RegulatoryID®
The Authoritative Transparency Reference Library Solution
Transparency Reporting and the Risk of Non-Compliance
The federal Centers for Medicare and Medicaid Services (CMS) Open Payments program, commonly known as the Sunshine Act, is designed to increase transparency around the financial relationships between physicians, teaching hospitals, and manufacturers of drugs, medical devices, and biologics.
Specifically, the legislation mandates that group purchasing organizations (GPOs) and manufacturers of specific drugs and devices report annually to the Centers for Medicare & Medicaid Services (CMS) regarding payments or other transfers of value made to US-licensed physicians, teaching hospitals, and select healthcare professionals referred to as “covered recipients.”
Since the law first went into effect in 2013, the Department of Health and Human Services (HHS), CMS, the HHS Office of Inspector General (OIG), and their designees, have each retained authority to audit, inspect, investigate, and evaluate reporting entities’ compliance with the law. While these government agencies have not historically exercised this auditing authority, recently CMS has signaled a shift in its attention to Sunshine Act compliance reporting.
The time is now for reporting entities to take note of new guidance from CMS and use this opportunity to confirm their tracking and reporting practices align with the Sunshine Act’s detailed requirements.
Researched, written, and verified by MedPro Systems’ in-house team of pharmaceutical and medical device compliance professionals and attorneys, RegulatoryID offers a centralized, easy-to-use resource library of Federal, State, and International requirements, including:
New! US State Drug Price Reporting
- New Product Reports
- Periodic Reports (Quarterly & Annual)
- Price Increase Report (Pre & Post Price Increase)
- Upon Jurisdiction Request
- Disclosure to HCP
- Prescription Drug Affordability Boards
US Aggregate Spend Reporting
- Transparency Reporting
- Gift Bans and Limitation
- Field Rep Registration and Licensure
- Compliance Program Requirements
Global Aggregate Spend Reporting
- Centralized Disclosure Compendium of 50+ Countries
- Industry Association-Based Requirements (including EFPIA & MedTech Europe)
- National Laws, Industry Codes, Guidance Documents and Disclosure Templates
- Gift Bans & Limitations
Stay Up-to-Date on New and Evolving Regulations with Proactive Notifications
Never miss a regulatory update with email alerts on industry news, evolving requirements, and deadline reminders sent directly to your inbox.
How RegulatoryID Can Reduce Your Risk of Non-Compliance
With the superior tools and real-world compliance expertise of a large corporation, and the dedicated support of a niche boutique, MedPro Systems is a full-service partner that life science companies rely on year after year.
With RegulatoryID, there is no longer a need to manually scraping disparate industry, legal, and government sources for the laws and regulations impacting your organization. Users can quickly search, filter and highlight relevant information by:
- Manufacturer Type: Narrow requirements by pharmaceutical or medical device
- Topic: Filter topics by Aggregate Spend or State Drug Price Transparency Reporting
- Region: Sort content into US-based (Federal, State, and Local) or International requirements
- Status: Focus on requirements that are pending, current, archived or those that did not pass
Curate Results to Match your Preferred Level of Detail
View content in summary or detail to best fit the needs of your search:
- Visual Summaries provide a quick reference guide of high-level requirements across all jurisdictions in scope per topic.
- Detailed Compilations (Navigators) outline requirements from disparate laws, regulations, and guidance documents in one convenient location, with links to authoritative sources for each topic and jurisdiction. As Navigators are updated, versions can be compared side by side with highlighted changes for quick review.
Featuring
Integrate Leading Reporting Software & Support
RegulatoryID is included for all MedPro ComplianceReportingID® customers, or can be licensed as a standalone solution.
MedPro’s Compliance Advisory Services engage with manufacturers at all stages of their lifecycles to build out and enhance all elements of effective compliance, including robust transparency programs.
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