Arizona Complete Health Infusion Site-of-Care Policy Update

Coverage Criteria

Initial Approval Criteria

Patient IV or injectable therapy is medically necessary when ALL of the following are met:

Main policy: 1) Drug meets applicable medical necessity criteria for coverage and is one applicable for alternative site of care (see Appendix B); 2) Services must be rendered in the least intensive appropriate setting unless criteria justify a higher-intensity outpatient hospital or non-hospital outpatient office/facility; 3) Provider submits documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.

See subnodes for permitted justifications.

Justifications for higher-intensity outpatient site

a: Request is for administration of the initial dose of the treatment or restart of treatment after a >=6-month disruption for a short duration (e.g., 4 weeks).restart >=6 months
Provider must submit request for initial visit with plan for continued administration at home infusion or ambulatory infusion suite.
b: Documentation that the FDA‑approved indication requires outpatient hospital administration.
c: Submitted documentation that home‑based therapy or ambulatory infusion center is a health risk for the member due to physical or behavioral impairment.
Examples include severe venous access issues (vein finder not available), lack of caregiver access, cardiopulmonary disorder, inability to tolerate IV fluid loads, cognitive concerns impacting patient safety; not an exhaustive list.
d: Submitted medical or infusion records documenting severe or life‑threatening adverse events that were non‑responsive to pre‑medications, analgesics, steroids, antihistamines, fluids or infusion rate reductions.
Examples include seizures, anaphylaxis with no other therapy options, myocardial infarction, renal failure. Non‑qualifying examples: trypanophobia, pediatrics, preference/convenience, frequent laboratory monitoring, continuation of services from previous plan.

Continuation Criteria

For continuation of services at the requested location:

Continued Approval: Provider must submit medical records or infusion records to reassess the member's site of care and document the need to continue monitoring and advanced treatment capabilities beyond routine infusion therapy.

Approval duration: Up to one year or length of approval for the drug.

Initial Therapy

Initial approval requires ALL of the following (updated rules):

Initial Approval (updated): 1) FDA approval for the site‑of‑care for the requested drug AND 2) evidence the drug is available from a specialty pharmacy or other allowable source AND 3) documentation that the member's setting is safe for infusion; plus the provider must document one of the medical necessity reasons (initial dose/restart, FDA indication requiring hospital, health risk for home therapy, or severe/life‑threatening adverse events).

Section I.A.1 revised to require both FDA site‑of‑care approval and drug availability; see Initial Approval Criteria subnodes for acceptable justifications and examples.

Continuation Therapy

Continued approval (updated):

Continued Approval: Continued approval requires submission of medical/infusion records documenting ongoing need for monitoring and advanced treatment capabilities beyond routine infusion therapy. Approval duration clarified to up to one year or the drug‑specific approval length.

See full policy for specific continued‑therapy documentation requirements.

AZ Medicaid Reinsurance drugs identified in Appendix B are excluded from the medical benefit (buy/bill) and must be billed through the pharmacy benefit. Providers requesting administration of a drug listed as AZ Medicaid Reinsurance should route drug acquisition and billing via the pharmacy benefit rather than medical buy/bill. Prior authorization for site of care remains required when the drug is eligible for alternative sites of care; documentation must demonstrate that a lower-intensity site (home infusion or ambulatory infusion center) is unavailable or that specialty pharmacy cannot provide the drug before approval of a higher-intensity outpatient site is considered.

The policy clarifies examples of non-qualifying reasons for approval of a higher-intensity outpatient hospital or non-hospital outpatient office/facility. Specifically, routine situations such as member preference or convenience, continuation of services from a previous plan, or other administrative reasons do not meet medical necessity for escalation of site of care. These items are explicitly listed as non-qualifying examples and should not be used in lieu of the required clinical justifications for a higher-intensity site.

The policy notes that certain clinical or patient-specific situations may justify a higher-intensity site when documented: for example, trypanophobia (fear of needles) is explicitly listed as a non-qualifying example and therefore does not by itself justify site escalation, whereas pediatrics are also listed among non-qualifying examples unless other medical criteria are met. When clinical evidence demonstrates that home or ambulatory infusion is a health risk (e.g., severe venous access issues, lack of caregiver, cardiopulmonary disorder, inability to tolerate IV fluids, cognitive concerns) or when initial dose/restart after a ≥6‑month disruption is required, higher-intensity administration may be approved with supporting documentation.

Requests that do not meet any of the stated medical necessity reasons for a higher-intensity outpatient site are considered not medically necessary. The policy directs that such requests should be provided in an alternate, less intensive site of care. Examples of non-medical-necessity reasons include trypanophobia, pediatrics (absent other qualifying clinical criteria), patient preference/convenience, frequent laboratory monitoring, and continuation of services from a previous plan; these alone do not meet criteria for inpatient or outpatient hospital administration.

Initial Therapy Criteria

Initial Therapy

Initial administration at a higher‑intensity outpatient site may be approved when ALL general requirements are met and ONE of the following specific conditions is documented:

Initial higher-site justifications

a: Initial dose administration or restart after a >=6‑month disruption for a short duration (e.g., 4 weeks).restart >=6 months
Provider must request initial visit with plan for continued administration at home infusion or ambulatory infusion suite.
b: The FDA‑approved indication requires outpatient hospital administration.
c: Home‑based therapy or ambulatory infusion center poses a health risk due to physical or behavioral impairment.

Continuation Therapy Criteria

Continuation Therapy

Continuation of therapy at the requested site requires documentation:

Continuation Documentation: Provider must submit medical records or infusion records demonstrating ongoing need for the requested site of care and justification that monitoring or advanced treatment capabilities beyond routine infusion remain necessary.

Approval duration: Up to one year or length of approval for the drug.

Coding and Drug Appendix

Examples of J-codes listed in Appendix BHCPCS | mixed

J0129	Abatacept (Orencia)
J0172	Aducanumab-Avwa (Aduhelm)
J0180	agalsidase beta (Fabrazyme)
J0202	alemtuzumab (Lemtrada)
J0218	Olipudase Alfa (Xenopozyme)
J0219	Avalglucosidase alfa-ngpt (Nexviazyme)
J0221	algucosidase alfa (Lumizyme)
J0222	patisiran (Onpattro)
J0223	givosiran (Givlaari)
J0224	lumasiran (Oxlumo)

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1/5

Appendix B: Examples of Specialty Infusion Drugs (J-/Q-/Q5xx series)HCPCSCovered

J2327	risankizumab-rzaa (Skyrizi)
J2329	ublituximab-xiiy (Briumvi)
J2350	ocrelizumab (Ocrevus)
J2356	tezepelumab-ekko (Tezspire)
J2357	omalizumab (Xolair)
J2406	oritavancin (Kimyrsa)
J2407	oritavancin (Orbactiv)
J2426	paliperidone injection (Invega Sustenna)
J2469	palonosetron (Aloxi)
J2501	paricalcitol (Zemplar)

1–10 of 87

1/9

Restart disruption threshold — initial-dose site escalation rule

Restart disruption thresholdRestart of treatment after a 6-month disruption qualifies for initial-dose administration in a higher-intensity outpatient site (short duration e.g., 4 weeks); provider must request an initial visit with plan for continued administration at home infusion or ambulatory infusion suite.

Context for restartApplies when no home infusion provider or ambulatory infusion center is available or specialty pharmacy cannot provide the drug.

Documentation requirementProvider must submit request for initial visit with plan for continued administration at home infusion or ambulatory infusion suite.

Approval duration

Standard approval durationUp to one year or length of approval for the drug.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required — Prior authorization is required to request an inpatient/outpatient hospital or non-hospital outpatient site for IV/injectable therapy. Requests for specialty infusion therapies listed in Appendix B require prior authorization; initial approvals require FDA approval for the requested site of care when applicable.

Prior authorization required for drugs listed in Appendix B
Initial approval requires FDA approval for site of care when applicable
Specialty pharmacy availability and member safety at the proposed site are considered

Prior Authorization

Prior Authorization for Appendix B Drugs

Prior authorization required for specialty infusion therapies listed in Appendix B. For new start requests, provider must submit request for the initial visit with documentation that continued administration will occur at home infusion or an ambulatory infusion center when appropriate.

Appendix B lists specialty infusion drugs requiring prior authorization

Site of Care and Place of Service

Note

Render services in the least intensive appropriate setting

Services should be rendered in the least intensive appropriate setting; alternative less intensive sites explicitly include home infusion, physician office, and ambulatory infusion centers, with hospital outpatient reserved only when justified.

Least intensive sites: home infusion, ambulatory infusion center, physician office
Higher-intensity outpatient hospital/office only with documented justification per policy

Billing Rule

Place of Service codes and specialty pharmacy as drug source

Place of Service codes for outpatient billing include Pharmacy (01), Office (11), Home (12), Off-campus Outpatient Hospital (19), On-campus Outpatient Hospital (22), and ESRD Facility (65). The policy allows specialty pharmacy to be used as the drug source when appropriate.

Step Therapy and Justifications

Justification for higher-intensity outpatient site	Notes / examples	Coverage status
Initial dose administration or restart after >=6-month disruption for short duration (e.g., 4 weeks)
Provider must request initial visit with plan for continued administration at home infusion or ambulatory infusion suite; restart threshold = 6 months
Authorized when documented
FDA‑approved indication requires outpatient hospital administration
Must document that the FDA‑approved indication requires administration in an outpatient hospital setting
Authorized when documented
Home‑based therapy or ambulatory infusion center poses a health risk due to physical or behavioral impairment
Examples: severe venous access issues (no vein finder), lack of caregiver, cardiopulmonary disorder, inability to tolerate IV fluids, cognitive concerns impacting safety
Authorized when documented
Severe or life‑threatening adverse events not responsive to pre‑medications or supportive measures
Examples: seizures, anaphylaxis with no other options, myocardial infarction, renal failure; document failure of pre‑meds/analgesics/steroids/antihistamines/fluids/infusion rate reductions
Authorized when documented

Step / sourcing consideration	Updated guidance	Coverage status
Use least intensive appropriate setting first (home infusion or ambulatory infusion center) if available and specialty pharmacy can supply the drug
If home infusion or ambulatory center is available and specialty pharmacy can provide the drug, those lower‑intensity sites should be used; higher‑intensity site requires documented justification per listed criteria
Neutral (requires criteria)
Include specialty pharmacy as an acceptable drug source for outpatient hospital or office administration requests
Policy updated to explicitly allow specialty pharmacy as a source when provider requires outpatient hospital or office administration; see main criteria for required documentation
Neutral (requires criteria)

Biosimilar Notes

Billing Rule

Rituximab first visit in AIS (includes biosimilars)

Rituximab (Rituxan) requires the first visit in an ambulatory infusion suite (AIS); this applies to rituximab and its biosimilars.

J9312 (rituximab) noted as first visit in AIS; biosimilars included

Definitions

Site of Care / Place of Service codes

PharmacyPlace of Service code 01.

OfficePlace of Service code 11.

HomePlace of Service code 12.

Off-campus Outpatient HospitalPlace of Service code 19.

On-campus Outpatient HospitalPlace of Service code 22.

End-Stage Renal Disease (ESRD) Treatment FacilityPlace of Service code 65.

Background

Specialty infusion therapy refers to intravenous or injectable medications used to manage complex or chronic conditions. This policy promotes delivering care in the least intensive appropriate setting and requires prior authorization when escalation to an in-network outpatient hospital or non-hospital outpatient office/facility is requested. Initial administration at a higher-intensity site may be authorized only when documented justifications are met (for example, initial dose or restart after a ≥6‑month disruption, FDA indication requiring hospital administration, documented health risk for home therapy, or severe/life‑threatening adverse events not responsive to standard mitigations). Providers must submit clinical documentation to support site-of-care requests and consider specialty pharmacy availability and Place of Service billing guidance when arranging administration.

OpenPayer

Clinical Policy: Infusion Therapy Site of Care Optimization