340B Drug Pricing Program Compliance
Podcast: Chevron Deference: Is It Time for Change? - Diagnosing Health Care
K&L Gates Triage: 340B Update: CMS Finalizes 340B Program Reimbursement Cut on Part B Drugs
K&L Gates Triage: 340B Regulatory Update: CMS Proposal and Draft Executive Order Could Have Big Impact on 340B Program
K&L Gates Triage: 340B Eligibility - Hospital Covered Entities
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
In 2021, we provided an overview of multiple federal lawsuits challenging the US Department of Health and Human Services (HHS) Health Resources and Services Administration’s (HRSA) enforcement of the 340B Drug Pricing...more
This Week in Washington: Senate Finance Committee Chairman sends letters concerning healthcare cybersecurity measures; House Energy and Commerce Committee Oversight and Investigations Subcommittee holds hearing on 340B...more
This Week in Washington: Senate Finance Committee releases draft proposal outline concerning GME program; Senate HELP Committee marks up seven healthcare bills; NIH issues first-of-its-kind policy proposal to promote equal...more
On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more
On April 18, 2024, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) released a new Final Rule for its oft-criticized 340B Administrative Dispute Resolution (ADR)...more
Disputes between 340B Drug Pricing Program-covered entities and the drug manufacturers required to sell outpatient drugs to those entities at discounted prices will be governed by an alternative dispute resolution (ADR)...more
A Quiet Healthcare Week on Capitol Hill. Congress was largely in recess this week, although the Senate returned briefly to complete consideration of a long-awaited foreign aid bill. Both chambers will return to session the...more
In a move long anticipated by 340B Program participants, the Department of Health and Human Services (HHS) recently published its finalized 340B Administrative Dispute Resolution (ADR) rule, establishing formal processes for...more
On April 18, 2024, the US Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) issued the long-awaited 340B Administrative Dispute Resolution (ADR) Final Rule. The final rule...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
On February 2, 2024, a bipartisan group of six U.S. senators released much-anticipated draft legislation to reform the Health Resources and Services Administration’s (HRSA) 340B drug discount program. Known as the SUSTAIN...more
On October 27, 2023, the Health Resources and Services Administration of HHS (HRSA) issued a Federal Register Notice (the Notice) requiring hospitals to register their off-site outpatient facilities to continue participating...more
Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more
On November 29, 2022, the Health Resources and Services Administration (HRSA) issued a proposed rule (Proposed Rule) to revise the alternative dispute resolution (ADR) procedures for disputes arising under the 340B drug...more
Through its Health Resources and Services Administration (HRSA), the U.S. Department of Health and Human Services (HHS) issued a proposed rulemaking on Nov. 29, 2022, that would drastically overhaul the 340B Drug Pricing...more
On November 30, 2022, the Health Resources and Services Administration (HRSA) published a proposed rule (Proposed Rule) in the Federal Register that proposes to introduce several changes to the current administrative dispute...more
The 340B program requires drug manufacturers to offer outpatient pharmaceuticals to statutorily defined covered entities (including certain hospitals and certain federal grantees, such as federally qualified health centers)...more
In this episode, Andrew Ruskin, Leah Richardson, and Victoria Hamscho analyze the U.S. Court of Appeals for the Fourth Circuit’s recent decision in Genesis Healthcare v. Becerra. They discuss its potential impact on the...more
A federal district court likely will determine the 340B program definition of “patient” following a decision by the US Court of Appeals for the Fourth Circuit in Genesis Healthcare v. Becerra. The issue was whether the...more
A recent case before the US Court of Appeals for the Fourth Circuit addressed the issue of which persons qualify as “patients” of a 340B program participating entity (covered entity). Court-ordered filings in ongoing...more