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 certain payments they make to defined healthcare professionals and teaching hospitals. The Sunshine Act also requires companies to report any physician ownership or investment interests.
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 provide a meal to a program attendee which may be required to be reported as a transfer of value to Covered Recipients.
The Center for Medicare and Medicaid Services (CMS) manages Sunshine Act transparency reporting.
Under the Sunshine Act, Genentech must report payments and other transfers of value made to Covered Recipients and Teaching Hospitals which includes direct and indirect payments and in-kind transfer of values such as meals, educational items, stocks, and expenses covered or reimbursed, such as hotel and travel arrangements as part of a contracted service such as speaker programs, advisory boards, consulting, and clinical trials.
The current definition of Covered Recipient according to CMS is as follows: "Any physician, physician assistant, nurse practitioner, clinical nurse specialist, certified registered nurse anesthetist, or certified nurse-midwife who is not a bona fide employee of the applicable manufacturer that is reporting the payment; or a teaching hospital, which is any institution that received a payment under 1886(d)(5)(B), 1886(h), or 1886(s) of the Act during the last calendar year for which such information is available."
Credentials currently covered under the Sunshine Act/Open Payments program include:
If you are a Covered Recipient and attend a Genentech-sponsored promotional speaker program, you have the option to opt out of receiving the in-kind benefits (e.g., meals, parking) at the program. If you choose to opt out, you may do so by acknowledging on the program sign in sheet and 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, you will have the option to opt out of the Genentech meal at an in-office interaction. You may opt-out by acknowledging on the sign-in sheet or by directly informing the Genentech representative that you wish to opt out.
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 when applicable. State marketing laws requiring explicit disclosure currently exist in Connecticut, Massachusetts, Minnesota, Nevada, Oregon, Vermont, 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:
Payments are reported to CMS based on defined nature of payments categories and not by activity type.
If you would like to see the information Genentech will be disclosing before the report is published, you may contact us by email at sunshinequestions-[email protected]
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.
Genentech is reporting medical editing support as research in-kind payments/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 support was completed.
No. Genentech must fully comply with the 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.
CMS disclose the reported payments on their public website (https://openpaymentsdata.cms.gov/). The Sunshine Act does not require companies to publish payments on their own websites.
Meals provided to nurses (e.g., RN) and office staff (non-Covered Recipients) will not be reportable for the Open Payments program and will not be attributed to other Covered Recipients. However, some state marketing disclosure laws require disclosure of payments to a broader group of recipients, including nurses and office staff. 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.
Yes, the Sunshine Act requires Genentech to report all payments and transfers of value made to US-licensed or certified healthcare professionals, regardless of where the activity took place.
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.
U.S. licensed Covered Recipients are reportable under the Sunshine Act. We are required to report spend activities from a number of our Roche affiliates. Please contact the Sunshine Help Desk Team at 877-313-5778 or email [email protected] if you would like clarification on which locations are reportable.
Yes, you may dispute Genentech payments in the CMS disputes portal.