The State of Healthcare Enforcement
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
UPIC Audits
AGG Talks: Home Health & Hospice Podcast - Episode 8: Hospice Special Focus Program: Pumping the Brakes
Hospice Insights Podcast - Upping the Ante: Will CMS’s Enhanced Oversight Efforts Cause Hospices to Fold?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
Preparing for CMS Staffing Mandates — Assisted Living and the Law Podcast
Hospice Insights Podcast - Meet the New Laws, Same as the Old Laws: Overpayment Recoupment Update
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
The CMS Interoperability and Prior Authorization Rules
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Findings from Gibbins’ Annual Healthcare Bankruptcy Report
A Fond Farewell: Musings on the End of the Medicare Advantage Hospice Carve-In Demonstration
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more
A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more
Earlier this week, the Supreme Court released its opinion in American Hospital Association et al. v. Becerra et al., a case that involves the proper method for the Medicare program to reimburse hospitals for outpatient drugs...more
In a 2-1 opinion issued on April 5, the Seventh Circuit Court of Appeals again held that an objectively reasonable interpretation of a relevant statute or regulation precludes the required finding of intent under the False...more
The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more
In a setback to hospitals challenging deep cuts to reimbursement for prescription drugs acquired through the 340B drug pricing program (“340B Program”), the U.S. Court of Appeals for the District of Columbia, on October 19,...more
In this week’s episode, Darlene Davis, Andrew Ruskin, and Gabriel Scott discuss notable recent developments for reimbursement under the Hospital Outpatient Prospective Payment System (“OPPS”) of drugs purchased under the 340B...more
Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more
n November 1, 2019, CMS posted the final rule establishing the payment rates for the Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgery Center (ASC) Payment System for calendar year (CY) 2020...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
On July 10, 2019, Judge Rudolph Contreras of the U.S. District Court for the District of Columbia granted HHS’ request for a final judgment, clearing the way for the government to immediately appeal his earlier decision that...more
On May 6, 2019, a federal district court held that the Department of Health and Human Services’ (HHS) 2018 and 2019 rate reductions for 340B Program participants, including safety net On May 6, 2019, a federal district court...more
The U.S. government has appealed a federal district court decision issued in December 2018 that found the Department of Health & Human Services (HHS) exceeded its authority by reducing Part B drug reimbursement to certain...more
Within the last five years, district courts in the Seventh Circuit have repeatedly denied motions to dismiss qui tam lawsuits brought under the FCA that allege a scheme to defraud government health programs by reporting...more
Dual Special Needs Plans - This part 6 of our 7 part series focuses on the provisions regarding dual special needs plans (“D-SNPs”) released by the Centers for Medicare and Medicaid Services (“CMS”) in the proposed rule...more
Medicare Advantage and Part D Preclusion List - The proposed rule issued November 1, 2018 (the “Proposed Rule”) by the Centers for Medicare and Medicaid Services (“CMS”) includes a number of regulatory changes to the...more
On April 2, 2018, CMS issued updated guidance related to the dramatic Medicare payment reductions that went into effect this year for certain 340B hospitals. The guidance explains the planned application of the payment cuts...more
A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more
OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more
This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more