S. 3304: Medical Foods and Formulas Access Act of 2025

This bill, titled the Medical Foods and Formulas Access Act of 2025, aims to improve access to medically necessary foods and related products for individuals with certain digestive and inherited metabolic disorders under various federal health programs. Here are the key provisions of the bill summarized:

Coverage Expansion

• Medicare Coverage: The bill amends the Medicare program to include coverage for medically necessary food, which encompasses specialized food products, nutritional formulas, individual amino acids, and vitamins that are prescribed for dietary management of specific medical conditions.
• Medicaid Coverage: It mandates similar coverage for medically necessary food under Medicaid, ensuring that states provide for these needs in their medical assistance programs.
• CHIP Coverage: The Children’s Health Insurance Program (CHIP) will be required to cover medically necessary food and related supplies for children diagnosed with appropriate conditions.
• Federal Employee Health Benefits Program (FEHBP): The bill mandates FEHBP plans to provide coverage for medically necessary food, aligning with other federal programs.

Definition of Medically Necessary Food

The bill defines "medically necessary food" as specially formulated food products that are prescribed by healthcare practitioners to individuals who cannot adequately digest or absorb normal food due to specific medical conditions. The food must be intended for medical use and cannot include regular foods or those intended for general dietary needs or weight loss, and includes items like:

• Low protein modified food products
• Amino acid preparations
• Specialized nutritional formulas

Federal Guidelines and Protections

• The bill institutes protections to ensure that medically necessary food is covered consistently under federal programs and that patients have access to it without unnecessary restrictions, such as requiring feeding tubes when oral consumption is sufficient.
• It establishes that the bill’s amendments will not preempt stronger state laws that mandate greater coverage than what is stipulated in this law.

Effective Dates

• The Medicare and Medicaid changes are set to go into effect three years and two years, respectively, after enactment, while CHIP amendments will take effect one year post-enactment.

Sense of Congress

The bill expresses the notion that all health plans, including private insurance, should also provide coverage for medically necessary food. This statement emphasizes the life-saving potential of these foods for patients with specific health conditions.

Financial Considerations

• The bill outlines that Medicare will cover 80% of the costs for medically necessary food under specific payment structures.
• States will not be penalized for delays in compliance if their plans require legislative adjustments to meet the new requirements.

Relevant Companies

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