One-Time Screening for Hepatitis C Virus (HCV) and Treatment Initiation

Measure Specification

Of the estimated 3.5 million people living in the United States with the hepatitis C virus infection (HCV), only 50% have been tested for HCV and are aware of their status. Reported cases of HCV have increased (approximately 20% per year) between 2010 - 2016 which is partially due to improved case detection and more likely due to rising rates of injection drug use.

Additionally, only one third have been referred for HCV care and only 5.6% receive recommended treatment. Studies indicate that even among high-risk patients for whom screening is recommended, only 49-75% are aware of their infection status. In a recent analysis of data from a national health survey, 67.9% of persons ever infected with HCV reported an exposure risk (e.

g., injection drug use, having sexual contact with suspected/confirmed hepatitis C patient), 2 weeks to 6 months prior to symptom onset, and the remaining 32.1% reported no known exposure risk. Current risk-based testing strategies have had limited success, as evidenced by the substantial number of HCV-infected persons who remain unaware of their infection.

As a result, many do not receive needed care (e.g., education, counseling, and medical monitoring), and are not evaluated for treatment. HCV causes acute infection, which can be characterized by mild to severe illness but is usually asymptomatic. In approximately 75%-85% of persons, HCV persists as a chronic infection, placing infected persons at risk for liver cirrhosis, hepatocellular carcinoma (HCC), and extrahepatic complications that develop over the decades following onset of infection.

HCV testing is the first step toward improving health outcomes for persons infected with HCV. The CDC and AASLD suggest one time screening for all patients aged 18 years or older and there is limited evidence to support the upper age limit suggested by the USPSTF of 79 years of age; therefore, we recommend one-time screening for HCV infection in all patients aged 18 years and older consistent with the evidenced based guidance.

In addition to testing adults of all ages at risk for HCV infection, CDC recommends that: Hepatitis C screening be performed at least once in a lifetime for all adults aged 18 years and older, except in settings where the prevalence of HCV infection (HCV RNA‑positivity) is less than 0.1%The CDC states that providers and patients can discuss HCV testing as part of an individual’s preventive health care.

For persons identified with HCV infection, CDC recommends that they receive appropriate care, including HCV- directed clinical preventive services (e.g., screening for alcohol use, hepatitis A and hepatitis B vaccination as appropriate, and medical monitoring of disease). Recommendations are available to guide treatment decisions. Treatment decisions should be made by the patient and provider after several factors are considered, including stage of disease, hepatitis C genotype, comorbidities, therapy-related adverse events, and benefits of treatment (CDC, 2012).

The USPSTF recommends screening for hepatitis C virus (HCV) infection in adults aged 18 to 79 years. (Grade B recommendation) (USPSTF, 2020). This recommendation incorporates new evidence and replaces the 2013 USPSTF recommendation, which recommended screening for HCV infection in persons at high risk for infection and 1-time screening in adults born between 1945 and 1965 (B recommendation).

The new USPSTF recommendation expands the ages for screening to all adults from 18 to 79 years. The treatment of HCV continues to evolve, resulting in greater benefits and fewer harms than when the USPSTF last considered the evidence. Direct-acting antiviral regimens are of shorter duration, with higher rates of sustained virologic response (SVR) and fewer serious harms than previous treatment regimens.

Since 2013, the prevalence of HCV infection has increased in younger persons aged 20 to 39 years. There are limited epidemiologic data available on HCV incidence in adolescents younger than 18 years. The HCV infection prevalence rates in older adults born between 1945 and 1965 remain relatively high, and prevalence in the elderly will increase as this population ages.

Clinical trials of DAA treatment included adults in their early 80s, which increases the evidence for the benefits of screening in older adults. In addition, many older adults could experience the benefits of screening. As a result, the USPSTF concluded that broadening the age for HCV screening beyond its previous recommendation will identify infected patients at earlier stages of disease who could greatly benefit from effective treatment before developing complications.

(USPSTF, 2020). Verbatim from AASLD and IDSA Recommendations for Testing, Managing, and Treating Hepatitis C, August 2020: One-time, routine, opt out HCV testing is recommended for all individuals aged 18 years or older. (Rating: Class I, Level B) (AASLD/IDSA, 2020) REFERENCES American Association for the Study of Liver Diseases & Infectious Diseases Society of America.

(2020, August). Hepatitis C guidance: Testing, managing, and treating hepatitis C virus infection: Recommendations of the HCV guidance panel. Retrieved from https://www.hcvguidelines.org/ Centers for Disease Control and Prevention. (2012). Prevention and control of influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP).

MMWR Recommendations and Reports, 61(4), 1-42. Retrieved from https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6104a1.htm U.S. Preventive Services Task Force. (2020). Hepatitis C screening: Recommendation statement. U.S. Preventive Services Task Force. Retrieved from https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/hepatitis-c- screening COPYRIGHT: Physician Performance Measures (Measures) and related data specifications have been developed by the American Gastroenterological Association (AGA) Institute.

These performance Measures are not clinical guidelines and do not establish a standard of medical care, nor have been tested for all potential applications. Neither the AGA, any of its affiliates, the American Medical Association (AMA), nor its members shall be responsible for any use of the Measures. Measures are subject to review and may be revised or rescinded at any time by the AGA.

The Measures may not be altered without the prior written approval of the AGA. Measures developed by the AGA, while copyrighted, can be reproduced and distributed, without modification, for noncommercial purposes, e.g., use by health care providers in connection with their practices. Commercial use is defined as the sale, license, or distribution of the Measures for commercial gain, or incorporation of the Measures into a product or service that is sold, licensed or distributed for commercial gain.

Commercial uses of the Measures require a license agreement between the user and the AGA. THE MEASURES AND SPECIFICATIONS ARE PROVIDED “AS IS” WITHOUT WARRANTY OF ANY KIND 2025 American Gastroenterological Association. All Rights Reserved. Limited proprietary coding is contained in the Measure specifications for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of these code sets.

The AGA, its affiliates, AMA the PCPI and its members disclaim all liability for use or accuracy of any current procedural terminology (CPT) or other coding contained in the specifications. CPT® contained in the Measure specifications is copyright 2004-2025 American Medical Association. LOINC® is copyright 2004-2025 Regenstrief Institute, Inc. This material contains SNOMED Clinical Terms® (SNOMED CT®) copyright 2025 International Health Terminology Standards Development Organization.

ICD-10 is copyright 2025 World Health Organization. All Rights Reserved. 2026 Clinical Quality Measure Flow Narrative for Quality ID #400: One-Time Screening for Hepatitis C Virus (HCV) and Treatment Initiation Disclaimer: Refer to the measure specification for specific coding and instructions to submit this measure. Multiple Performance Rates Accountability Reporting in the CMS MIPS Program: Sample Calculations: Overall Data Completeness (Submission Criteria One and Two) equals Performance Met (a1 plus a2 plus a3 plus a4 plus a5 equals 110 patients) plus Denominator Exception (b equals 10 patients) plus Performance Not Met (c1 plus c2 equals 20 patients) divided by Eligible Population/Denominator (d1 plus d2 equals 160 patients).

All equals 140 patients divided by 160 patients. All equals 87.50 percent. Overall Performance Rate (Simple Average) equals Performance Rate One (87.50 percent) plus Performance Rate Two (80.00 percent) divided by Number of Performance Rates (2). All equals 167.50 percent divided by 2. All equals 83.75 percent. *See the posted measure specification for specific coding and instructions to submit this measure NOTE: Submission Frequency: Patient-Process Submission Criteria One: 1.

Start with Denominator 2. Check Patients aged greater than or equal to 18 years: a. If Patients aged greater than or equal to 18 years equals No, do not include in Eligible Population/Denominator. Stop processing. b. If Patients aged greater than or equal to 18 years equals Yes, proceed to check At least one preventive encounter as listed in Denominator*.

3. Check At least one preventive encounter as listed in Denominator*: a. If At least one preventive encounter as listed in Denominator* equals No, proceed to check At least two patient encounters as listed in Denominator*. b. If At least one preventive encounter as listed in Denominator* equals Yes, proceed to check Diagnosis for Chronic Hepatitis C.

4. Check At least two patient encounters as listed in Denominator*: a. If At least two patient encounters as listed in Denominator* equals No, do not include in Eligible Population/Denominator. Stop processing. b. If At least two patient encounters as listed in Denominator* equals Yes, proceed to check Diagnosis for Chronic Hepatitis C. 5. Check Diagnosis for Chronic Hepatitis C during the performance period: a.

If Diagnosis for Chronic Hepatitis C during the performance period equals No, proceed to check Documentation or patient report of HCV antibody test or HCV RNA test which occurred prior to performance period. b. If Diagnosis for Chronic Hepatitis C during the performance period equals Yes, do not include in Eligible Population/Denominator. Stop processing.

6. Check Documentation or patient report of HCV antibody test or HCV RNA test which occurred prior to performance period: a. If Documentation or patient report of HCV antibody test or HCV RNA test which occurred prior to performance period equals Yes, do not include Eligible Population/Denominator. Stop processing. b. If Documentation or patient report of HCV antibody test or HCV RNA test which occurred prior to performance period equals No, include in Eligible Population/Denominator.

7. Denominator Population: • Denominator Population is all Eligible Patients in the Denominator. Denominator is represented as Denominator in the Sample Calculation listed at the end of this document. Letter d1 equals 100 patients in the Sample Calculation. 8. Start Numerator 9. Check Patient receives HCV antibody test with nonreactive result: a. If Patient receives HCV antibody test with nonreactive result equals Yes, include in Data Completeness Met and Performance Met.

• Data Completeness Met and Performance Met letter is represented in the Data Completeness and Performance Rate in the Sample Calculation listed at the end of this document. Letter a1 equals 10 patients in the Sample Calculation. b. If Patient receives HCV antibody test with nonreactive result equals No, proceed to check Patient receives HCV antibody test with reactive result.

10. Check Patient receives HCV antibody test with reactive result: a. If Patient receives HCV antibody test with reactive result equals Yes, include in Data Completeness Met and Performance Met. • Data Completeness Met and Performance Met letter is represented in the Data Completeness and Performance Rate in the Sample Calculation listed at the end of this document.

Letter a2 equals 60 patients in the Sample Calculation. b. If Patient receives HCV antibody test with reactive result equals No, proceed to check Documentation of medical reason(s) for not receiving HCV antibody test due to limited life expectancy. 11. Check Documentation of medical reason(s) for not receiving HCV antibody test due to limited life expectancy: a.

If Documentation of medical reason(s) for not receiving HCV antibody test due to limited life expectancy equals Yes, include in Data Completeness Met and Denominator Exception. • Data Completeness Met and Denominator Exception letter is represented in the Data Completeness and Performance Rate in the Sample Calculation listed at the end of this document.

Letter b equals 10 patients in the Sample Calculation. b. If Documentation of medical reason(s) for not receiving HCV antibody test due to limited life expectancy equals No, proceed to check Patient does not receive HCV antibody test OR patient does receive HCV antibody test but results not documented, reason not given. 12. Check Patient does not receive HCV antibody test OR patient does receive HCV antibody test but results not documented, reason not given: a.

If Patient does not receive HCV antibody test OR patient does receive HCV antibody test but results not documented, reason not given equals Yes, include in Data Completeness Met and Performance Not Met. • Data Completeness Met and Performance Not Met letter is represented in the Data Completeness in the Sample Calculation listed at the end of this document.

Letter c1 equals 10 patients in the Sample Calculation. b. If Patient does not receive HCV antibody test OR patient does receive HCV antibody test but results not documented, reason not given equals No, proceed to check Data Completeness Not Met. 13. Check Data Completeness Not Met: • If Data Completeness Not Met, the Quality Data Code or equivalent was not submitted.

10 patients have been subtracted from the Data Completeness Numerator in the Sample Calculation. Sample Calculations: Submission Criteria One Data Completeness equals Performance Met (a1 plus a2 equals 70 patients) plus Denominator Exception (b equals 10 patients) plus Performance Not Met (c1 equals 10 patients) divided by Eligible Population/Denominator (d1 equals 100 patients).

All equals 90 patients divided by 100 patients. All equals 90.00 percent. Performance Rate equals Performance Met (a1 plus a2 equals 70 patients) divided by Data Completeness Numerator (90 patients) minus Denominator Exception (b equals 10 patients). All equals 70 patients divided by 80 patients. All equals 87.50 percent. *See the posted measure specification for specific coding and instructions to submit this measure.

NOTE: Submission Frequency: Patient-Process The measure diagrams were developed by CMS as a supplemental resource to be used in conjunction with the measure specifications. They should not be used alone or as a substitution for the measure specification. Submission Criteria Two: 1. Start Denominator 2. Check Patients aged greater than or equal to 18 years: a.

If Patients aged greater than or equal to 18 years equals No, do not include in Eligible Population/Denominator. Stop processing. b. If Patients aged greater than or equal to 18 years equals Yes, proceed to check All eligible instances when M1232 is submitted for Performance Met (patient receives HCV antibody test and the test is reactive) in the numerator of Submission Criteria 1.

3. Check All eligible instances when M1232 is submitted for Performance Met (patient receives HCV antibody test and the test is reactive) in the numerator of Submission Criteria 1: a. If All eligible instances when M1232 is submitted for Performance Met (patient receives HCV antibody test and the test is reactive) in the numerator of Submission Criteria 1 equals No, do not include in Eligible Population/Denominator.

Stop processing. b. If All eligible instances when M1232 is submitted for Performance Met (patient receives HCV antibody test and the test is reactive) in the numerator of Submission Criteria 1 equals Yes, proceed to check At least one preventive encounter as listed in Denominator*. 4. Check At least one preventive encounter as listed in Denominator*: a.

If At least one preventive encounter as listed in Denominator* equals Yes, include in Eligible Population/Denominator. b. If At least one preventive encounter as listed in Denominator* equals No, proceed to check At least two patient encounters as listed in Denominator*. 5. Check At least two patient encounters as listed in Denominator*: a. If At least two patient encounters as listed in Denominator* equals No, do not include in Eligible Population/Denominator.

Stop processing. b. If At least two patient encounters as listed in Denominator* equals Yes, include in Eligible Population/Denominator. 6. Denominator Population • Denominator Population is all Eligible Patients in the Denominator. Denominator is represented as Denominator in the Sample Calculation listed at the end of this document. Letter d2 equals 60 patients in the Sample Calculation.

7. Start Numerator 8. Check Patient, who has a reactive HCV antibody test, and has a follow up HCV viral test that detected HCV viremia, is referred within 1 month of the reactive HCV antibody test to a clinician who treats HCV infection: a. If Patient, who has a reactive HCV antibody test, and has a follow up HCV viral test that detected HCV viremia, is referred within 1 month of the reactive HCV antibody test to a clinician who treats HCV infection equals Yes, include in Data Completeness Met and Performance Met.

• Data Completeness Met and Performance Met letter is represented in the Data Completeness and Performance Rate in the Sample Calculation listed at the end of this document. Letter a3 equals 20 patients in the Sample Calculation. b. If Patient, who has a reactive HCV antibody test, and has a follow up HCV viral test that detected HCV viremia, is referred within 1 month of the reactive HCV antibody test to a clinician who treats HCV infection equals No, proceed to check Patient, who has a reactive HCV antibody test, and has a follow up HCV viral test that detected HCV viremia, has HCV treatment initiated within 3 months of the reactive HCV antibody test.

9. Check Patient, who has a reactive HCV antibody test, and has a follow up HCV viral test that detected HCV viremia, has HCV treatment initiated within 3 months of the reactive HCV antibody test: a. If Patient, who has a reactive HCV antibody test, and has a follow up HCV viral test that detected HCV viremia, has HCV treatment initiated within 3 months of the reactive HCV antibody test equals Yes, include in Data Completeness Met and Performance Met.

• Data Completeness Met and Performance Met letter is represented in the Data Completeness and Performance Rate in the Sample Calculation listed at the end of this document. Letter a4 equals 10 patients in the Sample Calculation. 10. If Patient, who has a reactive HCV antibody test, and has a follow up HCV viral test that detected HCV viremia, has HCV treatment initiated within 3 months of the reactive HCV antibody test equals No, proceed to check Patient has a reactive HCV antibody test, and has a follow up HCV viral test that does not detect HCV viremia.

Check Patient has a reactive HCV antibody test, and has a follow up HCV viral test that does not detect HCV viremia: a. If Patient has a reactive HCV antibody test, and has a follow up HCV viral test that does not detect HCV viremia equals Yes, include in Data Completeness Met and Performance Met. • Data Completeness Met and Performance Met letter is represented in the Data Completeness and Performance Rate in the Sample Calculation listed at the end of this document.

Letter a5 equals 10 patients in the Sample Calculation. b. If Patient has a reactive HCV antibody test, and has a follow up HCV viral test that does not detect HCV viremia equals No, proceed to check Patient has a reactive HCV antibody test and does not have a follow up HCV viral test, OR Patient has a reactive HCV antibody test and has a follow up HCV viral test that detects HCV viremia and is not referred to a clinician who treats HCV infection within 1 month and does not have HCV treatment initiated within 3 months of the reactive HCV antibody test, reason not given.

11. Check Patient has a reactive HCV antibody test and does not have a follow up HCV viral test, OR Patient has a reactive HCV antibody test and has a follow up HCV viral test that detects HCV viremia and is not referred to a clinician who treats HCV infection within 1 month and does not have HCV treatment initiated within 3 months of the reactive HCV antibody test, reason not given: a.

If Patient has a reactive HCV antibody test and does not have a follow up HCV viral test, OR Patient has a reactive HCV antibody test and has a follow up HCV viral test that detects HCV viremia and is not referred to a clinician who treats HCV infection within 1 month and does not have HCV treatment initiated within 3 months of the reactive HCV antibody test, reason not given equals Yes, include in Data Completeness Met and Performance Not Met.

• Data Completeness Met and Performance Not Met letter is represented in the Data Completeness and Performance Rate in the Sample Calculation listed at the end of this document. Letter c2 equals 10 patients in the Sample Calculation. b. If Patient has a reactive HCV antibody test and does not have a follow up HCV viral test, OR Patient has a reactive HCV antibody test and has a follow up HCV viral test that detects HCV viremia and is not referred to a clinician who treats HCV infection within 1 month and does not have HCV treatment initiated within 3 months of the reactive HCV antibody test, reason not given equals No, proceed to check Data Completeness Not Met.

12. Check Data Completeness Not Met: • If Data Completeness Not Met, the Quality Data Code or equivalent was not submitted. 10 patients have been subtracted from the Data Completeness Numerator in the Sample Calculation. Sample Calculations: Submission Criteria Two Data Completeness equals Performance Met (a3 plus a4 plus a5 equals 40 patients) plus Performance Not Met (c2 equals 10 patients) divided by Eligible Population/Denominator (d2 equals 60 patients).

All equals 50 patients divided by 60 patients. All equals 83.33 percent. Performance Rate equals Performance Met (a3+a4+a5 equals 40 patients) divided by Data Completeness Numerator (50 patients). All equals 40 patients divided by 50 patients. All equals 80.00 percent. *See the posted measure specification for specific coding and instructions to submit this measure.

NOTE: Submission Frequency: Patient-Process The measure diagrams were developed by CMS as a supplemental resource to be used in conjunction with the measure specifications. They should not be used alone or as a substitution for the measure specification.

This measure contains two strata defined by two submission criteria. This measure produces two performance rates. There are 2 Submission Criteria for this measure: 1) All patients aged ≥ 18 years who have never been tested for HCV antibodies and who receive an HCV antibody test. AND 2) All patients aged ≥ 18 years who have a reactive (positive) HCV antibody test and have a follow up HCV viral test, and if HCV viremia is detected, have treatment initiated within three months or are referred to a clinician who treats HCV infection within one month of the reactive HCV antibody test.

This measure contains two submission criteria that aim to identify patients who are tested for HCV antibodies (Submission Criteria 1) and patients who have a reactive HCV antibody test and who have a follow up HCV viral test, and if HCV viremia is detected, have treatment initiated within three months or are referred to a clinician who treats HCV infection within one month of the reactive HCV antibody test (Submission Criteria 2).

By separating this measure into various submission criteria, the MIPS eligible clinician will be able to better ascertain where gaps in performance exist and identify opportunities for improvement. This measure will be calculated with 2 performance rates: 1) Percentage of patients aged ≥ 18 years who have never been tested for HCV antibodies and who receive an HCV antibody test.

2) Percentage of patients aged ≥ 18 years who have a reactive HCV antibody test, who have a follow up HCV viral test, and if HCV viremia is detected, have treatment initiated within three months or are referred to a clinician who treats HCV infection within one month of the reactive HCV antibody test. A simple average, which is the sum of the performance rates divided by the number of the performance rates will be used to calculate performance.

For the purposes of MIPS implementation of this measure, this patient-process measure is submitted a minimum of once per patient during the performance period. The most advantageous quality data code will be used if the measure is submitted more than once. The denominator of Submission Criteria 2 is a subset of the resulting numerator for Submission Criteria 1, as Submission Criteria 2 is limited to assessing if patients who have a reactive HCV antibody test, have a follow up HCV viral test, and if HCV viremia is detected, treatment is initiated within three months or they are referred to a clinician who treats HCV infection within one month of the reactive HCV antibody test.

For all patients aged ≥ 18 years who have never been tested for HCV antibodies, Submission Criteria 1 is applicable, but Submission Criteria 2 will only be applicable for those patients who have a reactive HCV antibody test. Include only eligible encounters and HCV antibody test results documented through September 30 of the performance period. This will allow the evaluation of at least 90 days for treatment initiation or documentation of referral made within the performance period.