On September 16, 2009, Sen. Max Baucus of the Senate Finance Committee released the "Chairman's Mark" of the proposed America's Healthy Future Act of 2009. Significantly, the bill includes a new version of Federal Physician Payment Sunshine legislation that is stricter and more expansive than the version proposed earlier this year in the Senate.
The following are the some of the more significant aspects of the bill:
Covered Entities: applies to certain manufacturers of covered drugs, devices, biologics, or medical supplies (although the disclosure of ownership/investment interests applies to related group purchasing organizations (GPOs) as well)
Covered Recipients: applies to any payment or another transfer of value to a physician, a physician medical practice, a physician group practice, or a hospital with an approved medical residency training program.
Data Elements: the annual report will include the following data elements: recipient‘s name, business address, amount of the payment, date of the payment, a description of the form of the payment, a description of the nature of the payment, if the payment is related to marketing, education, or research specific to a covered drug, device, biological or medical supply the name of that product, and any other category of information that the Secretary determines appropriate
Delayed Reporting Requirements: contains delayed reporting requirements for payments made pursuant to a product development agreement or clinical trial
De Minimis Exemption and Aggregate Reporting Threshold: exempts from reporting any payments or transfers of $10 or less, unless the aggregate annual payments or transfers to a recipient exceeds $100, in which case all payments or transfers shall be reported. (this means that payments or transfers less than $10 must be tracked, but are not necessarily reported)
Other Exemptions: exempts from reporting: samples intended for patient use; patient educational materials; loan of a covered device for a short-term time period; discounts and rebates; payments made to a physician for the provision of health care to employees payments to a physician who is also a licensed, non-medical professional if the payment is solely related to non-medical services; payments to a physician solely for services related to a civil or criminal action or an administrative proceeding; and in-kind items used for charity care
Reporting Deadline: reporting requirement would begin on March 31, 2012 and continue on the 90th day of each subsequent calendar year. There is currently no start date to begin tracking payments and other transfers, but tracking presumably would be required by January 1, 2011.
Disclosing Ownership or Investment Interests: requires any manufacturer, or related GPO, to report annually certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer or GPO during the preceding year
Penalties: manufacturers or GPOs would be subject to a civil money penalty (CMP) of not less than $1,000 but not more than $10,000 for each payment or transfer not reported. The total amount of the penalties for any annual submission shall not exceed $150,000. Any manufacturer or GPO that knowingly fails to submit information would be subject to a CMP of not less than $10,000 but not more than $100,000 for each payment or transfer not reported. The total amount of the penalties for this failure to report category of submissions shall not exceed $1,000,000 annually.
Public Availability: beginning September 30, 2012, submitted information would be available to the public on an internet website
Preemption: would preempt any state (or political subdivision of a state) law or regulation that requires manufacturers to disclose the type of information required under this provision regarding payments or transfers to covered recipients
No Preemption: would not preempt any state (or political subdivision of a state) law or regulation that requires the disclosure or reporting of (1) any information not required under this provision; (2) the types of information excluded from reporting requirements under this provision, with the exception of the $10 de minimis/$100 aggregate reporting requirement; (3) information by any person or entity other than an applicable manufacturer or covered recipient described above; and (4) information reported to a Federal, state, or local government for public health purposes
Click here to download the Baucus Bill Summary in its entirety (or scroll down to page 176 to view the "sunshine" provision). R-Squared will be monitoring Sunshine Act developments closely and will post periodic updates and alerts to the website.
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