Federal Judge Upholds Successful Challenge of 340B Reimbursement Cuts

HHS ordered back to the drawing board – and told to work quickly.

A federal judge has upheld a lower court’s ruling that the U.S. Department of Health and Human Services (HHS) exceeded its statutory authority when it reduced the 2018 Medicare reimbursement rate for drugs covered by the federal 340B Program.

U.S. District Court Judge Rudolph Contreras, sitting in the District of Columbia, issued the ruling Monday in the matter of American Hospital Association v. Alex M. Azar, HHS Secretary, ordering HHS back to the drawing board and warning it to act with haste to make a correction.

“On or before Aug. 5, 2019, the parties shall submit a status report regarding the agency’s progress on remand to remedy the issues raised in this litigation concerning the 2018 and 2019 OPPS (Outpatient Prospective Payment System) Rules,” Contreras concluded in his 22-page decision. “The Court expects that the agency will act expeditiously to resolve these issues.”

The ruling stopped short of vacating HHS’s 2018 and 2019 OPPS rules, “given the havoc … (it) may wreak on Medicare’s administration,” as Contreras put it. And it did not order that hospitals be compensated for 340B payments lost in the past two years.

Maureen Testoni, President and Chief Executive Officer of 340B Health and a repeat guest on Monitor Mondays, the weekly Internet radio broadcast hosted by RACmonitor, nonetheless hailed the decision as a clear win for providers nationwide.

“On behalf of the nearly 1,400 hospitals we represent that participate in 340B, we are pleased that the court has, once again, found that HHS exceeded its statutory authority by cutting what Medicare pays for outpatient drugs delivered to their patients,” Testoni said in a statement. “The cuts made in 2018 and again in 2019 have reduced hospitals’ ability to care for those in need. The sooner this policy is reversed, the better hospitals will be able to serve the needs of patients with low incomes and those in rural communities. HHS must act quickly, as any further delay will only harm patients and the hospitals they rely on for care.”

Healthcare Dive published a report online this week noting that the 340B Program has come under scrutiny from several angles in recent months, “largely prompted by concerted opposition from the pharmaceutical industry’s trade group, PhRMA,” as legislators have called for enhanced transparency and oversight from the Program.

The report also noted that the number of hospitals in the Program has jumped in the past few years, going from 1,465 in 2011 to 2,399 in 2016, according to the Government Accountability Office.

Program Note:
Listen to RACmonitor national correspondent Timothy Powell report this story live during Monitor Monday, May 20, 10-10:30 a.m. ET.

Facebook
Twitter
LinkedIn

Mark Spivey

Mark Spivey is a national correspondent for RACmonitor.com, ICD10monitor.com, and Auditor Monitor who has been writing and editing material about the federal oversight of American healthcare for more than a decade.

Related Stories

The Legislative Plight of 340B

The Legislative Plight of 340B

In December 2024, the U.S. Supreme Court declined to hear an appeal challenging an Arkansas law requiring pharmaceutical companies to provide drug discounts through third-party

Read More

Leave a Reply

Please log in to your account to comment on this article.

Featured Webcasts

The Cost of Ignoring Risk Adjustment: How HCCs Impact Revenue & Compliance

The Cost of Ignoring Risk Adjustment: How HCCs Impact Revenue & Compliance

Stop revenue leakage and boost hospital performance by mastering risk adjustment and HCCs. This essential webcast with expert Cheryl Ericson, RN, MS, CCDS, CDIP, will reveal how inaccurate patient acuity documentation leads to lost reimbursements through penalties from poor quality scores. Learn the critical differences between HCCs and traditional CCs/MCCs, adapt your CDI workflows, and ensure accurate payments in Medicare Advantage and value-based care models. Perfect for HIM leaders, coders, and CDI professionals.  Don’t miss this chance to protect your hospital’s revenue and reputation!

May 29, 2025
I050825

Mastering ICD-10-CM Coding for Diabetes and it’s Complications: Avoiding Denials & Ensuring Compliance

Struggling with ICD-10-CM coding for diabetes and complications? This expert-led webcast clarifies complex combination codes, documentation gaps, and sequencing rules to reduce denials and ensure compliance. Dr. Angela Comfort will provide actionable strategies to accurately link diabetes to complications, improve provider documentation, and optimize reimbursement—helping coders, CDI specialists, and HIM leaders minimize audit risks and strengthen revenue integrity. Don’t miss this chance to master diabetes coding with real-world case studies, key takeaways, and live Q&A!

May 8, 2025
2025 Coding Clinic Webcast Series

2025 ICD-10-CM/PCS Coding Clinic Update Webcast Series

Uncover critical guidance. HIM coding expert, Kay Piper, RHIA, CDIP, CCS, provides an interactive review on important information in each of the AHA’s 2025 ICD-10-CM/PCS Quarterly Coding Clinics in easy-to-access on-demand webcasts, available shortly after each official publication.

April 14, 2025

Trending News

Featured Webcasts

Medicare Advantage 2026: Navigating New Rules, Denial Protections & SDoH Shifts

Medicare Advantage 2026: Navigating New Rules, Denial Protections & SDoH Shifts

Stay ahead of Medicare Advantage’s 2025-2026 regulatory changes in this critical webcast featuring expert Tiffany Ferguson, LMSW, CMAC, ACM. Learn how new CMS rules limit MA plan denials, protect hospitals from retroactive claim reopenings, and modify Two-Midnight Rule enforcement—plus key insights on omitted SDoH mandates and heightened readmission scrutiny. Discover actionable strategies to safeguard revenue, ensure compliance, and adapt to evolving health equity priorities before the June 2025 deadline. Essential for hospitals, revenue cycle teams, and compliance professionals navigating MA’s shifting landscape.

May 28, 2025
Navigating the 3-Day & 1-Day Payment Window: Compliance, Billing, and Revenue Protection

Navigating the 3-Day & 1-Day Payment Window: Compliance, Billing, and Revenue Protection

Struggling with CMS’s 3-Day Payment Window? Join compliance expert Michael G. Calahan, PA, MBA, CCO, to master billing restrictions for pre-admission and inter-facility services. Learn how to avoid audit risks, optimize revenue cycle workflows, and ensure compliance across departments. Critical for C-suite leaders, providers, coders, revenue cycle teams, and compliance teams—this webcast delivers actionable strategies to protect reimbursements and meet federal regulations.

May 15, 2025
Audit-Proof Your Wound Care Procedures: Expert Insights on Compliance and Risk Mitigation

Audit-Proof Your Wound Care Procedures: Expert Insights on Compliance and Risk Mitigation

Providers face increasing Medicare audits when using skin substitute grafts, leaving many unprepared for claim denials and financial liabilities. Join veteran healthcare attorney Andrew B. Wachler, Esq., in this essential webcast and master the Medicare audit process, learn best practices for compliant billing and documentation, and mitigate fraud and abuse risks. With actionable insights and a live Q&A session, you’ll gain the tools to defend your practice and ensure compliance in this rapidly evolving landscape.

April 17, 2025
Utilization Review Essentials: What Every Professional Needs to Know About Medicare

Utilization Review Essentials: What Every Professional Needs to Know About Medicare

Dr. Ronald Hirsch dives into the basics of Medicare for clinicians to be successful as utilization review professionals. He’ll break down what Medicare does and doesn’t pay for, what services it provides and how hospitals get paid for providing those services – including both inpatient and outpatient. Learn how claims are prepared and how much patients must pay for their care. By attending our webcast, you will gain a new understanding of these issues and be better equipped to talk to patients, to their medical staff, and to their administrative team.

March 20, 2025

Trending News

Happy National Doctor’s Day! Learn how to get a complimentary webcast on ‘Decoding Social Admissions’ as a token of our heartfelt appreciation! Click here to learn more →

CYBER WEEK IS HERE! Don’t miss your chance to get 20% off now until Dec. 2 with code CYBER24