• We implemented the required modifications to DV and our processes

by the end of 2013 and have successfully generated the required

information for SA submissions

• Current technology was successfully leveraged in a practical and

efficient way to support SA reporting while minimizing the need for

additional resources

Results

Conclusion

• Our goal was to leverage Datavision (DV), the company’s current publication tracking system, to facilitate reporting of the TOV associated with publication related editorial support under the SA

Objective

.

Table: Datavision Requirements & Data InputInformation required to enable SA reporting

DV Tab where information is located

User Management• Utilize form to capture

required author information

• This form is used to create, update, and revoke external user accounts (e.g., authors)

• This form uses logic to require certain data elements based on country of residence and credentials

Research Design and Methods

Leveraging existing technology for reporting of editorial support under the Sunshine Act

Courtney Leoa and Lorna Fayb

aPfizer Inc, Collegeville, PA, USA bPfizer Inc, NY, USA

#18

Data Validation & QC

Run report

QC Raw Datareport

Transfer data toTransparency

Team

Run report

QC Final report

• The raw data report captures all publications submitted or presented within the last 2-month review period and includes information on authors and editorial support. The following are sample criteria used to identify in-scope data:

– What type of LOS was provided to the authors? º Exclude projects where authors declined editorial support – Do we have all required data on the external authors? º If not, request updates to author profile – Exclude Company authors – Exclude authors employed at Co-Promote and authoring publication

supporting co-promote drug – Exclude authors not identified as covered recipients

• The final report is generated with the same parameters as the raw data report

– Filter criteria is the same• TOV assigned

Update Datavision based

on QC findings

Covered Recipient (author) Details• Name & Role • Document Tab Author must have an account and assigned as a Document

Resource for all publications that will receive editorial support

• Affiliation & Address • User Administration

• Credential• Licensure, such as, NPI

number, State and State License number

• Software enhancements were required to create a new Tab to accommodate a number of additional fields for the NPI number, State and State License number

Data is provided by person or captured from IMS Health

• Contacts Tab Information is visible to publications team

Background• Effective August 1, 2013, the Sunshine Act (SA), part of the

Affordable Care Act (ACA), requires U.S. manufacturers of drugs, devices, biologicals, or medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Programs (CHIP) to report annually to the Centers for Medicare and Medicaid Services (CMS) information about certain payments and transfers of value (TOV) to a covered recipient1

• Since 2009, Pfizer has disclosed payments to U.S. licensed healthcare prescribers on www.Pfizer.com

With the complexity of identifying in-scope projects and covered recipients we decided to assess whether the publication tracking system could be utilized based on the following:

– Efficiency due to the volume and various types of data – Flexibility to expand data collection (e.g., role, location,

and licensure) – Most of the required information was in the system

1 Official website CMS.gov / Regulations & Guidance / Open Payments http://cms.gov/OpenPayments/Program-Participants/Applicable-Manufacturers-and-GPOs/Data-Collection.html & User Guide http://cms.gov/OpenPayments/Downloads/Open-Payments-User-Guide.pdf

A TOV is a transfer of anything having discernible economic

value on the open market. CMS considers editorial support to be

a TOV.

Physicians who are employees of the applicable manufacturer that is reporting the payment

are not covered recipients.

Covered recipients are defined as Physicians (MD, DO, DDS, DPM,

OD, DCP) licensed in the U.S. and Teaching Hospitals identified on a list

issued annually by CMS.

PUBLICATIONSM A N A G E M E N T T E A M

DISCLAIMER: THE NUMBERS AND INFORMATION BELOW ARE NOT REAL WORLD DATA. THEY ARE MERELY DEMONSTRATIVE EXAMPLES.

• An assessment of DV capabilities and the information required for SA reporting was undertaken to identify modifications that were required to DV and the process (table below)

Publication Details• Product • Profile Tab

• Publication journal/congress

• Document Tab

• Publication submission/ presentation date

• Document Tab

• Document Type & Title • Document Tab

Editorial Support• Did the publication

receive editorial support?

• Document Tab (requires DV Financial Module)

Example of category to identify if editorial support was provided to authors

Information required to enable SA reporting

DV Tab where information is located

Transfer of Value Details• Level of Support

(LOS) (e.g., support for abstract vs. manuscript)

• A source system unique ID is assigned to all LOS that include editorial support

Example of Source System Unique ID for New Data Poster support

• TOV associated with LOS

• Excel is used for mapping the TOV code to the dollar value to be reported

TOV data table maps to the reports outside DVExpense Code Category Description Expense Code Description TOV

TOV-AB Category 1: Abstracts New Data Abstract $

TOV-PS Category 2: New Data Orals & Posters New Data Poster $

TOV-RA-EC Category 6: Edit from Copy Manuscripts Edit from Copy Review Manuscript $

Publications without editorial support (#600)

This step was performed to identify publications with editorial support

These steps include data gathering to identify covered recipients and TOV

Financial Information of Level of ServiceAbstract (#150)Manuscript (#120)Poster/slides (#130)

Transfer of Value per AbstractManuscriptPoster/slides

Covered Recipient InformationAuthor details: Name, credentials, NPI #, etc., (#2800)*

Author = Covered Recipient (#1600)

Author = Not Covered Recipient (#1200)

* For example purposes Pfizer used 7 authors per publication

2014 Publications: congress and journal deliverables (#1000)

Information generated for SA reporting (Excel) Covered Recipient Details (#1600) and TOV

Publications with editorial support (#400)

Overview of Process