FDA and the Centers for Medicare
and Medicaid Services*
*Formerly the Health Care
Financing Administration (HCFA)
Federal funds cannot be used to reimburse state Medicaid programs for
prescription drug products classified by the FDA's Drug Efficacy Study
Implementation (DESI) review as less-than-effective (LTE) for all their
labeled indications and for drug products that are identical, related, or
similar (IRS) to these drug products. The Division of Compliance
Risk Management and Surveillance is responsible for identifying LTE/IRS
drug products. This program ensures that drug products available to
Medicaid patients are effective for their intended uses and that federal
funds are not expended for drugs that are not maximally effective. The
division reviews various agency publications and documents on a quarterly
basis to determine the effectiveness of marketed drug products.
The federal Medicaid Drug Rebate Program requires prescription drug
manufacturers to offer discounts on prescription medications to state
Medicaid programs. All drug manufacturers who want their products to be
eligible for Medicaid reimbursement must participate in this program,
which is administered by the federal Centers for Medicare and Medicaid
Services (CMS). Participating firms enter into an agreement with CMS to
rebate money to state Medicaid programs based on the total amount of drug
products dispensed. The firms are required to provide CMS with a list of
all their drug products.
The
division reviews and updates CMS's lists of non-reimbursable and
reimbursable drugs to ensure accuracy and reports drugs classified as
ineffective to CMS. In addition, the division also interprets policy
and provides guidance on CMS-related issues, marketed, unapproved drugs,
DESI drug listing and National Drug Code issues. This information is
shared with federal and local government agencies, state Medicaid offices,
third-party drug plans, pharmacists, drug manufacturers, distributors,
repackers, and private database firms.
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Compliance Risk Management and Surveillance
FDA/Center for Drug Evaluation and Research
Last Updated: June 16, 2003
Originator: OTCOM/DCRMS
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