House Energy and Commerce Committee Chairman Greg Walden (R-OR), Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), Senate Health, Education, Labor, and Pensions (HELP) Committee Chairman Lamar Alexander (R-TN), and Senate HELP Committee Ranking Member Patty Murray (D-WA) sent a letter to the Health Resources and Services Administration (HRSA) regarding the fact that they have not used their rulemaking authority to implement regulations to better administer the 340B Drug Pricing Program (340B Program).
The 340B Program enjoys strong bipartisan support in Congress and provides critical support to safety net care providers helping underserved communities across the country.
“Given the important role the 340B Program plays in our nation’s health care safety net, it is critical that program rules be clear and consistent for all stakeholders,” write Walden, Pallone, Alexander, and Murray. “Unfortunately, the agency has faced significant impediments to appropriate oversight and enforcement given recent judicial decisions that, in effect, left the agency without broad rulemaking authority.”
“HRSA has requested that Congress consider legislative action to give the agency broad rulemaking authority over the 340B Program,” the bipartisan leaders also wrote. “In testimony before the Senate Health, Education, Labor and Pensions Committee this June and before the House Energy and Commerce Committee last July, HRSA stated that specific regulatory authority to conduct rulemaking for all provisions of the 340B statute would allow the agency to better oversee and manage the program. Such specific authorities have been proposed in the president’s budget as well.”
The bipartisan leaders continued, “While HRSA has requested these additional authorities, the agency is not using its existing authorities. The [D.C. District] court ruling made clear that HRSA does have regulatory authority that includes (1) establishing and implementing a binding Administrative Dispute Resolution (ADR) process for the resolution of certain disputes relating to compliance with 340B Program requirements, (2) providing for the imposition of civil monetary penalties (CMPs) against manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug, and (3) issuing precisely defined standards of methodology for calculation of 340B ceiling prices.”
To read a copy of the letter, click here.