1. Newborn Screening & Medical Foods Policy Overview Fatty Oxidation Disorders/Organic Acidemia Association Annual Conference July 26, 2014 Melanie Lockhart Director, State Affairs Office of Government Affairs 1

2. The March of Dimes mission is to improve the health of babies by preventing birth defects, premature birth and infant mortality.

3. March of Dimes & Newborn Screening March of Dimes funded research Nationwide campaign for all states to adopt the RUSP Policy Documented medical benefit Reliable screening test Early detection

4. March of Dimes & Newborn Screening 2004 2008

5. Newborn Screening Policies Proliferation of tests led to a state-by-state patchwork Policies designed to promote more uniformity Children’s Health Act Creation of the Secretary’s Advisory Committee on Heritable Disorders Creation of the Recommended Uniform Screening Panel (RUSP) Newborn Screening Saves Lives Act of 2008

6. Newborn Screening Saves Lives Reauthorization Act The Newborn Screening Saves Lives Act is due for its 5-year renewal this year. S. 1417 introduced by Senators Kay Hagan (D-NC) and Orrin Hatch (R-UT). Passed Senate on January 29, 2014! H.R. 1281 introduced by Representatives Lucille Roybal-Allard (D-CA) and Mike Simpson (R-ID). Passed the House on June 24, 2014!

7. The NBSSLRA: Key Bill Provisions 5 Key Provisions: #1 – Reauthorizes the Secretary’s Advisory Committee on Heritable Disorders. #2 – Renews grants to states to expand and improve their screening programs. #3 – Supports consumer and provider education. #4 – Reauthorizes the Centers for Disease Control and Prevention (CDC) Newborn Screening Quality Assurance Program (NSQAP). #5 – Maintains the Hunter Kelly Newborn Screening program for research.

8. Medical Foods Equity Act of 2013 (H.R. 3665) Sponsored by Representative John Delaney (D-MD) Introduced December 5, 2013 Referred to House Subcommittee on Military Personnel Requires federal health programs (including Medicaid & CHIP)to cover the cost of medical foods for all inborn errors of metabolism. Based on the recommendations of the HHS Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children. Secretary of HHS would determine the yearly coverage amounts. Medical Foods not addressed by the ACA

9. Affordable Care Act ACA requires most insurance companies to follow new rules that help protect children with special health needs and their families: Not allowed to set annual limits & lifetime limits on certain benefits. Must cover preventative services at no cost.  Exception for grandfathered plans who may cover with a co-pay.

10. Affordable Care Act & Newborn Screening Requires health plans cover screening as preventive care for all conditions on RUSP (cost sharing with some plans) 1 year from when condition is added to RUSP for compliance RUSP condition may need to be required on state NBS panel for automatic screening (varies by state) Screen on request if not yet required Medicaid & CHIP – guided by AAP Bright Futures

11. Affordable Care Act & Essential Health Benefits Beginning in 2014, health plans offered in the individual & small group markets, inside & outside of the Exchange, must include ‘essential health benefits’ (EHB) covering the following 10 categories through a benchmark plan: – 1.Ambulatory patient services – 2.Emergency services – 3.Hospitalization – 4.Maternity and newborn care – 5.Mental health/substance use – 6. Prescription drugs – 7. Rehabilitative & habilitative services/devices – 8. Laboratory services – 9. Preventive and wellness services & chronic disease management – 10. Pediatric services, including oral and vision care

12. Affordable Care Act & Marketplace (Health Exchanges) Coverage began on January 1, 2014 (enrollment October 2013 – March 2014) ‐Next open enrollment is October – December 2014 ‐Birth or adoption of child – qualifying life event Each state has its own exchange with different benefits (state, federal and partnership) Medical foods are covered in 39 states that have insurance mandates (in place prior to ACA) but may differ from state to state.

13. Medicaid & Children’s Health Insurance Program (CHIP) Public health insurance programs no or low cost coverage. Medicaid provides comprehensive & medically necessary services under Early, Periodic Screening, Diagnosis and Treatment (EPSDT) – In 2014, easier to qualify due to Medicaid expansion with an income less than 138% FPF. (Only ½ states expanding) – Maintenance of Effort as of 3/23/10 for states not expanding CHIP provides comprehensive benefits guided by AAP (MOE also applies) Other public programs which provide assistance: Women, Infants and Children (WIC) Children with Special Health Care Needs (CSHCN)

14. Thank you! Melanie Lockhart mlockhart@marchofdimes.com 202-659-1800