The Sunshine Act: Disclosure Requirements Under the Patient Protection and Affordable Care Act
Frequently Asked Questions
- Q1 What is the Patient Protection and Affordable Care Act?
The Patient Protection and Affordable Care Act (the Act) is healthcare reform legislation signed into law on March 23, 2010. Among other things, the Act requires pharmaceutical manufacturers such as Shionogi Inc. (Shionogi) to disclose payments and other transfers of value provided to Covered Recipients. This provision of the Act is commonly known or referred to as the “Sunshine” Act or provisions.
The Centers for Medicare and Medicaid Services (CMS) is responsible for implementing the Act.
- Q2 Who are Covered Recipients?
The Act defines Covered Recipients as (1) a physician, which includes doctors of medicine and osteopathy, dentists, podiatrists, optometrists and licensed chiropractors, and (2) teaching hospitals. Nurses, physician assistants, and other medical office staff are not Covered Recipients under the Act.
- Q3 What about nurses and office staff?
Currently, the Act requires companies to report payments made to Covered Recipients, which the Act defines as physicians and teaching hospitals. Therefore, spend reports on non-physician healthcare professionals (HCPs), such as mid-level prescribers or other medical office staff, are not required.
Note: Some state laws require disclosure of payments to a broader group of healthcare professionals, including non-physician prescribers. The federal law does not preempt, or override, the obligation to report payments made to this broader group of recipients. Therefore, these payments will remain reportable in certain states.
- Q4 What is a payment or transfer of value?
A payment or transfer of value includes both cash and in-kind benefits or services conferred to a Covered Recipient. Examples include: consulting fees, speaker fees, honoraria, food, travel, educational items, including medical textbooks and journal reprints, research, charitable contributions and grants. A physician’s ownership or investment interest in a pharmaceutical or medical device manufacturer must also be disclosed.
- Q5 What will Shionogi report? Will my name be disclosed?
Under the Act, Shionogi will be required to disclose certain payments and transfers of value to Covered Recipients. A payment or a transfer of value less than $10 does not need to be reported unless the total value to a particular Covered Recipient exceeds $100 in a calendar year. Shionogi will track all payments and transfers of value to all Covered Recipients to determine whether the $100 threshold has been met.
The disclosure report to CMS will include the name and business address of the Covered Recipient as well as amount, date and nature (type) of the payment or transfer of value. CMS will make this data available on a public website.
- Q6 What if my contract with Shionogi for consulting and advisory services or as a clinical investigator is through my institution or partnership?
Contracts for certain types of services and activities (e.g., advisory boards, consulting services and speaker programs) are typically made with an individual and, therefore, your name will be disclosed in association with the payment or transfer of value you received. Even if you are not a party to the contract and payment is made directly to your organization (e.g., employer, partnership), as the professional who performed the services, your name will still be disclosed in the annual spend reports to CMS as the recipient of the payment or value.
Contracts for clinical trials, however, are typically between the manufacturer and a Clinical Research Organization (CRO) or other similar entity. The government has made it clear that research payments made to Covered Recipients, whether made directly to the Covered Recipient or indirectly through CROs, Site Management Organizations (SMOs) or clinical trial sites, must be reported under the federal law. Furthermore, we are required to report the names, addresses, specialties and National Provider Identifier (NPI) and state license numbers of all Principal Investigators (PIs) involved in such research, so long as the PI meets the definition of Covered Recipient (e.g., is a physician).
- Q7 What about drug samples?
In addition to spend disclosures, the Act also requires manufacturers to report the recipients’ identity and quantity of drug samples requested and distributed during a calendar year. Reporting under this section of the Act has already begun with companies reporting 2011 data in 2012. However, unlike the Sunshine provisions, the government has not announced plans to share this information publicly.
- Q8 Who will have access to the data disclosed under the Act?
Under the Act, the data disclosed by Shionogi (and other manufacturers) will be published on a publicly available website. CMS has created a website called OPEN PAYMENTS just for this purpose. (Note: The Act does not require companies to publish the spend information on their own websites, and Shionogi has no plans to do so.)
- Q9 How will Shionogi ensure that data being reported is accurate?
Shionogi is committed to ensuring that our spend disclosures will be thorough, complete and accurate. Consequently, we have invested in new technology, dedicated multiple resources and will be implementing robust procedures, processes and controls to ensure we get this right.
- Q9 Will I be able to review the data to be disclosed prior to it being publicly available?
Yes. The Act provides a 45-day review period for Covered Recipients to review the data submitted prior to the data being made publicly available.
- Q10 What are my options if I don’t want my data to be reported?
The Act requires the reporting of any payment or transfer of value to a Covered Recipient that is $10 or more. In addition, when the cumulative value of all the transfers to a particular Covered Recipient exceeds $100 in a calendar year, all transfers must be reported even if the dollar value of each transfer is less than $10. Interactions or engagements between Shionogi and Covered Recipients that do not include a payment or transfer of value require no disclosures.
If you do not want your data to be disclosed as required under the Sunshine provisions, you must avoid accepting payments or other transfers of value from Shionogi that are within the reporting scope. If this is your intent, please communicate the same to your Shionogi representative.
Note on Speaker Programs: If you attend a Shionogi speaker program, you may choose not to receive Shionogi’s in-kind benefits at the program (e.g., meals). If you choose to opt out of receiving these benefits, you must not consume any food or drink at the program. Please inform the Shionogi representative at the program if it is your intention to opt out.