An Overview of White Bagging: The Effect on Systems and Potential Strategies
Brandy Snyder, PharmD, MBA, BCOP
Pharmacy Director II,
Hematology/Oncology & Investigational Drug Services
Wake Forest Baptist Health
Winston-Salem, NC
Donna Feild, RPH, MBA
Vice President, Pharmacy
Atrium Health
Charlotte, NC
The distribution of oncology and non-oncology infusion therapies has been rapidly changing over the last several years due to the increased cost of drug therapies and changing trends in the insurance market. Payers have increased the requirements of “white-bagging,” which requires an external pharmacy contracted with the payer to deliver a patient’s prescription directly to the health care system. The medication is stored at the facility, which requires a separate inventory, and the patient visits the infusion clinic for administration.
This practice is becoming mandatory in some states and, among certain payers and infusion medications, it is increasing at alarming rates. White bagging has increased at, “double digits per year with more than 10% of the annual spend per year being shifted from the medical benefit to the pharmacy benefit for many specialty infusion drugs.”1
Insurance market trends are focusing on white-bagging or shifting hospital-based care to alternative sites of care, such as a non-hospital based clinic or the patient’s home. Commercial plans are primarily the stakeholders requiring this in some capacity and this may differ from state to state depending on the Board of Pharmacy legislation. Payer policies are rapidly changing. Table 1 below provides examples of some restrictions recently required by payers:2
Organizational implications from white bagging are multifactorial and directly influence patients and their continuity of care. There are safety and compliance concerns with white bagging as well as substantial financial implications to the organization. Significant delays in patient care of two to four weeks are commonplace. A one to two-week delay in treatment may impact patient outcomes if they are time sensitive infusion therapies and could result in avoidable hospital admissions.2
White-bagging Adds to Complexity of Pharmacy Operations
Delays in treatment for newly diagnosed oncology patients with curative disease have shown a decrease in survival for several solid tumor cancers.4 Drug shortages add to the difficulty of the situation if the specialty pharmacy cannot procure the medication but the health system can, which could also delay treatment.
Patients may also be required to go to an alternate location for treatment and may not be closely monitored while they are receiving complex therapies.3 White-bagging creates an additional layer of complexity for pharmacy operations for patient-specific inventory management and significant time for the staff to manage.3
The United States Food and Drug Administration (FDA) has requirements for pharmacy to confirm the drug integrity of the product via the Drug Supply Chain Security Act (DSCSA), by tracking all components of procurement and being able to identify drug recalls or other concerns from specific lot numbers of a product. Drug waste is also a consideration in the white-bagging model because the vial cannot be shared for these expensive medications.
White-bagging may disrupt the revenue cycle for the health care system; lost revenue generated from specialty infusions could be devastating to the financial health of the organization. Self-referrals to insurance owned or affiliated specialty pharmacies allows the insurance industry to retain the associated revenue, take advantage of rebates from pharmaceutical companies, and negotiate to obtain part of the 340b savings for eligible entities.
Table 1: Commercial Plan Requirements
| Commercial Plan | Requirements |
|---|---|
| Anthem/Blue Cross Blue Shield | Varies by state: Site of Care restrictions for select drugs |
| Cigna | List of oncology and non-oncology infusions require contracted specialty pharmacy applies only to Hospital Based Fee Schedule, not physician fee schedule |
| United Healthcare | Apples only to commercial plans, some states excluded |
| Aetna | Site of care managed program for select oncology drugs |
*Updated: December 2020, subject to change.
Pharmacy Organizations Take Varied Stances
Several pharmacy organizations at the federal and state level are working to address the issues with payers mandating white-bagging. The American Society of Health System Pharmacist (ASHP) has invested significant advocacy efforts and submitted a letter along with 61 health care systems to request a meeting with the FDA to discuss concerns regarding the payer-mandated distribution models and the DSCSA.5
ASHP is “opposed to payer-mandated white-bagging models and lobbying to the federal government” to support this stance.5 ASHP also is against, “payer-mandated distribution models that require clinician-administered drugs and strongly encourages the FDA to consider the patient safety and supply chain security risks of payer-mandated white-bagging models.”5
Table 2 below provides updates on the current stance of a number of national organizations on white-bagging. Several states are also working aggressively to address payer mandated white-bagging. Louisiana, Virginia, Arkansas, and Indiana passed white-bagging bills in 2021 and several states are in progress, as provided in Table 3.3,4,5
Table 2: Current Stance of National Pharmacy Organizations
| Organization | Current Stance |
|---|---|
| American Society of Health System Pharmacists (ASHP) | Opposed to payer-mandated white bagging models for clinician administered drugs dispensed via a third party |
| American Hospital Association (AHA) | No brown bagging. Prohibitions on certain white bagging, safety criteria when white bagging can apply |
| National Association Board of Pharmacist (NABP) | White and brown bagging pose legitimate patient protection issues when specialty drug is distributed to an entity other than the patient. State Boards of Pharmacy are left to determine who is accountable |
| American Society of Clinical Oncology (ASCO) | Does not support white bagging and states practices may “erode quality and access to care and should be addressed immediately.” Has developed committee to pursue an in-depth analysis of pharmacy benefit managers and impact on cost and waste, their role and impact on quality of care, and the impact of benefit design on patients’ ability to access the care they need.9 |
Table 3: State Legislation Status
| State | Legislation | Status and Key Points |
|---|---|---|
| Virginia | House Bill 2219 | Passed – Plan requires insurers and Pharmacy Benefit Managers (PBM) to allow non-contracted pharmacies to dispense covered drugs and be reimbursed at in-network rates. Bill prevents healthcare plans from imposing unequal cost sharing on patients who select out-of-network pharmacy providers. |
| Louisiana | Senate Bill 191 | Passed – Prevents healthcare plans and PBMs from refusing to pay a participating provider or pharmacy for providing covered physician-administered drugs. This law mandates that all white bagged drugs must meet supply chain security controls set forth by the Drug Supply Chain Security Act. |
| Indiana | House Bill 1405 | Passed – Requires Indiana Department of Insurance, Department of Health, and Board of Pharmacy to conduct a study on the impact of white bagging and issue recommendations for best practices by Dec 21st, 2022. |
| Arkansas | House Bill 1907 | Passed – Healthcare provider and enrollee determine it is in the patient’s best interest for the provider to administer any covered prescription medication; the payer must reimburse the provider. Bill prevents the payer from imposing unequal cost sharing or financial penalties on patients or providers. |
| Texas | House Bill 1586; Senate Bill 1161 |
Require insurer permit enrollees to obtain clinician-administered drugs from provider or pharmacy and equal reimbursement |
| Tennessee | Senate Bill 1617 | Combined white bagging & 340b reimbursement parity (same as LA and TX) |
| Massachusetts | Senate Bill 1808; House Bill 3407 |
Prohibit payer-mandated brown bagging and home infusion; only drugs supplied in “ready-to-administer” dosage can be white bagged |
| New Jersey | State Board of Pharmacy 13:39-3.10 |
It shall be unlawful for a pharmacist to enter into an arrangement to provide health care services for the purposes of directing/diverting patients to specified pharmacy |
| Ohio | State Board of Pharmacy 4729-9-01 |
“No drugs that has been dispensed and has left the physical premises of the terminal distributor shall be dispensed or personally furnished” |
Advocacy groups for pharmacy organizations and state boards of pharmacy are actively involved in working with policymakers and educating key stakeholders on the implications of requiring health care systems to administer white-bagged drugs. ASHP is working aggressively on this topic and has several white-bagging resources to aid in learning more about this topic and the impact to your health system.8 Pharmacy leadership should play a major role in educating physicians, managed care contracting, and government relations so that they can be aware of how each of their roles can affect the white-bagging issue.
Health System Engagement: Atrium Health Example
Health systems should actively engage their government relations staff to educate state legislatures on white-bagging’s effect on patient care and advocate for legislation to minimize the negative effects on patients and safety net providers.
As an example, Atrium Health in Charlotte, North Carolina took a two-pronged approach to manage white bagging. First, an operational team was assembled, which included clinic and infusion nursing, pharmacy staff, and prior authorization staff. Their purpose was to help develop processes for clinic nurses to setup initial ordering of pharmaceuticals from outside pharmacies, ensure proper notification of in-house pharmacy and infusion staff, track timing of reordering to try to ensure patients had needed doses on hand at the time of their next infusion, and track any changes to therapy that would require starting the ordering process over.
They also had to evaluate the additional storage needs, how to best segregate inventories, and how to deal with late shipments and consequent rescheduling of patients. Data was collected and reference materials developed, which could be accessed by staff to help track white-bagged patients and deal with the significantly increased insurance requirements associated with this patient population.
The second prong of the approach was to form a group of physicians, managed care contracting, pharmacy and governmental relations team members to discuss the impacts of white bagging on patients, staff, and the system. Pharmacy leadership engaged this team to help on a more global level to advocate for patients and safety net hospitals via contracting, meeting with state representatives, and supporting state legislation.
Continued Collaboration Moving Forward
ASHP has developed a self-assessment tool available to members on their website.10 Health systems should work to develop internal policies and procedures to manage white bagging and discuss if white bagging can be implemented into the medical staff bylaws. Other helpful advice is to work with the managed care team to address white-bagging when deciding on the terms of a managed care contract.2,3 Health care systems should work with their Boards of Pharmacy and national organizations on continued advocacy efforts to support legislation to prohibit white-bagging.
REFERENCES
- Shaw, Gina. Coalition Slams White Bagging Push by Payors. Pharmacy Practice News. https://www.pharmacypracticenews.com/Policy/Article/05-21/Coalition-Slams-White-Bagging-Push-by-Payors/63396. Published May 13th, 2021. Accessed online June 7th, 2021
- ASHP webinar; White Bagging Challenges: Patient Safety and Drug Integrity April 2021
- Amerine L, Koch.S, Zweerink K. White Bagging Implications in a Hospital Based Infusion Center, Vizient. Presented on Jan 21st, 2021
- Time to Initial Cancer Treatment in the United States and Association With Survival Over Time: An Observational Study 2019 Mar 1;14(3):e0213209. doi: 10.1371/journal.pone.0213209. eCollection 2019
- ASHP Stands Opposed to Payer-Mandated White Bagging. https://www.ashp.org/News/2021/03/18/ASHP-Stands-Opposed-to-Payer-Mandated-White-Bagging?loginreturnUrl=SSOCheckOnly. Published March 18th, 2021. Accessed online June 7th, 2021
- Robb, K. Addressing Payer-Mandated White Bagging of Drugs: 340B Insight. https://www.ashp.org/Advocacy-and-Issues/Key-Issues/White-Bagging?loginreturnUrl=SSOCheckOnly. Posted June 7th, 2021. Accessed online June 10th, 2021
- Kraus T, Robb K, and Chen D. Advocating for Impact: White Bagging-Implications for Patient Safety and Access to Care. https://www.ashp.org/Professional-Development/ASHP-Podcasts/Advocacy-Updates/White-Bagging---Implications-for-Patient-Safety-and-Access-to-Care?utm_source=GRDWeekly-061021&utm_medium=email&loginreturnUrl=SSOCheckOnly. Accessed online June 7th, 2021
- ASHP Advocacy and Issues, White Bagging. https://www.ashp.org/Advocacy-and-Issues/Key-Issues/White-Bagging?loginreturnUrl=SSOCheckOnly. Accessed online June 19th, 2021
- American Society of Clinical Oncology Position Statement: Pharmacy Benefit Managers and Their Impact on Cancer Care: 2018. https://www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/2018-ASCO-PBM-Statement.pdf. Accessed online June 15th, 2021
- ASHP Hospital and Health System Self-Assessment: Impact of Payer Mandated White Bagging Policies. https://www.ashp.org/-/media/assets/pharmacy-practice/resource-centers/practice-management/ASHP-Hospital-and-Health-System-Self-Assessment-White-Bagging.ashx. Accessed online June 23rd, 2021