Brett Guthrie U.S. House of Representatives from Kentucky's 2nd district | Official U.S. House Headshot
Brett Guthrie U.S. House of Representatives from Kentucky's 2nd district | Official U.S. House Headshot
Congressman Brett Guthrie (KY-02), Chairman of the House Energy & Commerce’s Health Subcommittee, introduced bill H.R. 9184, known as the Patient Access Act, aimed at providing greater access to life-saving therapies, including potentially curative cell-and-gene therapies.
"Today I was proud to introduce the Patient Access Act to help ensure patients have access to cutting-edge therapies that can be the difference between life and death," said Congressman Guthrie. "This bill permits pharmaceutical manufacturers to cover the costs of incidentals while a patient receives a treatment of a complex product, such as cell and gene therapy, which can often be lengthy and require significant travel to specialized facilities. Importantly, the legislation only allows for manufacturers to do so in situations where patients and their families have limited means to offset these expenses, serving as a bridge to ensure access to quality health care. I look forward to passing this legislation out of the Health Subcommittee and encourage my colleagues to support this bill."
The proposed legislation aims to address barriers posed by current federal limitations like the Federal Anti-Kickback Statute (AKS), which prohibits remuneration or kickbacks for patient referrals under federal health care programs. The statute currently restricts manufacturers from assisting with incidental costs related to complex therapies when it may benefit patient health.
The Patient Access Act seeks to allow manufacturers to cover incidental costs for patients and up to two caregivers during treatments. It includes safeguards against fraud, waste, and abuse by targeting those whose insurance or administering facility does not cover these costs. Manufacturers are prohibited from advertising cost coverage until after drug prescription.
The bill reflects principles outlined in an HHS OIG Advisory Opinion from December 2020 that recommended exceptions for antikickback regulations under specific circumstances involving rural patients needing critical drugs.
By codifying these principles, the Patient Access Act aims to increase access for vulnerable patients and support healthier lives across the country.
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