Every year, this survey highlights the major trends taking place among pharmaceutical, medical device and hybrid manufacturers; biotech, equipment and contract research firms.

The 2019 survey comprised responses from 45 different respondents, representing a broad range of industry stakeholders. In this year’s survey we aim to understand how companies are managing transparency reporting, so that Life Sciences companies can best leverage these findings and apply them to resource allocation, promotional programming, educational outreach and other strategic initiatives.

Company size as measured by annual revenue was spread over a fairly wide range with bimodal representation, with a mean of $3.95B: 46% of companies had revenue of less than $5B, 12% had revenue between $5B and $9.99B, 23% earned from $10B to $19.99B, and 19% had revenue of more than $40B.

Here is how companies today are complying with regulatory transparency and reporting requirements:

How Compliance is Executed

Nearly nine in 10 — 87% — of 2019 survey respondents say they are “very involved” personally in ensuring compliance with global, federal and state transparency and disclosure regulations.

As might be expected, responsibility for achieving and maintaining compliance with regulations falls to companies’ compliance departments: 73% of respondents report that their employer’s compliance department is “ultimately responsible for transparency reporting,” while 56% say their compliance department is responsible for gathering and aggregating transparency and disclosure reporting data.

In 2019, 43% of responding organizations use third-party technology solutions to meet compliance requirements, while 30% of respondents report that they manage compliance manually with spreadsheets, 24% use an internal software system and 4% report using an outsourced or “other” service provider.

Outside of the United States., 35% of respondents say they satisfy compliance requirements manually via spreadsheets, 33% use a third-party technology solution and 10% use an internal software system.

HCP/HCO Interaction Management

Just over half of organizations responding to the 2019 survey characterize their HCP/HCO interaction and engagement-tracking systems as “good” and “working well,” an 11 percentage point improvement over last year. In addition, 32% call the effectiveness of their data capture efforts “fair,” an improvement from the 52% who gave that response in the previous year’s survey, while 7% said their system “needs improvement” and 10% said they don’t know if it is working as intended.

Responding organizations are targeting a number of different aspects of the HCP/O interaction and data capture processes they wish to improve.

Roughly one third (34%) say they want to improve their integration of data capture and reporting; 25% seek to improve master data management — including tasks like licensure and HCP/HCO management; 22% are targeting the approvals workflow process for improvement, including tasks like needs assessments and contracting; 13% say they want to improve manual matching of data captured with no references to MDM identifiers, and 6% say their vendor management needs improvement.

Companies can facilitate improving on these processes through their choice of management solutions providers, firms that take a consultative approach to developing flexible, compliance-centric processes to achieve, maintain and monitor compliance and reporting.

How Reports are Used

About two-thirds — 66% — of organizations responding to the most recent survey say they generate reports on a regular, seasonal basis. The 2019 figure includes 41% of respondents who say they generate reports both for preview as well as for their compliance monitoring activities while 32% of respondents generate reports only when required for submission. Resource availability and allocation likely play a role in organizations’ choices.

For compliance reporting and analysis, 61% of this year’s survey respondents use other data assets. Industry-reported aggregations such as the CMS Open Payments Platform are the most widely used ancillary sources.

Just over one in five respondents say they use this aggregated data for business and compliance insights at both the regional and global level; 28% use this data for monitoring waste spend, and 28% use it to measure the effectiveness and efficiency of business processes. Nearly half of the survey respondents, though, say they do not use any of this aggregated data for any purpose other than reporting.

How CMS Open Payments Are Managed

Regarding CMS’s announcement that the agency will reach out to HCPs and review their Open Payments transaction data, 61% of responding organizations expect no difference in dispute levels, while 21% are preparing for either a “minor” or “significant” increase. More than four in five responding organizations report that they manage disputes manually.

Nearly two-thirds of responding organizations apply preemption and submit to states only what is not submitted to CMS, while 22% submit all reportable spend. The remaining 14% remain undecided.

In their most recent Open Payments submissions, 35% of respondents say they created and submitted an Assumptions Document with their reports, and 41% created one but didn’t submit it. The remaining 24% of respondents say they didn’t create one at all.

Global End-to-End Solutions Are the Gold Standard

Survey respondents rely to a significant degree on external technology solutions to execute their compliance requirements, with 43% saying they use third parties. Among those not currently using but considering a third-party solution, 9% say they will do so within the current reporting year, and 36% plan to do so within the following reporting year.

Nearly half of the respondents in the 2019 survey characterize a comprehensive, integrated, end-to-end solution encompassing disclosure reporting for HCP consultant and HCO interactions as a “requirement,” and 90% of respondents indicated a preference for using such solutions. Respondents also expressed a preference for global compliance solutions: 63% said they prefer a global third-party solution, with the remainder split evenly between those preferring regional and country-specific platforms.

Nearly half of the respondents in the 2019 survey characterize a comprehensive, integrated, end-to-end solution encompassing disclosure reporting for HCP consultant and HCO interactions as a “requirement,” and 90% of respondents indicated a preference for using such solutions. Respondents also expressed a preference for global compliance solutions: 63% said they prefer a global third-party solution, with the remainder split evenly between those preferring regional and country-specific platforms.

In an era of increasing regulatory scrutiny, finding scalable and flexible compliance technology solutions to manage HCP programs and their reporting and oversight requirements is more important than ever. Learn more about how companies are adapting and read the full transparency trends white paper here.

For more information about IQVIA Commercial Compliance, please email commercialcompliance@iqvia.com or visit our webpage. Our experts leverage the industry’s leading technologies to deliver streamlined processes and improved efficiencies that solve your toughest engagement and transparency challenges. From automating and managing the entire HCP/O contracting lifecycle, to capturing, collecting, and reporting global spend; to planning efficient and compliant HCP meetings and engagements—discover how our solutions can make compliance easier for you.