The 340B Drug Pricing Program continues to be under the microscope. The House Energy & Commerce Oversight and Investigations Subcommittee held a hearing last week titled “Oversight of 340B Drug Pricing Program.” While most lawmakers support the 340B program, several suggested adopting additional regulatory requirements. Additionally, Republican lawmakers in the House introduced the 340B Affording Care for Communities and Ensuring a Strong Safety-Net Act (ACCESS) Act. The Act, if implemented, would significantly limit provider access to the program and add new transparency measures. The legislation is supported by the Alliance to Save America’s 340B Program (ASAP 340B), which is led by the Pharmaceutical Research & Manufacturers of America and the National Association of Community Health Centers.

340B Congressional Hearing

In a rare moment of bipartisanship, legislators from both parties in the House Energy and Commerce Committee agreed on the idea of reforming the 340B program. However, how to reform the program continues to be up for debate. While the program has Congressional support, some lawmakers highlighted presumed bad actors, like Bon Secours Mercy Health, for boosting their revenue off the program with “little benefit” being given to underserved communities. Republican members were uniquely focused on charity care and believed 340B savings should directly impact patients. Critics of the 340B program referenced reports that major nonprofit systems have used the program to boost revenues with limited apparent benefit to underserved communities. Democrat lawmakers directed much of their questioning to the hearing’s provider witnesses and were interested in hearing about how the savings are being used. Some lawmakers, including Congresswoman Kathy Castor (D-FL), highlighted the benefits of the 340B program and how reforms restricting access to it would adversely impact patients.

New 340B Legislation

Republican lawmakers in the House introduced the 340B ACCESS Act, which aims to tighten 340B eligibility and adds new reporting requirements. Rep. Larry Buchson, M.D. (R-IN), Buddy Carter (R-GA), and Diana Harshbarger (R-TN) introduced the Act with the intent to “restore integrity” in the program. However, the Act represents the pharmaceutical industry’s wish list and would bring new restrictive hospital eligibility requirements that vary by hospital type. The Act would:

  • Require 340B entities to report how they use their savings.
  • Require that all registered child sites are located in an area with a shortage of personal health services.
  • Require child sites to provide charity care.
  • Impose civil monetary penalties equal to $2,500 for each violation of any provision of the Act.
  • Codify definitions of 340B patients and contract pharmacies — a move that speaks to recent years’ legal battles between hospitals, pharmacies and the federal government over which patients are eligible for discounts and whether manufacturers must offer the discounts to contracted pharmacies.

The Act does not appear to be gaining any traction due to it significantly limiting 340B eligibility. However, provisions of this bill could be piecemealed into larger legislative packages.