OFFICE OF FISCAL ANALYSIS

Legislative Office Building, Room 5200

Hartford, CT 06106 (860) 240-0200

http://www.cga.ct.gov/ofa

HB-5147

AN ACT CONCERNING NEWBORN SCREENING FOR CYTOMEGALOVIRUS AND ESTABLISHING A PUBLIC EDUCATION PROGRAM FOR CYTOMEGALOVIRUS.

AMENDMENT

LCO No.: 4918

File Copy No.: 494

House Calendar No.: 287


OFA Fiscal Note

The Out Years

State Impact:

Agency Affected

Fund-Effect

FY 17 $

FY 18 $

FY 19 $

Public Health, Dept.

GF - Cost

approx. 1,097,638

approx. 302,708

approx. 313,248

State Comptroller - Fringe Benefits

GF - Cost

approx. 82,168

approx. 85,866

approx. 89,730

Municipal Impact: None

The amendment requires newborn screening for globoid cell leukodystrophy (also known as Krabbe Disease) starting in FY 17, which results in a cost to the state of approximately $1.2 million in FY 17, $388,574 in FY 18 and $402,978 in FY 19. The state cost will continue into the future subject to inflation and the development of new methodologies for Krabbe Disease testing. The cost to the Department of Public Health reflects two Chemist II positions ($135,053 in FY 17, $141,130 in FY 18 and $147,481 in FY 19), one Nurse Consultant position ($89,083 in FY 17 $93,092 in FY 18 and $97,281 in FY 19), one-time equipment costs of $805,017 and on-going testing supply costs of $68,486. The cost to the State Comptroller – Fringe Benefits associated with these positions is $82,168 in FY 17, $85,866 in FY 18 and $89,730 in FY 19.

The Chemist II positions are provided to perform initial screenings and repeat testing to reduce the incidence of false positives, which are anticipated with testing. The Nurse Consultant is provided to report on abnormal screening and refer babies for follow-up with their primary care providers and specialty treatment centers. A one-time equipment cost of $721,812 reflects the cost of two tandem mass spectrometers with liquid chromatography pumps, autosampler delivery systems and includes a one-year service contract.1 An additional one-time equipment cost of $83,204 reflects ancillary instrumentation needed, including centrifuges, a heat plate sealer and plate dry-down units. On-going testing supply costs of $68,486 include deep-well filter plates, chemical solvents, solid chemicals, silica gels for sample extraction and aluminum plate seals.  No costs were included for specific substrate materials and internal standards as the Centers for Disease Control and Prevention provide materials for quality control and reagent-related testing at no cost to the state.

Many of the 66 genetic, metabolic and endocrine disorders in the existing Connecticut newborn screening panel are multiplexed such that a single analysis provides results for multiple disorders. This reduces the cost per disorder that can be bundled into a single analysis.  For example, the current amino acid and fatty acid disorders in the panel, of which there are approximately 48 different disorders tested for, are bundled into a single analysis.  Endocrine disorders, such as congenital adrenal hyperplasia and congenital hypothyroidism, are also bundled into a single analysis conducted with one type of instrument.  Krabbe Disease cannot be multiplexed with any of the other disorders that are currently screened for. It requires a separate analysis to obtain results. 

The change to line 38 under the amendment does not result in a fiscal impact as screening for cytomegalovirus will not be performed by the Department of Public Health's Katherine A. Kelley State Public Health Laboratory but by institutions caring for newborn infants. As such, no funding is appropriated for this purpose and no cost for this testing was identified in the fiscal note on the underlying bill.

explanation and does not represent the intent of the General Assembly or either chamber thereof for any purpose. In general, fiscal impacts are based upon a variety of informational sources, including the analyst's professional knowledge. Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.

Sources:

U.S. Department of Health and Human Services' Health Resources and Services Administration http://www.hrsa.gov/advisorycommittees/mchbadvisory/heritabledisorders/nominatecondition/reviews/krabbedisease.pdf

1 A report from the U.S. Department of Health and Human Services' Health Resources and Services Administration indicates that the start-up equipment cost to the New York State laboratory for Krabbe Disease testing was approximately $1 million, which included three tandem mass spectrometers and two liquid handlers.