Law requires disclosure of research bucks, gifts
Law requires disclosure of research bucks, gifts
The Patient Protection Affordable Care Act, which was signed into law in March 23, 2010, contains a Physician Payment Sunshine Provision that requires pharmaceutical and biotech companies to report all gifts and compensation made to physicians, including researchers.
Here are some of the provision's chief details:
Recording the information begins on Jan. 1, 2012;
Reporting the information begins on March 31, 2013;
The physician payment information will be reported first on Sept. 30, 2013, and on June 30th in future years.
Information included in the disclosure includes:
- Name;
- Business address;
- Physician specialty;
- National provider identifier;
- The value of the payment or transfer of value;
- The name of the related drug, device, or supply, if available; to the level of specificity available;
- A description of the form of payment: cash or cash equivalent; in-kind items or services;
- Drug samples, the name, number, date, and dosage units of the sample.
The provision's definition of payment includes these items:
- Gift;
- Food;
- Entertainment;
- Travel or trip;
- Honoraria;
- Research funding or grant;
- Education;
- Research;
- Charitable Contribution;
- Direct compensation for serving as faculty or speaker for medical education Program;
- Consulting fees;
- Ownership or investment interest;
- Royalties;
- License fee;
- Speaking fees;
- Dividends;
- Profit distribution;
- Stock or stock option grant;
- Any categories of information the secretary determines appropriat
Product development: Payments under a product development agreement must be reported for services furnished in connection with the development of a new drug, device, biological, or medical supply, and must also be reported with the following information:
- The date of the approval or clearance of the covered drug, device, biological, or medical supply by the Food and Drug Administration;
- Payments made four calendar years after this date.
Clinical Investigations are confidential until either:
- Date of FDA approval or clearance;
- Payments made four calendar years after this date.
The Patient Protection Affordable Care Act, which was signed into law in March 23, 2010, contains a Physician Payment Sunshine Provision that requires pharmaceutical and biotech companies to report all gifts and compensation made to physicians, including researchers.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.