Understanding Hospital White Bagging and Regulatory Implications

Impact of Hospital White Bagging and Future Regulatory Implications JACK DUFFNER, PHARMD CANDIDATE OSU COP CLASS OF 2022

Objectives Describe white bagging and indicate the differences between it and other types of drug dispensing done at NCH. Detail the potential benefits of and issues with this type of dispensing. Indicate how white bagged medications are dispensed and managed within NCH s current workflow. Identify new legislative activity at the state and federal level surrounding the practice of white bagging and cover related current events and concerns.

What is White Bagging? Distribution of patient-specific medication from a pharmacy to an administration site, typically a physician s office, clinic, or hospital Medications obtained by white bagging are usually prepared by a specialty pharmacy Ideally, reduces cost of drug purchasing and inventory cost for physicians/clinics and provides opportunities for pharmacist-managed medication monitoring In practice, implementation of white bagging has notable problems

Other Inpatient Dispensing Models BUY AND BILL/CLEAR BAGGING BROWN BAGGING Provider practice site maintains drug inventory and directly bills third party payer for administration Pharmacy dispenses medication directly to patient Patient transports own medication to clinic for administration Provider functions similar to pharmacy Clear bagging uses organizational specialty pharmacy to manage/dispense Significant safety concerns

Common White Bagged Medications Costly injectable or infusible medications that are more commonly seen in specialty pharmacies Chemotherapy infusions (not at NCH) Immunotherapy Immune Globulins Remicade Entyvio Botox

NCH Specifics Separate Workflow Clinical pharmacist manages Separate inventory Average pharmacist time investment to obtain drug from specialty pharmacy is around 20 minutes Pitfalls Prior authorizations Patient involvement Timing/delivery constraints Therapy changes 54 patients at NCH who utilize white bagging Total number who utilize clear bagging not tracked

Example of white bag tracking

Legal Implications Drug Supply Chain Security Act of 2013 requires transaction history and tracking of all drugs in supply chain White bagged medications are not always reliably tracked, could be tampered with or adulterated White bagging could technically be considered re-dispensing Hospitals take on more legal risk with less financial incentive

Safety Concerns Increased handling and transportation of drug = increased chance for errors Storage and shipping needs to be tracked more closely while transitioning between facilities Many white bagged drugs have a narrow therapeutic index, need lab monitoring Administering facility or dispensing pharmacy may be missing relevant EMR information

Patient Access Issues White bagging can fragment and delay the patient care process Shipping delays Delayed appointments Additional steps such as PAs/consults Patient must authorize/pay for medication from specialty pharmacy before administration process Health system handicaps A medication labeled for a specific patient cannot be returned to stock or re-used Leads to drug waste and inventory problems If patient needs immediate care, health system may need to administer drug from own stock

Payer Mandates Several large insurance companies began enacting new policies regarding white bagging in mid 2020 Cigna, Aetna, and Anthem Blue Cross began mandating that certain clinician-administered drugs be filled at specific in-network specialty pharmacies or clinics In-network pharmacies are often vertically integrated with payer Payers can financially de-incentivize medication filled out of network

Pharmacy Pushback Payer mandates met by strong opposition from individual pharmacists and professional organizations OSHP, ASHP, AHA all have released statements against the practice, citing legal and safety concerns Several lobbying efforts in the works to develop legislation to regulate white bagging

AHA Statement Asks policymakers to ensure insurers comply with these policies: Prohibit brown bagging Ban certain types of white bagging Restrict other types of white bagging Enhance clarification and notification for providers regarding white bagging procedures

ASHP Proposal Stance that patients and providers both should have choice in method of obtaining clinician- administered drugs Provided recommendation for key elements and specific wording of legislation to regulate white bagging

Allow any specialty pharmacy to dispense clinician-administered drugs Require health plans to allow enrollees to obtain drugs from the administering facility on equal financial terms to the specialty pharmacy Prohibit brown bagging entirely Effective White Bagging Legislation Prohibit plans from requiring home infusion or other outpatient administration site Clearly define drugs that should be clinician- administered

Legislative Action Louisiana passed a law banning white bagging on June 1st, 2021 Prohibits insurers from refusing to approve, authorize, or pay a provider for supplying a physician-administered drug Does not allow insurers to restrict, condition or deny a drug if provider obtained it from an out-of-network pharmacy Similar proposals in progress in Texas, Massachusetts, New York Possible utilization of Any Willing Provider laws

Ohio Legislation SB 230 bans chemotherapy medications from being brown bagged Strong OPA lobbying presence behind this bill No legislation currently proposed to address white bagging Community pharmacy pushback against PBMs/DIR fees and current legislative attention may help to set stage for future discussions

Conclusions The practice of white bagging has potential to be of benefit for patients and healthcare systems, but needs to be better regulated and managed to ensure patient safety and good outcomes. Payer-mandated white bagging is a significant current issue in healthcare practice that directly impacts patient care and needs to be addressed both at the state level and federally. Joint lobbying efforts by professional organizations and precedents set by legislation in other states could both help to clarify the white bagging process in Ohio.

Questions?

References Altendorf S. Lessons learned: Starting A HEALTH-SYSTEM, Oncology-focused specialty pharmacy. Pharmacy Times. https://www.pharmacytimes.com/view/lessons-learned-starting-a-healthsystem-oncologyfocused-specialty-pharmacy. Published March 8, 2021. Accessed August 23, 2021. Caffrey M. White, Brown bagging of Therapies creates extra steps for Oncology practices. AJMC. https://www.ajmc.com/view/white-brown-bagging- of-therapies-creates-extra-steps-for-oncology-practices. Published March 20, 2021. Accessed August 23, 2021. Health Insurer Specialty Pharmacy Policies Threaten Patient Quality of Care. March 2021. Maynes M. New Louisiana law Bans insurer practice known as WHITE BAGGING. America's NewsHub. https://americasnewshub.com/health/new- louisiana-law-bans-insurer-practice-known-as-white-bagging/. Published June 8, 2021. Accessed August 23, 2021. The Ohio Society of Health-System Pharmacists Position Statement on White Bagging. 2021. Rumore MM, Dresser JC. Emerging trends in PAYOR-MANDATED WHITE BAGGING. Frier Levitt - Attorneys at Law. https://www.frierlevitt.com/articles/emerging-trends-in-payor-mandated-white-bagging/. Published January 6, 2021. Accessed August 23, 2021. White bagging. ASHP. https://www.ashp.org/advocacy-and-issues/key-issues/white-bagging?loginreturnUrl=SSOCheckOnly. Published 2021. Accessed August 23, 2021. Wolf JD. 'White bagging': New insurer policies hurting chemotherapy drug dispersal. Pharos Tribune. https://www.pharostribune.com/news/article_f6707354-ae76-11eb-98e4-43dbc4654d0d.html. Published May 8, 2021. Accessed August 23, 2021.