Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
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
Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more
Summary: On October 30, 2025 despite HRSA being impacted by the government shutdown, the agency approved 8 drug manufacturers / 9 drugs for participation in HRSA’s 340B Rebate Model Pilot Program (340B Rebate Pilot)....more
On October 30, 2025, the Office of Pharmacy Affairs (OPA) posted information on its website announcing that they have approved 340B rebate models applicable to eight drug manufacturers. Consistent with the August Federal...more
In a move that will fundamentally change how the 340B Drug Pricing Program (“340B Program”) operates for a subset of medications, HRSA’s Office of Pharmacy Affairs (“OPA”) opted late last week to approve eight manufacturer...more
Government shutdown reaches one month. Congress did not make progress this week toward reopening the government, as concerns continued to mount regarding pay for federal workers and the November 1, 2025, depletion of...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
Government shutdown drags on. The House was out of session again this week while the Senate continued to vote on the House-passed “clean” continuing resolution (CR), which continued to fail to achieve the 60 votes necessary...more
As the government shutdown enters its fourth week, there is no clear end in sight. Democrats continue to insist that any bill to reopen and fund the government include an extension of the advanced premium tax credits (APTCs)...more
News Briefs - Amid Shutdown, Telehealth Coverage Flexibilities Expired Lawmakers missed a deadline to extend telehealth flexibilities in Medicare, disrupting virtual care reimbursement and access for beneficiaries across the...more
On September 24, 2025, the U.S. Food and Drug Administration (FDA) held a joint town hall with the Partnership for DSCSA Governance (PDG) about the impending expiration of the large dispenser exemption under the Drug Supply...more
Expected New Drug Pricing Model: We anticipate the Centers for Medicare & Medicaid Services (CMS) to release a significant proposed new drug pricing model through its Innovation Center called the Global Benchmark for...more
Twelve years after causing a government shutdown, funding for key Affordable Care Act (ACA) provisions is again at the center of government funding negotiations with a potential shutdown approaching. During the COVID-19...more
In the latest episode of Health Law Diagnosed, Of Counsel Bridgette Keller is joined by Associate Hassan Shaikh for a discussion on noteworthy developments relating to the IRA and drug pricing. Together, Bridgette and Hassan...more
A new chapter in the 340B Drug Pricing Program is unfolding as the Health Resources & Services Administration (“HRSA”) pursues its 340B Rebate Model Pilot Program (the “Pilot Program”)—a move signifying both innovation and...more
On September 12, 2025, the United States Court of Appeals for the Fifth Circuit, in AbbVie v. Fitch, Case No. 24-60375, (5th Cir. 2025), affirmed a federal District Court’s denial of a preliminary injunction sought by the...more
Over the last two and a half years, the management of the 340B program has increasingly come under legislative and regulatory scrutiny as hospitals and manufacturers dispute the role of contract pharmacies. As we’ve...more
In July 2025, CMS issued its 2026 Hospital Outpatient Prospective Payment System (OPPS) proposed rule, which includes two significant 340B policies. First, it includes cuts in the OPPS rates paid to hospitals to accelerate...more