Centers for Medicare & Medicaid Services

Key lines of business for the Centers for Medicare & Medicaid Services (CMS) are the following:

  • Medicare health plans
  • Medicare financial management
  • Medicare fee-for-service operations
  • Medicaid and children's health survey, certification, and quality improvement

CMS Deleted Products

The CMS Deleted Products memoranda include instructions sent to the state Medicaid directors concerning the Medicaid product coverage. The U.S. Food and Drug Administration (FDA) and the CMS have jointly determined that the following drugs/products lack approved applications and as a result, do not meet the definition of a "covered outpatient drug" under Medicaid programs. Consequently, as of the date of the notification, the drugs and products are no longer covered by Indiana Medicaid.

State Releases

The CMS State Releases include every note and instruction sent to the state Medicaid directors concerning the Medicaid drug rebate program. The releases are archived back to 1991.

desi drug list

The Federal Food, Drug, and Cosmetics Act of 1938 established the requirement that a manufacturer prove the safety of a drug before it could be marketed in the United States. In 1962, this act was amended to require that drugs sold in the United States be regulated more closely.

All new drugs must demonstrate, via adequate studies, safety and efficacy before introduction into the market. The Drug Efficacy Study Implementation (DESI) Program was established to ensure that drugs that did not have proven efficacy were ultimately removed from the market and not reimbursed by state Medicaid programs in the interim.

Federal law prohibits state Medicaid agencies from reimbursing for so-called less than effective (LTE) drugs, commonly called DESI drugs, or any drug that the federal government has determined to be identical, related, or similar (IRS) to such a drug. These drugs are not covered by the Indiana Health Coverage Programs (IHCP), and providers are not entitled to reimbursement.

If you have a question about a specific drug's current DESI indicator, contact HP Customer Assistance at (317) 655-3240 in the Indianapolis local area or toll-free at 1-800-577-1278.

Drug Rebate Labeler

Federal law requires that, for legend or nonlegend drugs to be covered by state Medicaid programs, the manufacturer must have a drug rebate agreement in effect with the CMS.

A complete list of manufacturers by labeler number -- the first five digits of the National Drug Code (NDC) -- that have entered into a rebate agreement with the federal government is available at www.CMS.gov. It is essential that pharmacies check this list for the status of a drug manufacturer before dispensing. If the labeler code of the manufacturer of any given drug does not appear on the list, the drug is not covered by the IHCP and providers are not entitled to reimbursement for such products.