Implementing CLIA-Waived Testing in NY Pharmacies

A Practical Guide

Community pharmacies already sit at the intersection of convenience and clinical care. Adding CLIA‑waived point‑of‑care testing (POCT) elevates that role—letting patients walk in, get a rapid diagnostic result, speak with a prescriber, and leave with the right treatment in a single visit. New York State adds a few twists: a required Limited Service Laboratory registration and strict rules around who can order tests and prescribe. This guide distills the entire process—regulatory steps, test selection, billing considerations, and a proven telehealth workflow—so your pharmacy can launch POCT confidently and compliantly.

1. Licensing & Certification: CLIA + NYS Limited Service Laboratory

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Renewals & updates: Notify NY DOH if you move, change ownership, or add new tests; both certificates are site‑specific.

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2. New York Scope‑of‑Practice: Testing vs. Treating

• Pharmacists may collect and perform CLIA‑waived tests under the pharmacy’s certificates.
• Ordering/interpreting remains medical practice. Outside public‑health emergencies, a provider (MD, DO, NP, PA) must authorize the test or operate under a standing order.
• Prescribing is likewise restricted. Current Senate Bill S3467A would create broad “test‑and‑treat” authority for flu, strep, COVID‑19, and RSV, but has not yet become law.

What this means today
A prescriber still must:

1. Order the test (standing order, patient‑specific script, or telehealth consult).
2. Diagnose based on the result.
3. E‑prescribe any medication.

Partnering with an on‑demand telehealth service such as Well Revolution lets you fulfil those steps without hiring an in‑house clinician.

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3. Choosing Your CLIA‑Waived Test Menu

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Pro tips

• Bundle related tests (e.g., flu + COVID panel) to boost value.
• Post prices clearly; patients accept cash pay when it’s simpler than urgent‑care visits.
• Stock control swabs or strips for every kit and record QC runs per manufacturer schedule.

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4. Financial Model: Cash First, Billing Optional

1. Cash‑Pay Simplicity – Most independent pharmacies launch POCT as a transparent cash service. No credentialing, no claim denials, immediate revenue.
2. Selective Insurance Billing – If you see high Medicare volume, you can enroll as a laboratory supplier and submit claims under your CLIA number. Evaluate ROI before diving into claim workflows.
3. Medicaid Watchlist – NY Medicaid currently allows pharmacies to bill certain respiratory tests (COVID‑19, flu, RSV) under emergency provisions; policy is evolving. New York State Department of Health
4. Receipts with CPT Codes – Give every cash patient an itemized receipt (e.g., “87880 – $35”) so they can file with FSA/HSA or private insurance.

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5. The Well Revolution Workflow: From Swab to Script in Minutes

1. Collect & run the waived test in your consultation room.
2. Patient texts your unique pharmacy code to the Well Revolution number on their own phone. A New York‑licensed clinician picks up the chat immediately—no app download, no appointment.
3. Share results via secure chat or video; clinician confirms diagnosis, checks contraindications, and e‑prescribes to your pharmacy.
4. Dispense immediately—patient leaves with meds and advice.
5. Document: store test result in your log; the clinician’s note lives in Well Revolution’s record, fulfilling the “ordered/diagnosed” requirement.
6. Follow up with the patient is provided by Well Revolution clinicians.

Why it works: Patients save a trip to urgent care; pharmacists stay inside legal scope; prescribers gain real‑time lab data; everyone wins.

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6. Launch & Stay Compliant

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Marketing ideas

• Street signage: A-frame or window posters with clear, bold messaging like “Flu, Strep & COVID Tests—Get Tested & Treated in One Visit.”
•  Social media: Short reels or stories showing how patients test, text, and get treated.
• ‍In-store promotion: Flyers in prescription bags or counter displays highlighting same-day testing + treatment.
• ‍SMS prompts: “Text CODE to 646-233-3485 for flu or strep treatment—no appointment needed.”
• ‍Community engagement: Announce testing services in local Facebook groups, community bulletin boards, or pharmacy email newsletters.

7. Looking Ahead

Legislators continue debating broader pharmacist “test‑and‑treat” privileges. Early adopters who already run compliant POCT programs will be best positioned to expand services the moment the laws change. Stay connected with PSSNY updates and Well Revolution news alerts.

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Launch Your Service with Confidence

By securing the right certificates, choosing high‑impact tests, setting clear prices, and integrating instant telehealth prescribing, your pharmacy transforms into a convenient neighborhood clinic—without overextending staff or violating New York regulations. Well Revolution’s plug‑and‑play service removes the last barrier between a positive test and effective treatment, letting you deliver faster care and build deeper patient loyalty.

Ready to start? Contact the Well Revolution pharmacy success team to walk through onboarding, service setup, and marketing assets tailored to your pharmacy.

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This guide reflects regulations and reimbursement policies current as of May 2025. Always verify the latest NY DOH, CMS, and payer updates before launching services.

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Go Deeper: Detailed Reference & Implementation Playbook

Use this section as the nuts‑and‑bolts companion to the concise guide above. It preserves the full research detail so you or your compliance officer can move from concept to launch with confidence.

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1. Regulatory Foundations — Forms, Fees & Timelines

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Timeline tips

• Average initial approval: 3–6 weeks CLIA, 2–4 weeks LSL (often concurrent).
• Keep certificates displayed in the testing area; inspectors expect to see originals.

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2. Quality Systems & Everyday Compliance

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Inspection readiness: Even waived labs receive surprise visits. A tidy three‑ring binder with logs, QC sheets, and training certificates keeps audits painless.

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3. Scope‑of‑Practice Mechanics in New York

• Testing – Pharmacists may perform CLIA‑waived tests once the lab is certified.
• Ordering/Prescribing – Still reserved for licensed prescribers except under emergency orders.
• Pending legislation – Bills S3467A / A6627B (“Test & Treat”) would grant pharmacists limited prescribe‑on‑the‑spot authority for flu, strep, COVID‑19, and RSV; monitor progress for future expansion. (Empire Report New York, LegiScan)
• Current workaround – Standing orders or real‑time telehealth (e.g., Well Revolution) satisfy the “ordered by provider” requirement today.

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4. Expanded CLIA‑Waived Test Catalogue

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*Always defer to the manufacturer instructions for use (IFU).

Selection strategy: Only stock tests you can (1) explain, (2) act on clinically via telehealth, and (3) market effectively to your demographic.

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5. Supplies & Space Planning Checklist

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6. Billing & Reimbursement Deep Dive

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Medicare

• Enroll the pharmacy as a laboratory via CMS‑855B in PECOS; add your CLIA number.
• Paid under the Clinical Laboratory Fee Schedule—e.g., 87880 strep ≈ US $16.12 (CY 2025).
• Requires provider order: telehealth note serves as documentation.

NY Medicaid

• Current policy (ARPA) allows pharmacies to bill COVID‑19, flu, RSV test codes; use NPI + CLIA on claim. (New York State Department of Health)
• Other tests (strep, A1C) not yet payable—treat as cash or bill through collaborating clinic.

Commercial Plans

• Out-of-network lab claims often deny; stick to cash or bundle the lab CPT code + E/M visit with Well Revolution where in-network.

Pricing blueprint

• Infectious tests: $30–$50
• Chronic‑care (A1C, lipid): $25–$40
• Bundles: 10–15 % discount for two or more tests in one visit.
• Post clear signage and give coded receipts for FSA/HSA reimbursement.

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7. Workflow Details with Well Revolution (Text‑to‑Treat)

1. Consent & Intake – Staff captures phone #, brief symptoms, HIPAA consent.
2. Run Test – Swab/fingerstick; start timer.
3. Initiate Consult – Patient texts “PHARMACYCODE” to Well Revolution's number; quick intake and live consultation with NY‑licensed clinician.
4. Share Result – Pharmacist or patient provides test type and result; clinician reviews and asks any clarifying questions.
5. E‑Prescription – Provider sends Rx to your dispensing queue; pharmacist counsels and sells meds.
6. Document – Log test in waived‑lab record; Well Revolution stores visit note (meets ordering/diagnosis requirement).
7. Follow‑up – Well Revolution follows up with patient throughout a minimum 14-day period; pharmacist can view thread for continuity.

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8. Marketing & Community Engagement

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Compliance note: Any advertising that references diagnoses or prescriptions must clearly state the prescribing is performed by a NY‑licensed clinician via telehealth.

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9. Continuous Improvement & Audit Prep

• Quarterly self‑audit: verify QC log completeness, compare test counts vs. supply usage, run mock inspector checklist.
• Incident tracking: near‑miss or positive‑control failures logged with corrective action.
• Regulatory watchlist: subscribe to PSSNY alerts for Test‑and‑Treat legislation progress.
• Proficiency testing (optional but smart): enroll in voluntary waived PT program to benchmark accuracy.

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10. Resource Appendix

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