ARC 7373C

ARC 7373C

PUBLIC HEALTH DEPARTMENT[641]

Notice of Intended Action

Proposing rulemaking related to hepatitis programs

and providing an opportunity for public comment

The Department of Health and Human Services (HHS) hereby proposes to rescind Chapter 2, "Hepatitis Programs," Iowa Administrative Code, and to adopt a new chapter with the same title.

Legal Authority for Rulemaking

This rulemaking is proposed under the authority provided in Iowa Code section 135.19.

State or Federal Law Implemented

This rulemaking implements, in whole or in part, Iowa Code section 135.19.

Purpose and Summary

This proposed chapter defines parameters of a viral hepatitis program. This program is designed to identify people most at risk of exposure to viral hepatitis, to distribute information regarding dangers presented by the disease, and to make available hepatitis A and hepatitis B vaccinations and hepatitis C testing.

This chapter defines a list of individuals by category who are at an increased risk for viral hepatitis exposure and details the nature of educational information to be provided to such individuals, as well as the form and manner of information distribution. A vaccination and testing program is established offering testing through local health departments, clinics, and community-based organizations to individuals most impacted by the viruses. Agencies offering testing and vaccination services are also to provide education materials, pretest and posttest counseling, and referral services.

A Regulatory Analysis, including the proposed rule text, was published on November 1, 2023. A public hearing was held on November 28, 2023. The HHS received no public comments. The Administrative Rules Coordinator provided preclearance for publication of this Notice of Intended Action on December 1, 2023.

Fiscal Impact

This rulemaking has no fiscal impact to the State of Iowa.

Jobs Impact

After analysis and review of this rulemaking, no impact on jobs has been found.

Waivers

Any person who believes that the application of the discretionary provisions of this rulemaking would result in hardship or injustice to that person may petition the HHS for a waiver of the discretionary provisions, if any, pursuant to 441—Chapter 6.

Public Comment

Any interested person may submit written comments concerning this proposed rulemaking. Written comments in response to this rulemaking must be received by the HHS no later than 4:30 p.m. on February 26, 2024. Comments should be directed to:

Public Hearing

Public hearings at which persons may present their views orally or in writing will be held as follows:

Persons who wish to make oral comments at a public hearing may be asked to state their names for the record and to confine their remarks to the subject of this proposed rulemaking.

Any persons who intend to attend a public hearing and have special requirements, such as those related to hearing or mobility impairments, should contact the HHS and advise of specific needs.

Review by Administrative Rules Review Committee

The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rulemaking by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rulemaking at its regular monthly meeting or at a special meeting. The Committee's meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).

The following rulemaking action is proposed:

Item 1. Rescind 641—Chapter 2 and adopt the following new chapter in lieu thereof:

CHAPTER 2

HEPATITIS PROGRAMS

VIRAL HEPATITIS PROGRAM—VACCINATIONS AND TESTING

641—2.1(135) Definitions. For the purpose of these rules, the following definitions shall apply:

"Contracted agencies" means local health departments, clinics, and community-based organizations that are funded by the department to provide HCV testing and vaccination services.

"HCV" means the hepatitis C virus as defined by the Centers for Disease Control and Prevention of the United States Department of Health and Human Services.

"HIV" means the same as defined in Iowa Code section 141A.1.

"Viral hepatitis" means inflammation of the liver caused by one of several viruses: hepatitis A, B, C, D, and E.

641—2.2(135) Exposure risks for hepatitis C virus. The following individuals are at increased risk of exposure to HCV as described by the Centers for Disease Control and Prevention of the United States Department of Health and Human Services:

1.People living with HIV;

2.People who have ever injected drugs;

3.People with selected medical conditions, including those who ever received maintenance hemodialysis;

4.Recipients of clotting factors made before 1987;

5.Recipients of blood transfusions, blood products, and organ transplants that occurred before 1992;

6.Health care, emergency medical, and public safety personnel after needle sticks, sharps, or mucosal exposures to HCV-positive blood; and

7.Infants born to mothers living with HCV.

641—2.3(135) Information for public distribution. The department will make available educational materials to the public on hepatitis C infection, transmission, and where to seek testing services as defined on the department's website.

641—2.4(135) Hepatitis vaccination and testing program.

2.4(1) When sufficient state and federal funds are available, the department will maintain a vaccination and testing program. The program shall offer HCV testing and hepatitis A and B vaccinations through local health departments, clinics, and community-based organizations to individuals at an increased risk of exposure to viral hepatitis as described in the Viral Hepatitis Prevention and Testing Services Manual dated December 2023 and available on the department's website. Contracted agencies offering testing and vaccination services shall be required to provide integrated HIV, viral hepatitis, and sexually transmitted infection education; pretest and posttest counseling; and referral services.

2.4(2) Contracted agencies shall provide individuals presenting for testing and/or vaccination services with education explaining viral hepatitis and how to reduce the risk of acquiring it.

2.4(3) Contracted agencies shall provide individuals testing positive for viral hepatitis with information about the diagnosis and treatment options and with a referral list of health care providers to aid in seeking treatment, additional follow-up testing, and other hepatitis-related services.

These rules are intended to implement Iowa Code section 135.19.