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Release of proposed AMP rule creates new issues for life-science industry
June 2012
SHARING OPTIONS:
On Jan. 27, the Centers for Medicare and Medicaid Services (CMS)
published the much-anticipated proposed Average Manufacturing Price (AMP) rule
for implementing the Medicaid prescription drug provisions of the Patient
Protection and Affordable Care Act (PPACA). The new guidelines will have a
wide-reaching financial impact on the life-science industry by creating serious
administrative and operational challenges that will have to be addressed
relatively quickly.
The proposed rule aims to lower costs for states and
taxpayers by aligning reimbursement rates to better reflect the actual price
the pharmacy pays for the drug; increasing rebates paid by drug manufacturers
that participate in Medicaid; and providing rebates for drugs dispensed to
individuals enrolled in a Medicaid managed-care organization.
History of the
Medicaid Rebate Act
In 1990, Congress passed the Medicaid Rebate Act in response
to increasing Medicaid expenditures for prescription drugs. The legislation’s
goal was to stop drug companies from overcharging Medicaid by giving taxpayers
(who fund Medicaid) the best discounts that other purchasers negotiated.
The mechanism Congress designed to achieve this goal
requires drug companies that seek Medicaid payments for their prescription
drugs to pay a rebate to each state each quarter that is based on the difference
between the price that the state paid and any lower price paid by other
purchasers, other than health maintenance organizations (HMOs) or government
entities, known as the Best Price (BP), or a rebate based upon a 23.1 percent
discount off the AMP, whichever provides the greatest rebates to the states.
According to pharmaceutical pricing data, the overwhelming majority of
manufacturer drug rebates are BP-based, not the flat 23.1-percent rebate.
The Best Price rule process
The rebates are based upon quarterly price reports the drug
companies submit to CMS. Using these price reports and the states’ prescription
drug-use data, CMS calculates the rebates owed by the drug companies to each state.
Not surprisingly, the Office of the Inspector General (OIG) has recognized
that, “manufacturers have a strong financial incentive to hide de-facto pricing concessions to other
purchasers to avoid passing on the same discounts to the states” in the form of
higher rebates based on a BP that would otherwise have included these
discounts.
The process of determining BP involves scrutinizing all
supply chain and financial transactions for those that yield the lowest net
price. This includes direct sales, indirect sale chargebacks, wholesaler
rebates, managed-care rebates and any other pertinent price concession.
Transaction attributes, transaction type, entity class of trade, pricing
arrangements, bundling, contingent-free goods and discounts are the foundation of
transaction selection logic, and form the basis for the OIG investigation
scrutiny.
BP litigation
The landscape is littered with significant BP offenses and
subsequent large fines and sanctions applied to major pharmaceutical
manufacturers by the OIG. The details for the offences include typically
fraudulent price reporting based on omitting certain BP setting transactions.
The offenses are recognized through “whistle-blowing” activities from internal
and external sources and OIG increased investigative diligence. Representative
offenses follow:
What the proposed AMP
rule means to you
With such aggressive goals from CMS, manufacturers should
focus on some of the major items included in the rule that will fundamentally change
the way they do business:
CMS is allowing stakeholders to submit public comments for
60 days from the publication date on the proposed rule. It is expected that CMS
will issue the final rule in October, although as we learned with the recent
situation concerning the Federal Sunshine Act guidelines, there is always a chance
of a delay.
In order to benefit from situations such as this,
manufacturers should not only continue to place focus on preparing to comply
with changing federal legislations, such as the proposed AMP rule, but also
consider how the process of compliance can best be leveraged to optimize their
business. Because legislative and regulatory change entails reductions in
reimbursement and margins, manufacturers will now need to leverage their
compliance infrastructure to maintain sales volume, profitability and
competitive advantage. Doing so provides for the manufacturer additional
efficiencies in data-driven analytics to enable better real-time quantitative
decision-making.
Tony Chen is the
associate director of government pricing and Chester Schwartz is a senior
consultant at Alliance Life Sciences Consulting Group Inc., a management and
technology consultancy firm that works with many life-science clients to
define, deploy and support business applications.
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