DAR File No. 38139

Health, Family Health and Preparedness, Children with Special Health Care Needs

Rule R398-4

Cytomegalovirus Public Health Initiative

Notice of Proposed Rule

(New Rule)

DAR File No.: 38139
Filed: 11/14/2013 01:16:01 PM

RULE ANALYSIS

Purpose of the rule or reason for the change:

The purpose of this rule is to clarify aspects of the Cytomegalovirus (CMV) Public Health Initiative.

Summary of the rule or change:

This rule identifies when newborn infant hearing screening result(s) requires testing for CMV, medical practitioner reporting requirements, and under what circumstances a newborn infant may not fall under the CMV testing requirements.

State statutory or constitutional authorization for this rule:

• Section 26-10-10

Anticipated cost or savings to:

the state budget:

Costs include staff time to distribute information to medical practitioners about the law and to collect and analyze provider reports of CMV testing.

local governments:

Minimal costs anticipated which may include staff time to distribute information provided by the Department of Health to affected constituents.

small businesses:

Cost--Time for medical practitioners to refer patients for CMV testing and follow-up when results are received. As this is a new program, there are no records to indicate cost burden or savings.

persons other than small businesses, businesses, or local governmental entities:

Cost to families--Time to obtain CMV testing. Savings to families--Timely follow-up when testing for CMV is positive may reduce medical burdens. As this is a new program, there are no records to indicate cost burden or savings.

Compliance costs for affected persons:

Cost to medical practitioners and families--Time to review hearing screening results, determine appropriate follow-up, complete CMV testing, and any related medical follow-up as needed for positive CMV results. As this is a new program, there are no records to indicate cost burden or savings.

Comments by the department head on the fiscal impact the rule may have on businesses:

This will have no impact on business.

David Patton, PhD, Executive Director

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Health
Family Health and Preparedness, Children with Special Health Care Needs
44 N MARIO CAPECCHI DR
SALT LAKE CITY, UT 84113

Direct questions regarding this rule to:

• Rebecca Giles at the above address, by phone at 801-538-6259, by FAX at , or by Internet E-mail at rgiles@utah.gov

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/31/2013

This rule may become effective on:

01/07/2014

Authorized by:

David Patton, Executive Director

R398. Health, Family Health and Preparedness, Children with Special Health Care Needs.

R398-4. Cytomegalovirus Public Health Initiative.

R398-4-1. Definitions.

(1) "UDOH" and "Department" means the Utah Department of Health.

(2) "Hearing screening" means the completion of an objective, physiological test or battery of tests administered to determine the infant's hearing status and the need for further diagnostic testing by an audiologist or physician using the Department approved instrumentation, protocols and pass/refer criteria.

(3) "Medical practitioner" means the newborn infant's primary medical caregiver.

(4) "Parent" means a natural biological parent, a step-parent, adoptive parent, legal guardian, or other legal custodian of a child.

 

R398-4-2. Purpose and Authority.

(1) The purpose of this rule is to clarify when a newborn infant hearing screening requires testing for CMV, medical practitioner reporting requirements and under what circumstances a newborn infant may not fall under the CMV testing requirements.

(2) This rule is authorized by Section 26-10-10(5) which provides that the Department may make rules to administer the provisions of this section.

 

R398-4-3. Clarification of When a Newborn Must Be Referred for CMS Testing.

(1) The newborn must be referred for CMV testing if the infant fails both the initial hearing screen routinely done at birth and the subsequent follow-up screen.

(2) The newborn must be referred for CMV testing when the initial failed screen is obtained after 14 days of age.

 

R398-4-4. Special Populations of Newborns.

(1) In special populations of newborns where newborn hearing screening(s) cannot be accomplished prior to 21 days of age, testing for CMV is left to the discretion of the medical practitioner(s) caring for the newborn.

(2) Special populations of newborns may include, but are not limited to, premature or medically fragile newborns or newborns receiving on-going medical care.

 

R398-4-5. Reporting Requirements.

Medical practitioners are required to submit results of the CMV testing to UDOH for each newborn under their care who is referred for CMV testing within 10 days of receiving results.

 

KEY: cytomegalovirus, CMV, newborn hearing screening

Date of Enactment or Last Substantive Amendment: 2014

Authorizing, and Implemented or Interpreted Law: 26-10-10