how boards of pharmacy are addressing white and brown bagging

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How Boards of Pharmacy Are Addressing White and Brown Bagging

Wednesday, August 11, 2021

Handouts for today’s presentations can be found at:

www.nabp.pharmacy/webinar

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NABP Webinar – August 11, 2021

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How Boards of Pharmacy Are Addressing White and Brown BaggingAugust 11, 2021

Panelists

Nathan Hanson, PharmD, MS BCPS

Division Director of Pharmacy Operations, Health Trust Performance Group

President-Elect, Missouri Society of Health-System Pharmacists

William Kernan, PharmD, MBA, FASHP

Executive Director of Pharmacy, Cleveland Clinic Florida

Immediate Past President, Florida Society of Health-System Pharmacists

Sarah Lake-Wallace, MS, PharmD, FTSHP

Director of Pharmacy Services, TIRR Memorial Hermann

Immediate Past President, Texas Society of Health-System Pharmacists

Moderator:

Kyle Robb, PharmD, BCPS

State Policy and Advocacy Associate, American Society of Health-System Pharmacists (ASHP)

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Disclosures

• The speakers and author for this presentation haveno relevant financial relationships to disclose.

Learning Objectives

• Define key terms “white bagging,” “brown bagging,” and“clear bagging” as related to distribution of clinician-administered drugs

• Discuss unique challenges to maintaining patient safety,access to care, and regulatory compliance that can arisefrom payer-driven white and brown bagging

• Review regulatory aspects of white and brown baggingand recent boards of pharmacy efforts to establish rulesaround white and brown bagging

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Presentation Outline

• Brief recap of drug distribution models for clinician-administered drugs

• Review of emerging payer-driven trends in drugdistribution

• Review boards of pharmacy actions to address white andbrown bagging

• Panelist discussion• Audience Q&A

Introduction

• In 2020, approximately 2 percent of all patientsreceived a specialty drug

• Specialty drugs accounted for nearly 50 percent of alldrug spending in 2020

IQVIA Institute. Medicine Use and Spending in the U.S.: A Review of 2018 and Outlook to 2023. IQVIA website. https://www.iqvia.com/en/insights/the‐iqvia‐institute/reports/medicine‐use‐and‐spending‐in‐the‐us‐a‐review‐of‐2018‐and‐outlook‐to‐2023 Published May 9, 2019.

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Clinician-Administered Drug

• An outpatient drug that cannot be reasonably self-administered by the patient to whom the drug isprescribed and is typically administered by a healthcare provider in a clinical setting

• Alternatively known as “physician-administered drugs”or “provider-administered drugs”

Payer Cost-Reduction Focus Areas in Specialty Care

• Site of Care Shifts

• Shifting Distribution Models of Specialty Medications

• Brown bagging• White bagging

• Clear bagging

• Vertical integration

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Learning Assessment Question 1

Approximately, what percent of patients received a specialty medication as part of their care in 2020?A. < 1%B. 2%C. 5%D. 7%E. 10%


As of 2020, specialty drugs account for what percent of pharmaceutical spend?

A. 2%B. 20%C. 35%D. 45%E. > 50%

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Traditional Drug Purchasing Process

• Hospital or clinic buys bulk drug from a wholesaler,then stores and prepares drugs for administration asneeded

• Medical plan reimburses the provider for costsassociated with both acquisition and administration ofthe drug

• Process is commonly known as “buy-and-bill”

What Is Payer-Mandated White Bagging?

• Plan requires a third-party specialty pharmacy topurchase and dispense patient-specific clinician-administered drugs

• Specialty pharmacy ships drug directly to the providerprior to administration

• Specialty pharmacy is reimbursed for drug cost andprovider is reimbursed for administration

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What Is Brown Bagging?

• A specialty pharmacy dispenses non-self-administereddrug directly into the patient’s custody

• Patient is responsible for proper storage, handling,and transportation to provider appointment prior toadministration

What Is Clear Bagging?

• A specialty pharmacy and provider under sharedcommon ownership coordinate distribution ofclinician-administered drugs

• Pharmacy is reimbursed for drug

• Provider is reimbursed for administration

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Drug Distribution Models

https://www2.deloitte.com/content/dam/Deloitte/us/Documents/life‐sciences‐health‐care/us‐hda‐role‐of‐distributors‐in‐the‐us‐health‐care‐industry.pdf

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Jane Smith receives infliximab infusions at an outpatient infusion center every eight weeks for rheumatoid arthritis. About one week before each infusion, an insurer-designated specialty pharmacy ships concentrated vials of infliximab to Jane’s house via FedEx. Jane then must store the vials in her house until transporting them to the infusion center prior to her scheduled appointment.

The above scenario is an example of:

A. Buy-and-bill

B. White bagging

C. Brown bagging

D. Clear bagging

E. Home infusion


What distinguishes white bagging and clear bagging?

A. Clear bagged drugs are dispensed by the administering provider ratherthan a pharmacy

B. Clear bagged drugs are dispensed from a pharmacy that is undercommon ownership with the administering provider

C. White bagged drugs are dispensed from a pharmacy that is undercommon ownership with the administering provider

D. The opacity of the packaging that the drug is supplied in

E. There is no difference. White bagging and clear bagging aresynonymous terms.

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Key Questions for Boards of Pharmacy

Is White Bagging Dispensing or Distributing?

• “Dispense to patients means the act of delivering aprescription drug product to a patient or an agent ofthe patient …”

• “Distribute means the act of delivering, other than bydispensing, a drug product to any person.”

• Is a health care entity the patient’s agent?

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Are White Bagged Drugs Redispensed?

• “Dispensed” white bagged drugs often require sterilecompounding or reconstitution prior to administration

• Is it lawful to manipulate and re-label a previouslydispensed prescription drug prior to administration?• “Redispensing” is not a defined term in most pharmacypractice acts

• Additional guidance needed to establish safe practices relatedto redispensing

Who Owns White-Bagged Drugs?

• “Dispensed” patient-specific medications are propertyof the patient

• Administering provider never takes formal ownershipof the medication• How do providers lawfully dispose of unusable product?• Drugs cannot be returned to dispensing specialty pharmacy• Restrictions on transferring product to a different physicaladdress

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Maintaining Product Integrity

• How is burden of responsibility established for drugsthat become adulterated as a result of mishandling?

• Dispensing pharmacy vs. receiving pharmacy vs. carrier

• Who is responsible for replacing mishandled andadulterated product?

• Difficult to establish burden of proof in many scenarios

Are All White-Bagged Drugs Suspect Products?

• Hospitals can’t determine if drugs are counterfeit,diverted, stolen, adulterated, or subject of afraudulent transaction

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Need for Safe Practice Procedures

• Many boards require pharmacies under commonownership to demonstrate policies and proceduresoutlining safe practices for dispensing, distributing,and transporting drugs from one pharmacy to another

• These requirements do not extend to dispensing ofdrugs between pharmacies that are not undercommon ownership

Is White Bagging a Form of Central Fill?

• Many states require pharmacies to have signedshared service agreements before engaging in centralfill operations

• Hospitals argue that white bagging is a form of acoerced shared service arrangement with the plan-affiliated specialty pharmacy acting as the central fillfacility

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Notable State BOP Actions

• Virginia BOP finalized white and brown baggingregulations in June 2021

• Rules for proper storage, handling, and transfer of clinician‐administered drugs

• Outlines shared service requirements for specialty pharmaciesand providers

Summary of Critical Issues Requiring Assessment

• Who is accountable for verifying authenticity and integrity of the drugbefore administration?

• Who is responsible when a delay in therapy, due to a lack ofcoordination between patient, prescriber, and pharmacy, leads toadverse outcomes for patients?

• Is white bagging dispensing or distribution?• Under what conditions is redispensing permissible?• How should unadministered white-bagged drug stock be handled?• Who is responsible for replacing adulterated drugs?• Which products can be reasonably self-administered by a patient or a

patient’s caregiver? Which products cannot?

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Additional Reading: 2021 BOP White Bagging Discussions

• Texas – February 2

• California – February 18

• Florida – April 14

• Missouri – April 15

• Washington – July 16

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