Guides Home infusion
Service-line guide
Home infusion
Home infusion is not one license or one benefit. It is usually four businesses: a pharmacy that compounds and dispenses the drug, a nursing agency that administers it in the home, a Medicare home infusion therapy supplier paid for professional services on visit days, and sometimes an ambulatory infusion suite. Each is regulated and paid differently, and states classify the nursing work in different ways.
Educational summary, last reviewed October 17, 2026. Not legal advice — confirm with the state licensing agency or counsel.
Last reviewed October 17, 2026. 40 findings: 26 verified, 14 provisional. 2 time-sensitive, flagged with a recheck date. How findings are sourced and labelled.
1What it is
The four business models below can sit in one organization or in four. Licensing, accreditation and payment attach to each model separately.
1. The home infusion pharmacy
VerifiedThe pharmacy compounds and dispenses the drug and furnishes the pump and supplies. For Medicare Part B, the pump, the drug, supplies and the compounding and dispensing services are paid under the durable medical equipment (DME) benefit and billed by a Medicare-enrolled DMEPOS supplier.
No federal license exists for a “home infusion nursing agency”. Each state decides how to classify it: as a home health agency or nurse registry (Florida), a home care agency (North Carolina), a home infusion therapy agency (Montana) or an ambulatory infusion agency (Kentucky).
In practice: The detail is in the startup guide: Starting a home infusion nursing agency.
Source: Fla. Stat. §400.464 (2025)N.C.G.S. §131E-136ARM 37.106 Subchapter 24902 KAR 20:450
Since January 1, 2021, Medicare Part B pays a qualified home infusion therapy (HIT) supplier for professional services only (nursing, training and education, remote monitoring and monitoring) on days a clinician is in the home, for the narrow list of drugs given through a DME external infusion pump. The supplier is “a pharmacy, physician, or other provider of services or supplier licensed by the State” and must be accredited. The full benefit is in the Medicare home infusion therapy guide.
Source: CMS: HIT services benefit FAQ (June 2022)42 CFR 486.505
4. The ambulatory infusion suite
VerifiedAn ambulatory infusion suite or center is an outpatient site of care, often operated by a pharmacy. Licensure is state-specific: Kentucky licenses ambulatory infusion centers under 902 KAR 20:450. Medicare HIT pays only for services “in the individual’s home”, so suite visits are not billable under that benefit. The full picture is in the infusion suites guide.
2Who regulates it
The state board of pharmacy licenses the pharmacy; the state health agency licenses the nursing agency (where the state licenses it); CMS and its recognized accreditors govern the Medicare supplier.
A home infusion pharmacy is licensed by the board of pharmacy in its home state. USP itself has no enforcement role: state boards of pharmacy and FDA decide how USP compounding chapters apply. Washington’s board, for example, extended enforcement discretion on USP <800> in 2022 (a dated example).
Not yet confirmed — check with the state board of pharmacy.
Source: Pharmacy Times: updated USP chapters 795, 797, 800 (secondary)WA DOH policy statement on USP <800> enforcement
Where a state licenses infusion nursing, the license comes from its health facility licensing agency, not the board of nursing: in Kentucky, applications go to the Office of Inspector General with a $500 fee; in Montana, the Department of Public Health and Human Services publishes the home infusion therapy agency rules.
A Medicare HIT supplier “must be currently and validly accredited as such by a CMS-recognized home infusion therapy supplier accreditation organization in order to enroll and remain enrolled.” CMS lists six: The Joint Commission, URAC, ACHC, CHAP, NABP and The Compliance Team. Approval terms are on the Accreditation & Surveys page.
Source: CMS Manual Transmittal r10467pi
NABP runs a Home Infusion Therapy accreditation and is recognized by CMS for HIT suppliers through September 26, 2030.
Source: NABP: Home Infusion Therapy accreditationFR 2024-21409 (NABP)
Pharmacy and ambulatory infusion center accreditation programs are non-deemed: no Medicare certification stands behind them, and they are often payer-driven. ACHC, CHAP and The Joint Commission are reported to inspect infusion pharmacies for USP compounding compliance; ACHC revised its infusion pharmacy standards for USP <797> effective June 1, 2024.
Not yet confirmed — check with the accrediting organization.
Source: ACHC: Navigating accreditation for infusion servicesInfusion magazine, Nov/Dec 2024: USP impact on home infusion pharmacy inspections (secondary)
3Federal rules
USP <797>: sterile compounding
ProvisionalThe revised USP <797> was published November 1, 2022 and became official November 1, 2023. Whether and how it binds a given pharmacy depends on the state board of pharmacy; state-by-state adoption was not surveyed.
Not yet confirmed — check with the state board of pharmacy.
Source: Drug Topics: USP <797> updated guidelines (secondary)Drug Topics: USP <797> updated guidelines (secondary)
USP <800>: hazardous drugs
ProvisionalWith the revised <795> and <797> official on November 1, 2023, USP <800> became compendially applicable. Its scope covers personnel handling hazardous drugs in all settings, including home care.
Not yet confirmed — check with the state board of pharmacy.
Source: Pharmacy Times: updated USP chapters 795, 797, 800 (secondary)WA DOH policy statement on USP <800> enforcement
INS Standards, 9th edition (2024)
ProvisionalThe Infusion Nurses Society’s Infusion Therapy Standards of Practice, 9th edition (2024), was published in the Journal of Infusion Nursing 47(1S Suppl 1). It has 66 standards, adds new standards including one on Home Infusion Therapy, and INS has moved to a 3-year revision cycle.
Not yet confirmed — check with the Infusion Nurses Society.
In practice: The standards are a clinical practice reference, not a regulation; the text itself is published by INS.
Source: INS: Infusion Therapy Standards of PracticeQueensland Health DORA record: INS Standards, 9th edition
A Medicare HIT supplier provides professional services, patient training and education, and remote monitoring and monitoring 7 days a week, 24 hours a day under the plan of care, and must follow “nationally recognized standards of practice” and applicable state and federal law (42 CFR 486.525).
Source: 42 CFR 486.525
Shipping into other states
ProvisionalA pharmacy that ships into other states generally needs a nonresident pharmacy license in each destination state. This was not verified against primary sources. One state rule points the same way: in Montana, solutions for home infusion therapy agencies must be dispensed by a pharmacist in a Montana-licensed pharmacy (ARM 37.106.2416).
Not yet confirmed — check with each destination state’s board of pharmacy.
Source: ARM 37.106.2416
4Payment
Medicare splits home infusion across several benefits; commercial payers usually pay a three-part model.
The HIT benefit pays a single bundled amount per drug category per “infusion drug administration calendar day”, a day the supplier is in the home. It does not pay for the drug, the pump or the pharmacy’s daily work. Rates and codes are in the Medicare home infusion therapy guide.
Source: CMS: HIT services benefit FAQ (June 2022)42 CFR 414.1550
A Medicare home health agency that is also enrolled as a qualified HIT supplier bills an HIT claim for a visit made solely to administer the home infusion drug. When the same visit also includes separate home health services, it may bill both a home health claim and an HIT claim for the distinct services, with the time properly separated. A home health agency that is not an HIT supplier must tell the patient the infusion service is no longer covered under home health and offer care from a qualified supplier.
In practice: Both enrollments must be in place, and the visit record must show which minutes belong to which benefit.
Medicare Part B DME (LCD L33794)
VerifiedThe external infusion pump is DME and the infused drug is a supply to it; coverage requires that administration through a durable external pump be reasonable and necessary. Disposable (elastomeric) pumps and their drugs are not covered because they are not DME, and implantable pumps and their drugs go to A/B MACs, not DME MACs.
Source: CMS LCD L33794 policy article (external infusion pumps)
Drugs outside the pump list
VerifiedProfessional services for other home infusion drugs, such as most IV antibiotics, are not covered by the HIT benefit. Depending on the patient, the drug may fall under Part D, and the nursing under the Part A home health benefit for a homebound patient, or under a Medicare Advantage plan. Medicare Advantage plans must cover all Part B benefits, including HIT services.
The Part D gap
ProvisionalNHIA states that Part B DME covers only about 40 infusion drugs, so most home-infused drugs fall to Part D, which pays for the drug only and leaves the services, equipment and supplies uncovered.
Not yet confirmed — check with CMS.
Most private insurers pay (1) the drug, (2) a per diem for supplies, equipment, pharmacy and non-nursing services, and (3) nursing per visit. Medicare has no comparable per diem.
In practice: The MedPAC source dates from 2011; the structure is the one NHIA describes today.
Source: MedPAC: Home infusion presentation (November 2011)NHIA: Commercial coverage for home infusion
The per diem and S-codes
ProvisionalNHIA defines the per diem as “each day that a given patient is provided access to a prescribed therapy,” for therapies dosed at intervals up to and including every 72 hours, billed with HCPCS S-codes under NHIA’s National Coding Standard (free to the public, 2026 edition), which also covers ambulatory infusion suite services. One payer policy, for example, lists per diem codes S9325 to S9379. Nursing is billed separately.
Not yet confirmed — check with each payer.
Source: NHIA: Commercial coverage for home infusionNHIA: National Coding StandardBCBS Minnesota: Commercial General Coding 031, Home Infusion (payer policy)
Who bills the nursing visit
ProvisionalWhether the pharmacy bills the payer for the nursing visit and pays the agency, or the agency bills the payer directly where it is credentialed, is set by the pharmacy–agency contract and payer credentialing. No single federal rule decides it; this is inferred from NHIA’s description of separately billed nursing.
Not yet confirmed — check with each payer and the contracting pharmacy.
April 1, 2027: enacted in law
VerifiedFederal law (Consolidated Appropriations Act, 2026, §6222(a)) treats certain external infusion pumps, their home infusion drugs and supplies as “appropriate for use in the home” under the DME definition from April 1, 2027, where the drug requires administration by or under the supervision of a health professional and is administered or supervised by a qualified HIT supplier.
Source: CMS fact sheet: CY 2027 HH PPS proposed rule (CMS-1844-P)McDermott Will & Schulte: CY 2027 HH PPS proposed rule (secondary)
CMS proposed how to implement the law in the CY 2027 home health proposed rule (July 2026), including limiting the professional to an MD or DO, NP, PA, CNS or RN licensed in the state of infusion and physically present (excluding LPNs and LVNs), and reading “at least 12 times a year” as at least monthly. These are proposals, not final rules.
Not yet confirmed — check with the CY 2027 final rule.
Time-sensitive. The final rule is expected around November 2026; recheck the proposed conditions then.
Source: CMS fact sheet: CY 2027 HH PPS proposed rule (CMS-1844-P)McDermott Will & Schulte: CY 2027 HH PPS proposed rule (secondary)HFMA: CY 2027 HH PPS proposed rule summary (secondary)
5How states differ
The pharmacy is always a board of pharmacy license. The nursing agency is where states diverge: some fold it into general home health or home care licensing, and some license the service itself. See the infusion licensing map.
“A home infusion therapy provider must be licensed as a home health agency or nurse registry” (Fla. Stat. §400.464(3)). No infusion-specific exemption appears in §400.464(6).
In practice: Florida state page
Source: Fla. Stat. §400.464 (2025)
North Carolina defines “home care services” to include “infusion nursing services”, and a home care agency is an organization providing home care services (G.S. 131E-136(3)). Infusion nursing therefore needs a home care agency license.
In practice: North Carolina state page
Source: N.C.G.S. §131E-136
Kentucky licenses “ambulatory infusion agencies” under 902 KAR 20:450, a rule that covers both home infusion and ambulatory infusion centers, separately from its general home health agency license (902 KAR 20:081). The infusion license, not the general home health license, is the one that names this work. Applications go to the Office of Inspector General with a $500 fee.
In practice: Kentucky state page
Montana licenses “home infusion therapy agencies” as a distinct license category (ARM 37.106, Subchapter 24), defining the services as preparation, administration or furnishing of parenteral medications or parenteral or enteral nutrition in a person’s residence. The agency needs an administrator, a pharmacist-in-charge or designee and a Montana-licensed nurse available 24 hours a day; medications are administered by Montana-licensed professionals.
In practice: Montana state page
Source: ARM 37.106 Subchapter 24MT DPHHS home infusion therapy rules
A 2004 Montana DPHHS survey tool states that Montana Medicaid participation requires a current home infusion therapy agency license (citing ARM 37.86.1502). The document is historical.
Not yet confirmed — check with Montana DPHHS.
The classifications found are a home health agency or nurse registry license (Florida), a home care agency license (North Carolina), a dedicated home infusion therapy agency license (Montana) and a combined ambulatory infusion agency license (Kentucky). Start with the state health agency’s home health or home care licensing, then the board of nursing. NHIA keeps a members-only state-by-state licensure tool.
Source: Fla. Stat. §400.464 (2025)N.C.G.S. §131E-136ARM 37.106 Subchapter 24902 KAR 20:450NHIA: Homecare licensure and regulations for HIT nurse services (members-only tool)
Nurses are licensed where the patient is
ProvisionalAn infusion nurse must hold a license valid in the patient’s state, so the Nurse Licensure Compact matters for multistate agencies. A secondary source counts 43 enacted jurisdictions, with Massachusetts’ tentative implementation in May 2027. See the Nurse Licensure Compact map.
Not yet confirmed — check with NCSBN or the state board of nursing.
Source: registerednursing.org: Nurse Licensure Compact (secondary, updated August 2026)
6How to start
Determine the state license class and obtain it (for example a Florida home health agency or nurse registry license, a North Carolina home care agency license, or a Montana home infusion therapy agency license), staff nurses licensed in the patient’s state, adopt infusion policies, and contract with pharmacies. Accreditation is optional unless the state or payers require it. The full sequence is in Starting a home infusion nursing agency.
Source: Fla. Stat. §400.464 (2025)N.C.G.S. §131E-136ARM 37.106 Subchapter 24
A Medicare HIT supplier
VerifiedHold a state license as a pharmacy, physician or other provider or supplier; meet the plan-of-care and required-services rules; obtain accreditation from a CMS-recognized accreditor; file a CMS-855B as a Part B supplier with specialty D6 and pass limited-risk screening (42 CFR 424.68); then bill the HIT G-codes paired with the drug’s J-code.
In practice: Medicare revenue from this benefit is limited to the pump drugs on LCD L33794.
Source: CMS: HIT services benefit FAQ (June 2022)CMS Manual Transmittal r10467pi42 CFR 424.68CMS MLN MM12108
A pharmacy that sends its own nurses
ProvisionalPharmacy licensure and nursing agency licensure are separate state regimes. A pharmacy that sends its own nurses into homes typically needs a home health or home care license in addition to its pharmacy permit in states that classify infusion nursing that way, such as Florida.
Not yet confirmed — check with the state licensing agency and the state board of pharmacy.
Source: Fla. Stat. §400.464 (2025)CMS: HIT services benefit FAQ (June 2022)
An ambulatory infusion suite
VerifiedCheck for a state facility license first (Kentucky requires one under 902 KAR 20:450) and plan payment around commercial site-of-care contracts, since Medicare HIT does not pay for suite visits. See the infusion suites guide.
7Common pitfalls
In Kentucky and Montana, infusion has its own license (an ambulatory infusion agency and a home infusion therapy agency license), distinct from general home health licensing.
Source: 902 KAR 20:450902 KAR 20:081ARM 37.106 Subchapter 24
HIT pays professional services on visit days for pump drugs only. The pump and drug are DME, most other infused drugs fall to Part D, and nursing for a homebound patient may be home health.
Disposable (elastomeric) pumps and their drugs are not covered under the DME benefit because they are not DME.
Source: CMS LCD L33794 policy article (external infusion pumps)
Billing a suite visit as HIT
VerifiedMedicare HIT pays only for services in the patient’s home, so infusion suite visits are not billable under it (42 CFR 486.505).
Source: 42 CFR 486.505
Treating the 2027 conditions as final
ProvisionalThe April 1, 2027 DME change is law, but the conditions CMS proposed for it (including the RN-or-higher, physically present requirement that would exclude LPNs and LVNs) are not final.
Not yet confirmed — check with the CY 2027 final rule.
Time-sensitive. The final rule is expected around November 2026; recheck then.
Source: CMS fact sheet: CY 2027 HH PPS proposed rule (CMS-1844-P)McDermott Will & Schulte: CY 2027 HH PPS proposed rule (secondary)
Official sources
- CMS: HIT services benefit FAQ (June 2022)
- Fla. Stat. §400.464 (2025)
- N.C.G.S. §131E-136
- ARM 37.106 Subchapter 24
- 902 KAR 20:450
- 42 CFR 486.505
- 902 KAR 20:450 (PDF)
- Pharmacy Times: updated USP chapters 795, 797, 800 (secondary)
- WA DOH policy statement on USP <800> enforcement
- MT DPHHS home infusion therapy rules
- CMS Manual Transmittal r10467pi
- NABP: Home Infusion Therapy accreditation
- FR 2024-21409 (NABP)
- ACHC: Navigating accreditation for infusion services
- Infusion magazine, Nov/Dec 2024: USP impact on home infusion pharmacy inspections (secondary)
- Drug Topics: USP <797> updated guidelines (secondary)
- INS: Infusion Therapy Standards of Practice
- Queensland Health DORA record: INS Standards, 9th edition
- 42 CFR 486.525
- ARM 37.106.2416
- 42 CFR 414.1550
- CMS LCD L33794 policy article (external infusion pumps)
- NHIA: Closing the Part D coverage gap
- MedPAC: Home infusion presentation (November 2011)
- NHIA: Commercial coverage for home infusion
- NHIA: National Coding Standard
- BCBS Minnesota: Commercial General Coding 031, Home Infusion (payer policy)
- CMS fact sheet: CY 2027 HH PPS proposed rule (CMS-1844-P)
- McDermott Will & Schulte: CY 2027 HH PPS proposed rule (secondary)
- HFMA: CY 2027 HH PPS proposed rule summary (secondary)
- 902 KAR 20:081
- MT DPHHS home infusion therapy survey tool (2004)
- NHIA: Homecare licensure and regulations for HIT nurse services (members-only tool)
- registerednursing.org: Nurse Licensure Compact (secondary, updated August 2026)
- 42 CFR 424.68
- CMS MLN MM12108
Revision history
| Date | Change |
|---|---|
| 2026-10-17 | First published |
About this guide. Published and maintained by Paloma Health Technologies; Findings are cited to official sources, dated and status-labelled; see the editorial policy. Educational summary, last reviewed October 17, 2026. Not legal advice — confirm with the state licensing agency or counsel.
Questions
Home infusion: common questions
Is there a federal license for a home infusion nursing agency?
No. Each state decides how to classify it: Florida requires a home health agency or nurse registry license, North Carolina a home care agency license, Montana a home infusion therapy agency license, and Kentucky an ambulatory infusion agency license.
Do Kentucky and Montana license home infusion separately from home health?
Yes. Kentucky licenses ambulatory infusion agencies under 902 KAR 20:450, separately from its home health agency rule, and Montana licenses home infusion therapy agencies under ARM 37.106, Subchapter 24.
Can a home health agency bill both home health and Medicare HIT for one visit?
Yes, if it is enrolled as both a Medicare home health agency and a qualified HIT supplier and the visit includes distinct services under each benefit, with the time properly separated.
How does Medicare pay for the pump and the drug?
Under the Part B DME benefit (LCD L33794), billed by a Medicare-enrolled DMEPOS supplier. The pump is DME and the drug is a supply to it; disposable elastomeric pumps are not covered.
How do commercial payers pay for home infusion?
Most pay three parts: the drug, a per diem for pharmacy services, supplies and equipment, and nursing per visit. Medicare has no comparable per diem.
What changes on April 1, 2027?
Federal law extends DME coverage to certain external pumps and their drugs that require professional administration by a qualified HIT supplier. CMS’s implementing rule was proposed in July 2026 and is not final.