URAC Infusion Pharmacy Accreditation: Frequently Asked Questions

What is URAC Infusion Pharmacy Accreditation?

URAC Infusion Pharmacy Accreditation is a voluntary quality credential for pharmacies and organizations that dispense infusion medications and provide infusion services to patients in the home or other ambulatory care settings. It covers non-Medicare patient populations and evaluates standards across patient management, pharmacy operations, infusion management, quality management, risk management, consumer protections, staff qualifications, and operations infrastructure.

A separate URAC program — the Medicare Home Infusion Therapy Supplier Accreditation — covers Medicare patients receiving infusion therapy at home. Many organizations pursue both programs.

What is the difference between URAC Infusion Pharmacy Accreditation and Medicare Home Infusion Therapy Supplier Accreditation?

URAC offers two distinct programs for infusion services:

• Infusion Pharmacy Accreditation — covers all patient populations except Medicare (commercial, Medicaid, self-pay) and all infusion administration sites including home and ambulatory.
• Medicare Home Infusion Therapy Supplier (MHITS) Accreditation — specifically for organizations providing infusion therapy to Medicare beneficiaries at home. Required by the 21st Century Cures Act as a condition of Medicare reimbursement.

Some organizations pursue both simultaneously. IHS can design a coordinated preparation strategy that satisfies requirements for both programs without duplicating documentation effort.

Who needs URAC Infusion Pharmacy Accreditation?

Organizations that should consider URAC Infusion Pharmacy Accreditation include:

• Home infusion pharmacies seeking payer network access or validation of clinical quality
• Hospital outpatient infusion programs expanding to home or ambulatory settings
• Specialty pharmacies adding infusion therapy to their service lines
• Ambulatory infusion centers operating pharmacy services
• Organizations whose commercial payer or PBM contracts require URAC or equivalent accreditation

For Medicare billing, the MHITS Accreditation is a legal requirement — not optional.

Is URAC Infusion Pharmacy Accreditation required by law?

The Infusion Pharmacy Accreditation (for non-Medicare patients) is voluntary, though many commercial payers require it as a condition of preferred network participation. The Medicare Home Infusion Therapy Supplier Accreditation is mandated by federal law under the 21st Century Cures Act. Organizations seeking Medicare reimbursement as Home Infusion Therapy Suppliers must hold accreditation from a CMS-approved accreditation organization. URAC is one of those approved organizations.

How long does URAC Infusion Pharmacy Accreditation take?

URAC states that organizations can achieve full accreditation in six months or less once the formal process begins. The actual timeline depends on your starting point. Organizations with strong existing policies, a functioning quality management program, and documented staff competencies move faster than those building from scratch.

IHS typically structures a preparation phase before the formal URAC process starts to ensure your submission is complete and defensible. A gap analysis at the outset gives you a realistic timeline based on your specific readiness level.

How much does URAC Infusion Pharmacy Accreditation cost?

URAC does not publicly disclose its fee schedule. Contact URAC directly at businessdevelopment@urac.org for current fees.

IHS consulting engagement fees are scoped per engagement — contact for a proposal.

What standards does URAC evaluate for infusion pharmacy accreditation?

URAC's Infusion Pharmacy standards span multiple operational domains:

• Patient management and care coordination across the infusion therapy episode
• Pharmacy operations, including sterile compounding compliance (USP <797>, USP <800>)
• Infusion management from referral through episode closure
• Quality improvement program structure and performance measurement
• Risk management and medication safety
• Consumer protections and patient rights
• Staff qualifications and competency documentation
• Organizational operations and infrastructure

Complete standards are available for purchase through URAC.

What are the most common deficiencies in URAC Infusion Pharmacy accreditation preparation?

Based on IHS experience with URAC accreditation programs, the most frequent preparation gaps include:

• Policy and procedure documentation gaps — missing effective dates, review dates, revision history, or documented approval authority chains
• Quality management program underdevelopment — policies exist but active data collection, analysis, and improvement cycles are not yet operational
• USP alignment gaps — sterile compounding pharmacies with USP <797> or USP <800> compliance issues that surface during URAC review
• Delegation oversight failures — subcontracted nursing or clinical services without documented performance monitoring agreements
• Staff competency documentation — competency programs exist operationally but are not structured to URAC's documentation requirements
• Evidence file disorganization — reviewers cannot easily locate documentation mapped to specific standards

Does URAC require an on-site survey for infusion pharmacy accreditation?

URAC's infusion pharmacy accreditation process is primarily a desktop review — URAC evaluates your submitted documentation against its standards. The specific survey structure, including whether any on-site component applies to your organization, is determined during the application and consultation phase. Contact URAC directly or IHS for current survey methodology details.

How does USP <797> and USP <800> compliance relate to URAC accreditation?

For infusion pharmacies engaged in sterile compounding, URAC's standards reference USP Chapter <797> (sterile compounding) and USP Chapter <800> (hazardous drugs handling) as baseline requirements. Gaps in USP compliance — whether in physical facility design, designated person accountability, documentation practices, or quality assurance — surface during URAC review.

Pharmacies pursuing URAC accreditation should conduct a USP gap analysis in parallel with their URAC standards preparation. IHS can coordinate that assessment or work alongside your USP compliance team.

Can a specialty pharmacy hold both URAC Specialty Pharmacy Accreditation and URAC Infusion Pharmacy Accreditation?

Yes. Specialty pharmacies that also provide infusion services often hold multiple URAC accreditations. URAC's program structure allows organizations to pursue coordinated accreditation across programs. There is meaningful overlap in core organizational standards — governance, quality management infrastructure, consumer protections — that can reduce duplicative documentation when both accreditations are pursued together. IHS can design a coordinated preparation strategy for multi-program applicants.

How long does URAC Infusion Pharmacy Accreditation remain valid?

URAC accreditation is typically awarded for a three-year cycle, after which organizations must pursue re-accreditation. URAC may also conduct interim reviews or require reporting during the accreditation period. Organizations should build their quality management and documentation practices to support ongoing compliance — not just point-in-time compliance for the initial submission.

What is a Request for Information (RFI) in the URAC review process?

A Request for Information (RFI) is URAC's mechanism for seeking clarification or additional documentation when a submitted standard does not provide sufficient evidence of compliance. RFIs are not automatic disqualifiers — they are an opportunity to address reviewer questions with targeted documentation.

IHS prepares RFI responses grounded in URAC's standards language and review criteria, with the goal of resolving deficiency findings without escalation to the accreditation committee. Organizations that attempt to respond to RFIs without consultant support frequently extend their accreditation timeline unnecessarily.

What role does IHS play in URAC Infusion Pharmacy Accreditation?

IHS provides end-to-end consulting support for URAC Infusion Pharmacy Accreditation and Medicare Home Infusion Therapy Supplier Accreditation. Services include:

• Gap analysis against current URAC standards
• Standards education for clinical and administrative staff
• Policy and procedure development to URAC documentation requirements
• Evidence file organization and mapping
• Mock desktop review before submission
• Submission support and URAC coordination
• RFI response preparation
• Post-accreditation maintenance support

IHS is led by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC.

How do I get started with URAC Infusion Pharmacy Accreditation?

URAC's formal process begins with obtaining the standards, requesting a consultation with URAC, and signing an application agreement. Before that, IHS recommends a readiness assessment to understand your starting point and define a realistic preparation timeline.

Schedule a free discovery session with IHS to begin that assessment. We will tell you where you stand and what the path to accreditation looks like for your specific organization.