Seattle Genetics Sunshine Act FAQs
This FAQ is directed to healthcare professionals and serves to answer questions related to the Sunshine Act, also referred to as the National Physician Payment Transparency Program (Open Payments) by the Centers for Medicare & Medicaid Services (“CMS”), and Seattle Genetics’ responsibilities under it.
CMS has a website dedicated to Open Payments which includes its own FAQs and a specific section on information for physicians here.
Also available for physicians to learn more about Open Payments is a continuing medical education (CME) activity, “Are You Ready for the National Physician Payment Transparency Program?”, accessible via MedScape, and accredited by the Accreditation Council for Continuing Medical Education. Physicians can receive a maximum of 1.00 AMA PRA Category 1 Credit™ by participating in the activity and receiving a minimum score of 70% on the post-test. Through the activity, participants will learn more about Open Payments the steps involved in collecting and reporting physician data, key dates for implementation, and actions they can take to verify physician information in advance of website publication. For more information visit: medscape.com.
What is the Sunshine Act?
- The National Physician Payment Transparency Program (Open Payments), also known as the Sunshine Act, is a section of the Patient Protection and Affordable Care Act of 2010 that requires pharmaceutical and medical device companies to report certain payments they make to physicians and teaching hospitals to the Federal government. The Sunshine Act also requires companies to report any physician ownership or investment interests.
Who is a “physician” under Sunshine?
- For the purposes of Sunshine, a “physician” is any of the following types of professionals that are legally authorized to practice, regardless of whether they are Medicare, Medicaid, or Children's health Insurance Program (CHIP) providers:
• Doctor of Medicine
• Doctor of Osteopathy
• Doctor of Dentistry
• Doctor of Dental Surgery
• Doctor of Podiatry
• Doctor of Optometry
• Doctor of Chiropractic Medicine
Note: Medical residents are excluded from the definition of physicians for the purpose of Sunshine.
How is a “teaching hospital” defined under Sunshine?
- For the purposes of Sunshine, “teaching hospitals” are hospitals that received payment for Medicare direct graduate medical education (GME), inpatient prospective payment system (IPPS) indirect medical education (IME), or psychiatric hospital IME programs during the last calendar year for which such information is available.
When will payments be reported?
- Reporting of information will begin on August 1, 2013 for the time period of August through December of 2013. The report is due to CMS by March 31, 2014 and CMS will release the data publicly by September 30, 2014. In the following years data for the entire calendar year will be reported on an annual basis.
What payments are reported?
- Under the Sunshine Act, Seattle Genetics must report payments and other transfers of value made to US physicians and teaching hospitals. This includes the cost of meals provided to physicians, 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, Seattle Genetics must report other transfers of value provided to a physician or teaching hospital, including, but not limited to, travel, educational items (including reprints), stocks, and grants. Also reportable are expenses covered or reimbursed, such as hotel and travel.
Are there dollar thresholds for what must be reported?
- Payments or items of value less than $10 do not need to be reported unless the aggregate cost of payments or items of value received reaches $100. Therefore all payments and items of value will be recorded by Seattle Genetics, regardless of dollar amount, in order to track for reporting when the $100 threshold is reached. Example: physician takes part in 10 activities with meals $8 in value ($80 total) and receives 3 reprints with a value of $9 each ($27 total). All items were recorded. As the combined total ($107) reached over $100, all items were reported.
If I participate in a CME or independent education activity will anything be reported?
- Per Sunshine, Seattle Genetics will not report payments or items of value provided in conjunction with accredited CME activities as defined by the law. Seattle Genetics will report payments or items of value (including meals) for activities that are unaccredited.
How will reprints be recorded?
- When a physician receives a reprint the amount that Seattle Genetics has spent on the reprint will be reported under the physician’s name.
How does Sunshine relate to state disclosure laws?
- 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 Seattle Genetics 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 type of detailed information will appear in the report?
- Each line item that Seattle Genetics 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
• Name(s) of trial, as applicable
Will I see the information Seattle Genetics provides to the government before it is published to the public?
- CMS will post information provided by Seattle Genetics on its site and provide 45 days for review by physicians and teaching hospitals. The manufacturer will then have 15 days to address any physician concern about his or her data before final posting on the CMS website.
Why have some pharma/biotech companies already disclosed payments on their websites, prior to Sunshine?
- Some companies are required to disclose payments and other information in connection with a Corporate Integrity Agreement (CIA) they entered into with the government. Other companies are disclosing some or all payments to physicians and teaching hospitals voluntarily. However, Seattle Genetics does not have plans to voluntarily disclose other payments to physicians and teaching hospitals ahead of the federally mandated date.
Where will the payment information 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.
If I was paid or provided other items of value, including meals, before August 1, 2013 will the information be included on the Sunshine report?
- Seattle Genetics 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.
Does Sunshine apply to nurses and office staff?
- Meals and items of value provided to nurses and office staff are not 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.
If my contract with Seattle Genetics 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, except for trials in which case both the institution name and the primary investigator information will be reported. If you request that we pay another entity, such as your LLC or a charity, 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 Seattle Genetics at firstname.lastname@example.org.
If the payment comes from a third party vendor rather than Seattle Genetics is the payment still reportable?
- Yes, if you are paid by a third-party vendor for work that is conducted on behalf of Seattle Genetics, Seattle Genetics must report your fee and any other transfers of value you receive, including travel and meals.
Do I need to pay taxes on items of value reported?
- Tax matters are not addressed by the Sunshine Act and Seattle Genetics has no visibility into whether there will be tax implications.
How will Seattle Genetics ensure the information posted is accurate?
- Seattle Genetics is committed to ensuring that our Sunshine Act report will be as accurate as possible. Should you have questions about your data on the reports, you can contact email@example.com.
What will be reported for company sponsored trials and ISTs?
- For either type of trial, the total budget of the trial, including any drug provided, will be reported for the principal investigator and his/her institution.