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WASHINGTON, D.C. - Congressman Brett Guthrie (KY-02), Chairman of the House Energy & Commerce’s Health Subcommittee, released the following statement after introducing his bill H.R. 9184, the Patient Access Act, to help provide greater access to life-saving therapies, like 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. 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,” said Congressman Guthrie.

Background

This bill helps to ensure patients have access to cutting edge therapies, including cell-nd-gene therapies. Many of these therapies require comprehensive care delivery in specialized health care facilities certified by the U.S. Food and Drug Administration that may be limited in number and location throughout the country, and require extended monitoring by the team of specialized health care providers to track a patient’s progress or to address adverse health events. While this ensures patients receive a high-quality of care, it also limits the availability of health care providers who can administer these therapies.

Current federal limitations pose barriers to accessing these life-saving and life-changing innovative therapies, such as cell-and-gene therapies. Specifically, the Federal Anti-Kickback Statute (AKS) prohibits the knowing and willful payment of remuneration, or a kickback, to incentivize or reward patient referrals for a service provided to a patient by federal health care programs. In the instance of more complex therapies, manufacturers are prohibited from helping to defray the costs of incidentals when it may best for the patient’s health to do so, leading to a significant barrier to accessing life-saving care for patients who cannot otherwise afford these costs themselves.

The Patient Access Act bridges this gap and ensures patients can gain access to life-saving therapies in limited circumstances. Specifically, the legislation would allow manufacturers to cover the costs of incidentals for a patient and up to two caregivers throughout the duration of these treatments. The legislation also includes important guardrails to protect against fraud, waste, and abuse because it is targeted for those whose insurance or the facility administering the drugs don’t cover these costs, and it prohibits manufacturers from advertising to patients that costs may be covered until after they have been prescribed the drugs.

This legislation also closely reflects an HHS OIG Advisory Opinion from December 2020, which set guardrails to prevent fraud, waste, and abuse. In that advisory opinion, OIG stated that an exception to current antikickback regulations was necessary to support patient access to a specific drug. OIG stated the payments provided by the drug’s manufacturer were targeted to rural patients who would be negatively impacted by serious health risks or death if they couldn’t travel and the payments allowed providers to meet FDA requirements to administer the drug in specialized settings. In that case, as with other cell-and-gene therapies, federal FDA requirements limit the number of providers available to treat patients and because these were one-time expenses to facilitate patient access, they didn’t pose the risk of incentivizing repeated prescribing of that drug.

This bill codifies many of the same principles outlined in this Advisory Opinion, and will significantly increase access to care for vulnerable patients and help support longer, healthier lives for thousands of patients across the country.

Click here to read the full bill.

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