High-expenditure Medicare drugs often qualified for Orphan Drug Act incentives designed to encourage the development of treatments for rare diseases Report in brief (United States. Department of Health and Human Services. Office of Inspector General) United States. Department of Health and Human Services Drug Development -- legislation & jurisprudence Government Regulation Medicare Part B -- economics Medicare Part D -- economics Orphan Drug Production -- economics Why OIG Did This Review. The Orphan Drug Act (ODA) provides financial incentives to encourage the development of drugs for rare diseases or conditions for which treatments might not be developed otherwise. In addition to the direct incentives specified in the ODA, an orphan designation excludes a manufacturer from requirements to sell its drug at a discounted price to some types of entities (i.e., certain providers eligible for the 340B drug discount program) even if the drug is being used for a common disease or condition. For a drug to qualify for an orphan designation, and for the associated financial incentives, the manufacturer must document that the drug is intended for a rare disease or condition that affects a small U.S. patient population (less than 200,000 persons), or that there is no reasonable expectation to recover costs associated with developing the drug. Washington, D.C. : U.S. Department of Health and Human Services, Office of Inspector General, September 2021 United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body. Technical Report Text Illustrations 1 online resource (1 PDF file (32 pages)) nlm:nlmuid-9918384885406676-pdf 9918384885406676 http://resource.nlm.nih.gov/9918384885406676 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0