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Implications, Applications and Approaches to Complying with the Sunshine (Dworkin)


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Implications, Applications and Approaches to Complying with the Sunshine (Dworkin)

  1. 1. IMPLICATIONS, APPLICATIONS & APPROACHES TO COMPLYING WITH THE SUNSHINE ACT Ross E. Dworkin Vice President, Blue Grotto Technologies, Inc. March 21, 2014
  2. 2. © 2014 Blue Grotto Technologies, Inc AGENDA  Disclaimer  Purpose of talk  Basics  Common interpretations  General guidelines  Technologies  Typical effort  Resources & reference material
  3. 3. © 2014 Blue Grotto Technologies, Inc DISCLAIMER Ross E. Dworkin Principal at Blue Grotto Technologies. Among other services, we provide technology to collect necessary information, at events, to comply with the Sunshine Act, manage meetings and administer CME content online NOTE: all information presented will be limited to CME/CE
  4. 4. © 2014 Blue Grotto Technologies, Inc PURPOSE OF TALK BE AWARE - Added Data Collection - - Additional Effort - -Budgets -Technology -Terms -Effect on Symposia
  5. 5. © 2014 Blue Grotto Technologies, Inc BASICS Items of Value Physicians Attending ? Reportable Incident ? Joe Public, Press, Pharma Centers for Medicare & Medicaid Services Grantors Aggregate Spend SystemWOW! My doc got $1,000 from Pfizer, he must be a GENIUS! September 31, 2014 March 31, 2014 state license #, Practice location, specialty, NPI Category, amount
  6. 6. © 2014 Blue Grotto Technologies, Inc BASICS (cont.) ATTENDEES RULE* Meals Reportable, for meals where the cost is separate and identifiable (trackable) Travel Prohibited under SCS Educational Value Not reportable SPEAKERS RULE Meals Not Reportable Travel Not Reportable Speaking Fees Not reportable • Assumes accredited by: ACCME, AOA, AFP, AMA ADA CERP • No direct payment by grantor • Grantor has no influence on the selection of participants Education Material Must be directly related to CME/CE program – or – Benefit patient directly (i.e. teaching chart)
  7. 7. © 2014 Blue Grotto Technologies, Inc COMMON INTERPRETATIONS* *From website Abbvie, Aptails, Boston Scientific, Cubist, Ethicon, Exelisxis, Eisai, Janssen, Mylan, Olympus, many more Allergan, Covidien, Lilly, Merck, Covidien Genentech, Gilead, Hospira, Novartis Celgene No Meals / Always Safe Buffets greater then X number of people, no reporting, less then X reporting – sometimes only large buffets Just follow the rules…If you can track the meal to the physician, report it… All Meals – Full Reporting
  8. 8. © 2014 Blue Grotto Technologies, Inc General Guidelines In grant requests* General Speaker Compensation Physician-Attendees • Completely adhere to ACCME Standards for Commercial Support 3.4, 3.5 3.6, 3.9, 3.10, • Completely adhere to all ACCME guidelines • Avoid itemizing food and beverage, travel, and speaking fee Combine them in a pre-determined, fair market value total speaker Compensation budget. • Do not include or list specific speakers in grant request • Avoid itemizing food and beverage as “per plate”. • Avoid listing any specific attendees • Do not distribute any educational items with commercial support • Information, must be directly related to content, etc. (ACCME SCS standard 4) OR Directley related to patient care * Very general see specific grantor guidelines for details
  9. 9. © 2014 Blue Grotto Technologies, Inc TECHNOLOGIES USED Aggregate Spend Systems (Grantor) Event Management Systems On-site Registration, Sign-in, Fulfillment NPI Look-up Services • Accumulate information from meetings (and events) • Validate and verify data • Upload to the CMS • Systems that manage Invitations, logistics, reporting • Pre-registration and reporting • Can facilitate accumulate the assignment of NPI information • On-site registration, sign-in opportunity to confirm/lookup NPI info • Sign-in (w/ attestation) helpful for future dispute resolution • Opt out important • Several free Services to look up a physicians NPI number • On web, iPad app, from Government, BGT offers one.
  10. 10. © 2014 Blue Grotto Technologies, Inc TYPICAL EFFORT Prior to Meeting On-Site Post Meeting • Send invites • Pre-register people • Match registrants with NPI Record* • Registration • Sign-in (potential attestation) • Lookup and confirm NPI Information • NPI Matching • Compilation and uploading of Spreadsheet *NPI Record includes NPI number, State license number, specialty, practice location
  11. 11. © 2014 Blue Grotto Technologies, Inc Resources • CME Coalition – 26 page write-up • D. Warnick Consulting, list of policies and requirements from various pharmaceutical manufactures • Physician Payment Sunshine Act Summary by Thomas Sullivan • Policy and Medicine – Healthcare policy blog: (quick reference guide on site) • Lookup of NPI information – – (BGT – iPad app) • CMS FAQs - • CMS – Open Payments Transparency-Program/index.html • Sunshine act –Final regulations Transparency-Program/Downloads/Final-Rule.pdf