Newborn Genetic, Metabolic, Endocrine, and Hemoglobinopathy Screening Program and Newborn Hearing Loss Screening Program (216-RICR-20-05-1)
216-RICR-20-05-1 ACTIVE RULE
These rules and regulations are promulgated pursuant to the authority conferred under R.I. Gen. Laws §§ 23-13-13 and 23-13-14, and are established for the purpose of updating a comprehensive genetic, metabolic, endocrine, and hemoglobinopathy screening program for newborns and a newborn hearing loss screening program and for adopting a fee structure for said programs.
A.Wherever used in this Part the following terms shall be construed as follows:
1."Act" means R.I. Gen. Laws Chapter 23-13 entitled, "Maternal and Child Health Services for Children with Special Health Care Needs."
2.“Department” means the Rhode Island Department of Health.
3."Director" means the Director of the Rhode Island Department of Health.
4."Health care facilities" means facilities licensed under the provision of R.I. Gen. Laws Chapter 23-17 and the regulations promulgated thereunder. Health care facilities include, but are not limited to, hospitals, birth centers, and other health care facilities subject to licensure.
5."Health care provider" means any person licensed by the State of Rhode Island to provide health care services, including, but not limited to, a physician, health care facility, nurse, pharmacist, and any officer, employee or agent of that provider acting in the course and scope of his or her employment or agency related to or supportive of health services.
6."Midwife" means a person who has successfully completed an approved educational program in midwifery and is licensed to practice midwifery in Rhode Island pursuant the Rules and Regulations for Licensing of Midwives (Part 40-05-23 of this Title) and R.I. Gen. Laws §§ 23-13-9 and 23-1-1.
7."Newborn disease" means conditions that have their origin in mutational events that alter the genetic constitution of an individual and/or disrupts normal functions through some other disease mechanism.
8."Newborn testing for hearing loss” means screening and evaluation through the Rhode Island Early Hearing Detection and Intervention Program (RI-EHDI), using procedures prescribed by the Director.
9."Physician" means a person with a license to practice medicine in Rhode Island pursuant to the provisions of R.I. Gen. Laws Chapter 5-37 entitled, "Board of Medical Licensure and Discipline."
10.“Newborn Screening Program” means the Rhode Island Department of Health, Office of Newborn Screening and Follow-Up program of screening all newborns for genetic, metabolic, endocrine, hemoglobin, hearing, and developmental conditions.
1.3Newborn Genetic, Metabolic, Endocrine, and Hemoglobinopathy Screening Program
A.The physician and/or midwife attending a newborn child shall cause said child to be subject to screening tests for the conditions listed below. Notwithstanding the foregoing, if parents of a newborn child object to the screening tests on the grounds that such tests conflict with their religious tenets and practices, such tests shall not be performed, in accordance with R.I. Gen. Laws § 23-13-14.
1.Amino Acid Metabolism Disorders
d.Maple Syrup Urine Disease
f.Tyrosinemia Type I
2.Organic Acid Metabolism Disorders
b.Glutaric Acidemia Type I
c.Hydroxymethylglutaric aciduria, HMG-CoA lyase Deficiency, or 3-OH 3-CH3 glutaric aciduria
e.3-Methylcrotonyl-CoA Carboxylase Deficiency
f.Methylmalonic Acidemia cbIA and cbIB forms
g.Methylmalonic Acidemia due to mutase deficiency
h.Multiple Carboxylase Deficiency
3.Fatty Acid Oxidation Disorders
a.Carnitine Uptake Defect
b.Long-chain 3-OH acyl COA Dehydrogenase Deficiency (LCHAD)
c.Medium-chain 3-OH acyl COA Dehydrogenase Deficiency (MCHAD)
d.Very Long-chain 3-OH acyl COA Dehydrogenase Deficiency (VLCAD)
e.Trifunctional Protein Deficiency
4.Hemoglobin Traits and Disorders
a.Sickle Cell Anemia
c.Hemoglobin S/C Disease
d.Others detectable through hemoglobin electrophoresis
a.Spinal Muscular Atrophy (SMA)
b.Congenital Adrenal Hyperplasia
f.Severe Combined Immunodeficiency (SCID)
g.Critical Congenital Heart Disease
B.The hospital or health care facility, or, in the event the birth occurred in a location other than a health care facility, the physician and/or midwife attending a newborn child shall cause a filter specimen for the newborn, on a slip supplied by the Department, to be submitted to the laboratory designated by the Department.
C.Any laboratory designated by the Department to analyze newborn screening tests shall be approved by the Director to perform the tests cited in § 1.3(A) of this Part and as required in this Part.
1.All reports of newborn screening tests shall be communicated by the designated laboratory to the Department's designee for follow-up. All such reports shall include actual value and reference ranges used for each disorder.
2.Any reports of inconclusive results shall be communicated by the Department's designee for follow-up to the newborn's primary care physician for repeat testing.
3.Any reports of positive results shall be communicated by the Department's designee for follow-up to the newborn's primary care physician and any applicable pediatric specialty diagnostic clinic for diagnosis confirmation.
4.Confirmation of diagnosis shall be communicated to the Newborn Screening Program by the confirming health care provider, e.g., specialty diagnostic clinic, within ninety (90) days of confirmation of the diagnosis. Such confirmation shall include:
a.Each confirmed newborn screening diagnosis;
b.Diagnostic test type;
c.Treatment type; and
d.Any additional information the Director may require for surveillance, or for other program or grant purposes.
1.4Testing for Hearing Loss
Pursuant to R.I. Gen. Laws § 23-13-13, the physician and/or midwife attending a newborn child shall cause said child to be subject to newborn testing for hearing loss in accordance with procedures approved by the Department. Notwithstanding the foregoing, if parents of a newborn child object to the newborn testing for hearing loss on the grounds that such testing conflicts with their religious tenets and practices, such testing shall not be performed, in accordance with R.I. Gen. Laws § 23-13-13.
The fee for the newborn screening (per newborn) and the coordination fee for testing for hearing loss in newborns (per newborn) shall be as set forth in the Fee Structure for Licensing, Laboratory and Administrative Services Provided by the Department of Health (Part 10-05-2 of this Title). These fees shall be adjusted annually to cover the cost of inflation using the Medicare Economic Index (MEI).
1.6Designation of the Newborn Screening Program as a Covered Benefit
A.The newborn screenings and testing for hearing loss shall be a covered benefit reimbursable by all health insurers, as defined in R.I. Gen. Laws § 27-38.2-2(4), providing health insurance coverage in Rhode Island except for supplemental policies which only provide coverage for specific diseases, hospital indemnity, Medicare supplement or other supplemental policies.
B.When the patient is eligible for Medical Assistance under the provisions of R.I. Gen. Laws Chapter 40-8, Medical Assistance, or R.I. Gen. Laws Chapter 42-12.3, Health Care for Children and Pregnant Women, the cost of the newborn screenings and testing for hearing loss shall be paid in accordance with R.I. Gen. Laws § 23-13-14(b).
C.In the absence of a third-party payor, or in the absence of insurance information sufficient for billing and collection, the cost for the newborn screenings and testing for hearing loss shall be paid by the hospital or other health care facility where the birth occurred, or, in the event the birth occurred in a location other than a health care facility, by the physician or midwife attending the newborn.
D.Any health care provider compensated for the newborn screenings and testing for hearing loss shall reimburse the Department for such newborn screenings and testing for hearing loss in accordance with Part 10-05-2 of this Title.
|Title||216||Department of Health|
|Subchapter||05||Maternal and Child Health|
|Part||1||Newborn Genetic, Metabolic, Endocrine, and Hemoglobinopathy Screening Program and Newborn Hearing Loss Screening Program (216-RICR-20-05-1)|
|Type of Filing||Periodic Refile|
R.I. Gen. Laws §§ 23-13-13 and 23-13-14
Purpose and Reason:
This rule is being refiled by the agency pursuant to R.I. Gen. Laws § 42-35-4.1. No changes were made to the text of this rule.