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.

As Amended by House "A" (LCO 5447)

House Calendar No.: 287


OFA Fiscal Note

State Impact:

Agency Affected

Fund-Effect

FY 15 $

FY 16 $

Public Health, Dept.

GF - Cost

approx. 40,000

approx. 27,000

Municipal Impact: None

Explanation

The bill results in a cost to the Department of Public Health (DPH) of approximately $40,000 in FY 15 and approximately $27,000 in FY 16 to establish a cytomegalovirus public education program. Further, the bill results in a future cost to the state currently estimated at $1.1 million in the first fiscal year of implementation and $360,257 in the second as it requires testing 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 the disease in its uniform screening panel. It is unknown when this will occur. As such, costs to DPH's Katherine A. Kelley State Public Health Laboratory for Krabbe Disease screening are anticipated in the future and are detailed in “The Out Years” section below.

The costs to DPH in FY 15 and FY 16 reflect the on-going publishing and distribution expenses for 155,000 English-language brochures, 16,000 Spanish-language brochures and 8,000 English-language/500 Spanish-language posters. These are anticipated to be distributed to various health care providers, daycares and school nurses. There is an anticipated one-time cost to DPH of $14,000 in FY 15 associated with the development and design of the brochure and poster. FY 16 printing costs were inflated by 2.1% and mailing costs were inflated by 6.5%.1 It is anticipated that DPH will also post information about cytomegalovirus on its website. There is no fiscal impact to DPH to post information on its website.

Cytomegalovirus screening for infants that fail their hearing screening will be performed by the institutions that administer newborn screening tests, not by DPH's Katherine A. Kelley State Public Health Laboratory and, therefore, there will be no cost to the agency from these tests.

House “A” required newborn screening for Krabbe Disease, resulting in a future cost to the state detailed below.

The Out Years

The cost in the first year to DPH for Krabbe Disease screening is currently anticipated to be $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 approximately $789,232 and on-going testing supply costs of approximately $67,143. The cost to the State Comptroller – Fringe Benefits associated with staff 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 $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 $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. 

This fiscal impact identified above would continue into the future subject to inflation.

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

 

United States Postal Service online: Postage Rates and Historical Statistics

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.

1 This is the percent increase in the United States Postal Services postage stamps from 1/27/13 ($0.42) to 1/26/14 ($0.49).