Alberto Coustasse, DrPH, MD, MBA, MPH

During the coronavirus disease 2019 (COVID-19) pandemic, organizations have promoted concepts such as "We are in this together" to ensure buy-in and build communication with employees and the public.

However, we should consider post-pandemic times. We do not always have a crisis to solve or a critical body of evidence to point to when we need to change a work process, influence employees to support changes, improve products, or increase medication safety. As leaders, we should always ask ourselves: Is change necessary? How do we effectively implement the change? How do we articulate the benefits of the change? How do we sustain efforts after the change?

Change management (CM) is a well-organized framework for managing the people side of change.

 It includes practices, processes, and planned activities designed to facilitate and lead organizations to move from the present state to a desired state.

 The goal of CM is not to eliminate resistance but to anticipate it, proactively plan for it, continuously manage it, and mitigate the consequences.

In some settings, such as hospitals, there are important challenges to changing processes. Clinicians have high individual autonomy and show various degrees of professional dominance over management and patients, which gives them control and power.

 CM practices are often only considered retrospectively in practice after challenges or implementation difficulty occur.

STEP 1: IDENTIFYING WHAT NEEDS TO BE CHANGED

The first step in most CM models is identifying what needs to be changed. A good way to examine this in health care is the Swiss cheese model related to patient safety.

 Perhaps the task or item is not meeting expectations or there is a need to increase effectiveness, operational efficiency, patient safety, or productivity. In either event, the element that needs to be changed is identified. Then we recognize what exactly should change, who will be affected, and who the stakeholders are. Leadership must realize that change may not be positive for all stakeholders and may be perceived as negative by some.

An example is rationing products for personal protective equipment (PPE) during supply chain disruptions from the pandemic. Another is increasing telepharmacy use to provide care and education to patients while protecting clinicians and patients from unnecessary exposure to COVID-19 and advancing medication management and safety. In these cases, what needed to change was apparent to those involved. If a patient could not come to the clinic to get care or equipment was not available, an alternative was required.

STEP 2: DETERMINING THE NEW WAY OF DOING BUSINESS

Once a needed change is identified, a new process should be identified. One case in pharmacy practice is using alternative compounded products instead of commercially available products to address supply shortages caused by stressors during the pandemic. A matrix can be developed to aid in this process, such as the Six Thinking Hats, in which various points of view are considered to evaluate the best ideas.

 This type of thinking can help determine the best choice and provide feedback to stakeholders about why the option(s) being proposed are better. This will allow the proposed change to build critical mass to support the change.

To implement and sustain change, it must address who is going to do what and when. An example would be inventory-control functions for the COVID-19 vaccine supply. Everyone involved with the supply chain and planning needs to understand their role. The COVID-19 vaccine supply chain includes managing cold storage, thawing, and complex administration and scheduling processes.

Once a plan is in place, stakeholders need to be informed that the change is starting. Once implemented, it should be determined if the results were obtained. Depending on the change, a new policy may be written and employees trained accordingly to sustain the change. Step 3 is the point in which CM can fail and cause a new process to increase the number of errors in the short term, if the new standard work is not written clearly. Finally, there is a need to codify the change so the process does not backslide over time.

The pandemic has caused leadership to implement change more rapidly than usual and rethink how business and process operates, including managing the supply chain, deploying staff, ensuring medication safety, and using personal protective equipment. Additionally, to effectively manage identified change, CM should encompass a standardized procedure. Although CM can be a daunting process, a thoughtful application will reduce the resistance to change and improve overall operations, regardless of where it is applied if it follows consistent steps.

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Articles

Thoughtful application can reduce resistance and improve overall operations, if consistent steps are followed.

Change Management Is a Consideration Beyond the Pandemic

The 340B drug pricing program was created to improve access to outpatient medications for low-income and underinsured or uninsured patients.

The program grants reduced pricing on biologics, FDA-approved prescription drugs, insulins, and some OTC drugs with a prescription.

 Originally, this program was limited to about 90 safety-net hospitals known as qualified “covered entities.” Through the passage of the Affordable Care Act, these entities expanded to include cancer centers, critical access hospitals, federally qualified health centers, rural referral centers, sole community hospitals, and other settings.

The program has exponentially grown with the expansion of the definition of a covered entity and the change to allow multiple contract pharmacies. Still, there are debates about the program’s financial impact and whether the discounts are passed along to enough underinsured or uninsured patients.

 The Health Resources and Services Administration predicted that covered entities saved $3.8 billion on outpatient drugs through the program in 2013 and estimated that covered entities applying the 340B program reached more than $16 billion in 2016.

 Hospitals have claimed that they have expanded services and reduced overall costs to patients.

 However, the Centers for Medicare & Medicaid Services (CMS) has contended that financial gains for hospitals have not been associated with clear evidence of expanded care or lower mortality among patients.

In 2018, the US Department of Health & Human Services (HHS) amended the program by cutting Medicare Part B outpatient drug payments to 340B hospitals by 28.5%, seeking to close a gap between those prices and Medicare Part B payments.

 Proposed amendments would further reduce the payment to certain covered entities by an estimated $1.6 billion.

 As a result, a lawsuit was filed by the American Hospital Association, the Association of American Medical Colleges, Eastern Maine Healthcare Systems, Fletcher Hospital, and Henry Ford Health System.

The most recent decision was from the US Court of Appeals for the District of Columbia Circuit on July 31. The court decreed in favor of HHS, allowing the lower 340B program reimbursement.

 Hospitals have continued to challenge the rule and have argued dire financial consequences resulting from this policy change that includes an increased impact on small community hospitals without a significant financial cushion.

 All covered entities, hospitals, and those affected by these cuts to the program should provide comments by October 5 on this new rule.

Additionally, on August 4, CMS recommended a shift to the Medicare Hospital Outpatient Prospective Payment System methodology. If enacted, this change would mean that certain covered entities would have a change in reimbursement from the average sale price (ASP) plus 6% to ASP minus 28.7% for separately payable drugs or biologicals acquired through the 340B program. It was also requested to continue the Medicare payment policy of paying an ASP of 22.5% for 340B-acquired drugs for calendar year 2021 and subsequent years.

 This would add to previous cuts to total an estimated $2 billion to $2.5 billion reduction of 340B-covered medications.

If these proposed CMS changes are implemented, affected covered entities must be ready and understand the direct impact on the organization, which could be critical.

Facilities designated as disproportionate share hospitals or rural referral centers will receive reduced payment for certain separately payable drugs or biologicals specified by CMS purchased under the program and furnished to a Medicare beneficiary.

When determining the organizational cost of maintaining the 340B program rules, consider the cost of any employees added, such as individuals to the revenue integrity area to monitor the program or a purchasing agent position. Alternatively, additional expenses could occur in the internal auditing department to maintain compliance with the program, as many organizations have used third-party consultants to conduct annual program audits and reviews.

Additionally, staff members must be trained in the program, increasing the cost, and administrative costs associated with the program include planning, audit and meeting preparation, audit review, and response. Some other items to consider are the potential loss of goodwill related to the public release of the 340B audit findings and the hardware and software needed to maintain the split billing program and contract pharmacy compliance. Those entities subject to the group purchasing prohibition will also have a cost increase based upon the requirement to purchase medications at the wholesale acquisition cost.

Hospitals must take a systematic approach and undertake financial calculations to ensure a clear understanding of the program’s real cost. Many hospitals have financially struggled during the COVID-19 pandemic and this reduction without a significant increase in outpatient payments (proposed just 6%) aggregate on handling and overhead costs

 adds another hurdle for these organizations.

, is vice president of operations support 

, is director of experiential learning, manager of clinical support services, and associate professor of pharmacy practice, administration, and research at Marshall University School of Pharmacy in Huntington, West Virginia.

, is a professor of health care administration at the Management and Healthcare Administration Division at Lewis College of Business at Marshall University. 

Government Accountability Office. Drug pricing. September 2011. Accessed August 20, 2020. https://www.gao.gov/assets/330/323702.pdf

340B eligibility. Health Resources & Services Administration. Updated May 18, 2018. Accessed August 21, 2020. https://www. hrsa.gov/opa/eligibility-and-registration/index.html

340B pricing/covered outpatient drugs. 340B Prime Vendor Program. Accessed August 21, 2020. https://www.340bpvp.com/ resource-center/faqs/340b-pricing-/-covered-outpatient-drugs/

How hospitals and PBMs profit—and patients lose&mdash;from 340B contract pharmacies. Drug Channels. July 23, 2020. Accessed August 21, 2020. https://www.drugchannels.net/2020/07/how-hospitals- and-pbms-profitand.html

Vandervelde A, Blalock E. Measuring the relative size of the 340B program: 2012-2017. Berkeley Research Group. July 2017. Accessed August 23, 2020. https://media.thinkbrg.com/wp-content/ uploads/2020/06/17122912/Vandervelde_Measuring340Bsize- July-2017_WEB_FINAL.pdf

Gerlach J, McSweeney S, Swearingen A, Coustasse A. Examining the benefits of the 340b drug discount program. 

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Conti RM, Nikpay SS, Buntin MB. Revenues and profits from Medicare patients in hospitals participating in the 340B drug discount program, 2013-2016. 

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Desai S, McWilliams JM. Consequences of the 340B drug pricing program. 

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Daly R. Hospitals decry appeals court decision upholding 340B cuts. Healthcare Financial Management Association. August 3, 2020. Accessed August 20, 2020. https://www.hfma.org/topics/ news/2020/08/hospitals-decry-appeals-court-decision-upholding- 340b-cuts.html

CY 2021 Medicare hospital outpatient prospective payment system and ambulatory surgical center payment system proposed rule (CMS-1736-P). News release. Centers for Medicare & Medicaid Services. August 4, 2020. Accessed August 20, 2020. https://www. cms.gov/newsroom/fact-sheets/cy-2021-medicare-hospital-outpatient- prospective-payment-system-and-ambulatory-surgical-center

Thomas S, Schulman K. The unintended consequences of the 340B safety‐net drug discount program. 

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Federal Register. Medicare program: hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs; new categories for hospital outpatient department prior authorization process; clinical laboratory fee schedule: laboratory date of service policy; overall hospital quality star rating methodology; and physician-owned hospitals. August 12, 2020. Accessed August 21, 2020. https://www.federalregister.gov/ documents/2020/08/12/2020-17086/medicare-program-hospital-outpatient- prospective-payment-and-ambulatory-surgical-center-payment

LaPointe J. CMS to boost outpatient reimbursement, remove inpatient only list. Revcycle Intelligence. August 5, 2020. Accessed August 20, 2020. https://revcycleintelligence.com/news/ cms-to-boost-outpatient-reimbursement-remove-inpatient-only-list

CMS-1736-P. Centers for Medicare & Medicaid Services. August 12, 2020. Accessed August 21, 2020. https://www.cms.gov/ medicaremedicare-fee-service-paymenthospitaloutpatientppshospital- outpatient-regulations-and-notices/cms-1736-p

Proposed CMS changes could hurt many health systems that are already struggling due to COVID-19 pandemic.

Consider Real Costs Before Implementing a 340B Program

Many pharmacies may have prepared standard downtime procedures but may not have given much thought to developing a crisis continuity plan.

The purpose of continuity planning is to ensure that dispensing operations continue, that pharmacy information systems’ data remain protected and accessible, and that telecommunications to support critical organization function during and after business interruption. Interruptions can occur for various reasons, such as earthquakes, fires, flooding, hurricanes, pandemics, power loss, tornadoes, and wildfires. Devising a crisis continuity plan can enable pharmacies to continue to provide patient care, ensure staff safety, and maintain financial viability after a disaster. The coronavirus disease 2019 (COVID-19) pandemic and the resulting business closures brought about by the shutdown have highlighted this need to plan for all health care—related essential businesses.

Each year, the National Hurricane Center reinforces through public service announcements and planning tools the importance of planning for floods, hurricanes, and other disasters.

 Also, the Small Business Administration (SBA) has developed a free, online practical guide that is directly applicable to pharmacies.

 It provides guidance for business owners on incorporating their past operational changes into current procedures, a template for combining their tools, and SBA insight into the updated policy. The guide also identifies lessons learned from previous disasters. This gives pharmacies a tool to help ensure that staff members have been trained on any changes that were made and that they are all on the same page in the event of an emergency. In addition, for more in-depth information, the US Department of Health and Human Services (HHS) has a comprehensive crisis assessment and vulnerability analysis plan. It covers contingency policy and procedures, cybersecurity, data backup and recovery strategies, electronic health records, pharmacy disaster recovery, pharmacy operation plans, risk assessment, and utility failure.

During the planning process, pharmacies should assess which events would cause the business to close or require a necessary change of operations. They should determine how to function with reduced staffing if employees must work from home and which personnel are key to restoring operations. For pharmacies that are institution based, the American Society of Health-System Pharmacists has developed a pandemic assessment tool that covers communication with the media and public affairs, coordinating planning with area health systems, departmental leadership and succession, downtime operations, education and training, policy and procedures, and staffing.

For those who are unsure about where to start or which hazards might affect a pharmacy in a particular geographic area, the Federal Emergency Management Agency offers guide templates to help with natural disasters such as earthquakes, floods, hurricanes, landslides, and wildfires.

Cybersecurity, Electronic Health Records, Data Recovery 

Cybersecurity, data recovery, and downtime access to data have become crucial as pharmacies rely more extensively on integrated electronic data systems. Boards of pharmacy and other regulatory bodies, the Centers for Medicare & Medicaid Services, and the Drug Enforcement Administration have issued multiple waivers during the COVID-19 pandemic. Further, various governors have announced executive orders that make procedures more straightforward, and with less regulatory burden, when continuing work during a disaster.

 However, pharmacies must plan to operate regardless of whether waivers are implemented to reduce the burden.

Note that during an event such as a cyberattack, flood, or hurricane, those who provide essential services, including pharmacies, have to figure out how to continue business without access to the internet and sometimes even power, and they may need to recover data quickly. A plan for accessing or assessing patient health records in such a setting can be applied to many types of events and is vital for developing proper downtime procedures.

 This strategy has become even more vital as the frequency of cyberattacks, including ransomware attacks, has increased. Infrastructure and Utility Failure Continuity plans should address infrastructure and utility failures and what to do in the event that crucial personnel have been affected or cannot get to work, facilities have been impacted, and there is an associated communication crisis. Pharmacies should determine which processes are the most important and in which order they would need to be brought back online, and document applicable procedures in advance. Staff members may not be able to contact health care providers or insurers during an event. Also, there could be drug shortages and/or interruptions in pharmacy deliveries and a lack of access to online claim adjudication, and patients may not be able to use credit or debit cards. A continuity plan’s procedures should reflect how to handle these events. Understanding how to meet regulatory guidelines in terms of assessment and documentation is critical, as patients will continue requesting service during most disaster events.

Having a well-drafted business continuity plan could enable pharmacies to stay operational, while mitigating potential risk circumstances. Many resources are available to help pharmacists, and they should integrate continuity planning into their regular downtime operations plans. Poorly performing these tasks or skipping the process altogether could result in adverse patient impact, significant interruption to operations, or business closure. Devoting the appropriate thought and time now can prevent catastrophic loss later.

is the vice president of operations support at 

, is the director of experiential learning, manager of clinical support services, and an associate professor of pharmacy practice, administration, and research at Marshall University School of Pharmacy in Huntington, West Virginia.

, is a professor of health care administration in the Management and Healthcare Administration Division at Marshall University Lewis College of Business. 

Comprehensive hospital preparedness checklist for coronavirus disease 2019 (COVID-19). Centers for Disease Control and Prevention. March 24, 2020. Accessed June 29, 2020. https://www. cdc.gov/coronavirus/2019-ncov/downloads/HCW_Checklist_508.pdf

National hurricane preparedness. National Weather Service. Accessed June 29, 2020. https://www.weather.gov/wrn/ hurricane-preparedness

Disaster preparedness and recovery plan. SBA. Accessed June 29, 2020. https://www.sba.gov/document/support--disasterpreparedness- recovery-plan

Healthcare coalition recovery plan template. HHS. Accessed June 29, 2020. https://files.asprtracie.hhs.gov/documents/aspr-tracie-hccrecovery- plan-template.pdf

ASHP COVID-19 pandemic assessment tool for healthsystem pharmacy departments. American Society of Health-System Pharmacists. Accessed June 29, 2020. https://www.ashp.org/-/media/ assets/pharmacy-practice/resource-centers/Coronavirus/docs/ASHP_ COVID19_AssessmentTool.ashx?loc= ashphero3-covid19assessmenttool-03182020

Hazard identification and risk assessment. Federal Emergency Management Administration. Accessed June 29, 2020. https://www. fema.gov/hazard-identification-and-risk-assessment

Federal recovery programs for healthcare organizations. HHS. July 2019. Accessed June 29, 2020. https://files.asprtracie.hhs.gov/ documents/aspr-tracie-federal-recovery-programs-for-healthcare-organizations- final.pdf

Tips for retaining and caring for staff after a disaster. HHS. Updated September 2018. Accessed June 29, 2020. https://files. asprtracie.hhs.gov/documents/tips-for-retaining-and-caring-for-staffafter- disaster.pdf

A well-drafted business continuity plan enables continued operations, mitigates potential risks.