White bagging and brown bagging are two distinct ways of delivering specialty medications to patients that have gained prominence in recent years. But how do they stack up to clear bagging and the newest standard of gold bagging? And where does traditional buy and bill fit into the mix? Let’s delve into these practices, define their key features, compare and contrast them, and explore their roles in hospital pharmacy and health system settings.
What Are White Bagging and Brown Bagging?
White bagging is when a specialty pharmacy that is outside the health system sends medication directly to a healthcare facility or physician for administration and requires them to store it.
Brown bagging involves patients obtaining their specialty medications from an external pharmacy and bringing them to the healthcare facility for administration. This practice is often used for outpatient or ambulatory care but can also be used for home infusions.
What are Gold Bagging and Clear Bagging?
Gold bagging is considered the highest level of care for the patient. This term has essentially replaced clear bagging as the newest standard.
With gold bagging everything happens internally. The health system’s own specialty pharmacy prepares the drug in a sterile compounding environment and delivers it directly to the health care provider to administer it to the patient. A clinical pharmacist will help with lab monitoring and discussing any treatment changes with the provider. And all of this happens at a very high level of care.
Also in gold bagging, electronic medical records (EMR) are often shared so everyone has real-time access. For example, if a patient comes in and the regimen has to be changed, it can be done on the fly. The patient doesn’t have to be rescheduled for treatment.
Traditional Buy and Bill
In the traditional buy and bill process, hospitals purchase and maintain their medication inventory, billing payers for medications administered to patients. Everything happens within the same health system. As a part of the gold bagging process, it contributes to the highest standard of patient care.
Buy and bill is most commonly used with chemotherapy medications, although other specialty drugs in neurology and rheumatology also fall in this category.
How Common is Brown or White Bagging vs. Buy and Bill?
The adoption of white bagging and brown bagging practices varies across healthcare systems, though some states have passed legislation against the practice.
Some hospitals and health systems have allowed these methods, but others rely on the traditional buy and bill process. The choice often depends on factors like patient population, available resources, and the complexity of medication regimens. Some PBMs require the use of an approved specialty pharmacy, which would require white bagging, but health systems can often avoid this by prohibiting the practice in their policies and procedures.
While specialty drugs are used in less than 5% of the population, they account for half of the total drug spend in the U.S. – around $265 billion in 2020. Almost 30% of oncology drugs under commercial insurance plans were subject to white bagging, which means they did force a patient to go to a specialty pharmacy or receive their meds from the specialty pharmacy. At 43%, white bagging is more common in the non-chemotherapy specialty meds versus 11% in chemotherapy.
Benefits of White Bagging & Brown Bagging
- Increased patient autonomy and choice in pharmacy selection.
- Potential lower costs for patients with insurance plans that incentivize external pharmacy use. The discount that the insurance company receives may or may not trickle down to the patient, but it decreases the payer spend overall. So, hopefully, that would mitigate any rate hikes and get distributed to the insured.
Challenges of White Bagging & Brown Bagging
- Limited control over medication quality, storage and handling.
- Potential for medication shortages or delays in scheduling.
- Medication is wasted because it cannot be used on another patient if the designated patient is unable to use it.
- Concerns about medication traceability and recalls.
- Burden on hospital pharmacy inventory due to requiring separate storage for the extra stock.
- Potential for patient confusion, medication errors, and dangerous drug interactions.
- Doesn’t allow for changes in patient’s condition, stats, or information,
- Challenges in billing and reimbursement for the hospital. Providers and health systems are unable to bill for the drug, but they use resources to administer the medication.
- Often takes providers out of care decisions.
Benefits of Clear/Gold Bagging
- As the gold standard of care, clear or gold bagging provides the best patient safety.
- Entire chain of custody happens within the healthcare system, providing more control and transparency.
- Patients get the correct dosage when and where they need it.
- Medications are able to be tracked from prescription to administration, reducing risk of error.
- Better cost management.
- Higher level of patient care through comprehensive service.
Challenges of Clear/Gold Bagging
- Specialty pharmacies must be in-network
- Patients may still have to wait on prior authorization for their medication.
Benefits of Buy and Bill
- Control over supply chain, from purchasing to storing to inventory management to administration.
- Potential for higher reimbursements and increased revenue for the health system.
- Medications can be used for any patient and are more readily available. So, patients can start necessary treatment sooner.
- If the patient has to be rescheduled, the medication is not wasted and may be used for another patient.
Challenges of Buy and Bill
- Can be more expensive for patients and payers
- A higher financial risk
- Responsibility of managing stock and inventorySkilled prior authorization specialists may be needed
Is White Bagging or Brown Bagging Allowed in Medicare?
In Part B, there is no white or brown bagging, but the Centers for Medicare & Medicaid Services (CMS) says that Part D plans may not restrict access to certain Part D drugs to specialty pharmacies. In essence, this means that they allow the option for the patient to go to a specialty pharmacy if they choose to.
Keep in mind, though, that Medicare policies can change, and it’s essential to consult the latest regulations and guidance from the CMS or seek expert advice to determine the current status.
Recommendations from the Experts
Medical experts have very clear views on white bagging and brown bagging. The American Society of Clinical Oncology (ASCO) is opposed to brown bagging and encourages caution and careful consideration when it comes to white bagging.
The American Society of Hospital Pharmacy (ASHP) is also opposed, stating that “white bagging and brown bagging undermine hospitals’ patient safety and jeopardize patient care.” They are actively working to change policies and enforce safety requirements around these practices.
The American Medical Association’s (AMA) policy on the practices says that doctors should be allowed the right to accept or not accept these drugs.
While the choices between white bagging vs. brown bagging and gold bagging or buy and bill depends on a wide variety of factors, careful consideration and expert guidance can help pharmacies and healthcare systems make informed decisions to enhance patient care while managing costs effectively.
About the Author
Dr. Jennifer Allen joined the CompleteRx team in 2017 and is the Area Clinical Manager. In her role, she works closely with medical staff to coordinate Antimicrobial Stewardship Programs, Pain Management Programs, Pharmacy and Therapeutics Committee meetings, formulary management, staff education, performance improvement projects, medication use evaluations (MUE) and develops clinical tools for health systems under the direction of the Director of Clinical Services. Jennifer has served as the Residency Program Director for an ASHP accredited program and precepts the advanced experiential clinical administration pharmacy rotation.
With more than 15 years of hospital clinical pharmacy experience, Jennifer previously served as a Clinical Pharmacy Manager in an 11-hospital health system prior to joining the CompleteRx team. She was responsible for growing the clinical pharmacy program as the general clinical and infectious disease pharmacist. Jennifer also developed staff training competencies, precepted pharmacy students, and ensured compliance with Joint Commission standards and regulatory compliance.
Jennifer received her Pharm. D. from Mercer University in 2008 and started her career as a licensed pharmacist in Georgia. She currently maintains licensure in Georgia. Jennifer has received several safety awards including a pharmacy-nursing joint project on Medication Reconciliation, a pilot program that was expanded to the entire health system as well as two Team Covenant awards with CompleteRx. Jennifer is certified in Antimicrobial Stewardship through MAD-ID (2012), the Society of Infectious Disease Pharmacists (2019), and is a Board-Certified Pharmacotherapy Specialist (2018).
Jennifer has also been published in Managed Care Executive on current topics such as biosimilars, long-acting injectable antipsychotics, and pipeline vaccines.