Chapter 3701-40 Hearing Evaluations

3701-40-01 Definitions.

As used in this chapter of the Administrative Code:

(A) "Address," in the case of an individual, means the individual's residence and, in the case of a government agency, means the office at which the records pertaining to a particular child are maintained.

(B) "Attending physician" means the newborn's or infant's primary care physician who will provide care for the newborn or infant after discharge. If there is no known primary care physician, the physician treating the infant or newborn while the newborn or infant is in the hospital will be deemed the attending physician.

(C) "Audiologist" means an individual authorized under the section 4753.07 of the Revised Code to practice audiology.

(D) "Birth clerk" means an integrated perinatal health information system (IPHIS) user with the ability to enter data to create birth records.

(E) "Board of health" means the board of health of a city or general health district or the authority having the duties of a board of health under section 3709.05 of the Revised Code.

(F) "Certified nurse-midwife" means a registered nurse who holds a valid certificate of authority issued under Chapter 4723. of the Revised Code that authorizes the practice of nursing as a certified nurse-midwife in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

(G) "Certified nurse practitioner" means a registered nurse who holds a valid certificate of authority issued under Chapter 4723. of the Revised Code that authorizes the practice of nursing as a certified nurse practitioner in accordance with section 4723.43 of the Revised Code and rules adopted by the board of nursing.

(H) "Custodian" means a government agency, or an individual, other than a parent or guardian, with legal or permanent custody of a child as defined in section 2151.011 of the Revised Code.

(I) "Department" means the Ohio department of health.

(J) "Diagnostic hearing evaluation" means evaluation through the use of a battery of pediatric audiology test procedures by an audiologist.

(K) "Director" means the director of health in the state of Ohio or person designated by the director of health.

(L) "Discharge" means the release of a patient from a hospital or freestanding birthing center to a non-institutional setting.

(M) "Freestanding birthing center" has the same meaning as the term is defined in section 3702.51 of the Revised Code.

(N) "Filed" means received by the director.

(O) "Guardian" has the same meaning as the term is defined in section 2111.01 of the Revised Code.

(P) "Healthcare facility" means any of the following:

(1) A hospital that is registered under section 3701.07 of the Revised Code;

(2) A free standing birthing center as defined in section 3702.51 of the Revised Code; or

(3) A building, office, clinic, or other location in which a physician or an audiologist is licensed to practice in Ohio and provides hearing evaluations.

(Q) "Hearing clerk" means an integrated perinatal health information systems (IPHIS) user with the ability to enter data on the hearing screening tab.

(R) "Hearing loss" refers to a permanent loss of hearing in one or both ears in the frequency region important for speech recognition and comprehension.

(S) "Hearing screening" means the use of a physiologic test in each ear to identify newborns and infants who may have hearing loss.

(T) "Hospital" means an institution classified and registered as a hospital under section 3701.07 of the Revised Code that has a maternity unit or newborn nursery.

(U) "In collaboration with a physician or audiologist" means a formal arrangement between the individual conducting the screening and the physician or audiologist responsible for the oversight of the facility's hearing screening program. The formal arrangement must provide that the physician or audiologist is continuously available to communicate with the individual conducting the screening.

(V) "Infant" means a child who is at least thirty days but less than twenty-four months old.

(W) "Maternity unit" means any unit or place in a hospital where women are regularly received and provided care during all or part of the maternity cycle, except that "maternity unit" does not include an emergency department or similar place dedicated to providing emergency health care.

(X) "Medical home" means the primary care team led by a physician managing health care delivery for patients with the goal of maximizing health outcomes.

(Y) "Newborn" means a child who is less than thirty days old.

(Z) "NICU" means neonatal intensive care unit" and is a facility in which a neonatologist provides primary care for the infant.

(AA) "Non pass result (Refer)" means the newborn did not pass the hearing screening in the test ear at the time of screening and requires follow up.

(BB) "Nursery" means any area, including an individual patient room, in a hospital or freestanding birthing center where a newborn or infant is housed prior to being discharged into the custody of his or her parent, guardian, or custodian other than for transport to another hospital. Nurseries are divided into three categories:

(1) Level I nursery: a unit that provides basic, well-infant care.

(2) Level II nursery: a unit that provides specialty care by a neonatologist.

(3) Level III nursery: a unit that provides both specialty and subspecialty care including the provision of life support.

(CC) "Parent" means either parent, unless the parents are separated or divorced or their marriage has been dissolved or annulled, in which case "parent" means the parent who is the residential parent and legal custodian.

(DD) "Pass result" means the newborn did pass the hearing screening in the test ear at the time of screening and does not requires follow up; but is likely to demonstrate a low risk for hearing loss.

(EE) "Patient-identifying information" means individually identifiable information relating to the past, present or future physical or mental health or condition of an individual, provision of health care to an individual, or the past, present or future payment for health care provided to an individual.

(FF) "Physician" means an individual authorized under Chapter 4731. of the Revised Code to practice medicine and surgery or osteopathic medicine and surgery.

(GG) "Physiological screening" means a screening method that can detect a response to acoustic stimulation from the cochlea or the brainstem.

(HH) "Provider" means the hospital or freestanding birthing facility that provided a hearing screening under rule 3701-40-02 of the Administrative Code.

(II) "Recommendations from the joint committee on infant hearing" means the year 2007 position statement: "Principles and Guidelines for Early Hearing Detection and Intervention Programs," as published in Pediatrics, volume 120, number 4, October 2007, pages 898-921. The web link ishttp://pediatrics.aappublications.org/content/120/4/898.full.

(JJ) "Regional infant hearing program" means a regional program that is funded by the Ohio department of health, to provide statewide coverage for follow along and tracking of newborns or infants who do not pass a newborn or infant hearing screening, and provide services for families with newborns, infants and toddlers who are deaf and hard of hearing.

(KK) "Screening methods" means automated otoacoustic emissions screening and automated auditory brainstem evoked response.

(LL) "Third party payer" means any person or agency, government or otherwise, other than the department of health, that provides reimbursement for hearing screenings for newborns and infants.

(MM) "Transfer" means the release of a patient from a hospital or freestanding birthing center to another healthcare facility, which undertakes responsibility for the patient.

Replaces: 3701-40-01

Effective: 11/12/2013
R.C. 119.032 review dates: 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.504
Rule Amplifies: 3701.503 , 3701.505 , 3701.506 , 3701.507 . 3701.508 , 3701.509 , 3923.55 , 3923.56
Prior Effective Dates: 2/1/2003, 5/19/08

3701-40-02 Hearing screening requirements for hospitals and freestanding birthing centers.

(A) Each hospital and each freestanding birthing center shall:

Designate a hearing screening coordinator who is responsible for the coordination of the facility's hearing screening program. The coordinator shall be an individual with staff privileges at the facility and either:

(1) A physician or audiologist; or

(2) An individual working under the supervision of or in collaboration with a physician or audiologist.

(B) Each hospital and each freestanding birthing center shall develop a written protocol following the recommendations of the joint committee on infant hearing for these criteria:

(1) Conduct hearing screenings on all newborns born, admitted, or transferred into a hospital or free-standing birthing center prior to discharge, or when determined to be medically appropriate.

(2) Conduct a second hearing screening when the newborn or infant does not pass the first hearing screening in:

(a) Well baby (level I) nurseries; and

(b) Special care (level II and III) and NICU nurseries.

(3) Communicate the results of the hearing screening for every newborn or infant to the attending physician, certified nurse-midwife, certified nurse practitioner, primary care physician, or designated medical home to include:

(a) Results of the hearing screening for each ear;

(b) Type of hearing screening; and

(c) Risk factors for hearing loss, if any.

(4) Report the following categories of infants to the attending physician, certified nurse midwife, certified nurse practitioner, primary care physician, or designated medical home within forty-eight hours of discharge for:

(a) Infants who did not pass a hearing screening; and

(b) Infants who were discharged from the facility without a hearing screening.

(5) Communicate written results of the newborn or infant's hearing screening to the parent, guardian, or custodian prior to discharge to include:

(a) Results of the hearing screening for each ear; and

(b) Type of hearing screening; and

(c) Risk factors for hearing loss, if any.

(6) Provide the parent, guardian or custodian of a newborn or infant that did not pass the hearing screening or did not receive a hearing screening with the following prior to discharge:

(a) A referral to audiologist for hearing evaluation; and

(b) Assistance in scheduling an appointment for hearing evaluation before discharge; and

(c) Information on the importance of making and keeping an appointment for a hearing evaluation; and

(d) A list of audiology facilities where newborn hearing screenings and evaluations are conducted within a sixty mile radius of the family's home.

(7) Provide the parent, guardian, or custodian of every newborn with printed information provided by the department as outlined in paragraph (D) of rule 3701-40-10 of the Administrative Code, prior to discharge including obtaining the signature of the parent, guardian, or custodian indicating receipt of the information.

(8) Notify the director of the name and contact information of the individual designated as the hearing screening coordinator, the supervising physician or audiologist, the birth clerk, and the hearing clerk on an annual basis and whenever changes occur.

(9) Report the following categories of infants to the director of ODH, in the manner and format prescribed, within ten days of initial screening, discharge, or transfer:

(a) Infants who received a hearing screening and the results of the hearing screening;

(b) Infants who did not receive a hearing screening and the reason(s) not screened;

(c) Infants whose parents, guardian, or custodian objected to a hearing screening; and

(d) Infants who were transferred to or from another hospital.

Hospitals and free standing birthing facilities reporting transferred infants shall also report the name of the hospital facility the infant was transferred to or from.

(10) Report to the director, for each infant, the name and address of the primary care physician, the certified nurse-midwife, certified nurse practitioner, or medical home where the parent will take the newborn or infant for followup care after discharge.

Replaces: 3701-40-02

Effective: 11/12/2013
R.C. 119.032 review dates: 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.504
Rule Amplifies: 3701.503 , 3701.505 , 3701.506 , 3701.507 , 3701.508 , 3701.509 , 3923.55 and 3923.56
Prior Effective Dates: 2/1/2003, 5/19/2008

3701-40-03 Requirements for boards of health.

(A) Each board of health registrar, upon notification of the birth of a newborn or infant born in the area served by the board, who is not born in a hospital or freestanding birthing center, shall, within ten business days of the receipt of notification:

(1) Distribute the printed information prepared by the director in accordance with paragraph (D) of rule 3701-40-10 of the Administrative Code, to the parent, guardian, or custodian of every newborn or infant whose birth is registered by the board of health, including

(a) Information about hearing loss; and

(b) A list of audiology facilities where newborn hearing screenings and/or evaluations are conducted within a sixty mile radius of the family's home.

(2) Obtain a signature from the parent, guardian, or custodian of every newborn or infant whose birth is registered at the board of health, using the form prepared by the director, indicating that they have received the printed information and list of audiologists.

(3) If the parent, guardian, or custodian refuses to sign the form, the board of health shall document the refusal to sign the form in the signature space.

(B) Each board of health shall annually report to the director in a format prescribed by the director:

(1) The number of newborns registered;

(2) The number of parents, guardians, or custodians receiving the printed materials and list of audiologists; and

(3) The number of parents, guardians, or custodians who signed that the information was received.

Replaces: 3701-40-03, 3701-40-08

Effective: 11/12/2013
R.C. 119.032 review dates: 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.506 , 3701.509
Prior Effective Dates: 2/1/2003, 5/19/08

3701-40-04 Objections to hearing screening.

(A) The parent, guardian or custodian of a newborn or infant may object to a hearing screening on the grounds that the hearing screening conflicts with the parent's, guardian's or custodian's religious tenets and practices or for reasons other than religious tenets and practices.

(B) A parent's, guardian's or custodian's refusal to consent to a hearing screening must be documented on a form provided by the director or in a written statement signed by the parent, guardian or custodian. A refusal set forth in a written statement must include all of the following:

(1) The parent, guardian or custodian is fully informed and understands the possible consequences to their child's health resulting from undetected and untreated hearing loss;

(2) The parent, guardian or custodian has received hearing screening information;

(3) The parent, guardian or custodian is objecting on the grounds that the screening conflicts with their religious tenets and practices, or for reasons other than religious tenets and practices; and

(4) The parent, guardian or custodian releases and holds harmless the director, the hospital or freestanding birthing center, the person responsible for conducting the hearing screening, for any injury, illness, and/or consequences which may result from such refusal.

(C) If the parent, guardian, or custodian of a newborn or infant objects to a hearing screening and refuses to sign the form or written statement, the hospital or freestanding birthing center shall document the parent's, guardian's, or custodian's refusal to sign the objection form or statement.

(D) A signed copy of the objection form or written statement shall be sent to the director within ten days of completion.-.

Effective: 11/12/2013
R.C. 119.032 review dates: 08/16/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.508
Prior Effective Dates: 2/1/2003

3701-40-05 Qualifications of personnel conducting hearing screenings.

(A) A hearing screening conducted under rule 3701-40-02 of the Administrative Code shall be conducted under the direction of an audiologist or physician or in collaboration with an audiologist or physician.

(B) Any individual conducting hearing screenings must complete annual training addressing at a minimum the following topics:

(1) The significance of and rationale for universal newborn hearing screening;

(2) Reasons for a "non-passing" result and the need for further screening and evaluation;

(3) Conveying information to parents, guardians or custodians in a culturally competent manner and in accordance with written materials prepared by the director; and

(4) Usage of hearing screening equipment to include hands-on-training with newborns, competency evaluation, skills demonstration and written testing.

(C) All training of individuals conducted pursuant to this paragraph shall be completed prior to the administration of a hearing screening and on an annual basis thereafter and made available to the director upon request.

Effective: 11/12/2013
R.C. 119.032 review dates: 08/16/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.505 , 3701.508
Prior Effective Dates: 2/1/2003, 5/19/2008

3701-40-06 Hearing screening and equipment requirements.

(A) Each hospital and freestanding birthing center required to conduct a hearing screening on a newborn or infant shall, before discharge, conduct a hearing screening on each ear of every newborn or infant born in, admitted to or transferred into a hospital or freestanding birthing center through the use of a physiologic test.

(B) The hospital and freestanding birthing center shall conduct a second screening on newborn or infant, if the first screening in either ear was a non-pass.

(C) The second screening shall

(1) Be a physiological test,

(2) Test both ears, and

(3) Be completed prior to discharge.

(D) The hospital or facility shall conduct only two hearing screenings prior to discharge unless there is clearly an equipment error or an error in administering the screening. Only two complete hearing screenings shall be reported to the director.

(E) The equipment used for screening shall be capable of giving reliable results, maintained in good working order, and calibrated annually per manufacturer's guidelines,

(F) The hospital or free standing birthing facility shall have a contingency plan for continued provision of hearing screening when equipment is malfunctioning or awaiting repair or replacement.

Replaces: 3701-40-06

Effective: 11/12/2013
R.C. 119.032 review dates: 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.504 , 3701.505 , 3701.508
Prior Effective Dates: 2/1/2003, 5/19/2008

3701-40-07 Reimbursement for hearing screening.

(A) The director shall reimburse providers for a maximum of one hearing screening per newborn or infant in accordance with this rule at a rate determined by the director if all the following criteria are met:

(1) The screening is performed before the newborn or infant is discharged by the provider;

(2) The parent, guardian, or custodian certifies with a signed statement that the family

(a) Is financially unable to pay for the screening;

(b) Is not eligible for medicaid; and

(c) Does not have insurance coverage for the screening.

(3) The provider is not reimbursed by a third-party payer.

(B) The provider seeking reimbursement from the director for a hearing screening shall submit an invoice for reimbursement to the director no later than twelve months after the completion of the screening. The invoice shall contain at least the following information:

(1) The name and address of the provider of the screening;

(2) The name and Ohio license number of the audiologist performing or supervising the performance of the hearing screening or the name and license number of the physician performing or supervising the hearing screening;

(3) The date and nature of service provided and the amount of the charge for this service;

(4) The name and date of birth of the newborn or infant screened;

(5) The name and address of the newborn's or infant's parent, guardian, or custodian;

(6) A written statement signed by the newborn's or infant's parent, guardian, or custodian attesting to an inability to pay for the screening and explaining the circumstances and reasons why the individual is unable to pay;

(7) Documentation of compliance with paragraph (D) of this rule; and

(8) Signature of the billing agent.

(C) The provider shall:

(1) Submit claims for all third-party benefits, including medicaid, for which the newborn or infant may be eligible, which may provide payment for the screening;

(2) Make all reasonable efforts to assist the parent, guardian, or custodian of the newborn or infant who was screened to submit claims and appeal denials for third-party benefits; and

(3) Provide any information necessary for processing the claims.

(D) Claims for third-party benefits shall have been submitted no less than sixty days before a request for payment is submitted to the director under this rule.

(E) The director shall not make payment for the screening under this rule:

(1) If any payment is made by the medicaid program established by Chapter 5111. of the Revised Code; and

(2) If the newborn's or infant's parent, guardian, or custodian has applied for medicaid reimbusement; and

(a) The medicaid program has not denied payment for the screening; and

(b) The medicaid administrative appeals process has not been exhausted by the parent, guardian, or custodian.

(F) The director shall review the request for reimbursement and may request any additional information necessary for making a determination regarding reimbursement.

(1) The provider shall file any requested information with the director no later than forty-five calendar days after the date on the director's request for additional information.

(2) The director shall deny payment if the provider has failed to comply with the requirements established by this rule or if the criteria for payment prescribed by paragraph (B) of this rule have not been met.

(G) Providers reimbursed by the director, medicaid or any third party payers for a hearing screening shall accept the amount paid by the director, medicaid or any third-party payers as payment in full and shall not seek payment from the parent, guardian, or custodian. This paragraph is not intended to prohibit the provider from collecting from the parent, guardian or custodian any applicable copayment or deductible when payment is made by a third party payer.

(H) The director shall send written notification to the provider of:

(1) A decision to deny reimbursement under this rule; and

(2) Procedures for reconsideration.

(I) The provider may submit a written request for reconsideration no later than thirty calendar days after the date on the notice of the proposed action and shall provide:

(1) A statement of the reasons why the provider believes that the proposed decision is incorrect or inappropriate; and

(2) Any written documentation, arguments, or other materials that the provider wishes to sumit in defense of the claim.

(J) For the purposes of reconsideration, the director may request from the provider additional relevant records of documentation within forty-five calendar days of receipt of the request for reconsideration or of additional information previously submitted under this paragraph. The provider shall file any requested information with the director no later than forty-five calendar days after the date on the request for additional information.

(K) Within forty-five calendar days after receipt of a request for reconsideration from the provider that complies with paragraph (G) of this rule and of all necessary additional information requested and timely filed under paragraph (H) of this rule, the director shall notify the provider who requested the reconsideration, in writing, of his decision on reconsideration. The director's decision rendered upon reconsideration shall be final.

Effective: 11/12/2013
R.C. 119.032 review dates: 08/16/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.505 , 3701.508
Prior Effective Dates: 2/1/2003, 5/19/2008

3701-40-08 Hearing evaluations.

(A) Infants that do not pass a hearing screening shall be immediately referred to an audiologist with expertise in evaluating newborns and infants for further examination.

(B) Protocols for hearing evaluation should be consistent with protocols in the recommendations from the joint committee on infant hearing.

(C) Any audiologist that conducts a hearing evaluation of a newborn or infant referred to such provider shall report the diagnostic hearing evaluation results to the director, in the manner and format prescribed by the director, upon confirmation of the infant's hearing status.

All diagnostic results shall be reported to the director within seven business days.

Replaces: 3701-40-08

Effective: 11/12/2013
R.C. 119.032 review dates: 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.504 , 3701.508 , 3701.509
Prior Effective Dates: 2/1/2003, 5/19/2008

3701-40-09 Hearing screening tracking and follow-up.

(A) Patient identifying information, submitted to the department of health under rule 3701-40- 02 of the Administrative Code by hospitals, freestanding birthing centers, or boards of health, shall be used by the director to maintain the statewide tracking and early intervention components of the program.

(B) The department of health shall provide patient-identifying information to other entities such as the regional infant hearing programs, help me grow programs, and other programs, bureaus, service providers, state agencies, individuals, or departments as it considers necessary to maintain the statewide tracking and early intervention components of the program established under section 3701.504 of the Revised Code.

(C) The department of health and any entity that receives patient-identifying information from the department shall maintain the confidentiality of the information.

Effective: 11/12/2013
R.C. 119.032 review dates: 08/16/2013 and 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.508 , 3701.509
Prior Effective Dates: 2/1/2003

3701-40-10 Ohio department of health training and materials.

(A) The director shall provide educational programs for personnel conducting and documenting newborn hearing screenings including hearing screening coordinators, screeners, supervising audiologists, supervising physicians, data entry personnel, local boards of health, and any other persons identified as responsible for conducting, documenting, and reporting newborn hearing screening information and diagnostic evaluations.

(B) Educational programs may be provided as computer based learning, self study modules, teleconferences on selected topics, or classroom experiential training at the discretion of the director.

(C) The director shall provide training for personnel including the following:

(1) The significance of universal newborn hearing screening, risk factors for hearing loss, and the importance of diagnostic follow-up and early intervention for infants with a permanent hearing loss,

(2) Conveying culturally appropriate messages to families about the importance of screening, follow-up for non-pass screening results, early intervention for hearing loss, and developmental milestones for speech and language acquisition,

(3) Documenting and completing paper and electronic records, including quality assurance activities, and

(4) Requirements for reporting hearing screenings, diagnostic evaluation results, and board of health registrations.

(D) The director shall make written materials available to hospitals, birth facilities, and local boards of health as follows:

(1) Culturally appropriate information for parents and caregivers of infants on the importance of hearing screening, hearing evaluation, early intervention, and speech and language acquisition milestones, and

(2) A listing of pediatric audiology facilities and healthcare facilities where hearing screenings and diagnostic hearing evaluations are conducted.

Replaces: 3701-40-10, 3701-40-11

Effective: 11/12/2013
R.C. 119.032 review dates: 11/01/2018
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.506 , 3701.508
Prior Effective Dates: 2/1/2003

3701-40-11 [Rescinded] Ohio department of health training.

Effective: 11/12/2013
R.C. 119.032 review dates: 08/16/2013
Promulgated Under: 119.03
Statutory Authority: 3701.508
Rule Amplifies: 3701.506 , 3701.508
Prior Effective Dates: 2/1/2003

3701-40-12 Implementation of this chapter. [Rescinded].

Rescinded eff 5-19-08