Financial Relationship with Industry: Section 6002 of the “The Patient Protection and Affordable Care Act”
| Attending Heart Rhythm 2010? Don't miss the Health Policy Town Hall Meeting, addressing “Financial Relationships with Industry in this Changing Environment," on Wednesday, May 12. Financial relationships with industry have been under increased scrutiny in recent years; the following panels will encompass the viewpoints of Congress, academic and private practice physicians, industy, and more in a format that encourages a lively discussion: - Panel One: Physician and Industry Relationships
- Panel Two: Industry Funding of Education
- Panel Three: Industry Funding and Professional Associations
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In response to growing concerns of potential conflict of interest between physicians and the pharmaceutical and medical device industries, the so-called Physician Payment Sunshine Provision (Section 6002, "Transparency Reports and Reporting of Physician Ownership or Investment Interests") was included in the Patient Protection and Affordable Care Act signed into law on March 23, 2010, by U.S. President Barack Obama.
The Society has prepared a two-page summary (PDF, 41K) highlighting the key elements to help our members better understand this provision and its requirements.
The Section 6002 provision requires that beginning in 2013, all manufacturers of a drug, device, biological or medical supplies must report any transfers of value or payments exceeding $10 (as indexed by Consumer Price Index) to physicians and/or teaching hospitals to the Secretary of Health and Human Services on an annual basis. This information will be available on a public, searchable website. These new federal requirements were originally proposed in 2007 and reintroduced in 2009 as the “Physician Payments Sunshine Act” by Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI).
What Must Be Disclosed?
The annual report by all manufacturers of a drug, device, biological, or medical supplies must disclose payments or transfers of value to a physician and/or teaching hospital (excludes physicians who are full-time employees of the applicable manufacturer):
- the name of the recipient
- the business address of the recipient
- physician’s specialty and National Provider Identifier
- the amount of the payment or other transfer of value
- the dates on which the payment/transfer was provided
- a description of the form of payment or transfer of value (i.e., cash or cash equivalent; in-kind items or services; stock, stock option, or other ownership interest, dividend, profit, or other return on investment; or any other form of payment or other transfer of value)
- a description of the nature of the payment or transfer of value ( i.e., consulting fees; compensation for services other than consulting; honoraria; gift; entertainment; food; travel — including destinations; education; research; charitable contribution royalty or license; current or prospective ownership or investment interest; direct compensation for serving as faculty or as a speaker for a medical education program; grant; or any other nature of the payment or other transfer of value)
- if the payment/transfer is related to marketing, education, or research specific to a covered drug, device, biological, or medical supply, the name of the covered drug, device, biological, or medical supply
- any other categories of information regarding the payment or transfer of value.
For more information on the new health care reform law, please visit the health care reform section of the website.
