K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
Previously, we discussed how the US Supreme Court’s opinion in Loper Bright Enterprises v. Raimondo and Relentless, Inc. v. Department of Commerce could create opportunities for private litigants to challenge health...more
The U.S. Department of Health and Human Services (HHS) continued its commitment to timely and full access to health records on June 24, 2024, through the finalization of its information blocking disincentives rule for...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
On February 23, 2024, CMS published a final rule updating the regulatory requirements of the Medicaid disproportionate share hospital (DSH) program in response to the Consolidated Appropriations Act (CAA) of 2021. The final...more
Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...more
On May 5, 2023, the World Health Organization declared an end to the global health emergency caused by the SARS-CoV-2 virus, known as COVID-19. While the emergency has, in many ways, waned, the virus and the need for COVID-19...more
The end of an era looms for employee benefits plans, as the Biden administration has announced the end of both the Public Health Emergency and the National Emergency periods on May 11, 2023. The two emergency periods were...more
As employers plan for the impact of the anticipated May 11, 2023, end of the two federal COVID-19 emergency orders, they have some important new clarity on test and vaccine coverage and on how to unwind COVID-19–era extended...more
Meta description: With the federal public health emergency (PHE) ending in May, changes to telehealth prescription rules are set to change. Read on to learn about proposed permanent changes. DEA Proposes Rules for...more
The legal status of mifepristone and misoprostol, drugs legally prescribed by physicians since 2000 for the medical termination of early pregnancy, may soon be decided by a federal court in Texas in a lawsuit known as...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 September 28, 2022, the Centers for Medicare & Medicaid Services (CMS) issued approval letters for Section 1115 Medicaid demonstration applications previously submitted by Oregon and Massachusetts. Section 1115 waivers...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
On April 12, 2022, Department of Health and Human Services (HHS) Secretary Xavier Becerra again renewed the declaration of a Public Health Emergency (PHE) under the Public Health Service Act, averting an April 16, 2022...more
April 14, 2022 On April 12, 2022, Secretary Becerra of the U.S. Department of Health and Human Services extended the existing public health emergency for 90 days, effective April 16, 2022, until July 15, 2022...more
On January 25, 2022, the U.S. Court of Appeals for the Second Circuit issued an important opinion in Barrows v. Becerra that will have a significant impact on hospitals, skilled nursing facilities and, potentially, other...more
Nearly two years after declaring a public health emergency exists due to the COVID-19 pandemic, the U.S. Department of Health and Human Services (“HHS”) has extended that determination yet again. On January 14, 2022, U.S....more
On November 15, the U.S. Department of Health and Human Services (HHS) withdrew a controversial Trump-era HHS Policy Change that effectively prevented the Food and Drug Administration (FDA) from reviewing laboratory-developed...more
In response to President Biden’s Executive Order on Promoting Competition in the American Economy—which called for the Secretary of Health and Human Services to publish for notice and comment a proposed rule on...more
The pandemic may be waning, but the requirement for Colorado employers to provide supplemental public health emergency leave to employees under certain COVID-19–related circumstances continues. On October 15, 2021, U.S....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
In July 2020, the Trump Administration issued an Executive Order (the EO) directing the Secretary of the Department of Health and Human Services (HHS) to take certain actions and finalize rulemakings designed to “support the...more
By letter dated April 13, 2021 (Letter), the Democrat and Republican leadership of the House Committee on Energy and Commerce and its Subcommittee on Health, wrote United States Health and Human Services Secretary, Xavier...more
On January 28th, President Biden issued an “Executive Order on Strengthening Medicaid and the Affordable Care Act.” The E.O. states that the Biden Administration will promote policies that “protect and strengthen Medicaid and...more