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OPEN PAYMENTSAn Explanation of Section 6002 of the Affordable Care Act
Center for Program IntegritySeptember, 2013
CMS Disclaimer: This information is a summary of the final rule implementing the OPEN PAYMENTS 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.
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Agenda
• Introduction
• OPEN PAYMENTS Overview
• Tools & Resources
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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
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Public Policy
• OPEN PAYMENTS (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
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Objectives
OPEN PAYMENTS 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
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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 practicePhysicians
•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
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OPEN PAYMENTS 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
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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
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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)
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Continuing Medical EducationCompensation 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.
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Continuing Medical EducationIndirect 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)
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Program Operations
Center for Program Integrity
Submission & Attestation
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Review & Dispute
3
Dispute Resolution
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IndustryApplicable
Manufactures & GPO’s
Covered RecipientsPhysicians &
Teaching Hospitals
Registration1
cms.gov
Audit6
Publication5
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2013 Program Cycle
1Q 2014 2Q 2014August – 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
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Stakeholder Outreach
• CMS’ goals include:– Creating awareness – Providing useful and easy to understand information – Providing tools that will support stakeholders
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Awareness
• We are creating awareness about the OPEN PAYMENTS 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
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Information & ToolsCMS has released various information sources and supporting tools about OPEN PAYMENTS 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 OPEN PAYMENTS Brochure for patients describing OPEN PAYMENTS Publications in national professional magazines Help Desk Mobile Application for Industry and Physicians
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Mobile Applications
• Two FREE mobile applications to aid physicians and industry in tracking data collected for OPEN PAYMENTS.– OPEN PAYMENTS Mobile for Physicians– OPEN PAYMENTS 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.
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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
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Exchanging Information is Easy
Physician App Industry AppSend Profile Information
Send Profile Information
Send TOV Information
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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
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Questions
• For more information contact the Help Desk at [email protected] or visit us at http://go.cms.gov/openpayments
THANK YOU