CONGRESSWOMAN ELISE STEFANIK
On Wednesday, May 11, 2016, the House will consider H.R. 4978, the NAS Healthy Babies Act, as amended, under suspension of the rules. The bill was introduced on April 18, 2016, by Rep. Evan Jenkins (R-WV) and was referred to the Committee on Energy and Commerce, which ordered the bill reported, as amended, on April 27, 2016 by unanimous voice vote.
H.R. 4978 would require the Comptroller General of the United States to submit a report to Congress on neonatal abstinence syndrome (NAS) in the U.S. no later than one year after enactment. The report would include: the prevalence of NAS, the services Medicaid covers for treatment of infants with NAS, the settings for such treatment, and the prevalence of utilization of these various settings. The report would also include recommendations to increase access to treatment for infants with NAS. H.R. 4978 would also exclude abuse-deterrent formulations of prescription drugs from the Medicaid additional rebate requirement for new formulations of prescription drugs.
Neonatal abstinence syndrome (NAS) is a group of problems that occur in a newborn who was exposed to addictive opiate drugs while in the mother’s womb. Neonatal abstinence syndrome may occur when a pregnant woman takes drugs such as heroin, codeine, oxycodone, methadone or buprenorphine. These and other substances pass through the placenta that connects the baby to its mother in the womb. If the mother continues to use the drugs within the week or so before delivery, the baby will be dependent on the drug at birth. From 2000 through 2009, the incidence of the neonatal abstinence syndrome in the United States nearly tripled, with several states reporting even larger recent increases. In fact, a 2015 study in The New England Journal of Medicine noted that “from 2004 through 2013, the neonatal abstinence syndrome was responsible for a substantial and growing portion of resources dedicated to critically ill neonates in neonatal intensive care unit (NICU) nationwide.”
According to the bill sponsor, “Nearly every community in every state has been impacted by heroin and opioid addiction, and newborns are the most vulnerable victims of this epidemic. The sounds of babies crying as they experience drug withdrawal are heartbreaking, and we can only truly address this crisis by working together. The NAS Healthy Babies Act will build on efforts in Congress to combat the drug crisis, identify federal barriers to care, and expand our knowledge of care and treatment of neonatal abstinence syndrome.”
The Medicaid Drug Rebate Program is a program that helps to offset the federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. The program requires a drug manufacturer to enter into a national rebate agreement with the Secretary of the Department of Health and Human Services in exchange for state Medicaid coverage of most of the manufacturer’s drugs. Currently, abuse-deterrent forumulations (ADF) are subject to additional obligations under this program. By exempting ADF from these requirements, it will help incentivize the innovation of these medicines which could help reduce addition to opioids.
According to the Committee, “The cost of the ADF policy is being offset by a policy to protect tools used to identify and prevent fraud, waste and abuse in Medicare, Medicaid and CHIP. The Centers for Medicare and Medicaid Services (CMS) uses mathematical algorithms and predictive technologies to uncover fraud, waste and abuse. However, if various aspects of these algorithms were to become publicly known, fraudsters could utilize the information to re-direct their schemes to other areas of the Medicare, Medicaid, and CHIP programs or adjust their schemes to avoid detection. Protecting these algorithms from public disclosure would allow for the free sharing to these anti-fraud tools among CMS and State Medicaid and CHIP programs.”
 See U.S. National Library of Medicine, “Neonatal abstinence syndrome”
 See The New England Jounral of Medicine, “ Increasing Incidence of the Neonatal Abstience Syndrome in U.S. Neonatal ICUs,” May 25, 2015.
 See Press Release, “Reps. Jenkins and Buston Introduce NAS Healthy Babies Act,” April 19, 2016.
 See Medicaid.gov “Medicaid Drug Rebate Program.”
A Congressional Budget Office (CBO) estimate is currently unavailable. According to the Committee, based on conversations with CBO, the bill is expected to be budget neutral.
For questions or further information please contact Molly Newell with the House Republican Policy Committee by email or at 21374.