Universal Newborn Hearing Screening Act

Policy and program purpose

The State shall protect and promote the right to health of the people, including children’s rights to survival, full and healthy development, and a better quality of life (Section 2).
The State shall formulate a comprehensive program for the prevention, early detection, and diagnosis of congenital hearing loss among newborns and infants through applied research and consultations with concerned sectors (Section 2).
The Universal Newborn Hearing Screening Program (UNHSP) shall institutionalize prevention and early diagnosis of congenital hearing loss, referral follow-up, recall, early intervention services, and counseling/support services for families of newborns with hearing loss (Section 3).
The UNHSP shall ensure that all newborns have access to hearing loss screening (Section 3).
The UNHSP shall establish linkages to diagnosis and the community system of early intervention services, and shall support models for effective screening, referral, and linkage to appropriate diagnostic and early intervention services in the community (Section 3).

Key definitions under the Act

“Audiologic diagnostic evaluation” means a diagnosis-related service related to hearing loss administered by professionals or by Newborn Hearing Screening Centers (Section 4).
“Congenital hearing loss” means hearing impairment already present at birth (Section 4).
“Follow-up” means monitoring an infant with possible hearing loss to ensure the infant receives additional diagnostic services and intervention or treatment (Section 4).
“Healthcare practitioner” means physicians, nurses, midwives, nursing aides, and traditional birth attendants (Section 4).
“Health Institutions” means hospitals, health infirmaries, health centers, lying-in centers, or puericulture centers with obstetrical and pediatric services, whether public or private (Section 4).
“Intervention” means any service rendered to an infant diagnosed with hearing loss, including counseling, diagnosis, provision of hearing aid, or medical procedures for correction (Section 4).
“Newborn” means an infant from the time of complete delivery to thirty (30) days old (Section 4).
“Newborn hearing loss screening” means an objective, physiological procedure performed on a newborn to determine whether the newborn has hearing impairment (Section 4).
“Newborn Hearing Screening Reference Center” refers to the central facility at the National Institutes of Health (NIH) that defines testing and follow-up protocols, maintains an external laboratory proficiency testing program, oversees the national testing database and case registries, assists in training, and oversees educational materials content (Section 4).
“Recall” means locating an infant with possible hearing loss for diagnostic services to confirm hearing condition and, as appropriate, provide intervention or treatment (Section 4).
“Referral” means sending a patient to another service provider within the network for continuation of care (Section 4).
“Universal Newborn Hearing Screening Program” or “UNHSP” means the program developed to carry out hearing screening for all newborns in the Philippines and to provide adequate interventions for infants with congenital hearing loss (Section 4).

Coverage and obligation to inform parents

Any healthcare practitioner who delivers or assists in delivering a newborn in the Philippines shall, prior to delivery, inform parents or the legal guardian of the availability, nature, and benefits of hearing loss screening among newborns or infants three (3) months old and below (Section 5).
After newborn hearing loss screening results show congenital hearing loss, parents or the legal guardian shall be informed of the availability, nature, and benefits of diagnostic audiologic evaluation, intervention and treatment options, and counseling regarding hearing loss (Section 5).
The Department of Health (DOH) shall coordinate with the NIH and other stakeholders to prepare, produce, and disseminate informational and educational materials on the nature, benefits, and available medical interventions for hearing loss (Section 5).

Universal screening, diagnostic follow-up, and referral

All infants born in hospitals in the Philippines shall undergo newborn hearing loss screening before discharge, unless the parents or legal guardians object under Section 7 (Section 6).
Infants not born in hospitals shall undergo screening within the first three (3) months after birth (Section 6).
If the newborn screening result is positive, the newborn shall undergo audiologic diagnostic evaluation in a timely manner so that follow-up, recall, and referral for intervention occur before the age of six (6) months (Section 6).
Audiologic diagnostic evaluation shall be performed by Newborn Hearing Screening Centers duly certified by the DOH (Section 6).
The parents or legal guardian and the healthcare practitioner shall jointly ensure that hearing screening is performed (Section 6).
The DOH shall provide an informational brochure on the role and duties of parents and guardians, and such brochure shall be distributed to all health institutions and made available to any healthcare practitioner for appropriate distribution (Section 6).
If the newborn is born at home or anywhere outside birthing facilities, the attending healthcare practitioner shall refer the newborn to the municipal or city health center of the barangay having jurisdiction for screening and audiologic diagnostic evaluation (Section 6).

Refusal waiver based on religion/culture

A parent or legal guardian may refuse hearing loss screening on the grounds of religious and/or cultural beliefs (Section 7).
The parent or legal guardian shall acknowledge in writing that they have been informed of their responsibility to perform screening and the risks of underdiagnosed congenital hearing loss if screening is not administered (Section 7).
A copy of the waiver shall be made part of the newborn’s medical record (Section 7).
The waiver copy shall be entered into the national newborn hearing screening database (Section 7).

Education and training requirements

The DOH, with assistance of the NIH and other concerned government agencies, professional associations, and civil society organizations, shall conduct continuing information, education, reeducation, and training programs for healthcare practitioners on the rationale, benefits, and procedures of hearing loss screening (Section 8).
The DOH shall prepare, produce, and disseminate information materials on newborn screening annually to all health personnel involved in maternal and pediatric care (Section 8).

Lead agency responsibilities and coordination

The DOH shall be the lead agency implementing the Act (Section 9).
The DOH shall coordinate with the Department of the Interior and Local Government (DILG), the Department of Education, local government units, and the private sector (including other recognized medical associations and professional-based organizations) for policy development and proper implementation of early hearing detection, diagnosis, and treatment/intervention (Section 9).
The DOH shall coordinate with the NIH Newborn Hearing Screening Reference Center for the certification of Newborn Hearing Screening Centers and preparation of testing protocols and quality assurance programs (Section 9).
The DOH shall coordinate with consumer groups for individuals who are deaf or hard-of-hearing and their families, qualified professionals proficient in deaf or hard-of-hearing children’s language with specialized knowledge and skills, other health and education professionals and organizations, third party payers and managed care organizations, and related commercial industries (Section 9).
The DOH shall monitor the extent to which hearing loss screening and audiologic diagnostic evaluation are conducted in health institutions and assist in developing universal newborn hearing screening programs for hospitals and non-hospital sites (Section 9).
The DOH shall develop a program for the rehabilitation of deaf children through available intervention services, therapies, and other necessary services for patients diagnosed with hearing disorders (Section 9).

Advisory committee membership expansion

The membership of the Advisory Committee on Newborn Screening created under Section 11 of Republic Act No. 9288 (Newborn Screening Act of 2004) shall be expanded to include representatives from the Philippines Society of Otorhinolaryngology and the Philippine Society of Audiology (Section 10).

Newborn Hearing Screening Centers

Newborn Hearing Screening Centers shall undertake newborn hearing loss screening, audiologic diagnostic evaluation, recall, follow-up, and referral programs for infants with hearing loss (Section 11).
Newly established centers shall be certified by the DOH based on standards formulated in collaboration with the NIH (Section 11).
Newborn Screening Centers (NSC) established under Section 12 of Republic Act No. 9288 shall adopt and implement a program to develop capacity to become Newborn Hearing Screening Centers (Section 11).
The DOH shall develop incentives to encourage establishment of Newborn Hearing Screening Centers other than those under the Newborn Screening Centers (Section 11).

Data management, registries, and grants

Hospitals and Newborn Screening Centers shall periodically submit copies of screening test results to the NIH Newborn Hearing Screening Reference Center for consolidation of patient databases (Section 12).
The NIH Newborn Hearing Screening Reference Center shall maintain a national database of children tested and a separate registry for those diagnosed with hearing loss (Section 12).
The NIH Newborn Hearing Screening Reference Center shall submit annual reports to the DOH on status and relevant health information derived from the database (Section 12).
Within one (1) year from the Act’s effectivity, the NIH shall develop a plan for long-term outcome evaluation using case registries in consultation with various stakeholders (Section 12).
The Secretary of Health, in collaboration with the NIH, shall make awards of grants or cooperative agreements to provide technical assistance to agencies and conduct applied research on infant hearing detection, diagnosis, and treatment/intervention (Section 12).
The applied research and technical assistance program shall include: data collection and management technical assistance; standardized data management procedures for quality monitoring; studies on costs and effectiveness; identification of causes and risk factors for congenital hearing loss to develop preventive interventions; assessment of health, developmental, cognitive, and language status at school age; and promotion of data sharing regarding early hearing loss with birth defects and development disabilities monitoring programs to identify previously unknown causes (Section 12).

Government intervention and referral hospitals

If a newborn is diagnosed with congenital hearing loss, the Newborn Hearing Screening Center or barangay health workers shall provide referral for treatment to the provincial hospital of the local government unit concerned (Section 13).
If the provincial hospital cannot clinically handle treatment, it shall refer the newborn to a DOH Tertiary Hospital, the Philippine General Hospital, or other national non-DOH hospitals funded by national government subsidy (Section 13).
Provincial hospitals shall have funds for newborn hearing loss treatment from the internal revenue allotment of the concerned local government unit (Section 13).

Hearing screening fees and PHIC coverage

The Philippine Health Insurance Corporation (PHIC) shall include the cost of hearing loss screening in its benefit package (Section 14).
The PHIC shall ensure that the screening benefit may include testing costs, registry, follow-up, and reasonable overhead expenses (Section 14).
The PHIC shall develop a program for gradual coverage of hearing loss screening, audiologic diagnostic evaluation, and intervention services subject to Section 10 of Republic Act No. 7875, as amended by Republic Act No. 9241 (Section 14).
The DOH shall periodically review and recommend newborn hearing loss screening fees charged by Newborn Screening Centers (Section 14).
No screening fee shall be charged to a patient who availed of accredited behavioral tests, such as the Tuning Fork and Penlight method and other indigenous methods (Section 14).
On DOH-accredited methods recommended by the NIH, those methods shall be allowed as newborn hearing screening processes (Section 14).

Funding and implementing rules

The amount necessary to effectively carry out the Act shall be included in the annual General Appropriations Act (Section 15).
Within thirty (30) days from the Act’s effectivity, the DOH shall develop the implementing rules and regulations in collaboration with relevant government agencies and professional associations (Section 16).
The DOH shall issue a special protocol on the deaf and people with hearing impairment in implementing Section 5 of the Act (Section 16).

Repeal and separability

All laws, decrees, executive orders, proclamations, administrative regulations, or parts thereof contrary to or inconsistent with the Act are repealed or modified accordingly (Section 17).
If any provision is held unconstitutional or invalid, the other provisions remain valid and in full force and effect (Section 18).