CurrentEmblemHealthPolicy MG.MM.PH.148

Hepatitis B immune globulin (HepaGam B) - Medical Policy

Clinical coverage and medical necessity criteria for use of Hepatitis B immune globulin (HepaGam B) for post-exposure prophylaxis and prevention of HBV recurrence following liver transplantation for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyHepatitis B immune globulin (HepaGam B) - Medical Policy

Policy CodePolicy MG.MM.PH.148

Change TypeNo material change

Effective Date

Next Review DateApr 2, 2025

Key ActionPrior authorization is required with clinical documentation demonstrating the member meets one of the specified medical necessity indications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthslength of authorization

J1571primary applicable HCPCS code

5 NDC groupslisted NDC prefixes

Initial + renewalcoverage decision structure

Coverage and Medical Necessity Criteria

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Initial Approval Indications: 1) Prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients

Refer to dosing schedule for transplant prophylaxis: initial 20,000 IU IV concurrent with grafting, 20,000 IU IV once daily postoperative days 1–7, 20,000 IU IV every 2 weeks starting day 14 through week 12, then 20,000 IU IV once monthly from month 4 onward to achieve anti-HBs > 500 IU/L.

Postexposure Prophylaxis - Acute Blood Exposure: 2A) Acute exposure to blood containing HBsAg

Dose 0.06 mL/kg IM as a single dose as soon as possible and preferably within 7 days of exposure; give a second dose 1 month later to known non-responders.

Postexposure Prophylaxis - Perinatal: 2B) Perinatal exposure of infants born to HBsAg-positive mothers

Dose 0.5 mL IM within 12 hours of birth plus appropriate hepatitis B vaccine series; if vaccine delayed up to 3 months, give HBIG and repeat at 3 months; if vaccine refused, give HBIG and repeat at 3 and 6 months.

Postexposure Prophylaxis - Sexual Exposure: 2C) Sexual exposure to HBsAg-positive persons

Dose 0.06 mL/kg IM as a single dose and initiate hepatitis B vaccine series within 14 days of contact or if contact will continue.

Postexposure Prophylaxis - Household Exposure: 2D) Household exposure to persons with acute HBV infection

Included as an eligible postexposure setting for prophylaxis with HepaGam B.

Use of HepaGam B for indications that are not supported by CMS-recognized compendia or acceptable peer‑reviewed literature is considered not medically necessary and not approvable. Clinical documentation must demonstrate that the requested indication is consistent with recognized compendia or peer‑reviewed evidence to be considered for coverage.

Applicable Codes and Clinical Thresholds

Applicable Procedure CodesHCPCSCovered

J1571	Injection, Hepatitis B immune globulin (HepaGam B) intramuscular, 1 billable unit 0.5 mL.
J1573

Applicable NDCsNDC

49591-0051-XX	HepaGam B 312 Unit/mL
49591-0052-XX	HepaGam B 312 Unit/mL
70257-0051-XX	HepaGam B 312 Unit/mL
70257-0052-XX	HepaGam B 312 Unit/mL
70257-0053-XX	HepaGam B 312 Unit/mL
70257-0054-XX	HepaGam B 312 Unit/mL

ICD-10 DiagnosesICD-10

B16.0	Acute hepatitis B with delta-agent with hepatic coma.
B16.1	Acute hepatitis B with delta-agent without hepatic coma.
B16.2	Acute hepatitis B without delta-agent with hepatic coma.
B16.9	Acute hepatitis B without delta-agent and without hepatic coma.
B18.0	Chronic viral hepatitis B with delta-agent.
B18.1	Chronic viral hepatitis B without delta-agent.
B19.10	Unspecified viral hepatitis B without hepatic coma.
B19.11	Unspecified viral hepatitis B with hepatic coma.
Z23	Encounter for immunization

Target anti-HBs level — post‑transplant

Target anti-HBs level post-transplant> 500 international units/L

Intended method to attain levelDosing schedule described in dosing limits (20,000 IU IV at grafting; daily days 1–7; every 2 weeks weeks 2–12; then monthly from month 4)

Measurement contextSerum levels of antibodies to hepatitis B surface antigen (anti-HBs) after liver transplantation

Prior Authorization, Documentation, and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for HepaGam B (HCPCS J1571). The treating provider must submit clinical documentation demonstrating the member meets one of the medical necessity indications (see criteria for prevention of recurrence after HBsAg-positive liver transplant or for postexposure prophylaxis: acute blood exposure, perinatal exposure to infants born to HBsAg-positive mothers, sexual exposure, or household exposure to persons with acute HBV infection). Requests without prior authorization may be denied.

Affected code: J1571 (HepaGam B)
Prior authorization required before coverage/administration

Documentation Required

Submit Clinical Evidence

The treating provider must submit clinical evidence that the member meets the clinical criteria for the requested treatment to EmblemHealth. Without adequate clinical documentation, EmblemHealth will not be able to properly review the preauthorization request or perform post-payment review.

Include documentation supporting one of the Initial Approval Criteria (see policy)
Attach relevant clinical notes, laboratory results, transplant records, or exposure history

Denial Risk

Documentation and Evidence Requirements

Requests lacking clinical documentation that the member meets the stated criteria may be denied. Indications not supported by CMS-recognized compendia or acceptable peer‑reviewed medical literature may be considered not medically necessary and therefore non‑approvable and not reimbursable.

Absence of supporting documentation = possible denial
Indications unsupported by CMS compendia or peer‑reviewed literature may be non‑approvable

Note

Provider-facing highlight: ensure all required documentation is submitted with the authorization request to avoid delays or denials.

Background and Clinical Description

HepaGam B is an immune globulin containing antibodies against hepatitis B surface antigen that provides passive immunity to patients exposed to hepatitis B virus. It is used for post‑exposure prophylaxis in specified settings and to help prevent hepatitis B recurrence following liver transplantation.