Point-of-care (POC) testing offers a significant opportunity for pharmacies to expand patient care services, generate revenue, and improve community health outcomes. This article explores the benefits, regulations, and implementation of point-of-care testing in pharmacies.
What is Point of Care Testing?
Point-of-care testing refers to medical diagnostic testing performed at or near the site of patient care, providing immediate, actionable results. These rapid tests aid in identifying and monitoring acute infections and chronic diseases, facilitating timely treatment decisions. POCT encompasses a wide range of tests, delivering results within minutes.
The Four Primary Goals of POCT
POCT aims to achieve the following objectives:
- Rapid Disease Identification: Quickly diagnose infections and diseases, enabling prompt intervention.
- Effective Disease Monitoring: Track disease progression and treatment effectiveness in real-time.
- Informed Behavior Modification: Empower patients to make informed decisions about their health based on test results.
- Reduced Barriers to Care: Provide convenient and accessible testing, especially for underserved populations.
Why Pharmacies are Ideal for POCT
Independent pharmacies are well-positioned to offer POCT due to their accessibility, established trust within the community, and convenient operating hours. Early disease detection through POCT leads to faster diagnosis and treatment, potentially saving lives. Furthermore, pharmacies contribute to antibiotic stewardship by ensuring appropriate antibiotic use based on accurate diagnoses. Industry research indicates that point-of-care testing may soon surpass immunizations as a primary revenue source for community pharmacies.
Navigating Rules and Regulations for Pharmacy-Based POCT
State regulations govern the scope of pharmacy-based POCT services. These regulations define pharmacists’ authority to order, administer, and interpret lab tests, and in some states, even prescribe medications based on test results. Key considerations include:
- Prescription Requirements: Determine if patients need a physician’s prescription for POC tests.
- Collaborative Practice Agreements (CPAs): Understand the necessity of CPAs or protocols for acting on test results.
- Reporting Requirements: Adhere to state guidelines for reporting test results to appropriate authorities.
Consult your State Pharmacy Association, State Board of Pharmacy, or State Health Department for specific requirements.
CLIA Waivers for POCT in Pharmacies
Pharmacies conducting POCT must obtain a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver. This waiver allows non-clinical settings to perform CLIA-waived tests, which are simple with a low risk of error.
The process involves identifying desired tests (refer to the FDA website for a list of waived tests), completing the CMS-116 application form, and submitting it to your state’s CLIA State Agency. Certificate fees are payable biennially, and waivers must be updated when new tests are added.
Implementing POCT: A Step-by-Step Guide
Successfully implementing POCT requires careful planning:
Establish Legality and Safety Protocols
Develop comprehensive protocols outlining testing procedures for each device and disease state. Adhere to manufacturer instructions and CLIA regulations. Maintain existing policies for record keeping, sharps disposal, and bloodborne pathogen training.
Develop a Comprehensive Business Plan
Consider these essential elements:
- Testing Location: Designate a dedicated space within the pharmacy.
- Test Selection: Choose tests relevant to community needs and local prevalence of diseases.
- Competitive Analysis: Research services offered by local competitors.
- Target Market: Identify the specific patient population to be served.
- Marketing Strategy: Develop a plan to promote POCT services.
- Staff Training: Provide adequate training on test administration and interpretation.
- Reporting Procedures: Establish clear processes for reporting results to patients, physicians, and public health agencies.
- Counseling Resources: Ensure access to resources for patient education and follow-up care.
- Support Staff: Optimize staffing to ensure service sustainability.
- Follow-up Care: Determine if prescriptions or collaborative practice agreements are required for treatment based on test results.
Procurement of Supplies
Establish relationships with reliable suppliers for POCT devices and consumables. Consider partnering with pharmacy wholesalers offering POCT support programs. Essential supplies include tests for HbA1c, blood glucose, cholesterol, urine albumin, strep, mononucleosis, UTIs, tuberculosis, and STIs.
Revenue Generation and Billing
Patients often expect a fee for POCT services. Research local market rates to establish competitive cash prices. Factor in costs for supplies, training, and potential test failures. To bill Medicare, enroll as an Independent Clinical Laboratory with your Medicare Administrative Contractor (MAC). CMS provides a list of waived test manufacturers and CPT codes. Several companies specialize in assisting with medical billing for POC testing.
Conclusion
Point-of-care testing presents a valuable opportunity for pharmacies to enhance patient care, generate revenue, and improve public health. By understanding the regulatory landscape, implementing comprehensive protocols, and developing a robust business plan, pharmacies can successfully integrate POCT into their service offerings. This proactive approach positions pharmacies as essential healthcare providers, meeting the evolving needs of their communities.
