False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
Understanding Pharmacy Benefit Managers: The PBM Landscape Explained
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
340B Drug Pricing Program Compliance
Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
ACI's virtual 6th Annual Passport to Proficiency on Rx Drug Pricing & Rebate Fundamentals will help you master the fundamentals, comprehend the consequences of new developments, and prepare for the complexities and nuances of...more
Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more
On April 15, 2025, the Centers for Medicare & Medicaid Services (“CMS”) published the Contract Year 2026 Policy and Technical Changes Final Rule which amends the regulations governing various Medicare programs, including the...more
Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more
ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more
Hospitals that participate in the 340B program may be entitled to additional monies from Medicare Advantage plans in the wake of the Supreme Court’s decision in AHA v. Becerra. In AHA v. Becerra, a unanimous Supreme Court...more
On January 10, 2023, Judge Contreras of the United States District Court for the District of Columbia ruled that CMS’s 340B drug reimbursement rates dating back to January 1, 2018, were unlawful and underpaid affected...more
On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more
On Friday, June 24th, the Supreme Court unanimously agreed with the American Hospital Association (AHA) and 340B hospitals regarding their challenge to outpatient prescription drug reimbursement methodologies issued by the...more
As the nomination of Dr. Robert Califf to head the federal Food and Drug Administration advances, he and the agency already are confronting a major regulatory crisis over Aduhelm, a prescription drug targeted for Alzheimer’s...more
On November 19, 2021, OIG issued Advisory Opinion No. 21-17 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain Medicare cost-sharing obligations in the context of a...more
On August 10, 2021, the Centers for Medicare and Medicaid (“CMS”) published a proposed rule (“Proposed Rule”) to rescind the Most Favored Nation Model (“MFN Model”) interim final rule that was published on November 26, 2020...more
On Monday, July 19, 2021, the Centers for Medicare and Medicaid Services (CMS) released the CY 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) Proposed Rule (Proposed Rule). While the Proposed Rule...more
How far can an agency go to allow agency-developed policy objectives to supersede concerns about faithful adherence to the law? Similarly, how much should health systems and others regulated by Medicare be concerned about...more
The COVID-19 pandemic continues to demonstrate the importance and effectiveness of telemedicine as a means of providing patients with access to safe and quality medical care through the use of technology... Originally...more
On September 13, 2020, President Trump issued an Executive Order (the “Executive Order”) directing the Department of Health and Human Services (“HHS”) to issue regulations instituting two most-favored-nations (“MFN”) payment...more
On December 2, 2020, the Centers for Medicare & Medicaid Services (CMS) released the calendar year 2021 Final Rule implementing changes to the Medicare hospital Outpatient Prospective Payment System (OPPS) and Ambulatory...more
On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) issued an interim final rule with comment period (IFC) to implement a payment model that will significantly reduce Medicare reimbursement rates for...more
On August 4, 2020, the Centers for Medicare & Medicaid Services (CMS) released its CY 2021 Medicare Hospital Outpatient Prospective Payment System (OPPS) proposed rule. CMS proposes to reduce OPPS payments for 340B drugs from...more
On 31 July 2020, the U.S. Court of Appeals for the District of Columbia Circuit (D.C. Circuit) upheld the U.S. Department of Health and Human Services’ (HHS) decision to allow the Centers for Medicare and Medicaid Services...more
Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more
In this episode, Ryan Severson and Victoria Hamscho discuss recent developments in pharmaceutical pricing and the 340B Drug Pricing Program heading into 2020, including reimbursement cuts for 340B drugs under the Outpatient...more
In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more
Following a number of drug pricing reforms implemented or proposed in 2018, 2019 likely will bring more action from HHS and Congress to reduce drug prices. Key Points: ..In 2018, the Administration implemented and...more
In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more