In a recent blog post, we urged providers to ready themselves for publication of the 340B mega rule. The Health Resources and Services Administration (HRSA), however, has halted publication of that rule indefinitely. HRSA made this decision a month after the Pharmaceutical Research and Manufacturers of America (PhRMA) launched a new lawsuit challenging HRSA’s latest “interpretive rule” concerning treatment of orphan drugs. HRSA published its “interpretive rule” after PhRMA won a lawsuit that voided HRSA’s previous substantive 340B rule making on the issue.
HRSA will likely wait until 2015 before it issues proposed guidance for notice and comment that will address key policy issues regarding the integrity of the 340B program. HRSA is also planning to issue proposed rules pertaining to civil monetary penalties for manufacturers, calculation of the 340B ceiling price, and administrative dispute resolution.