Sunshine Act Frequently Asked Questions

The Physician Payment Sunshine Act was passed in March 2010 as part of the Patient Protection and Affordable Care Act. The purpose of the Sunshine Act is to create greater transparency of the financial relationships among pharmaceutical and medical device manufacturers, physicians and teaching hospitals. It is administered by the Centers for Medicare and Medicaid Services (CMS) under a program called the Open Payments Program.

Open Payments requires reporting of the following information annually to CMS:

• Applicable manufacturers of covered drugs, devices, biologicals and medical supplies must report payments or other transfers of value they make to physicians and teaching hospitals.
• Applicable manufacturers and applicable group purchasing organizations (GPOs) must report certain ownership or investment interests held by physicians or their immediate family members.
• Applicable GPOs must report payments or other transfers of value made to physician owners or investors if they held ownership or an investment interest at any point during the reporting year.

CMS collects, aggregates and publishes this data on a public website.

Note: medical students, residents, support and office staff, nurses, advance practice nurses, physician assistants and others are excluded from the reporting requirement.

Manufacturers must report payments and transfers of value made directly or indirectly to physicians and teaching hospitals and GPOs must report such payments or transfers to physicians with ownership or investment interests. Manufacturers as well as GPOs are also required to report ownership interests held by physicians and their immediate family members. When a report is made, payments and other transfers of value must be categorized as falling into one of the following possible categories:

• Consulting fee
• Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program
• Honoraria
• Gift
• Entertainment
• Food and beverage
• Travel and lodging (including the destinations)
• Education
• Research
• Charitable contribution
• Royalty or license
• Current or prospective ownership or investment interest
• Compensation for serving as faculty or as a speaker for an unaccredited or non-certified continuing education program
• Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program
• Grant
• Space rental or facility fees (teaching hospital only).

An indirect payment goes from a manufacturer to a physician or teaching hospital through an intermediary, such as a specialty society or research organization (e.g., grant, earmarked donation). A payment is considered indirect and reportable if an applicable manufacturer or GPO requires, instructs, directs or causes an intermediary to provide the payment or other transfer of value to a specific physician or teaching hospital. Applicable manufacturers are required to identify each physician who received a payment or transfer of value and report appropriately. For example, if payment was given to a specific physician to cover travel and lodging expenses for a meeting or event, it would need to be reported.

• Payments or transfers of value less than $10, unless the aggregate amount exceeds $100 in a calendar year¹  
• Product samples that are not intended to be sold and are intended for patient use
• Educational materials or items directly benefiting patients or intended to be used by or with patients. Textbooks and reprints are not excluded under this provision
• Buffet meals, snacks, soft drinks or coffee generally available to physicians at large-scale events
• In-kind items used for the provision of charity care
• Discounts or rebates
• Loan of a medical device for the short-term
• Transfers of value and payments made to a physician in return for non-physician services from the physician (e.g., physician who is also a lawyer providing legal services to an applicable manufacturer or GPO)
• Items or services provided under a contractual warranty
• A dividend or other profit distribution or ownership or investment interest in a publicly traded security and mutual fund

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¹CMS adjusts these numbers each year based on the consumer price index for all urban consumers (CPI-U). For 2018, the exclusion applies to payments or transfers of value less than $10.49, unless the aggregate exceeds $104.90 in a calendar year.

Manufacturers and GPOs must submit the reports on payments and transfers of value to CMS on an annual basis. Manufacturers and GPOs must report ownership interest held by physicians and their immediate family members¹.

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¹CMS defines immediate family members to include a:

1. spouse
2. natural or adoptive parent, child or sibling
3. stepparent, stepchild, stepbrother or stepsister
4. father-, mother-, daughter-, son-, brother- or sister-in-law
5. grandparent or grandchild
6. spouse of a grandparent or grandchild

If a vendor takes you out (e.g., for a meal, etc.) during the ASTRO Annual Meeting, the vendor must report it to CMS. Amounts less than $10 do not have to be reported unless the annual value of items from the same vendor exceeds $100. (These limits increase incrementally each year to account for inflation. For 2018, the limits are $10.49 and $104.90, respectively.)

While physicians and teaching hospitals are not required to register or report information, it is important that they understand the type of information that will be reported to CMS. ASTRO encourages members to keep records of payments and transfers of value so that information submitted to CMS can be verified for accuracy. During the “review and dispute” period, physicians and teaching hospitals are encouraged to review the data reported about them to verify the accuracy before it is made public.

Physicians have an opportunity to review data before it is made public but you must register with CMS in order to review or dispute any of your reported information. CMS registration is a two-part process: physicians must first register in CMS’s Enterprise Identity Management (EIDM) system (if you are not currently registered with this system). This registration must be completed before you can access CMS’ Open Payments system. More information on how to register with EIDM and request access to the Open Payments system can be found on CMS’ website and in its Quick Reference Guide.

Manufacturers can participate in an optional pre-submission review that allows the physician, teaching hospital or physician owner/investor to review the data before it is submitted to CMS. CMS recommends that manufacturers voluntarily provide physicians and teaching hospitals the opportunity to do a pre-submission review, but it is not required. CMS does not administer or manage the pre-submission review process.

Providers will have an opportunity to review and dispute data prior to it being publicly available. ASTRO urges all members to take advantage of this opportunity. Physicians and teaching hospitals are encouraged to register with CMS so they can review submitted data to ensure it is accurate and complete or to dispute the information and work with applicable manufacturers or applicable GPOs to make any necessary corrections to the information before CMS makes it public.

Once the manufacturer has submitted data listing the physician’s name to CMS, CMS must give physicians 45 days to review and work with the manufacturer, or applicable GPO, to correct the information. After the 45 days have passed, the manufacturer or applicable GPO will have an additional 15 days to submit corrections based on any disputes identified by physicians and physician owners/investors. The review and correction period starts at least 60 days before the information is made public.

During the review and correction period, physicians and physician owners/investors can dispute information about them they do not think is correct. If data is disputed, CMS will notify the applicable manufacturer or applicable GPO that some of their data has been disputed. However, CMS will not mediate the dispute directly.

Once the dispute is resolved, the applicable manufacturer or GPO must send CMS a revised report for the correct data and re-attest that it is correct. Though the review and correction system will be open year-round, only the data corrections noted during the 45-day review and correction period, and subsequent 15-day dispute resolution period, will be updated before publication. CMS will update data from the current and previous year at least once annually, in addition to the initial data publication that followed data submission, in order to update disputes resolved outside of that timeframe.

CMS will publish the data most recently submitted by the applicable manufacturer or GPO on its website, and it will mark the data as disputed.

The Sunshine Act does not require ASTRO to submit any reports to the government. However, indirect payments or transfers of value made to physicians (e.g., grants) are reportable if the manufacturer requires, instructs, directs, or otherwise causes that money will be “paid” to physicians in any of the reportable categories.

In general, the following timeline applies to the collection of data under the Open Payments program.

• Step 1: Applicable Manufacturers and GPOs collect data (January 1 – December 31).
• Step 2: Applicable Manufacturers and GPOs submit data submission to CMS (February 1 - March 31 of the year after the collection year).
• Step 3: Physicians and teaching hospitals review and dispute data that has been submitted about them (45-day period between April and May of the year after the collection year – announced by CMS each year).
• Step 4: Applicable Manufacturers and GPOs review and correct the data (15-day period in May or June of the year after the collection year, after Step 3 is completed).
• Step 5: Publication of data on CMS public website (June 30 of the year after the collection year).

More information is available on the CMS website. CMS has also set up a help desk that can be reached via email at [email protected]. For live assistance, you may also call CMS Help Desk Support at 1-855-326-8366, Monday through Friday, from 9:00 a.m. to 5:00 p.m. Eastern time, excluding Federal holidays.