Time to Validate Your Company s Open Payment Submission Data. July 22, 2014

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Clara Hawkins
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1 Time to Validate Your Company s Open Payment Submission Data July 22, 2014

2 Introduction Today s Speakers MARK LINVER I New York, NY Mark is a Managing Director in the Life Sciences Advisory Practice at Huron and has over 23 years experience in implementing appropriate solutions that solve real business needs. He is particularly experienced in employing IT Strategy, CRM, Business Intelligence, Knowledge Management, Artificial Intelligence and Data Management solutions in FDA regulated industries. JEFF FISHER I Denver, CO Jeff Fisher has 20 years of experience providing software solutions for the healthcare, finance and pharmaceutical and medical device industries. His focus within the last four years has been the implementation and validation of Aggregate Spend systems for 15 pharmaceutical and medical devices companies. Before joining Huron, Jeff worked for the NYS Office of Medicaid Inspector General, and designed and implemented auditing software and data analytics to facilitate Medicaid audits. 2

He is particularly experienced in employing IT Strategy, CRM, Business Intelligence, Knowledge Management, Artificial Intelligence and Data Management solutions in FDA regulated industries.

3 Introduction Today s Speakers MICHELLE SCHARFENBERG I Princeton, NJ Chief Compliance Officer for Integra LifeSciences. Michelle is responsible for implementing Integra s Compliance Program, including managing the Compliance Committee, writing policies, monitoring compliance, managing the employee hotline, investigating complaints, and working with Internal Audit to audit policies. She also ensures compliance with the AdvaMed Code of Ethics and aggregate spend laws. 3

writing policies, monitoring compliance, managing the employee hotline, investigating complaints, and working with

4 Today s Agenda Today, we hope to provide insights into the validation of your companies Open Payments submission. Specifically, the agenda is comprised of the following: WHY VALIDATE YOUR DATA COMMON ISSUES VALIDATION APPROACH CLOSING REMARKS: Additional Trends: Data Analytics OPERATIONALIZE FINDINGS INTEGRA CASE STUDY 4

Specifically, the agenda is comprised of the following: WHY VALIDATE YOUR DATA

5 Will Your Open Payments Submission Be Audited? To ensure data accuracy, CMS is required to conduct audits of the data submitted and levy civil monetary penalties against applicable manufacturers and applicable GPOs for failing to submit data or submitting inaccurate data. - CMS Website Works.html 5

penalties against applicable manufacturers and applicable GPOs for failing to submit data or submitting

6 Penalties Action Failure to timely, accurately, or completely report Knowing failure to timely, accurately, or completely report Potential Penalty $1k - $10k per transaction (<$150k) $10k - $100k per transaction (<$1M)* * $1M maximum cap can significantly increase for manufacturers with multiple subsidiaries 6

$10k per transaction (<$150k) $10k - $100k per transaction (<$1M)* * $1M

7 How May CMS Target Manufacturers? CMS will monitor the frequency of disputes reported by physicians, teaching hospitals, and physician owners or investors and the volume of disputes unresolved between physicians, teaching hospitals, and applicable manufacturers to inform the auditing process. - CMS Fact Sheet Manufacturer-fact-sheet.pdf 7

investors and the volume of disputes unresolved between physicians, teaching hospitals, and applicable manufacturers

8 What Additional Information Will They Collect During An Audit? CMS requires all applicable manufacturers and applicable GPOs to keep all records related to payments or other transfers of value for at least five years from the date that the payment or other transfers of value are posted. - CMS website Manufacturer-fact-sheet.pdf 8

transfers of value for at least five years from the date that the payment or other transfers of value are posted.

9 What Additional Information Will They Collect During An Audit? T&E Receipts Contracts Sign-In Sheets Full Data Extracts Assumption Documents 9

10 Additional Risks Inappropriate interactions with HCPs Appearance of kickbacks CIA investigations Damaged reputation Damaged relationships with HCPs/HCOs 10

11 It s Time To Validate Your Open Payments Data NOW! Second generation aggregate spend systems should be driven by failures in data accuracy. The first filing provides many manufacturers with their first opportunity to validate the success of their system. Until a data validation is Common Issues performed, the issues within a system are not known. Some issues may be severe, and take a long time to correct root causes. Source Systems Customer Master Open Payments Template 11

The first filing provides many manufacturers with their first opportunity to validate the success of their system.

12 Common Issues Source Systems Source systems often fail to extract reportable payments, and also capture data inaccurately. Three examples are: A physician classified as a business guest is not extracted to the repository. Under-reporting of attendees results in an inflated per person meal amount. Entire batches not loaded to the repository. 12

Three examples are: A physician classified as a business guest is not extracted to the

13 Common Issues Customer Master The accuracy of your Open Payment submission is only as good as your master data. Common problems include: Wrong covered recipient identified, such as a physician with the same name in another state. Key identifiers are missing such as NPI, State License Number, TIN or Specialty. Specialty does not match the NPPES taxonomy. 13

Common problems include: Wrong covered recipient identified, such as a physician with the

14 Common Issues Open Payment Template CMS has defined what values are required on their submission templates. Common missed information includes: Required fields missing data (eg. travel destination for travel related payments.) Research payments missing related information including Principal Investigators. Invalid NPI or SLN. 14

Common missed information includes: Required fields missing data (eg.

15 Operationalize Your Findings The problems you ve identified can be used to improve your system and lower the remediation effort going forward. This can be accomplished with the following 4-step approach: Validate Historical Data The objective of this step is to analyze the data captured in the source systems to validate that it is complete and correct. Identify Root Causes Determine why the identified issues are occurring and build approaches for addressing or correcting them. 15

This can be accomplished with the following 4-step approach: Validate Historical Data The objective of this step is to

16 Operationalize Your Findings Operationalize Improvements Improve validation up-front within the systems that capture data. This includes T&E, ERP, Research, and Third-Party. Implement data monitoring through various tools: Use in-house data warehouse and business intelligence tools to identify issues with pre-set queries. Leverage analytical and alert capabilities within your Aggregate Spend tool. Educate Employees Capitalize on this opportunity to educate the organization on the root causes of inaccurate payment information, potential consequences, and proper procedures for a sustainable process 16

Implement data monitoring through various tools: Use in-house data warehouse and business intelligence tools to identify issues with pre-set queries.

17 Sample Validation Checks The following are some validation checks that can be done to validate your data: Source Issue Check ERP System Vendors not flagged as reportable Missed payments Review vendor master with relationship owners Perform reconciliation of ERP output vs reporting tool output T&E System HCPs entered as business guest Under / Over reporting of attendees Trend analytics Search for business guest trans. with reportable titles (eg, M.D.) Search for in-office meals with questionable per-person costs Graph spend trends identify outliers 17

reporting tool output T&E System HCPs entered as business guest Under / Over reporting of attendees Trend analytics Search for business

19 Additional Trends: Data Analytics Data Analytics Data analytics around Open Payments data is becoming more sought after by various areas of the business to accomplish: Internal certification Validation and monitoring Operational insight Risk analysis 19

various areas of the business to accomplish: Internal

20 Data Analytics: What does it take? Data!! All data relevant to the analytics must be in one place, updated frequently, preferably through an automated integration. Companies may chose to house this internally, externally as outsourced analytics, or within your aggregate spend tool. A robust data architecture is required for more advanced analytics, which integrates non-open Payments data. Divisional and Functional Hierarchies Sales data and call activity Source System data Master data HCP contract and interactions 20

Companies may chose to house this internally, externally as outsourced analytics, or within your aggregate spend tool.

25 Thank You Contact Huron Consulting Group To Learn More About How to Implement Data Validation and Analytics Mark Linver: Jeff Fisher: Michelle Scharfenberg 25

Disclosure of Drug Promotion Expenses: The Importance of Master Data Management and Considerations for Choosing a Reporting Solution

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