URAC Medicare Home Infusion Therapy Supplier Accreditation: Frequently Asked Questions

What is URAC Medicare Home Infusion Therapy Supplier (MHITS) accreditation?

URAC Medicare Home Infusion Therapy Supplier (MHITS) accreditation is a CMS-recognized program that validates a home infusion therapy supplier's compliance with federal Conditions of Coverage under the Medicare home infusion benefit. The 21st Century Cures Act established the Medicare home infusion therapy benefit and required suppliers to be accredited by a CMS-approved accrediting organization to receive reimbursement. URAC is one of six organizations with this CMS approval, currently approved through March 27, 2030.

Is URAC accreditation required to bill Medicare for home infusion therapy?

Yes. Under the Medicare home infusion therapy benefit, suppliers must hold accreditation from a CMS-approved organization to receive Medicare Part B reimbursement for infusion nursing visits and professional services provided in the home. Providing services without accreditation means the supplier cannot bill Medicare — accreditation is a payment prerequisite, not an optional credential.

How long does URAC MHITS accreditation take?

URAC states that organizations can be fully accredited in six months or less once the process begins. The actual timeline depends on your organization's baseline readiness. Organizations with documented policies, existing quality management programs, and operationally consistent clinical practices tend to move through the process faster. Organizations building infrastructure from scratch will need more preparation time before submitting an application.

What standards does URAC evaluate in the MHITS program?

URAC's MHITS standards are organized across several domains:

• Practice Management — regulatory compliance, business continuity planning, information systems risk management
• Consumer Protection and Empowerment — privacy and security of consumer information, healthcare ethics, patient rights
• Complete Care Services — care coordination, multidisciplinary team communication, patient education, clinical assessment and monitoring
• Practice Standards, Guidelines and Protocols — clinical protocols for infusion administration, medication management, adverse event monitoring, infection control
• Quality Management — continuous quality improvement programs, performance measurement, adverse event reporting

Which organizations are CMS-approved to accredit home infusion therapy suppliers?

CMS has approved six accrediting organizations for the home infusion therapy supplier benefit: URAC, the Accreditation Commission for Health Care (ACHC), The Joint Commission (TJC), the Community Health Accreditation Partner (CHAP), the National Association of Boards of Pharmacy (NABP), and The Compliance Team (TCT). Each organization has its own standards structure, application process, and fee schedule. URAC's CMS approval runs through March 27, 2030.

How much does URAC MHITS accreditation cost?

URAC does not publicly disclose its fee schedule. Contact URAC directly at businessdevelopment@urac.org for current accreditation fees applicable to your organization type and size. IHS consulting fees are scoped per engagement — contact us for a proposal tailored to your organization's specific situation.

How does the URAC MHITS program relate to CMS requirements?

CMS requires home infusion therapy suppliers to hold accreditation from an approved accrediting organization to participate in the Medicare Home Infusion Therapy benefit. URAC is one of the CMS-approved accrediting organizations for this purpose. Achieving URAC MHITS accreditation satisfies the CMS accreditation requirement and demonstrates compliance with national quality standards.

What types of organizations are eligible for URAC MHITS accreditation?

Any organization that provides infusion therapy services to Medicare beneficiaries for administration in the home is eligible for URAC MHITS accreditation. This includes:

• Infusion pharmacies seeking to bill Medicare for home infusion services
• Specialty pharmacies with a home infusion service line
• Hospital-affiliated home infusion programs
• Integrated health systems that have established or acquired infusion therapy capabilities

What is a URAC Request for Information (RFI) and how should we respond?

A URAC Request for Information (RFI) is issued when a surveyor identifies a potential gap or deficiency during the accreditation review. The RFI asks the organization to provide additional documentation, clarification, or evidence of corrective action. RFI responses are not merely explanatory — they must demonstrate that the identified gap has been remediated or that the surveyor's interpretation was incorrect, supported by documentation. IHS provides RFI response drafting and documentation strategy as part of post-survey support.

What are the most common reasons organizations struggle with URAC MHITS accreditation?

Common failure points include:

• Policies that exist on paper but are not operationally implemented
• Staff who cannot speak to the standards during surveyor interviews
• Clinical protocols that do not reflect actual practice
• Quality management programs that lack documented metrics and improvement cycles
• Gaps in patient education documentation
• Care coordination records that do not demonstrate multidisciplinary team communication
• Privacy and security programs that are incomplete or undocumented

Most of these are preventable with structured preparation before the application is submitted.

Can an organization hold both URAC MHITS accreditation and another CMS-approved accreditation simultaneously?

Yes. CMS requires only that a supplier hold accreditation from at least one CMS-approved organization. Some organizations choose a single accrediting body; others pursue multiple accreditations to satisfy payer requirements or demonstrate quality across multiple accrediting relationships. Whether dual accreditation makes sense depends on your payer mix, referral source expectations, and organizational capacity.

How does IHS prepare staff for a URAC MHITS survey?

IHS conducts pre-survey staff education covering the standards domains relevant to each staff role, interview simulation exercises, documentation review protocols, and competency verification for clinical staff. URAC surveyors routinely interview clinical, operational, and administrative staff — not just leadership. Staff who understand what the standards require and can articulate their organization's practices confidently are a significant advantage in the survey process.

What happens after URAC accreditation is granted?

Once accredited, the organization maintains its status by operating in continuous compliance with URAC's standards, participating in URAC's quality reporting requirements, and submitting for renewal before the accreditation term expires. URAC may also conduct interim reviews or respond to complaints during the accreditation period. IHS provides ongoing compliance monitoring and renewal preparation for accredited clients who wish to retain consulting support between cycles.

Does URAC's MHITS accreditation satisfy all payer requirements for home infusion therapy?

URAC MHITS accreditation satisfies the CMS Conditions of Coverage for the Medicare home infusion therapy benefit. For commercial payer contracting, payers may have their own accreditation requirements that differ from CMS's. Some commercial payers accept any CMS-approved accreditation; others specify a particular accrediting organization in their network agreements. IHS recommends auditing your payer contracts before selecting an accrediting body to ensure alignment with all payer requirements.

Why choose IHS for URAC MHITS accreditation consulting?

IHS is led by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC. No consulting firm has deeper institutional knowledge of how URAC standards are designed, interpreted, and applied in the survey process. IHS brings that perspective to every engagement — from gap analysis through RFI response — giving clients an advantage that cannot be replicated from reading the standards manual alone.