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Early Intervention Program Memorandum 2003-3 - Newborn Hearing Screening

To:	Early Intervention Officials Providers of EI Services Newborn Hearing Screening Program Managers Families Other Interested Parties
From:	Early Intervention Program
Date:	June 2003
Subject:	Newborn Hearing Screening

This memorandum provides information about newborn hearing screening, the program requirements for maternity hospitals and birthing centers, and guidance on the role of the Early Intervention Program in facilitating follow-up for infants referred from Newborn Hearing Screening Programs.

Background and Rationale for Newborn Hearing Screening

Early identification of hearing loss is supported by the American Academy of Audiology, the American Academy of Otolaryngology-Head and Neck Surgery, the American Academy of Pediatrics, the American Speech-Language-Hearing Association, and the Council on Education of the Deaf. The Joint Committee on Infant Hearing (JCIH) Year 2000 Position Statement endorses early detection of and intervention for, infants with hearing loss.¹ The goal of Healthy People 2010 (Objective 28.11) is to "increase the proportion of newborns who are screened for hearing loss by age one month, have audiologic evaluation by three months, and are enrolled in appropriate intervention services by age six months."²

Statute and Regulations

New York State Public Health Law, Section 2500-g, enacted in 1999, requires the Commissioner of Health to establish a program to screen newborn infants for hearing problems. To identify newborns with significant hearing loss, the New York State Department of Health has implemented a statewide comprehensive Newborn Hearing Screening Program. The Department, in collaboration with health care providers, hospital representatives, parent representatives and audiologists has developed a new Subpart 69-8 of Title 10 (Health) of the New York Codes, Rules and Regulations (NYCRR) to implement the Newborn Hearing Screening Program (Appendix A). This regulation was adopted on August 22, 2001, became effective on October 20, 2001, and requires all facilities caring for newborn infants to administer a newborn hearing screening program as of that date.

Options for administering the program vary depending on the number of births per year in the facility, as follows:

Facilities with over 400 births per year, based on a rolling three-year average,* are required to provide newborn hearing screening prior to the infant's discharge from the hospital to home for all newborns born in or transferred to their facilities.
Facilities with 400 births or fewer per year, based on a rolling three-year average, have the option to administer the program directly or to refer infants born in their hospitals to qualified providers in their communities with prescriptions for hearing screenings.

*Average number of births based on the three most recent years for which complete data are available.

Incidence of Hearing Loss

The number of infants born with significant permanent hearing loss is one to three infants per 1,000, and an estimated additional three infants per 1,000 with moderate degrees of hearing loss, according to figures from the American Speech-Language-Hearing Association.³ The National Center for Hearing Assessment and Management (NCHAM) concurs that three of every 1,000 newborns in the United States have a permanent hearing loss, making hearing loss the most frequently occurring birth defect.⁴ Consequences of late identification of hearing loss include delayed speech and language development, and associated effects on social and emotional growth and academic achievement.⁵ Advances in technology have made it possible to detect the presence of hearing loss in the neonatal period. Research has demonstrated that infants with hearing impairment have significantly better language outcomes when they are identified earlier (by six months of age) versus later.⁶ When early detection of hearing loss is coupled with the provision of effective early intervention, the impact of the hearing loss on language and other areas of development may be lessened.

Newborn Hearing Screening Definition and Techniques

Newborn hearing screening is defined in regulation as the use of an objective measurement of the auditory system to identify infants at risk for hearing loss.⁷ The objective measures currently used for newborn hearing screening are evoked otoacoustic emissions (OAE) and the auditory brainstem response (ABR). Both techniques provide objective information about auditory system function. To obtain OAEs, a small probe is placed in the baby's ear, sounds are introduced, and the response from the baby's ear is recorded. If automated auditory brainstem response (AABR) is used, electrodes are attached to the baby, who also wears earphones. Sounds are introduced through the earphones and the response from the baby's auditory system is recorded.

The methodology used in screening should have a low false-positive rate, with the proportion of infants referred for re-screening below 4%.⁸ A number of factors, including the screening protocol selected, and the training and experience of the screener, have an impact on failure/referral rates following the initial newborn hearing screening (conducted prior to discharge in most instances). Possible protocols include conducting the initial screening using one type of technology (OAE technology alone or ABR technology alone) or using a two stage screening protocol. Some facilities may incorporate use of a two step process for infants who fail the initial screening, either repeating one technique a second time or using a combination of OAE and ABR.

Definition of Hearing Loss

The newborn hearing screening regulations define hearing loss to mean a permanent unilateral or bilateral hearing loss of mild (30 to 40 dB HL) or greater degree in the frequency region (500-4000 Hz) important for speech recognition and comprehension.⁹ This means that the hearing loss may be in one ear or both ears and may range in degree from mild to profound. The frequencies referenced in the regulation include those that carry the sounds in speech that help to distinguish words from one another. For example, in spoken language, distinguishing the word "dish" from "fish" requires the ability to hear the difference between the two initial sounds in those words.

The Role of Maternity Hospitals and Birthing Centers

Facilities that care for newborns are required to administer, directly or by contract, newborn hearing screening programs. The general requirements for hospitals or birthing centers conducting newborn hearing screening programs are found in section 69-8.2(b) of the Newborn Hearing Screening regulations and include:

Conducting inpatient infant hearing screening prior to discharge from the facility;
Communicating results of infant hearing screenings to parents by designated personnel, including provision of written materials supplied by the Department;
Conducting follow-up infant hearing screening or providing referrals to obtain follow-up screening on an outpatient basis for those infants who fail or do not receive infant hearing screening prior to discharge from the facility;
Referring infants who are suspected of having a hearing loss as defined in this part to the Early Intervention Program for appropriate evaluation and early intervention services;
Reporting of aggregate data on newborn hearing screening to the Department of Health on a quarterly basis; and,
Establishing facility quality assurance protocols to determine and evaluate the effectiveness of the program in ensuring all infants are screened for hearing loss.¹⁰

Administering Newborn Hearing Screening Programs

The newborn hearing screening regulations describe the personnel requirements for newborn hearing screening programs, including the program manager and screening personnel, in Section 69-8.3. The program manager is responsible for ensuring training and supervision of individuals performing the screening, documentation of screening results, data reporting, staff and parent education, and coordination of services and follow-up. The specific qualifications of personnel who perform newborn hearing screening depend on the type of equipment used. Individuals who are not audiologists can perform newborn hearing screening as long as automated equipment is used, results are reported as pass or refer,¹¹ and they have been trained as described in the newborn hearing screening regulations.¹² If the equipment requires clinical decision-making, only personnel licensed under State Education Law and authorized to perform infant hearing screening (audiologists and physicians) can perform the screening.

Procedures for Newborn Hearing Screening

Procedures for infant hearing screening for facilities that conduct inpatient screening are described in section 69-8.4 of the regulations. Steps for infants who pass the screening, those who are missed, and those who require re-screening because they did not pass the inpatient screening are outlined. Newborn hearing screening regulations require that parents be supplied with educational materials about newborn hearing screening prior to the hearing screening. After the screening, parents should be given the results of the screening and written materials consistent with the screening outcome. In addition, the primary health care provider may receive information about hearing screening results through documentation in the infant's discharge summary. The Department of Health has developed four brochures to assist in the implementation of statewide newborn hearing screening. Descriptions of these materials and ordering information may be found in Appendix B.

For babies who pass the hearing screening, the next steps include documenting the results of the screening in the infant's record, and documentation in the discharge summary. In addition, the parents must be provided with the screening results and educational materials that include information on developmental milestones for communication and signs of hearing loss in young children. If a baby does not receive a hearing screening prior to discharge (is missed), the hospital staff must make an attempt to schedule an appointment for an outpatient screening prior to discharge if possible, or must make a reasonable effort to contact the family and schedule the hearing screening after discharge.¹³

Babies who do not pass (who "refer") following their initial hearing screening may be re-screened prior to discharge if feasible.¹⁴ This helps to minimize the likelihood of false positive results and the need for a follow-up outpatient screening. It has been found that most infants (80-90%) that fail the first screening will pass when they are re-screened.¹⁵ If re-screening prior to discharge is not possible, or passing results are not obtained, the baby will be referred for re-screening to take place after discharge. Parents of babies who do not pass (who "refer") following the inpatient screening must be given a prescription for their baby to have an outpatient hearing screening, either at the birth hospital or from a provider qualified to perform the screening in their community. The prescription will include a request that the results of the follow-up hearing screening be returned to the birth facility. The discharging hospital must supply parents with a prescription for the infant to obtain an out-patient hearing screening under all circumstances, and provide a list of qualified providers of infant hearing screening if the parents opt to pursue follow-up at a different facility.

Data Reporting, Tracking, and Follow-up

All facilities with newborn hearing screening programs are required to submit aggregate data about newborn hearing screening to the Department of Health on a quarterly basis. Required data elements include the number of infants screened, the number of infants who pass the screening, the number of missed infants, and the number of infants referred for re-screening due to a failed initial screen. For those infants who "refer," facilities are also required to report the results of re-screening they have received. Facilities that conduct in-patient screening are required to ascertain whether follow-up screening results have been received within 75 days from discharge. If no follow-up results are received by the hospital after 75 days post-discharge, infants are to be referred as at-risk to the Early Intervention Official in their county of residence for follow-up purposes, unless the parent has objected to such a referral.

Reimbursement for Newborn Hearing Screening Services

Reimbursement for newborn hearing screening services is available through Medicaid fee-for-service, Medicaid Managed Care, or commercial insurance. If a child is determined to be eligible for Child Health Plus B, hearing screening is a covered benefit. Specific information on the reimbursement for newborn hearing screening program services through Medicaid was provided in the October 2001 (Volume 16, No. 10) Medicaid Update and is included in Appendix C. The State Insurance Department's Circular Letter No. 16 (November 1, 2001) clarifies that newborn hearing screening services are within the scope of preventive and primary care services covered under the New York State Insurance Law. The text of the Circular Letter is included in Appendix D.

The Role of the Early Intervention Program

Referral to the County Early Intervention Program

Timely follow-up is important for those infants who do not pass their initial hearing screening and for those infants who fail two newborn hearing screenings. Infants who have failed two hearing screenings are considered to have a suspected disability, and, as such, are required to be referred to the Early Intervention Program under existing Public Health Law, section 2542, and Early Intervention Program regulations.¹⁶

Referral to the Early Intervention Program in the infant's county of residence can take place at two main junctures in the newborn hearing screening process:

After an infant fails two hearing screenings, they may be referred to early intervention for a confirmatory (diagnostic) hearing test; and,
If an infant who has failed their initial hearing screening does not receive a follow-up screening within 75 days post-discharge, the facility responsible for reporting data to the Department (usually the birth facility) may refer the family to early intervention for the purpose of facilitating a second hearing screening.

In the first instance, infants who fail two screenings are considered to have a suspected hearing loss and should be referred for diagnostic audiological evaluation. This can take place through early intervention. In instances where ruling out hearing loss by obtaining a confirmatory diagnostic audiological evaluation is the primary concern upon referral to early intervention, the evaluator may decide to do a screening to determine whether a multidisciplinary evaluation is warranted. For children referred on the basis of two failed newborn hearing screenings, the evaluator may first provide an audiological evaluation to screen the child to determine whether a hearing loss exists.

The decision about whether to proceed with a multidisciplinary evaluation would be contingent on 1) whether hearing loss is confirmed and/or 2) other concerns exist about the infant's development. In the event that the confirmatory audiological evaluation yields normal findings and there are no further concerns about the infant's developmental status, the multidisciplinary evaluation should be deferred, and the child should be discharged from early intervention. Infants with a confirmed diagnosis of hearing loss would meet early intervention eligibility requirements and would go on to receive a complete multidisciplinary evaluation and Individualized Family Service Plan, if the parents do not object. In the event that hearing loss is ruled out but other concerns exist about the child's development, the multidisciplinary evaluation would take place to address the other developmental concerns. In this case, eligibility for early intervention services would be based on the presence of either a developmental delay meeting established criteria in the Early Intervention Program regulations¹⁷ or a diagnosed condition that connotes automatic eligibility for early intervention services.

In the second instance, infants who have failed one screening and have not received a follow-up screening 75 days after discharge, the county's role is to facilitate the visit for the second hearing screening, not to pay for the re-screen. This may include making reasonable efforts to locate the family and to help the family secure an appointment for the hearing re-screen visit.

Assistive Technology for Children Diagnosed with Hearing Loss

Personal Amplification Devices

Personal amplification devices are considered assistive technology devices under the Early Intervention Program. The recommended devices, and services to support the use of the devices, should be included in the child's Individualized Family Service Plan (IFSP). Audiology services, including monitoring of the child's hearing loss, fitting amplification, and assessing the effectiveness of the selected amplification devices are included as early intervention services under the Early Intervention Program.

Cochlear Implants

Audiology services described above are included as early intervention services. Devices that are medical/surgical in nature, such as cochlear implants, are not covered under the Early Intervention Program. However, the child's service coordinator is responsible for coordinating the provision of early intervention services and other services needed by the child and family. This includes providing appropriate referrals and facilitating access to other services needed by the child and family that are not provided under the Early Intervention Program.

Concerns About Hearing After the Newborn Period

The advent of newborn hearing screening programs will not eliminate referrals of children to the Early Intervention Program due to concerns about their hearing status. Concerns about young children's hearing may arise for a variety of reasons, including: speech and language delay, lack of response to sounds, a change in the child's response to sounds, or illness or injury. Parental or caregiver concern regarding hearing, speech, language and/or developmental delay is among the risk indicators for hearing loss in infants and young children. Referral for diagnostic audiological evaluation to rule out hearing loss is appropriate in these instances.

Public Education Materials and Resources

Newborn Hearing Screening Publications

The Department of Health has developed four brochures, available in English, Spanish, French, Chinese, Russian, Bengali, and Urdu, on newborn hearing screening. Each of the brochures includes developmental milestones for communication and signs of hearing loss in young children, as well as information on how to contact the Early Intervention Program. Descriptions of each brochure and a Newborn Hearing Screening Publication order sheet may be found in Appendix B. These materials are available to hospitals and providers in New York State.

Clinical Practice Guidelines/Early Intervention Program Publications

The Department of Health Web site, referenced in Appendix B, also contains ordering information for a variety of Early Intervention Program publications, including Clinical Practice Guidelines on Communication Disorders, which have been developed by the Department. Three versions of each guideline have been produced, including a Technical Report, a Report of the Recommendations, and a Quick Reference Guide.

Further Guidance

This memorandum is designed to provide information and guidance on issues related to newborn hearing screening and early intervention. Individuals with questions about the Newborn Hearing Screening Program or the Early Intervention Program should call the Department of Health at 518-473-7016.

Footnotes

¹ Year 2000 Position Statement: Principles and Guidelines for Early Hearing Detection and Intervention Programs (June 2000). Joint Committee on Infant Hearing. American Journal of Audiology, Vol. 9, 9-29.
² U.S. Department of Health and Human Services 2010 (Conference ed., in Two Volumes). Washington DC: January 2000.
³ American Speech-Language-Hearing Association (1999). Facts on Hearing Loss in Children. www.asha.org/infant_hearing/facts.htm
⁴ National Center for Hearing Assessment and Management (2002). Universal Newborn Hearing Screening Fact Sheet. www.infanthearing.org
⁵ American Speech-Language-Hearing Association (1999). Facts on Hearing Loss in Children. www.asha.org/infant_hearing/facts.htm
⁶ Yoshinaga-Itano, C., Sedey, A. L., Coulter, D.K., & Mehl, A.L. (1998). Language of early- and later-identified children with hearing loss. Pediatrics, 5, 1161-1171.
⁷ 10 NYCRR Section 69-8.1(f)
⁸ American Academy of Pediatrics (1999). Newborn and Infant Hearing Loss: Detection and Intervention. Task Force on Newborn and Infant Hearing. Pediatrics, 103, 527-530.
⁹ 10 NYCRR Section 69-8.1(c)
¹⁰ 10 NYCRR Section 69-8.2(b)(1-6)
¹¹ 10 NYCRR Section 69-8.3(e)
¹² 10 NYCRR Section 69-8.3(c) and (d)
¹³ 10 NYCRR Section 69-8.4(e)
¹⁴ 10 NYCRR Section 69-8.4(f)
¹⁵ Prieve, B., Dalzell, L., Berg, A., Bradley, M., Cacace, A., Campbell, D., DeCristofaro, J., Gravel, J., Greenberg, E., Gross, S., Orlando, M., Pinheiro, J., Regan, J., Spivak, L., and Stevens, F. (2000). The New York State universal newborn hearing screening demonstration project: Outpatient outcome measures. Ear and Hearing, Vol. 21, No. 2, 104-117.
¹⁶ 10 NYCRR 69-4.3(f)
¹⁷ 10 NYCRR Section 69-4.1(g)(1)

Attachments

Appendix A: Newborn Hearing Screening Regulations
Appendix B: Newborn Hearing Screening Publications
Appendix C: Excerpt from October 2001 (Volume 16, No. 10) Medicaid Update
Appendix D: State Insurance Department Circular Letter No. 16 (November 1, 2001)

Appendix A - Newborn Hearing Screening Regulations

Pursuant to the authority vested in the New York State Department of Health by Section 2500-g of the Public Health Law and Chapter 585 of the Laws of 1999, Part 69 of Subchapter H of Chapter II of Title 10 (Health) of the Official Compilation of Codes, Rules and Regulations of the State of New York is amended by the addition of a new Subpart 69-8 to be effective upon filing with the Secretary of State and publication in the State Register.

Part 69 - Testing for Phenylketonuria and Other Diseases and Conditions/Early Intervention Program/Newborn Hearing Screening

A new Subpart 69-8 is added as follows:

Subpart 69-8
Newborn Hearing Screening
(Statutory authority: Public Health Law Section 2500-g)
Section 69-8.1 Definitions
Section 69-8.2 General Requirements for Infant Hearing Screening Programs and Responsibilities of the Administrative Officers or Designees of Facilities
Section 69-8.3 General Requirements for Administration of the Infant Hearing Screening Program
Section 69-8.4 Procedures for Infant Hearing Screening
Section 69-8.5 General Requirements for Institutions Caring for Infants that Provide a Referral for Infants to Obtain Hearing Screening
Section 69-8.6 Responsibilities of Institutions Caring for Infants in Special Circumstances

Section 69-8.1 Definitions

Administrative officer means the chief executive officer of the hospital, as defined in section 405.3 of this title.
Audiologic evaluation means the use of physiologic and behavioral procedures to evaluate and diagnose hearing loss.
Hearing problems (hearing loss) shall mean a permanent unilateral or bilateral hearing loss of mild (30 to 40 dB HL) or greater degree in the frequency region (500-4000 Hz) important for speech recognition and comprehension.
Institution caring for infants (facility) means all general hospitals having maternity and infant services or premature infant services as defined in section 405.21 of this title and primary care hospitals and critical access hospitals as defined in section 407.1 of this title and birthing centers as defined in section 754.1 of this title.
Newborn infant (infant) means a minor child who is less than ninety days of age.
Newborn infant hearing screening (infant hearing screening) means the use of an objective electrophysiologic or otoacoustic measurement of the auditory system using equipment approved by the United States Department of Health and Human Services, Food and Drug Administration (FDA), to identify infants at risk for hearing loss.
Parent means a parent by birth or adoption, legal guardian, or any other person legally authorized to consent to medical services for the infant.
Article 28 facility shall mean a health care facility established under article 28 of the Public Health Law.

Section 69-8.2 General Requirements for Infant Hearing Screening Programs and Responsibilities of the Administrative Officers or Designees of Facilities

Each facility shall administer an infant hearing screening program, directly or by contract pursuant to section 400.4 of this title, as required by this part and as generally described in subdivision (b) of this section, except for those facilities identified in subdivision (c) of this section.
1. Facilities that establish a contract(s) with providers of infant hearing screening shall designate a staff member responsible for contract management and general oversight of the program.
2. Contracts may be established for the conduct of inpatient and/or outpatient infant hearing screening.
3. Contractors must be article 28 facilities or health care providers licensed under state education law and authorized under such law to perform infant hearing screening.
4. Contractors shall have the capacity to meet general requirements for infant hearing screening programs as set forth in subdivision (b) of this section.
General requirements of an infant hearing screening program are:
1. The conduct of inpatient infant hearing screening prior to discharge from the facility.
2. Communication of results of infant hearing screenings to parents by designated personnel, including provision of written materials supplied by the Department.
3. The conduct of follow-up infant hearing screening or provision of referrals to obtain follow-up screening on an outpatient basis for those infants who fail or do not receive infant hearing screening prior to discharge from the facility. On an annual basis, facilities shall notify the Department whether the facility will conduct follow-up infant hearing screening or provide referrals for infants to obtain such screening from another facility or provider licensed under State Education Law and authorized to provide infant hearing screening.
4. Referral of infants who are suspected of having a hearing loss as defined in this part to the Early Intervention Program for appropriate evaluation and early intervention services pursuant to section 69-4.3 of this title including, but not limited to:
  1. providing a general explanation of the Early Intervention Program and the purpose of referral and the parents' right to object to the referral;
  2. ensuring confidentiality of referral information transmitted; and
  3. transmitting of personally identifying information as necessary to ensure follow-up.
5. The reporting of aggregate data on infant hearing screenings to the Department upon Department request, in a format and frequency prescribed by the commissioner.
6. The establishment of facility quality assurance protocols as necessary pursuant to section 405.6 of this title to determine and evaluate the effectiveness of the program in ensuring all infants are screened for hearing loss.
Facilities with 400 or fewer births annually, based on a three year rolling average, may provide referrals for infants to receive hearing screening from an article 28 facility or a provider licensed under State Education Law and authorized under such law to perform infant hearing screening.
1. Such referrals shall include a prescription issued by the facility, including a request for results of the screening to be returned to that facility, for infants to receive hearing screening from an article 28 facility or a provider licensed under State Education Law and authorized under such law to provide infant hearing screening.
2. Such facilities shall submit screening results returned to the facility by the outpatient provider as required by the Department to determine the effectiveness of referral procedures in ensuring infants are screened for hearing loss.

Section 69-8.3 General Requirements for Administration of the Infant Hearing Screening Program

The administrative officer of each facility caring for infants or their contractor(s) shall designate a program manager responsible for management and oversight of the infant hearing screening program.
1. The program manager shall be a licensed audiologist, physician, physician's assistant, registered nurse or nurse practitioner.
2. If the program manager is not an audiologist, infant hearing screening procedures and training shall be established and monitored in consultation with an audiologist.
The program manager shall be responsible for ensuring:
1. training and supervision of the individuals performing the screening;
2. review, recording and documentation of screening results;
3. data reporting;
4. staff and parent education; and,
5. coordination of services and follow-up including referrals for re-screening or diagnostic audiologic evaluation as appropriate.
All personnel performing infant hearing screening must be supervised and trained in the performance of infant hearing screening.
Training shall include the following:
1. the performance of infant hearing screening;
2. the risks including psychological stress for the parent;
3. infection control practices;
4. the general care and handling of infants in hospital settings according to established hospital policies and procedures;
5. the recording and documentation of screening results as directed; and,
6. procedures for communicating screening results to parents.
Personnel other than licensed audiologists may perform infant hearing screening provided that:
1. the screening equipment and protocol used are fully automated;
2. equipment parameters are not accessible for alteration or adjustment by such personnel; and,
3. the results of the screening are determined without clinical decision-making and are reported as pass or fail.
Equipment that requires clinical decision-making shall be used to conduct infant hearing screenings only by personnel licensed under State Education Law and authorized to perform infant hearing screening.
Equipment used for infant hearing screening shall be maintained and calibrated in accordance with section 405.24 (c)(2) of this title.
The facility shall provide adequate physical space for equipment and supplies and an environment suitable to obtain reliable infant hearing screening results.

Section 69-8.4 Procedures for Infant Hearing Screening

All infants born in the facility shall receive an initial hearing screening prior to discharge from the facility except as provided in section 69-8.2(c) of this Part.
Prior to the hearing screening, parents shall be provided educational materials, supplied by the Department to the facility, or consistent in content with Department-supplied materials, regarding infant hearing screening.
If the infant passes the hearing screening, the results shall be documented in the infant's record by the individual who performed the screening and documented in the discharge summary.
1. The parent shall be informed of the screening results prior to the infant's discharge from the facility.
The parent shall be provided educational materials, supplied by the Department to the facility, on developmental milestones for communication and signs of hearing loss in young children.
In the event that an infant is not screened for hearing loss prior to discharge from the facility, the program manager shall ensure that:
1. The parent is offered the opportunity to schedule an appointment for the infant to be screened for hearing loss on an outpatient basis within four weeks from the infant's discharge from the facility. Whenever practicable, the parent shall be afforded such opportunity to schedule an outpatient screening prior to the infant's discharge from the facility.
2. If the parent is not provided the opportunity to schedule an appointment for an outpatient screening prior to the infant's discharge from the facility following birth, a minimum of two documented attempts, either by United States mail or by telephone, excluding busy signals or no answer, shall be made to contact the parent post-discharge to schedule an appointment for an outpatient screening for the infant.
3. If the parent agrees to schedule an appointment for an outpatient hearing screening by the facility or a provider under contract with the facility, the appointment shall be scheduled and documented in the infant's record.
4. If the parent returns to the facility or provider under contract with the facility for an outpatient screening, the screening results shall be documented in the infant's record and reported to the Department as prescribed by the commissioner.
5. If the parent declines to schedule an appointment for an outpatient hearing screening for the infant by the facility or by a provider under contract with the facility, such declination shall be documented in the infant's record and discharge summary.
  1. The parent shall be provided instead with a prescription for the infant to obtain an outpatient hearing screening from an article 28 facility or provider licensed by and authorized under State Education Law to perform infant hearing screening.
  2. The prescription shall specify that the results of the hearing screening shall be returned to the facility.
If the infant fails the inpatient hearing screening, a repeat screening shall be conducted whenever possible prior to the infant's discharge from the facility to minimize the likelihood of false positive results and need for a follow-up outpatient screening.
If the infant fails the inpatient screening and any repeat screening, if performed, an outpatient follow-up screening shall be performed to confirm the results of the inpatient screens.
If the facility has elected to conduct follow-up hearing screening either directly or through a contractual agreement, the following procedures shall be followed:
1. The parent shall be informed of the infant's screening results by an individual trained as required in subdivisions (c) and (d) of section 69-8.3 to counsel the parent(s) on the importance of a follow-up screening.
2. The parent shall be provided with educational materials on the importance of early detection of hearing loss, supplied by or consistent with Department materials.
3. The parent shall be provided, prior to the infant's discharge, a prescription to obtain follow-up infant hearing screening post-discharge to be performed at the facility or by a provider under contract with the facility.
4. If the parent agrees, an appointment shall be scheduled prior to the infant's discharge from the facility except under circumstances where such scheduling is not practicable, such as on weekends, or within ten days post-discharge.
5. The appointment shall be documented in the infant's record and discharge summary to facilitate follow-up by the infant's primary health care provider.
6. If an infant does not present for a scheduled appointment for a follow-up screening based on the infant's failure of an in-patient screen, the facility or provider under contract with the facility shall make at least two documented attempts either by United States mail or by telephone, excluding a busy signal or no answer, to contact the parent and reschedule the appointment.
7. If the facility or provider under contract with the facility cannot reach the family or for any other reason cannot schedule and complete a follow-up screening within seventy-five days from discharge, the infant shall be referred to the Early Intervention Official in his or her county of residence as an at-risk child in accordance with section 69-4.3 of this title, unless the parent objected to the referral at the time of the inpatient hearing screening.
8. If the parent declines to schedule a follow-up screening with the facility or provider under contract with the facility for an infant who has failed the inpatient infant hearing screening, the following procedures shall be used:
  1. The parent(s) shall be provided with a prescription issued by the facility for the infant to obtain a follow-up screening from a provider licensed under State Education Law and authorized under such law to perform infant hearing screening.
    1. The prescription shall include a request that results of the screening be submitted back to the facility.
  2. The parent shall be provided with a list of qualified providers of infant hearing screening, which shall consist of providers licensed under state education law and authorized under such law to perform infant hearing screening and article 28 facilities.
  3. The individual counseling the parent shall document in the infant's record and discharge summary the parent(s)' decision not to schedule an appointment with the facility and the issuance of a prescription to obtain follow-up screening from another qualified provider.
  4. The infant's primary health care provider, when such provider is known, shall be notified of the parents' decision to obtain a follow-up outpatient screening.
  5. If the prescription is filled and the results of the follow-up screening are returned to the facility, such results shall be documented in the infant's record.
If the facility elects to refer infants who fail the inpatient hearing screening to other facilities or providers licensed under the State Education Law and authorized by such law to perform infant hearing screening on an outpatient basis, the following procedures shall be used:
1. The parent shall be informed that the screening should be completed within four weeks from the infant's discharge from the facility if possible and not later than twelve weeks following birth.
2. The parent shall be provided with educational materials on the importance of early detection of hearing loss, supplied by the Department to the facility, or consistent in content with Department-supplied materials, and a list of licensed providers and/or article 28 facilities where infant hearing screening may be obtained.
3. The parent shall receive a prescription for an outpatient screening by a provider licensed under the State Education Law and authorized under such law to perform infant hearing screening, or by an article 28 facility. Such prescription shall state that results shall be returned to the facility.
4. The parent shall be informed that if results of a follow-up outpatient screening are not returned to the facility, the infant will be referred as an at risk child to the Early Intervention Official in their county of residence for follow-up purposes unless the parent(s) object to such a referral, in accordance with section 69-4.3 of this part.
5. The referral, including issuance of a prescription, shall be documented in the infant's record and discharge summary to facilitate follow-up by the infant's primary health care provider.
6. The infant's primary health care provider, when such provider is known, shall be notified of the inpatient results and need for a follow-up outpatient screening.
7. If results of a follow-up outpatient screening are not returned to the facility within seventy-five days, the infant shall be referred as an at-risk child to the Early Intervention Official in his/her county of residence for follow-up purposes, in accordance with section 69-4.3 of this part, unless the parent has objected to such a referral.

Section 69-8.5 General Requirements for Institutions Caring for Infants that Provide a Referral for Infants to Obtain Hearing Screening.

This section shall apply to those exempt from direct administration of the infant hearing screening program. The administrative officer of a facility as described in subdivision (c) of section 69-8.2 of this Part shall designate a program manager responsible for infant hearing screening who shall ensure infants are referred for an outpatient screening for hearing loss.
The program manager for infant hearing screening shall ensure that infants are referred, prior to discharge from the facility, to a provider licensed under State Education Law and authorized under such law to perform infant hearing screening or an article 28 facility.
1. The parent shall be informed that the screening should be completed within four weeks of the infant's discharge from the facility if possible and not later than twelve weeks following birth.
2. The parent shall be provided with educational materials on the importance of early detection of hearing loss, supplied by or consistent with department materials; and, a list of licensed providers and/or article 28 facilities where infant hearing screening may be obtained.
3. The parent shall receive a prescription for an outpatient screening by an article 28 provider or a provider licensed under the State Education Law and authorized by such law to perform infant hearing screening. The prescription shall require that results be returned to the facility issuing the prescription.
4. The referral, including issuance of a prescription, shall be documented in the infant's record and discharge summary to facilitate follow-up by the infant's primary health care provider.
The program manager shall be responsible for ensuring that results of infant hearing screening reported to the facility are documented in the infant's record and reported to the Department as prescribed by the commissioner.
The Department may seek corrective action as necessary to ensure infants are screened for hearing loss under the referral process provided for in this section.

Section 69-8.6 Responsibilities of Institutions Caring for Infants in Special Circumstances

In the event that an infant is transferred from one facility to another such facility, the facility discharging the infant to home shall be responsible for ensuring that infant hearing screening services are provided to the infant in a manner consistent with the applicable provisions set forth in this part.
If the infant fails both an initial and follow-up screening, the infant shall be referred for an evaluation to the Early Intervention Official in his or her county of residence, according to the procedures set forth in Section 69-4.3 of this part unless the parent objects.
Medically unstable infants shall receive infant hearing screening prior to discharge to home and as early as development or medical stability will permit such screening. In instances where the medical condition of the infant contraindicates infant hearing screening, a decision to forgo such screening may be made and documented in the medical record.

Appendix B - Description of Public Education Materials and Resources Related to Newborn Hearing Screening and Ordering Information

Brochures and Posters

The Department of Health has developed four brochures, available in English, Spanish, French, Chinese, Russian, Bengali, and Urdu, to assist in the implementation of statewide newborn hearing screening. These include:

Can Your Baby Hear You? – Information for Parents (a general brochure for all expectant parents and parents of newborns, to be distributed prior to newborn hearing screening);
Can Your Baby Hear You? – Your Baby Passed (a brochure for parents of infants who pass the screening);
Can Your Baby Hear You? – Your Baby Needs Another Screening (a brochure for parents of infants who need to be re-screened); and,
Can Your Baby Hear You? – How to Get Your Baby's Hearing Screened (a brochure for parents who deliver in hospitals with 400 or fewer births per year and who will be referred to have newborn hearing screening completed after discharge).

Posters have also been developed in each of the languages listed above. These newborn hearing screening publications are available free of charge to hospitals and providers in New York State from:

New York State Department of Health
Box 2000
Albany, New York 12220
FAX: (518) 486-2361

An Early Intervention Program Publications order form is available at: www.health.state.ny.us/community/infants_children/early_intervention/index.htm

Appendix C - Hospital Reimbursement For Newborn Hearing Screening Program Services

Hearing loss is the most common congenital disorder in newborns. Early detection of hearing loss during infancy, followed with appropriate early intervention, can greatly enhance the language, cognitive and social development of these infants so that they may be on par with their hearing peers.

To identify newborns with significant hearing impairment, the New York State Department of Health (NYSDOH) has implemented a statewide comprehensive
Enhanced Reimbursement

Effective October 20, 2001, facilities directly administering the Program will be permitted to bill for the enhanced reimbursement
The facility may also issue a prescription for the infant to obtain the missed initial or re-screening service from another provider in the community authorized to provide infant hearing screening services. In such circumstances, the actual provider of the referred newborn hearing screening service will be reimbursed based on the applicable NYS Medicaid Fee Schedule amount.

Rate Codes & Billing Issues

The rate codes established for billing the newborn hearing screening services are as follows:

billable as an outpatient claim in HCFA Version 5 format IN ADDITION TO the inpatient claim

The rate codes will initially be made available to all Article 28 hospitals/birthing centers certified for maternity beds/maternity services and will be added only to the specific locator code site(s) where maternity services are provided.

Rate codes for facilities with 400 or fewer births per year <that elect the referral option

Q & A

Any questions or concerns related to the enhanced reimbursement for newborn hearing screening services should be directed to the Bureau of Primary and Acute Care Reimbursement, NYSDOH at (518) 474-3267.

Source: Excerpt from Medicaid Update, October 2001, Volume 16, No. 10.

Appendix D - Circular Letter No. 16 (2001) - November 1, 2001

To:	All Insurers Authorized to Write Accident and Health Insurance in New York State, Including Article 43 Corporations and HMOs
Re:	Additional Information on Implementation of Chapter 728 of the Laws of 1993, Requiring Coverage for Preventive and Primary Care Services
Statutory Reference:	Insurance Law Sections 3216(i)(17); 3221(l)(8) and 4303(j) and Public Health Law Section 2500-g.

Chapter 728 of the Laws of 1993 requires that every policy providing medical, major medical or similar comprehensive type coverage provide coverage for preventive and primary care services for dependent children to age nineteen.

The legislation sets forth the preventive and primary care services which must be covered, including well child visits. The schedule of well child visits, as well as the services to be provided at such visits, are to be in accordance with the prevailing clinical standards of a national association of pediatric physicians as designated by the New York State Commissioner of Health. The legislation also requires coverage for necessary immunizations. Coverage shall be provided for preventive and primary care services rendered in a hospital, in a physician's office or in the office of a professional licensed under Article 139 of the Education Law whose scope of practice includes the authority to provide the specified services.

By Circular Letter No. 3 (1994), the Insurance Department advised insurers, Article 43 corporations and HMOs that the standards of the American Academy of Pediatrics had been designated by the Commissioner of Health as the clinical standards to be utilized in determining the schedule of well child visits and the services to be provided at such visits. By Circular Letter No. 34 (2000), the Insurance Department updated the list of covered immunizations.

The purpose of this Circular Letter is to inform all insurers, Article 43 corporations and HMOs that, pursuant to Public Health Law Section 2500-g and as set forth in 10 NYCRR Part 69, the Commissioner of Health implemented a newborn hearing screening program effective October 20, 2001 to screen newborn infants for hearing problems. The Commissioner was advised by the American Academy of Pediatrics that newborn hearing screening constituted a prevailing standard of care endorsed by the Academy. As such, newborn hearing screening services are within the scope of preventive and primary care services covered under the Insurance Law.

Please direct any questions concerning this Circular Letter to:

Deborah A. Kozemko
Associate Insurance Attorney
New York State Insurance Department
Agency Building 1
Empire State Plaza
Albany, NY 12257

or by e-mail to: dkozemko@dfs.ny.gov.

Department of Health