By Mara Lee | August
17, 2017
A rule that would set new ceiling prices in the 340B drug discount program has been delayed until July
2018, HHS announced Thursday. The rule, which was supposed to take effect in April would
also authorize HHS to levy fines against drug manufacturers that intentionally
charge a hospital more than the ceiling price.
The 25-year-old program requires drug companies to provide discounts to hospitals and clinics, with the goal of providing low-income patients greater access to medications. The program, however, has been criticized for not having stringent enough guidelines on who receives the discounts and how those savings are used by the participating hospitals.
The change would have paid hospitals 22.5% less than the average sales price for drugs acquired under the 340B program.
This is not the first delay of the rule, which was first proposed during the Obama administration. Most recently, the rule was expected to take effect at the beginning of October.
HHS says that there are " substantial questions of fact, law and policy raised by the rule," and that it needs more time to fully consider previous objections to the rule, including compliance challenges.
"HHS proposes this action in order to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking," the notice said.
The American Hospital Association responded that it is disappointed with the continued delay, especially during a time of sharply rising drug prices.
"HRSA's rulemaking on these issues began seven years ago, and these multiple delays are unjustified given the exhaustive rule development process that has already occurred," wrote Ashley Thompson, AHA senior vice president for public policy analysis and development.
The 25-year-old program requires drug companies to provide discounts to hospitals and clinics, with the goal of providing low-income patients greater access to medications. The program, however, has been criticized for not having stringent enough guidelines on who receives the discounts and how those savings are used by the participating hospitals.
The change would have paid hospitals 22.5% less than the average sales price for drugs acquired under the 340B program.
This is not the first delay of the rule, which was first proposed during the Obama administration. Most recently, the rule was expected to take effect at the beginning of October.
HHS says that there are " substantial questions of fact, law and policy raised by the rule," and that it needs more time to fully consider previous objections to the rule, including compliance challenges.
"HHS proposes this action in order to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking," the notice said.
The American Hospital Association responded that it is disappointed with the continued delay, especially during a time of sharply rising drug prices.
"HRSA's rulemaking on these issues began seven years ago, and these multiple delays are unjustified given the exhaustive rule development process that has already occurred," wrote Ashley Thompson, AHA senior vice president for public policy analysis and development.
Mara Lee covers developments in health care
policy in Congress and around Washington. This is her second time covering the
Hill. In a previous life, she covered Midwestern delegations for Scripps and
Gannett newspapers in Indiana and Michigan. Over her 20-year-plus-career, she’s
spent more time outside the Beltway, both as a business reporter for The
Hartford Courant and nine years in Ohio, mostly at the Dayton Daily News. She
won an award for coverage of Oxycontin addiction Ohio in 2003, as well as for
Census, business and breaking news coverage in Ohio and Connecticut. She’s a
Virginia native, and graduated from the University of North Carolina-Chapel
Hill. Twitter handle: MaraRhymesSarah
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