OAR 410-121-0420
DESI Less-Than-Effective Drug List

(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 LTE/IRS drugs is available at https://www.medicaid.gov/medicaid/prescription-drugs/medicaid-drug-rebate-program/data/index.html. The list is updated on approximately a quarterly basis by CMS after being reviewed for accuracy by the FDA.

(4)

The US Food & Drug Administration (FDA) has the responsibility of determining the DESI status of a drug product.

Source: Rule 410-121-0420 — DESI Less-Than-Effective Drug List, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=410-121-0420.

410‑121‑0000
Foreword and Definition of Terms 410‑121‑0021
Organizations Authorized to Provide Pharmaceutical Prescription Services 410‑121‑0030
Practitioner-Managed Prescription Drug Plan 410‑121‑0032
Supplemental Rebate Agreements 410‑121‑0033
Polypharmacy Profiling 410‑121‑0040
Prior Authorization Required for Drugs and Products 410‑121‑0060
How to Get Prior Authorization for Drugs 410‑121‑0061
Durable Medical Equipment, Medical Supplies, and Medical Surgical Services (Physician Administered Drugs) 410‑121‑0100
Drug Use Review 410‑121‑0111
Pharmacy and Therapeutics Committee 410‑121‑0135
Pharmacy Management Program 410‑121‑0143
Client Confidentiality 410‑121‑0145
Prescription Requirements 410‑121‑0146
Dispensing Limitations 410‑121‑0147
Exclusions and Limitations 410‑121‑0148
Dispensing in a Nursing Facility or Community Based Care Living Facility 410‑121‑0150
Billing Requirements 410‑121‑0155
Reimbursement 410‑121‑0157
Participation in the Medicaid Drug Rebate Program 410‑121‑0160
Dispensing Fees 410‑121‑0185
Pharmacy Based Immunization Delivery 410‑121‑0190
Medication Therapy Management Services and Clozapine Therapy Monitoring 410‑121‑0200
Billing Forms 410‑121‑0220
Instructions for Completion of the Prescription Drug Invoice 410‑121‑0280
Billing Quantities, Metric Quantities and Package Sizes 410‑121‑0300
CMS Federal Upper Limits for Drug Payments 410‑121‑0420
DESI Less-Than-Effective Drug List 410‑121‑0580
Oregon Medicaid and Pharmaceutical Manufacturers’ Dispute Resolution Procedures 410‑121‑0625
Items Covered in the All-Inclusive Rate for Nursing Facilities
Last Updated

Jun. 8, 2021

Rule 410-121-0420’s source at or​.us