You asked about screening newborns for cystic fibrosis. Specifically, you wanted to know (1) how many states require such screening as part of their newborn screening programs, (2) how many Connecticut hospitals offer screening and what percent of newborns in the state are screened, (3) how much screening tests cost, and (4) the extent to which private and public insurance covers cystic fibrosis screening.

Twenty-nine (29) states and the District of Columbia require universal cystic fibrosis (CF) screening as part of their mandatory newborn screening programs. Another nine (9) require, but have not yet implemented, screening. In three states, including Connecticut, screening is offered (but not required) either statewide or in various areas.

Twenty (20) of Connecticut's 29 birthing hospitals offer CF screening for newborns. Parents of approximately 70% of the 43,000 babies born annually in Connecticut (about 30,000) are offered screening, which is performed by UConn Health Center and Yale-New Haven Hospital. UConn tests between 22,000 and 23,000 newborns a year; Yale tests between 4,500 and 5,000 a year.

The Department of Public Health (DPH) estimates that universal CF screening would cost about $ 170,000. The Office of Fiscal Analysis estimates the cost of incorporating CF screening into the state's newborn screening program would be double that figure, mainly because its estimate includes education and counseling for parents whose children test positive for CF.

The HUSKY A and HUSKY B programs pay for CF screening, as do several private health care plans.

Twenty-nine (29) states and the District of Columbia require universal cystic fibrosis screening as part of their mandatory newborn screening programs according to an August 2007 report by the National Newborn Screening and Genetics Resource Center, a federally funded program at the University of Texas Health Science Center at San Antonio. Eleven (11) of these states adopted this mandate within the past year. Laws or administrative rules in an additional nine states require CF screening, but the states have not yet implemented screening programs. Table 1 shows states' CF screening status.

Table 1: Newborn Screening for Cystic Fibrosis in the U. S.

Source: National Newborn Screening and Genetics Resource Center, 8/3/07

Twenty (20) of Connecticut's 29 birthing hospitals offer CF screening for newborns. They are Backus, Bristol, Charlotte Hungerford, Day Kimball, Griffin, Hartford, John Dempsey, Johnson Memorial, Lawrence and Memorial, Midstate Medical, New Britain, Manchester, Norwalk, Rockville, St. Francis, St. Raphael's, Sharon, Waterbury, Windham, and Yale New Haven. Eight of the hospitals that do not offer screening are in the western part of the state (Bridgeport, Danbury, Greenwich, Milford, New Milford, Stamford, St. Mary's (Waterbury), and St. Vincent's (Bridgeport)). Middlesex is the ninth hospital that does not offer CF testing. The UConn Health Center conducts screening for 18 hospitals; Yale-New Haven does it for the other two.

About 43,000 children are born in Connecticut each year. Parents of approximately 70% of these babies (about 30,000) are offered screening, according to a 2006 DPH report on newborn CF screening. This leaves 30% (about 13,000) who are not offered screening.

Because CF screening is not mandated, DPH does not track the number of babies who are actually tested. UConn reports screening between 22,000 and 23,000 babies a year; Yale reports testing between 4,500 and 5,000 a year.

CF screening is not a diagnostic test and does not detect all affected children. The initial screening, which is called immunoreactive trypsinogen or IRT, is conducted within 48 hours of birth. If it shows elevated levels, the child is referred for a second IRT or a DNA test, depending on which protocol is followed. An IRT test costs about $ 1. 50, while the most common DNA test costs about $ 20. 50 and a more comprehensive one, $ 50. 70, according to DPH. If the second test is also positive, the child is referred for a sweat test, which is definitive for diagnosis. A sweat test costs about $ 160.

DPH estimates that screening all newborns, including the sweat test, would cost about $ 170,000 a year or about $ 3. 90 per newborn. The costs are shown in table 2.

Table 2: Estimated Costs of CF Screening in Connecticut

Source: DPH, Universal Screening for Cystic Fibrosis in Connecticut, 2006 (data is for 2003)

The Office of Fiscal Analysis (OFA) estimated in 2006 that it would cost DPH about $ 350,000 annually if the legislature made CF screening part of the state's mandatory newborn screening program. The higher cost would result from (1) transferring responsibility for the screenings to DPH's laboratory (OFA's analysis did not consider keeping the screenings at the two hospitals), which would need to add a position (at $ 48,900 a year plus fringe benefits) and purchase laboratory supplies ($ 160,500) and (2) providing education and referrals for families whose newborn tests positive, which are components of the newborn screening program. To provide the education and referral services, OFA believed DPH would have to add a nurse and a health associate (with combined annual salaries of $ 125,100 plus fringe benefits) and spend about $ 10,000 for education materials. One-time computer hardware and software purchases would cost about $ 25,000 (OFA Fiscal Note, SB 162, 2006).

UConn charges hospitals $ 15 for the initial IRT test and any needed follow-up test. (It performs about 800 follow-up screens a year. ) The charge for a sweat test (which about 50 infants of the infants it screens each year need) is extra.

The DPH lab currently performs the tests for the over-40 metabolic and genetic disorders included in the state's newborn screening program. All birthing hospitals pay DPH $ 28 per child for this service. If CF screening was mandated and transferred to DPH, the cost would be paid out of that fee. But, the DPH commissioner has discretion to set the fee, so it could be increased to accommodate the added costs.

DPH financially supports genetic disease treatment centers at Yale-New Haven Hospital and the Connecticut Children's Medical Center that provide counseling for families whose children are identified through the newborn screening program and treatment for the children. OFA stated that DPH would spend an additional $ 200,000 a year to support these centers on behalf of families with children who test positive for CF.

The HUSKY A and HUSKY B programs pay for CF screening. We asked the Connecticut Association of Health Plans to survey its eight members about their coverage. Three plans responded, all of which cover screening, one under its preventive health care coverage, one under its prenatal and newborn coverage, and one if the hospital orders the screening. Anthem Blue Cross also covers screenings.

SS: dw