Health Care Alerts

On March 18, 2024, the Office for Civil Rights ("OCR") at the U.S. Department of Health and Human Services ("HHS") published updated guidance on the use of online tracking technologies by HIPAA covered entities and business associates (the "2024 Update"). The 2024 Update replaces the original guidance that OCR published on December 1, 2022 (the "2022 Guidance"). The 2024 Update attempts to clarify when information captured by tracking technologies constitutes individually identifiable health information ("IIHI") and provides guidance to covered entities and business associates on their obligations with respect to the use of online tracking technologies. 

On February 24, 2022, the Centers for Medicare & Medicaid Services (“CMS”) announced the redesign and renaming of its Global and Professional Direct Contracting model (“GPDC”), which was paused in March of 2021.  The model, now known as the Accountable Care Organization Realizing Equity, Access, and Community Health model (“ACO REACH”), was renamed in response to stakeholder feedback and to advance Administration priorities.  CMS also announced its cancellation of the Geographic Direct Contracting model. 

On January 1, 2022, two Interim Final Rules (the “Rules”) that implement key aspects of the No Surprises Act (“NSA”) became effective. The first Interim Final Rule was initially issued by the U.S. Departments of Health and Human Services (“HHS”), Labor, and Treasury, and the Office of Personnel Management (collectively, the “Departments”) on July 1, 2021. The second, issued by the same agencies, was issued on October 7, 2021. Generally, the NSA, which was signed into law on December 27, 2020, (1) limits cost-sharing and prohibits balance billing in certain situations and (2) requires providers to provide good faith estimates (“GFE”) of charges to uninsured or self-pay patients. The NSA and the Rules also establish notice and consent requirements and dispute resolution processes in both instances.

On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) held a Special Open Door Forum to discuss a new final rule amending the regulations that interpret the federal physician self-referral law (the “Stark Law”). 

On December 4, 2020, separate lawsuits filed in federal courts in Maryland and California allege that the new Medicare drug-pricing regulation released by the Centers for Medicare and Medicaid Services (CMS) on November 20, 2020, known as the Most Favored Nation Rule (MFN Rule), violates federal law, including the United States Constitution.[1] 

On April 26, 2020, the Centers for Medicare and Medicaid Services (CMS) announced that it is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. CMS had expanded these programs in late March of this year to provide short term loans to address cash flow issues for providers and suppliers during the COVID-19 pandemic.

On April 8, 2020, North Carolina Governor Roy Cooper issued Executive Order 130 (the “Executive Order”) to provide necessary waivers to expand health care resources for treatment of COVID‑19 patients and to provide additional waivers for certain child care, emergency management, food establishment, elder care, developmental disability, mental health and substance use disorder treatment services, and social services.  The complete Executive Order is linked here:  https://files.nc.gov/governor/documents/files/EO130-Meeting-North-Carolinas-Health-and-Human-Services-Needs.pdf.

On April 8, 2020, North Carolina Governor Roy Cooper issued Executive Order 130 (the “Executive Order”) to provide necessary waivers to expand health care resources for treatment of COVID‑19 patients and to provide additional waivers for certain child care, emergency management, food establishment, elder care, developmental disability, mental health and substance use disorder treatment services, and social services. The complete Executive Order is linked here: https://files.nc.gov/governor/documents/files/EO130-Meeting-North-Carolinas-Health-and-Human-Services-Needs.pdf.

On March 30, 2020, the Secretary of the Department of Health and Human Services (the “Secretary”) authorized blanket waivers of Section 1877(g) of the Social Security Act (the “Stark Law”). The Stark Law prohibits physicians from making referrals for designated health services[1] to an entity if the physician or an immediate family member has an ownership interest in, or financial arrangement with, the entity, unless an exception applies.

As summarized below, the Department of Health and Human Services (HHS) and Office for Civil Rights (OCR) have issued a series of bulletins and other guidance regarding the ability to use and disclose protected health information during the nationwide public health emergency concerning COVID-19.  Generally, the guidance is intended to provide greater flexibility during the emergency and to communicate existing abilities to use and disclose patient information, while confirming that the HIPAA Privacy Rule’s protections are not suspended as a whole. In addition, the Coronavirus Aid, Relief and Security (CARES) Act contains provisions related to Part 2 protections and additional HIPAA guidance.

Like many areas, the U.S. immigration system has been greatly impacted by the COVID-19 pandemic. Below is a summary of the most critical information effecting employers and their foreign workforce during this time.

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued additional broad and unprecedented regulatory waivers and new rules to enable the U.S. healthcare system to have maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic.

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued additional broad and unprecedented regulatory waivers and new rules to enable the U.S. healthcare system to have maximum flexibility to respond to the 2019 Novel Coronavirus (COVID-19) pandemic.