The Physician Payments Sunshine Act (S.301) requires drug, biologic, and medical device manufacturers to report certain gifts and payments made to physicians

Introduced – January 22, 2009

The Physician Payment Sunshine provisions were included in the Patient Protection and Affordable Care Act of 2009 which was signed into law on March 23, 2010

Start Date for Recording - January 1, 2012
Start Date for Reporting - March 31, 2013
Publication of Reports - September 30, 2013 and June 30th of every future year

Sunday, July 18, 2010

Physician Payment Sunshine Act of 2010

As Physician Payment Sunshine Act became a law under President Obama’s Patient Protection Affordable Care Act, any Purchasing Organization that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply or Manufacturer of a covered drug, device, biological, or medical supply operating in the United States, or in a territory, possession, or commonwealth of the United States is required to publicly disclose gifts and payments made to physicians. Additionally, a referring physician is required to inform the individual in writing at the time of the referral that the individual may obtain the services for which the individual is being referred. Payments under a product development agreement must also be reported as well for services furnished in connection with the development of a new drug, device, biological, or medical supply. Annual report is to be submitted to Congress and State.

Excluded from reporting is a transfer of anything the value of which is less than $10, unless the aggregate amount transferred to, requested by, or designated on behalf of the covered recipient by the applicable manufacturer during the calendar year exceeds $100.

Penalty for each payment not reported can be up to $10,000. Penalty for knowingly failing to submit payment information can be up to $100,000, for each payment.

Reference -

Sunday, July 5, 2009

Reporting Requirements for Physician Payments Sunshine Act

By Ela Sharma

It is premature to gain an understanding of precise reporting requirements and the reporting format for Physician Payments Sunshine Act, as HHS, the governing authority, has not yet commenced this effort. However, this does not preclude the drug, biologic or medical device manufacturers from proactively ascertaining the data challenges and risks, and instituting steps to address the reporting requirements if Physician Payments Sunshine Act becomes a law.

Maine, Massachusetts, Minnesota, Vermont, West Virginia and the District of Columbia have enacted “sunshine laws” setting limits on industry payments to physicians and/or requiring disclosure of the payments. Although, some are limited by resources or mechanism for enforcement and have short-term and manually intensive solutions, the interpretation of state requirements will facilitate understanding of data collection, consolidation and validation process for Physician Payments Sunshine Act reporting requirements.

Most of the data that is required to be reported is either manually captured, exists in legacy systems and flat files and/or is distributed across disparate applications and databases. The figure below illustrates the categories of data elements that will be required.

What can companies do to prepare for compliance with the Physician Payments Sunshine Act? First step, is an assessment of Current State and development of a roadmap that will encompass business process and technology aspects of the required future sate. Most corporations have Master Data Management projects on their strategic planning path. Corporations that have established Customer Master will have an added advantage as unique customer identification will be necessary for reporting. Similarly, corporations that have implemented ERP systems for Medical Affairs, Sales and Marketing, HR and legal data will reap the benefits of data consolidation. This, however, does not undermine the effort of a consolidated Data Integration and Validation strategy that will be required.

Tuesday, June 16, 2009

Q&A on Physician Payments Sunshine Act of 2009

How is it different from 2007or 2008 bill?
S.301 Physician Payments Sunshine Act of 2009 introduced by Senators Chuck Grassley and Herb Kohl is similar to the original bill introduced in 2007 but not taken up by congress. It was reintroduced in 2008 as an amendment to title XI of the Social Security Act but was dropped again.

Would the states duplicate the effort?
S.301 prohibits states from collecting identical information. However, states may collect other types of information.

What company information will be reported?
Manufacturers of drug, biologic and medical devices will be required to disclose company name, business name, company address, value of the payment or transfer of value, dates of the payments or transfers and description of the form of payment or transfer of value.

What are the implementation timelines?
If passed, the government will require yearly reporting of all physician payments over a cumulative value of $100 dollars beginning in 2010. The first report will be due by March 31, 2011 and posted publicly by September 20, 2011. Bill states that the Secretary of Department of Health and Human Services (HHS) has until November of 2009 to establish procedures for implementation of the bill. Governor Sebelius, Secretary of HHS, has ensured that the public interest will always be put first.

What is the implementation platform?
A website will be hosted that will have a search mechanism by company or physician. It will contain a description of any enforcement actions and penalties as a result of the legislation. Since the bill has not been passed by HHS, it is premature to gain further insight.

Monday, June 8, 2009

What will be excluded from the disclosure?

Excluded from the disclosure would be anything physicians receive in their roles as patients, devices loaned for less than 90 days for physicians to evaluate, discounts, dividends or profits from stock ownership in publicly traded industry firms, educational materials that directly, benefit patients or are intended for patient use, items used for providing charity care, items or services provided under contractual warranty and product samples intended for patient use. Source -

Why Physician Payments Sunshine Act?

Inquiries led by Senator Chuck Grassley have revealed that physician industry funding of researchers who received millions in industry payments had allegedly failed to report the income as required by the National Institute of Health (NIH). The bill requires reporting of every kind of industry compensation to doctors, ranging from small gifts to royalties and consulting income.

Senator Chuck Grassley has also examined financial ties that members of advisory boards for the Food and Drug Administration have with the drug industry. He said he is considering MedPAC’s recommendation that reporting requirements also be applied to industry payments to medical organizations, hospitals, pharmacy benefit managers, pharmacists and pharmacies, continuing medical education groups, and medical schools. Senator Herb Kohl has also raised concern that pharmaceutical companies are now developing profiles of individual physicians’ prescribing information as part of their marketing efforts.

At present, six states have laws that require physicians to disclose any payments of $100 or more over the course of year, received from drug or medical devices manufacturers.

Penalties for non compliance are fines of up to $10,000 for each transfer of value that is not reported (not to exceed $150,000 annually) and up to $100,000 for knowingly failing to report (not to exceed $1,000,000 annually). Penalties applied will be posted on the public website.

What is Physician Payments Sunshine Act anyway?

On January 22, 2009, Senators Chuck Grassley and Herb Kohl introduced legislation to require makers of pharmaceuticals, medical devices and biologics to publicly report money they give to doctors over $100 every year. The Physician Payments Sunshine Act (S.301) requires drug, biologic, and medical device manufacturers to report certain gifts and payments made to physicians. The information will be registered in a national and publicly accessible online database. Companies failing to report incur financial penalties.

Quote by Senator Chuck Grassley – “Shedding light on industry payments to physicians would be good for the system. Transparency fosters accountability, and the public has a right to know about financial relationships. Patients rely on their doctors’ advice. Taxpayers spend billions every year on prescription drugs and medical devices through Medicare and Medicaid. They also fund tens of billions of dollars of medical research each year, and the doctors conducting that research have a big influence on the practice of medicine.” (quotation source is

Quote by Senator Herb Kohl - “Since we first introduced the bill, there has been a groundswell of support from every corner. Patients want to know that they can fully trust the relationship they have with their doctor. I am confident this legislation will pass during the 111th Congress.” (quotation source is

Wednesday, May 27, 2009

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