Fines For 340B Drug Companies?

Action by Congress could be seen as thunder and flurry.

A strange thing happened recently. A bipartisan letter was sent from a group of U.S. House representatives. In the letter sent to Health and Human Services (HHS) Secretary Xavier Becerra, 181 representatives asked that HHS conclude its review of the drug companies refusing to give 340B discounts to providers using contracted pharmacy services.

Legally, the Office of Inspector General (OIG) for HHS could impose penalties of up to $6,000 per claim for knowingly overcharging providers. 

It would seem that the wind is at the back of providers in the 340B battle, after the Supreme Court ruled in favor of providers on the June 15 on the cuts the Centers for Medicare & Medicaid Services (CMS) made to Medicare payments for certain drugs. While legally this seems to make sense, I want to point out the differences in the issues in the June 15 ruling and the current dispute. In the June 15 ruling, the issue were Medicare payment rates and how those rates were determined.

In the current case, HHS has the hurdle of arguing that drug providers “knowingly and intentionally” overcharged providers when, from their perspective, they are following the regulations as they interpret them. HHS, in referring the drug companies to the OIG, would have to prove that they know their position is without merit and they are simply doing it anyway.

Short of finding a whistleblower in the drug company ranks this seems impossible. Not only would you have to find one whistleblower, HHS in making a referral to the OIG would have to prove that all seven companies in identified in its letter had colluded in coming to the same conclusions.

I also think it is safe to say in the current environment trying to guess what the Supreme Court will do on any issue is extremely difficult.

Facebook
Twitter
LinkedIn

Timothy Powell, CPA, CHCP

Timothy Powell is a nationally recognized expert on regulatory matters, including the False Claims Act, Zone Program Integrity Contractor (ZPIC) audits, and U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) compliance. He is a member of the RACmonitor editorial board and a national correspondent for Monitor Mondays.

Related Stories

You Down with CfC?

You Down with CfC?

Anyone who has worked within the scope of hospital case/utilization management for any period of time has heard of the Centers for Medicare & Medicaid

Read More

Leave a Reply

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

Featured Webcasts

I022426_SQUARE

Fracture Care Coding: Reduce Denials Through Accurate Coding, Sequencing, and Modifier Use

Expert presenters Kathy Pride, RHIT, CPC, CCS-P, CPMA, and Brandi Russell, RHIA, CCS, COC, CPMA, break down complex fracture care coding rules, walk through correct modifier application (-25, -57, 54, 55), and clarify sequencing for initial and subsequent encounters. Attendees will gain the practical knowledge needed to submit clean claims, ensure compliance, and stay one step ahead of payer audits in 2026.

February 24, 2026
Mastering Principal Diagnosis: Coding Precision, Medical Necessity, and Quality Impact

Mastering Principal Diagnosis: Coding Precision, Medical Necessity, and Quality Impact

Accurately determining the principal diagnosis is critical for compliant billing, appropriate reimbursement, and valid quality reporting — yet it remains one of the most subjective and error-prone areas in inpatient coding. In this expert-led session, Cheryl Ericson, RN, MS, CCDS, CDIP, demystifies the complexities of principal diagnosis assignment, bridging the gap between coding rules and clinical reality. Learn how to strengthen your organization’s coding accuracy, reduce denials, and ensure your documentation supports true medical necessity.

December 3, 2025

Proactive Denial Management: Data-Driven Strategies to Prevent Revenue Loss

Denials continue to delay reimbursement, increase administrative burden, and threaten financial stability across healthcare organizations. This essential webcast tackles the root causes—rising payer scrutiny, fragmented workflows, inconsistent documentation, and underused analytics—and offers proven, data-driven strategies to prevent and overturn denials. Attendees will gain practical tools to strengthen documentation and coding accuracy, engage clinicians effectively, and leverage predictive analytics and AI to identify risks before they impact revenue. Through real-world case examples and actionable guidance, this session empowers coding, CDI, and revenue cycle professionals to shift from reactive appeals to proactive denial prevention and revenue protection.

November 25, 2025
Sepsis: Bridging the Clinical Documentation and Coding Gap to Reduce Denials

Sepsis: Bridging the Clinical Documentation and Coding Gap to Reduce Denials

Sepsis remains one of the most frequently denied and contested diagnoses, creating costly revenue loss and compliance risks. In this webcast, Angela Comfort, DBA, MBA, RHIA, CDIP, CCS, CCS-P, provides practical, real-world strategies to align documentation with coding guidelines, reconcile Sepsis-2 and Sepsis-3 definitions, and apply compliant queries. You’ll learn how to identify and address documentation gaps, strengthen provider engagement, and defend diagnoses against payer scrutiny—equipping you to protect reimbursement, improve SOI/ROM capture, and reduce audit vulnerability in this high-risk area.

September 24, 2025

Trending News

Featured Webcasts

Top 10 Audit Targets for 2026-2027 for Hospitals & Physicians: Protect Your Revenue

Stay ahead of the 2026-2027 audit surge with “Top 10 Audit Targets for 2026-2027 for Hospitals & Physicians: Protect Your Revenue,” a high-impact webcast led by Michael Calahan, PA, MBA. This concise session gives hospitals and physicians clear insight into the most likely federal audit targets, such as E/M services, split/shared and critical care, observation and admissions, device credits, and Two-Midnight Rule changes, and shows how to tighten documentation, coding, and internal processes to reduce denials, recoupments, and penalties. Attendees walk away with practical best practices to protect revenue, strengthen compliance, and better prepare their teams for inevitable audits.

January 29, 2026

AI in Claims Auditing: Turning Compliance Risks into Defensible Systems

As AI reshapes healthcare compliance, the risk of biased outputs and opaque decision-making grows. This webcast, led by Frank Cohen, delivers a practical Four-Pillar Governance Framework—Transparency, Accountability, Fairness, and Explainability—to help you govern AI-driven claim auditing with confidence. Learn how to identify and mitigate bias, implement robust human oversight, and document defensible AI review processes that regulators and auditors will accept. Discover concrete remedies, from rotation protocols to uncertainty scoring, and actionable steps to evaluate vendors before contracts are signed. In a regulatory landscape that moves faster than ever, gain the tools to stay compliant, defend your processes, and reduce liability while maintaining operational effectiveness.

January 13, 2026
Surviving Federal Audits for Inpatient Rehab Facility Services

Surviving Federal Audits for Inpatient Rehab Facility Services

Federal auditors are zeroing in on Inpatient Rehabilitation Facility (IRF) and hospital rehab unit services, with OIG and CERT audits leading to millions in penalties—often due to documentation and administrative errors, not quality of care. Join compliance expert Michael Calahan, PA, MBA, to learn the five clinical “pillars” of IRF-PPS admissions, key documentation requirements, and real-life case lessons to help protect your revenue.

November 13, 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. 1 with code CYBER25

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