Pharmacies across America are responding in this unprecedented time by helping patients access critical healthcare needs. In additional to overcoming the physical distancing challenges, many pharmacies are expanding their patient care services by offering Point-of-Care (POC) testing for the detection of COVID-19.
With over 60,000 pharmacies across the United States, and 90% of Americans living with 5 miles of a pharmacy, community pharmacies are embedded in cities across the country. COVID-19 presents a unique opportunity to accelerate adoption of expanded testing within community pharmacies and create longstanding impacts in the neighborhoods they serve.
Movement Toward Chronic Disease Support and Prevention
Over the past 10 years, preventive and chronic care roles of community pharmacists have blossomed to encompass POC testing for HIV, hepatitis C, flu, streptococcus pharyngitis (strep throat) and tuberculosis in more than 40 states, and initiation of treatment, in 17 of the 40 states, for flu and strep throat among other minor ailments (1). In addition, pharmacies are have or are adding other healthcare offerings such as Nutrition Programs, Diabetes Counseling and Health Screenings. Many POC tests can be used to compliment these programs and provide more robust ongoing patient care and/or screen for potential disease.
Chronic Disease in United States
According to the CDC, 6 out of 10 adults in the United States have a chronic disease, and 4 of 10 have 2 or more (2).
- Diabetes: 34.2 million people have diabetes
- Pre-diabetes: 88 million adults have pre-diabetes, more than 8 of 10 do not know they have it
- Chronic Kidney Disease (CKD): 37 million people or 15% of adults have CKD, 9 of 10 don’t know they have it
- Obesity: 40% of adults are obese, 13.7 million children are obese
- Heart Disease: more than 859,000 Americans die of heart disease or stroke every year—that’s one-third of all deaths
Not only is the prevalence of disease of concern, but also the alarming statistics of adults who are unaware of a condition they have. Creating rapid and accessible testing at the local pharmacy can help identify disease earlier for more people.
Testing in Pharmacy
To perform POC testing, pharmacies must adhere to various requirements both at the federal and state level, including the pharmacy boards. While this current complexity may be a barrier, COVID-19 has put a spotlight on these complexities and the Trump Administration, Congress, and governors have taken steps to remove many thus far. The U.S. Department of Health and Human Services’ (HHS’) issued guidance in April authorizing pharmacists to order and administer COVID-19 tests, including serology tests (3). In addition, the fees for CLIA certification have been waived and the process to obtain a certificate have been expedited, allowing pharmacies to obtain certification within 2-7 business days.
As we continue to see barriers removed and more organizations supporting pharmacy testing, I believe pharmacies will provide meaningful impacts across the United States in COVID-19 mitigation and showcase the embedded reach pharmacies have within their neighborhoods. Therefore, as pharmacies, why not expand that reach with other services already available?
“Point-of-care testing services are anticipated to surpass immunizations to drive revenue” – according to research from Deloitte(4).
Today, pharmacies are already engaging in these various testing opportunities aligning with the services they offer:
- Fasting Blood Glucose
- Hemoglobin A1C
- Fasting Cholesterol (full lipid profile)
- Non-fasting Cholesterol (TC/HDL)
- Clotting Time (INR)
- Nutrition Deficiencies
- Influenza A & B
- Strep A
- Hepatitis C
In addition to these services, pharmacies who become CLIA certified can expand to perform more tests.
The full list of CLIA Waived testing is available here: CLIA Waived Tests Billing codes for waived testing here: Billing Codes for Waived Testing We summarized the types of analytes and number of tests at the end of this article.
Testing & Reimbursements Overview
In 2017 among Medicare Providers, (123.3M) 72% of CLIA waived tests were billed in Clinical Laboratories or Family Practice.
Tests Ranked by Number of Services:
Tests Ranked by Average Payment Amount:
The average Medicare reimbursement per test was $11.99.
Medicare is not the only payor, and many customers will pay cash for the accessibility of the testing and the services pharmacies can provide.
"Pressure from payers to detect high-cost diseases early will help speed up the growth of pharmacy-based diagnostic >screening services” -Deloitte(4)
Our analysis estimates that approximately 12,898 (4.8%) of all CLIA sites are pharmacies and provide testing. This presents vast opportunity to expand as POC diagnostic technology is advancing and the barrier to see a pharmacist is low..
CLIA Pharmacies by State:
Full file of detailed CLIA Laboratory information available here: View File for Download
Pharmacies have the opportunity now to help address the nationwide crisis with COVID-19, and in the future, additionally provide a more comprehensive health service offering. Consumerism in healthcare is growing, and customers are seeking faster, more cohesive, and less expensive care.
Today, pharmacies are under financial pressures as the drug market continues to diverge into a low-cost, low-margin generic and high-cost specialty marketplace. A strategic POC plan can drive additional revenues and advance community health using POC diagnostics to aid in prevention, early diagnosis, and management of chronic conditions.
Waived Tests - Number of Waived Tests Available by Analyte (May 22, 2020)
- NACDS: Pharmacies: A Vital Partner in Reopening America available at: https://www.nacds.org/pdfs/government/2020/Pharmacies-Reopening-America-COVID-19-NACDS-May2020.pdf
- CDC, accessed May 2020, available at: https://www.cdc.gov/chronicdisease/about/index.htm
- HHS guidance
- Deloitte, available at: https://www2.deloitte.com/content/dam/Deloitte/us/Documents/risk/us-risk-deloitte-retail-health-and-wellness.pdf