TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 37. MATERNAL AND INFANT HEALTH SERVICES

SUBCHAPTER S. NEWBORN HEARING SCREENING

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes the repeal of §§37.501 - 37.507, and new §§37.501 - 37.509, concerning Newborn Hearing Screening.

BACKGROUND AND PURPOSE

The purpose of the proposal is to repeal the rules in Chapter 37, Subchapter S, and replace with new rules. The repeal and replace is necessary to comply with amendments to Texas Health and Safety Code Chapter 47, Hearing Loss in Newborns, made by House Bill 2255 and Senate Bill 1404 passed during the 86th Legislature, Regular Session, 2019. This proposal also serves as the four-year review of rules required by Texas Government Code §2001.039.

DSHS administers the Newborn Hearing Screening Program and provides guidance for performing point-of-care hearing screening required for all newborns in the state. The proposed new rules are structured to refine roles and responsibilities, update definitions, emphasize required reporting, and clarify the purpose of consent. The proposed new rules will also implement new legislative mandates. Referrals to the primary statewide resource center at the Texas School for the Deaf will be required for infants who are suspected or confirmed to be deaf or hard of hearing, and DSHS will make educational resources available for parents.

SECTION-BY-SECTION SUMMARY

Proposed new §37.501 describes the purpose and application of the Texas Health and Safety Code Chapter 47 to ensure all babies born in Texas receive a hearing screening, intervention, and referrals to services if they are suspected or diagnosed as deaf or hard of hearing.

Proposed new §37.502 provides definitions of terms used within the subchapter.

Proposed new §37.503 describes the process of screening and consent to release individually identifying information.

Proposed new §37.504 describes the process of required reporting using the DSHS's Texas Early Hearing Detection and Intervention Management Information System.

Proposed new §37.505 describes the birthing facility screening provider responsibilities.

Proposed new §37.506 describes the follow-up screening provider responsibilities.

Proposed new §37.507 describes the diagnostic evaluation provider responsibilities.

Proposed new §37.508 describes DSHS responsibilities.

Proposed new §37.509 describes the authorized newborn hearing screening services.

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules do not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;

(2) implementation of the proposed rules will not affect the number of DSHS employee positions;

(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations;

(4) the proposed rules will not affect fees paid to DSHS;

(5) the proposed rules will create new rules;

(6) the proposed rules will repeal existing rules;

(7) the proposed rules will not change the number of individuals subject to the rules; and

(8) the proposed rules will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas and the rules do not impose a cost on regulated persons.

PUBLIC BENEFIT AND COSTS

Manda Hall, M.D., Community Health Improvement Associate Commissioner, has determined that for each year of the first five years the rules are in effect, the public benefit will ensure all babies born in Texas receive a hearing screening and receive proper intervention and referrals to services as early as possible, if suspected or diagnosed as deaf or hard of hearing.

Donna Sheppard has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules, because programs are already required to make referrals to early childhood intervention and DSHS educational materials are distributed free of charge.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to DSHS, Newborn Screening Unit, TEHDI Program Mail Code 1918, P.O. Box 149347, Austin, Texas 78714-9347, by email to TEHDI@dshs.texas.gov, or by fax to (512) 776-7593.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) faxed or emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When faxing or emailing comments, please indicate "Comments on Proposed Rule 19R073" in the subject line.

25 TAC §§37.501 - 37.507

STATUTORY AUTHORITY

The repeals are authorized by Texas Government Code §2001.039, which authorizes a state agency to periodically review its existing rules. The new sections and repeals are authorized by Texas Government Code §531.0055, Texas Health and Safety Code §1001.075, and Texas Health and Safety Code §47.010, which authorizes the Executive Commissioner of HHSC to adopt rules necessary for the operation and provision of health and human services by DSHS, and for the administration of Texas Health and Safety Code, Chapter 1001.

The repeals affect Texas Government Code §531.0055 and Texas Health and Safety Code, Chapter 47, Hearing Loss in Newborns.

§37.501.Purpose.

§37.502. Definitions.

§37.503.Confidentiality and General Access to Data.

§37.504.Information Management and Tracking System.

§37.505.Screens, Follow-up, and Reporting.

§37.506.Program Protocols and Certification.

§37.507.Authorized Newborn Hearing Services.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on July 22, 2020.

TRD-202003000

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 6, 2020

For further information, please call: (512) 776-7726


25 TAC §§37.501 - 37.509

STATUTORY AUTHORITY

The new sections are authorized by Texas Government Code §2001.039, which authorizes a state agency to periodically review its existing rules. The new sections and repeals are authorized by Texas Government Code §531.0055, Texas Health and Safety Code §1001.075, and Texas Health and Safety Code §47.010, which authorizes the Executive Commissioner of HHSC to adopt rules necessary for the operation and provision of health and human services by DSHS, and for the administration of Texas Health and Safety Code, Chapter 1001.

The new sections affect Texas Government Code §531.0055 and Texas Health and Safety Code, Chapter 47, Hearing Loss in Newborns.

§37.501.Purpose.

The purpose of this subchapter is to describe the newborn hearing screening process administered by the Department of State Health Services pursuant to Texas Health and Safety Code Chapter 47 to ensure all babies born in Texas receive a hearing screening, proper intervention, and referrals to services if they are suspected or diagnosed as deaf or hard of hearing.

§37.502.Definitions.

The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Birthing facility:

(A) a hospital licensed under Texas Health and Safety Code Chapter 241 that offers obstetrical services;

(B) a birthing center licensed under Texas Health and Safety Code Chapter 244;

(C) a children's hospital licensed under Texas Health and Safety Code Chapter 241 that offers obstetrical or neonatal intensive care unit services or both; or

(D) a facility maintained or operated by this state or an agency of this state that provides obstetrical services.

(2) Case level information--Demographic information, hearing outcome results, and care coordination efforts.

(3) Consent--Permission related to the release of individually identifying information that may be disclosed to the department or resource center.

(4) Consent form (form)--A form that contains required language prescribed by the department found at https://www.dshs.texas.gov/tehdi to capture consent, as defined in this subchapter.

(5) Department--The Department of State Health Services.

(6) ECI--Early Childhood Intervention. The early intervention services described in Part C Early Childhood Intervention, Individuals with Disabilities Education Act, 20 United States Code §§1431-1443.

(7) Follow-up care--Additional screening, diagnostic audiological evaluation, or intervention services to include medical and therapeutic treatment services for newborns or infants who do not pass the initial hearing screening.

(8) Healthcare provider--Any licensed professional along the hearing continuum, including:

(A) a registered nurse recognized as an advanced practice registered nurse by the Texas Board of Nursing or a physician assistant licensed by the Texas Physician Assistant Board;

(B) a midwife, as defined by Texas Occupations Code §203.002, including a nurse midwife described by Texas Occupations Code §301.152;

(C) a physician who is licensed to practice medicine by the Texas Medical Board; or

(D) a licensed audiologist, as defined by Texas Occupations Code Chapter 401.

(9) Hearing loss--A hearing threshold averaging 15 dB hearing level or greater in the frequency region important for speech recognition and comprehension in one or both ears that is confirmed by a diagnostic audiological evaluation.

(10) Hearing screening--The initial physiologic measurement of hearing to identify an increased risk for hearing loss before birthing facility discharge.

(11) Individually identifying information--Confidential information that identifies the parent or newborn.

(12) Infant--A child who is at least 30 days old but who is younger than 24 months old.

(13) Newborn--A child younger than 30 days old.

(14) Parent--A natural parent, stepparent, adoptive parent, legal guardian, or other legal custodian of a child.

(15) Protocols--Guidelines or procedures based on the latest Joint Committee on Infant Hearing position statement, found at http://www.jcih.org/posstatemts.htm, as updated, used by programs to conduct newborn hearing screening.

(16) Resource center--Primary statewide resource center as defined by Texas Education Code §30.051.

(17) TEHDI MIS--Texas Early Hearing Detection and Intervention Management Information System. The department's central information source of results and referrals related to newborn hearing screens, audiological evaluations, and any type of intervention for newborns or infants.

§37.503.Screening and Consent to Release Individually Identifying Information.

(a) The birthing facility shall inform the parents during admission that:

(1) the facility is required by law to screen a newborn or infant for hearing loss; and

(2) the parents may decline the screening.

(b) The birthing facility is responsible for obtaining and documenting, during admission, on the form prescribed by the department, consent to release individually identifying information. Consent may be obtained and stored electronically and must be documented in the TEHDI MIS.

(1) If the birthing facility contracts for hearing screening services, the birthing facility is responsible for ensuring its contractor is in compliance with Texas Health and Safety Code Chapter 47 and this subchapter, as it relates to newborn hearing screening.

(2) If the parent declines the consent to release individually identifying information during admission, the parent may later consent to release individually identifying information during subsequent follow-up screenings or diagnostic evaluations.

(c) Healthcare providers shall document and maintain consent, if obtained, in the medical record, and the consent must be provided at the request of the department.

(d) Any healthcare provider who performs initial hearing screening, follow-up screening, diagnostic evaluations, follow-up care, or interventions must verify that the status of consent to release information is documented in the TEHDI MIS.

(e) A healthcare provider is not criminally or civilly liable for furnishing information in good faith to the department or its designee in accordance with Texas Health and Safety Code §47.009.

(f) At any time, a parent may request in writing to the department or resource center that individually identifying information concerning their child be removed from:

(1) the department's TEHDI MIS;

(2) the resource center's records; or

(3) both.

§37.504.Required Reporting.

(a) Any healthcare provider who performs initial hearing screening, follow-up screening, diagnostic evaluations, follow-up care, or interventions is required to report all patient encounters and outcomes, including pass and do not pass results, in the TEHDI MIS within five calendar days after the date of the patient encounter.

(b) If a parent declines the hearing screening for the newborn, the non-consent must be documented in the medical record and the TEHDI MIS.

§37.505.Birthing Facility Screening Provider Responsibilities.

(a) A birthing facility screening provider ("provider") shall be a department-certified newborn hearing screening program. A provider that is not certified is required to refer the infant to a department-certified newborn hearing screening program.

(b) A provider shall:

(1) perform the initial hearing screening, or document why the screening was not performed, in accordance with Texas Health and Safety Code §47.003;

(2) provide screening results and educational materials to the parents;

(3) provide screening results to the applicable healthcare providers; and

(4) report results in accordance with §37.504 of this subchapter (relating to Required Reporting).

(c) Infants who do not pass the initial hearing screening must be offered a follow-up screening or referral consistent with Joint Committee on Infant Hearing guidelines, found at http://www.jcih.org/posstatemts.htm, as updated.

§37.506.Follow-up Screening Provider Responsibilities.

(a) A follow-up screening provider shall:

(1) perform a follow-up screening no later than 30 days after birth;

(2) provide screening results to the applicable healthcare providers;

(3) provide screening results and educational materials to the parents; and

(4) report results in accordance with §37.504 of this subchapter (relating to Required Reporting).

(b) If the infant does not pass, a follow-up screening provider shall:

(1) refer to ECI due to suspected deaf or hard of hearing diagnosis;

(2) provide follow-up screening results to the resource center; and

(3) schedule or refer for diagnostic audiological evaluation consistent with Joint Committee on Infant Hearing guidelines, http://www.jcih.org/posstatemts.htm, as updated.

§37.507.Diagnostic Evaluation Provider Responsibilities.

A diagnostic evaluation provider shall:

(1) perform a diagnostic evaluation no later than three months after birth;

(2) provide results to the parents, applicable healthcare providers, and the resource center;

(3) refer children confirmed as deaf or hard of hearing to ECI within seven days of the encounter; and

(4) report in accordance with §37.504 of this subchapter (relating to Required Reporting).

§37.508.Department Responsibilities.

(a) The department shall:

(1) maintain the TEHDI MIS;

(2) certify newborn hearing screening programs, as described by program protocol at https://www.dshs.texas.gov/tehdi/FacilityCertRequire.aspx; and

(3) make available standardized educational resources.

(b) The department may assist in coordination of follow-up care and diagnosis.

(c) The department shall ensure ECI services are available to a child suspected or diagnosed as deaf or hard of hearing.

(d) The department shall report de-identified, aggregate data to the Centers for Disease Control and Prevention and the Health Resources and Services Administration Maternal and Child Health Bureau annually.

§37.509.Authorized Newborn Hearing Services.

(a) A newborn hearing screening performed by a birthing facility and any related diagnostic follow-up care, provided in accordance with Texas Health and Safety Code Chapter 47 and the requirements of this subchapter, for a newborn who receives medical assistance or who is Medicaid-eligible, is a covered service of the Texas Medical Assistance (Medicaid) Program, in accordance with Texas Human Resources Code Chapter 32.

(b) The reimbursement rates and methodology for covered services described in this section shall be established by the Texas Health and Human Services Commission.

(c) Screening for hearing loss from birth through the date the infant is 30 days of age and any diagnostic follow-up care related to the screening from birth through the date the child is 24 months of age, as provided under this subchapter, shall be a covered benefit pursuant to Texas Insurance Code, §§1367.101 - 1367.103. Co-payments or co-insurance requirements are permitted; however, deductible requirements or dollar limits are prohibited.

The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.

Filed with the Office of the Secretary of State on July 22, 2020.

TRD-202003001

Barbara L. Klein

General Counsel

Department of State Health Services

Earliest possible date of adoption: September 6, 2020

For further information, please call: (512) 776-7726