PHYSICIAN PAYMENTS SUNSHINE ACT (OPEN PAYMENTS) Mary Evelyn Armstrong MA, CRA Conflict of Interest Officer

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1 PHYSICIAN PAYMENTS SUNSHINE ACT (OPEN PAYMENTS) Mary Evelyn Armstrong MA, CRA Conflict of Interest Officer

2 WHAT IS IT? Section 6002 of the Affordable Care Act requires the establishment of a transparency program, now known as Open Payments. The program increases public awareness of financial relationships between drug and device manufacturers and certain health care providers through annual reporting on a public website.

3 HOW DOES IT WORK? Manufacturers and Group Purchasing Organizations (GPO s) will report to CMS every year: 1. Payments and other transfers of value to physicians and teaching hospitals ( Covered Recipients ) 2. Ownerships or investments held by physicians or their immediate family in manufacturers and GPOs The reported data will be published June 30th each year on a public website and will include payments from the previous calendar year Review and dispute 45 days to review and dispute incorrect data Additional 15 days to resolve dispute If not resolved, will still be published and flagged as disputed

4 WHO DOES THIS APPLY TO? Covered Recipients Physicians who are legally authorized to practice: Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry, Chiropractic Medicine Does not include Residents Teaching Hospitals Receive payment under Medicare direct graduate medical education (GME), inpatient hospital prospective payment system (IPPS), indirect medical education (IME), or psychiatric hospital IME programs

5 WHAT IS REPORTED? All payments or other transfers of value Amount of payment Date of payment Nature of payment Form of payment Related products (drug, device, biological or medical supply) Physician information: Name, specialty, business address, NPI, State professional license number(s) Research payments will be reported separately from general payments and ownership/investment interests.

6 WHAT IS REPORTED? Ownership or investment interests held by physicians or their immediate family members Physician information: Name, specialty, business address, NPI, State professional license number(s) Dollar amount of the investment Value and terms of the ownership or investment interest

7 NATURE OF PAYMENT Consulting fees Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program Honoraria Gifts Entertainment Food and beverage Travel and lodging Education Research Charitable contributions Royalty or license Current or prospective ownership or investment interest Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program Grants Space rental or facility fees (teaching hospital only)

8 NATURE OF PAYMENT: FOOD & BEVERAGE Group settings Total cost divided by number of individuals who partook in the meal and reported for covered recipients only Meals eaten by support staff are not attributed to physicians Conferences and large events When the setting would make it difficult to establish the identities of covered recipients, not reportable (e.g., buffet meals at conferences)

9 NATURE OF PAYMENT: RESEARCH Information reported: Name of Institution receiving the payment Total amount of the research payment Aggregated amount of payment for everything included in the written agreement Payments made outside of agreement are reported separately in the appropriate nature of payment category (e.g., additional fees for study steering committee) Research payments will not be aggregated on database as personal payments to physicians Name of the study Name of the related covered product Principal Investigator(s) ClinicalTrials.gov identifier (optional)

10 NATURE OF PAYMENT: RESEARCH Research delays in publication: Manufacturers (or GPOs) may request a delay in publication Research on or development of new products/new product applications Clinical investigations regarding a new product (written research or development agreement is required) Publication is delayed until (whichever comes first): Date of FDA approval, licensure or clearance of the product 4 calendar years after the date of the payment or other transfer of value

11 FORM OF PAYMENT Cash or cash equivalent In-kind items or services Stock or stock options or any other ownership interest Dividend, profit or other return on investment

12 TYPES OF PAYMENT Direct payments - Payments or other transfers of value provided directly to physicians or teaching hospitals. Indirect payments Payments or other transfers of value made through an intermediary. Manufacturer (or GPO) requires, instructs, directs, or otherwise causes the third party to provide the payment to a physician or teaching hospital. Third party payments - Payments or other transfers of value provided to a third party at the request of or designated on behalf of a physician or teaching hospital.

13 WHAT IS NOT REPORTED? Indirect payments where the applicable manufacturer is unaware of recipient Payments under $10, unless over $100 in aggregate Samples Educational materials for patients Short term loans defined as 90 days (equipment, devices, supplies) Items or services under warranty Transfers of value to a physician who is a patient or research subject Discounts and rebates In-kind items for use in charity care Dividends from publicly traded securities or mutual funds

14 WHAT IS NOT REPORTED? Payments to provide healthcare for employees/families Non-medical professional services of a physician Legal services of a physician Personal, non-business related transfers of value

15 WHAT SHOULD YOU DO? Operate within University policies, including full disclosure of activities and adherence to allowable and prohibited activities. Relevant policies include: Industry Relations Policy Prohibits speakers bureaus; promotional/marketing activities; receipt of food and gifts MUSC/MUHA Conflict of Interest Policy MUSC Intellectual Property Policy (Section of the MUSC Faculty Handbook) Keep track of payments and transfers of value made to you. Mobile app is available - OPEN PAYMENTS Mobile for Physicians Be mindful of ownership and investment interests held by you and immediate family members.

16 WHAT SHOULD YOU DO? Ask companies to let you review reportable transfers before they report them. Verify your information in the NPI enumerator database is current and update as needed. Register with CMS in order to receive notifications and information. Review your information for accuracy.

17 RESOURCES ama-assn.org/go/sunshine COI Office: Mary Evelyn Armstrong