Newborn Newborn Screening and Screening and

Health Care Health Care Reform Reform

Presented at the NCC/RC PI Presented at the NCC/RC PI Annual Meeting, November Annual Meeting, November

16, 200916, 2009

Newborn Screening and Newborn Screening and Health Care Reform: Health Care Reform:

ACHDNC paperACHDNC paperOVERVIEWOVERVIEW

As with health care system overall, there is As with health care system overall, there is unequal access to newborn screening (NBS) unequal access to newborn screening (NBS) services across services across the country the country

The reasons behind disparities in NBS mirror The reasons behind disparities in NBS mirror problems with the broader health system:problems with the broader health system: Public financingPublic financing Payment systemsPayment systems Administrative inefficienciesAdministrative inefficiencies Insurance coverage issuesInsurance coverage issues

Unequal Access to Unequal Access to ServicesServices

Public FinancingPublic Financing

Public FinancingPublic Financing

Payment systemsPayment systems

Payment systemsPayment systems

Payment systemsPayment systems

Administrative Administrative InefficienciesInefficiencies

AdministrativAdministrative e

InefficienciesInefficiencies

Insurance Coverage Insurance Coverage IssuesIssues

Insurance Coverage Insurance Coverage IssuesIssues

Insurance Coverage Insurance Coverage IssuesIssues

Insurance Coverage Insurance Coverage IssuesIssues

Insurance Coverage Insurance Coverage IssuesIssues

Insurance Coverage Insurance Coverage IssuesIssues

Federal Medical Foods Federal Medical Foods LegislationLegislation

S 2766 FDA definition of medical foodsS 2766 FDA definition of medical foods

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

Federal Medical Foods Federal Medical Foods LegislationLegislation

Coverage requirements apply to federal health Coverage requirements apply to federal health insurance plans, plans governed by the Employee insurance plans, plans governed by the Employee Retirement Income Security Act (ERISA), individual Retirement Income Security Act (ERISA), individual and group health insurance plansand group health insurance plans

Coverage requirements address medical necessary Coverage requirements address medical necessary foods, foods modified to be low in protein, foods, foods modified to be low in protein, pharmacological doses of vitamins and amino acids pharmacological doses of vitamins and amino acids

Secretary, HHS to determine minimum yearly Secretary, HHS to determine minimum yearly coveragecoverage

(Source: National PKU Alliance)(Source: National PKU Alliance)

Federal Medical Foods Federal Medical Foods LegislationLegislation

HR 3262HR 3262

• Internal Revenue Code of 1986 (relating to medical, Internal Revenue Code of 1986 (relating to medical, dental, etc., expenses) amendment:`(C) for foods for dental, etc., expenses) amendment:`(C) for foods for special dietary use, dietary supplements (as defined in special dietary use, dietary supplements (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act), section 201 of the Federal Food, Drug, and Cosmetic Act), and medical foods,'.and medical foods,'.

• SPECIAL RULE FOR INSURANCE COVERING FOODS FOR SPECIAL RULE FOR INSURANCE COVERING FOODS FOR SPECIAL DIETARY USE, DIETARY SUPPLEMENTS, AND SPECIAL DIETARY USE, DIETARY SUPPLEMENTS, AND MEDICAL FOODS- Amounts paid for insurance covering MEDICAL FOODS- Amounts paid for insurance covering foods and supplements referred to in paragraph (1)(C) foods and supplements referred to in paragraph (1)(C) shall be treated as described in paragraph (1)(E) only if shall be treated as described in paragraph (1)(E) only if such foods and supplements comply with applicable good such foods and supplements comply with applicable good manufacturing practices prescribed by the Food and Drug manufacturing practices prescribed by the Food and Drug Administration or with other comparable standards.'.Administration or with other comparable standards.'.

Contact InformationContact Information

Alissa JohnsonAlissa Johnson

Johnson Policy ConsultingJohnson Policy Consulting

Ph: (703) 272-7847Ph: (703) 272-7847

ajohnson@policyconsult.com

www.policyconsult.com