A part of the Patient Protection and Affordable Health Care Act (“PPACA”), also known as “Obamacare” requires reporting of all payments made to physicians by manufacturers of prescription drugs, biologics or medical devices. The reported information will be available on a website maintained by the Department of Health and Human Services (DHHS) to the public in a searchable form. This information will be used by the public to understand the financial relationship between manufacturers and their doctors. This article will talk further on the purposes of the Sunshine Act and what are the things covered under the act and the best practices.
Purpose of the Rule
The purpose of the Sunshine Act was to increase transparency to patients about financial relationship between physicians and manufacturers. Cover all products available by prescription where the physician influences what products the patient purchases. It covers both the current and future products.
Things Covered Under the Act
The things that are covered under the Act include any product which requires or would need prescription from a doctor, and any manufacturer of prescription products. Even if one product is marketed or would be marketed in the US it does not need to be currently marketed (investigational products intended for marketing approval by FDA), any physician who is not a direct employee of the manufacturer.
What is New in the Sunshine Act, 2010
Sunshine Act, 2010 includes details such as types of payments, covered products and manufacturers, and web-based exposure of information. It introduces stricter time-lines and penalties for deliberate non-reporting, which includes clinical trial expenses.