Open Payments ActAKA 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 ResearchOhio State University

Leeanne B. Walker, JDDirector, Compliance & Research Integrity

University of North Carolina School of Medicine

June Anne InscoOutside Interests and COI Manager

Office of Regulatory AffairsUniversity of Michigan Medical School

National Council of University Research Administrators

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The ‘Sunshine Act’ is a New Regulation that Makes Public Physician-Industry Financial Relationships.

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“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 Grassley

@ 2014 National Council of University Research Administrators

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The Goal is to Shed Light on the Relationships Between Industry, Research, and Individual Medical Practices.

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 PATIENTS

@ 2014 National Council of University Research Administrators

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Manufacturers & Group Purchasing Organizations Must Report Financial Information to CMS.

REPORT ABOUT DOCS TO

@ 2014 National Council of University Research Administrators

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Companies Must Report Data about Licensed MDs*, DOs, Podiatrists, Optometrists, Chiropractors, Dental

Surgeons, Dentists, and Teaching Hospitals.

NOT*Residents

Medical StudentsNurses

Physician AssistantsOther Healthcare Providers

@ 2014 National Council of University Research Administrators

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Charitable contributionsCompensation (e.g., Speaking)

Consulting FeesEntertainment, Food, Gifts

GrantsHonoraria

Ownership/Investments (includes interests of family members)

EducationResearch 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 >$100.

@ 2014 National Council of University Research Administrators

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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

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Companies can request a delay in publication of research information to protect R&D.

• 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.

@ 2014 National Council of University Research Administrators

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

Programs?

What are the biggest concerns of the faculty physicians?

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What can physicians do to prepare?

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What educational information is being provided for faculty?

For patients?

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Does your institution intend to assist its faculty with disputes?

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Does your institution plan to use the data available on the CMS

website? If so, how?

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Appendix APublic 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

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Appendix BPublic 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

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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

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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