Measure Description
Percentage of patients aged ≥ 18 years who have never been tested for Hepatitis C Virus (HCV) infection who receive an HCV infection test AND who have treatment initiated within three months or who are referred to a clinician who treats HCV infection within one month if tested positive for HCV.
Instructions
This measure is to be submitted a minimum of once per performance period for all patients aged ≥18 years AND who were seen twice for any visits or who had at least one preventive visit through September 30 of the performance period AND who have never received an HCV antibody test. This measure may be submitted by Merit-based Incentive Payment System (MIPS) eligible clinicians who perform the quality actions described in the measure based on the services provided and the measure-specific denominator coding.
This measure will be calculated with 2 performance rates:
- Percentage of patients aged ≥ 18 years who have never been tested for HCV antibodies and who receive an HCV antibody test.
- 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.
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.
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.
NOTE: 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.
NOTE: Patient encounters for this measure conducted via telehealth (including but not limited to encounters coded with GQ, GT, 95, POS 02, POS 10) are allowable.
Measure Submission Type:
Measure data may be submitted by individual MIPS eligible clinicians, groups, or third-party intermediaries. The listed denominator criteria are used to identify the intended patient population. The numerator options included in this specification are used to submit the quality actions as allowed by the measure. The quality data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third-party intermediaries that utilize this modality for submissions; however, these codes may be submitted for those third-party intermediaries that utilize Medicare Part B claims data. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.
THERE ARE TWO 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.
SUBMISSION CRITERIA 1: PATIENTS WHO HAVE NEVER BEEN TESTED FOR HCV ANTIBODIES AND WHO RECEIVE AN HCV ANTIBODY TEST
DENOMINATOR (SUBMISSION CRITERIA 1):
All patients aged ≥ 18 years who are seen twice for any visits or who have at least one preventive visit between January 1 and September 30 of the performance period
DENOMINATOR NOTE: *Signifies that this CPT Category I code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for MIPS CQMs.
Denominator Criteria (Eligible Cases):
Patients aged ≥ 18 years
AND
At least one preventive encounter (CPT or HCPCS): 99385*, 99386*, 99387*, 99395*, 99396*, 99397*, G0438, G0439
OR
At least two patient encounters (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99242*, 99243*, 99244*, 99245*, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350
AND NOT
DENOMINATOR EXCLUSION:
Diagnosis for Chronic Hepatitis C (ICD-10-CM): B18.2
OR
Documentation or patient report of HCV antibody test or HCV RNA test which occurred prior to the performance period: M1235
DENOMINATOR NOTE: Either documentation of the prior HCV antibody test or HCV RNA test in the medical record or patient self-report of prior HCV antibody test or HCV RNA test is acceptable for this exclusion
NUMERATOR (SUBMISSION CRITERIA 1):
Patients who receive an HCV antibody test between January 1 and September 30 of the performance period
NUMERATOR NOTE: Denominator Exception(s) are determined on the date of the most recent denominator eligible encounter.
Numerator Options:
Performance Met: Patient receives HCV antibody test with nonreactive result (M1231)
OR
Performance Met: Patient receives HCV antibody test with reactive result (M1232)
OR
Denominator Exception: Documentation of medical reason(s) for not receiving HCV antibody test due to limited life expectancy (G9452)
OR
Performance Not Met: Patient does not receive HCV antibody test OR patient does receive HCV antibody test but results not documented, reason not given (M1233)
SUBMISSION CRITERIA 2: PATIENTS WITH A REACTIVE (POSITIVE) HCV ANTIBODY TEST WITH A FOLLOW UP HCV VIRAL TEST, AND IF HCV VIREMIA IS DETECTED, TREATMENT IS INITIATED WITHIN THREE MONTHS OR RECEIVES A REFERRAL TO A CLINICIAN WHO TREATS HCV INFECTION WITHIN ONE MONTH OF THE REACTIVE HCV ANTIBODY TEST
DENOMINATOR (SUBMISSION CRITERIA 2):
Patients aged ≥ 18 years who are seen twice for any visits OR who have at least one preventive visit AND have documentation of a reactive HCV antibody test between January 1 and September 30 of the performance period
DENOMINATOR NOTE: *Signifies that this CPT Category I code is a non-covered service under the Medicare Part B Physician Fee Schedule (PFS). These non-covered services should be counted in the denominator population for MIPS CQMs.
Denominator Criteria (Eligible Cases):
Patients aged ≥ 18 years
AND
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
AND
At least one preventive encounter (CPT or HCPCS): 99385*, 99386*, 99387*, 99395*, 99396*, 99397*, G0438, G0439
OR
At least two patient encounters (CPT): 99202, 99203, 99204, 99205, 99212, 99213, 99214, 99215, 99242*, 99243*, 99244*, 99245*, 99304, 99305, 99306, 99307, 99308, 99309, 99310, 99341, 99342, 99344, 99345, 99347, 99348, 99349, 99350
NUMERATOR (SUBMISSION CRITERIA 2):
Patients who have an HCV viral test conducted that (a) does not detect HCV viremia, or (b) detects HCV viremia and 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
Definitions:
Examples of clinicians who treat HCV infection include but are not limited to:
- Gastroenterologist
- Hepatologist
- Infectious disease clinicians
Initiation of treatment definition for clinicians who do not refer patients to specialists for care - Initiation of antiviral treatment, as appropriate, based on clinical guideline recommendations and patient characteristics.
HCV viral test - is defined as a test measuring an established marker of active HCV infection, including:
- HCV RNA test
- HCV core antigen test
Numerator Options:
Performance Met: 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 (M1229)
OR
Performance Met: 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 (M1228)
OR
Performance Met: Patient has a reactive HCV antibody test, and has a follow up HCV viral test that does not detect HCV viremia (M1234)
OR
Performance Not Met: 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 (M1230)
Rationale
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.
Clinical Recommendation Statements
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).20 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)