Proposed legislation to secure insurance coverage for certain medical foods could eliminate coverage for others

By A. Wes Siegner, Jr. and Ricardo Carvajal  
 
Sen. Kerry has introduced the Medical Foods Equity Act of 2009 with the goal of securing insurance coverage for certain medical foods.  The legislation would secure coverage under federal insurance plans (e.g., Medicaid and Medicare), plans governed by the Employment Retirement Income Security Act (ERISA), and plans on the individual and group markets for the following types of food:

medically necessary food and food modified to be low protein that is  formulated to be consumed or administered under the supervision of a qualified medical provider, for the treatment of conditions as recommended by the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC);

pharmacological doses of vitamins and amino acids used for the treatment of inborn errors of metabolism, for the treatment of conditions as recommended by the ACHDNC and as prescribed by a qualified medical provider.
 
The legislation defines “medically necessary food” in a manner that is generally consistent with the definition of "medical food" in section 5(b) of the Orphan Drug Act (21 U.S.C. § 360ee(b)(3)), and includes both “nutritionally modified counterparts of traditional foods” and “other forms of foods such as formulas, pills, capsules, and bars, so long as consumed or administered enterally.” 
 
As matters now stand, coverage of medical foods by insurance plans appears to be fairly widespread.  Although this proposed legislation would secure coverage for the types of medical foods that fall within its narrow scope, it could well have the effect of reducing existing coverage for other types of medical foods.  Whether efforts to broaden the scope of the legislation would be successful is open to question, given rumblings of discontent from FDA suggesting that the agency views the medical food category as ripe for a crackdown.