key: cord-0984864-xqewlafy
authors: O’Connor, Shanna K.; Healey, Patricia; Mark, Nicole; Adams, Jennifer L.; Robinson, Renee; Nguyen, Elaine
title: Developing Sustainable Workflows for Community-Pharmacy Based SARS-CoV-2 Testing
date: 2021-08-14
journal: J Am Pharm Assoc (2003)
DOI: 10.1016/j.japh.2021.08.012
sha: 2edbe2ad28dc49790f635c62057e2632bdcc1a26
doc_id: 984864
cord_uid: xqewlafy

Background The COVID-19 Rapid Antigen Testing Expansion Program (Program) employed a drive-thru model to maximize pharmacy staff and the public’s safety. Objectives To quickly design, implement, and disseminate a pharmacy-based point-of-care testing program during a public health crisis Practice Description Community pharmacies in Idaho were engaged in the state’s public health efforts to boost SARS-CoV-2 testing statewide. Geographic location was a major recruitment factor. Two recruitment periods were held to extend the Program’s reach into more remote underserved communities. Practice Innovation Program and pharmacy staff developed workflows and materials in an iterative process. Pharmacies received testing supplies. Program staff created e-Care plans for documentation and reimbursement and designed a web portal for state reporting of positive rapid antigen test results. Evaluation Methods Testing data (pharmacy location, patient insurance status, test type and results, number of submitted Medicaid claims) were captured in an online form. Results From September to December 2020, 13 pharmacies opted into a drive-thru, rapid antigen point-of-care testing and nasal swab for off-site testing program. A total of 2,425 tests were performed. Approximately 29.4% of point-of-care tests were positive and 70.6% required backup PCR confirmatory analysis. Patient insurance breakdown was 72.1% private, 8% Medicare, 11.4% Medicaid, and 8.5% uninsured. On average, pharmacies tested patients an average of 2.3 hours per day, and 2.6 days per week. As a group, they provided 77.5 hours of testing per week statewide. Program pharmacies accounted for an average of 5.1% of testing across the entire state at the end of December 2020. Conclusion Independent community-based pharmacies should be considered as partners in public health initiatives.

Objectives: To quickly design, implement, and disseminate a pharmacy-based point-of-care 4 testing program during a public health crisis 5

Practice Description: Community pharmacies in Idaho were engaged in the state's public health 6 efforts to boost SARS-CoV-2 testing statewide. Geographic location was a major recruitment 7

factor. Two recruitment periods were held to extend the Program's reach into more remote 8 underserved communities. 9 Practice Innovation: Program and pharmacy staff developed workflows and materials in an 10 iterative process. Pharmacies received testing supplies. Program staff created e-Care plans for 11 documentation and reimbursement and designed a web portal for state reporting of positive 12 rapid antigen test results. 2  The coronavirus disease of 2019 (COVID-19) pandemic poses particular challenges to rural  3  states, which have lower healthcare capacity, hindering access to laboratory testing and health  4 services. Idaho's expanded scope of pharmacy practice allows pharmacists to independently 5 provide immunization services, prescribe short-term or bridge medications, and provide disease 6 testing via CLIA (Clinical Laboratory Improvement Amendments)-waived devices. 1 7 8

Pharmacists in independently-owned, community-based pharmacies are often the closest 9

available healthcare providers to rural residents. with population centers of 7,500 or fewer peopleand these areas are medically underserved 22

with reduced healthcare access. 3 Therefore, Program staff targeted recruitment of pharmacies 23 in rural areas (population <2,500) or urban clusters (population centers <50,000) across all 24 public health districts. 4 Independent pharmacies and small regional chains were prioritized for 25 recruitment and Program participation due to their ability to quickly and effectively implement 26 new workflows, requiring few internal and external approvals to implement program change. ISU 27 engaged with a network of clinically integrated community-based pharmacies across Idaho, 28 known as Community Pharmacy Enhanced Services Network of Idaho (CPESN-ID). CPESN-ID 29 pharmacies were optimal sites for Program implementation because they all had established 30 workflows that could be adapted to support testing in a pandemic. As members of CPESN, 31 these pharmacies all have access to support for practice change in the form of written guidance, 32

virtual and in-person meetings, and CPESN-specific trainings. These pharmacies also had 33 experience in delivery of enhanced services such as comprehensive pharmacy care 34 management, medication synchronization, and administration of vaccines. 5 35

The purpose of the Program was to rapidly implement a statewide COVID-19 pharmacy-based 37 testing program.The intent was to create an easily replicable program for others seeking to 38 develop programs with independently-owned or other community-based pharmacies, especially 39 during a public health emergency. Program via a standing network-wide emailed newsletter and two topic-specific recruitment 2 emails sent over the course of two weeks in August 2020. In order to participate in the Program, 3

pharmacies were asked to consider current workflow, staffing, volume of business, and 4

considerations unique to their businesses that could influence feasibility such as parking lot 5 capacity and traffic flow, location, and available space for testing separate from current 6 pharmacy customers. Pharmacies were requested to opt in or out of the Program through an 7 online form by the end of August; non-responsive pharmacies were followed up with via phone. 8

Participating pharmacies were offered incentives in exchange for meeting participation 9

requirements (Table 1) . 10 11

A second recruitment phase for non-CPESN pharmacies occurred beginning in November 2020 12 afterlaunch and pilot of workflows in CPESN sites (roughly six weeks into the project). Non-13 CPESN pharmacies were identified using a list of community pharmacies registered with the 14

Idaho Board of Pharmacy. Pharmacies with CLIA waivers in place were prioritized for initial 15 contact, then an overlay of pharmacy location was used to identify geographical gaps in 16 pharmacy-based COVID testing state-wide (only pharmacy-based testing availability formally 17 mapped, but general access concerns communicated by health districts were considered). A 18

'priority' list of 20 pharmacies was identified and contacted via email with phone follow up. 19

Pharmacies were contacted via phone three times for this recruitment effort. They were required 20 to do mock run-throughs of their proposed workflow changes, opt into the Program using the 21 same opt-in form as used in the initial recruitment, and to complete an attestation form 22

indicating that they had worked through this process, as well as identifying days and times to 23 offer testing. 24 25

Practice Innovation 26

Materials Provided 27

All participating pharmacies were provided with two Becton-Dickenson Veritor System for Rapid 28

Detection of SARS-CoV-2 (BD Veritor+) testing machines. They received a three-month supply 29 of rapid testing kits and nasal swab kits and transport materials. All pharmacies were 30 recognized as state testing providers and had access to public Personal Protective Equipment 31 (PPE) supplies. 32 33

Program Communication 34

In order to promote Program communication, pharmacies were required to have at least one 35

representative attend at least one of two weekly interactive check-in meetings, which were 36 conducted via video conference. These meetings were designed to address concerns 37 (collaboratively across pharmacies), disseminate information (e.g., information on rapidly 38 changing public health guidance, updates on medical billing developments), and share 39 pharmacy-identified lessons learned and best practice strategies. Pharmacies that could not 40 attend weekly sessions were asked to contact Program staff via phone or email to ensure at 41 least project-directed communication was maintained. Attendance, phone calls, and other 42 contacts were recorded as a measure of participation. Feedback from participants was used to 43 iteratively update Program materials. All Program materials were organized and maintained in a 44 University-sponsored shareable online cloud storage system; materials could be viewed and 1 downloaded for use or modification by anyone added to the online shared folder but could not 2 be modified within the shared system. 3 4

Initial and Ongoing Workflow Development 5

An initial draft workflow plan was developed by the Program team using state and Centers for 6

Disease Control and Prevention (CDC) guidance to ensure inclusion of all broad components of 7 the testing workflow, including patient intake, testing, and reporting. The workflow plan also 8 provided testing teams with a shared infrastructure from which to build their formal workflows 9

and targeted messaging for patient and provider communication. Contact information for all 10 public health districts was collected by the project team and organized in an online spreadsheet. 11

Patient education resources were adapted from CDC resources with guidance from public 12 health contacts (e.g., form with CDC counseling and images embedded) to tailor materials to 13 testing workflows. As an example, a one-page resource from CDC was combined with patient 14

information into a single-page, double-sided tool to use for counseling patients on their test 15 results. Resources to support billing the medical benefit were identified. 16 17

Patient triage guidance was developed and updated consistently throughout the Program to 18 ensure alignment with both Federal and state-level guidance, which changed frequently. 19

Symptomatic individuals, as defined by the Centers for Disease Control (updated with changing 20

guidance, e.g. days since symptom onset, presence and definition of fever) and the BD Veritor+ 21 eligibility profile, were eligible for POCT. All other individuals who did not meet these criteria 22

were administered a nasal swab for PCR analysis. While patient triage was standardized, site-23 specific workflow was tailored by individual pharmacies based on available trained staff, space 24 and pharmacy layout constraints, and other pharmacy-specific factors. Sample collection was 25 performed by pharmacists, technicians, and/or interns in compliance with Idaho law. The 26 flexibility of how workflows were adapted was important due to the differences between 27 individual independent pharmacies. 28 29

The anticipated time between receipt of testing supplies and rollout of testing was roughly two 30 weeks. Pharmacies were tasked initially with tailoring the workflow materials to their specific 31 needs and pharmacy organization. Ongoing communication between ISU Program staff and the 32 primary pharmacy contacts was maintained via weekly web-based meetings and as-needed 33 telephone communication. Once pharmacies had piloted workflow (including training of all staff 34 on appropriate PPE donning/doffing procedures and testing protocols), they were able to launch 35

testing. Pharmacies were required to attest to piloting their workflow via an online form, which 36 served as a safeguard to ensure pharmacies had completed necessary groundwork to promote 37 successful launch of testing. 38 39

When 80% of pharmacies reported readiness for testing, a statewide press release was created 40

by Program staff and the project was presented to state public health district leadership. 41

Pharmacy testing days and times were also included on a statewide testing website (outside of 42 this project) that listed all available testing locations across the state as part of an effort to 43 ensure patients knew where to find COVID-19 testing. 6 Public health districts were also apprised 44 J o u r n a l P r e -p r o o f of the pharmacies and the hours of testing in their areas and disseminated the information to 1 their respective communities. 2 3

Dissemination of Information 4

A public-facing, open-access website was created six weeks into testing to facilitate rapid 5 dissemination of workflow best practices identified from this program; the audience for this 6 website was anyone interested in creating or streamlining community pharmacy-based testing 7

for COVID-19 (https://covidrxpoct.org/). Click-rates and click-through rates were tracked for the 8 first 30 days of this website. Because materials could be downloaded and then shared, it is 9

understood that the click rates would potentially underestimate actual dissemination, but sharing 10 of information quickly was prioritized over tracking dissemination, so this disparity was 11 determined to be acceptable. The main reasons for pharmacies opting out of the Program were staff capacity, staff safety, 40

and perceived need for service in their community. 41 42

Pharmacy Characteristics 43 Aside from three in Pocatello (an urbanized area of 50,000 or more people) and one in Twin 1

Falls (an urban cluster of 2,500-49,999 people), the participating pharmacies were exclusively 2 located in rural areas (<2500 people). All pharmacies had CLIA test waivers in place prior to 3 enrollment in the Program. All but one health district were covered by the first phase of 4 pharmacy recruitment. Coverage of all seven public health districts was achieved during the 5 second phase of recruitment. The geographic distribution of pharmacies is presented in Figure  6 1. 7 8 A total of six workflow iterations were made and disseminated to pharmacies (see Table 2 ). 9

Feedback and questions were responded to and revisions made to the workflow based on real-10 time data, with roughly one week between proposed revisions and published updates. All 11 materials were disseminated at the same time, with initial pharmacies launching actual testing 12 2.5 weeks after dissemination and all pharmacies offering testing within four weeks of 13 dissemination. The launch for the second wave of pharmacies was significantly shorter, with 14 both pharmacies offering services within two weeks of material dissemination. (in this instance, COVID testing, but in the future other services); these services are not 37 reimbursed via the pharmacy benefit, the usual source of reimbursement for community 38

pharmacies, but the medical benefit. To do this, establishment of public and private payer 39 provider-level funding streams was determined critical to support community-based pharmacy 40 testing beyond the grant. While most demonstration or grant-funded projects do not involve 41 seeking reimbursement for services, the Idaho Board of Pharmacy and Program team deemed 42 it appropriate in this instance in order to facilitate long-term sustainability of the services, 43

particularly for those patients who may be less likely to be able to afford testing after the project 44 period ended. Pharmacists were recognized as providers under Idaho Medicaid in April 2020, 1 so the requirement to submit at least one claim to the medical benefit per week for testing was 2 reasonable and was designed to help catalyze pharmacies' readiness to submit medical claims 3 to all non-Medicare medical insurers. The expectation was that 100% of claims would be 4 submitted to Medicaid, but one pharmacy shifted to submitting medical claims for services to 5

private payers as well. The ownder of the pharmacy in question also owns a pharmacy in 6

Washington, where medical billing has been established for more payers for multiple years, so 7 the owner was able to leverage pre-existing expertise in medical billing for this project. No other 8 pharmacy submitted claims to private insurance during the project time period, although many 9

were beginning to explore this option due to the establishment of medical billing via Medicaid. 10 11

This program demonstrated that the process of billing the medical benefit for health services 12 provided to Medicaid patients is possible in independently-owned community pharmacies, 13

although it continues to present challenges related to the integration of pharmacies into 14 established medical billing systems. Medicaid billing codes are almost exclusively geared 15 toward physician practices, hospitals, and clinics, so submitting claims successfully is often a 16 matter of trial and error. Claims are not approved or rejected in real time, and it can take 17 pharmacies weeks to learn that the method they have been using results in rejections.

Pharmacies with dedicated billing support staff may find these challenges somewhat easier to 19

navigate, since they are often involved in the dispensing and billing of durable medical 20 equipment, which typically follows pathways for reimbursement outside of the 'usual' 21 prescription reimbursement pathways. This project required pharmacies to navigate the 22 relatively unexplored world of medical billing with an established payer that recognized 23

pharmacists as providers; with the workflows established for medical billing processes, it is 24

hoped that pharmacists will continue to explore opportunities for offering services that are 25 reimbursed by the medical benefit. 26 27

This project has limitations that should be considered when interpreting the data presented and 28 by those working to launch similar services. First, the pharmacy opt-in process precluded even 29 geographic distribution of testing sites, resulting in a preponderance of sites in the southeastern 30 section of the state. However, all public health districts, even those with low population density, 31 had at least one participating pharmacy. 32 33

Second, pharmacies that participated in the Program were more likely to be CPESN leaders 34

and were able to adapt and implement new workflows quickly; once workflows were 35 established, the two additional pharmacies were able to launch the service on a very short 36 timeline of two to three weeks. The rapid rollout of Phase 2 pharmacies suggests materials 37 developed by pharmacy leaders were useful for launch--a consideration for future projects is to 38 ensure pharmacy leaders are involved in initial workflow development. Despite existing workflow 39 support, significantly more pharmacies opted out of participating than anticipated, suggesting a 40 need for an alternative approach to recruitment for this sort of program. In addition, over 92% of 41 pharmacies participating in this program were CPESN member pharmacies, which may 42 influence the reproducability of these services in non-CPESN pharmacies. Because CPESN 43 regularly (before COVID-19) provides member pharmacies with structured support for practice 44 change, it is possible that these pharmacies are more adept at adjusting to practice change than 1 a non-CPESN pharmacy. 2 3

Third, another limitation is that access to data reported to the state via PCR was unavailable, so 4 a 'true negative' rate for patients presenting for this service cannot be determined. Finally, 5

because only Medicaid claims were required to be submitted by each pharmacy per week (one 6 per week), the sustainability of the service as it pertains to non-Medicaid claims remains in 7 question. Furthermore, many claims remain pending at the conclusion of this project, so a true 8

'success rate' for Medicaid claims cannot yet be determined. 9 10

Despite these limitations, the Program findings should be considered by community pharmacies 11

and others weighing partnering with these entities in the launch of COVID-19 or other disease 12 state testing programs. J o u r n a l P r e -p r o o f Program sub-contract to software engineer to create community pharmacy-friendly web portal for data reporting; portal collected all state and district-specific data in single place and reported via usual mechanism (used by labs) to streamline with overall reporting workflow used at the state.

While the portal was being created, interim fax reporting was used to ensure districts had information specific to positive POCT findings. 

Idaho State Board of Pharmacy. Idaho Pharmacy Laws. Title 54 -Professions

Idaho Statutes. Title 39 Health and Safety: Chapter 4 Public Health Districts, Sections 6 401 through 426

University of Idaho Profile of Rural America. Idaho Commerce & Labor Division of 10 Commerce Website

Responsive/Files/president/direct-reports/mcclure-center/Idaho-at-a-Glance/IDG-Profile-12 of-Rural-Idaho.pdf

Community Pharmacy Enhanced Services Network. Services available from CPESN 17 network pharmacies. Community Pharmacy Enhanced Services Network Website

One Idaho Website