Opportunities in point-of-care testing

February 1, 2018 by Smart Retailing Rx
point-of-care

New clinical and revenue opportunities for community pharmacies

In brief:

  • Point-of-care (POC) testing represents a significant opportunity for community pharmacies.
  • The number of POC tests has increased and experts expect demand to grow. Pharmacies are well positioned to integrate POC testing into their business.
  • For pharmacies to take advantage of this opportunity, it requires addressing regulatory, operational and marketing issues.

Point-of-care tests

Some pharmacies have been doing in-pharmacy testing for over 20 years.1 This includes testing for total cholesterol and HDL, blood glucose, vitamin D and A1C.

The Clinical Laboratory Improvement Amendments, CLIA, regulate all U.S. facilities that perform lab testing on human specimens.2 CLIA has identified tests that pharmacies can perform if they receive a CLIA waiver. More than 10,000 pharmacies are CLIA-waived facilities. CLIA-waived tests:3

  • Are so simple and accurate that erroneous results are negligible
  • Are non-technical and of little difficulty to conduct
  • Pose minimal risk of patient harm if performed correctly
  • Have been cleared for home use by the FDA

Over the past two decades the number of CLIA-waived tests has grown significantly.4 A list of the CLIA-waived tests is available on the FDA website.5

19932015
# of analyticss (or chemical substances) for which CLIA-waived tests are available9123

 

POC tests are a subset of CLIA-waived tests. POC tests are tests that:6

  • Aid in disease screening, diagnosis and/or patient monitoring
  • Pharmacies can perform at the point of care
  • Provide a rapid and reliable result

The opportunity for pharmacies

Deloitte wrote in a report on retail health and wellness:

“Point-of-care testing services are anticipated to surpass immunizations to drive revenue [in retail pharmacies]. Pressure from payers to detect high-cost diseases early will help speed up the growth of pharmacy-based diagnostic screening services.” 7

Areas for pharmacy-based POC tests include:

  • Acute disease screening such as influenza or strep
  • Chronic disease management and monitoring such as diabetes (blood glucose and A1C), cholesterol, HIV, hepatitis C and more
  • Other important tests like tests for blood lead levels or genetic tests

Influenza testing example8

  • A study involved 55 pharmacies in three states (MI, MN, NE)
  • All pharmacists completed a POC certificate training program
  • All pharmacies identified a physician to sign a population-specific collaborative practice agreement
  • Pharmacies gave patients who complained of signs/symptoms consistent with influenza a rapid diagnostic influenza test via nasal swab
  • ~11% of patients tested positive and received an antiviral, with no adverse events noted
  • 44% of patients came outside normal physician hours; 37% did not identify a primary care provider
  • Patient satisfaction was >90%

Delivering POC tests

In preparing to offer POC tests, or expand the tests already offered at your pharmacy, important considerations include:

  • Targeting. Targets include busy families, people needing care outside of normal hours, those with no primary care provider, the uninsured and underinsured, and travelers.
  • Regulations. It may be necessary to get a CLIA waiver (state rules vary) and to form a partnership with a physician covered by a collaborative practice agreement.
  • Operations. It is necessary to train staff (pharmacists and technicians) and develop workflows.
  • Payment/reimbursement. Today, payment for point-of-care tests in retail pharmacies is typically cash pay. Many patients are willing to pay out of pocket when they understand the value of these services for their health. An example of a possible pricing structure on some POC tests is shown below. In the future it is possible that payers may begin covering POC tests.
Pricing9

  • Influenza: $75–$126
  • Strep: $59–$96
  • HIV and HCV: $40–$65

Getting started

To learn more about this opportunity, an excellent presentation is available here from the American Pharmacists Association.

Also, the Centers for Disease Control and Prevention (CDC) has a self-assessment checklist for good POC testing practices.10

Checklist for Good Point-of-Care Testing Practices
(Examples of a few of the many items on CDC checklist)

YesNoN/A
Regulatory requirements
  • Do you have a current CLIA Certificate of Waiver?
  • Do you perform only CLIA-waived tests?
Self-assessmentReady

  • Do you clean work surfaces before testing?
  • Do you perform testing in a well-lit area?
  • Do you inspect equipment and electrical connections to make sure they are safe and working properly?

Set

  • Do you follow the manufacturer’s instructions for use of the appropriate device and sample volume needed for testing?
  • Do you check patient identification with test orders?

Test

  • Do you verify that samples are properly collected or handled?
  • Do you follow the manufacturer’s instructions in the exact order?

POC tests fit well as community pharmacies evolve into more comprehensive local health centers that provide a range of health-related services. Pharmacies are well positioned to take advantage of the trends related to point-of-care testing, and there are many resources available to help you get started.

1 “Point of Care Testing: Making It Work in Your Pharmacy,” 2017 McKesson ideaShare Presentation by Donald G. Klepser.
2 Clinical Laboratory Improvement Amendments (CLIA), Waived Tests, CDC. LINK
3 “Quick Read: Do Point-of-Care Tests Add Value?” Presentation from APhA 2016 Conference by Alex J. Adams and Michael E. Klepser. LINK
4 “Quick Read: Do Point-of-Care Tests Add Value?” Presentation from APhA 2016 Conference by Alex J. Adams and Michael E. Klepser. LINK
5 CLIA — Clinical Laboratory Improvement Amendments — Currently Waived Analytes, U.S. Food and Drug Administration. LINK
6 “Quick Read: Do Point-of-Care Tests Add Value?” Presentation from APhA 2016 Conference by Alex J. Adams and Michael E. Klepser. LINK
7 “Retail Health and Wellness: Innovation, Convergence, and Healthier Consumers,” Deloitte, 2015. LINK
8 “Point-of-Care Testing: Making It Work in Your Pharmacy,” 2017 McKesson ideaShare Presentation by Donald G. Klepser.
9 “Quick Read: Do Point-of-Care Tests Add Value?” Presentation from APhA 2016 Conference by Alex J. Adams and Michael E. Klepser. LINK
10 Self-Assessment Checklist for Good Testing Practices, CDC. LINK