newborn screening & medical foods policy overview fatty oxidation disorders/organic acidemia...

Newborn Screening & Medical Foods Policy Overview

Fatty Oxidation Disorders/Organic Acidemia

Association Annual Conference

July 26, 2014

Melanie LockhartDirector, State Affairs

Office of Government Affairs

1

The March of Dimes mission is to improve the health of

babies by preventing birth defects, premature birth and

infant mortality.

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

March of Dimes & Newborn Screening

2004 2008

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

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!

The NBSSLRA: Key Bill Provisions5 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.

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

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.

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

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

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.

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)

Thank you!

Melanie Lockhartmlockhart@marchofdimes.com

202-659-1800