A BILL TO BE ENTITLED
AN ACT increasing the fee for laboratory tests performed by the state laboratory of public health under the newborn screening program; adding a screening test for severe combined immunodeficiency to the newborn screening panel; and appropriating funds to the department of health and human services, division of public health, to purchase necessary equipment and upgrades at the state laboratory of public health for newborn screening and all other laboratory operations.
Whereas, severe combined immunodeficiency (SCID), often known as "bubble boy disease," is a primary immune deficiency caused by several different genetic defects, most of which are hereditary; and
Whereas, children born with SCID lack immunity against bacteria, viruses, and fungi and are prone to repeated and persistent infections that would not cause serious illness in a person or infant with a normal immune system; and
Whereas, unless treated early, a child will mostly likely die from opportunistic infections as an infant; and
Whereas, it has been known for the past 15 years that early recognition of SCID through newborn screening is critical to successful management of patients with SCID; and
Whereas, Baby Carlie Nugent of Harrisburg died in 2000 at the age of 7 months from complications of SCID following a bone marrow transplant because her condition was not diagnosed until she was more than 6 months old; and
Whereas, early screening for SCID prior to 3.5 months of age could have saved her life; and
Whereas, development and implementation of a screening test for T‑Cell lymphopenia has been accomplished, which led to the unanimous recommendation by the United States Secretary of Health and Human Service's Advisory Committee on Heritable Disorders of Newborns and Children in January 2010 to add SCID to the list of conditions routinely screened for at birth; and
Whereas, as of November 2014, there are 26 states screening for SCID, and the North Carolina Newborn Screening Advisory Committee unanimously approved adding SCID to this State's newborn screening panel in January 2011, yet SCID screening still has not started in this State; and
Whereas, the leading center for treatment of SCID in the United States is located in North Carolina at the Duke University Medical Center; and
Whereas, that Center demonstrated in 1999 that, if a bone marrow transplant could be performed before a baby is 3.5 months of age, there is a 94% survival rate, compared with a 70% survival rate if the infant is transplanted after that age; and
Whereas, infants who do not receive a bone marrow transplant are likely to die before the age of two; and
Whereas, in addition to saving lives, the early diagnosis of SCID also saves money, considering the cost of testing a SCID newborn who is not diagnosed until there is a serious infection can range from five hundred thousand dollars ($500,000) to well over four million five hundred thousand dollars ($4,500,000), while the cost of transplanting a SCID infant who is not sick is usually less than one hundred thousand dollars ($100,000); Now, therefore,
The General Assembly of North Carolina enacts:
SECTION 1.  G.S. 130A‑125(c) reads as rewritten:
"(c)	A fee of twenty‑four dollars ($24.00) applies to a laboratory test performed by the State Laboratory of Public Health pursuant to this section. The fee for a laboratory test is a departmental receipt of the Department and shall be used to offset the cost of the Newborn Screening Program."
SECTION 2.  The Commission for Public Health shall amend rules adopted pursuant to G.S. 130A‑125 to implement the Newborn Screening Program established under said section to add to the newborn screening panel a screening test for severe combined immunodeficiency (SCID) and other T‑Cell lymphopenias detectable as a result of SCID.
SECTION 3.  There is appropriated from the General Fund to the Department of Health and Human Services, Division of Public Health, the sum of four hundred sixty‑six thousand one hundred thirty‑two dollars ($466,132) for the 2015‑2016 fiscal year. These funds shall be used to purchase laboratory instrumentation and upgrades to the existing North Carolina State Laboratory of Public Health (NCSLPH) Laboratory Information System in order to provide the required informatics capabilities for newborn screening and all other laboratory operations at the NCSLPH.
SECTION 4.  This act becomes effective July 1, 2015.