- HHS is planning to once again delay the 340B program rule that penalizes drug companies for overcharging hospitals that buy medicine through the program.
- Implementation of the rule has already been delayed several times, and HHS is now proposing a start date in July 2018.
- The agency said additional “time is needed to allow a more deliberate process of considering the alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking.” It added the delay would also allow more time to consider objections to the rule and challenges of complying with it.
The American Hospital Association (AHA) said the delay is unjustified because the process for rule development has already been exhaustive. “Given the skyrocketing prescription drug price increases that have presented hospitals and their patients with remarkable challenges, the 340B program is as critical as it has ever been in helping eligible hospitals obtain a reduced price for outpatient drugs, allowing them to stretch scarce federal resources to expand and improve access to comprehensive healthcare services for our nation’s most vulnerable patients,” said Ashley Thompson, AHA senior vice president for public policy analysis and development.
The pharmaceutical industry, however, is unsurprisingly happy with the delay. A spokeswoman for Pharmaceutical Research and Manufacturers of America (PhRMA) told Bloomberg BNA the group continues “to have a number of concerns with the rule as it imposes significant burdens on biopharmaceutical manufacturers.”
PhRMA has said the program needs better oversight to ensure the savings are getting to the hospitals and patients that truly need them, and charges that not all 340B hospitals are good stewards of the program.
Payments under the 340B program, which requires pharmaceutical companies to sell outpatient drugs to certain providers at reduced costs, recently received a major cut that also angered hospitals groups. AHA at the time said the program accounted for less than 3% of annual drug purchases, but is imperative for safety net hospitals and other organizations caring for the uninsured and people with low incomes.
High drug costs continue to be a major public concern, but despite President Donald Trump’s frequent criticism of drug manufacturers and the soaring prices for prescription drugs, no major regulatory or legislative changes are currently being considered.