Newborn Screening and Health Care Reform

1. Newborn Screening and Health Care Reform Presented at the NCC/RC PI Annual Meeting, November 16, 2009

2. Newborn Screening and Health Care Reform: ACHDNC paper OVERVIEW • As with health care system overall, there is unequal access to newborn screening (NBS) services across the country • The reasons behind disparities in NBS mirror problems with the broader health system: • Public financing • Payment systems • Administrative inefficiencies • Insurance coverage issues

3. Unequal Access to Services

4. Public Financing

5. Public Financing

6. Payment systems

7. Payment systems

8. Payment systems

9. Administrative Inefficiencies

10. Administrative Inefficiencies

11. Insurance Coverage Issues

12. Insurance Coverage Issues

13. Insurance Coverage Issues

14. Insurance Coverage Issues

15. Insurance Coverage Issues

16. Insurance Coverage Issues

17. Federal Medical Foods Legislation S 2766 FDA definition of medical foods • “… a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”(section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3))) In addition to nutritionally modified counterparts of traditional foods, medical foods are recognized for purposes of this Act to include, but not be limited to, other forms of foods such as formulas, pills, capsules and bars, so long as consumed or administered enterally. The term “enterally” refers to consumption or administration through gastrointestinal tract, whether orally or by tube. (Source: National PKU Alliance)

18. Federal Medical Foods Legislation • Coverage requirements apply to federal health insurance plans, plans governed by the Employee Retirement Income Security Act (ERISA), individual and group health insurance plans • Coverage requirements address medical necessary foods, foods modified to be low in protein, pharmacological doses of vitamins and amino acids • Secretary, HHS to determine minimum yearly coverage (Source: National PKU Alliance)

19. Federal Medical Foods Legislation HR 3262 • Internal Revenue Code of 1986 (relating to medical, dental, etc., expenses) amendment:`(C) for foods for special dietary use, dietary supplements (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act), and medical foods,'. • SPECIAL RULE FOR INSURANCE COVERING FOODS FOR SPECIAL DIETARY USE, DIETARY SUPPLEMENTS, AND MEDICAL FOODS- Amounts paid for insurance covering foods and supplements referred to in paragraph (1)(C) shall be treated as described in paragraph (1)(E) only if such foods and supplements comply with applicable good manufacturing practices prescribed by the Food and Drug Administration or with other comparable standards.'.

20. Contact Information Alissa Johnson Johnson Policy Consulting Ph: (703) 272-7847 ajohnson@policyconsult.com www.policyconsult.com