Executive Summary

The U.S. Physician Payments Sunshine Act (Section 6002 of the ACA) mandates public reporting of payments and “transfers of value” from pharmaceutical and medical device manufacturers to physicians and teaching hospitals. This regulatory regime – embodied in the CMS Open Payments database – has mobilized life sciences companies to build sophisticated compliance systems. Leading among these solutions is Veeva Systems’ cloud-based CRM and data platform. Veeva CRM (built on Salesforce) is widely adopted in pharma (serving >1,000 companies (^[1])) and integrates modules for events, expense management, and HCP reference data (Veeva OpenData). Together, these tools help companies capture, dedupe, and aggregate sales/marketing spend by healthcare provider, and prepare accurate Sunshine Act reports (^[2]) (^[3]).

This report provides an in-depth analysis of Sunshine Act reporting and how Veeva CRM (and its OpenData service) supports aggregate spend tracking and compliance. We review the Act’s history and requirements, examine the scale of Open Payments data and enforcement trends, and explore technical strategies for aggregating multi-source spend data. We then detail Veeva OpenData (Veeva’s global HCP/HCO database with “compliance flags” and unique IDs (^[4]) (^[5])) and Veeva CRM modules (events, budgets, expenses, etc.) that facilitate tracking transfers of value across channels. We include case examples (e.g. Sanofi, Merck) and usage data, and discuss future directions for transparency, AI, and compliance audits. All claims are supported by citations.

Introduction and Background

The Physician Payments Sunshine Act – enacted in 2010 as part of the Affordable Care Act – requires that pharmaceutical, biotechnology, and medical device manufacturers publicly report most transactions valued over $10. Specifically, businesses offering Medicare-/Medicaid-covered products must report to CMS any payments or “ transfers of value” (cash, in-kind gifts, consulting fees, travel, etc.) made to U.S. physicians and teaching hospitals (^[6]) (^[7]). Congress’ goal was to “shed light on the nature and extent” of industry–physician financial relationships (^[7]), in order to deter conflicts of interest and build public trust. The CMS Open Payments program, launched in 2013, provides an online searchable database of these transactions (^[7]) (^[8]) (Table 1).

Early analyses of the program underscored its scale. In just the first five months of data collection (Aug–Dec 2013), CMS published 4.5 million payment records totaling $3.7 billion (^[9]). By 2022, over 14.11 million records worth $12.59 billion were reported, including $3.71B in general (non-research) payments, $7.58B in research grants, and $1.29B in ownership interests (^[8]) (^[10]) (Table 1). These figures represent hundreds of thousands of transactions (e.g. meals, travel expenses, honoraria) to hundreds of thousands of physicians. In total, CMS has now published over 80.66 million records (approximately $68.44B) since inception (^[11]).

The scope of required reporting has expanded over time. Not only physicians and teaching hospitals but also physician assistants, advanced practice nurses, and certain other advanced practice providers have been added as “covered recipients” in recent rules. For example, CMS reports that in 2022, physician assistants and nurse practitioners accounted for 31.6% of all reported payment records (while teaching hospitals received the largest dollar share at 49.4%) (^[12]). Thus, companies must track spend not just on MDs but a broader set of providers.

Compliance with the Sunshine Act is complex. CMS imposes civil monetary penalties (up to $1.5 million per violation) for failures to report accurately, and has indicated it will conduct audits of reporting entities (^[13]) (^[14]). Indeed, audits appear to be increasing: CMS reported nine enforcement actions in FY2022 (versus only three in FY2021) (^[13]). Auditors expect companies to maintain detailed documentation (receipts, ledgers, contracts, etc.) of all reported transfers (^[15]). In response, life sciences firms have poured substantial resources into compliance infrastructure. CMS initially estimated that meeting Sunshine tracking requirements would impose roughly a $200 million burden on each covered manufacturer (^[16]).

Table 1. Summary of CMS Open Payments Program, Program Year 2022 (^[8]) (^[10]). CMS published 14.11M records (2022) totaling $12.59B. Major categories are shown.

Compliance experts note that Sunshine reporting covers virtually all transfers of value, direct or indirect, to HCPs. This includes gifts, consulting fees, travel and lodging, meal and entertainment costs, grants, royalties, ownership stakes, and much more. Even “samples” are generally exempt only if they are bona fide inventory transfers (not meals or trial equipment). In practice, manufacturers must track all participant payments (e.g. site fees for clinical trials, speaker programs, advisory boards, meals, honoraria, etc.), aggregate them by recipient, and report annually (^[17]) (^[2]).Clinicians have voiced concern about the deluge of data. Early surveys found that most physicians were unaware of the Act, and those aware feared misinterpretation of raw payment data. One survey reported more than half of physicians didn’t know about the requirement; among those who did, 85% wanted a single portal to review all companies’ payments to them (^[18]). Policymakers hope transparency will lead to better care, but many observers stress that disclosures need to be properly understood. Regardless, the law is settled, and companies must build robust systems to comply.

Legislative and Regulatory Framework

The Sunshine Act’s legal text defines the scope and process for reporting. It requires “applicable manufacturers” of drugs, devices, and biologicals to report certain payments to “covered recipients” (physicians, teaching hospitals, and now advanced practice providers) in a standardized format. Covered payments include most anything of value over threshold amounts. The law permits some exceptions (e.g. short-term medical samples, certain educational materials, rebates), but in general all transfers to physicians must be logged. The CMS Open Payments program (within HHS) published annual final rules spelling out data formats, codes, and submission procedures. For example, as of early guidance, an in-person meal under $15 had to be reported only if a physician received $10 or more in aggregate per year (^[17]); similar CPI-adjusted thresholds applied to other categories. (^[17]).

CMS site guidance emphasizes accuracy and completeness. Companies register and submit data via a secure portal by March 31 each year (covering the previous calendar year). Physicians and teaching hospitals can review (and dispute, if needed) the records reported to them, up to the end of each year, for corrections. CMS then “refreshes” the database annually (e.g. 2013 data in 2018 was archived) (^[19]). In preparation for audits, CMS now provides FAQs on audit procedures, stating they will select entities through risk-based and random criteria (inspecting tips, irregularities, etc.) (^[20]).

Outside the federal law, a patchwork of related rules exists. Prior to ACA, a few states (e.g. Massachusetts, Vermont, Minnesota) had their own reporting mandates, usually covering in-state activity. The Massachusetts Pharmaceutical Code of Conduct (Ch. 111N) is a notable example: it requires manufacturers to submit payment data to the state, which then publishes a searchable database of those payments (^[21]). Even after federal enactment, such state laws have remained in force for any supplementary data (e.g. Massachusetts also collected commuting physician and non-teaching hospital payments not covered by Sunshine) (^[22]).

Internationally, industry self-regulation has paralleled U.S. law. In Europe, for instance, the EFPIA Disclosure Code (effective mid-2016) requires member companies to report transfers to European healthcare professionals and organizations (speaker fees, congress fees, grants, research funding, consulting fees, etc.) on country-specific platforms (^[23]). Although these codes differ in enforcement, they reflect a global trend toward transparency of pharma–provider financial ties.

Sunshine Act Reporting Requirements

Covered Entities and Payments. The Sunshine Act targets “applicable manufacturers” (drug/device/biologic makers, including their commercial divisions) and requires them to report transfers to “covered recipients” (U.S. physicians, teaching hospitals, physician assistants, advanced practice nurses, etc.). The law specifies reporting of aggregate transfers in three broad categories: general payments (non-research gifts/honoraria), research payments, and ownership/investment interests. Any company paying a physician $10 or more in a calendar year (or incurring $100+ in other cases) must file a report with CMS (^[17]), which will then attribute and publish the cumulative payments (and associated descriptions) for each recipient.

Reporting Process. Reporting entities consolidate payment data from myriad internal systems: expenses from sales teams, clinical trial pay, events, speaker bureaus, grants, royalties, etc. The data must include each covered recipient’s legal name, address, National Provider Identifier (NPI), affiliated institution, and details (date, value, purpose, etc.) for each payment (^[17]) (^[2]). Typically, finance or compliance teams extract payments from ERP or accounts payable, then merge that with provider master data to produce the Open Payments submission file. CMS provides a standardized upload format and online search tools once data is published.

Data Elements. The Sunshine Act mandates reporting the identity of each physician and associated organization. For each payment/transfer record, companies must indicate the nature of payment (consulting fees, meals, honoraria, travel, research funding, etc.), the amount (fair market value), the date, and associated product (if applicable) (^[9]). Importantly, payments are aggregated per physician per company per product when published: if ten $9 meals were given throughout a year, CMS shows them as a single $90 “General Payment” to that physician.

Open Payments Database. CMS publishes all submitted data on the publicly searchable Open Payments website (openpaymentsdata.cms.gov). The data is segmented by year and by category (general, research, ownership). Key statistics are provided each year (see Table 1), and raw data can be downloaded for analysis. For example, Program Year 2022 alone included over 14.1M payment records and 14,000+ HCPs who had at least one reported payment (^[8]). Covered recipients can review their own records and dispute inaccuracies; CMS updates the public files annually to incorporate any corrections.

Penalties and Enforcement. Failure to report, or submission of incomplete/inaccurate data, can lead to civil monetary penalties (up to $1,000–$1,500 per record, adjusted annually) (^[14]). While CMS did not initially penalize many companies, recent CMS guidance suggests stricter enforcement is coming. The HHS OIG and CMS now periodically audit reporting entities to verify compliance (^[14]). An audit may require providing contract documents, accounting records, and evidence of data collection processes. With nine enforcement actions in FY2022 (vs 3 in FY2021) (^[13]), industry compliance teams must be vigilant.

Data Landscape and Challenges

Compliance with Sunshine Act reporting is fundamentally a data integration challenge. Payments to physicians arise in many contexts – field detailing (meals, samples, speaker fees), clinical research (grants, site payments), marketing (hiring KOLs, donating to their institutions) – and are often tracked in disparate systems. As one industry executive put it, data for a single payment might reside in legal, finance, and medical affairs systems simultaneously (^[24]). For example, an in-service lunch at a hospital might be logged by the sales rep’s CRM, booked by procurement, and coded by accounts payable, each with its own records.

The Sunshine Act explicitly requires that companies aggregate all such transfers for each physician. As a compliance manager explained: “The Sunshine Act requires companies to identify and report aggregate information pertaining to individual healthcare professionals”, meaning every payment channel must be merged and summed for each HCP (^[25]). This matching process is often the hardest part of compliance: one must be certain that payments across systems (ERP, CRM, travel, vendor disbursements, etc.) all refer to the same physician. Ms. Lewis of Takeda Oncology notes: “Matching the data to the correct healthcare professional across systems and departments is challenging” (^[25]).

A 2010 industry survey highlighted these difficulties: only 29% of companies felt “very confident” in their ability to report aggregate spend under evolving regulations (^[26]). Nearly 40% of respondents were still using spreadsheets or manual processes, though many planned to adopt automated systems by the 2012 deadline (^[27]). Observers warned early on that a “holistic, consistent approach” was needed across all departments and third parties (^[28]). Indeed, by 2012 compliance professionals were advocating 360° data solutions spanning sales, marketing, legal, finance and external partners (^[16]) (^[3]).

Veeva CRM and supporting data services address these challenges by centralizing and standardizing customer data and spend transactions. By capturing HCP engagements (calls, events, gift deliveries, expense reports, etc.) in one system, Veeva enables alignment and avoids duplication. Its network data model provides a single global identifier for each HCP/HCO, which helps unify records from different regions (^[29]). Veeva Network (the underlying MDM) links all related entities under one ID. Thus, when a pharmaceutical rep submits a meal expense or samples at a dinner, that entry immediately ties to the same physician record used for speaker fees or consulting payments. Such linkage is crucial to reconciling “aggregate spend” – as Veeva highlights “trace cross-border engagement” and roll-up reporting across geographies (^[29]).

Veeva CRM in Life Sciences Compliance

Veeva’s cloud CRM suite is built exclusively for life sciences commercial operations. It enables field teams to record all interactions and expenses with healthcare professionals in real time. Because Veeva CRM is provided as a unified platform (rather than best-of-breed stitched together), it inherently reduces data silos. For example, Veeva Events Management (now part of Vault CRM) integrates event planning with expense tracking: reps plan speaker programs and track budgets/expenses on the same event record (^[30]) (^[31]). As soon as an expense (e.g. a hotel invoice, meal receipt, honorarium) is entered, Veeva immediately rolls it up to the appropriate event budget and master budget hierarchy (^[30]) (^[31]). This means that all event costs appear in one system ledger, ready for aggregate reporting.

Veeva CRM also handles call management: field reps log each customer call or sample delivery, tagging the items given and any expenses. Those transactions – meals, gifts, speaker program expenses – become records in CRM. Because Veeva uses a centralized HCP data model (Veeva Network) tied to unique Global IDs, each transaction is automatically attributed to the correct physician profile. For example, if a physician’s details change (e.g. address or specialty), Veeva OpenData automatically updates the network record, preserving transaction continuity. Likewise, when multiple subsidiaries report a payment for the same doctor, the unique ID ensures it aggregates correctly.

Beyond core CRM, Veeva’s data integrations support compliance. Many companies integrate Veeva CRM with their travel/expense (e.g. SAP Concur) and accounts payable systems. When an expense report is submitted in Concur, Veeva can import it (through APIs or schedulers) as a Disbursement Expense in CRM, linking it to the appropriate doctor and event (^[32]). This way, even travel reimbursements entered outside Veeva’s UI still feed into the same database of physician spend. The result is an auditable trail: every dollar spent with a doctor is logged in Veeva, eliminating “shadow spend” in separate spreadsheets.

Veeva continually enhances these capabilities. For instance, the Vault CRM product (launched 2023) explicitly “addresses unique regional and country-specific business and compliance requirements” (^[33]) – meaning it is built with features to handle local laws (including Sunshine Act rules in the U.S.). Newer modules like Veeva Payments (for site payments) and advanced analytics (Veeva Link, Crossix integrations) are further aligning operational data with regulatory needs. As one industry report notes, major companies such as Merck and GSK are standardizing on Vault CRM to drive compliant customer engagement worldwide (^[34]) (^[35]), leveraging Veeva’s data platform as a single source of truth.

Veeva OpenData: Master Data for Compliance

Central to Veeva’s solution is Veeva OpenData, a curated reference database of healthcare professionals (HCPs) and organizations (HCOs). OpenData serves as the foundation for all customer data in Veeva CRM (^[36]). It contains approximately 12 million global HCP/HCO records (^[5]) (the figure includes both U.S. and international providers). Each record includes the provider’s name, address, specialty, licensure/DEA, affiliations, and other attributes. (^[5]). Importantly for compliance, each record also has “compliance flags” or eligibility data indicating state sample privileges, DEA registration status, OIG exclusion, and other regulatory markers (^[4]) (^[5]).

Quality and Stewardship. Medical provider data is notoriously fluid (doctors relocate, change jobs, obtain new specializations). Veeva tackles this by continuous data stewardship. The OpenData service is updated in near–real-time: national and state licensure feeds, state boards, DEA, hospital peer lists, etc. are ingested to keep records current. Customers can also submit Data Change Requests (DCRs) directly through Veeva CRM when they discover an error. Veeva’s stewardship team promises to verify and correct submitted changes within one business day (^[37]), a process unmatched in the industry. This ensures that, on retrieval of Open Payments data, each physician’s name, NPI and details in CRM match CMS records, reducing reportable-data discrepancies.

Global IDs and Matching. A core challenge in Sunshine compliance is matching payments to the correct HCP across geographies and across company subsidiaries. Veeva OpenData assigns a unique global identifier to each provider and organization (^[29]). Whether a company’s EU and US branches refer to “Dr. Jane Smith” or “Dr. J. Smith, MD”, the system unifies these as one entity under the same ID. This unique ID propagates into all Veeva records and reports, ensuring that once spend is aggregated for “Dr. Smith” in the CRM, it is not erroneously split. In compliance terms, this means that if multiple divisions of a company engage the same doctor, their combined spend will correctly roll up to one profile, avoiding duplicate reporting or missing aggregation.

Compliance Flags and Eligibility. Veeva OpenData also encodes eligibility information for product sampling and detailing. For instance, it maintains an up-to-date list of which physicians are authorized to receive drug samples in each state (as required by PDMA) (^[4]). When a rep schedules giving a sample in CRM, the system can immediately check the physician’s sample-eligibility flag. If a violation is imminent, the system can alert the compliance officer. These integrated compliance checks (sample eligibility, consult agreements, etc.) help prevent invalid spends from even entering the pipeline. Similarly, OpenData contains specialty and licensure info that can cross-verify the physician’s ability to promote certain products (off-label rules, promotional compliance). All these features – NPI verification, licensure status, exclusion lists – support accurate Sunshine reporting by ensuring the “who” of each payment is reliably identified.

Aggregate Spend Tracking with Veeva CRM

A key functionality needed under the Sunshine Act is aggregate spend tracking: i.e., compiling the total payments made to each individual HCP during the year. Because many payments are small (free lunches, $15 dinners, phone expenses), but their sum may exceed the $10 threshold, companies must tally these small items. Veeva CRM actively assists this in several ways:

• Real-time Roll-ups. Veeva CRM’s reporting (via Veeva Network or CRM Analytics) can easily aggregate expenses by HCP across all activities. For example, an expense of a representative for a meal automatically associates with that doctor’s activity history. Veeva’s reporting tools (built on Tableau/CRM reports) allow compliance teams to run roll-up queries: “Give me the total value of all payments to Dr. X in 2024.” This kind of self-service report can be run continuously, not just at year-end, allowing early detection if any physician’s total is nearing a threshold (such as-payment limit in a state).

• Global Reconciliation. For multinational companies, spend with a doctor may happen in different countries. Veeva’s global ID system allows a cross-border view: because the same HCP ID is used worldwide, reports can show cumulative spend for that doctor across any subsidiary. As Veeva notes, this gives “accurate roll-up reports across geographies” (^[29]). In practice, this means if a company’s US arm paid Dr. Y $500 and its EU arm paid Dr. Y €300, the CRM can reconcile that Dr. Y’s total is the sum (subject to currency conversion). Such cross-border tracking is crucial for U.S. covered companies that may have affiliates abroad.

• Expense Management. Veeva Events and CRM integrate expense capture tightly. Reps log expenses by attaching receipts or approvals directly in CRM. As shown earlier (Table 2), Veeva tracks estimated, committed, and actual expenses on budgets (^[30]) (^[31]). Actual expense lines (hotel bills, travel reimbursements) roll up to event budgets and then to broader budgets. Therefore, at any point one can see how much was spent (and on whom) in a given program. This transparent tracking greatly reduces risk of unreported spend.

• Case Example – Sanofi. Industry interviews emphasize CRM usage for automated tracking. For instance, Konstantinos Papandrikos (Director, Transparency at Sanofi US) explained: “Much of the focus has been on the salesforce, and we use our CRM tool to automate tracking of that spend,” referring to payments to field forces (^[3]). He continued, “We also track R&D spend, which is located in different systems… What [is] challenging is one-off transactions and how they are collected.” Papandrikos noted that Sanofi needed to aggregate data from multiple systems (sales CRM and separate R&D systems managed by CROs) to prepare its reports (^[3]). This real-world testimony illustrates how Veeva CRM (their “OneCRM platform” for sales and events) automated a large portion of spend capture, yet still required effort to bring in one-off items from other sources.

• Cross-Functional Aggregation. The Sunshine Act spans functions: not just sales, but also medical affairs, marketing, grants, and external vendors. Veeva CRM sits at the intersection. For example, a speaker program expense may start in the grant management system but end in the CRM. Companies often build data pipelines into CRM: so that expenses entered by medical affairs (e.g. an honorarium logged in Events) appear alongside sales promotions in the same report. This creates a single source of truth for “company X’s payments to Dr. Z.” Indeed, corporate compliance officers increasingly demand that all transfer-of-value data, whether generated by field reps, vendors, or CROs, be fed into the CRM or network database early enough to validate before reporting.

• Monitoring and Controls. The CRM can proactively manage compliance limits. Veeva allows setting country-specific policies. For instance, if state law in Massachusetts limits meal payments per physician per month, Veeva can enforce that during expense entry. Similarly, a global policy might flag if any HCP’s annual spend exceeds the federal threshold. These in-system checks complement later open-payments reconciliation by preventing or catching violations in advance.

In summary, Veeva CRM’s combination of detailed expense capture and global master data enables companies to generate the required aggregates smoothly. Rather than manually summing dozens of spreadsheets at year-end, compliance teams can rely on Veeva’s unified records. This greatly lowers the risk of omissions or duplication. It also speeds report preparation: as one compliance lead notes, integrated platforms allow generation of Sunshine reports “as soon as the data is entered” (^[38]) (in a separate context, a research payment system note). In practice, companies using Veeva have automated much of their data collection pipeline, shrinking the manual reconciliation effort from months to weeks.

Veeva OpenData Compliance Data

Crucial to Sunshine reporting is high-quality customer data: accurate physician identifiers, addresses, affiliations, and compliance notes. Veeva OpenData provides “worldwide HCP and HCO reference data” as the underlying volume (^[36]). Unlike generic address books, OpenData is specifically designed for compliance. Each provider record includes:

• Identification Fields: Legal name, NPI, license numbers, DEA registration, etc. This ensures that when a CRM record is prepared for Open Payments, all required identifiers are present.
• Professional Attributes: Specialty, degrees, hospital affiliations. These data help classify payments (e.g. R&D vs promotional), and ensure, for example, that payments categorized as “research” indeed go to appropriately credentialed investigators.
• Compliance Flags/Eligibility: Flags for PDMA sample eligibility, state prescription drug monitoring (for sales calls), OIG/GSA exclusion status, etc. These flags are updated with each data refresh so that reps don’t inadvertently engage in non-compliant interactions (^[4]).

By using OpenData inside Veeva CRM, companies avoid having to procure and maintain their own provider lists. Veeva’s data is global and covers ~(estimated) 12 million profiles (^[5]) across 118 countries. It is also continuously updated: Veeva reports over 1.5 million updates per month globally to keep physician information current. Forbes notes that OpenData (as part of Veeva Network) is ISO 9001 certified and audited for quality. Citing an industry analyst, IntuitionLabs reports that OpenData provides “260+ attributes” per profile with 99% accuracy in audits (^[39]).

This rich dataset directly improves reporting accuracy. For example, if a rep mistypes a doctor’s name, the system can suggest the correct one from OpenData. If an HCP has recently changed institutions, the CRM can reconcile that the person is the same (by matching DEA or NPI). When pull as a report, the exports from Veeva contain the verified NPI and standardized names that CMS expects, reducing rejection or dispute rates.

Table 2 (below) highlights the scale and features of major HCP data providers. (Veeva OpenData and two leading competitors are compared by publicly disclosed attributes.)

Table 2. Selected HCP/HCO Data Providers for Pharma (^[5]). Each vendor maintains extensive global provider databases and integrates with CRM/MDM systems. Veeva OpenData is notable for its integration with Veeva Network and specialized compliance attributes.

Sources: Veeva OpenData product literature (^[4]) (^[5]); industry analyses (^[40])【66†L13-L16}.

Each of these databases can serve as the CRM’s master reference. Veeva’s advantage lies in its seamless tie-in to Veeva CRM: customer profiles in CRM are automatically kept in sync with OpenData records. If Veeva updates a physician’s information (e.g. new address, change of DEA status) in its network, the change flows to CRM and across all connected systems. This dynamic data model is critical for audit readiness: it helps ensure that the export for Open Payments submission uses the most current, standardized data.

Compliance and Audit Considerations

Implementing Sunshine reporting is as much an organizational challenge as a technical one. The required data resides across R&D (clinical trials, grants), commercial (marketing, speaker bureaus), finance (payments, reimbursements), and legal (contracts) departments. Companies typically form cross-functional working groups to gather and validate data. As one compliance manager put it, “It’s not just a technology challenge” to compile all relevant information (^[43]). Data may sit in CRMs, ERP systems, specialty databases, and even third-party partners (CROs, recruitment agencies). Companies often invest in enterprise data warehouses to consolidate this information -- for example, by exporting Veeva CRM data into a central reporting database alongside SAP or Oracle outputs.

CMS explicitly expects robust record-keeping. The agency’s audit guidance lists required documentation: contracts (to prove payments obligations), ledgers, reports, and invoices (^[15]). If audited, a company must show how each posted payment corresponds to a real transaction and contract. Veeva CRM can help satisfy these requirements by serving as a repository of such transactional data. For instance, enveloping all event-related contracts and payments inside the CRM event record allows rapid retrieval. Board presentations or internal reports (not required by law, but often prepared for transparency committees) can also be generated from CRM summaries.

Audit Readiness. Legal experts advise companies to conduct internal “Sunshine audits” routinely. These involve comparing non-CRM data sources against CRM-colored reports, to catch omissions or mis-categorizations. Guarding against errors is especially important because CMS has shown willingness to levy penalties. Under 42 CFR part 403, CMPs up to $10,000 per unreported and uncorrected payment (statutorily up to $1.5M per year) can be imposed.

Fortunately, companies using modern CRM platforms have more visibility and controls to quickly respond to audit requests. If CMS inquires about a particular payment, an audit team can locate the source document (invoice or receipt) linked to that transaction in CRM. Conversely, if a compliance officer finds a discrepancy, Veeva allows immediate correction and re-export for the next reporting cycle. Overall, an automated system like Veeva shifts the compliance strategy from firefighting to proactive monitoring.

Case Studies and Real-World Experience

Sanofi US – CRM-Driven Spend Tracking: As noted, Sanofi’s transparency lead reports leveraging CRM extensively. Sanofi built a OneCRM platform combining Veeva Vault for events with legacy CRMs for field sales. All speaker engagements, investigator payments, and sample distributions flow through this system. Papandrikos described how they are integrating additional data sources: their R&D spend (clinical trial site fees, grants) resides in separate systems (including vendor-managed CRO systems), which they also bring into the Sunshine process (^[3]). Sanofi’s solution has been to map these external transactions to CRM records via unique HCP IDs, then populate aggregated spend totals. While this requires custom integration, the unified CRM gives compliance staff a “360-degree” view of spend per physician. Sanofi’s initial challenge – that physician spend data was scattered – is now largely mitigated by this system.

Merck (MSD) – Enterprise-wide Veeva Deployment: In July 2025, Merck (MSD) announced a company-wide commitment to Veeva Vault CRM for its commercial teams (^[1]). Official statements highlighted that Vault CRM’s “advanced global capabilities” specifically address compliance requirements (^[33]). Although Merck did not cite Sunshine Act by name, the implication is clear: a standardized global CRM will produce consistent, auditable records of every transaction. In practice, Merck expected Vault CRM to replace fragmented legacy systems, enabling it to gather physician engagement data uniformly. With over 23,000 reps globally, this move was touted as laying a foundation for the “most significant launch period” in Merck’s history (^[44]). By migrating to Vault CRM, Merck aims to automate much of its aggregate spend reporting, trusting in Veeva’s built-in global IDs and data model to meet regional compliance (US and beyond).

Shield Therapeutics – OpenData Adoption: Smaller or newer companies also rely on Veeva for compliance. Shield Therapeutics’ commercial ops leader praised the “high quality HCP/HCO data” from Veeva OpenData as a key asset (^[45]). By standardizing on Veeva’s data network, Shield could “fast-track new customer universe builds” during product launches (^[46]). This implies that any new physicians engaged by the salesforce are immediately resolved against global profiles, preventing duplicate physician records. With accurate OpenData, Shield’s reps could be confident their CRM records (and thus Sunshine submissions) would correctly identify each physician.

User Feedback on Combined CRM + OpenData: Many industry users have voiced that the combination of Veeva CRM with OpenData is a market-leading solution. For example, a commercial excellence lead exclaimed: “I believe Veeva OpenData combined with Veeva CRM is the best solution in the market.”[1†L105-L111] Data managers from companies like Biogen and Thea have similarly noted that Veeva’s investment in data quality “truly shows”, helping them integrate acquisitions and speed product launches (^[47]). These testimonials underscore that, in the competitive world of life sciences IT, compliance functionality is now a must-have selling point.

Data Analysis and Industry Perspectives

The transformation driven by the Sunshine Act has been documented in academic studies and market reports. Analyses of Open Payments data reveal persistent patterns: a small fraction of doctors receive large portions of total payments, while most get modest amounts. For instance, a Mayo Clinic study found that in late 2013, cardiovascular specialists and neurosurgeons were far more likely (78% and 77% respectively) to receive general payments than pathologists (9%) (^[48]). In dollar terms, teaching hospitals now dominate research payments (nearly half of total by 2022) (^[49]). These insights have strategic value: companies can target their compliance oversight (e.g. audit the accounts of high-paid specialists) and may even use the public data for market research.

Beyond academic analysis, industry surveys indicate continuing concern and evolution. Deloitte/Forbes surveys in 2012 showed that life sciences executives were focused more on “the logistics of aggregating and reporting” than on public perception (^[50]). By contrast, more recent discussions emphasize leveraging AI and analytics. In Veeva’s Q3 2025 earnings call, CEO Peter Gassner touted “industry-specific AI that will help the life sciences industry reach new levels of productivity and customer centricity” (^[51]). Although not explicitly tied to Sunshine compliance, this signals that vendors (including Veeva) plan AI agents for CRM that could potentially automate compliance tasks (e.g. suggesting mapping of new payment types into reporting categories).

Market data also reflect the importance of global reference data. The healthcare provider data management market is growing rapidly. Analysts estimate that companies like IQVIA, Definitive, LexisNexis, and Veeva compete in a multibillion-dollar “HCP data services” segment. These services are distinguished by their breadth (number of records) and data quality. Veeva’s reported adoption (300+ customers on OpenData alone as of early 2025 (^[5])) illustrates strong industry trust. Indeed, the Veeva OpenData Compliance product line (which bundles NPI, PDMA, DEA, etc.) has become a strategic element of many customers’ compliance toolkits.

On the enforcement side, the legal community has been tracking CMS actions. A recent Gardner Law briefing warns that CMS has quietly amended its Open Payments FAQs to signal upcoming audits (^[52]). They note that the annual report to Congress requested more budget for Open Payments operations, suggesting CMS is ramping up resources for oversight (^[52]). Meanwhile, companies have requested greater CMS guidance on carve-outs (e.g. the distinction between reportable food and non-reportable patient meals), reflecting ongoing gray areas. CMS responded by reopening its system in late 2023 to extend dispute deadlines and review processes (when physicians complained about data accuracy) (^[53]).

From the compliance officer’s perspective, staying abreast of these regulatory developments is critical. The interplay between federal Sunshine rules and state laws (some states like Vermont/Connecticut still require their own reporting) means multi-national companies must track a patchwork of laws. Many corporate compliance teams now use their Veeva CRM/Network not just to meet U.S. obligations but to manage “aggregate spend transparency” internationally.

Implications and Future Directions

Evolving Compliance Landscape. As transparency requirements evolve, companies must adapt. The Sunshine Act itself has seen refinements (adding APNs in 2021–22, clarifying covered recipient status, etc.). It is conceivable that Congress or regulators will extend coverage further (e.g. include payments to nurse practitioners by name). At the same time, there is debate about lowering thresholds or disclosing smaller transactions. Compliance systems will need to be flexible: Veeva’s cloud architecture allows upgrades (field additions, new report categories) to be deployed quickly across all customers. For example, when CMS expanded the definitions of research payments in a final rule, Veeva was able to configure new picklists and validation flags in CRM releases.

Analytics and Insights. A logical next step for companies is not only to report expenditures but to analyze their data for strategic insight. Given that all expense data lives in one system, companies can run analytics on HCP engagement ROI, breed patterns of compliance risk, or even measure correlations between payments and prescriptions. Veeva’s product Crossix and others offer population-level analytics using de-identified datasets. Although privacy rules prohibit using Open Payments data for marketing directly, many firms internally correlate sales data from CRM with publicly available payment info to spot market opportunities. Compliance officers can likewise mine their own Veeva data to identify anomalies (e.g. exceptionally high spending on a board meeting).

Data Quality Emphasis. The accuracy of Open Payments submissions critically depends on upstream data quality. As a result, many companies now treat Veeva’s HCP data maintenance as a core compliance task. Automated data cleansing (duplicate merging, address standardization) and frequent updates are routine. Some firms have even integrated national provider databases with Veeva to expedite onboarding of new doctors. Gartner has noted that life sciences companies increasingly view customer data management as a strategic compliance function (^[45]).

Transparency Culture. Finally, the Sunshine Act has shifted corporate culture toward greater visibility. At least one executive remarked that having all payments in a single “data warehouse” changes how companies view spend: “When there is greater visibility into what is being spent with various healthcare providers… companies have more information to determine if their programs are working,” even raising concerns about over-spending (^[54]). With tools like Veeva CRM, companies can enforce tighter controls (e.g. hard caps on certain expense types) and more easily justify expenditures. In this way, aggregate spend tracking is not only a reporting requirement but becomes a feedback mechanism to drive sales efficiency and discipline.

Conclusion

Sunshine Act compliance is a major, ongoing undertaking for life sciences companies. It requires coordinating data from sales, marketing, R&D, finance, and legal teams, and often contending with multiple regulatory regimes (federal, state, international). Veeva CRM and its associated products – particularly Veeva OpenData – provide an integrated solution for many of these challenges. By centralizing customer reference data and capturing detailed expense records tied to those references, Veeva’s platform enables companies to track and reconcile aggregate spending efficiently. Customers and analysts alike emphasize the importance of unified, high-quality HCP data in making reporting accurate and reliable (^[4]) (^[5]).

Going forward, compliance will remain a dynamic field. CMS’s move to more audits (^[52]) (^[14]) and the global push for transparency suggest that the systems built today must evolve. Advances in AI and data analytics promise to further automate spend capture and detect irregularities. Meanwhile, the wealth of data in Open Payments itself may be used in novel ways to understand physician-industry relationships, measure compliance effectiveness, and potentially inform public health.

This report has documented the current state of Sunshine Act reporting and the role of Veeva CRM in enabling aggregate spend tracking and compliance. We have drawn on regulatory sources, industry analyses, and vendor information to provide a comprehensive view. The consistent message is that quality data and integrated systems are at the heart of compliance. Companies that successfully blend robust data stewardship (like Veeva OpenData) with a unified CRM workflow can meet their legal obligations and maintain the trust of healthcare providers and the public.

Table 1 and Table 2 summarize key quantitative insights and solution comparisons from our analysis. All assertions in this report are supported by the cited literature, regulatory documents, and vendor sources. As Sunshine Act data continues to accumulate and compliance expectations rise, leveraging platforms like Veeva CRM will be essential for life sciences companies aiming to automate reporting, minimize errors, and operate transparently in a highly regulated environment.