Human Immunodeficiency Virus (HIV) Screening and Pre-exposure - JE Part B

CMS has determined that Pre-Exposure Prophylaxis (PrEP) using antiretroviral drugs to prevent Human Immunodeficiency Virus (HIV) is covered as an additional preventive service as recommended with a grade of A by the United States Preventive Services Task Force (USPSTF). CMS determined that PrEP using antiretroviral drugs to prevent HIV is reasonable and necessary for the prevention of an illness or disability and is appropriate for individuals entitled to Medicare benefits under Part A or enrolled under Part B.

PrEP Antiretroviral Drugs to Prevent HIV - Transition from Part D to Part B (October 1, 2024)

• Includes supplying or dispensing and administration of injectable PrEP
• Billable to A/B MAC by providers and not DME MAC
  1. Up to eight individual counseling visits every 12 months
     • Includes HIV risk assessment (initial or continued), HIV risk reduction, and medication adherence
     • Counseling may be furnished by physician, qualified healthcare practitioner (QHP), or clinical staff
     • Individuals must be competent and alert at time counseling provided
     • G0011: Individual counseling for pre-exposure prophylaxis (PrEP) by physician or QHP to prevent human immunodeficiency virus (HIV), includes HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence, 15-30 minutes,
     • G0013: Individual counseling for pre-exposure prophylaxis (PrEP) by clinical staff to prevent human immunodeficiency virus (HIV), includes HIV risk assessment (initial or continued assessment of risk), HIV risk reduction and medication adherence
  2. Up to eight HIV screening tests every 12 months (using FDA-approved lab tests and point-of-care)
     • G0475 - HIV antigen/antibody, combination assay, screening
     • G0432 - Infectious agent antibody detection by enzyme immunoassay (EIA) technique, HIV-1 and/or HIV-2, screening,
     • G0433 - Infectious agent antibody detection by enzyme-linked immunosorbent assay (ELISA) technique, HIV-1 and/or HIV-2, screening,
     • G0435 - Infectious agent antibody detection by rapid antibody test, HIV-1 and/or HIV-2, screening, G0475 - HIV antigen/antibody, combination assay, screening, or
     • 80081 - Organ Disease Oriented Panel
     • Every 12 months for individuals assessed for or using PrEP to prevent HIV with primary diagnosis ICD-10 Z29.81.
  3. Single screening for hepatitis B virus (HBV) - one time only
     • G0499 - Hep B screening; high risk individual, for asymptomatic non-pregnant beneficiaries
       • ICD-10 N18.6 (End Stage Renal Disease for CKD that requires chronic dialysis)

Other HCPCS billed to A/B MAC:

• • Drug codes (all FDA approved prescriptions for HIV pre-exposure; not for HIV treatment):
    • J0739 (HIV prep; injection, cabotegravir)
    • J0750 (Emtrictabine 200 mg. & tenofovir disoproxil fumarate 300 mg. ORAL)
    • J0751 (Emtrictabine 200 mg. & tenofovir alafenamide 25 mg. ORAL)
    • J0799 (Not otherwise classified; priced per invoice per drug name, dose, and NDC product code 
      • Priced by invoice or Contractor C Status, effective September 30 - December 31, 2024
      • Priced by CMS Average Sales Pricing (ASP) for 2025
    • Physician or practitioner buys injectable PrEP drug
    • Part B enrolled pharmacy supplier
  • G0012: Injection of PrEP for HIV prevention; under skin or into muscle
  • A/B MACs allow payment for supply fees (Q0516-Q0521), ONLY when billed on SAME claim as covered drug (J0739, J0750, J075,1 and J0799) 
• ICD-10 diagnosis codes
  • Z29.81 - Encounter for HIV pre-exposure prophylaxis
  • Z11.4 - Encounter for screening for HIV
    • Increased risk factors - additional diagnoses F11.10, F11.20, F11.21, F11.90, Z11.3, Z11.59, Z20.2, Z20.5, Z20.6, Z20.828, Z20.89, Z20.9, Z32.00, Z32.01, Z32.02, Z72.51, Z72.52, Z72.53, Z72.89, Z79.899, Z86.59, Z87.898, Z72.89

HCPCS billed to DME MAC:

• Discontinued December 31, 2024:
  • Pharmacy supplying fees for FDA-approved prescription oral drugs: Q0516 (30 days), Q0517 (60 days), Q0518 (90 days) and injectables Q0519 (30 days), and Q0520 (60 days)
• 2025: Q0521 replaces above (30, 60, 90 days-added January 1, 2025)
  • Pharmacy supplying fees for HIV PrEP FDA-approved prescription
  • See added diagnoses (A51, A52, A53, A54, A56 range, etc.)
• Note: If pharmacy enrolled as DMEPOS supplier, bill DME MAC for injection or oral drug, with supply fee
  • Place of service can be either be 01 (pharmacy) or beneficiary’s residence typically 12 (home)
    OR
  • If pharmacy enrolled as Part B pharmacy, bill A/B MAC for either injection or oral drug along with supply fee
    OR
  • Invoice physician for injection or oral drug, along with supply fee, and physician bills A/B MAC for HIV PrEP, along with their services

Pricing and Payment (after January 1, 2025)

• J0739, J0750, J0751, J0799 (via ASP Drug Pricing Files)
• G0011, G0012, G0013 (via Physician Fee Schedule)
• Coinsurance and deductible waived

Noridian Medicare Portal

Yes - G0475

Resources

• CMS Internet Only Manual (IOM), Publication 100-04, Medicare Claims Processing Manual, Chapter 18, Section 130
• CMS Medicare Preventive Services
• CMS Internet Only Manual (IOM) Publication 100-03, Chapter 1, Part 4, National Coverage Determinations Manual
• CMS PrEP for HIV and Related Preventive Services
• CMS NCD 210.15 - Pre-Exposure Prophylaxis (PrEP) for Human Immunodeficiency Virus (HIV) Prevention