2024-10006. Notice for Public Comments on Potential Viral Hepatitis Quality Measures in Medicaid

AGENCY:

Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

ACTION:

Notice for public comment.

SUMMARY:

The Department of Health and Human Services' (HHS) Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) invites public comment on potential viral hepatitis quality measures for implementation at the state and territory level. In March 2024, OIDP hosted a technical consultation meeting ( https://youtu.be/​YCVC8GwFE7E) to initiate the process of understanding the needs and developing national consensus on clinically meaningful and feasible viral hepatitis quality measures for proposal to the Medicaid Adult Core Set.

DATES:

All comments must be received by 5 p.m. ET on June 7, 2024 to be considered.

ADDRESSES:

All comments must be submitted electronically to [e-mail] to be considered.

FOR FURTHER INFORMATION CONTACT:

Jessica Deerin, Ph.D., MPH, OIDP, Viral Hepatitis Policy Advisor at [e-mail] or 202-795-7625.

SUPPLEMENTARY INFORMATION:

CDC released updated hepatitis C and hepatitis B screening recommendations to screen all adults aged 18 years and older at least once in a lifetime and all pregnant women during each pregnancy in April 2020 and March 2023, respectively. Screening is an important first step in the viral hepatitis continuum of care and a necessary tool to reach viral hepatitis elimination by 2030.

Additionally, hepatitis C has a life-saving treatment resulting in a cure in >95% of patients. Yet, many patients are not linked to care and complete treatment. Less than 1 in 3 people with health insurance initiated DAA treatment within a year of hepatitis C diagnosis and people with Medicaid were less likely to initiate treatment than those with private insurance. Hepatitis B treatment can reduce hepatitis B viral load, lowering the risk of liver cancer and mortality.

Quality measures are tools to monitor and improve the quality of health care. Scaling up viral hepatitis screening, linkage to care, and access to treatment will ultimately reduce transmission, incidence of new infections, prevent liver cancer and mortality, and allow the U.S. to make strides in reaching viral hepatitis elimination by 2030.

There are currently no viral hepatitis quality measures in the Medicaid Adult Core Set. The Medicaid Adult Core Set is a core set of health care quality measures related to physical and behavioral health for adult Medicaid enrollees. The Adult Core Set encourages standardized reporting by States on a uniform set of measures to drive quality improvement. Since Medicaid provides coverage for a disproportionate number of people with hepatitis B and hepatitis C, OIDP is leading an initiative to develop consensus around clinically meaningful and feasible state level viral hepatitis quality measures to propose to the Medicaid Adult Core Set.

OIDP hosted a Viral Hepatitis Quality Measures Technical Consultation Meeting on March 7, 2024. State panelists from Medicaid and public health departments shared their experience in selection, testing, and implementation of current state viral hepatitis quality measures, as well as recommendations for measures to propose to the Medicaid Adult Core Set. State panelists reached consensus to prioritize the development, use, and adoption of a hepatitis C screening and treatment initiation measure based on the following rationale:

• Clinical and public health insights are high, leading to an understanding of the cascade of care for infected people who access treatment and cure;
• The measure drives screening and linkage to care by translating recently updated CDC recommendations into routine practice in the health care delivery system;
• Data for a screening and treatment initiation measure is available to state Medicaid programs through administrative claims and encounter data, and is consistent and comparable across states; and
• The method of using administrative data sources to represent hepatitis C treatment through pharmacy claims was explained as an acceptable proxy for receipt of treatment.

HHS hereby requests public comment on the clinical significance, usability, feasibility, and likely uptake of hepatitis C screening and hepatitis C treatment initiation quality measures, as well as recommendations with adequate justifications on other feasible viral hepatitis measures to consider.

Information Needs

HHS is seeking responses with adequate justification to the questions listed below.

1. Are you in support of adopting a hepatitis C screening and treatment initiation measure within state Medicaid programs?

a. If you represent a state Medicaid program, what is the likely uptake of this measure?

2. What other measures should HHS consider for testing and proposal to the Medicaid Adult Core Set ( i.e., hepatitis B screening, hepatitis B linkage to care, hepatitis C sustained virological response (SVR))? Please provide support for how that measure is clinically meaningful, feasible, and actionable for state Medicaid programs. What data source or data element can be utilized to calculate the measure?

3. Would it be feasible and clinically meaningful to implement a hepatitis B screening, hepatitis C screening and hepatitis C treatment initiation quality measure within state Medicaid programs? If you represent a state Medicaid program, what is the likely uptake of this measure?

Dated: May 2, 2024.

B. Kaye Hayes,

Deputy Assistant Secretary for Infectious Disease, Department of Health and Human Services.