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Affordable Care Act

The Affordable Care Act was passed by Congress and then signed into law by the President on March 23, 2010. On June 28, 2012 the Supreme Court rendered a final decision to endorse the health care law. The Affordable Care Act is a federal statute aimed at decreasing the number of uninsured Americans and reducing the overall costs of health care. Many of its provisions significantly impact children and youth with special health care needs, a population important to the purpose of the Southeast Regional NBS & Genetics Collaborative.


Key Features
·    Children under the age of 19 can no longer be denied insurance for pre-existing conditions. Young adults up to the age of 26 can now stay on their parents insurance plan. Elimination all lifetime maximum limits. Millions of uninsured Americans will gain access to affordable coverage through Affordable Insurance Exchanges and improvements in Medicaid and CHIP.
·    Preventive Care Is Covered: Many insurers are now required to cover preventive services at no cost to you. This includes new preventive benefits for mothers and vaccinations for kids. Insurance Companies Are Held Accountable: Your premium dollars must be spent primarily on health care, not advertising or bonuses for executives. And insurance companies must now publicly justify any unreasonable rate hikes.
In addition, beginning in 2014, all health plans must:
·    Stop denying coverage for all people with pre-existing conditions. Eliminate annual limits on “essential benefits” like prescription drugs. In the law however, “essential benefits”  do not apply to self-funded plans currently regulated by ERISA (the Employee Retirement Income Security Act of 1974).


Resources for the Affordable Care Act (ACA)

Resource Title


Clickable state information

Clickable state information

CHIP program

CHIP program

The Affordable Care Act and Children with Special Health Care Needs: An Analysis and Steps for State Policymakers [PDF, 48 pages]

This report is designed to help inform state policymakers' decisions in implementing health care reform. Developed for the Catalyst Center by the National Academy for State Health Policy (NASHP), the report reviews and analyzes key provisions of the ACA and their potential impact on CYSHCN and their families.


The Affordable Care Act: A Side-by-Side Comparison of Major Provisions and their Implications for CYSHCN [PDF, 16 pages]

A companion piece to the publication described above, this brief offers a concise description of select provisions in the ACA with a side-by-side analysis of what they may mean for CYSHCN and their families.


Are Families of Medicaid-enrolled Children with Disabilities Eligible for Subsidized Marketplace Coverage? [PDF, 3 pages]

An overview of Marketplace coverage for children with disabilities who receive Medicaid due to family income, waiver eligibility, or Family Opportunity Act Medicaid buy-in. This question was answered in detail in the December 2013 issue of Catalyst Center Quarterly.


Presentation Slides: The ACA and Genetic Conditions: Opportunities and Challenges [PDF] This webinar was a collaboration between HRSA Genetic Services and the Catalyst Center on June 19, 2013.
The Affordable Care Act, Section by Section The complete text of the ACA is available at
Kaiser Family Foundation State Health Facts - Health Reform indicators

State Health Facts provides free, up-to-date, and easy-to-use health data for all 50 states, the District of Columbia, the United States, counties, territories, and other geographies. Data come from a variety of public and private sources, including Kaiser Family Foundation reports, public websites, government surveys and reports, and private organizations.


Insure Kids Now national outreach and enrollment campaign provides information about Medicaid and CHIP services for families who need health insurance coverage. These programs are designed to be affordable for families who are not able to afford health insurance coverage in the private market or do not have coverage available to them. Even if you've been turned down in the past, you may be able to get health coverage for your child now.Learn more about health coverage programs in your state.

The national portal to the State Health Insurance Marketplaces - choosing your state from the drop-down menu will bring you to your state's Marketplace website, if it has one, or link you directly to eligibility, cost and enrollment information.


The Center for Consumer Information and Insurance Oversight

The Center for Consumer Information and Insurance Oversight (CCIIO), under the Centers for Medicare and Medicaid Services (CMS), oversees the implementation of the ACA provisions related to private health insurance.


Maternal and Child Health Library at Georgetown University A compilation of resources on the ACA for MCH professionals


Medicaid and CYSHCN

Resource Title


Public Insurance Programs and Children with Special Health Care Needs: A tutorial on the basics of Medicaid and the Children's Health Insurance Program (CHIP) [PDF, 56 pages] An online, self-directed overview of the Medicaid and CHIP programs, the many different populations these programs serve, and how these programs are changing as a result of the ACA. It provides suggestions to help readers think about opportunities for Title V programs, family leaders, and others to work together with Medicaid and CHIP in their states to improve the financing of care for CYSHCN.
Fact Sheet: Medicaid and Children with Special Health Care Needs/Disabilities [PDF, 2 pages] An overview of the importance of Medicaid in covering children with special health care needs and disabilities.
Fact Sheet: The Children's Health Insurance Program and Children with Special Health Care Needs [PDF, 2 pages] An overview of the importance of CHIP in covering children with special health care needs.
Infographic: Medicaid & CHIP: What's the Difference? [PDF, 1 page] An at-a-glance comparison of Medicaid & CHIP, with an explanation of what the differences might mean for a child with special health care needs.
Your Questions About the Medicaid Expansion Provision of the Affordable Care Act Answered [PDF, 6 pages] The Supreme Court's June 28, 2012 decision made the Medicaid expansion optional for states. This brief discusses the implications of that decision for youth and young adults with special health care needs.
State Health Fact Sheets

The State Health Facts pages of the Kaiser Family Foundation provides updated health insurance and health reform data for each state. Use this interactive map to create customized fact sheets to compare one state to the U.S. average or to compare two states to each other.


Medicaid Waivers

This CMS (Centers for Medicare & Medicaid Services) website provides information about the different types of Medicaid waivers (the specific conditions under which a state can petition CMS in order to provide specific services to defined populations. See the waivers that are pending, in effect, or expired in your state.



SERN Highlights
May 2018

FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders

FDA permits marketing of first newborn screening system for detection of four, rare metabolic disorders

The U.S. Food and Drug Administration today permitted marketing of the Seeker System for the screening of four, rare Lysosomal Storage Disorders (LSDs) in newborns. The Seeker system is designed to detect Mucopolysaccharidosis Type I (MPS I), Pompe , Gaucher and Fabry . It is the first newborn screening test permitted to be marketed by the FDA for these disorders.

LSDs are a group of rare, inherited metabolic disorders in which enzymes (proteins) that normally eliminate unwanted substances in the body's cells are not at normal levels or functioning properly. According to the U.S. Department of Health and Human Services' Advisory Committee on Heritable Disorders in Newborns and Children, MPS I, Pompe, Gaucher and Fabry occur in approximately 1 in 1,500 to no more than 1 in 185,000 newborns and children, depending on the disorder. If not detected and treated in a timely manner, these disorders may cause organ damage, neurological disability or death.
"The Secretary of HHS recently added Pompe and MPS I to the list of routine recommended newborn screening programs and it is anticipated that additional states will begin requiring use of screening tests to detect these disorders," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "Accurate screening tests will help with early detection, treatment and control of these rare disorders in newborns, before permanent damage occurs. That's why availability of LSD screening methods that have been assessed for accuracy and reliability by the FDA are so important."
Several states currently mandate LSD screening in all newborns, including Arizona, Illinois, Kentucky, Michigan, Missouri, New Jersey, New Mexico, New York, Ohio, Pennsylvania and Tennessee. However, until today there were there were no FDA-authorized devices for screening of these disorders. Availability of the Seeker System provides laboratories with a screening tool that has been reviewed by the FDA for clinical and analytical validity.
The Seeker System, consisting of the Seeker LSD Reagent Kit- IDUA|GAA|GBA|GLA and Seeker Instrument, works by measuring the activity level of proteins required for healthy lysosomal storage found in dried blood samples collected from the prick of a newborn's heel 24 to 48 hours after birth. The Seeker Instrument is a device that automates the analysis of dried blood spots. Reduced enzyme activity of proteins associated with any of the four LSDs detected by the kit may indicate presence of a disorder. Results showing reduced enzyme activity must be confirmed using other testing methods, such as biopsies, genetic and other laboratory tests.
The FDA reviewed the data for the Seeker System through the de novo premarket review pathway, a regulatory pathway for devices of a new type with low-to-moderate-risk that are not substantially equivalent to an already legally marketed device and for which special controls can be developed, in addition to general controls, to provide a reasonable assurance of safety and effectiveness of the devices. During this process, the FDA evaluated data from a clinical study of 154,412 newborns in Missouri whose dried blood samples were tested for protein activity associated with MPS I, Pompe, Gaucher and Fabry. Efficacy was determined because the system was able to accurately identify at least one of each of these four LSDs in 73 of the screened newborns.
Risks associated with use of the screening system include false negative findings. As part of this study, the Missouri State Public Health Laboratory conducted active surveillance of four of the state's metabolic clinical centers for new diagnoses of these disorders. The state laboratory's surveillance activities extended 15 months following the study's completion to determine cases of false negatives that had not been identified during the study. No false negative results were identified either through the study or the state's 15-month surveillance program.
The Seeker System was created with funding from the Small Business Innovation Research program in National Institutes of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development. It is manufactured by Baebies Inc., located in Durham, North Carolina.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
JELILI OJODU, MPH | Director, Newborn Screening and Genetics
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