K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
On Tuesday, April 29, the Supreme Court of the United States issued one decision: Advocate Christ Medical Center v. Kennedy, No. 23-715: This case addresses the proper method for calculating the “disproportionate share...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
In January 2020, Alex M. Azar, II, then secretary of the U.S. Department of Health and Human Services (HHS), signed a nationwide declaration of a Public Health Emergency (PHE) that would largely shape the response of public...more
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
Drug Pricing Initiatives: In advance of the midterm elections in November, discussion continues in Congress and among stakeholders of drug pricing reform measures, including those that were originally part of H.R. 5376 (the...more
Drug Pricing Initiatives: Debate continues regarding the drug pricing measures pending in Congress. On June 22, 2021, Senate Finance Committee Chair Ron Wyden released legislative principles that, among other things, would...more
On November 13, 2020, the D.C. Court of Appeals upheld a key ruling regarding disproportionate share hospital (“DSH”) payments, in Bethesda Health Inc. v. Azar, a significant victory for hospitals. Hospitals that treat a...more
On October 2, 2020, Health and Human Services (HHS) Secretary, Alex M. Azar II, announced the renewal of the public health emergency declaration due to the continued consequences of the COVID-19 pandemic. The 90-day renewal...more
As previously reported, the CARES Act impacts long-term care (LTC) facilities, including skilled nursing facilities (SNFs) and nursing facilities (NFs). In addition to this legislative action, the Centers for Medicare and...more
SUPPLY SHORTAGES - Provides for the National Academies to examine and report on the security of the U.S. medical product supply chain in order to assess U.S. dependence on critical drugs and devices sourced outside of the...more
In this week’s episode, Mary Beth Johnston, Carolyn Merritt and Leah Richardson discuss the ways in which the Centers for Medicare and Medicaid Services’ (CMS) response to the ongoing COVID-19 outbreak is easing certain...more
On March 30, 2020, the Secretary of the United States Department of Health and Human Services (“HHS”) exercised his authority to waive certain Medicare requirements during an emergency and issued blanket waivers of sanctions...more
In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated...more
While providers struggle to provide health care to their patients amid the coronavirus contagion concerns, recent regulatory and reimbursement changes will help ease the path to the provision of healthcare via telehealth....more
On September 17, 2019, the US District Court for the District of Columbia ruled in American Hospital Association, et al. v. Alex Azar, II, et al that the Centers for Medicare & Medicaid Services (CMS) exceeded its statutory...more
In an unexpected turn of events, the Trump administration has apparently reversed course and has withdrawn the proposed rule that would have amended the discount safe harbor under the Anti-Kickback Statute to eliminate...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more
Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health care policy news and legislation. *Please note that we...more
On Feb. 9, 2018, the Trump Administration released a 30-page report analyzing domestic and global factors influencing drug pricing. The report by the Council of Economic Advisers (CEA) is expected to inform the HHS' Fiscal...more
On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served...more
As Part of an ongoing series, we have previously provided details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program, Medicare therapy caps, and community health...more
In the wake of some of the worst storms our Country has ever faced, as seen in the devastation caused by Hurricane Harvey, in Texas, Hurricane Irma, in Florida, and now Hurricane Maria, in Puerto Rico and the U.S. Virgin...more
As Hurricane Harvey continues to have a devastating impact throughout Southeast Texas, Louisiana and the Southeast, our thoughts are with the hundreds of thousands struggling through this difficult time....more
In contemplating the ways in which physicians may be affected by the possible repeal of the Affordable Care Act (ACA)—and certain features of any legislation that may replace it—a good place to start is with the person...more
President-elect Donald Trump announced on November 28, 2016, that current House Budget Chair Representative Tom Price is his choice for Health and Human Services (HHS) Secretary. Many providers are wondering what health care...more