In a letter this week to the Health Resources and Services Administration (HRSA), bipartisan leaders of two congressional committees responded to the agency’s desire for new regulatory authority over the 340B Drug Pricing Program by pointing out that HRSA has not fully used its existing authority.
In the Aug. 27 letter, the chairs and ranking members of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor, and Pensions (HELP) noted that, while HRSA has appealed to Congress for greater rulemaking authority, it has “repeatedly delayed issuing rules and guidance” on:
- processes to ensure compliance in administration dispute resolutions;
- enforcement of civil monetary penalties against drug manufacturers that knowingly overcharge; and
- a standard methodology for ceiling price calculations.
“While we appreciate that HRSA has requested … additional authorities, we remain concerned that the agency is not using its existing authorities,” the lawmakers wrote.
In May, HRSA proposed delaying from July 1, 2018, to July 1, 2019, a final rule on ceiling prices and manufacturer civil monetary penalties in the 340B program. The final rule was issued in 2017, but its implementation has been delayed several times. America’s Essential Hospitals urged HRSA to make the rule final, emphasizing that it is an important step toward transparency and accountability for the program. The association also encouraged HRSA to follow directions from Congress, issued in 2010, that instructed the agency to carry out the regulations.