NABP Home Infusion Therapy Pharmacy Accreditation — Frequently Asked Questions
Common questions from home infusion pharmacies and specialty pharmacies about NABP Home Infusion Therapy Pharmacy Accreditation and CMS Medicare billing requirements. For situation-specific guidance, schedule a free discovery session.
What is NABP Home Infusion Therapy Pharmacy Accreditation?
NABP Home Infusion Therapy Pharmacy Accreditation is a CMS-approved 3-year accreditation for pharmacies that furnish infusion therapy to patients in their homes and bill or seek to bill Medicare Part B for those services. CMS requires accreditation from a CMS-approved organization as a condition of Medicare enrollment as a home infusion therapy supplier.
Is home infusion therapy pharmacy accreditation required by Medicare?
Yes. Pharmacies billing Medicare for the administration of home infusion therapy services in a patient's home must hold accreditation from a CMS-approved accrediting organization to be eligible to bill under Part B. Without accreditation, a pharmacy cannot enroll as a home infusion therapy supplier.
What is the 24/7 coverage requirement?
NABP requires accredited home infusion pharmacies to ensure safe and effective provision of home infusion therapy on a 7-day-a-week, 24-hour-a-day basis. This means documented pharmacist-on-call coverage at all hours, every day of the year, with capacity to respond to adverse events, device malfunctions, and urgent medication needs. Operationalizing and documenting 24/7 coverage is one of the most common challenges IHS encounters in these engagements.
Does home infusion pharmacy accreditation require USP 797 compliance?
Yes. Home infusion pharmacies preparing sterile parenteral products must comply with USP Chapter 797. For pharmacies handling hazardous drugs such as chemotherapy, USP Chapter 800 applies. USP 797 compliance covers clean room design, environmental monitoring, beyond-use dating, personnel competency testing, and quality assurance. IHS evaluates sterile compounding compliance as a core component of every home infusion accreditation engagement.
What drug categories are covered under the Medicare home infusion therapy benefit?
Covered Part B home infusion drugs include certain antibiotics, antifungals, antivirals, inotropic therapy drugs, and other CMS-designated categories. The drug itself is typically billed under Part D; the professional services are billed under Part B by the accredited supplier. IHS helps clients identify which drug categories trigger the Part B accreditation requirement.
How long is the accreditation valid?
NABP Home Infusion Therapy Pharmacy Accreditation is issued for a 3-year term with annual compliance reviews in years 2 and 3. NABP contacts the pharmacy prior to each anniversary date to initiate the compliance review. IHS supports clients through initial accreditation and all annual reviews throughout the cycle.
What does the patient education requirement involve?
Patients or caregivers administering infusions at home must receive structured education and demonstrate competency in infusion technique, device operation, aseptic technique, adverse event recognition, and emergency procedures. The pharmacy must document education and competency assessment for every patient, tailored to literacy level and language needs.
Can a specialty pharmacy with home infusion as one service line apply?
Yes. Specialty pharmacies that have added home infusion therapy as a service line are eligible. NABP evaluates the home infusion operations specifically — including sterile compounding, 24/7 coverage, patient education, and clinical monitoring — regardless of what other services the pharmacy offers.
What is the difference between Medicare Part B and Part D for home infusion?
The drug product is typically billed under Medicare Part D. The professional services associated with administering the infusion — nursing visits, clinical monitoring, patient education, and infusion-related professional services — are billed under Medicare Part B by the accredited home infusion therapy supplier. The accreditation requirement applies specifically to Part B billing for professional services.
How does IHS help home infusion pharmacies prepare for accreditation?
IHS provides gap assessment against NABP's standards, policy and SOP development (including 24/7 coverage protocols, USP 797/800-aligned compounding SOPs, patient education programs, and clinical monitoring workflows), sterile compounding compliance review, quality assurance program design, pre-accreditation mock review, and application support. Thomas G. Goddard, JD, PhD — IHS's principal consultant and former Chief Operating Officer and General Counsel of URAC — leads every engagement.
More Questions?
Schedule a Free Discovery Session with IHS to discuss your home infusion pharmacy's specific accreditation questions.