ALABAMA STATE BOARD OF HEALTH

ALABAMA DEPARTMENT OF PUBLIC HEALTH

BUREAU OF FAMILY HEALTH SERVICES

ADMINISTRATIVE CODE

CHAPTER 420-10-1 CARE AND TREATMENT OF INFANTS IDENTIFIED THROUGH THE NEWBORN SCREENING PROGRAM

TABLE OF CONTENTS

420-10-1-.01 Purpose

420-10-1-.02 Definitions

420-10-1-.03 Designation Of Additional Heritable Diseases

420-10-1-.04 Reporting And Notification

420-10-1-.05 Counseling And Management

420-10-1-.06 Fees

420-10-1-.01 Purpose. The purpose of these rules is to provide administrative details and procedures for the care and treatment of newborns identified with phenylketonuria, hypothyroidism, hemoglobinopathies, hearing loss and heritable diseases.

Author: Lloyd Hofer, M.D.

Statutory Authority: Code of Ala. 1975, §§22-2-2, 22-20-3.

History: Filed December 21, 1987. Amended: Filed September 18, 2002; effective October 23, 2002. Repealed and New Rule: Filed December 17, 2003; effective January 21, 2004.

420-10-1-.02 Definitions.

(a) Phenylketonuria - A congenital disease due to a deficit in the metabolism of the amino acid phenylalanine.

(b) Hypothyroidism - A deficiency of thyroid gland activity with underproduction of thyroxin or the condition resulting from it.

(c) Hemoglobinopathy - Any hemoglobin phenotype which is other than AA.

(d) Physician of Record - The physician who requests the test.

(e) Galactosemia - An inherited error in the metabolism of galactose.

(f) Congenital adrenal hyperplasia - an inherited error in steroid biosynthesis. (CAH).

(g) Hearing loss - the total or partial inability to hear sound in one or both ears.

(h) Biotinidase deficiency – inherited deficiency caused by the lack of an enzyme biotin.

(i) Amino acid disorders B inherited disorders in amino acid metabolism.

(j) Fatty acid oxidation disorders B inherited disorders in fatty acid metabolism.

(k) Organic acid disorders B inherited disorders in organic acid metabolism.

Authors: Lloyd Hofer, M.D., William J. Callan, Ph.D.

Statutory Authority: Code of Ala. 1975, §§22-2-2, 22-20-3.

History: Filed December 21, 1987. Amended: Filed September 21, 1992; effective October 26, 1992. Amended: Filed September 18, 2002; effective October 23, 2002. Repealed and New Rule: Filed December 17, 2003; effective January 21, 2004.

410-10-1-.03 Designation Of Additional Heritable Diseases. The State Board of Health hereby designates the following as a heritable disease subject to testing, reporting and notification requirements herein below specified. Galactosemia, congenital adrenal hyperplasia, biotinidase deficiency, aminoacidopathies, fatty acid oxidation disorders, and organic acidurias and acidemias.

Authors: Lloyd Hofer, M.D., William J. Callan, Ph.D.

Statutory Authority: Code of Ala. 1975, §22-2-2, 22-20-3.

History: Filed December 21, 1987. Amended: Filed September 21, 1992; effective October 26, 1992. Repealed and New Rule: Filed December 17, 2003; effective January 21, 2004.

420-10-1-.04 Reporting And Notification.

(1) The Alabama Department of Public Health shall report all results of phenylketonuria, hypothyroidism, galactosemia, congenital adrenal hyperplasia, hearing loss, hemoglobinopathy, biotinidase deficiency, aminoacidopathies, fatty acid oxidation disorders, and organic acidurias and acidemias testing to the submitting health care provider. Test results on transferred infants may be made available to both the transferring and receiving facilities.

(2) The submitting health care provider shall report all results, including positives, suspected positive results, and unsatisfactory specimens, to the physician of record (the physician indicated on the collection form) of the newborns tested and shall use such forms and follow such guidelines as shall be determined by the State Health Officer. The health care provider shall report the results of any hearing tests performed on the newborns to the Alabama Department of Public Health and shall use such forms and follow such guidelines as shall be determined by the State Health Officer.

(3) The Department of Public Health may release results of newborn screening tests, including hearing screening results, to any physician registered with the Alabama Voice Response System under the terms and conditions of the system without a signed release from the parent or guardian.

Authors: Lloyd Hofer, M.D., William J. Callan, Ph.D.

Statutory Authority: Code of Ala. 1975, §§22-2-2, 22-20-3.

History: Filed December 21, 1987. Amended: Filed September 21, 1995; effective October 26, 1992. Amended: Filed October 24, 1995; effective November 29, 1995. Amended: Filed September 18, 2002; effective October 23, 2002. Repealed and New Rule: Filed December 17, 2003; effective January 21, 2004.

420-10-1-.05 Counseling And Management. The Alabama Department of Public Health shall make contact with the physician of record on newborns who test positive, for penylketonuria, hypothyroidism, galactosemia, congenital adrenal hyperplasia, hemoglobinopathies, biotinidase deficiency, aminoacidopathies, fatty acid oxidation disorders, or organic acidurias and acidemias to ascertain whether or not these newborns are under the care of a private physician. Additionally, the Alabama Department of Public Health shall make contact with the physician of record and parents/caretakers on newborns who test positive for and/or have high-risk indicators for hearing loss, and those who did not receive an initial hearing screening to ascertain whether or not these newborns are under the care of a private physician. The Alabama Department of Public Health will advise the physician of the services available through the Alabama Department of Public Health. Newborns who are under the care of a private physician may additionally utilize the services available through the Alabama Department of Public Health. When it is determined that the newborn is not under the care of the physician of record or another private physician, the Alabama Department of Public Health may make contact with the family to make their services available to the newborn and the family or may assist the family in obtaining the services of a private physician. Services include health assessments, treatment, and referrals to tertiary care centers.

Authors: Lloyd Hofer, M.D., William J. Callan, Ph.D.

Statutory Authority: Code of Ala. 1975, §22-20-3.

History: Filed December 21, 1987. Amended: Filed September 21, 1992; effective October 26, 1992. Amended: Filed September 18, 2002; effective October 23, 2002. Repealed and New Rule: Filed December 17, 2003; effective January 21, 2004.

420-10-1-.06 Fees. The Board shall assess and collect newborn

screening fees from hospitals and birthing centers or third party payors. The newborn screening fee shall be set by the State Committee of Public Health based on the schedule of laboratory fees established by Centers for Medicare and Medicaid Services (CMS)for use by Medicare and Medicaid. The Board shall bill the Medicaid Agency for Medicaid eligibles.

(1) Hospitals classified as "rural" by CMS or which have less than 105 beds and are located at least twenty (20) miles from the nearest acute care facility with obstetrical capabilities may have newborn screening fees waived for non-Medicaid eligible patients where there is no third party payor for such fees. The State Health Officer shall annually submit a list of hospitals to the Board which are eligible for waiver of fees.

(2) Additional reasonable and necessary fees may be charged to other payors by the hospital or physician in connection with this rule. The State Health Officer may waive fees deemed uncollectible because of a patient’s inability to pay.

(3) There shall be only one (1) fee per birth collected from a hospital by the Board.

Authors: Lloyd Hofer, M.D., William J. Callan, Ph.D.

Statutory Authority: Code of Ala. 1975, §22-20-3.

History: Filed February 19, 1992. Amended: Filed September 21, 1992; effective October 26, 1992. Repealed and New Rule: Filed December 17, 2003; effective January 21, 2004.