The National Physician Payment Transparency Program (Open Payments), a.k.a. Sunshine Act, is a section of the Patient Protection and Affordable Care Act of 2010 that requires pharmaceutical and medical device companies to report to the Federal government on certain payments they make. The Sunshine Act also requires companies to report any physician ownership or investment interests.
Under the Sunshine Act, Genentech must report payments and other transfers of value made to US Physicians and Teaching Hospitals. This includes the cost of meals provided to Physicians in any setting, as well as payments made to Physicians or Teaching Hospitals as part of a contracted service such as speaker programs, advisory boards, consulting, and clinical trials. In addition to meals and payments, companies will also have to report other transfers of value provided to a Physician or Teaching Hospital, including, but not limited to, travel, educational items, stocks, and grants. Also reportable are expenses covered or reimbursed, such as hotel and travel arrangements.
If you are a physician and receive payments, meals, or other items of value from Genentech from August 1, 2013 and beyond, you will be included in our Sunshine report. If you are not contracted with Genentech for any speaking, advisory, consulting or other services, and if your interactions with Genentech do not involve transfers of value paid for by Genentech, either directly or indirectly, then Genentech will not be required to report anything to your name (Please note that in some cases, Genentech may indirectly sponsor a meal provided to program attendees, such as at a medical education event, and in that case we may be required to report this meal as a transfer of value to physician attendees).
If you attend a Genentech-sponsored promotional speaker program, you have the option to opt out of receiving Genentech's in-kind benefits (e.g., meals, valet parking) at the program. If you choose to opt out you may either pay for the meal and parking on your own, or not consume anything at the program. For all program attendees who receive Genentech's in-kind benefits at the program, Genentech will report the attendee's name and the value received as required by federal and state disclosure laws.
In addition, starting on August 1, 2013, you will have the option to opt out of the Genentech meal at an in-office interaction. If you opt out of the meal, then Genentech will not be required to report anything to your name for that interaction. If you have specific questions around whether your interactions will be disclosed, or about the opt out process, please contact Genentech at firstname.lastname@example.org.
No, the Sunshine Act does not replace state laws. Any meal or spending prohibitions that exist in your state remain in place, and any state can add such prohibitions in the future. The Sunshine Act requirements will preempt some similar state reporting requirements, but Genentech currently plans to continue reporting all required spend to these states. State marketing laws requiring explicit disclosure currently exist in Massachusetts, Vermont, West Virginia, and Washington DC.
Each line item that Genentech reports to CMS will be available on the public report in detail, including but not limited to:
Genentech has developed an online tool, Sunshine Track™, which will enable physicians to review their reportable payments and other transfers of value from Genentech before Genentech submits them to the government. Sunshine Track will be available on Genentech’s external Sunshine website, sunshine.gene.com, on November 1, 2013.
Samples are not reportable under the Sunshine Act. However, in 2012, Genentech began fulfilling a federal government requirement to report annually the identity and quantity of all drug samples requested and distributed per the Prescription Drug Sampling Transparency Provision. This Provision is distinct from the Sunshine Act, and the government has not announced any plans to share this information publicly. If you have specific questions about a Genentech sample program, please contact the Genentech Sample Accountability Hotline at 888.714.3336.
CMS requires we report medical editing, but they do not designate which specific Nature of Payment category to report it in. Genentech is reporting medical editing support as a consulting fee, in-kind payments and services. The payment date reflected will be the last day of the quarter in which the service was performed. However, this will not necessarily be the date that the medical editing was completed.
No. Genentech must fully comply with the new Federal law so there is no ability for you to opt out of the Sunshine report if we make payments or provide meals or other transfers of value to you from August 1, 2013 through any later dates.
Some companies are required to report in connection with a Corporate Integrity Agreement they entered into with the government. Other companies are disclosing some or all payments to physicians and teaching hospitals voluntarily. Genentech has been voluntarily disclosing payments for independent medical education grants and charitable contributions on a quarterly basis since August 2010 on our gene.com site. However, Genentech does not have plans to voluntarily report other payments to physicians and teaching hospitals ahead of the federally mandated date.
The Sunshine Act states that CMS will make reported payments available on a public website. The Sunshine Act does not require companies to publish payments on their own websites, and Genentech currently has no plans to do so.
Genentech is not disclosing payments or other transfers of value provided to Physicians or Teaching Hospitals prior to August 1, 2013, except where already required by state marketing disclosure laws in Massachusetts, Vermont, Washington DC, and West Virginia.
Meals provided to nurses and office staff will not be reportable and will not be attributed to physicians. However, some state marketing disclosure laws require disclosure of payments to a broader group of recipients, including non-physician prescribers, nurses and office staff. Often times, this spend is attributed to the physician or other prescriber in the office. For states with these types of disclosure requirements, these payments will not be preempted by the Federal law, and thus will still be reportable to the state.
Genentech will report the fee under your name, and will list the entity paid as the third party recipient on the same line item. In addition, any expenses we cover or reimburse as part of your contract, such as travel and lodging expenses, will also be reported under your name.
Yes, if you are paid by a third-party vendor for work that is conducted on behalf of Genentech, then Genentech must report your fee and any other transfers of value you receive.
If you attend an independent/certified medical education activity that is supported by Genentech and where a meal is served, the value of an individual meal may be reported in your name if the organizer used Genentech funds to purchase meals.
Yes, the Sunshine Act requires Genentech to report all payments and transfers of value made to physicians with active licenses in the United States, regardless of where the activity took place.
The Sunshine Act does not address this, and we have no visibility into whether there will be tax implications.
Genentech is committed to ensuring that our Sunshine Act report will be as accurate as possible. We have implemented extensive processes to validate all payment information we collect. We are validating these processes now. Should you have questions about your data on the reports, you can contact email@example.com.
Only U.S. licensed physicians are reportable under the Sunshine Act. We are required to report spend activities from a small number of our Roche affiliates. Please contact the Sunshine Track Help Desk Team at 877-313-5778 or email firstname.lastname@example.org if you would like clarification on which locations are reportable.
Please check which browser you are using to see if it is supported. For PC users, the tool does not support Internet Explorer 8. Please upgrade to IE 9 or 10 to successfully launch Sunshine Track. Additional supported browsers are Google Chrome, Firefox and Safari.
Yes, you may dispute in either portal, but we encourage you to use Sunshine Track. Unlike the CMS portal, Sunshine Track allows you to review and dispute your Genentech payments on an ongoing basis, and access live customer support. Our team will communicate dispute resolution details to you by your preferred choice of phone or email, and will send any needed data corrections to CMS. Currently, you can review and dispute your 2014 Genentech payments on Sunshine Track well in advance of submission to CMS.
Our team will thoroughly research the payment and make necessary corrections regardless of when the dispute is submitted. We are waiting for CMS guidance on the process to submit 2013 corrected or omitted data. We are also waiting for information on when the corrected data will be made public by CMS.