1. O PEN P AYMENTS An Explanation of Section 6002 of the Affordable Care Act Center for Program Integrity September, 2013 CMS Disclaimer: This information is a summary of the final rule implementing the O PEN P AYMENTS Program (Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests [CMS-5060-F], codified at 42 CFR Parts 402 and 403) The summary is not intended to take the place of the final rule which is the official source for information on the program.

2. 2 Agenda Introduction O PEN P AYMENTS Overview Tools & Resources

3. 3 Industry-Physician Relationships Collaborations between physicians and the medical industry can be beneficial by promoting discovery and development of new technologies that improve health and/or lower costs. Financial relationships may also influence professional judgment and conflicts of interest can potentially arise. Conflicts of Interest Discovery and Development

4. 4 Public Policy O PEN P AYMENTS (or the “Sunshine Act”) implements Section 6002 of the Affordable Care Act, which was finalized in February 2013. –Final Rule: Medicare, Medicaid, Children’s Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests

5. 5 Objectives O PEN P AYMENTS is a national transparency program requiring certain manufacturers and group purchasing organizations to disclose their financial relationships with physicians and teaching hospitals Objectives Make certain financial relationships transparent on a national scale Give consumers the information needed to ask questions and make more informed decisions about their healthcare professionals CMS’ Role Remain neutral and present the data on a public website Ensure reporting and disclosure are complete, accurate, and clear

6. 6 Some Key Players Entities that operate in the US and that either produce or prepare at least covered one drug, device, biological, or medical supply covered by Medicare/Medicaid/CHIP or operate under common ownership (5% ownership interest) and provides assistance and support to applicable manufacturers. Applicable Manufactures Entities that operate in the US and that purchase, arrange for, or negotiate the purchase of covered drugs, devices, biologicals, or medical supplies Applicable Group Purchasing Organizations Doctors of Medicine/Osteopathy, Dental Surgery/Dental Medicine, Podiatric Medicine, Optometry, and Licensed Chiropractors Legally authorized by the State to practice Physicians Hospitals that CMS has recorded as receiving a payment(s) under Medicare direct graduate medical education (GME), indirect medical education (IME) or psychiatric hospitals IME programs. Teaching Hospitals Covered Recipients Industry

7. 7 O PEN P AYMENTS at a High Level Applicable manufacturers of covered products AND entities under common ownership with applicable manufacturers who provide assistance and support are required to: report annually to CMS report payments or other transfers of value made to covered recipients and physician owners/investors report certain ownership or investment interests held by physicians or their immediate family members Applicable group purchasing organizations are required to: report annually to CMS report certain ownership or investment interests held by physician owners or investors and their immediate family members report payments or other transfers of value to physician owners or investors

8. 8 Three Types of Reporting Categories Captures payments or other transfers of value not made in connection with a research agreement General Payments Captures payments or other transfers of value made in connection with a research agreement Research Payments Captures ownership or investment interests Ownership & Investment Interest

9. 9 Types of Payments This program captures payments or other transfers of value: –Paid directly to physicians and teaching hospitals (known as Direct Payments) –Paid indirectly to physicians and teaching hospitals (known as Indirect Payments) It also collects information on payments designated by physicians or teaching hospitals to be paid to another party (known as Third Party Payments)

10. 10 Continuing Medical Education Compensation for speaking at a continuing education program is not required to be reported, if all of the following conditions are met: 1.The program meets the accreditation or certification requirements and standards of the ACCME, AOA, AMA, AAFP or ADA CERP. 2.The manufacturer does not directly pay the physician speaker. 3.The manufacturer does not select the physician speaker nor does it provide the third party vendor with a distinct, identifiable set of individuals to be considered as speakers for the accredited or certified continuing education program.

11. 11 Continuing Medical Education Indirect payments associated with CME activities: Physician- Attendees Physician- Faculty/ Speakers Physician- Attendees Physician- Faculty/ Speakers Accredited or certified *Non-accredited or non-certified Meals ** Travel and Lodging Tuition Fees Educational Materials included in CME Tuition Fees Educational Materials not included in CME Tuition Fees * Must meet all of the conditions in accordance with § 403.904(g)(1) ** Special rules apply in accordance with § 403.904(h)

12. 12 Program Operations Center for Program Integrity Submission & Attestation 22 Review & Dispute 33 Dispute Resolution 44 Industry Applicable Manufactures & GPO’s Covered Recipients Physicians & Teaching Hospitals Registration 11 cms.gov Audit 66 Publication 55

13. 13 2013 Program Cycle 1Q 20142Q 2014 August – December 2013 Industry will: Collect information on payments and other transfers of value, as well as ownership or investment interests held by physicians and their family members Industry will: Register and submit 2013 information to CMS Physicians should: Keep track of payments and transfers of value made to you and be mindful of ownership and investment interests held by both you and your immediate family Physicians should: Register with CMS in order to receive notifications and information submitted by the industry Industry will: Correct disputed information Physicians should: Review your information for accuracy Sep 2014 CMS Public Website: 2013 Information Posted

14. 14 Stakeholder Outreach CMS’ goals include: –Creating awareness –Providing useful and easy to understand information –Providing tools that will support stakeholders

15. 15 Awareness We are creating awareness about the O PEN P AYMENTS among stakeholders by:  Hosting National Provider Calls  Keeping national professional associations abreast of program developments  Leveraging national publications, Medicare Learning Network and existing CMS contractors  Distributing information using email

16. 16 Information & Tools CMS has released various information sources and supporting tools about O PEN P AYMENTS including: Webpage dedicated to stakeholders Fact Sheets specific to stakeholders Operational tools for Industry: Guidance documents, submission specifications, teaching hospital list Continuing Medical Education modules (2) for physicians Brochure describing O PEN P AYMENTS Brochure for patients describing O PEN P AYMENTS Publications in national professional magazines Help Desk Mobile Application for Industry and Physicians

17. 17 Mobile Applications Two FREE mobile applications to aid physicians and industry in tracking data collected for O PEN P AYMENTS. –O PEN P AYMENTS Mobile for Physicians –O PEN P AYMENTS Mobile for Industry The applications are available on mobile platforms Apple (iOS) and Android. They can be used as a personal information collection and storage tool only.

18. 18 Benefits of Using the App Provides a tool to track payments and other transfers of value in real-time Serves as a reference tool during review or information disputes Allows physician to provide accurate profile information to industry Minimizes the risk of data mismatches later when submitted by industry Allows physicians to receive event and payment or transfer of value, and profile information from industry

19. 19 Exchanging Information is Easy Physician AppIndustry App Send Profile Information Send TOV Information

20. 20 Track & Review Your Information Physicians should track all interactions they have with industry involving payments or transfers of value to ensure accuracy Register to receive a preview of the data to be made public Tools and resources are available to help

21. 21 Questions For more information contact the Help Desk at openpayments@cms.hhs.gov or visit us at http://go.cms.gov/openpaymentsopenpayments@cms.hhs.govhttp://go.cms.gov/openpayments THANK YOU