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

IMPLICATIONS, APPLICATIONS & APPROACHES TO COMPLYING WITH

THE SUNSHINE ACT

Ross E. DworkinVice President, Blue Grotto Technologies, Inc.

March 21, 2014

© 2014 Blue Grotto Technologies, Inc

AGENDA

Disclaimer

Purpose of talk

Basics

Common interpretations

General guidelines

Technologies

Typical effort

Resources & reference material


DISCLAIMER

Ross E. DworkinPrincipal at Blue Grotto Technologies.

Among other services, we provide technology to collect necessaryinformation, 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


PURPOSE OF TALK

BE AWARE- Added Data Collection -

- Additional Effort --Budgets

-Technology-Terms

-Effect on Symposia


BASICS

Items of Value Physicians Attending? Reportable Incident ?

Joe Public, Press, Pharma Centers for Medicare& Medicaid Services

Grantors AggregateSpend SystemWOW! My doc got $1,000 from Pfizer, he

must be a GENIUS!

September 31, 2014 March 31, 2014

state license #,Practice location,

specialty, NPICategory, amount


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)


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, noreporting, less then X reporting – sometimesonly large buffets

Just follow the rules…If you can trackthe meal to the physician, report it…

All Meals – Full Reporting


General GuidelinesIn 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 feeCombine 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


TECHNOLOGIES USED

Aggregate SpendSystems

(Grantor)

Event ManagementSystems

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.


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


Resources• CME Coalition – 26 page write-up http://cmecoalition.org/SunshineActGuidelines.pdf• D. Warnick Consulting, list of policies and requirements from various pharmaceutical

manufactureshttp://www.thecmeguy.com/sunshine/

• Physician Payment Sunshine Act Summary by Thomas Sullivanhttps://www.southfloridarec.org/publications/pdfs/Physician_Payment_Sunshine_Act_Top_50_Elements.pdf

• 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