- (1) An October 23, 1981 ruling by District of Columbia Federal Court directed the Department of Health and Human Services to stop reimbursement, effective October 30, 1981, under Medicaid and Medicare Part B for all DESI less-than-effective drugs which have reached the Federal Drug Administration Notice-of-Opportunity-for-Hearing stage.
- (2) In accordance with Section 1903(i)(5) of the Social Security Act, federal funds participation (FFP) is not available for drugs deemed Less Than Effective (LTE) or Identical, Related of Similar (IRS) drugs for which the Food and Drug Administration (FDA) issued a Notice of Opportunity for a Hearing (NOOH) for all labeled indications. These drugs are also termed Drug Efficacy Study Implementation (DESI) drugs. Division does not reimburse for drugs designated as less than effective or drugs identical, related, or similar to a DESI drug.
- (3) A current list of DESI LTE/IRS drugs is available at https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/medicaid-drug-rebate-program-data/index.html. DESI drugs are identified by Covered outpatient Drug (COD) Status of 5 or 6.
- (4) The US Food & Drug Administration (FDA) has the responsibility of determining the DESI status of a drug product.
Statutory/Other Authority
ORS 413.042 & 414.325
Statutes/Other Implemented
ORS 414.065
History
DMAP 96-2022, amend filed 12/28/2022, effective 01/01/2023
DMAP 38-2018, minor correction filed 05/25/2018, effective 05/25/2018
DMAP 39-2009, f. 12-15-09, cert. ef. 1-1-10
OMAP 18-2004, f. 3-15-04 cert. ef. 4-1-04
OMAP 29-2000, f. 9-29-00, cert. ef. 10-1-00
OMAP 1-1999, f. & cert. ef. 2-1-99
HR 20-1994, f. 4-29-94, cert. ef. 5-1-94
HR 20-1991, f. & cert. ef. 4-16-91
HR 29-1990, f. 8-31-90, cert. ef. 9-1-90, Renumbered from 461-016-0390
HR 17-1990(Temp), f. 6-29-90, cert. ef. 7-1-90
AFS 79-1989, f. & cert. ef. 12-21-89
AFS 64-1989(Temp), f. 10-24-89, cert. ef. 11-15-89
AFS 56-1989, f. 9-28-89, cert. ef. 10-1-89