As of August 1, medical drug and device manufacturers and group purchasing organizations (GPOs) began collecting data on payments and transfers of value (TOV) made to U.S. healthcare providers. The data collection is required under the Physician Payment Sunshine Act (Sunshine Act), which establishes a publicly accessible database disclosing potential conflicts of interest between physicians and applicable medical drug and device manufacturers.

The data collected between Aug. 1 and Dec. 31, 2013, must be reported to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014 and will be publicly accessible through an online federal database by Sept. 30, 2014. Thus, 2013 is a condensed data collection period with just 5 months of data reporting. Thereafter, manufacturers and GPOs are required to report for each full calendar year.

Following are some frequently asked questions about the Sunshine Act and data collection.

Who collects the data?
Manufacturers of drugs, devices, and biologic and medical supplies covered under Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) are required to disclose to CMS any payments or other TOV made to physicians and teaching hospitals. The law also requires manufacturers and GPOs to report any physician ownership or investment interests.

What must be reported?
Under the Sunshine Act, the following information must be reported:

• The name and address of the physician
• The amount and date of the payment
• The form of the payment, such as cash or stocks
• The nature of the payment, such as consulting fees, gifts, or entertainment expenses

What’s considered a payment or TOV?
Payments or other TOV are anything of value given by an applicable manufacturer or applicable GPO to a covered recipient or physician owner/investor that does not fall within one of the excluded categories in the rule. Payments provided to a consulting firm or third party, which in turn provides the payment to a covered recipient, must also be reported.

Compensation paid by a manufacturer to a physician for expenses made in connection with interviewing the physician for possible employment must be reported, as well as the value of materials used to educate physicians, such as medical textbooks or journal reprints.

What’s this about a $10 limit?
Payments less than $10 are exempt from reporting until the aggregate annual total per company per covered recipient reaches $100, at which point all payments must be disclosed. To determine if payments or other TOV exceed the $100 threshold and must be reported, manufacturers and GPOs must aggregate payments of less than $10 across multiple payment categories.

If the manufacturer provides a physician with multiple separate payments valued under $10 each, and the cumulative amount of those separate payments exceeds $100 during the year, the threshold will have been met and these payments must be reported. So, if a manufacturer provides tickets to a sporting event (one ticket to each of three events at $9 per ticket, or $27 total), plus cab fare to the events ($9 per cab per event; $27 total) and two hot dogs during each event (a total of six hot dogs at $9 per hot dog, or $54), it will have given the physician $108 and must disclose all payments.

Is anything NOT reportable?
According to CMS.gov, education materials and items that directly benefit patients or are intended to be used by or with patients are not reportable TOV. Additionally, printing and time development of education materials are not reportable as long as they directly benefit patients or are intended for patient use.

In addition, speaker compensation at continuing medical education (CME) events is not required to be reported by an applicable manufacturer as long as the CME program meets accreditation or certification requirements, the applicable manufacturer does not select or suggest the covered recipient, and the applicable manufacturer does not directly pay the covered recipient speaker.

When it comes to CME accreditation, however, CMS will not recognize accrediting bodies that are not on its list of approved accrediting bodies. The five accrediting/certifying bodies include: the Accreditation Council for Continuing Medical Education, the American Academy of Family Physicians, the American Dental Association’s Continuing Education Recognition Program, the American Medical Association, and the American Osteopathic Association.

What should I do?
According to Anita Griner, deputy group director for the Center for Program Integrity (the group implementing the program), physicians should “keep records of all these payments and transfers of value that you may receive from an applicable manufacturer, and ownership interest and payments from group purchasing organizations that you may be an owner in … so that you can then compare those records against what the applicable manufacturers or GPOs submit.”

Can I challenge the data?
Yes, if you think the information is false or misleading. Before the collected information is posted to the public website, companies, GPOs, and physicians will have 45 days to review and challenge the information. The companies will have an additional 15 days to correct the information.

According to CMS.gov, covered recipients and physician owners or investors may initiate disputes at any time after the 45-day review and correction period begins, but before the end of the calendar year. However, any changes resulting from disputes initiated after the 45-day review period may not be made until the next time the data are refreshed.

If a dispute is not resolved by 15 days after the end of the 45-day period, CMS will report the applicable manufacturer or applicable GPO’s version of the payment or TOV, but will mark it as disputed.

“Data accuracy is the number one goal of our program,” said Ms. Griner. “We want the data put on the public website to be complete and accurate. We do not want it to be disputed. We do not want it to be inaccurate. We do not want to perpetuate any false information about a physician or teaching hospital. So data accuracy is key. And that will come from physicians tracking their own transfers and checking the website before it goes public.”

Where can I get more information?
For more information, visit go.cms.gov/openpayments; links to additional information on the Sunshine Act and its requirements can be found below.

Elizabeth Fassbender is the communications specialist in the AAOS office of government relations. She can be reached at fassbender@aaos.org

Additional Information

• What the Sunshine Act Brings to Light
• What do You Know About the Sunshine Act?