The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more
Efforts to draw attention to and, in some instances, dissuade private equity investment in healthcare have been on the rise. For example, in late 2023, the Centers for Medicare & Medicaid Services finalized a rule increasing...more
Baker Donelson recently published Anticipating SCOTUS Ruling on Chevron Deference – What to Know and Five Ways to Prepare explaining the United States Supreme Court's upcoming ruling which is expected to impact the regulatory...more
In coordination with the Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS) and Office of the National Coordinator for Health Information Technology (ONC) proposed a...more
On August 1, 2023, CMS issued its annual Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule for FY 2024 (the Final Rule). In the Final Rule, CMS,...more
On June 30, 2023, the United States District Court for the Eastern District of Texas (the Court) granted the State of Texas’ preliminary injunction motion, enjoining CMS from implementing and enforcing its Informational...more
Key Points - The Supreme Court invalidated 2018 and 2019 cuts to Medicare reimbursement rates for hospital outpatient drugs acquired through the 340B Drug Pricing Program, effectively reinstating the default rate of ASP...more
Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured...more
In this second installment of this blog series on the No Surprises Act interim regulations (NSA) we discuss: i) notice and consent requirements for out of network providers providing services at participating health care...more
On August 10, 2021, CMS notified Ohio, South Carolina, and Utah that it is withdrawing its prior approval of the Medicaid demonstration projects in these states, which had established work requirements as a condition for...more
Earlier this month, the U.S. Department of Health and Human Services, Department of Labor, Department of the Treasury, and the Office of Personnel Management issued an interim final rule with a comment period on the issues of...more
On April 22, 2021, thirteen Medicaid beneficiaries, represented by the National Health Law Program, the Tennessee Justice Center, and King & Spalding, filed a complaint in the U.S. District Court for the District of Columbia...more
On March 17, 2021, HHS notified Arkansas and New Hampshire officials that it was withdrawing its approval of demonstration projects which had permitted those states to impose work requirements as a condition for eligibility...more
On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more
On Friday, October 2, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days, beginning on October 23 (the date the...more
Section 1115 of the Social Security Act permits states to waive certain Medicaid statutory requirements through demonstration projects that advance state policy priorities and test innovations in their Medicaid programs....more
On August 3, 2020, President Trump signed an Executive Order that could potentially extend the easing of restrictions on telemedicine that were put in place during the COVID-19 public health emergency (PHE) beyond the...more
On Thursday, July 23, the U.S. Department of Health & Human Services (HHS) announced that the Public Health Emergency (PHE) declaration for COVID-19 will be renewed for another 90 days through October 22. This update...more
Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more
On March 13, 2020, the President of the United States issued a proclamation that the 2019 Novel Coronavirus (previously referred to as 2019-nCoV, now as COVID-19) outbreak in the United States constitutes a national emergency...more
This post is the second installment in our blog series looking back on the 10-year anniversary of the Affordable Care Act (ACA) and will examine Medicaid expansion under the ACA. Medicaid is joint federal-state program that...more
On March 13, 2020, the President declared the Novel Coronavirus (COVID-19) outbreak in the U.S. a national emergency. The President’s declaration, coupled with Section 1135 (of the Social Security Act) waivers issued by the...more
On a daily basis, if not more frequently, we are astounded by our clients’ efforts to prepare for and respond to the COVID-19 pandemic. As the federal government works to respond to the COVID-19 pandemic, guidance from HHS...more
Following the President’s proclamation on March 13 that the COVID-19 outbreak constitutes a national emergency, Secretary of the Department of Health and Human Services (HHS) Alex Azar issued a Waiver or Modification of...more