Prior authorization/coverage guidance: screening tests and repeat limits

Order an antigen/antibody combination assay for initial HIV screening for individuals aged 11–65; repeat antigen/antibody screening is covered up to once every 90 days. Reserve nucleic acid testing (qualitative or quantitative) — no more than one test per month — for situations where initial screening is positive, indeterminate, or recent exposure is suspected or reported.

• Initial antigen/antibody screening: individuals 11–65 years — covered.
• Repeat antigen/antibody screening: covered no more than one test every 90 days.
• Nucleic acid testing (qualitative or quantitative): covered no more than one test every month when initial screen is positive, indeterminate, or recent exposure suspected.

Confirmatory RNA testing for ambiguous serology

When an initial Ag/Ab assay is reactive but antibody differentiation is negative or indeterminate, perform quantitative or qualitative HIV RNA testing. If low-positive RNA results are obtained, repeat RNA testing on a new specimen to confirm acute infection or to document seroconversion.

• Reactive Ag/Ab with negative/indeterminate differentiation → order quantitative or qualitative HIV RNA.
• Repeat quantitative HIV RNA testing or subsequent testing to document antibody seroconversion when confirming infection; repeat RNA on a new specimen for low-positive results.

Timing for resistance testing before ART and when switching

Send genotypic resistance testing before initiating antiretroviral therapy and when changing regimens in patients with HIV RNA above resistance-testing thresholds (commonly >500–1,000 copies/mL; consider testing down to ≥200 copies/mL in some contexts).

• Genotype should be sent to the laboratory prior to ART initiation.
• Perform resistance testing when changing regimens if plasma HIV RNA exceeds suggested thresholds (>500–1,000 copies/mL; consider ≥200 copies/mL).

Resistance testing recommendations: genotype preferred, phenotype for complex cases

Order genotypic resistance testing at diagnosis, prior to initiating ART, and at confirmed virologic failure; consider phenotypic testing for complex or suspected multidrug resistance scenarios (often in addition to genotype).

• Genotypic testing preferred at time of diagnosis and before starting therapy in ART‑naïve patients.
• At virologic failure perform resistance testing (preferably while on failing regimen); phenotypic testing indicated for suspected complex multidrug resistance.

Viral load monitoring schedule: early and follow-up intervals

Monitor plasma HIV RNA early after starting or changing ART (IDSA recommends recheck at 2–4 weeks and no later than 8 weeks; IAS/IAS suggests within 6 weeks) and then monitor frequently until suppression (every 4–8 weeks per IDSA); once suppressed, monitor every 3 months and may extend to every 3–6 months for stable patients.

• Obtain baseline HIV RNA at entry into care and at ART initiation.
• Reassess HIV RNA 2–4 weeks (IDSA) and no later than 8 weeks after ART start or change; IDSA recommends every 4–8 weeks until suppression.
• After suppression: monitor every 3 months; may extend to every 3–6 months for clinically stable, adherent patients.

Conflict with government policies: government policy governs

If this Policy conflicts with an applicable government policy (e.g., LCDs, NCDs, or state Medicaid), follow the government policy for coverage determinations.

• Government policies (LCD/NCD/state Medicaid) take precedence over this Policy when conflicts exist.
• Refer to CMS or applicable state Medicaid websites for up-to-date determinations.

Prior authorization / coverage limits and allowable testing frequencies

Follow the updated coverage and frequency limits: antigen/antibody combination assays for ages 11–65 meet coverage (initial and repeat up to once every 90 days); nucleic acid testing (qualitative or quantitative) meets coverage up to once monthly in defined situations; plasma HIV RNA quantification is limited to no more than one test per month for monitoring and specified indications. Genotyping/phenotyping meet coverage in specified scenarios but routine combined genotype+phenotype and genotype-based phenotype prediction do not meet coverage.

• CC1: Initial antigen/antibody screening for ages 11–65 — meets coverage.
• CC2: Repeat antigen/antibody screening — covered no more than once every 90 days.
• CC3: Nucleic acid testing (qualitative or quantitative) — covered no more than once per month for positive/indeterminate screens or suspected recent exposure.
• Genotyping/phenotyping covered for specified indications (e.g., prior to doravirine, treatment failure, pregnancy situations); routine combined genotype+phenotype not covered.