The Sunshine Act

The Sunshine Act

Description of the Sunshine Act

Why does Purdue interact with Health Care Professionals?

What is reportable under the Sunshine Act?

What level of detail will be reported?

Want more information about the Sunshine Act?

Are you a Health Care Professional under contract with Purdue?

Still have questions?

Description of The Sunshine Act

The Sunshine Act, also known as OPEN PAYMENTS, requires pharmaceutical, biologic, and medical device manufacturers (collectively, Manufacturers) to annually disclose to the Department of Health and Human Services (DHHS) all payments and other transfers of value (collectively Payments) furnished to U.S.-licensed physicians and teaching hospitals (collectively, Covered Recipients).

Consistent with the Sunshine Act, Purdue will collect and report to the government all payments and transfers of value to Covered Recipients from all Purdue sources. Purdue will annually submit data to CMS no later than March 31st. CMS is expected to make the data publicly available no later than June 30th each year.

Covered Recipients will have an opportunity to review the Manufacturer-submitted information and submit disputes via a CMS portal for at least 45 days before the information becomes publicly available on the government website.

Why does Purdue interact with Health Care Professionals?

Purdue values its relationships with healthcare professionals (HCPs), and recognizes that by partnering with HCP colleagues, we learn from their expertise and experience. Purdue engages HCPs in a variety of ways, including but not limited to:

  • Presentations with Purdue personnel, both in and out of the office, where we share the latest information regarding our products, including information about risks and benefits, disease states, and appropriate prescribing of our products;
  • Peer-to-peer speaker education programs, where HCPs can learn from their peers about the appropriate use of our products;
  • R & D activities, including clinical studies that investigate the safety and effectiveness of our products; and
  • Various advisory and consulting capacities, where we interact with academic researchers and various HCPs to gather insights that help us develop and improve our products, create meaningful education, and provide input on the design of clinical studies in the advancement of R&D activities.

Purdue is first and foremost committed to excellence in the care of patients and the improvement of the products we develop, manufacture, and market. Purdue is likewise committed to compliance with all federal and state laws, including but not limited to the Sunshine Act and related state transparency requirements, as well as compliance with other standards, most notably the PhRMA Code, Purdue’s Code of Business Ethics, and Purdue’s Healthcare Law Compliance Policies.

What is reportable under the Sunshine Act?

Examples of Reportable Transfers of Value include:

  • In-service meals, that is meals accompanied by an educational presentation by a sales representative in a physician’s office
  • Meals consumed at Promotional Speaker Programs, Investigator Meetings, Advisory Boards, and Product Theaters, provided the identity of participants is known.
  • Any travel costs related to but not limited to speaker programs, advisory boards
  • Fee-for-service arrangements such as consultant, speaker, advisory board member
  • Fee-for-service arrangements such as clinical trial investigator
  • Grants
  • Educational materials that are not intended for use by a patient

Examples of Non-Reportable Transfers of Value include:

  • Indirect payments made through a third party where the manufacturer does not know the identity of the recipient (e.g., blinded market research).
  • Anything less than $10.00 in value, unless the total value of all of the payments or transfers of value during the calendar year to that particular Covered Recipient is more than $100.00 in value.
    • It is recommended that Covered Recipients assume that any transfer of value, even one valued at less than $10.00, will be reported. If the aggregate amount is $100.00 or less, Purdue will not report it.
    • In accordance with the regulation, these values are adjusted annually consistent with the consumer price index. Please refer to http://cms.gov/openpayments/ for updates.
  • Educational materials that directly benefit patients or are intended for patient use (e.g., journal for patient to chart own symptom level, anatomical charts).

What level of detail will be reported?

Each line item that is reported 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

Want more information about the Sunshine Act?

Dispute Resolution

When Purdue submits transfers of value to the OPEN PAYMENTS Enterprise Portal, Covered Recipients will have an opportunity to review the data that has been submitted about them prior to publication of the data. If the Covered Recipient finds discrepancies with the submitted data, a dispute can be initiated by the Covered Recipient in the CMS Enterprise Portal. Once the dispute is reviewed, it can be resolved in one of three ways:

  • Resolved – Purdue updates and resubmits the disputed data.
  • Resolved No Change – indicates that Purdue and the Covered Recipient have resolved the dispute in accordance with the guidance in the Final Rule.
  • Withdrawn – a Covered Recipient can withdraw a dispute initiated against a record. In this instance, no action is taken by Purdue.

Research Spend – Each research payment record submitted to the OPEN PAYMENTS Enterprise Portal is attributed to the physician, teaching hospital, or non-covered recipient that received the payment. As appropriate, the names of physician principal investigator(s) associated with the research payment are also provided. If you are a physician who served as a principal investigator on a research study, you may see the payments associated with that research study listed under your name. This does not necessarily mean the payments are attributed to you. The dollar amount of the record corresponds to the total payment; the amounts do not accrue to each individual physician, meaning these dollars are not included in any aggregate amount reported against the physician typically. As a principal investigator, you should only dispute your own association with the payment or other transfer of value, assuming that you were not the primary investigator associated with a particular payment. You should not dispute any other information about the transaction, such as payment amount, nature of payment, etc.

Are you a Health Care Professional under contract with Purdue? If so, click these links as needed.

Still have questions?

  • Please send in your question via e-mail from your preferred address to SunshineAct@pharma.com
  • If you are a Covered Recipient, should you wish to receive a report of spend that Purdue has collected year-to-date that we plan to report to CMS, please send a signed request on your company/institution letterhead making the request. Be sure to include your NPI (National Provider Identifier) number in the request. Such requests may be sent to SunshineAct@pharma.com or to the following address:
    Sunshine Act Team
    c/o Ethics & Compliance
    Purdue Pharma L.P.
    201 Tresser Blvd. 9th Floor
    Stamford, CT 06901