OFFICE OF FISCAL ANALYSIS

Legislative Office Building, Room 5200

Hartford, CT 06106 (860) 240-0200

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

sHB-5147

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

AMENDMENT

LCO No.: 5447

File Copy No.: 494

House Calendar No.: 287


OFA Fiscal Note

FUTURE COST

The amendment requires newborn screening for globoid cell leukodystrophy (also known as Krabbe Disease) to be administered to every newborn in Connecticut after the U.S. Department of Health and Human Services' Discretionary Advisory Committee on Heritable Disorders in Newborns and Children includes Krabbe Disease in its uniform screening panel. It is unknown when this will occur. As such, the amendment results in a future cost to the state, estimated currently at $1.1 million in the first fiscal year of implementation and $360,257 in the second. This fiscal impact would continue into the future subject to inflation.

The cost in the first year to the Department of Public Health (DPH) is currently anticipated to be approximately $1,061,623 and reflects two Chemist II positions ($123,672 in the first year and $129,237 in the second), one Nurse Consultant position ($81,576 in the first year and $85,247 in the second), one-time equipment costs of $789,232 in the first year and on-going testing supply costs of $67,143. The cost to the State Comptroller – Fringe Benefits associated with these positions is currently estimated at $75,244 in the first year and $78,630 in the second.

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. The one-time equipment cost of approximately $707,659 reflects two tandem mass spectrometers with liquid chromatography pumps, autosampler delivery systems and includes a one-year service contract. An additional one-time equipment cost of approximately $81,573 reflects ancillary instrumentation needed, including centrifuges, a heat plate sealer and plate dry-down units. 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. On-going testing supply costs of $61,143 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 preceding Fiscal Impact statement is prepared for the benefit of the members of the General Assembly, solely for the purposes of information, summarization and 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