Toolkit for Physician Financial Transparency Reports (Sunshine Act)
The Physician Payments Sunshine Act (Sunshine Act) requires manufacturers of drugs, medical devices and biologicals that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. The Centers for Medicare & Medicaid Services has been charged with implementing the Sunshine Act and has called it the Open Payments Program.
Manufacturers are required to collect and track payment, transfer and ownership information as of Aug. 1, 2013. Manufacturers will submit the reports on an annual basis. In addition, manufacturers and group purchasing organizations (GPOs) must report certain ownership interests held by physicians and their immediate family members.
The majority of the information contained in the reports will be available on a public, searchable website. Physicians have the right to review their reports and challenge reports that are false, inaccurate or misleading. Read below for additional information or download a PDF of the full Sunshine Act toolkit that is printer-friendly.
Review and update forms & disclosures
Ensure that all financial and conflict-of-interest disclosures required by your employer or other entities that provide you funding (or that you advise) are current and updated regularly. Review and update these disclosures several times each year. Those entities requiring financial or conflict-of-interest disclosures may compare information posted on the public website to disclosures you have made.
Update your info
Update your professional information and ensure your specialty is designated correctly. Physicians who have a National Provider Identifier (NPI) should verify the information in the NPI enumerator database is current and update it as needed. This information—among other unique identifiers—will be used by industry to confirm they have identified you accurately.
Understand reportable transfers
Learn what financial transfers and ownership interests must be reported by drug and device manufacturers and group purchase organizations. Understand what exemptions apply and when indirect transfers (i.e., those not made directly to a physician) are reportable.
Get the OPEN PAYMENTS Mobile for Physicians app
This free app allows you to capture and confidentially collect information on reportable transfers between you and industry representatives so you can challenge any inaccurate information reported by industry to the government. Download the OPEN PAYMENTS Mobile for Physicians app on your Apple™ or Android™ device.
Ask to review transfers
Ask industry representatives to let you review reportable transfers before they report them. While physicians will have an opportunity to review an individualized report that consolidates all reported transfers and ownership interests, it will not occur until after companies submit the information to the government. Ask your industry contacts to provide transfer information in advance for correction before transmitting it to the government.
Webinar: Preparing for the Sunshine Act
Watch an archived broadcast of the AMA's webinar "Physicians Preparing for the Sunshine Act: What You Need to Know and How to Prepare" (presented on April 24, 2013) or access the slidedeck.
This webinar will help you:
- Identify the two central provisions of the Sunshine Act including the (1) financial interactions that are subject to reporting; (2) the ownership interests that are subject to reporting.
- Identify the major financial interactions and ownership interests that are excluded from reporting.
- Initiate and complete key steps to prepare for reporting.
- Identify and utilize resources that are available to ensure that reportable financial interactions between a physician and industry and ownership interests are accurately and fairly reported.
Being transparent with your patients
Your patients may wish to know whether you have or have had financial interactions with industry. When a patient asks about this topic, it is important that you discuss the matter candidly in a way that will enhance the patient's understanding without compromising trust or the patient-physician relationship. Some of the issues you might want to address with the patient are what sources you rely on for information about medical innovations and new evidence, your role in medical research, and how you believe research will improve outcomes for patients.
Purpose of Transparency Reports
There are many interactions between physicians and manufacturers of drugs, medical devices, and medical supplies that benefit patients and advance the art and science of medicine. The Sunshine transparency reports provide patients and the public with information on the financial interactions of physicians and industry. These interactions often drive innovation, discovery, and changes in medical practice that promote better patient outcomes. The congressional sponsors of the ACA reporting provisions have stated that this process is not designed to stop, chill, or call into question beneficial interactions between physicians and industry, but to ensure that they are transparent.
Summary of Key Provisions of the Sunshine Act
Financial Transfers that Are Subject to Reporting:
- Direct. Manufacturers of a drug, device, biological, or medical supplies participating in federal health care programs will have to report to CMS any direct payments or transfers of value to physicians and/or teaching hospitals of $10 or more. However, there are 12 exceptions where a direct payment or transfer of value is not subject to reporting. These include product samples and educational materials that directly benefit patients.
- Indirect. Transfers that are not made directly to physicians. These are categorized as third party transfers and other types of indirect transfers.
- Third party transfers are those where a physician does not receive the payment or transfer. For example, a physician (or someone acting on his or her behalf) may specify that a transfer of value should be given to another person or entity, such as a preferred charity.
- Other types of indirect transfers occur when an entity transfers value to a physician indirectly by way of a third party or intermediary. A good example would be when a pharmaceutical company makes a payment to a physician organization and then requires, instructs, or directs the payment or transfer of value to be provided to a specific physician or intended for physicians (in the latter case without regard to whether specific physicians are identified in advance).
Ownership: Manufacturers and GPOs participating in federal health care programs will have to report to CMS certain ownership interests held by physicians and their immediate family members. However, there are certain ownership interests, such as securities which may be purchased on terms generally available to the public and which are listed on a stock exchange in which quotations are published on a daily basis, which are not reportable ownership interests.
Review & Public Reports: The majority of the information contained in the transparency reports will be available on a public, searchable website. By statute, physicians are provided, at a minimum, 45 days to review their own consolidated transparency report and make corrections before the report is made public. Physicians have additional time, cumulatively two years, to dispute reports even after the reports are made public. If a physician utilizes the dispute process, the public data will be marked as disputed in the public database.
State Sunshine Laws
Prior to the ACA, however, several states enacted "sunshine" type laws. It is important for physicians to recognize that the federal Sunshine Act, when fully implemented, may create additional requirements for physicians in states that already have a state law. In states where there is no state law, federal law will govern. If a state is not listed in this chart, please consult with your state medical society for specific guidance.
Open Payments: CMS Informational Website
This CMS website is your one-stop-shop for information about the Open Payments program.
Public Webpage – Transparency Reporting
CMS is required to provide most of the information contained in the transparency report in a public Webpage. When the link is available, it will be posted here.
CMS is required to provide information on the annual transparency reports to physicians before the reports are made public. Physicians are strongly urged to register to receive reports. There are three steps physicians must complete to obtain their individual report.
Step 1: Complete CMS e-verification process today
CMS requires a two-phase registration process. In phase 1, which is now open, physicians complete CMS' e-verification process via the CMS Enterprise Portal (EIDM). Access step-by-step instructions.
Step 2: Register with CMS' Open Payments system
Once physicians have completed Step 1 and gained access to EIDM, physicians can move onto phase two and register in CMS' Open Payments System via EIDM. Use the Quick Reference Guide on how a physician can register in the Open Payments system.
Step 3: Review and dispute data by Sept. 10*
Physicians can request their individual report, review it and flag disputes after completing Step 2. CMS has indicated that it will not resolve disputes, but errors can be reported to manufacturers through the Open Payments System or directly through Open Payments contacts listed on most manufacturer websites.
*Physicians must initiate disputes by Sept. 10 to have potentially erroneous data flagged in the initial public release. Physicians can still initiate disputes on 2013 data until Dec. 31, 2014, but it will not be flagged in the public database until 2015.
Other important dates:
Sept. 30: Data released publicly
CMS publishes majority of data including physician-specific information
Dec. 31: Last day to file dispute for 2013 report data
This is the deadline for initiating a dispute of incorrect data reported for transfers made and ownerships held in 2013. If a physician waits until after data has been made public to initiate a dispute, the data will not be marked as disputed in the public database until the agency updates the information, which could be six months to a year later.
- Physicians will have at least 45 days once CMS provides access to individual physicians' consolidated industry reports via an online portal to challenge reports. (Note: The Open Payments system was taken offline from Aug. 3-15 to correct a technical problem. It is now available once again. CMS adjusted the date for physicians to initiate disputes to have potentially erroneous data flagged in the initial public release. The original deadline for this was Aug. 27; it is now Sept. 10.)
- Access will not occur until after the calendar year has come to a close. The portal will allow physicians to contact the manufacturer(s)/GPO(s) that submitted inaccurate, misleading, false information in order to resolve disputed submissions.
- If a physician and manufacturer(s)/GPO(s) cannot resolve the dispute, they are provided an additional 15 days before the report is made public to try to achieve resolution.
- If resolution is still not reached, the disputed information will be flagged, but the report will be posted on the public webpage CMS develops for such reports.
- Physicians are also able to seek correction or contest reports for two years after access has been provided to a report with disputed information.
- Once CMS establishes the online portal, physicians will be urged to sign up in order to receive direct notice when the reports are made public.
- You should check with any manufacturer from which you have received payment or any item of value to see what information they are tracking and intend to report.
- If you hold any ownership interests in a manufacturer or GPO, you should also check to ascertain what ownership interest(s) they intend to report. (Ownership or investment interests in publicly traded security and mutual funds are excluded from reporting.)
The AMA along with 49 medical specialty societies and 43 state medical associations, submitted a sign-on comment letter on the proposed rule. In addition, the AMA joined a sign-on letter submitted by national organizations involved in Continuing Medical Education (CME) in the United States, including Accreditation of CME Providers, granting of CME Credit for CME activities, and fulfillment of the responsibility of the Profession of Medicine to self-regulate in the arena of CME.
AMA policy and principles
The AMA has long supported efforts to promote transparency in the interactions of physicians and industry. Beyond reporting transfers of value, the AMA believes that physicians' relationships with industry should always be transparent, meaningfully independent, and focused on benefits to patients. This includes providing information physicians and the public need to make informed, critical judgments about interactions with industry and taking steps to ensure that physicians' clinical judgments are objective and evidence based. AMA policy also endorses transparency and independence. The AMA has also sought to refine the provisions of the Sunshine Act in the interests of patients and physicians. Newly adopted policy commits AMA to continuing efforts to ensure that the burden on physicians is minimized and that CMS does not expand the Sunshine Act without appropriate authorization by Congress, as well as urging CMS to provide for a physician comment section on its public database. (H-140.848 Physician Payments Sunshine Act; see Additional AMA Policy.)