Since mid-July, a proposed rule
has been languishing at the Office of Management and Budget that could remove
the safe-harbor protections that shelter the rebates drugmakers give to PBMs
from penalties under the federal antikickback statute.
In the meantime, CMS on Nov. 26 released another rule that could
essentially force Medicare Part D plans to pass all types of price concessions
negotiated with pharmacies onto consumers at the point of sale. The
introduction of the new Part D rule, which also seeks to revamp the protected
classes of drugs and make other Part D changes, led to renewed speculation
about the status of the administration's safe-harbor rebate rule.
Miryam Frieder, a vice president at Avalere, says the new Part D
rule is not in opposition to the regulation still being reviewed, "but it
kind of could be seen as complementary."
But the fact that the safe-harbor rebate rule has been stuck in
the review process since July 18 "to me indicates there's a lot of
discussion going on about this," says Larry Kocot, a principal at KPMG and
national leader of its Center for Healthcare Regulatory Insight.
One of the major questions the administration has to grapple
with is whether it actually has the authority to remove prescription-drug
rebates' exemption from the federal antikickback statute, he says. In addition,
the administration will have to figure out how to actually go about removing
safe-harbor protections for rebates and replacing the current system with a new
one.
The way the Citi analysts see it, removing the safe-harbor
protection for drug rebates, in isolation, would have a muted impact.
"While the market has focused on PBM-negotiated rebates as the chief
driver contributing to drug price inflation, the PBM industry has moved over
the last 3 years to reduce rebate retention to <5% as indicated in recent
CVS [Health Corp.] and [Express Scripts Holding Co.] disclosures," they
wrote in a research note.
No comments:
Post a Comment