Applicable Manufacturer Law and Legal Definition

The term applicable manufacturer in the context of health care means a manufacturer of a covered drug, device, biological, or medical supply that is operating in the U.S, or in a territory, possession, or commonwealth of the U.S. On March 31, 2013, and on the 90th day of each calendar year thereafter, any applicable manufacturer that provides a payment or other transfer of value to a covered recipient (CR) or to an entity or individual at the request of or designated on behalf of a CR, shall submit to the secretary of Health and Human Services (secretary) specific information with respect to the preceding calendar year. Here, CR includes physicians who are not employees of the applicable manufacturer or teaching hospitals. The information submitted by an applicable manufacturer must include the name and business address of the CR, physician specialty and National Provider Identifier, amount and date of payment or transfer, form of payment, and nature of payment or transfer.