Summary & Overview

HCPCS M1485: HCV No Sustained Virological Response

HCPCS Level II code M1485 denotes patients with hepatitis C virus (HCV) infection who did not achieve a sustained virological response (SVR) based on HCV RNA testing, with a negative/undetectable HCV RNA result occurring 20 weeks to 12 months after the initial positive/detectable HCV RNA within the denominator period. This measure captures treatment or surveillance outcomes that are important for public health tracking, quality reporting, and payer coverage determinations for HCV care.

Key national payers relevant to this code include Aetna, Blue Cross Blue Shield, Cigna Health, UnitedHealthcare, and Medicare. Readers will find a concise overview of what M1485 represents, clinical context around HCV RNA testing using CPT 87521/CPT 87522, and the typical service setting for reporting these outcomes. The publication outlines benchmarks and policy implications related to HCV treatment success measurement, common billing and reporting contexts, and what to expect in terms of documentation and timing windows for identifying lack of SVR. This information is written for a national audience of clinicians, coding and billing professionals, and policy analysts involved in HCV program evaluation and quality measurement.

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Billing Code Overview

HCPCS Level II code M1485 identifies patients with hepatitis C virus (HCV) infection who did not achieve sustained virological response (SVR) as determined by HCV RNA testing. The definition specifies a negative/undetectable HCV RNA result that occurred 20 weeks to 12 months after the first positive/detectable HCV RNA test within the denominator identification period, indicating failure to achieve sustained virological clearance in the specified follow-up window.

Service type: Laboratory surveillance and outcome measurement related to HCV RNA testing and post-treatment virological response
Typical site of service: Outpatient laboratory or clinic-based testing where HCV RNA assays such as CPT 87521 or CPT 87522 are performed and reported

Data not available in the input for modifiers, associated taxonomies, ICD-10 diagnoses, related codes, and service line.

Clinical & Coding Specifications

Clinical Context

A 54-year-old patient with chronic hepatitis C virus (HCV) infection receives antiviral therapy. Initial diagnostic molecular testing identified HCV RNA detectable by CPT 87521/CPT 87522. Twenty-four weeks after the first detectable HCV RNA within the reporting period, the patient undergoes repeat HCV RNA testing to assess sustained virological response (SVR). The billing code M1485 is used to classify patients who did not achieve SVR because the repeat CPT 87521/CPT 87522 HCV RNA test remains detectable between 20 weeks and 12 months after the first positive result.

Clinical workflow:

The treating clinician documents prior detectable HCV RNA and dates of antiviral therapy initiation and completion.
The laboratory performs quantitative or qualitative HCV RNA testing using CPT 87521 (HCV RNA; quantification) or CPT 87522 (HCV RNA; presence/absence) at the 20-week to 12-month interval.
Results demonstrating persistent detectable HCV RNA are recorded in the medical record and trigger classification under M1485 for quality reporting and denominator exclusion logic.
The clinician documents counseling, follow-up testing plans, and any additional management decisions (e.g., retreatment evaluation) based on persistent viremia.

Coding Specifications

Modifier	Description	When to Use
`25`	Significant, separately identifiable evaluation and management service by the same physician on the same day of the procedure	Use when an E/M visit is documented as distinct from the HCV RNA specimen collection or testing encounter.
`26`	Professional component	Use when billing only professional interpretation of laboratory molecular test results where applicable.
`59`	Distinct procedural service	Use when a separate unrelated procedure is performed the same day as specimen collection/testing.
`90`	Reference (outside) laboratory	Use when the HCV RNA test is performed by an outside independent lab and only the referral is billed by the ordering provider.
`91`	Repeat clinical diagnostic laboratory test	Use when a repeat HCV RNA test is performed on the same day to confirm an unexpected result.
`TC`	Technical component	Use when billing only the technical component of the laboratory testing (equipment, supplies, technician).
`QW`	CLIA waived test	Use only if the HCV RNA test performed meets waived testing criteria (rare for molecular HCV RNA assays).
`XP`	Separate payment for identifiable portion of service	Use in specific payer contexts to indicate distinct portions of composite services where permitted.
`XE`	Separate encounter	Use when the testing encounter is distinct from other services on the same date.
`ZF`	Not a CMS modifier (placeholder)	Data not applicable; not used clinically for this service.

Taxonomy Code	Specialty	Notes
`207RH0000X`	Infectious Disease	Specialists managing HCV therapy, treatment failure, and retreatment decisions.
`208D00000X`	Gastroenterology	Clinicians providing longitudinal care for chronic HCV and liver disease assessment.
`207K00000X`	Internal Medicine	Primary care physicians coordinating testing, follow-up, and referrals for HCV.
`208000000X`	Hepatology	Providers focused on liver disease management and interpretation of virologic treatment response.
`3336C0003X`	Clinical Laboratory Director	Laboratory physicians overseeing molecular testing quality and reporting.

ICD-10 Code	Description	Clinical Relevance
`B18.2`	Chronic viral hepatitis C	Primary diagnosis indicating chronic HCV infection; directly relevant to HCV RNA monitoring and SVR assessment.
`B19.20`	Unspecified viral hepatitis C without hepatic coma	Used for documented HCV infection when chronicity is not otherwise specified; associated with HCV RNA testing.
`K76.9`	Liver disease, unspecified	Captures patients with liver-related symptoms or findings who require HCV management and virologic monitoring.
`R76.8`	Other specified abnormal immunological findings in serum	May be used when abnormal serologic markers prompt molecular HCV RNA testing.
`Z22.52`	Carrier of Hepatitis C	Indicates carrier status and the need for periodic monitoring including HCV RNA testing.

CPT Code	Description	Relationship to This Procedure
`87521`	Infectious agent detection by nucleic acid (DNA or RNA); Hepatitis C virus (HCV), amplified probe technique, quantification	Often used as the initial or follow-up quantitative HCV RNA assay to determine viral load and to assess SVR.
`87522`	Infectious agent detection by nucleic acid (DNA or RNA); Hepatitis C virus (HCV), presence/absence (qualitative)	Used for qualitative detection of HCV RNA to determine presence versus absence of viremia at follow-up testing between 20 weeks and 12 months.
`36415`	Collection of venous blood by venipuncture	Commonly performed to obtain specimens for `CPT 87521`/`CPT 87522` testing during the follow-up visit.
`99213`	Office or other outpatient visit for the evaluation and management of an established patient, typically 15 minutes	Typical E/M level used when documenting treatment response discussion and follow-up planning after HCV RNA test results.
`87491`	Infectious agent antigen detection by immunoassay technique, qualitative or semiquantitative, multiple-step method; Hepatitis C	May be used in some settings for screening workflows prior to molecular confirmatory testing when applicable.

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