OPEN PAYMENTS

1. OPEN PAYMENTS

2. Overview • What is the Sunshine Act? “OPEN PAYMENTS creates greater transparency around the financial relationships of manufacturers, physicians, and teaching hospitals.” • Who reports and what’s reported? • What do we need to do to prepare?

3. “Sunshine” Rule • Why OPEN PAYMENTS? • Collaboration among physicians, teaching hospitals, and industry manufacturers can contribute to the design and delivery of life-saving drugs and devices. However, while some collaboration is beneficial, payments from manufacturers to physicians and teaching hospitals can also introduce conflicts of interests. • Encourage transparency of reporting financial ties; • Reveal the nature and extent of relationships; • Minimize risk of increased health care costs.

4. Important Dates • After many delays, Final Rule issued February 8, 2013 • Industry must begin complying with Rule on August 1, 2013 • First annual reports to HHS are due in March 2014 (for August 1 to December 31, 2013 data) • Database expected to launch September 2014

5. How it will work • Companies can begin reporting data on August 1, 2013. Beginning in 2014, they will be required to register on a CMS website, and will submit data using templates. • In 2014, physicians and teaching hospitals will be able to: • Register to access their data prior to public posting; • Initiate data disputes; and • Work with applicable manufacturers and applicable GPOs on dispute resolution. Gary D. Wimsett, Jr., J.D. Director, Conflict of Interest Program

6. Who reports? • “Applicable Manufacturers” • Companies that have a physical presence in the US or conduct activity here and manufacture a covered product: • Drugs and biologicals • Devices that require approval • Medical supplies • Physicians and Teaching Hospitals have NO reporting obligations

7. Penalties • CMS or OIG may impose a penalty of $10,000 for each failure to report a payment. Annual cap of $150,000. • Each knowing failure to report a payment may result in a fine of up to $100,000 with a $1M annual cap. • Incentive to “over report” Gary D. Wimsett, Jr., J.D. Director, Conflict of Interest Program

8. What gets reported • All payments or other transfers of value from an applicable manufacturer to a physician or teaching hospital • Data is collected on a calendar year cycle and reported once annually

9. Who’s In? Who’s Out? • Includes: • Physicians as defined in Social Security Act • Must be legally authorized to practice • Identified by NPI and state professional license number • Excludes: • Residents (but not fellows) • Allied health professionals • Non-physician prescribers

10. Research Payments • “Teaching Hospital” defined: CMS has published a list of teaching hospitals deemed to be covered recipients but the Rule defines Teaching Hospitals as: “Entities that received indirect medical education (IME) or direct graduate medical education (GME) payment.” • Separate section of database; but will be associated with name of PI.

11. What gets reported • Name of “covered recipient” • Business Address • Indentifiers (for Physicians) • Physician specialty • Amount • Date • Form • Nature of payment • Related covered drug, device or medical supply (if related) • More … (eligibility for delayed publication, payments to third parties, payments to physician owners/investors, contextual information)

12. Reporting Categories • Consulting fees • Compensation for services other than consulting • Honoraria • Gifts • Entertainment • Food and Beverage • Travel and Lodging • Education • Research • Charitable Contributions • Royalty or License payments • Current or prospective ownership interests • Speaker fees for unaccredited non-certified continuing education program • Speaker fees for accredited or certified continuing education program • Grants • Space Rental or Facility Fees

13. Data disputes • If physicians and teaching hospitals dispute the accuracy of the data submitted to CMS, they will have 45 days to review the data and work with the manufacturer to resolve. • If no resolution, company data will be used but database will note amount is in dispute.

14. A Few Key Issues • “Indirect payments”: payment by a company to a physician here company makes payment to a third party and requires, instructs, directs, or otherwise causes the third party to provide the payment to a physician. • “NEW! CMS has released two mobile applications (apps) to assist physicians and manufacturers with tracking and reviewing data for the OPEN PAYMENTS program. The apps are intended to help reporting entities and physicians track payment information more accurately by making tracking easier throughout the year.  Use of the apps is optional and completely voluntary, and both are available for download now for iOS (Apple™) and Android™ mobile phones. ” Gary D. Wimsett, Jr., J.D. Director, Conflict of Interest Program

15. The Food Rule • “When allocating the cost of food and beverage among covered recipients in a group setting where the cost … is not separately identifiable, such as a platter provided to physicians in a group setting, applicable manufacturers must calculate the value per person by dividing the entire cost of the food or beverage by the total number of individuals who partook in the meal …” Gary D. Wimsett, Jr., J.D. Director, Conflict of Interest Program

16. CME • Are payments provided to physicians for speaking at a continuing medical education event reportable? • Speaker compensation at continuing education event is not required to be reported if all of the following criteria are met: • (1) the CME program meets the accreditation or certification requirements and standards of the Accreditation Council for Continuing Medical Education • (2) the company does not select or suggest the speaker nor does it provide the third party vendor with distinct, identifiable individuals to be considered as speakers for the accredited or certified continuing education programs; AND • (3) the applicable manufacturer does not directly pay the covered recipient speaker. Gary D. Wimsett, Jr., J.D. Director, Conflict of Interest Program

17. How will you know? • Will CMS notify physicians and teaching hospitals that applicable manufactures or applicable GPO’s reported data about them? • Physicians, teaching hospitals, and physician owners or investors will receive a general notification when the reported information is ready for review. However, the physician, teaching hospital, and physician owners or physician investors will only receive this notification if they have previously registered with CMS Gary D. Wimsett, Jr., J.D. Director, Conflict of Interest Program

18. NEJM • Perspective, The Sunshine Act — Effects on Physicians • ShantanuAgrawal, M.D., Niall Brennan, M.P.P., and Peter Budetti, M.D., J.D. • N Engl J Med 2013; 368:2054-2057 May 30, 2013 DOI: 10.1056/NEJMp1303523 Gary D. Wimsett, Jr., J.D. Director, Conflict of Interest Program

19. Proposed Action Plan • Physicians should become familiar with information being reported. • Keep records on all payments. • Register with CMS to receive updates on the transparency program • Consider contractual strategies (re: outside consulting agreements) for keeping burden on Industry.

20. COI Program Contact • Contact Information: • Gary Wimsett, Jr., JD • gwimsett@ufl.edu • (352) 273-7508 • www.coi.med.ufl.edu