Sunshine Act

In summary, Section 6002 of the Affordable Care Act requires manufacturers of covered drugs, devices, biologics, and medical supplies operating in the United States to report to the Centers for Medicare and Medicaid Services (CMS) any payments or transfers of value they make to teaching hospitals or physicians. CMS will collect the data annually, requiring data to be submitted by manufacturers to CMS by March 31, 2014. CMS will then aggregate the data and publish it on a public website. As of August 1, 2013, manufacturers are required to collect data on payments or transfers of value they make. Only medical residents are excluded from the Sunshine Act’s application.

However, a significant exemption from the reporting requirements exists for certain payments or transfers of value made to speakers of certified or accredited continuing medical education (CME) programs, including travel, accommodations and meals for speakers. Such payments are completely exempt from reporting if such payments meet three conditions. Speaker compensation must: (i) relate to an event satisfying CME accreditation standards; (ii) not be paid directly by the manufacturer; and (iii) the manufacturer cannot select the speaker or provide a list of individuals to be considered as speakers.

For further detail on the PPSA, visit the CMS official site on Open Payments.

1. Payments or transfers of value exceeding $10 must be reported.  If a PPSA exclusion applies, it can supersede the “$10 or greater” reporting rule and result in manufacture reporting not being mandated. However, all minor payments (less than $10 value) are subject to reporting if they exceed $100 per individual in a reporting year, so must be tracked.
2. Non-Accredited/Non-CME programs are not exempt from being reported, even if you are a speaker. All items not covered by tuition and education fees, as well as any lodging meals, travel funds if you are a speaker physician must be reported.
3. Education materials a physician receives that are not meant to benefit a patient or not used by a patient is reportable. These include medical textbooks and journal reprints provided by an applicable pharmaceutical or medical device manufacture.
4. Meals at meetings where the physician is identifiable to the manufacturer is reportable if the value of the meal exceeds $10 and the persons partaking of the meal are “readily identifiable” at the time the meal is being provided to the applicable manufacturer. However there is a reporting exception for meals that are being served to physicians as a buffet or part of a large-scale meeting where the physicians partaking in the buffet/self serve meal are not “readily identifiable”.
5. Indirect payments or transfers of value that an applicable manufacturer makes to a third party are reportable when the manufacture requires, instructs, or directs payment or transfer of value being provided to a specific physician. It doesn’t matter if the manufacturer doesn’t know ahead of time who the physician(s) is/are because they are requiring, instructing or directing the transfer be made to a certain group.
6. The physician serving as the principal investigator as well as the institution will be reported for payments or transfers of value for research.  However this is reported in a separate section of the Open Payments public website.

Applicable manufactures and GPO’s began to collect the required date as of August 1, 2013 and reported the date collected through December 31, 2013 to CMS by March 31, 2014.

By September 30, 2014 CMS will publish the reported data on a publicly available website.

To see details on reportable data key dates on the CMS website, visit:
http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Data-Collection-Details.html

Under the PPSA reporting the applicable manufactures will include in its report to the CMS the physician’s name, address, NPI number, and other identifying information all based on the information in the NPPS database.

To see the template of information manufactures must use for reporting payments or transfers of value made to physicians, visit: http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/downloads/research-payments-submission-file-specifications.pdf

As part of Open Payments, physicians should register with CMS to review information about payments or other transfers of value given to them by the industry prior to public posting of the data. Physicians and teaching hospitals that choose to participate will need to initially register in CMS’ Enterprise Portal (the gateway to CMS’ Enterprise Management system) in order to access and review the information submitted about them by the industry. As a part of this overall process, registered users will be able to dispute information with industry that they believe to be inaccurate or incomplete.

To visit the CMS physician page on their website for more detail visit:
https://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Physicians.html

Registered physicians will have 45 days to review and work with the manufacturer regarding data they reported to correct the information. After the 45 days have passed, the manufacture will have an additional 15 days to summit corrections based on any disputes identified by physicians. 

See more detailed information on the dispute process by visiting:
https://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-Transparency-Program/Dispute-and-Resolution.html

The Clinical Immunology Society receives unrestricted educational grants for their educational programs from manufacturers of drugs, devices, biologics, and/or medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program (CHIP) and therefore may need to report information back to these manufactures to report.

CIS is accredited by the ACCME and all educational programs are CME accredited.  Because the education programs are CME accredited, they meet all three conditions established in the final rule and are exempt from reporting faculty/speaker travel, lodging and meals.

Physician attendees of the CME programs pay a registration fee that includes the education materials and are not covered by a grant of a manufacturer and therefore is not reportable. CIS’ standard practice is to serve food and beverage as a buffet/self serve style and therefore is not reportable back to the manufacturer. However, in the rare instance that there is a plated meal served, CIS would report the value of the food & beverage back to the applicable manufacturers.

CIS reporting Policy:
CIS will not report any information regarding faculty/speakers for any accredited CME programs because they are exempt from reporting, even if requested by the manufacture. CIS will report any other reportable information per the PPSA to the applicable manufacturer.

As part of the registration process for any CIS program, attendee’s will be required to provide us with your National Provider Identifier (NPI) number, Specialty, and State professional license number (for at least one state where the physician maintains a license), and the state in which the license is held.  CIS will inform any physician that CIS is providing information to an applicable manufacturer for the Open Payment program prior to submission and will allow 5 working business days to respond with a dispute.

Fact Sheet for Physicians

FAQ’s

Open Payments User Guide

Definitions and Acronyms

Apps for Helping with Tracking