`J3397` Inj., vestronidase alfa-vjbk

Injection, vestronidase alfa-vjbk, 1 mg

Medicare coverage: Carrier judgment
Status: active (October 2026 file)

Medically Unlikely Edits (effective October 1, 2026)

Practitioner: max 600 units per day (clinical), rationale: Prescribing Information
Outpatient hospital: max 600 units per day (clinical), rationale: Prescribing Information

Medicare pricing for J3397

Physician Fee Schedule (CY 2026, RVU26D)

Status E: excluded from the PFS by regulation.

Payer policies and prior authorization for J3397

94 of 94 payer prior-auth lists that name J3397 require prior authorization or set conditions: Aetna, Arkansas Blue Cross and Blue Shield, Blue Cross Blue Shield of Arizona (AZ Blue), Blue Cross and Blue Shield of Illinois, Blue Cross and Blue Shield of Texas, Blue Shield of California Promise Health Plan, CarePlus Health Plans, Cigna, Humana, Molina Complete Care (Virginia), Molina Healthcare of Arizona, Molina Healthcare of California, Molina Healthcare of Idaho, Molina Healthcare of Illinois, Molina Healthcare of Iowa, Molina Healthcare of Michigan, Molina Healthcare of Mississippi, Molina Healthcare of Nevada, Molina Healthcare of New Mexico, Molina Healthcare of Ohio, and others.

Payer	Plan	State	Prior auth	Conditions	Since	Source
Arkansas Blue Cross and Blue Shield	Drugs under the medical benefit (not ASE/PSE or FEP, which use EBRx and Prime)	AR	prior auth required		Sep 1, 2018	Medical Benefit Pharmacy Prior Approval List
Blue Cross Blue Shield of Arizona (AZ Blue)	AZ Blue-administered Medicare Advantage (M2K)	AZ	prior auth required		Sep 1, 2026	AZ Blue Medicare Advantage Prior Authorization Requirements Code List (Effective 09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	Standard PA code list (most commercial plans)	AZ	prior auth required	site of care: site-of-service review	Sep 1, 2026	AZ Blue Standard Prior Authorization Requirements Code List (09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	Standard PA code list (most commercial plans)	AZ	prior auth required	site of care: site-of-service review	Sep 1, 2026	AZ Blue Standard Prior Authorization Requirements Code List (09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	State of Arizona employee group (SYD, S3Z)	AZ	prior auth required	site of care: site-of-service review	Sep 1, 2026	State of Arizona Group Prior Authorization Requirements Code List (09/01/2026)
Blue Cross Blue Shield of Arizona (AZ Blue)	Teamsters group (TYW)	AZ	prior auth required		Sep 1, 2026	Teamsters Group Prior Authorization Requirements Code List (Updated 09/01/2026)
Blue Shield of California Promise Health Plan	Promise Health Plan Medi-Cal	CA	prior auth required		Sep 1, 2026	Medi-Cal Prior Authorization List
Aetna	Medicare Advantage	All	prior auth required		Aug 25, 2026	Aetna Medicare Part B drug list (partbname.xml)
Aetna	Commercial	All	prior auth required	site of care: drug and site of care	Oct 1, 2026	Participating provider precertification list for Aetna®
Aetna	Medicare Advantage	All	prior auth required		Oct 1, 2026	Participating provider precertification list for Aetna®
Cigna	ACA/IFP	All	prior auth required		Jan 1, 2019	Master Precertification List (For Health Care Providers)
Cigna	Basic Standard	All	prior auth required		Jan 1, 2019	Master Precertification List (For Health Care Providers)
Cigna	Complete/PHS+/Preferred	All	prior auth required		Jan 1, 2019	Master Precertification List (For Health Care Providers)
Blue Cross and Blue Shield of Illinois	Blue Cross Community Health Plans (BCCHP), Illinois Medicaid	IL	prior auth required		Jan 1, 2026	Illinois Medicaid Prior Authorization Code List, Effective 10/1/2026
Blue Cross and Blue Shield of Illinois	Blue Cross Community MMAI (Medicare-Medicaid Alignment Initiative)	IL	prior auth required	eviCore-managed	Jan 1, 2020	Procedure Code List, Effective 1/1/2025
Blue Cross and Blue Shield of Texas	Texas PA exemption (gold card), outpatient, fully insured	TX	prior auth required	Gold-card exemption available	Nov 1, 2024	BCBSTX Outpatient Prior Authorization Exemption Clinical Guidelines (max units, PA exempt date range)
CarePlus Health Plans	CarePlus Health Plans	FL	prior auth required		Jan 1, 2027	Medicare Advantage and Dual Eligible Special Needs Plans Prior Authorization and Notification List We have updated our CarePlus Health Plans Prior Authorization and Notification List for CarePlus Medi
Humana	Humana D-SNP (FL)	FL	prior auth required		Jul 1, 2026	H1036-280 Humana Fully Integrated Florida prior authorization and notification list
Humana	Humana D-SNP (IL)	IL	prior auth required		Jan 1, 2027	Humana Dual Fully Integrated Illinois prior authorization and notification list
Humana	Humana D-SNP (IN)	IN	prior auth required		Jan 1, 2027	Humana PathWays Dual Care (HMO-POS D-SNP) prior authorization and notification list Important notes:
Humana	Humana D-SNP (MI)	MI	prior auth required		Oct 14, 2026	Humana Dual Integrated (health maintenance organization Dual Eligible Special Needs Plan (HMO D- SNP) Michigan prior authorization and notification list (PAL)
Humana	Humana D-SNP (SC)	SC	prior auth required		Jul 1, 2026	Humana Dual Integrated South Carolina prior authorization and notification list
Humana	Humana D-SNP (VA)	VA	prior auth required		Jul 1, 2026	Prior authorization and notification list Humana Dual Fully Integrated H2875-001 (Virginia) Humana Dual Fully Integrated H2875-003 (Virginia)
Humana	Humana Healthy Horizons	FL	prior auth required		Jan 1, 2027	Humana Healthy Horizons in Florida Prior Authorization and Notification List
Humana	Humana Healthy Horizons	IN	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Indiana prior authorization and notification list for provider-administered medications
Humana	Humana Healthy Horizons	KY	prior auth required		Oct 7, 2026	Humana Healthy Horizons in Kentucky Prior Authorization and Notification List
Humana	Humana Healthy Horizons	LA	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Louisiana Prior Authorization and Notification List
Humana	Humana Healthy Horizons	OH	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Ohio prior authorization and notification List
Humana	Humana Healthy Horizons	OK	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Oklahoma Prior Authorization and Notification List
Humana	Humana Healthy Horizons	SC	prior auth required		Oct 14, 2026	Humana Healthy Horizons in South Carolina prior authorization and notification list
Humana	Humana Healthy Horizons	VA	prior auth required		Oct 14, 2026	Humana Healthy Horizons in Virginia professionally administered medication prior authorization and notification list
Humana	Humana Healthy Horizons	VA	prior auth required		Jan 1, 2027	Humana Healthy Horizons in Virginia Prior Authorization and Notification List (PAL)
Humana	Humana MA and D-SNP	All	prior auth required		Jan 1, 2027	Medicare Advantage and Dual Eligible Special Needs Plans prior authorization and notification list Important notes:
Molina Complete Care (Virginia)	Medicare-only PA matrix for D-SNP	VA	prior auth required		Jan 1, 2022	Medicare Prior Auth (PA) Code Matrix (Virginia), effective Q1 2022
Molina Complete Care (Virginia)	Medicaid	VA	prior auth required		Apr 1, 2025	Virginia Medicaid PA Code Matrix and Virginia code/benefit exceptions, effective Q2 2025
Molina Healthcare of Arizona	Medicare-only PA matrix for D-SNP	AZ	prior auth required		Jan 1, 2022	Medicare Prior Auth (PA) Code Matrix (Arizona), effective Q1 2022
Molina Healthcare of California	Medicaid	CA	prior auth required		Apr 1, 2026	Medicaid Prior Auth (PA) Code Matrix (California), effective Q2 2026
Molina Healthcare of Idaho	Medicaid	ID	prior auth required		Jan 1, 2025	Idaho Medicaid Prior Auth (PA) Code Matrix and Idaho code/benefit exceptions, Q1 2025
Molina Healthcare of Illinois	Medicaid	IL	prior auth required		Jan 1, 2022	Molina Healthcare of Illinois Codification Grid Q3 2026
Molina Healthcare of Iowa	Medicaid	IA	prior auth required		Jul 1, 2023	IA Prior Authorization Matrix, effective Q3 2023
Molina Healthcare of Michigan	Medicaid	MI	prior auth required		Jul 1, 2026	Molina Healthcare of Michigan PA Matrix 2026-Q3
Molina Healthcare of Michigan	Medicare Advantage	MI	prior auth required		Jul 1, 2026	Molina Healthcare of Michigan PA Matrix 2026-Q3
Molina Healthcare of Michigan	Exchange	MI	prior auth required		Jul 1, 2021	Molina Healthcare of Michigan PA Matrix, effective 7/1/2021
Molina Healthcare of Mississippi	Medicaid	MS	prior auth required		Jan 1, 2025	Mississippi Medicaid Prior Auth (PA) Code Matrix and exceptions, effective Q1 2025
Molina Healthcare of Nevada	Medicaid	NV	prior auth required		Oct 1, 2022	Medicaid Prior Auth (PA) Code Matrix, effective Q4 2022
Molina Healthcare of New Mexico	Medicaid	NM	prior auth required	Molina follows New Mexico Senate Bill 39 and waives PA where applicable	Jul 1, 2026	New Mexico Medicaid Prior Auth (PA) Code Matrix, effective July 1, 2026
Molina Healthcare of Ohio	Medicaid and MyCare Ohio (MMP) Medicaid	OH	prior auth required		Oct 1, 2023	Molina Healthcare of Ohio Prior Authorization (PA) Code List, effective 2023-10-01
Molina Healthcare of Ohio	Medicare and MyCare Ohio (MMP) Medicare	OH	prior auth required		Oct 1, 2023	Molina Healthcare of Ohio Prior Authorization (PA) Code List, effective 2023-10-01
Molina Healthcare of Ohio	Exchange	OH	prior auth required		Oct 1, 2023	Molina Healthcare of Ohio Prior Authorization (PA) Code List, effective 2023-10-01
Molina Healthcare of Texas	Outpatient drug services (medical benefit)	TX	prior auth required		Aug 1, 2026	Medicaid Prior Authorization (PA) Code Matrix for Outpatient Drug Services (Texas), 2026-08
Molina Healthcare of Texas	STAR	TX	prior auth required		Feb 19, 2025	Molina Healthcare of Texas Prior Authorization Annual Review Report (STAR), reviewed 2025-02-19
Molina Healthcare of Texas	STAR+PLUS	TX	prior auth required		Feb 19, 2025	Molina Healthcare of Texas Prior Authorization Annual Review Report (STAR+PLUS), reviewed 2025-02-19
Molina Healthcare of Texas	Exchange	TX	prior auth required		Sep 1, 2019	Marketplace Prior Authorization (PA) Code Matrix (Texas), effective July 1, 2026
Passport by Molina Healthcare (Kentucky)	Medicaid	KY	prior auth required		Jul 1, 2026	Kentucky Medicaid Prior Auth (PA) Code Matrix and Kentucky PA Code Exceptions, effective Q3 2026
Neighborhood Health Partnership	Neighborhood Health Partnership	FL	prior auth under conditions	place of service 19, 22	Sep 1, 2026	Prior authorization requirements for Neighborhood Health Partnership Effective September 1, 2026
Oxford Health Plans	Oxford Health Plans	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior Authorization Requirements for Oxford Effective October 1, 2026
Rocky Mountain Health Plans	Rocky Mountain Health Plans CHP+	CO	prior auth required		Oct 1, 2026	Rocky Mountain Children’s Health Plan - prior authorization Effective October 1, 2026
Rocky Mountain Health Plans	Rocky Mountain Health Plans Prime / RAE	CO	prior auth required		Oct 1, 2026	Rocky Mountain Health Plans PRIME Effective October 1, 2026
Surest	Surest health plans	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior Authorization Requirements for Surest Effective October 1, 2026
Surest	Surest health plans	All	prior auth required		Oct 1, 2026	Prior Authorization Requirements for Surest Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Commercial	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior authorization requirements for UnitedHealthcare commercial plans Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Complete (Individual & Family plans)	All	prior auth required		Sep 1, 2026	Prior authorization requirements for UnitedHealthcare Complete Effective September 1, 2026
UnitedHealthcare	UnitedHealthcare Individual Exchange plans	All	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Individual Exchange plans Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare Mid-Atlantic Health Plans	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Mid-Atlantic Health Plans Effective October 1, 2026
UnitedHealthcare	UnitedHealthcare of the River Valley	All	prior auth under conditions	place of service 19, 22	Oct 1, 2026	Prior authorization requirements for UnitedHealthcare of the River Valley Effective October 1, 2026
UnitedHealthcare Community Plan	AHCCCS Complete Care (ACC)	AZ	prior auth required		Oct 1, 2026	Prior authorization requirements for AHCCCS Complete Care (ACC) Medicaid effective October 1, 2026
UnitedHealthcare Community Plan	ALTCS Developmentally Disabled	AZ	prior auth required		Oct 1, 2026	Prior authorization requirements for Arizona Developmental Disabilities Effective October 1, 2026
UnitedHealthcare Community Plan	ALTCS Long Term Care	AZ	prior auth required		Oct 1, 2026	Prior authorization requirements for Arizona Long Term Care Effective October 1, 2026
UnitedHealthcare Community Plan	Indiana Hoosier Care Connect	IN	prior auth required		Oct 1, 2026	Prior authorization requirements for Indiana Hoosier Care Connect Effective October 1, 2026
UnitedHealthcare Community Plan	Indiana PathWays for Aging (MLTSS)	IN	prior auth required		Oct 1, 2026	Prior authorization requirements for Indiana MLTSS Pathways Effective October 1, 2026
UnitedHealthcare Community Plan	Louisiana Medicaid (Healthy Louisiana)	LA	prior auth required		Jan 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Louisiana
UnitedHealthcare Community Plan	Maryland HealthChoice	MD	prior auth required		Sep 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Maryland Effective September 1, 2026
UnitedHealthcare Community Plan	Michigan Medicaid, Healthy Michigan Plan, CSHCS	MI	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Michigan, Healthy Michigan Plan and Children’s Special Health Care Services Effective October 1, 2026
UnitedHealthcare Community Plan	Minnesota Metro Medicaid	MN	prior auth required		Oct 1, 2024	Prior authorization requirements for Minnesota Medicaid Effective October 1, 2024
UnitedHealthcare Community Plan	Mississippi CHIP	MS	prior auth required		Apr 1, 2025	Prior authorization requirements for Mississippi Children’s Health Insurance Program Effective Apr. 1, 2025
UnitedHealthcare Community Plan	MississippiCAN	MS	prior auth required		Apr 1, 2025	Prior authorization requirements for UnitedHealthcare Community Plan of Mississippi – Mississippi Coordinated Access Network (MississippiCAN) Effective Apr. 1, 2025
UnitedHealthcare Community Plan	Nebraska Heritage Health	NE	prior auth required		Jul 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of Nebraska Effective July 1, 2026 General Information This list contains prior authorization requirements for participating United
UnitedHealthcare Community Plan	New Jersey FamilyCare	NJ	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of New Jersey Effective October 1, 2026 General Information This list contains prior authorization requirements for participating U
UnitedHealthcare Community Plan	New Mexico Turquoise Care	NM	prior auth required		Oct 1, 2026	Prior authorization requirements for UnitedHealthcare Community Plan of New Mexico Effective October 1, 2026
UnitedHealthcare Community Plan	Ohio Medicaid	OH	prior auth required		Nov 1, 2025	Prior authorization requirements for Ohio Medicaid Effective November 1, 2025 General Information This list contains prior authorization requirements for participating UnitedHealthcare Community Plan

Payer coverage policies that name J3397

J3397 appears in 19 coverage policies from Aetna, Blue Cross & Blue Shield of Mississippi, Centene, Cigna, Health Care Service Corporation (BCBS IL, TX, OK, NM, MT), Premera Blue Cross, UnitedHealthcare, Wellmark Blue Cross Blue Shield.

Payer	Policy	Role in policy	Reviewed	Document
Aetna	Injectable Medications (0020)	listed, no stance (range J2550-J3520)	Mar 5, 2026	payer document
Aetna	Lysosomal Storage Disorder Treatments (0442)	covered if criteria are met	Jul 8, 2026	payer document
Blue Cross & Blue Shield of Mississippi	Lysosomal Storage Disorders (S.5.01.526)	listed, no stance		payer document
Blue Cross & Blue Shield of Mississippi	Lysosomal Storage Disorders (L.5.01.526)	listed, no stance		payer document
Centene	Vestronidase Alfa-vjbk (Mepsevii) (CP.PHAR.374)	covered if criteria are met	May 1, 2026	payer document
Cigna	Enzyme Replacement Therapy – Mepsevii (IP0449)	covered if criteria are met	May 15, 2026	payer document
Health Care Service Corporation (BCBS IL, TX, OK, NM, MT)	Enzyme-Replacement Therapy for Lysosomal Storage Disorders (RX501.067) HCPCS Codes C9399, G0138, J0180, J0218, J0219, J0220, J0221, J1203, J1322, J1458,	listed, no stance	Oct 1, 2026	payer document
Health Care Service Corporation (BCBS IL, TX, OK, NM, MT)	Specialty Medication Administration Site of Care HCPCS Codes J0129, J0174, J0175, J0180, J0218, J0219, J0221, J0222, J0223, J0224,	listed, no stance	Jan 1, 2026	payer document
Premera Blue Cross	Drugs for Rare Diseases (5.01.576) Page \| 68 of 128 \| ∞	listed, no stance	Aug 11, 2026	payer document
UnitedHealthcare	Denied Drug Codes – Pharmacy Benefit Drugs (for Arizona Only) (CS2026D0990AB)	listed, no stance	Jul 1, 2026	payer document
UnitedHealthcare	Medical Therapies for Enzyme Deficiencies (2026D0052AE)	listed, no stance	May 1, 2026	payer document
UnitedHealthcare	Medical Therapies for Enzyme Deficiencies (CS2026D0052AG)	listed, no stance	Apr 1, 2026	payer document
UnitedHealthcare	Medical Therapies for Enzyme Deficiencies (for Indiana Only) (CSIND0052.16)	listed, no stance	Mar 1, 2026	payer document
UnitedHealthcare	Medical Therapies for Enzyme Deficiencies (for Ohio Only) (CSOH2026D0052.E)	listed, no stance	Jan 1, 2026	payer document
UnitedHealthcare	Provider Administered Drugs – Site of Care (2026D0121W)	listed, no stance	Sep 1, 2026	payer document
UnitedHealthcare	Provider Administered Drugs – Site of Care (CS2026D0121P)	listed, no stance	Jul 1, 2026	payer document
UnitedHealthcare	Provider Administered Drugs – Site of Care (for Ohio Only) (CSOH2026D0121.I)	listed, no stance	Aug 1, 2026	payer document
UnitedHealthcare	Provider Administered Drugs – Site of Care (for Pennsylvania Only) (CSPA2026D00121J)	listed, no stance	Aug 1, 2026	payer document
Wellmark Blue Cross Blue Shield	Enzyme Replacement Therapy (05.02.91)	listed, no stance	Jun 1, 2026	payer document

Recent prior-auth changes

Oct 1, 2026: conditions changed, Surest
Jul 1, 2026: PA added, Humana
Jan 1, 2026: conditions changed, Blue Cross and Blue Shield of Illinois
Jan 1, 2026: PA added, Humana
Jan 1, 2026: conditions changed, Surest
Jan 1, 2026: PA removed, Blue Cross and Blue Shield of New Mexico
Nov 1, 2025: PA added, UnitedHealthcare Community Plan
Feb 19, 2025: PA added, Molina Healthcare of Texas
Feb 19, 2025: PA added, Molina Healthcare of Texas
Jan 1, 2025: PA added, Molina Healthcare of Mississippi

Medicaid fee-for-service

Prior authorization required or conditional in NE, VA, VT, WA.

AZ: $266.09 (asc), effective Oct 1, 2026
IN: $252.14 (professional, Advanced Practice Nurse (85%), non-facility), effective Apr 1, 2026
KS: $263.70 (asc, facility), effective Apr 1, 2024
KY: $280.09 (asc), effective Jan 1, 2026
MS: $280.15 (comprehensive), effective Jul 1, 2026
NE: $301.71 (injectables), effective Jul 1, 2026
OH: $226.31 (provider_administered_drugs), effective Jan 1, 2019
OK: $211.50 (physician, non-facility), effective Jul 1, 2026
TX: $288.15 (nurse_practitioner_clinical_nurse_specialist, Nurse Practitioner/Clinical Nurse Specialist, non-facility), effective Sep 1, 2026
VT: $212.75 (outpatient_hospital_opps), effective Feb 1, 2026
WY: $121.27 (outpatient_hospital_apc, Ambulatory Surgical Centers), effective Apr 1, 2026

From payers' published prior-auth lists, coverage policies and state Medicaid fee schedules, updated Oct 16, 2026. The role is what the policy's own code table or text says about the code. Not a guarantee of coverage or payment; verify with the payer. CPT® is a registered trademark of the American Medical Association.

J3397 Inj., vestronidase alfa-vjbk