Guides Starting a home infusion nursing agency
Startup guide
Starting a home infusion nursing agency
Most home infusion nursing agencies send nurses into patients’ homes under contracts with infusion pharmacies. That business is licensed by the state, not by Medicare. Becoming a Medicare home infusion therapy supplier is a separate, optional step with its own accreditation and enrollment.
Educational summary, last reviewed October 17, 2026. Not legal advice — confirm with the state licensing agency or counsel.
Last reviewed October 17, 2026. 26 findings: 19 verified, 7 provisional. 1 time-sensitive, flagged with a recheck date. How findings are sourced and labelled.
1Two different businesses
Keep these apart from the start: they are licensed, paid and surveyed differently.
No federal license exists for a “home infusion nursing agency”. Each state decides how to classify it: as a home health agency, a home care agency, a nurse registry, or under a license specific to infusion.
Source: Fla. Stat. §400.464N.C.G.S. §131E-136ARM 37.106 Subchapter 24902 KAR 20:450
A Medicare home infusion therapy supplier is a state-licensed pharmacy, physician or other provider that is accredited by a CMS-recognized organization and enrolled in Part B. It is paid per visit day only for drugs on the external infusion pump coverage list, and the pump and drug stay with a DME supplier.
In practice: The full rules are in the Medicare home infusion therapy guide.
Source: CMS: HIT services benefit FAQ (June 2022)42 CFR 486.505
2Form the business
The license is issued to a named entity
ProvisionalState licenses are issued to the legal entity named in the application. Hawaii, for example, licenses a home health agency “only for the agency named in the application”, and Delaware voids a license on a change of ownership. Form the entity the license will be issued to before applying. No federal rule sets this order.
Not yet confirmed — check with the state licensing agency and your state’s business registry.
Source: HAR ch. 11-9716 Del. Admin. Code 3350 (27 DE Reg 44)
3State licensing by model
Check the state health department’s home health or home care licensure first, then the board of nursing. These are the patterns found so far.
Each state page answers the licensing question for that state, with its source and status:
- Alabama Provisional
- Alaska Provisional
- Arizona Provisional
- Arkansas Provisional
- California Verified
- Colorado Verified
- Connecticut Verified
- Delaware Provisional
- District of Columbia Provisional
- Florida Verified
- Georgia Provisional
- Hawaii Provisional
- Idaho Verified
- Illinois Provisional
- Indiana Provisional
- Iowa Provisional
- Kansas Provisional
- Kentucky Verified
- Louisiana Provisional
- Maine Provisional
- Maryland Verified
- Massachusetts Provisional
- Michigan Verified
- Minnesota Provisional
- Mississippi Provisional
- Missouri Provisional
- Montana Verified
- Nebraska Provisional
- Nevada Provisional
- New Hampshire Provisional
- New Jersey Provisional
- New Mexico Verified
- New York Provisional
- North Carolina Verified
- North Dakota Provisional
- Ohio Provisional
- Oklahoma Verified
- Oregon Provisional
- Pennsylvania Provisional
- Rhode Island Provisional
- South Carolina Provisional
- South Dakota Verified
- Tennessee Verified
- Texas Provisional
- Utah Provisional
- Vermont Provisional
- Virginia Verified
- Washington Verified
- West Virginia Provisional
- Wisconsin Provisional
- Wyoming Provisional
“A home infusion therapy provider must be licensed as a home health agency or nurse registry” (Fla. Stat. §400.464(3)).
In practice: Florida state page
Source: Fla. Stat. §400.464
“Infusion nursing services” are a listed home care service (G.S. 131E-136(3)), so an agency providing them needs a home care agency license. The rules require an RN with infusion training, a physician-signed plan of care and 24-hour on-call infusion nursing (10A NCAC 13J .1108).
Kentucky licenses “ambulatory infusion agencies” (902 KAR 20:450), covering home infusion and ambulatory infusion centers, separately from its general home health license (902 KAR 20:081). Applications go to the Office of Inspector General with a $500 fee.
In practice: Service-specific licensing: the infusion license, not the home health license, is the one that names this work. Kentucky state page
Source: 902 KAR 20:450902 KAR 20:081
Montana licenses “home infusion therapy agencies” (ARM 37.106, Subchapter 24): an administrator, a pharmacist-in-charge or designee, and a Montana-licensed nurse available 24 hours a day; medications administered by Montana-licensed professionals; solutions dispensed by a Montana-licensed pharmacy.
In practice: Service-specific licensing, separate from the general home health license. Montana state page
Source: ARM 37.106 Subchapter 24MT DPHHS home infusion therapy rules
Connecticut’s home health care agency rules name infusion therapy: blood products excluded, a monitoring program, RNs trained in infusion, and written policies on scope, credentials, orders, documentation and adverse reactions (Regs. §19-13-D72).
Texas lists who “need not be licensed” (HSC §142.003(a)). An RN or LVN “who provides home health services as a sole practitioner” ((a)(2)); an RN whose home services are “a part of and incidental to” a private office practice ((a)(1)); “a person who provides one health service through a contract with a person licensed under this chapter” ((a)(7)), which lets an unlicensed nurse business subcontract one service to a licensed HCSSA but not run its own home health business; and an individual hired and paid directly by the client or family ((a)(13)). “Sole practitioner” is not defined in HSC ch. 142 or 26 TAC §558.2; once a second RN or LVN goes into homes for the business, as an employee or a 1099 contractor, the sole-practitioner exemption no longer fits, and it never extends to a multi-nurse company. A pharmacy is exempt only if it furnishes nothing but supplies ((a)(9)). None of these exemptions grants prescribing or ordering authority, and an exempt provider may not imply it is licensed by using the words “home health services” (§142.002(b)).
Recheck on the official site. Read on a verbatim mirror; confirm on the official site. HHSC has published no guidance on what counts as a sole practitioner.
In practice: Elective wellness IV in Texas is also governed by Occupations Code ch. 172: mobile IV hydration guide; state findings: Texas page.
Source: HSC §142.003 (public.law mirror)HSC §142.002 (public.law mirror)26 TAC §558.2 (LII)Texas Health and Safety Code ch. 142 (official)
Texas: the licensed home health category
ProvisionalThe statutory definition of home health service includes “intravenous therapy” (HSC §142.001(13)(D)), so a visiting infusion nursing agency that sends its nurses, employees or contractors, into homes needs the licensed home health category of the HCSSA license for each place of business that directs those services. State guidance naming home infusion nursing was not found.
Not yet confirmed — check with Texas HHSC.
In practice: Texas state page
Source: HSC §142.001
4Example: Delaware
What is known, and what is not, for a nurse planning a pharmacy-contracted infusion nursing agency in Delaware.
The skilled home health license
VerifiedSkilled Home Health Agencies are licensed by the Division of Health Care Quality under 16 Del. Admin. Code 3350; a separate license is required for each office, the office must be in Delaware, and service is limited to the office’s county and adjacent Delaware counties.
In practice: Delaware state page
The “two or more services” question
ProvisionalRule 3350 defines a home health agency as one providing “two (2) or more home care services, one of which must be either licensed nursing services or home health aide services.” Whether a nursing-only infusion agency meets that definition is not settled; it needs a written answer from the Division of Health Care Quality. Rule 3350 has no infusion-specific provisions.
Not yet confirmed — check with the Delaware Division of Health Care Quality, in writing.
The staffing exemption does not fit
ProvisionalStaff supplied to licensed home health agencies are exempt only when the staffing firm makes no direct agreements with patients (§2.9.3). A pharmacy is not a licensed home health agency, so nurses sent under pharmacy contracts are not covered by that exemption. No Delaware nurse staffing agency license was found.
Not yet confirmed — check with the Delaware Division of Health Care Quality.
Source: 16 Del. Admin. Code 3350 (27 DE Reg 44)HB 199 (2023)
Delaware nurses
VerifiedDelaware is an implemented Nurse Licensure Compact state: a nurse with a multistate license from another compact state may practice there, while the agency still needs Delaware’s own authority.
5Pharmacy contracts
The pharmacy is licensed separately
ProvisionalA home infusion pharmacy is licensed by the board of pharmacy and compounds under USP <797> (revision official November 1, 2023) and <800>; boards of pharmacy and accreditors enforce them, not USP. Pharmacy licensure and nursing-agency licensure are separate state regimes.
Not yet confirmed — check with the state board of pharmacy.
Source: Drug Topics: USP <797> updated guidelines (secondary)
Most commercial payers pay home infusion in three parts: the drug; a per diem for pharmacy services, supplies and equipment (HCPCS S-codes, defined in NHIA’s National Coding Standard); and nursing per visit, billed separately.
Source: NHIA: Commercial coverage for home infusionMedPAC: Home infusion (2011)
Who bills for the nursing visit
ProvisionalWhether the pharmacy pays the agency per visit or per hour and bills the payer, or the agency bills the payer directly where it is credentialed, is set by the contract and payer credentialing, not by a federal rule.
Not yet confirmed — check with each pharmacy contract and payer.
6Nurse licensure
The patient’s state decides
VerifiedA nurse must be licensed in the patient’s state or hold a multistate compact license that covers it. Agencies certified by Medicare must also have personnel “qualified in all States in which they provide services” (SOM §2184).
In practice: Each state page gives that state’s compact status.
Source: NCSBN Nurse Licensure Compact mapCMS State Operations Manual §2184
For drugs newly covered as DME from April 1, 2027, CMS has proposed requiring administration by an RN or higher, physically present, excluding LPNs and LVNs. This is a proposal.
Not yet confirmed — check with the CY 2027 final rule.
Time-sensitive. Recheck when the final rule issues, expected around November 2026.
Source: CMS fact sheet: CY 2027 HH PPS proposed rule (CMS-1844-P)
7Optional: Medicare HIT enrollment and accreditation
The steps, in order
VerifiedHold the state license; meet the supplier standards (plan of care, 24/7 professional services, training, monitoring); obtain accreditation from ACHC, The Joint Commission, URAC, CHAP, NABP or The Compliance Team; then file a CMS-855B as specialty D6 with limited-risk screening.
Source: CMS: HIT services benefit FAQ (June 2022)CMS Manual Transmittal r10467pi42 CFR 424.68
What it adds
VerifiedThe benefit pays only for drugs on the external infusion pump list (L33794) and only on days a clinician is in the home; for many pharmacy-contracted patients it adds no Medicare revenue.
8Readiness
Clinical standards
VerifiedThe Infusion Nurses Society’s Infusion Therapy Standards of Practice, 9th edition (2024), has 66 standards, including new standards on home infusion therapy, vasopressor administration and drug diversion.
Round-the-clock availability
VerifiedWhere the state or the payer requires it, plan for 24-hour coverage: North Carolina requires 24-hour on-call infusion nursing, Montana a licensed nurse available 24 hours a day, and Medicare HIT suppliers services 7 days a week, 24 hours a day.
Source: 10A NCAC 13J .1108ARM 37.106 Subchapter 2442 CFR 486.525
9Common pitfalls
A pharmacy permit does not license nursing in the home. Texas’s pharmacy exemption, for example, covers only pharmacies furnishing nothing beyond supplies.
Source: HSC §142.001
The Nurse Licensure Compact covers the nurse only; the agency still needs the authority of each state where its patients live.
An ambulatory infusion suite is a different site of care; Kentucky licenses it under the ambulatory infusion agency rule, and Medicare HIT does not pay for suite visits.
Source: 902 KAR 20:45042 CFR 486.505
Official sources
- Fla. Stat. §400.464
- N.C.G.S. §131E-136
- ARM 37.106 Subchapter 24
- 902 KAR 20:450
- CMS: HIT services benefit FAQ (June 2022)
- 42 CFR 486.505
- HAR ch. 11-97
- 16 Del. Admin. Code 3350 (27 DE Reg 44)
- 10A NCAC 13J .1108
- 902 KAR 20:081
- MT DPHHS home infusion therapy rules
- Regs. Conn. State Agencies §§19-13-D66 to D79
- HSC §142.003 (public.law mirror)
- HSC §142.002 (public.law mirror)
- 26 TAC §558.2 (LII)
- Texas Health and Safety Code ch. 142 (official)
- HSC §142.001
- HB 199 (2023)
- NCSBN Nurse Licensure Compact map
- Drug Topics: USP <797> updated guidelines (secondary)
- NHIA: Commercial coverage for home infusion
- MedPAC: Home infusion (2011)
- CMS State Operations Manual §2184
- CMS fact sheet: CY 2027 HH PPS proposed rule (CMS-1844-P)
- CMS Manual Transmittal r10467pi
- 42 CFR 424.68
- INS: Infusion Therapy Standards of Practice
- 42 CFR 486.525
Revision history
| Date | Change |
|---|---|
| 2026-10-17 | First published |
| 2026-10-17 | Texas: the licensed home health category is kept for an agency that sends nurses; the HSC §142.003(a) exemptions (sole practitioner, incidental to office practice, one service under contract, hired directly by the family) added with their limits |
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
Starting a home infusion nursing agency: common questions
Does a home infusion nursing agency need a license?
In most states, yes, under the state’s home health, home care or nurse registry license, or a license specific to infusion (Kentucky, Montana). No federal license exists. Each state page states the rule with its source.
Is becoming a Medicare HIT supplier required to work with pharmacies?
No. It is a separate, optional Part B enrollment that pays for professional services for a narrow list of pump drugs.
Can a nurse in Delaware start a nursing-only infusion agency under the home health license?
It is not settled. Delaware’s rule defines a home health agency as providing two or more home care services; whether a nursing-only infusion agency qualifies needs a written answer from the Division of Health Care Quality.
Does a multistate nurse license let the agency serve another state?
No. It covers the nurse; the agency needs each state’s own authority.