Section 410IAC3-3-2.5. Equipment and supplies for newborn screening

  5. (a) The state-contracted newborn screening laboratory will furnish filter paper kits, without additional cost, annually to hospitals, midwives, birthing centers, and other collections sources. Manufacturer and lot number for the filter paper must be included on the filter paper section of the kit in accordance with the Clinical Laboratory Standards Institute (CLSI)-approved national standard. Sequential system control numbers for each collection kit must be printed on each information section of the collection card and on the filter paper section, if that section is detachable.

  (b) The state-contracted newborn screening laboratory must provide filter paper kits, without additional cost, to local health departments, MCH/CSHCS clinics, or other outside organizations/individuals as designated by the department for the collection of newborn screening specimens.

  (c) The department's newborn screening program will ensure that all Indiana residents who are diagnosed with one (1) of the metabolic conditions included in the newborn screening panel have access to the appropriate metabolic formula necessary for treatment as follows:

(1) A single brand of metabolic formula for each metabolic condition on the newborn screen will be designated by the state-contracted metabolic geneticist and made available to all Indiana residents as appropriate.

(2) The appropriate metabolic formula will be made available to all Indiana residents diagnosed with one (1) of the metabolic conditions included on Indiana's newborn screening panel, regardless of the individual's ability to pay or socioeconomic status as follows:

(A) Payment for metabolic formula will be based on a sliding-fee scale as designated by the department.

(B) All efforts will be made to collect payment for metabolic formula from private insurance companies or other third-party payers.

(C) The department's newborn screening program will serve as a payer of last resort for patients without private insurance coverage or for whom reimbursement cannot be obtained from another third-party payer.

  (d) All other costs related to purchasing equipment or supplies that are required to perform mandated newborn screening must be covered by the hospital, birthing center, midwifery, or physician practice. (Indiana State Department of Health; 410 IAC 3-3-2.5; filed Apr 25, 2012, 3:46 p.m.: 20120523-IR-410100504FRA)