White bagging may not be a familiar concept for some rheumatologists, especially those in large practices or at academic institutions. For small and independent practices, however, this policy of designating specific sources for drugs represents a significant threat to patient safety and the way practices function. White bagging has also emerged as a hot topic of discussion in many state capitols this legislative session. None of the bills have passed yet, but the ACR is monitoring legislation in more than 10 states and expects that some of those states may approve bills this year.
What Is White Bagging?
Mandatory white bagging policies require physicians to acquire provider-administered drugs through a preferred specialty pharmacy designated by a payer or pharmacy benefit manager (PBM). Often, these preferred pharmacies are under the same corporate umbrella as the PBM or payer. Mandatory white bagging policies effectively end the buy and bill system that has worked for providers and patients for years.
In a buy and bill system, providers can purchase medications and administer them as needed to patients. By contrast, under a white bagging policy, a medication is ordered through a payer-preferred pharmacy for a specific patient and can only be used for that patient. If that patient is unable to receive the medication before it expires, the drug must be wasted; it cannot be used for another patient. White bagging also does not allow for last-minute adjustments by the provider. If, at the time of administration, less than the ordered amount of drug is needed, the excess must be wasted. If more is needed, the patient can’t receive an appropriate dose because there is no allowance for extra medication. One reason that the buy and bill system is so important to patient care is that it allows for adjustments right up to the moment of infusion. Buy and bill ensures that patient care is personalized and determined by the provider and not a payer or a PBM.
Additionally, white bagging raises serious issues related to safety and timeliness. White bagging relies on “just in time” delivery of medications to providers. Delivery systems have long been plagued by disruption issues, problems that have been exacerbated during the pandemic. Delivery delays increase the chances of mishandling and drug spoilage. They can also delay care, raising the risk of a patient having a flare or incurring irreversible damage.
State Activity
White bagging is attracting a lot of attention in state legislatures this year, largely driven by state hospital associations, because hospitals are an early target of white bagging policies. Thus far, hospital associations have been good partners on this issue. We have worked with them and our other partners in several states to ensure that the language in introduced bills is inclusive of providers.
As white bagging bills have emerged in many states this session, we have observed a few trends in legislative approaches. The most common approach is for states to introduce a straightforward ban on white bagging mandates. Louisiana adopted this type of bill last year, and similar bills have emerged in Kentucky, Nebraska and West Virginia. One key difference between these bills is that the Kentucky legislation is wrapped in a larger PBM package, which makes the bill much more difficult to move forward. The Nebraska and West Virginia legislation are standalone bans on mandatory white bagging. The Nebraska bill has been voted out of committee and the West Virginia bill has cleared the House and is now in the Senate. These standalone bills have an obvious advantage over complex proposals because they enable easier discussion with legislators about white bagging specifically.
A second approach is to place safety guardrails around white bagging mandates. This option is being explored by legislation in New York, which seeks to require proper handling of white bagged drugs to ensure patient safety. Although these safeguards are welcome, it is unclear how such a law would be enforced or whether it would make any practical difference. These considerations make this approach the least preferred for addressing white bagging.
The last approach we have observed combines a ban on mandatory white bagging with bans on home infusions and mandatory brown bagging, a practice in which patients are required to pick up their own medication at a designated pharmacy. This approach is being pursued in Wisconsin with a bill colloquially known as Koreen’s Law, named after a cancer patient. The bill has had one hearing and enjoys broad support, with 83 cosponsors in the Assembly. This comprehensive approach protects patient safety and the provider’s ability to manage care, and we hope this will become the prevailing approach as more states look to adopt white bagging laws.
Conclusion
White bagging will likely remain an active topic in state legislatures for several years. As more states look at ways to protect patients and providers from these practices, it is important that the rheumatology community remains engaged and at the table for these discussions. Working with our traditional partners and hospital associations, we can ensure that providers are not left out of any proposed legislation. Most importantly, we can ensure that patients can continue to receive physician-administered drugs in a provider’s office, where care can be delivered in the safest, most cost-effective way.
Joseph Cantrell, JD, is the senior manager of state affairs for the ACR.
