“Plan E”: A Proposal for a Universal Benefit for Cell and Gene Therapies

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Cell and gene therapies (CGTs) have provided new optimism for patients living with diseases previously considered untreatable. These groundbreaking treatments involve introducing genetic material to the targeted cells in the body to treat diseases through various mechanisms, including by enhancing the production of healthy proteins or reducing the production of disease-causing ones. Despite their potential, the elevated costs of these therapies have raised concerns about the healthcare system’s ability to manage these growing expenses and guarantee fair access for patients. Some private insurers have introduced plans to cover select gene therapies, but critics argue that these programs may prioritize profits over patient well-being.

To address these challenges, a proposal suggests creating a universal benefit, named “Part E” through the Medicare program. This benefit would cover a specific group of CGTs, reducing financial risk through a national risk pool. By consolidating purchasing power, the federal government could negotiate lower prices for these therapies. Part E would be open to individuals meeting Medicare requirements, without age, disease, or income restrictions. The program aims to shift the financial responsibility for high-cost drugs to Medicare, potentially reducing premiums for other payers. The CMS administrator would determine coverage eligibility based on FDA approval, negotiating payment agreements with manufacturers. Funding could come from the Part B Supplementary Medical Insurance Trust Fund, which would require a small increase in employer and employee contributions.

The proposal is likely to face pushback from stakeholders worried about added administrative workload, potential reduced payments, increased price regulation, and consumer accessibility. Despite these challenges, the proposal suggests an incremental approach to healthcare reform necessary to address the growing number of high-cost CGTs entering the market and to ensure affordable access for all Americans. Read the proposal here.

Last Updated on January 31, 2024 by Aimed Alliance

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