Newborn screening legislation awaiting reauthorization

Dec. 13, 2013

This year marks the 50th anniversary of newborn screening in the United States. It has been only during the past few years, however, that the number of conditions for which newborns are routinely screened has increased significantly in many states—from fewer than eight to nearly 30. This has resulted in more than four million babies being screened annually for disorders that, if left untreated, could result in disability or death. This success is due to the collaborative efforts of Congress, federal and state agencies, and healthcare professionals in identifying and expanding the number of conditions for which newborns can be tested and treated.

Why the increase in testing over the past few years? In 2003, the General Accountability Office (GAO) released a report, “Newborn Screening: Characteristics of State Programs,” which identified wide variability in the number of screening tests performed by different states. The report indicated that more than half of the states screened for eight or fewer conditions, while others tested for up to 36 disorders. In 2008, Congress responded by passing the Newborn Screening Saves Lives Act. This legislation established national newborn screening guidelines, funded efforts to improve the quality of the tests, and assisted states in expanding their screening programs.

Since the enactment of the 2008 law, the number of states testing for 29 of the 31 treatable core conditions has increased from 10 to 44. Now more than 98% of all newborns are screened for these 29 conditions. According to the Centers for Disease Control and Prevention (CDC) 12,500 babies annually receive life-saving treatments and interventions due to screening newborns. As with many statutes, however, this law has a five-year “sunset” provision that requires new congressional authorization for its continuation.

To this end, Representatives Lucille Roybal-Allard (D-CA) and Mike Simpson (R-ID) introduced H.R.1281, the “Newborn Screening Saves Lives Reauthorization Act of 2013.” In announcing the legislation, Rep. Roybal-Allard stated, “Newborn screening not only transforms and saves lives—it saves money. In my home state of California, newborns are screened for more than 40 preventable and treatable conditions, and every dollar California spends on screening yields a benefit of more than $9 as we prevent disease in children who are diagnosed with these treatable conditions.” Rep. Simpson added, “Just one small blood sample from the newborn’s foot identifies infants with genetic or other conditions that can be treated quickly and effectively, saving and improving thousands of lives.”

Specifically, H.R.1281 would help state screening programs better assess and coordinate newborn treatments, including providing follow-up care to infants identified with a condition; fund the National Institutes of Health (NIH) Hunter Kelly Newborn Screening Research Program, which provides research grants to identify treatments for conditions that can be detected through early testing; continue to underwrite the CDC Newborn Screening Quality Assurance Program, which ensures the quality of newborn screening tests; and renew the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), which expired in April.

Renewing SACHDNC is critical to the ongoing efforts of the screening initiative. First created in 2003, the panel was authorized to advise the Secretary of Health and Human Services (HHS) “about the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders.” Screening tests recommended by the panel, and approved by the Secretary, are placed on the Recommended Uniform Screening Panel (RUSP), used by states to determine which tests to screen. For the moment, the panel has gotten a short reprieve. The Secretary of Health and Human Services used her discretionary authority to extend the group for two years while Congress deliberates reauthorization.

On the Senate side, Senators Kay Hagan (D-NC) and Orrin Hatch (R-UT) have introduced similar legislation, S.1417, with few minor modifications. Among the changes, the Senate measure would require the HHS Secretary to respond to a panel recommendation within days, or the test would automatically be added to the list. S.1417 would also create a priority review mechanism for nominated conditions that are linked to a drug treatment that has been given FDA fast track status by the Secretary. The Advisory Committee would have eight months to review and vote upon the condition and ten months for other evaluations.

The good news is that given the success of the program, and strong support on both sides of the political aisle for children’s health, the legislation has a good chance of passing. However, without grassroots involvement, the issue could be lost among many other issues on the political agenda. AACC has endorsed both measures and urges laboratory professionals to join its members in writing their Members of Congress in support of these measures. You can do that by going to AACC’s Advocacy Network ( and sending a pre-written e-mail supporting the legislation. By working together we can succeed in advancing children’s health.

Vince Stine, PhD, is the Director of Government Affairs for the American Association for Clinical Chemistry (AACC). He is responsible for legislative and regulatory affairs for the Association, and is staff liaison to the Government Relations and Pediatric Reference Range Committees.  Dr. Stine is also an Adjunct Professor of Political Science at George Washington University, where he teaches “American Political Parties” and “Religion and Politics.”