The medical meetings industry has seen many changes since the Sunshine Act was made federal law as part of the Affordable Care Act in 2010. Giveaways and gifts have all but disappeared from the show floor. Regulatory teams are taking the strictest stance on vague PhRMA and AdvaMed guidelines. U.S. doctors are hesitant to take anything from exhibitors.
All that may be changing.
In February 2013, the Centers for Medicare and Medicaid Services (CMS) released its final ruling on the Physician Payment Sunshine Act1 and relieved some of the long-building tension. At events open to the public, such as DDW, CMS recognized that “it will be extremely difficult for applicable manufacturers to identify physician covered recipients2.”
Here are the 10 things you need to know about the Sunshine Act as a DDW exhibitor:
- You can give stuff away!! Bring on the pens, lab coats, stuffed animals and gadgets. CMS finalized “that small incidental items that are under $10 (such as pens and note pads) that are provided at large-scale conferences and similar large-scale events will be exempted from the reporting requirements, including the need to track them for aggregation purposes.”
- If it educates the patient, you do not need to report it. If you are giving something away that is ultimately intended to be used with a patient or to help explain to patients how a procedure would work, such as a wall model or anatomical model, you do not need to report it. You may also provide educational materials to a physician on a flash drive to be distributed to patients. CMS also stated that overhead expenses, such as printing and time, should be included in the exclusion as long as they are directly related to the development of the materials, which directly benefit patients or are intended for patient use. Be aware that items such as medical textbooks and journal reprints do need to be reported.
- You must make a good faith effort to obtain an NPI number for the physician. A good faith effort includes, but is not limited to, specifically requesting an NPI from the physician, checking the NPPES database, and calling the NPPES help desk. DDW does not collect NPI numbers at the point of registration but we do encourage you to include it in your qualifying questions to attendees who visit your booth. Lead Retrieval devices are programmable so that you can enter NPI as a manual field.
- You may provide food. Exhibitors are not required to report or track buffet meals, snacks, soft drinks or coffee made generally available to all participants of DDW. You are only required to report food and beverage when it is given to a limited number or to specific individuals.
- You can have a paid physician speaker at your Satellite Symposium. Payments or other transfers of value provided as compensation for speaking at a continuing education program are not required to be reported, if all of the following conditions are met:
- The event at which the covered recipient is speaking meets the accreditation or certification requirements and standards for continuing education of the ACCME, AAFP, ADA, AMA or AOA;
- The applicable manufacturer does not pay the covered recipient speaker directly. You should use a third-party, such as a continuing education vendor, to coordinate your Symposium and contact with the speaker;
- The applicable manufacturer does not select the speaker or provide the Symposium planner with a list of speakers to consider.
- You do not need to report on residents. CMS clarified that “Payments or other transfers of value to residents will not be required to be reported for purposes of this regulation.”
- You may give donations. A company may give an unrestricted donation to a physician professional organization to use at the organization’s discretion, and the organization can choose to use the donation to make grants to physicians. Those grants would not constitute “indirect payments” because the company did not require, instruct, or direct the organization to use the donation for grants to physicians. However, if an applicable manufacturer gave money to a medical professional society earmarked for the purpose of funding awards or grants for physicians, the awards or grants would constitute indirect payments to covered recipients and would be subject to the reporting requirements.
- You can give incentives during market research. If you are using a third party to conduct a double-blind market research study, you do not need to report the incentive as the covered recipient remains anonymous. For example, an exhibitor may hire a market research firm to conduct a double-blinded market research study, which includes paying physicians $50 for responding to a set of questions. The exhibitor clearly intends a portion of the payment to be provided to physicians, but given that the reason for the third party’s involvement is specifically to maintain the anonymity of the respondents and sponsor, CMS does not intend this to be considered a reportable indirect payment or other transfer of value. However, if the exhibitor were to direct the third party to only make payments to the top billing gastroenterologist in a certain city or the chiefs of staff of a certain class of hospitals then the payments would be required to report these payments, even though they do not have actual knowledge of the identities of such individuals.
- You will need to report even if you only use your company name. If a payment or other transfer of value is not related to at least one covered product and/or only promoted under the company name, the exhibitor should report the item under “none.” Conversely, “if the payment or other transfer of value is related to a specific product, which is not a covered product, the exhibitors should report the item as a “non-covered product.” Finally, if the payment or other transfer of value is related to at least one covered product, the exhibitor must report the covered products by name.
- Include the marketing name and the National Drug Code (NDC). For drugs and biologicals, CMS finalized that companies must report the market name of the product and must include the NDC (if any). If a market name is not yet available, applicable manufacturers should use the name registered on clinicaltrials.gov.
These clarifications should help guide you as you plan your marketing at DDW. Give attendees a reason to come to your booth. Be bold and be fun.
What are you planning to give away at your DDW booth? Let us know in the comments!
1You can download the full CMS ruling at http://www.gpo.gov/fdsys/pkg/FR-2013-02-08/pdf/2013-02572.pdf.
2Please keep in mind that each state also has their own rules and requirements. You can find a breakdown of the rulings in different states at https://www.ama-assn.org/resources/doc/washington/state-sunshine-laws-chart.pdf.