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Sunshine Act FAQs

• What is the Sunshine Act?

  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.

• What types of payments must be reported under the Sunshine Act?

  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.

• WHAT IF MY STATE ALREADY HAS DISCLOSURE LAWS OR PROHIBITIONS? DOES THE SUNSHINE ACT REPLACE THOSE?

  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.  

• WHAT LEVEL OF DETAIL WILL THE REPORT HAVE? WILL IT CATEGORIZE PAYMENTS AND TRANSFERS OF VALUE BY ACTIVITY TYPE (E.G., SPEAKER PROGRAMS, ADVISORY BOARDS, CLINICAL TRIALS)?

  Each line item that Genentech reports to CMS will be available on the public report in detail, including but not limited to:

  • ∗ Applicable manufacturer’s name
  • ∗ Name of teaching hospital or physician
  • ∗ Specialty (physician only)
  • ∗ Business address
  • ∗ Amount of payment or other transfer of value
  • ∗ Date of payment
  • ∗ Form of payment (e.g., cash, in-kind items or services, stock)
  • ∗ Nature of payment (e.g., consulting, food, travel, education)
  • ∗ Name(s) of the related covered drug, as applicable

• CAN I SEE THE INFORMATION YOU'LL BE DISCLOSING BEFORE THE REPORT IS PUBLISHED?

  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.

• What about samples? How will they be reported?

  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.

• Can Genentech decline to report?

  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.

• Why are some companies already reporting payments?

  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.

• Where will reported payments be posted?

  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.

• If I'm paid or provided a meal prior to August 1, 2013, will it end up on the Sunshine Act report?

  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.

• What about my nurses and office staff?

  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.

• What if my contract with you is through my institution? Will my name be disclosed?

  If your fee is paid to your institution, and that institution is a reportable teaching hospital, then the fee will be reported under your institution’s name rather than yours. However, if you request that we pay another entity, such as your LLC, for a contracted service instead of you personally, and that entity is not a reportable teaching hospital, then the Sunshine Act requires that we report the fee under your name and list the entity paid as a third party recipient on the same line item. Keep in mind that any expenses we cover or reimburse as part of your contract, such as travel and lodging expenses, will be reported under your name. If you have a question about a specific contract, please contact Genentech at sunshinequestions-d@gene.com.

• IF I AM PAID BY A THIRD-PARTY VENDOR, IS MY FEE STILL REPORTABLE UNDER SUNSHINE?

  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.

• WILL THE PAYMENTS AND TRANSFERS OF VALUE I RECEIVE FOR INTERNATIONAL ENGAGEMENTS BE REPORTED?

  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.

• WILL I BE TAXED ON THE REPORTED SPEND?

  The Sunshine Act does not address this, and we have no visibility into whether there will be tax implications.

• How will Genentech ensure that the data they post is accurate?

  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 sunshinequestions-d@gene.com.

• If I do not receive any transfer of value from Genentech, will I still be on the report?

  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, then Genentech will not be required to report anything to your name.
  
  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.
  
  If you have specific questions around whether your interactions will be disclosed, or about the opt out process, please contact Genentech at sunshinequestions-d@gene.com.