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Unless otherwise indicated, the following definitions apply throughout this subchapter:

(1) "Applicant" means a child or youth with special health care needs (CYSHCN) who has applied or whose parent or guardian has applied on the child's behalf to receive children's special health service (CSHS) financial assistance from the department.

(2) "Child or Youth with Special Health Care Needs" (CYSHCN) means a child or youth, under the age of 22, who has or is at increased risk for chronic physical, developmental, behavioral, or emotional condition and who also requires health and related services of a type or amount beyond that required by children generally.

(3) "Client" means a CYSHCN who is eligible to receive CSHS financial assistance as determined by the department under this subchapter.

(4) "CSHS" means the children's special health services program of the department, authorized by 50-1-202, MCA, that serves children and youth with special health care needs.

(5) "Department" means the Montana Department of Public Health and Human Services.

(6) "Disability" or "disabling condition" means a chronic physical, developmental, behavioral or emotional condition requiring health and related services of a type or amount beyond that required by children generally.

(7) "Disabled" means having any physical defect or characteristic, congenital or acquired, that prevents or restricts normal growth or capacity for activity.

(8) "Eligibility year" means the federal fiscal year in which a CYSHCN receives CSHS direct payment financial assistance.

(9) "Enabling services" means nonclinical services that enable individuals to access health care and improve health outcomes. Enabling services include, but are not limited to: case management, care coordination, referrals, home visiting, respite care, specialized daycare or preschool, translation/interpretation, transportation, eligibility assistance, health education for individuals or families, and outreach.

(10) "Family" means a group of related or non-related individuals who are living together as a single economic unit.

(11) "Federal fiscal year" means the period beginning October 1 and ending the following September 30.

(12) "Financial Assistance" means payment by the department for CSHS-authorized treatment and enabling services for a CYSHCN eligible for the CSHS program.

(13) "HMK" means Healthy Montana Kids (Children's Health Insurance Program or CHIP) insurance plan administered by the department.

(14) "HMK Plus" means Healthy Montana Kids Plus (children's Medicaid) plan administered by the department.

(15) "Initial diagnosis and evaluation" means taking a medical history and performing a physical examination, medical procedures, laboratory tests, hearing and other diagnostic tests, or other procedures necessary for the diagnosis of a condition.

(16) "Poverty income guidelines" means the poverty income guidelines published in 2018 in the Federal Register by the U.S. Department of Health and Human Services. The department adopts and incorporates by reference the federal poverty guidelines that establish income thresholds according to family unit size for purposes of determining eligibility for government assistance or services and that are published in the January 2018, Federal Register. A copy of the 2018 poverty guidelines may be obtained from the Department of Public Health and Human Services, Public Health and Safety Division, Children's Special Health Services Program, 1400 Broadway, Rm A-116, Helena, MT 59620, telephone (406) 444-3617.

(17) "Program" means the department's children's special health services program for a CYSHCN, authorized by 50-1-202, MCA.

(18) "Provider" means a supplier of medical care or services, enabling services, interventions, medical appliances, prescribed medications, formula or foods, and consultations.

(19) "Risk category" means any condition of a child or youth's life which qualifies them as being at an increased risk for chronic physical, development, behavioral, or emotional condition, further qualifying them as a CYSHCN. This may include but is not limited to: living in poverty, in the foster care or Child Protective Services system, having a parent with a disabling condition, multiple adverse childhood experiences, or homelessness.

(20) "Services" means enabling or treatment services covered by the rule.

(21) "Special Health Care Need" means a chronic condition that requires

health and related services of a type or amount beyond that generally required by children.

(22) "Third-party payer" means a public or private entity that is or may be liable to pay all or part of the medical costs for a client.

(23) "Treatment" means medical, corrective, and/or surgical intervention to alleviate a disabling condition or as recommended by a provider based on a CYSHCN's risk category, including for initial testing and diagnosis. This includes medications and medical equipment.

(1) In order to receive CSHS financial assistance for a particular benefit a CYSHCN must meet the eligibility requirements of ARM 37.57.106.

(1) Eligibility criteria for CSHS financial assistance are:

(a) an individual under the age of 22 who meets the definition of a child or youth with special health care needs (CYSHCN);

(b) a resident of the state of Montana and either a U.S. citizen or a qualified alien as defined under federal statute; and

(c) in need of a treatment or enabling services related to their disabling condition or risk category, which is recommended by a medical professional, where an out-of-pocket expense would be the responsibility of the family and no other means of payment is available to cover the out-of-pocket expenses.

(2) Family income must be verified to determine eligibility. CSHS will request documentation of income from the applicant.

(a) Family income may include one or more of the following:

(i) the income of both parents if the child resides with both parents;

(ii) the income of the parent with whom the child resides the majority of the year, including any child support received for the child, if the child resides with one parent in a single parent household;

(iii) if the parent with whom the child resides the majority of the year has remarried, the stepparent's income is imputed to the parent's income with whom the child resides the majority of the year; and

(iv) the income of individuals under the age of 19 who live in the home but do not attend school is imputed to the parent with whom the child resides the majority of the year.

(b) Family income does not include:

(i) money received from assets drawn down such as withdrawals from a savings account, an annuity, or for the sale of a house or car;

(ii) gifts, loans, one-time insurance payments, or lump sum compensation for an injury;

(iii) the first $2,000 of an enrolled tribal member's per capita payment; or

(iv) the first $2,000 of an enrolled tribal member's tribal land income.

(i) $1,440 per year for each family member whose earned income is counted;

(ii) $2,400 per year, regardless of the actual expense amount, for each individual for whom dependent care is paid out-of-pocket and the care is provided so a parent can work, look for work, or attend school; and

(iii) out-of-pocket expenses for health insurance premiums.

(d) A family whose income, less any out-of-pocket expenses for health insurance premiums, care expenses for children, disabled or elderly adults while adults are working, and earned income disregards is at or less than 300% of the federal poverty income guidelines and one of the following:

(i) ineligible for HMK Plus or HMK;

(ii) eligible for HMK Plus or HMK, but in need of services or financial assistance that are not covered by HMK Plus or HMK, or determined inaccessible but are covered by CSHS; or

(iii) potentially eligible for HMK Plus or HMK from information provided on the application, the family will be referred to the county office of public assistance for HMK Plus or HMK eligibility determination.

(3) Eligibility for program financial assistance will be determined within 30 days of receipt of the application by the department.

(4) Eligibility begins on the date an application is received by CSHS and continues for the duration of the federal fiscal year in which the application is received unless the age of the CYSHCN precludes them from participation or the CYSHCN no longer resides in Montana. Services provided up to six months prior to the date of eligibility are reimbursable by CSHS.

(5) A new or renewal application for a subsequent year must be submitted to the department in order for the department to determine if eligibility is to continue and must be completed and approved before any CSHS financial assistance in a subsequent year may be provided.

(6) A CYSHCN attending an interdisciplinary team pediatric specialty clinic funded by CSHS does not need to apply for financial assistance to cover the cost of clinic visits.

(1) A person who desires CSHS financial assistance for a CYSHCN must submit a completed CSHS financial assistance application, along with required supporting documents. This application is available by contacting CSHS at 1-800-762-9891 or visiting www.cshs.mt.gov.

(2) If the department notifies the applicant that the application is incomplete, the requested missing information must be received by CSHS within six weeks from the date of notification; otherwise the application will be considered inactive. If the requested information is subsequently received and the CYSHCN is found to be eligible, the eligibility year will begin on the date the additional requested information is received.

(3) If the CYSHCN is determined ineligible, the department will send the applicant a written notice stating the reasons for ineligibility and explaining how an informal reconsideration of its determination may be obtained pursuant to ARM 37.57.112.

(4) When the CYSHCN is determined eligible, the department will send the applicant a written notice specifying which services are eligible for CSHS financial assistance and the term of eligibility.

This rule has been repealed.

(1) The department will provide financial assistance for a CSHS-eligible CYSHCN with a covered condition:

(a) if the benefit is not covered by another payment source, with the exception of the Indian health service (IHS), which is a payer of last resort;

(b) if the department has sufficient federal funds to provide the benefit;

(d) for a CYSHCN under age three, CSHS will pay after the early intervention program, part C, of the disabilities services division; and

(e) after all third parties, if any, have paid the provider, in which case the department pays any balance remaining for services to the lower of the health care coverage allowed amount or the CSHS allowed amount for the services in question.

(2) When possible, CSHS will pay providers directly for CSHS-eligible services and will not reimburse clients. Clients may be reimbursed if the services were rendered prior to eligibility and proper documentation is provided as requested by CSHS.

(3) The department will pay eligible providers after the department receives a signed authorization, claim form, or invoice, and requested documentation that the care has been provided.

(4) Any individual who erroneously or improperly receives payment from the department must promptly refund that payment to the department.

(5) A provider who accepts the CSHS level of payment for covered services may not seek additional payment from a CSHS client or their family.

(6) The department will pay up to the following limits for orthodontia care:

(a) Orthodontia may only be covered for CYSHCN who have a medical condition with orthodontic implications. This may include but is not limited to: cleft/craniofacial anomalies, facial deformities, speech impediments, Treacher-Collins Syndrome, Marfan Syndrome, or Craniosynostosis.

(7) For services to a CSHS client, a provider will be paid 85% of the actual submitted charge. If the CSHS client has third-party coverage, the department will pay the remaining balance for services to the lower of the health care coverage allowed amount or the CSHS allowed amount of the approved services.

(8) In addition to the above, the department will pay:

(a) the lesser of either the actual charge for drugs and other prescribed supplies, or the wholesale price cited, less 15%, plus a dispensing fee on the Medicaid point-of-sale system;

(b) 85% of the cost of durable medical equipment to the appropriate amount when allowing financial assistance, or to the maximum amount set by the program for the federal fiscal year;

(c) 85% of the cost of specialized formula and foods and prescriptive or nonprescriptive medications prescribed by a physician for inborn errors of metabolism; and

(d) 85% of the cost of syringes and disposable medical equipment for the treatment of covered conditions.

(9) A CYSHCN who attends interdisciplinary pediatric specialty clinics, supported by CSHS, is not responsible for copays, deductibles, or coinsurance, nor will they be balance-billed.

(1) A CYSHCN who has been denied eligibility for CSHS, a provider who has been denied reimbursement for services or covered benefits, or anyone who is otherwise adversely affected by denial for CSHS financial assistance may have informal reconsideration. The party requesting such a reconsideration must do so within 60 days after notice of the adverse action in question has been placed in the mail or otherwise communicated to the aggrieved party.

(2) A request for a reconsideration, in order to be considered, must be in writing, include refutation of the department's findings, and be postmarked no later than the 60th day after notice of the adverse action referred to in (1) was given.

(3) If the department receives a request for an informal reconsideration, it will conduct the reconsideration within 30 days after the date the request is received unless both the requestor and the department agree to a later date.

(4) An informal reconsideration will be conducted in accordance with the procedures prescribed for informal reconsideration in ARM 37.5.311, with the exceptions noted in (1) and (5). Such informal reconsideration is not subject to the provisions of the Montana Administrative Procedure Act, Title 2, chapter 4, MCA, or, except as provided in this rule, the provisions of ARM 37.5.304, 37.5.307, 37.5.310, 37.5.313, 37.5.316, 37.5.318, 37.5.322, 37.5.325, 37.5.328, 37.5.331, 37.5.334 and 37.5.337.

(5) In addition to the procedures specified in ARM 37.5.311, an applicant shall be provided an opportunity to appear and present evidence and arguments in person.

(6) The decision by the department after an informal reconsideration is final.

(1) In order to be a CSHS provider for a CSHS client, a provider must meet the following requirements:

(a) A physician or surgeon must:

(i) be currently licensed by the state of Montana pursuant to Title 37, chapter 3, MCA, or currently licensed to practice medicine in the state in which they reside;

(ii) provide the department, upon request, with adequate documentation of credentials needed to prove program eligibility.

(b) An orthodontist must:

(i) be currently licensed as a dentist in the state of Montana or the state of residence;

(ii) have completed two years of graduate or post-graduate orthodontic training recognized by the council of dental education of the American dental association or the American orthodontic association; and

(iii) limit their practice to the area of orthodontics.

(i) be currently licensed as a dentist by the state of Montana or the state of residence; and

(ii) have completed a minimum of two academic years of a graduate or post-graduate pediatric dentistry program accredited by the council on dental accreditation of the American dental association.

(d) A hospital must be accredited by the joint commission of accreditation of healthcare organizations and be currently licensed and certified by the department, if in-state, or by the state in which it is located, if out-of-state.

(e) Any provider other than those listed in (1)(a) through (1)(d) must be certified and/or licensed by the appropriate Montana authority, or if Montana has no certification or licensure requirements for the provider, be certified by a nationally recognized professional organization in the provider's area of expertise.

(2) A provider must immediately supply the department with requested reports to permit effective evaluation of claims.

(3) A provider must accept CSHS level of payment for services and may not seek additional payment from a CSHS client or family.

(1) The department will retain specialty clinic participants case files of CSHS services provided for a client for a period of five years after the child reaches the age of 18 as set forth in the Montana Secretary of State records retention schedule, records series title "Specialty Clinic Participant Case Files."

(2) Prior to destroying specialty clinic participant case files, the department will advertise that the case files may be obtained by those to whom they pertain by publishing a notice in Montana's major newspapers once per week for three consecutive weeks.

(3) Case files remaining unclaimed for three months after the public notice described in (2) is completed will be destroyed after the department receives the approval of the state records committee required by 2-6-212, MCA.

(4) The department will retain CSHS financial assistance case files for five years from the last service date, as set forth in the Montana Secretary of State records retention schedule, records series title "Financial Assistance Case Files."

(5) The financial assistance case files will be destroyed after the program receives approval from the state records committee required under 2-6-212, MCA.

(6) The department will retain CSHS clinic billing files for five calendar years as set forth in the Montana Secretary of State records retention schedule, record series title "Clinic Billing Reimbursement Records."

(7) Clinic billing files will be destroyed after the program receives approval from the state records committee required under 2-6-212, MCA.

(8) The department will retain all electronic data as set forth in the Montana Secretary of State records retention schedule, records series title "CHRIS Files."

This rule has been repealed.

As used in this subchapter, the following definitions apply:

(1) "Health care facility" means a hospital or other facility licensed by or located in the state of Montana for the purpose of providing health care services, and which provides primary health care services for newborns at birth.

(2) "Newborn" means an infant in the first 28 days of life.

(3) "Newborn screening tests" are screening tests, procedures, or both for the following conditions:

(a) Acylcarnitine Disorders:

(i) Fatty Acid Oxidation Disorders:

(A) Carnitine uptake defect;

(B) Long-chain L-3-OH acyl-CoA dehydrogenase deficiency;

(D) Trifunctional protein deficiency; and

(E) Very long-chain acyl-CoA dehydrogenase deficiency;

(ii) Organic Acidemia Disorders:

(A) 3-hydroxy-3-methylglutaryl-CoA lyase deficiency;

(B) 3-Methylcrotonyl-CoA carboxylase deficiency;

(D) Glutaric acidemia type I;

(E) Isovaleric acidemia;

(F) Methylmalonic acidemia (Cbl A,B);

(G) Methylmalonic acidemia (mutase deficiency);

(H) Multiple carboxylase deficiency; and

(I) Propionic acidemia;

(b) Amino Acid Disorders:

(i) Argininosuccinic acidemia;

(ii) Citrullinemia type 1;

(iii) Homocystinuria;

(iv) Maple syrup urine disease;

(v) Classic Phenylketonuria; and

(vi) Tyrosinemia type I;

(d) Classical galactosemia;

(e) Congenital adrenal hyperplasia;

(f) Primary congenital hypothyroidism;

(g) Cystic fibrosis;

(h) Hemoglobinopathies, including:

(i) Hb S/β -thalassemia;

(ii) Hb SC disease; and

(iii) Hb SS disease; and

(i) Critical congenital heart disease, including:

(i) hypoplastic left heart syndrome;

(ii) pulmonary atresia;

(iii) tetralogy of Fallot;

(iv) total anomalous pulmonary venous return;

(v) transposition of the great arteries;

(vi) tricuspid atresia;

(vii) truncus arteriosus;

(j) Severe combined immunodeficiency disease; and

(k) Spinal muscular atrophy (SMA).

(1) If a newborn is hospitalized for neonatal intensive care, a specimen of its blood must be taken for testing prior to nonrespiratory treatment and no later than 48 hours of age, unless medically contraindicated, in which case the specimen must be taken as soon as the infant's medical condition permits.

(2) In the event that the initial screening blood specimen is taken at less than 24 hours of age, another screening specimen must be taken after 48 hours of age, and no later than 7 days of age.

(3) In the event that the newborn stays in a health care facility past 7 days of age, an additional screening blood specimen must be taken either at the time of discharge if the stay is less than one month, or at one month of age if the stay is one month or longer.

(4) Hospitals providing neonatal intensive care are responsible for developing and implementing a protocol to ensure a newborn hospitalized for neonatal intensive care receives screening for critical congenital heart disease.

(1) For newborns not requiring neonatal intensive care, the required blood specimen must be taken between 24 and 48 hours of age.

(2) In the event the newborn is discharged from a health care facility prior to 24 hours of age, the blood specimen must be taken immediately before discharge and, in addition:

(a) another specimen must be taken and submitted to the department's laboratory between the second and seventh day of the newborn's life; and

(b) the health care facility must:

(i) explain the reasons why it is of utmost importance to return for these tests; and

(ii) ensure that the parent or legal guardian of the newborn signs a statement assuming responsibility to cause a specimen to again be taken between the second and seventh day of life of the newborn and to submit it to the department for testing.

(3) For newborns not requiring neonatal intensive care, a pulse oximetry screening for CCHD must be completed per the department's recommended protocol prior to discharge and after 24 hours of age and screening results reported to the department as required by this subchapter.

(4) In the event the newborn is discharged from a health care facility prior to 24 hours of age, pulse oximetry screening must be completed immediately before discharge and the health care facility must:

(a) provide education to the newborn's family on the implications of screening prior to 24 hours of age;

(b) provide information on the optimal timing of a repeat screening and a location where repeat screening can be done; and

(1) In the event of transfer of a newborn from one health care facility to another, or from a place of birth that is not a health care facility to a health care facility, a screening blood specimen must be taken and submitted by the receiving health care facility.

(2) A receiving health care facility must take specimens as necessary for follow-up tests as required by this subchapter.

(3) In the event of a transfer of a newborn from one health care facility to another, or from a place of birth that is not a health care facility to a health care facility, pulse oximetry screening for CCHD must be completed after 24 hours of age by the receiving health care facility and screening results reported to the department as required by this subchapter.

(1) When an infant is born outside of a health care facility and is not subsequently transferred to a health care facility for initial newborn care, it is the responsibility of one of the persons designated in 50-15-221(4)(a), (b), and (c), MCA, in the order of priority indicated therein, to cause the blood specimen to be taken and submitted, and to cause pulse oximetry screening to be performed as required by this subchapter.

(1) A physician, nurse-midwife, or any other person who assists at the birth of any newborn must, within the time limit stated in (3), instill or have instilled into each conjunctival sac of the newborn, erythromycin (0.5%) ophthalmic ointment or drops from single-use tubes or ampules.

(2) A prophylactic agent referred to in (1) above may not be flushed from a newborn's eyes after instillation.

(3) The prophylactic agent must be administered to a newborn within one hour after its birth unless it is physically impossible to obtain the agent within that time, in which case the agent must be administered as soon as possible.

(1) If a newborn needs a transfusion, blood specimens for the tests required by this subchapter must be taken before the transfusion takes place unless medically contraindicated.

(2) If the newborn is transfused prior to collection of the initial newborn screening specimen, a screening specimen must be taken 90 to 120 days after the last transfusion to screen for classical galactosemia and hemoglobinopathies. This specimen is in addition to those required elsewhere in this chapter.

(1) If screening results on an infant's blood specimen are within the expected or normal range the department will report the results to the submitter of the specimen and, in addition, to the infant's healthcare provider(s) upon request.

(2) If the infant's blood specimen is of unsatisfactory quality for testing, the department will notify the submitter of the need for collection of an additional specimen. The submitter must ensure collection of this specimen in a timely manner within three days of notification.

(3) If screening results on an infant's blood specimen are outside the expected or normal range:

(a) the department will report results to the submitter of the specimen and to the healthcare provider(s) for the infant. Recommendations for follow-up actions contained in the report are determined by the department;

(b) the provider(s) will ensure that all repeat screening, confirmatory testing, or both, as recommended, is collected and submitted to the department or an approved laboratory within 48 hours or as clinically appropriate;

(c) if a referral to a contracted specialist is made by the department, the specialist will ensure that all confirmatory testing results and final diagnosis are reported to the department within one week of the determination of the final diagnosis.

(4) An approved laboratory for confirmatory testing following out-of-range blood screening results includes any state or territorial health department laboratory and any laboratory within their jurisdictions which is approved by them, a U.S. public health service laboratory, a laboratory operated by the U.S. Armed Forces or Veteran's Administration, a Canadian provincial public health laboratory, and any laboratory licensed under the provisions of the Clinical Laboratories Improvement Act of 1967, as amended.

(5) Each person in charge of any health care facility and each person responsible under ARM 37.57.307 for a birth occurring outside a health care facility must report to the department regarding pulse oximetry screening per department guidelines.

(1) Each person in charge of any health care facility and each person responsible under ARM 37.57.307 for a birth occurring outside a health care facility must:

(a) ensure that a blood specimen is taken from each newborn for which the health care facility or person is responsible, in conformity with this subchapter, for the purpose of performing newborn screening tests;

(b) be certain that the specimen to be forwarded to the laboratory is adequate for testing purposes;

(c) within 24 hours after the taking of the specimen, cause such specimen to be forwarded to the department's laboratory by either courier or first-class mail or its equivalent;

(d) record in the newborn's medical record the date of taking of the test specimen and the results of the tests performed when reported by the department;

(e) ensure that pulse oximetry is performed per the department's recommended protocol for the purpose of performing newborn screening for CCHD as follows:

(i) ensure that the screening is performed on equipment that has been approved by the FDA for use on newborns and is motion tolerant;

(ii) ensure that screening is performed by licensed staff who have been trained on the screening procedure and protocol;

(iii) record in the newborn's medical record the date, time, and screening results;

(iv) ensure that the pulse oximetry screening results are reported to DPHHS as required by this subchapter;

(v) ensure that a policy and procedure is in place for immediate follow-up of a failed CCHD screen; and

(f) use educational materials provided by the department and must provide education to the newborn's family on the following:

(i) the conditions that may be detected through bloodspot screening and pulse oximetry screening;

(ii) the importance of newborn screening tests to detect potentially life- threatening conditions;

(iii) the process for collecting bloodspot screening and conducting pulse oximetry screening; and

(iv) after hearing all the benefits of newborn screening and the risks involved in refusing testing, a parent/legal guardian may refuse either of the above screenings. In that case, the parent/legal guardian must sign a waiver for the newborn's medical record in which they accept responsibility for adverse consequences. A copy of this waiver must be provided to the department.

(1) Only those newborn screening blood tests performed by the department laboratory or a laboratory approved by the department meet the requirements of 50-19-201, 50-19-202, 50-19-203, and 50-19-204, MCA.

(2) Dried blood specimens remaining after newborn screening test completion are the property of the department laboratory and will be stored for one calendar year prior to destruction. Any dried blood specimens sent to a laboratory approved by the department for testing will be destroyed after one year by the approved laboratory. An exception is made for screening specimens with results that are out of range which may be kept for quality improvement and new method development within the laboratory. These specimens may be stored by the laboratory for an indefinite period of time.

(1) "Health care provider" means a person licensed in the state of Montana to provide health care services to pregnant women and/or newborn infants and who is the primary health care provider in attendance at the birth of a newborn infant born outside of a hospital or health care facility. The term includes direct-entry midwives.

(2) "Hospital or health care facility that provides obstetric services" means any hospital or health care facility licensed by or operating in the state of Montana that routinely provides or holds itself out as providing obstetric services, without regard for the number of births actually occurring in that hospital or health care facility on an annual basis.

(3) "Newborn" means any infant from birth through 28 days of age.

(1) Each licensed hospital and health care facility shall provide education to the parents of any newborn born in the hospital or health care facility or transferred to the hospital or health care facility from the newborn's place of birth, unless the newborn has previously been provided a hearing screening test by a hospital or health care facility from which the newborn was transferred, on:

(a) hearing loss;

(b) the importance of early hearing screening; and

(2) Each licensed health care provider in attendance at any birth outside of a hospital or health care facility shall provide education to the newborn's parents on:

(a) hearing loss;

(b) the importance of early hearing screening; and

(3) Each hospital, health care facility, and health care provider required to provide newborn hearing screening education shall comply with education protocols developed by the department and shall use educational materials provided by the department. Protocols and educational materials may be obtained from the Department of Public Health and Human Services, Newborn Screening Program, Children's Special Health Services Section, Family and Community Health Bureau, P.O. Box 202951, Helena, Montana 59620-2951.

(1) Each health care provider who is required to provide newborn hearing screening education shall also provide referral information to the parents of any newborn who was born outside of a hospital or health care facility. The referral information shall identify the hospitals, health care facilities, and other health care providers in the region that are able to provide hearing screenings for newborns.

(1) Each licensed hospital or health care facility that provides obstetric services shall establish a newborn hearing screening program in order to ensure that a hearing screening is provided for each newborn born in the hospital or health care facility or transferred to the hospital or health care facility from the newborn's place of birth, unless the newborn was previously provided a hearing test by a hospital or health care facility from which the newborn was transferred.

(a) An initial hearing screening must be performed prior to the infant's discharge from the hospital or health care facility.

(b) If the results of the initial hearing screening were inconclusive or indicated a possible hearing loss, a second screening must be performed prior to the newborn's discharge from the hospital or health care facility, if possible. If a second hearing screening cannot be performed prior to the infant's discharge from the hospital, the hospital or health care facility must, prior to the discharge, work with the newborn's parents to schedule a second hearing screening for the newborn. The second screening shall be scheduled at the hospital or health care facility from which the newborn is being discharged. It shall be scheduled to occur within 30 days of the newborn's birth.

(2) Each hospital or health care facility shall use equipment designed to perform hearing screenings that utilizes either otoacoustic emissions (OAE) or auditory brainstem response (ABR) technology. Hearing screening equipment shall be maintained, calibrated, and used in strict conformance with manufacturers' guidelines.

(3) Newborn hearing screening shall be performed by staff members who are properly trained to conduct and interpret the tests and shall be performed in strict conformity with the testing protocols set by the equipment manufacturer.

(1) The hospital or health care facility shall document all hearing screening results in the newborn's chart and shall provide the hearing screening results to the parents of the newborn on the newborn's Report Card form. If the newborn hearing screening indicates a possible hearing loss, the written notification of results to the newborn's parents must include a recommendation for an audiological assessment.

(2) The hospital or health care facility shall also provide the newborn's primary care provider with written notification of the results of the newborn hearing screening. If the newborn hearing screening indicates a possible hearing loss, the written notification of results sent to the newborn's primary care provider must include a recommendation for an audiological assessment.

(1) Each hospital and health care facility required to provide newborn hearing screenings must make a report to the department each month using the department's designated reporting software regarding newborn hearing screenings.

(2) Each hospital and health care facility shall enter the following information by the 15th day of each month for each newborn born in or transferred to the hospital or health care facility during the preceding month:

(a) the newborn's full name, date of birth, gender, mother's maiden name, and the location of the newborn's birth;

(b) that the education protocol and educational materials developed by the department on newborn hearing screening were provided to the parents of the newborn;

(c) whether the facility did or did not provide a complete hearing screening to the newborn as required in ARM 37.57.407;

(d) for any newborns not fully screened, a statement of any reason(s) the newborn has not been not fully screened;

(e) if the newborn was provided an initial screening prior to discharge, and the results of that screening indicated possible hearing loss, the date scheduled for the follow-up hearing screening;

(f) all of the newborn's hearing screening results; and

(g) contact information for the newborn's primary care provider if the initial or follow-up hearing screening(s) indicated possible hearing loss.

(3) If a newborn was discharged from a hospital or health care facility after an initial screening that indicated a possible hearing loss, the hospital or health care facility shall file an updated screening report regarding the newborn's hearing screening status by the 15th day of the month immediately following the appointment date set for the second screening.

(4) By the 15th day of each month, each hospital and health care facility shall provide the department a signed facsimile copy of any completed parent refusal form for each baby born in the previous month who did not receive newborn hearing screening or who did not have complete hearing screening because the parent refused the initial or follow-up screening. The refusal form used by the hospital or health care facility must contain at minimum the content of the "Parental Attestation of Refusal of Newborn Hearing Screening" form distributed as a suggested template by the department.

(1) Each licensed health care provider in attendance at any birth occurring outside a hospital or health care facility shall file a report with the department that documents:

(a) the newborn's full name, date of birth, gender, mother's maiden name, and the location of the newborn's birth;

(b) that the education protocol and educational materials developed by the department on newborn hearing screening were provided to the parents of the newborn;

(c) that referral information has been provided to the newborn's parents which identifies the hospitals, health care facilities, and other health care providers in the area that are able to provide hearing screenings for newborns.

(d) that the newborn's primary care provider, if other than the health care provider attending the birth, has been notified that newborn hearing screening has been provided to the newborn's parents.

(2) The report shall be made to the department by the 15th day of each month for the babies delivered in the previous month on a form available from the Department of Public Health and Human Services, Newborn Screening Program, Children's Special Health Services Section, Family and Community Health Bureau.

(1) Each licensed audiologist to whom an infant is referred for audiological assessment following a newborn hearing screening shall file a report with the department each month regarding the results of the infant's audiological assessment. The report shall be filed using the department's designated reporting software. The audiologist shall enter and report the following information by the 15th day of each month for each infant assessed during the previous month:

(a) the newborn's full name, date of birth, gender, mother's maiden name, and the location of the newborn's birth;

(b) the name and address of the hospital or health care facility in which the baby was born or transferred to or the name and address of the health care provider attending the birth;

(2) Each licensed audiologist to whom an infant is referred for audiological assessment following newborn hearing screening shall request written authorization from the infant's parents for the audiologist to provide the infant's identifying information and test results to the department for subsequent referral for intervention services to the Montana School for the Deaf and Blind.

(a) Authorization shall be obtained on authorization forms approved and provided by the department.

(b) The audiologist shall submit a copy of the signed authorization form to the department by facsimile or as a scanned electronic attachment within three days of the date it is signed.

(1) In order for any county or other local entity to receive federal maternal and child health (MCH) block grant funding from the department, that entity must contractually agree to the following:

(a) MCH block grant funds will be used solely for providing health services to mothers and children.

(b) No MCH block grant funds will be used to supplant local funds that would be otherwise available.

(c) MCH block grant funds will be used solely for the core maternal and child health services listed in (2) below, unless the contractor has proved to the department prior to entering into the contract that all core services have already been provided for or, through a formal needs assessment process meeting the requirements of (3) below, that the contractor has shown there is no need for the particular core service not being provided. If there is such an exception made to provision of all of the core services, the exception must be specifically set out in the contract.

(d) For every $4 of MCH block grant funding it spends, it must expend $3 from other non-federal funding sources to provide the services required of it by the contract.

(e) If the contractor has a medicaid billing mechanism in place, it will bill medicaid for services provided under the contract that qualify for medicaid reimbursement; and if a medicaid billing mechanism is not in place, the contractor will work with department staff to establish such a mechanism or to determine the feasibility of medicaid billing by the contractor, and will utilize the mechanism once it is established.

(f) No more than 10% of the funds available under the contract may be used for administration of the contract, i.e., for services that do not directly contribute to the delivery of direct services to clients; examples of administrative costs are those for bookkeeping, legal aid, and supervision by persons who are not health professionals.

(g) If the contractor conducted maternal and child health programs during the state fiscal year prior to that in which the contract is to be performed, the contractor must maintain during the term of the contract at least the same level of effort as it provided for those programs during prior fiscal year.

(h) Any grant-related income (for example, income from fees charged or donations) accruing to the contractor from activities funded, in whole or in part, under the contract will be used only to pay for the allowable costs of providing the services described in the contract, during the term of the contract or within one year thereafter. Careful documentation

of the use of grant-related income must be maintained.

(2) Core maternal and child health services are the following, when provided to pregnant women, non-pregnant women of childbearing age, infants younger than one year of age, children and adolescents 18 years of age or younger, or children with special health care needs:

(a) population based individual services, such as immunizations, public health education, and screening for health problems;

(b) enabling and non-health support services, such as outreach and referral, that ensure that persons are informed about and referred to other services and programs which they need or for which they may be eligible;

(c) direct health services, including but not limited to public health nursing, home visiting, school health services, nutrition services, health care coordination, preventive and primary care, and other specific health services meeting the specific requirements or needs of the above target groups; and

(d) addressing public health infrastructure needs, including but not limited to assessment of local health problems, health program development, augmentation of service capacity, evaluation and management, and quality assurance.

(3) In order to use MCH block grant funds for services other than the core services listed in (2) above, a contractor must use a formal needs assessment process that includes developing a broad-based and local working group composed of representatives of health professionals, educators, consumers, social services providers, business leaders, and others interested in the health needs of the groups named in (2) above, and with that group, analyzing available statistics and utilizing consensus decision-making to determine the extent to which the objectives are met that are contained in Healthy People 2000 National Health Promotion and Disease Prevention Objectives, published by the U.S. department of health and human services.

(4) In distributing MCH block grant funds, the department will give priority to the counties, regions, and communities with the least resources, the largest proportion of underserved families, and the most serious maternal and child health problems, and will determine who should have priority by utilizing objective health indicators, including, at a minimum, the following:

(a) the number of children in poverty;

(b) the number of women of childbearing age; and

(5) The calculations required by (4) above must be based on 1990 census data, updated by projections made by the census and economic information center of the state department of commerce.

(6) The department hereby adopts and incorporates by reference Healthy People 2000 National Health Promotion and Disease Prevention Objectives (DPHHS Publication No. 91-50213) , published by the U.S. department of health and human services, September, 1990, and which contains a national strategy for significantly improving the nation's health through the 1990s, and addresses prevention of major chronic illness, injuries, and infectious diseases. A copy of Healthy People 2000 may be obtained from the department's Family Health Bureau, Cogswell Building, P.O. Box 202951, Helena, MT 59620-2951 (phone: 406-444-4743 ) .