Hepatitis C Virus (HCV): Sustained Virological Response (SVR)

Measure Specification

Achieving SVR is the first step toward reducing future HCV morbidity and mortality. Once achieved, SVR is associated with long-term clearance of HCV infection, which is regarded as a virologic ‘‘cure,’’ as well as with improved morbidity and mortality. Patients who achieve SVR usually have improvement in liver histology and clinical outcomes. American Association for the Study of Liver Diseases (AASLD) guidelines state that the shortest treatment is 8 weeks and SVR is measured 12 weeks after completing treatment.

Nineteen cohort studies (n=105 to 16,864) evaluated the association between SVR after antiviral therapy and mortality or complications of chronic HCV infection. Duration of follow-up ranged from 3 to 9 years. Ten studies were conducted in Asia (60, 67-72, 75, 77, 78). Eight studies (64-66, 72, 75-78) were rated as poor-quality and the remainder as fair quality.

Although all studies reported adjusted risk estimates, only 8 (60, 61, 63, 67-70, 73) evaluated 5 key confounders (age, sex, genotype, viral load, and fibrosis stage). No study clearly described assessment of outcomes blinded to SVR status. The largest study (n=16,864) had the fewest methodologic shortcomings (61). It adjusted for multiple potential confounders, including age, sex viral load, presence of cirrhosis, multiple comorbid conditions, aminotransferase levels, and others.

In a predominantly male, Veterans Affairs population, SVR after antiviral therapy was associated with lower risk for all-cause mortality than was SVR, after median of 3.8 years (adjusted hazard ration, 0.71 [CI, 0.60 to 0.861], 0.62[CI, 0.44 to 0.87], and 0.51 [CI, 0.35 to 0.75] for genotypes 1, 2, and 3 respectively). Mortality curves began to separate as soon as 3 to 6 months after SVR assessment.

Eighteen other cohort studies also found SVR to be associated with decreased risk for all-cause mortality (adjusted hazard rations, 0.07 to 0.39) (60, 69, 72, 73, 75-78), liver-related mortality (adjusted hazard rations, 0.12 to 0.46)(60, 62, 63, 67, 68, 71, 73-76, 78), and other complications of end-stage liver disease versus no SVR, with effects larger than in the Veterans Affairs study.

The subgroup of studies that focused on patients with advanced fibrosis or cirrhosis at baseline (60, 67-72, 75, 77, 78) reported similar risk estimates.

With the advent of new direct acting antiviral treatments, SVR can be as high as 90-95% for most patients. However, adherence to recommended treatment is crucial to ensure the high rate of response. Emerging data from clinical practice show variation in SVR rate across different institutions, ranging from 65 to 87% for the most widely used combination in 2014. This wide variation provides an opportunity to improve the care of HCV patients. (Yehia, B, et al, 2014)

This measure contains one strata defined by a single submission criteria. This measure produces a single performance rate. Implementation Considerations For the purposes of MIPS implementation, this patient-process measure is submitted a minimum of once per patient for the performance period. The most advantageous quality data code will be used if the measure is submitted more than once.

The CPT codes 87522 and 87521 can be used to determine if a Hepatitis C Virus Quantitative or Qualitative RNA Test was performed to support both denominator and numerator identification. Telehealth: TELEHEALTH ELIGIBLE: This measure is appropriate for and applicable to the telehealth setting. Patient encounters conducted via telehealth using encounter code(s) found in the denominator encounter criteria are allowed for this measure.

Therefore, if the patient meets all denominator criteria for a telehealth encounter, it would be appropriate to include them in the denominator eligible patient population. Telehealth eligibility is at the measure level for inclusion within the denominator eligible patient population and based on the measure specification definitions which are independent of changes to coding and/or billing practices.

Measure Submission Type: The quality data codes listed do not need to be submitted by MIPS eligible clinicians, groups, or third party intermediaries that utilize this collection type for submissions; however, these codes may be submitted for those third party intermediaries that utilize Medicare Part B claims data. The coding provided to identify the measure criteria: Denominator or Numerator, may be an example of coding that could be used to identify patients that meet the intent of this clinical topic.

When implementing this measure, please refer to the ‘Reference Coding’ section to determine if other codes or code languages that meet the intent of the criteria may also be used within the medical record to identify and/or assess patients. For more information regarding Application Programming Interface (API), please refer to the Quality Payment Program (QPP) website.