Point-of-care (POC) testing provides an excellent opportunity for community pharmacies to enhance revenue by expanding patient care services while improving health at the patient and population levels.

What is Point-of-care Testing?

Point-of-care tests produce rapid, reliable results that aid in identification and monitoring of acute infections or chronic disease. POCT involves screenings and tests at or near the point of care, which produce actionable results within minutes.

There are 4 primary goals of POCT

1. Disease identification

2. Disease monitoring

3. Behavior modification

4. Reduced barriers to care

Why Pharmacy?

Independent pharmacies are convenient, accessible, trusted, and preferred healthcare destinations. Earlier identification of acute infection and chronic diseases leads to earlier diagnosis and earlier access to treatment, which can be lifesaving in some cases. Antibiotic stewardship is a plus too!

Point-of-care testing is predicted to exceed immunizations as a driver of revenue for community pharmacies, according to research from Deloitte.

Rules & Regulations

What pharmacists can or cannot do as it relates to Pharmacy-based POCT services depends on state-level regulatory requirements. In some states, pharmacists can even prescribe therapy based on the results of a rapid diagnostic test.

State pharmacy practice laws outline whether pharmacists can:

• Order lab tests

• Administer lab tests

• Interpret the results of the lab test

• Prescribe medication based on the results of a lab test

Requirements for POCT in pharmacies vary by state and may include, but are not limited to, Collaborative practice agreements (CPA), additional certifications, (ie Collaborative practice pharmacist certification), or written protocols.

Before getting started ask yourself...

• Will my patients need a prescription from their doctor before I can order or administer a POC test?

• Do I need a Collaborative Practice Agreement or Protocol to be able to act on the results of the test?

• What are the requirements for reporting results?

If you don’t know the answers to the above questions, reach out to your state authority for answers — State Pharmacy Association, State Board of Pharmacy, State Health Department.

Resources

• State CLIA-waiver requirements [Excel download]

• NASPA Pharmacist Prescribing authority: “Test and Treat” [Website]

• CPA One-Pager [PDF]

CLIA Waivers

Point-of-Care tests are waived under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and pharmacies that conduct point-of-care testing must obtain a certificate of waiver. This waiver allows a “non-clinical” facility to utilize CLIA-waived tests.

Before applying for a CLIA Certificate of Waiver, you must know which tests you want to provide. A list of CLIA-waived tests is available at the U.S. Food & Drug Administration website.

Then, complete the CLIA application form, CMS-116, and mail it to your CLIA State Agency contact based on your pharmacy location.

In addition to completing a CLIA-waiver, pharmacies must pay applicable certificate fees every two years and update CLIA waivers each time a new test is added to workflow.

CLIA Resources

• How to Apply for a CLIA Certificate of Waiver [Video]

• How to update your CLIA Certificate of Waiver [Video]

• How to obtain a CLIA Certificate of Waiver [PDF]

• CLIA Application [Form CMS-116]

• CLIA State Agency Contacts [PDF]

Implementing POCT in Your Pharmacy

Several things should be considered when preparing your pharmacy to offer point-of-care testing services.

Establish Legality

To prevent liability, ensure protocols are in place that define point-of-care testing procedures for each device used and disease state encountered. Most liability insurance policies will cover appropriate legal practice in terms of dispensing, immunizations, and point-of-care testing.

It is imperative to follow manufacturer test instructions and obey CLIA regulations. Pharmacies providing vaccinations should already have policies in place regarding record keeping, needle-stick prevention, blood borne pathogen training, and proper disposal of sharps and samples.

Business Plan Considerations

• Where will POCT testing take place in the pharmacy?

• What tests will be administered?

• What services are local competitors providing?

• Who is my target market?

• How will these services be advertised?

• What training does my team need?

• How will test results be reported to patients, physicians, and any required public health agencies?

• What additional resources will I need for counseling patients?

• How can I best deploy support staff to make this service sustainable?

Follow-up Care

• Will patients receive a prescription medication following test results?

• Am I able to treat patients based on a collaborative practice agreement?

What are some characteristics of an ideal POCT site?

• Appointment scheduling

• Extended hours

• Staff proficient in sample collection and test device

Resources

• NASPA Pharmacy-based Point-of-Care Test & Treat National Certificate Program, hosted by the NCPA Innovation Center [Website]

• Implement POCT in 8 Steps [PDF]

• PRS Pharmacy Point of Care Testing Resource (POCTTrack)

• Example Influenza Testing Policy, Duquesne University [PDF]

Supplies

POCT supplies can be purchased directly from a testing device manufacturer. It would be in your best interest to have more than one supplier. Some pharmacy wholesalers also have programs that provide POCT protocols, resources, supplies, business guidance, and more to help pharmacies elevate their POCT services.

• CLIA-waived POCT Tests

• HbA1c and blood glucose

• Cholesterol

• Urine albumin

• Strep test

• Mononucleosis

• UTI

• Tuberculosis purified protein derivative test

• STIs (chlamydia, gonorrhea, hepatitis, HIV, herpes, syphilis, trichomoniasis, genital warts)

POCT Device Manufacturers

• Abbott

• BD

• INSTI

• KSL Biomedical

• OraSure

• PHASE Scientific Americas

• Pts Diagnostics

• Quidel

• Roche

• Ulta Lab Tests

Revenue

Many people are used to being charged a copay when seeking POCT services from places like urgent care clinics or their doctor’s office. On average, urgent care visits can cost patients more than $100, depending on copay or clinic costs (Debt.org).

Most people who seek out POCT services are between the ages 18 – 44 with no primary care provider and about a third do not have health insurance (Rand Corp), so pharmacists can charge competitive cash prices to patients directly for POCT, or take necessary steps to seek reimbursement from third party payers.

Conducting a market analysis to assess what other healthcare facilities are charging for POCT can help in determining the best cash price to charge for your pharmacy’s POCT services. It is also important to be aware of all associated costs, including staff training and ancillary supplies.

Costs for POCT vary depending on supplier and type of test

• Flu antigen~ $15

• Flu NAAT~ $49

• Strep antigen~ $4

• Strep NAAT~ $28

• Covid antigen ~ $16

• Covid PCR ~ $60

• Covid NAAT~ $41

• RSV NAAT~ $38

Additional Cost Considerations

• Testing Supplies and PPE

• Marketing

• Training

• Failure rate

• Quality control

To bill Medicare, you will first need to work with your designated Medicare Administrative Contractor (MAC) to enroll as an Independent Clinical Laboratory. For pharmacies who already have a PTAN, you will get an additional PTAN.

A list of available CLIA-waived testing manufacturers and CPT codes is provided at this Centers for Medicare and Medicaid (CMS) website.

Companies that assist with medical billing:

• Change Healthcare

• Enliven Health

• Electronic Billing Services (ebs)

• OmniSYS

Resources

• CMS Form 855b - Enrollment Application [PDF]

• PECOS - Medicare Enrollment Application [Online]

Who is Already Doing POCT?

Community pharmacists across the nation are offering point-of-care testing services to improve patient access to care and enhance pharmacy revenue. Explore the pharmacies listed below to learn more about their programs.

• Chamber’s Apothecary, Chambersburg, PA

• Hospital Pharmacy West, Sheridan, WY

Where Can I Learn More?

Want to learn more? Review current literature published on providing point-of-care testing in the community pharmacy setting as well as other resources and companies who assist community pharmacies with point-of-care testing services.

Figueira, I., et al. Point-of-care HIV and hepatitis screening in community pharmacies: a quantitative and qualitative study. Int J Clin Pharm (2022).

Community pharmacy interventions to improve antibiotic stewardship and implications for pharmacy education: A narrative overview. Res Social Adm Pharm. 2019 Jun;15(6):627-631.

Additional Resources

• Point-of-Care Testing Playbook. NCPA Convention 2022 [PDF]

• Point-of-Care Testing (Beyond COVID-19). NCPA Convention 2021 [PDF]

• CDC To Test or Not to Test [PDF]

• Preparing for Flu Season: Point-of-Care Testing in the Pharmacy [Video]

• What does my CLIA certificate of waiver allow me to do? [OnDemand CE]