innovation to support health equity and high quality, person centered care. CMS’ 2022 Physician Fee Schedule final rule (the “Final Rule”), will focus on, amongst other things:

  • promoting greater

“The guidance reminds the public that the HIPAA Privacy Rule does not apply to employers or employment records.”[1]

On September 30, 2021, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) released guidance (the “Guidance”) entitled, “HIPAA, COVID-19 Vaccination, and the Workplace,” regarding the applicability of

On October 4, 2021, the California Senate Bill 650 (“SB 650”), also known as the Corporate Transparency in Elder Care Act of 2021, was signed by Governor Gavin Newsom. As described below, SB 650 is designed to provide the public with greater transparency as to skilled nursing facility (‘SNF”) ownership and finances.

Currently, an organization