It is the last day of IIR’s
GP Summit with a focus on the 340B Program and it was well worth it to stick
around. Commander Krista Pedley, from the
Office of Pharmacy Affairs (“OPA”), took us through the recent audits of Covered
Entities (“CEs”). Of significance is the
number of CEs found to be requesting a Medicaid rebate for product purchased
through the 340B program (“duplicate discounts”) and those diverting product
purchased at the 340B discount for inpatient utilization (“diversion”). Full audit results will soon be up on the OPA
website along with the correction plans to be implemented by the CEs and CEs
found to be violating terms of their agreements are required to submit their
corrective action plan within 60 days of the findings or they face exclusion
from the 340B program.
On the manufacturer side,
the OPA is conducting its first manufacturer audit and is also developing
documentation to assist manufacturers in their preparations for an OPA audit. Manufacturers such as Daiichi Sankyo and
Pfizer shared their experience in identifying duplicate payments and as Ed
McAdam from Daiichi Sankyo stated, there is no silver bullet to fix this issue,
but is a worthwhile investment for manufacturers to audit 340B transactions at
least twice a year. Not doing so means
manufacturers could be “leaving money on the table.” Identifying duplicate discounts and diversion
may require a significant effort on behalf of the manufacturer, including the
purchase of third party data in some instances, but the return on investment
for many manufacturers has been worth it.
One other recent area
getting additional attention is Gross-to-Net which was covered by Ankur Bansal
from Alliance Life Science. Bansal walked attendees through optimizing
Gross-to-Net to help with accurately project Best Price the impacts of Medicaid
liability. With price increases, many manufacturers
plot out the Best Price for three to five years and project sales by
customer. Pricing strategy teams that include
marketing, contracting, brand management, and government pricing, can be
important for manufacturers to fully understand the impact of price
changes. A price increase or decrease will
usually have an impact on some, if not all, of the government price points,
therefore, all price changes should include a comprehensive review, customer-by-customer
and product-by-product, to understand the overall effect of the price change. Ultimately, manufacturers want to find the
“sweet spot” where revenues from both the commercial and government businesses
are maximized.
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