This FAQ is directed to healthcare professionals and serves to answer questions related to the Open Payments Program (formerly known as the “Sunshine Act”), which implements the National Physician Payment Transparency Program 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.
Formerly known as the Sunshine Act, Open Payments is the program which implements the National Physician Payment Transparency Program. Open Payments aims to create greater transparency around the financial relationships of manufacturers, physicians, and teaching hospitals. Open Payments 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. Open Payments also requires companies to report any physician ownership or investment interests.
Under §1128G(a)(1) of the Social Security Act, applicable manufacturers are required to report payments or other transfers of value made to physicians, which includes doctors of medicine and osteopathy, dentists, podiatrists, optometrists and chiropractors who are legally authorized to practice by the State in which they practice, and teaching hospitals, as is defined on an annual basis by CMS.
The statute excludes from the definition of a covered recipient a physician who is an employee of the applicable manufacturer.
Under Open Payments, 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.
Payments and other transfers of value are reported on a calendar year basis, from January 1 to December 31 of the reporting year. Seattle Genetics reports all payments and other transfers of the value of the preceding year to CMS on or before March 31 on an annual basis.
For all payments that took place prior to January 1, 2016, if the payment was provided in conjunction with an accredited CME activity as defined by the law, Seattle Genetics will not report the payment. The law was, however, amended eliminating this exemption from reporting for payments to speakers at accredited CMEs. Thus, starting with payments that took place on from January 1, 2016 forward, Seattle Genetics will report all payments associated with all CME activities.
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.
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. This spend often 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 the contract for services is with 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 Open Payments regulations require 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 email@example.com.
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.
Open Payments regulations do 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. Open Payments 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, and Washington DC.
Tax matters are not addressed by Open Payments and Seattle Genetics has no visibility into whether there will be tax implications.
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.