Open Payments Act AKA the ‘Sunshine Act’ Open Payments Act AKA the ‘Sunshine Act’ Public Postings of Physician Ownership, Investments, & Transfers of Value on the Centers for Medicare & Medicaid Services Website Suzann VanNasdale, J.D. COI Administrator, Compliance Manager Office of Research Ohio State University Leeanne B. Walker, JD Director, Compliance & Research Integrity University of North Carolina School of Medicine June Anne Insco Outside Interests and COI Manager Office of Regulatory Affairs University of Michigan Medical School National Council of University Research Administrators

The ‘Sunshine Act’ is a New Regulation that Makes Public Physician-Industry Financial Relationships. 2 $ “There's a lot of skepticism about financial relationships between doctors and drug companies. Disclosure of those ties would help to build confidence that there's nothing to hide..” -- Senator Charles 2014 National Council of University Research Administrators

The Goal is to Shed Light on the Relationships Between Industry, Research, and Individual Medical Practices. 3 Lack of transparency created a culture that this law should begin to change substantially. Senator Grassley ~Interactions can create conflicts between the best interest of patients and the influence of gifts and favors on decisions. This website will enable consumers to make informed decisions. REFORM $ INFLUENCE DOCS INFORMED 2014 National Council of University Research Administrators

Manufacturers & Group Purchasing Organizations Must Report Financial Information to CMS. 4 REPORT ABOUT DOCS 2014 National Council of University Research Administrators

Companies Must Report Data about Licensed MDs*, DOs, Podiatrists, Optometrists, Chiropractors, Dental Surgeons, Dentists, and Teaching Hospitals. NOT *Residents Medical Students Nurses Physician Assistants Other Healthcare Providers 2014 National Council of University Research Administrators

Charitable contributions Compensation (e.g., Speaking) Consulting Fees Entertainment, Food, Gifts Grants Honoraria Ownership/Investments (includes interests of family members) Education Research Funding (includes Name of Teaching Hospital and Physician PIs) Royalties Travel CMS will Post Ownership, Investments, and ‘Transfers of Value’ worth $10* or cumulative values of >$ National Council of University Research Administrators

Important Dates First reporting period 8/1/13 to 12/31/13. Companies report data to CMS by 3/31/14. Physicians have 45 days to review starting August 1.* After the 45 days, CMS will allow another 15 days for dispute resolution. Public Posting September 30, 2014 (maybe) 2014 National Council of University Research Administrators

Companies can request a delay in publication of research information to protect R&D. – Information must still be reported. – Information will be posted when a new drug, device, etc. is approved by the FDA or in 4 years, whichever comes first National Council of University Research Administrators

What does this new rule have to do with COI and Sponsored Programs? 9

What are the biggest concerns of the faculty physicians? 10

What can physicians do to prepare? 11

What educational information is being provided for faculty? For patients? 12

Does your institution intend to assist its faculty with disputes? 13

Does your institution plan to use the data available on the CMS website? If so, how? 14

Appendix A Public Postings of Physician Compensation Data Applicable manufacturer’s name Physician’s Name Specialty Primary business address Amount of payment or other transfer of value in U.S. dollars Date of payment or other transfer of value Form of payment or other transfer of value Nature of payment or other transfer of value Name(s) of the related covered drugs, devices, biologicals, or medical supplies, as applicable National Drug Codes (NDCs) of related covered drugs and biologicals, if any Name of the entity that received the payment or other transfer of value, if not provided to the covered recipient directly Statement providing additional context for the payment or other transfer of value (optional) 2014 National Council of University Research Administrators

Appendix B Public Postings of Ownership & Investment Data Applicable manufacturer’s or GPO’s name Physician’s Name Specialty Primary business address Whether the interest is held by the physician or an immediate family member of the physician Dollar amount invested Value and terms of each ownership or investment interest Amount of payment or other transfer of value in U.S. dollars Date of payment or other transfer of value Form of payment or other transfer of value Nature of payment or other transfer of value Name(s) of the related covered drugs, devices, biologicals, or medical supplies, as applicable. National Drug Codes (NDCs) of related covered drugs and biologicals, if any* Name of the entity that received the payment or other transfer of value, if not provided to the physician directly Statement providing additional context for the payment or other transfer of value (optional) 2014 National Council of University Research Administrators

Appendix C—Public Postings of Research Data Name of research institution/entity receiving payment Total amount of research payment Name of study Name(s) of the related covered drugs, devices, biologicals or medical supplies NDCs of related covered drugs and biologicals, if any* Principal investigator(s): – Name – Specialty – Primary business address Context of research ClinicalTrials.gov identifier (optional) 2014 National Council of University Research Administrators

Appendix D—Categories of Payments, Ownership, and Investments Reportable to CMS Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program Compensation for serving as faculty or as a speaker for a continuing education program Honoraria Consulting fee Royalty or license Current or prospective ownership or investment interest Grant Gift Entertainment Food and beverage Travel and lodging Education Charitable contribution 2014 National Council of University Research Administrators