White-Bagging in 2026: How Insurance Rules Affect Medication Safety and Access

By Vanessa Muller, PharmD

Introduction

Specialty medications, especially infused oncology and autoimmune therapies now account for approximately 49% of U.S. drug spending, despite representing only 2% of total prescriptions (AHA, 2023). As costs rise, insurers have expanded specialty-pharmacy distribution models. These approaches are intended to control spending, but they can also alter when, where, and how patients receive essential clinician-administered treatments.This article explains how white-bagging evolved in 2025, and what patients and clinicians may experience as these policies continue to develop in 2026 and beyond.

What Is White-, Brown-, and Clear-Bagging?

Clinicians and insurers use these terms to describe how specialty medications reach the infusion chair:

• White-bagging: Medication is dispensed by an insurer-designated specialty pharmacy and shipped directly to the clinic for a specific patient.

• Brown-bagging: Medication is shipped to the patient’s home; the patient stores and transports it to the infusion suite.

• Clear-bagging: Medication is prepared and dispensed by the health system’s own specialty pharmacy and delivered internally to the infusion site.

White- and brown-bagging emerged largely as payer-driven cost-containment strategies, whereas clear-bagging is typically an internal health-system workflow model rather than an insurer mandate. The FDA regulates drug quality, labeling, and storage conditions, but it does not determine which pharmacy must dispense a medication or how insurers structure distribution pathways.

Specialty pharmacies and PBM pharmacists also provide valuable services, including adherence support, education, affordability programs, and complex cold-chain handling, even when insurer-mandated pathways create downstream clinical challenges.

What’s Changing From 2025 to 2026?

Analyses from Drug Channels, ICER (Institute for Clinical and Economic Review), HOPA (Hematology/Oncology Pharmacy Association), and managed-care groups highlight several trends:

• Growth in payer-mandated white-bagging: Drug Channels’ 2024 analysis found that white-bagging and clear-bagging displaced traditional buy-and-bill for a meaningful share of specialty biologics.

• Supporting data: According to a 2024 Drug Channels infusion-site survey, 84% of hospitals reported that at least one insurer required them to obtain certain clinician-administered specialty drugs through white-bagging or clear-bagging rather than buy-and-bill.

• Market consolidation: Increasing vertical integration across insurers, PBMs, and specialty pharmacies influences where medications are filled and how they are delivered to clinics.

• Payer rationale: Insurers emphasize price transparency and benefit sustainability as key motivations for expanding these requirements.

• Collaborative vs. mandatory models: Many health systems use internal clear-bagging successfully, but clinicians remain most concerned about insurer-mandated pathways that limit flexibility at the point of care.

AMA/ASCO (American Medical Association/American Society of Clinical Oncology) and National Medical Society Positions

While insurer mandates most commonly involve white-bagging and, increasingly, clear-bagging, physician groups such as AMA and ASCO have also raised concerns about brown-bagging, a less common but higher-risk pathway in which patients transport their own medication. A joint AMA/ASCO issue brief states that mandatory white- or brown-bagging can disrupt chain-of-custody, delay treatment, and limit same-day dose adjustments. Although AMA and ASCO highlight safety risks associated with both white- and brown-bagging in their joint issue brief, the AMA's 2024 House of Delegates resolution specifically targets insurer-mandated white-bagging for legislative action.

State Laws Restricting Mandatory White-Bagging

By 2024–2025, at least five states including Arkansas, Louisiana, Texas, Rhode Island, and Virginia enacted laws limiting white-bagging for clinician-administered drugs in state-regulated plans. Approaches vary:

• Some prohibit insurers from requiring white-bagging for infused therapies

• Others require exceptions when not clinically appropriate.

• Several require alternative pathways such as buy-and-bill.

NCSL (National Conference of State Legislators) and Drug Channels Institute categorize these states as significantly restricting insurer-mandated white-bagging.

Infusion-Center Observations

Infusion centers report:

• Delayed or missing shipments

• Damaged or temperature-excursion products

• Inability to adjust doses the same day

• Increased administrative burden

A 2024 HOPA/ICAN (Hematology and Oncology Pharmacy Association/International Cancer Advocacy Network) survey found that more than 40% of infusion centers experienced delays tied to white-bagging.

Example Scenario

A woman with Crohn’s disease arrives for her induction biologic infusion. Her dose is missing due to a cold-chain excursion during transport. Without a backup supply, the visit must be rescheduled, delaying symptom control and possibly affecting disease progression.

Safety and Workflow Concerns

Risks associated with mandatory white-bagging include:

• Cold-chain failures

• Inability to adjust doses based on same-day labs

• Increased clinic workload

• Risk of wasted medication

• Disproportionate challenges in rural areas

Why Rural Patients Face Greater Barriers

Rural infusion programs frequently report:

• No contracts with insurer-designated specialty pharmacies

• Patients traveling long distances to alternate infusion sites

• Inability to stock costly backup biologics

• Higher cancellation rates

These issues can escalate from inconvenience to clinically inappropriate delays, especially in areas with limited healthcare infrastructure.

How Patients Experience These Changes

Patients may experience:

• More rescheduled appointments

• Delays when shipments arrive late or compromised

• Confusion about pharmacy restrictions

• Longer lead-times before infusions

• Increased administrative work

• Treatment gaps during insurance transitions

In addition to these logistical challenges, some patients also face financial effects. Copay-accumulator programs may increase out-of-pocket costs when insurers require the use of a specific specialty pharmacy.

What Clinicians Can Do Today

Clinicians can:

• Verify shipment integrity

• Request exceptions when appropriate

• Document delays and wasted doses

• Engage health-system leadership

• Educate patients about expected timelines

Conclusion

White-bagging continues to evolve as insurers explore ways to manage rising specialty-drug costs. While the model may improve price transparency for payers, it can shift logistical and clinical challenges onto infusion centers and patients. These effects appear across many settings, but rural patients face disproportionately greater risks where delays can become clinically inappropriate. As benefit designs grow more complex in 2026, the question becomes how to align white-bagging with safe, timely, and equitable patient care. Strengthening exception pathways, improving coordination, and documenting real-world delays are practical steps that can protect vulnerable patients while policymakers refine the broader system.

Disclosure

The author is a federal pharmacist writing in a personal capacity. The views expressed do not represent the U.S. Navy or Department of Defense.

References

1. AMCP. White, Brown, Clear, and Gold Bagging: https://www.amcp.org/resource-center/white-brown-clear-and-gold-bagging

2. HOPA. White-Bagging Issue Brief: https://www.hoparx.org/latest-news/white-bagging-issue-brief/

3. JMCP. Specialty Drug Spending Trends: https://www.jmcp.org

4. Drug Channels Institute. Specialty Pharmacy Trends: https://www.drugchannels.net

5. ACCC. Impact of White-Bagging: https://www.accc-cancer.org

6. COA. White-Bagging and Site-of-Service Policies: https://communityoncology.org

7. ICER. PBM Consolidation: https://icer.org

8. NCSL. White-Bagging Policy Tracker: https://www.ncsl.org

9. AMA & ASCO Joint Issue Brief: https://www.ama-assn.org

10. AMA Resolution A-24-233: https://www.ama-assn.org

Assessed and Endorsed by the MedReport Medical Review Board