More Related Content Similar to Implications, Applications and Approaches to Complying with the Sunshine (Dworkin) Similar to Implications, Applications and Approaches to Complying with the Sunshine (Dworkin) (20) More from D. Warnick Consulting More from D. Warnick Consulting (10) Implications, Applications and Approaches to Complying with the Sunshine (Dworkin)1. IMPLICATIONS, APPLICATIONS & APPROACHES TO COMPLYING WITH
THE SUNSHINE ACT
Ross E. Dworkin
Vice President, Blue Grotto Technologies, Inc.
March 21, 2014
2. © 2014 Blue Grotto Technologies, Inc
AGENDA
Disclaimer
Purpose of talk
Basics
Common interpretations
General guidelines
Technologies
Typical effort
Resources & reference material
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. © 2014 Blue Grotto Technologies, Inc
PURPOSE OF TALK
BE AWARE
- Added Data Collection -
- Additional Effort -
-Budgets
-Technology
-Terms
-Effect on Symposia
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. © 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. © 2014 Blue Grotto Technologies, Inc
COMMON INTERPRETATIONS*
*From theCMEguy.com 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. © 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. © 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. © 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. © 2014 Blue Grotto Technologies, Inc
Resources
• CME Coalition – 26 page write-up http://cmecoalition.org/SunshineActGuidelines.pdf
• D. Warnick Consulting, list of policies and requirements from various pharmaceutical
manufactures
http://www.thecmeguy.com/sunshine/
• Physician Payment Sunshine Act Summary by Thomas Sullivan
https://www.southfloridarec.org/publications/pdfs/Physician_Payment_Sunshine_Act_To
• Policy and Medicine – Healthcare policy blog: http://www.policymed.com/ (quick
reference guide on site)
• Lookup of NPI information
– https://npiregistry.cms.hhs.gov/NPPESRegistry/NPIRegistryHome.do http://npi.ecare.com/
– www.NPILookup.com (BGT – iPad app) http://www.npinumberlookup.org/
• CMS FAQs - https://questions.cms.gov/
• CMS – Open Payments http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-
Transparency-Program/index.html
• Sunshine act –Final regulations http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-Payment-
Transparency-Program/Downloads/Final-Rule.pdf