Physician Payment Sunshine Act: Lessons Learned in Preparation and Implementation: Summary, Video Archive, FAQ’s and Slides
Policy and Medicine and Pharma Leaders recently held a webinar titled: "Physician Payment Sunshine Act: Lessons Learned in Preparation and Implementation." Lead by Thomas Sullivan, President of Rockpointe and Marc Eigner, Partner of Polaris Management Partners, the webinar discussed the implementation and training that organizations need to remain compliant with the Physician Payment Sunshine Act.
We have included access to important materials from this session:
Some key points from the 45-minute presentation include:
In general
- The Sunshine Act requires applicable manufacturers (AM) of "covered" drugs, devices, biologics, or medical supplies to report annually to the Secretary of HHS certain payments or other transfers of value to covered recipients (CR)–physicians and teaching hospitals.
- The Sunshine Act does not "ban" any payments but simply requires reporting of payments and transfers of value
Who reports?
- Applicable manufacturers of covered drugs, devices, biologicals, and medical supplies
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Applicable Group Purchasing Organizations (GPOs)
- Report only physician ownership, investment interests
- Definition includes physician owned distributors (PODs) that purchase products for resale
- Report only physician ownership, investment interests
- If you bill Medicare, Medicaid and SCHIP
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Excludes OTC Only Makers
Covered recipients
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Physician/and or group practice
- MD's, DO's, Dentists, Dental Surgeons, Podiatrists, Optometrists, or Chiropractors
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All physicians that have a current license
- Regardless of whether enrolled with CMS
- Regardless of whether treating patients
- Regardless of whether enrolled with CMS
- MD's, DO's, Dentists, Dental Surgeons, Podiatrists, Optometrists, or Chiropractors
- Does not include payments to residents
- Payments to non-CRs meant to pass through to physician à must report as indirect payment
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Excludes payments to non-U.S. physicians
- Includes foreign transactions with U.S. physicians
- Includes foreign transactions with U.S. physicians
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Teaching hospital
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Any Institution receiving payments under:
- Indirect medical education (IME) (1886(d)(5)(B) SSA)
- Direct Graduate Medical Education (GME) (1886)(h))
- Psychiatric hospital IME (1886(s))
- Indirect medical education (IME) (1886(d)(5)(B) SSA)
- CMS has published a list of 1,000 hospitals
- Does not include payments to non-healthcare departments at universities affiliated with hospital
- Must report indirect payments as required
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Does not include nurses, NPs, PAs, Pharmacists, Nurses, other allied health professionals
- Must comply with State laws (e.g., MA, DC, VT)
- Must comply with State laws (e.g., MA, DC, VT)
- Not legal agents of AM w/ MD on staff
- Does not include payments to physician who is a "bona fide" employee of the AM
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CMS will use case-specific analysis to determine
- If (1) board members, (2) medical directors, (3) retirees, and (4) prospective employees are CRs
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Employees who are physician investor/owners
- If (1) board members, (2) medical directors, (3) retirees, and (4) prospective employees are CRs
What information must be reported?
- Covered recipient name and business address
- NPI, Number and Specialty
- State professional license #(s) at least one State
- The amount and date of payment
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Form of Payment
- Cash or cash equivalent
- In-kind items or services
- Stock, stock option, ownership interest,
- Dividend, profit or other return on investment
- Cash or cash equivalent
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Nature of such payment (16 categories)
- If payment or transfer relates to marketing, education, or research of a drug, device, biological, or medical supply, the related product must also be identified
- If payment or transfer relates to marketing, education, or research of a drug, device, biological, or medical supply, the related product must also be identified
- Product Market Name and NDC Code
- Context: 200 characters
Natures of Payment Categories
- Travel & lodging (destination)
- Consulting fee
- Current or prospective ownership or investment interest
- Research
- Gift
- Entertainment
- Food & Beverage
- Royalty or license
- Natures of Payment Categories (Education)
- Education
- Honoraria
- Compensation for services other than consulting, e.g. speaking at non-CE event
- Compensation for serving as faculty or speaker at accredited/certified CE event
- Compensation for serving as faculty or speaker at unaccredited/non-certified CE
Related Posts
Research Payments
- All payments made in connection with an activity that meets the definition of research, and that are subject to a written agreement, contract, or research protocol, or both, are reported under "special rules."
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Certain research payments made to a CR by an AM under a product research or development agreement may be delayed from publication on the Web site.
What is an Indirect Payment?
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Direct Payment
- Manufacturer pays physician or hospital directly
- Manufacturer pays physician or hospital directly
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Indirect Payment
- Manufacturer pays a 3rd party directly, the 3rd party then pays a physician or Hospital
- Manufacturer pays a 3rd party directly, the 3rd party then pays a physician or Hospital
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Payments on Behalf of or At the Request of
- Payments "at the request of" or "designated on behalf of" a covered recipient refers to a situation in which an entity or individual receives and keeps the payment that was made on behalf of (or at the request of) the covered recipient and the covered recipient does not receive the payment or other transfer of value.
- Rather, the covered recipient directs the payment or other transfer of value and does not receive the payment personally.
- Payments "at the request of" or "designated on behalf of" a covered recipient refers to a situation in which an entity or individual receives and keeps the payment that was made on behalf of (or at the request of) the covered recipient and the covered recipient does not receive the payment or other transfer of value.
- Such payments are different than indirect
Exemption Criteria for CME Programs
- The CME program is accredited by the ACCME, AOA, AAFP, AMA, ADA CERP; AND
- The manufacturer does not make a payment or transfer of value directly to speakers/faculty or attendees/ participants that are deemed covered recipients; AND
- The manufacturer does not select or influence the selection of speakers/faculty or attendees/participants.
Lessons Learned from Planning and Implementing Sunshine: Where to Start? Aggregate Spend Implementation Steps
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Process & Project Management
- Spend Discovery and Gap Assessment
- Strategic Aggregate Spend Solution Roadmap
- Policy, Procedure and Process Map Development
- Organizational Structure Advisory Services
- Spend Discovery and Gap Assessment
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Legal
- Legal Perspective Assessment
- State Law Data Repository
- Legal Updates
- Legal Perspective Assessment
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Technology
- Spend Capture Systems
- Semi-Automated Aggregate Spend Solution
- End – to – End Aggregate Spend Solution
- Implementation Management
- Requirements Gathering
- Business Rule Configuration
- Integration with MDM and Reporting Tools
- Spend Capture Systems
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Operations
- Monitor collected information to ensure timeliness and accuracy across vendor and
- home office users
- Validate line item expense and profile details for each reporting state
- Work with spend capture submitters to follow up and review potential items of issue
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Run and monitor spend cap reports and thresholds
- Monitor collected information to ensure timeliness and accuracy across vendor and
Detailed Steps of an Assessment
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Phase 1: Plan
- Conduct kickoff meeting with key stakeholders
- Meet with Core Team to finalize scope and gain baseline understanding of the existing process
- Request necessary documentation, such as Policies, Procedures, SOPs, etc
- Schedule interviews
- Develop assessment tools
- Conduct kickoff meeting with key stakeholders
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Phase 2: Assess and Benchmark
- Review policies and SOPs
- Conduct interviews to gain understanding of applicable processes, technology and all possible spend items
- Identify all spend item sources for capture and develop Spend Matrix
- Compare currently captured spend at Client to industry practices and state law requirements
- Identify gaps in reporting for state laws, aggregate spend capture, process efficiencies and system technologies
- Review policies and SOPs
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Phase 3: Recommend and Develop Roadmap
- Develop recommended action steps to address gaps
- Develop prioritized roadmap for implementation of action steps
- Develop project plan and timeline for implementing short term action steps
- Develop recommended action steps to address gaps
Considerations For Effective Audit Planning and Scoping
- Understand all of the business processes requiring spend capture.
- Obtain a general awareness of current state, federal and international laws and regulations.
- Understand existing policies and procedures across functional areas.
- Understand the stakeholders across functional areas Commercial, R&D, Medical Affairs where interactions with HCPs are taking place
- Understand technology applications used to enable spend capture and aggregate reporting.
- Understand the organizational structure supporting accurate spend capture and effective reporting.
Considerations For Conducting An Effective Organizational Review
- Inventory the departments interacting with HCPs across the enterprise including Sales, Marketing, R&D and Medical Affairs.
- Understand how HCP/O transactions are being captured and classified?
- Understand the key stakeholders, process owners and control owners within each functional area, including those responsible for overseeing spend capture.
- Understand the roles and responsibilities for persons responsible for enterprise consolidation of spend capture and preparation of statutory reports.
Required Considerations For Effectively Assessing Process and Internal Control Design
- Automation – Evaluate the level of automation within the spend capture processes. Have controls been established to ensure complete capture of Spend Data?
- Data Completeness – Are all reportable details for each interaction captured in the source system?
- Reporting Integration – To what extent has the spend capture processes and technology been integrated with statutory reporting systems or templates?
- Data Integrity – How is data integrity assured when spend data is extracted from source systems or repositories and consolidated?
- Reporting Requirements – Are the applicable reporting requirements defined in a controlled standard report or data consolidation template? To what extent do reports need to be manually generated for the various authorities?
Open Payment Resources
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Centers for Medicare and Medicaid Services
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Policy and Medicine
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American Medical Association
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Partners for Healthy Dialogs
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Advamed
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CME Coalition (Including Guide and Q&A)
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Medscape (CME Accredited Web courses)