Republic Act No. 9709: Universal Newborn Hearing Screening and Intervention Act of 2009

Fourteenth Congress Second Regular Session

Begun and held in Metro Manila, on Monday, the twenty-eighth day of July, two thousand eight.

REPUBLIC ACT No. 9709 August 12, 2009

AN ACT ESTABLISHING A UNIVERSAL NEWBORN HEARING SCREENING PROGRAM FOR THE PREVENTION, EARLY DIAGNOSIS AND INTERVENTION OF HEARING LOSS

Be it enacted by the Senate and House of Representative of the Philippines in Congress assembled:

Section 1. Short Title

- This Act shall be known as the "Universal Newborn Hearing Screening and Intervention Act of 2009".

Section 2. Declaration of Policy

- It is the policy of the State to protect and promote the right to health of the people, including the rights of children to survival, full and healthy development as individuals, and a better quality of life.

Recognizing the fact that newborns and children who are deaf or hard-of hearing have unique language or learning and communication needs, the State shall formulate a comprehensive program for the prevention, early detection and diagnosis of congenital hearing loss among newborns and infants based on applied research and consultations with the sectors concerned.

Section 3. Universal Newborn Hearing Screening Program

- There is hereby established a Universal Newborn Hearing Screening Program (UNHSP) to institutionalize measures for the prevention and early diagnosis of congenital hearing loss among newborns, the provision of referral follow-up, recall and early intervention services to infants with hearing loss, and counseling and other support services for families of newborns with hearing loss, to afford them all the opportunities to be productive members of the community. The objectives of the UNHSP are:

(a)To ensure that all newborns have access to hearing loss screening; (b)To establish a network among pertinent government and private sector stakeholders for policy development, implementation, monitoring, and evaluation to promote universal newborn hearing screening program in the country; (c)To provide continuing capacity building which includes training for healthcare practitioners, conduct of applied research, and other such activities to aid in the effective implementation of a universal newborn hearing screening program; (d)To establish and maintain a newborn hearing screening database; (e)To include a component which ensures linkages to diagnosis and the community system of early intervention services; (f)To develop public policy in early hearing detection, diagnosis and intervention that is based on applied research and the recognition that infants, toddlers and children who are deaf or hard-of-hearing have unique language, learning and communication needs. It should be the result of consultation with pertinent public and private sectors; and (g)To develop models which ensure effective screening, referral and linkage with appropriate diagnostic, medical, and qualified early intervention services, providers, and programs within the community.

Section 4. Definition of Terms

- Under this Act, the following terms shall mean the following:

(a)Audiologic diagnostic evaluation" shall refer to a service related to diagnosis of hearing loss administered by professionals or by Newborn Hearing Screening Centers. (b)"Congenital hearing loss" shall refer to hearing impairment already present at birth. (c)"Follow-up" shall refer to the monitoring of an infant with possible hearing loss for purpose of ensuring that the infant receives additional diagnostic services and intervention or treatment. (d)"Healthcare practitioner" shall refer to physicians, nurses, midwives, nursing aides and traditional birth attendants. (e)"Health Institutions" shall refer to hospitals, health infirmaries, health centers, lying-in centers or puericulture centers with obstetrical and pediatric services, whether public or private. (f)"Intervention" shall refer to any service rendered to an infant diagnosed with hearing loss ranging from counseling, diagnosis, provision of hearing aid or the administration of any medical procedure for correction of hearing loss. (g)"Newborn hearing screening database" shall refer to an organized body of information related to newborn hearing screening. (h)"Newborn" shall refer to an infant from the time of complete delivery to thirty (30) days old. (i)"Newborn hearing loss screening" shall refer to an objective, physiological procedure performed on a newborn for the purpose of determining if the newborn has hearing impairment. (j)Newborn Hearing Screening Reference Center" shall refer 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 activities in all aspects of the program, and oversees content of educational materials. (k)"Recall" shall refer to a procedure of locating an infant with a possible hearing loss for purposes of providing diagnostic services to confirm hearing condition and, as appropriate, provide intervention or treatment. (l)"Referral" shall refer to an act of sending a patient to another service provider within the network for continuation of care. (m)"Universal Newborn Hearing Screening Program" or "UNHSP" shall refer to 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 5. Obligation to inform

- Any healthcare practitioner who delivers, or assists in the delivery, of a newborn in the Philippines shall prior to delivery, inform the parents or legal guardian of the newborn of the availability, nature and benefits of hearing loss screening among newborns or infants three (3) months old and below.

Parents or legal guardians of newborns who, after undergoing newborn hearing loss screening, have been found to have congenital hearing loss shall be informed of the availability, nature and benefits of diagnostic audiologic evaluation, intervention and treatment options, and counseling regarding hearing loss.

The Department of Health (DOH) shall, in coordination with the NIH and other stakeholders, undertake the preparation, production and dissemination of informational and educational materials on the nature, benefits and available medical interventions for hearing loss.

Section 6. Obligation to Perform Newborn Hearing Loss Screening and Audiologic Diagnostic Evaluation

- All infants born in hospitals in the Philippines shall be made to undergo newborn hearing loss screening before discharge, unless the parents or legal guardians of the newborn object to the screening subject to Section 7 of this Act. Infants who are not born in hospitals should be screened within the first three (3) months after birth.

In the event of a positive newborn hearing loss screening result, the newborn shall undergo audiologic diagnostic evaluation in a timely manner to allow appropriate follow-up, recall and referral for intervention before the age of six (6) months: Provided, That audiologic diagnostic evaluation shall be performed by Newborn Hearing Screening Centers duly certified by the DOH.

It shall be the joint responsibility of the parents or legal guardian, and the healthcare practitioner to ensure that hearing screening is performed. An appropriate informational brochure on the role and duties of parents and guardians is fulfilling this responsibility shall be made available by the DOH and shall be distributed to all health institutions and made available to any healhcare practitioner requesting it for appropriate distribution.

In case the newborn is born at home or anywhere outside birthing facilities, the attending health care practitioner shall refer the newborn to the municipal or city heath center of the barangay having jurisdiction over the area for newborn hearing loss screening and audiologic diagnostic evaluation.

Section 7. Refusal to be Tested

- A parent or legal guardian may refuse hearing loss screening on the grounds of religious and/or cultural beliefs but shall acknowledge in writing that they have been informed of their responsibility to perform said screening and of the risks of underdiagnosed congenital hearing loss in case of failure to administer hearing loss screening on their newborn. A copy of this waiver shall be made part of the newborn's medical record and shall be entered into the national newborn hearing screening database.

Section 8. Continuing Education, Re-education and Training Health Personnel

- The DOH, with the assistance of the NIH and other concerned government agencies, professional associations and civil society organizations, shall:

(a)Conduct continuing information, education, reeducation and training programs for healthcare practitioners on the rationale, benefits, and procedures of hearing loss screening; and (b)Prepare, produce, and disseminate information materials on newborn screening annually to all health personnel involved in maternal and pediatric care.

Section 9. Lead Agency

- The DOH shall be the lead agency in implementing the provisions of this Act. For this purpose, the DOH shall perform the following functions:

(a)Coordinate with the Department of the Interior and Local Government (DILG), the department of Education, the local government units, and the private sector including other recognized medical associations and professional-based organizations with respect to early hearing detection, diagnosis and treatment/intervention for policy development and proper implementation of the provisions of this Act; (b)Coordinate with the NIH Newborn Hearing Screening Reference Center for the certification of Newborn Hearing Screening Centers and the preparation of defined testing protocols and quality assurance programs; (c)Coordinate with consumer groups serving individuals who are dead and hard-of-hearing; person who are deaf and hard-of-hearing and their families; qualified professional personnel who are proficient in deaf or hard-of-hearing children's language and who possess the specialized knowledge, skills and attributes needed to serve deaf and hard-of-hearing infants, toddlers, children and their families; other health and education professionals and organizations; third party payers and managed care organizations; and related commercial industries; (d)Monitor the extent to which hearing loss screening and audiologic diagnostic evaluation are conducted in health institutions, and assist in the development of universal newborn hearing loss screening programs for hospitals and non-hospital sites; and (e)Develop a program for the rehabilitation of deaf children through available intervention services, therapies, and such other services necessary for a patient diagnosed with hearing disorders.

Section 10. Advisory Committee on Newborn Screening

- To ensure the effective implementation of this Act, the membership of the Advisory Committee on Newborn Screening created under Section 11 of Republic Act No. 9288, "Newborn Screening Act of 2004" shall expanded to include the representatives from the Philippines Society of Otorhinolaryngology and the Philippine Society of Audiology.

Section 11. Establishment of Newborn Hearing Screening Center

- Newborn Hearing Screening Centers shall be established to undertake newborn hearing loss screening, audiologic diagnostic evaluation and recall, follow-up and referral programs to infants with hearing loss: Provided, That such Centers to be established shall be certified by the DOH based on standards formulated in collaboration with the NIH.

Newborn Screening Centers (NSC) established pursuant to Section 12 of Republic Act No. 9288, otherwise known as the "Newborn Screening Act of 2004", shall adopt and implement a program to develop its capacity to become Newborn Hearing Screening Centers. The DOH shall develop incentives to encourage the establishment of Newborn Hearing Screening Centers other than those under the Newborn Screening Centers.

Section 12. Data Management and Applied Research

- All hospitals and Newborn Screening Centers shall periodically submit copies of the results of the screening tests to the NIH Newborn Hearing Screening Reference Center for consolidation of patient databases. 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. It shall submit reports annually to the DOH on the status of and relevant health information derived from the database.

A plan for long-term outcome evaluation of hearing loss screening utilizing the case registries shall be developed within one (1) year from the effectivity of this Act by the NIH in consultation with various stakeholders.

The Secretary of Health in collaboration with the NIH shall make awards of grants or cooperative agreements to provide technical assistance to agencies to complement an intramural program and to conduct applied research related to infant hearing detection, diagnosis and treatment/intervention. The program shall carry out the following:

(a)Provide technical assistance on data collection and management; (b)Develop standardized procedures for data management to ensure quality monitoring of infant hearing loss detection, diagnosis and intervention programs; (c)Study the costs and effectiveness of hearing detection conducted by programs in order to answer issues of importance to policy makers; (d)Identify the causes and risk factors for congenital hearing loss that might lead to the development of preventive interventions; (e)Study the effectiveness of early hearing detection, diagnosis and treatment/intervention programs by assessing the health, developmental, cognitive, and language status of these children at school age; and (f)Promote the sharing of data regarding early hearing loss with birth defects and development disabilities monitoring programs for the purpose of identifying previously unknown causes of hearing loss.

Section 13. Government Intervention on Newborn Hearing Loss

- If the newborn is diagnosed to have congenital hearing loss, the Newborn Hearing Screening Center or barangay health workers shall provide referral for the treatment of the newborn to the provincial hospital of the local government unit concerned.

If the treatment of the congenital hearing loss of the newborn is beyond the clinical capability of the provincial hospital, the latter shall provide referral for the treatment of the newborn to a Department of Health Tertiary Hospital, the Philippine General Hospital, or other national non-DOH hospitals funded by the national government subsidy.

The provincial hospitals concerned shall have the funds for the treatment of newborn hearing loss from the internal revenue allotment of the local government unit concerned.

Section 14. Newborn Screening Fees

- The Philippine Health Insurance Corporation (PHIC) shall include the cost of hearing loss screening in its benefit package. Such screening test may include among others testing costs, registry, follow-up and the reasonable overhead expenses. For this purpose, the PHIC shall develop a program for the 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, otherwise known as the "National Health Insurance of 1995".

The DOH shall periodically review and recommend the newborn hearing loss screening fees to be charged by Newborn Screening Centers: Provided, That 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: Provided, further, That on the methods accredited by the DOH, upon recommendation by the NIH, shall be allowed as newborn hearing screening process.

Section 15. Funding

- The amount necessary to effectively carry out the purposes of this Act shall be included in the annual General Appropriations Act.

Section 16. Implementing Rules and Regulations

- Within thirty (30) days from the effectivity of this Act, the DOH, in collaboration with relevant government agencies and professional associations, shall develop the implementing rules and regulations necessary to effectively implement the provisions of this Act: Provided, That the DOH shall issue a special protocol on the deaf and people with hearing impairment in the implementation of Section 5 of this Act.

Section 17. Repealing Clause

- All laws, decrees, executive orders, proclamations and administrative regulations, or any part thereof, contrary to or inconsistent with this Act are hereby repealed or modified accordingly.

Section 18. Separability Clause

- If any provision of this Act shall be held unconstitutional or invalid, the other provisions hereof shall remain valid and continue to be in full force and effect.

Section 19. Effectivity Clause

- This Act shall take effect fifteen (15) days after its publication in at least two (2) newspapers of general circulation.

Approved,

| JUAN PONCE ENRILE President of the Senate | PROSPERO C. NOGRALES Speaker of the House of Representatives |

This Act which is a consolidation of Senate Bill No. 2390 and House Bill No. 2677 was finally passed by the Senate and House of Representatives on June 3, 2009.

EMMA LIRIO-REYES

Secretary of the Senate

MARILYN B. BARUA-YAP

Secretary General House of Representatives

Approved: AUG 12 2009

GLORIA MACAPAGAL - ARROYO

President of the Philippines

For information and research only, and not legal advice. This text may not reflect later amendments. For certified copies, refer to the Official Gazette or the issuing agency.

In plain language