Manufacturers of branded and generic drugs, biologicals, devices, or medical supplies subject to reimbursement under Medicare, Medicaid, or the Children's Health Insurance Program must report to the federal government data on their payments to physicians or teaching hospitals starting in August, under new regulations completed last week and officially published today in the Federal Register.
The rules—required under section 6002 of President Obama’s Affordable Care Act (ACA)—require manufacturers to report their data on payments or “transfers of value” by March 31, 2014, and every year thereafter to the Centers for Medicare & Medicaid Services (CMS).
Included among manufacturers subject to the new rules are contract research organizations and contract manufacturing organizations.
However, manufacturers can delay publication of data for up to four years if they apply to research connected with the development of a new drug, device, biological, or medical supply; to a clinical investigation for those new products; or to a potential new medical technology or new application of an existing medical technology.
The delay only applies where the new drug or biological is being made under product research or development agreements that are in writing, with a written research protocol, and even then, “only if they were made in the context of a relationship for bona fide research or clinical investigation activities.”
“This provision seeks to balance the need for confidentiality of proprietary information with the need for public transparency of payments to covered recipients that could affect prescribing habits or research outcomes,” the final rules state.
Manufacturers can delay publication until either “the approval, licensure, or clearance by the FDA” of new drugs or biologics, or four calendar years after the date of payment or other transfer of value, whichever is earlier.