wv-wv-18530: 64-81 — BIRTH DEFECTS INFORMATION SYSTEM

6/25/2026 1:53:42 PM Office of West Virginia Secretary Of State NOTICE OF PUBLIC COMMENT PERIOD AGENCY: Health TITLE-SERIES: 64-81 RULE TYPE: Legislative Amendment to Existing Rule: Yes Repeal of existing rule:No RULE NAME: BIRTH DEFECTS INFORMATION SYSTEM CITE STATUTORY AUTHORITY: W.Va. Code §§16-1-4 and §16-40-7 COMMENTS LIMITED TO: Written DATE OF PUBLIC HEARING: LOCATION OF PUBLIC HEARING: DATE WRITTEN COMMENT PERIOD ENDS: 07/25/2026 5:00 PM COMMENTS MAY BE MAILED OR EMAILED TO: NAME: Virginia M Payne 321 Capitol Street ADDRESS: Charleston, WV 25301 EMAIL: virginia.m.payne@wv.gov PLEASE INDICATE IF THIS FILING INCLUDES: No RELEVANT FEDERAL STATUTES OR REGULATIONS: (IF YES, PLEASE UPLOAD IN THE SUPPORTING DOCUMENTS FIELD) INCORPORATED BY REFERENCE: No (IF YES, PLEASE UPLOAD IN THE SUPPORTING DOCUMENTS FIELD) PROVIDE A BRIEF SUMMARY OF THE CONTENT OF THE RULE: This rule establishes and implements a statewide birth defects information system for the collection and reporting of congenital anomalies and abnormal conditions. SUMMARIZE IN A CLEAR AND CONCISE MANNER CONTENTS OF CHANGES IN THE RULE AND A STATEMENT OF CIRCUMSTANCES REQUIRING THE RULE: Amendments to the rule include technical cleanup and updates to diagnostic codes. SUMMARIZE IN A CLEAR AND CONCISE MANNER THE OVERALL ECONOMIC IMPACT OF THE PROPOSED RULE: A. ECONOMIC IMPACT ON REVENUES OF STATE GOVERNMENT: None B. ECONOMIC IMPACT ON SPECIAL REVENUE ACCOUNTS: None C. ECONOMIC IMPACT OF THE RULE ON THE STATE OR ITS RESIDENTS: None D. FISCAL NOTE DETAIL: Effect of Proposal Fiscal Year 2026 2027 Fiscal Year (Upon Increase/Decrease Increase/Decrease Full (use "-") (use "-") Implementation) 1. Estimated Total Cost 0 0 0 Personal Services 0 0 0 Current Expenses 0 0 0 Repairs and Alterations 0 0 0 Assets 0 0 0 Other 0 0 0 2. Estimated Total 0 0 0 Revenues E EXPLANATION OF ABOVE ESTIMATES (INCLUDING LONG-RANGE EFFECT): N/A BY CHOOSING 'YES', I ATTEST THAT THE PREVIOUS STATEMENT IS TRUE AND CORRECT. Yes Virginia M Payne-By my signature, I certify that I am the person authorized to file legislative rules, in accordance with West Virginia Code §29A-3-11 and §39A-3-2. 64CSR81 TITLE 64 LEGISLATIVE RULE DEPARTMENT OF HEALTH BUREAU FOR PUBLIC HEALTH SERIES 81 BIRTH DEFECTS INFORMATION SYSTEM §64-81-1. General. 1.1. Scope. -- This rule establishes and implements a statewide birth defects information system for the collection and reporting of congenital anomalies and abnormal conditions. This rule should be read in conjunction with W. Va. Code §§16-1-18 and §16-40-1 et seq. The W. Va. Code is available in public libraries and on the Legislature’s web page, http://www.legis.state.wv.us/. 1.2. Authority. -- W.Va. Code §§16-1-4 and §16-40-7. 1.3. Filing Date. -- April 29, 2004. 1.4. Effective Date. -- April 29, 2004. 1.5. Sunset. -- This rule shall terminate and have no further force or effect on August 1, 2032. §64-81-2. Application and Enforcement. 2.1. Application. -- This rule applies to all infants born in West Virginia and to the health care providers caring for children at birth and up to the age of six (6) that are diagnosed with a congenital anomaly or abnormal condition based upon national standards. 2.2. Enforcement. -- This rule is enforced by the commissioner of the Bureau for Public Health. §64-81-3. Definitions. All terms contained in this rule shall have the same meaning as set forth in W. Va. Code §16-40-1. This section sets forth definitions for terms that are not otherwise defined, but that appear through this rule 3.1. Advisory Council. -- The committee appointed pursuant to W. Va. Code §16-40-6 to advise on the establishment and implementation of the birth defects information system. 3.2. 3.1. Birth Defects Information System -- The data base that contains individual case demographic and diagnostic information maintained by the Office of Maternal, Child and Family Health within the Bureau for Public Health. 3.3. 3.2. Congenital Anomaly and Abnormal Condition. -- An abnormality of the body’s structure or inherent function present at birth, whether the abnormality is detected at the time of delivery or becomes apparent at a later date. 3.4. Freestanding Birthing Center. -- A health care facility in which births routinely occur, that is not licensed under W. Va. Code §16-5B-1 et seq. 3.5. 3.3. Health Care Providers. -- A physician, or his or her designee, at any medical facility 1 64CSR81 including, but not limited to private clinics, health departments, and hospitals. 3.6. Hospital. -- A facility licensed as a hospital pursuant to W. Va. Code §16-5B-1 et seq. and Welch Emergency Hospital. 3.7. Nurse-Midwife. -- An individual authorized under W. Va. Code §30-15 to practice nurse- midwifery. §64-81-4. Reporting Requirements. 4.1. Each physician, nurse-midwife, hospital, and freestanding birthing center shall provide information to the birth defects information system on all patients up to the age of six (6) that have been diagnosed with a congenital anomaly or abnormal condition. 4.1.a. 4.1.1. The commissioner may not require the reporting of personal identifying information or enter into the system any personal identifying information regarding congenital anomalies or abnormal conditions of a child whose parent or legal guardian objects on the basis of religious beliefs according to W. Va. Code §16-40-2. 4.2. The information shall be provided on forms obtained from the Office of Maternal, Child and Family Health in the Bureau. 4.3. Cases to be included in the information system shall consist of the International Classification of Diseases (ICD) diagnoses. After the information is submitted, the advisory council shall recommend the following types of cases that are reportable to the information system based on national standards. The ICD-10-CM Codes, and the type of cases that are reportable to the information system, as set forth in this section, are non-inclusive, and may be modified to meet national standards ICD DIAGNOSIS CODE All Congenital Anthalies th40-759) (Reports would include 4 and 5 digit attachments, i.e. 740.0 or 743.30) 740 Anencephalus and similar anomalies 741 Spina Bifida 742 Other congenital anomalies of nervous system 743 Congenital anomalies of eye 744 Congenital anomalies of ear, face and neck 745 Bulbus cordis anomalies and anomalies of cardiac septal closure 746 Other congenital anomalies of heart 747 Other congenital anomalies of circulatory system 748 Congenital anomalies of respiratory system 749 Cleft palate and cleft lip 2 64CSR81 750 Other congenital anomalies of upper alimentary tract 751 Other congenital anomalies of digestive system 752 Congenital anomalies of genital organs 753 Congenital anomalies of urinary system 754 Certain congenital musculoskeletal deformities 755 Other congenital anomalies of limbs 756 Other congenital musculoskeletal anomalies 757 Congenital anomalies of the integument 758 Chromosomal anomalies 759 Other and unspecified congenital anomalies Specified Conditions in the Perinatal Period (760-763) (including 4 and 5 th digit attachments, i.e., 765.2 or 765.20) 760.71 Fetal Alcohol Syndrome 764 Slow fetal growth and fetal malnutrition 765 Disorders relating to short gestation and low birthweight 766 Disorders relating to long gestation and high birthweight ICD-10-CM Code Chapter Q00-QA0 – Congenital malformations, deformations, chromosomal abnormalities, and genetic disorders; select codes listed below: Q00.0-Q00.1 Anencephaly Q01.0-Q01.9 Encephalocele Q02 Microcephaly Q04.2 Holoprosencephaly Q05.0-Q05.9, Q07.01, Q07.03 Spina bifida without anencephaly Q11.0-Q11.2 Anophthalmia/microphthalmia Q12.0 Congenital cataract Q16.0, Q17.2 Anotia/microtia Q20.0 Common truncus Q20.1 Double outlet right ventricle (DORV) Q20.3 Dextro-transposition of great arteries Q20.4 Single ventricle Q20.5 Transposition of great arteries Q21.0 Ventricular septal defect 3 64CSR81 Q21.1 Atrial septal defect Q21.2 Atrioventrical septial defect (AVSD) Q21.3 Tetralogy of Fallot Q22.0 Pulmonary valve atresia Q22.1 Pulmonary valve atresia and stenosis Q22.4 Tricuspid value atresia Q22.4 Tricuspid value atresia and stenosis Q22.5 Ebstein's anomaly Q23.0 Aortic valve stenosis Q23.4 Hypoplastic left heart syndrome Q25.1 Coarctation of aorta Q25.2, Q25.4 Interrupted aortic arch (IAA) Q26.2 Total anomalous pulmonary venous connection Q30.0 Choanal atresia Q35.1-Q35.9 Cleft palate without cleft lip Q36.0-Q36.9 Cleft lip without cleft palate Q37.0-Q37.9 Cleft lip with cleft palate Q39.0-Q39.4 Esophageal atresia/tracheosophageal fistula Q41.0 Small intestinal atresia/stenosis Q42.0-Q42.9 Rectal and large intestinal atresia/stenosis Q44.2-Q44.3 Biliary atresia Q54.0-Q54.3, Q54.5-Q54.9 Hypospadias Q60.0-Q60.6 Renal agenesis/hypoplasia Q64.10, Q64.19 Bladder exstrophy Q64.12 Cloacal exstrophy Q64.2 Congenital posterior urethral valves Q66.0, Q66.89 Clubfoot Q71.0-Q71.9, Q72.0-Q72.9, Limb deficiencies (reduction defects) Q73.0-73.8 Q75.0 Craniosynostosis Q79.0-Q79.1 Diaphragmatic hernia Q79.2 Omphalocele Q79.3 Gastroschisis Q90.0-Q90.9 Trisomy 21 (Down syndrome) Q91.0-Q91.3 Trisomy 18 (Edwards syndrome) Q91.4-Q91.7 Trisomy 13 (Patau syndrome) Q96.0-Q96.9 Turner syndrome Chapter P00-P96 – Certain conditions originating in the perinatal period; select codes listed below: P00-P04 Newborn affected by maternal factors and by complications of pregnancy, labor, and delivery P05-P08 Disorders of newborn related to length of gestation and fetal growth P09 Abnormal findings on neonatal screening P10-P15 Birth trauma P19-P29 Respiratory and cardiovascular disorders specific to the perinatal period P35-P39 Infections specific to the perinatal period Chapter H00-H59 – Diseases of the eye and adnexa; select codes listed below: 4 64CSR81 H47.03 Optic nerve hypoplasia Chapter H60-H95 – Diseases of the ear and mastoid process; select codes listed below: H90.0-H90.8 Conductive and sensorineural hearing loss H91.0-H91.9 Other and unspecified hearing loss H90.A Conductive and sensorineural hearing loss with restricted hearing on the contralateral side 4.4. If a child’s parent or legal guardian wants information concerning the child removed from the birth defects information system for religious reasons: 4.4.a. 4.4.1. The commissioner shall remove all identifying information from the record, but leave the case in the system for reporting purposes; and 4.4.b. 4.4.2. A form for the parent or legal guardian to complete for the removal of the child’s identifying information shall be mailed to all birthing facilities and made available upon request at the Bureau for Public Health office and on the Bureau’s web page: http://www.wvdhhr.org/. §64-81-5. Confidentiality. 5.1. Only those persons employed by the Bureau for Public Health dealing specifically with the birth defects registry shall have access to the database. All others requesting data from the registry shall complete a request form detailing what information is requested and how it shall be used. The person requesting the information then shall be given compiled data with no identifying information attached. 5.2. Anyone who obtains confidential information while implementing W. Va. Code §16-40-1 et seq. may disclose it only to reporting sources, persons demonstrating a need that is essential to health related research or care of persons with congenital anomalies and abnormal conditions, or as required or permitted by law. 5.3. Anyone who obtains confidential information while implementing W. Va. Code §16-40-1 et seq. shall provide a written statement to the commissioner that he or she fully understands the confidentiality of the information and will maintain it. 5.4. The commissioner may publish reports with statistical data relating to birth defects and other adverse birth outcomes that do not in any manner identify individual patients or individual sources of information are permissible, provided that the data is not for such small geographic areas or in categories with few entries that, together with other publicly available information, the patients could be identified. §64-81-6. Penalties. 6.1. Anyone who violates the provisions of W. Va. Code §16-40-1 et seq. or this rule is subject to the penalties in W. Va. Code §§16-1-17 and §16-1-18. 5