Sunshine Act Compliance

Physician Payments Sunshine Act (PPSA)

The Physician Payments Sunshine Act requires applicable manufacturers of drugs, devices, biological, or medical supplies to report annually to the Secretary of Health & Human Services (HHS) for certain payments or other transfers of value to physicians and teaching hospitals organizations to become compliant.  The ruling also finalized requirements for these same applicable manufacturers as well as Group Purchasing Organizations (GPOs) to annually report information about certain ownership or investment interests held by physicians and immediate family members of physicians, as well as payments and other transfers of value to such physicians.

Applicable manufacturers include all companies operating in the US that manufacture drugs, devices, biologics, or medical products that are reimbursable by the US Federal Government or are under common ownership of such companies. Similar to other compliance requirements in other areas, the proposed rules suggest that the Sunshine Act will apply to all companies that manufacture products that are reimbursed by the US federal government, irrespective of geographic location.

In terms of compliance dates, applicable companies must be compliant starting as of August 1, 2013. This means they will need to submit submitted data collected from August through December 31, 2013 to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014.  Moreover, this data will be published to a public website by September 30, 2014.

Identifying HCPs

The first step of any Sunshine Act compliance framework requires you to uniquely identify Health Care Providers (HCPs), upfront and across systems. Sorting through the various systems and flagging HCPs retrospectively can be a daunting task. Therefore, most organizations are looking to onboard HCPs in the same way as other types of suppliers. This ensures a common process to easily identify each new HCP, collect the necessary information, and assign a unique number to be used by other systems –such as accounting, CRM, event management, and travel and expenses.

You should be concerned with:

  • Significant internal costs associated with manually identifying HCPs
  • Difficulty in uniquely identifying HCPs across multiple systems
  • Missing HCP degree information, ownership/investment interests, and “agreement to disclosure” on HCPs
  • Revenue loss due to noncompliance

Organizations that can establish a common onboarding process for HCPs will avoid much of the manual effort required for Sunshine Act compliance, such as ensuring HCPs have agreed to Sunshine Provisions disclosure. Furthermore, organizations can avoid the lengthy manual data cleansing and identification exercises required to aggregate and reconcile the different payment sources.

Identifying HCP Spend

Compliance with the Sunshine Act, and other similar laws about to be passed across different states and the EU, will make the efforts of meeting planners, legal, marketing, sales, and sourcing departments more difficult as they learn to cope with the additional requirements.

You should be concerned with:

  • Cost inefficiencies of manually collecting and categorizing the different categories of HCP spend
  • Ability to capture physician ownership or investment interests
  • Ability to capture second-tier HCP payments made by third parties on your behalf
  • Ensuring HCPs agree to disclose the required information as per the Sunshine provisions
  • Ensuring compliance to local payment restrictions for HCPs

The key issue around HCP reporting is that the required information may come from a variety of different sources, such as a sales meeting, speaker fees, or attendance at a specific event. Some of the costs may come directly through invoices or expense receipts, or from third parties managing events and making payments on your behalf. Reconciling all these items without a unique identifier and repository for all HCPs becomes a near impossible task for organizations without intelligent compliance management solutions.

A seamless, automated, and integrated approach to collecting the HCP spend data is vital – and the ability to provide self-service directly to HCPs and Tier-2 agencies further reduces internal compliance efforts.

HCP Reporting

HCP Reporting is set to grow beyond just the Sunshine Act. Eight states already have legislation. Six states require the reporting of payments to individual HCPs, and three more require the adoption of a Code of Conduct or Compliance program. Twenty-three other states as well as the US Congress are considering similar legislations.

You should be concerned with:

  • Compliance with existing and upcoming regulatory requirements around HCP reporting
  • Ability to monitor, across organizations and systems, all payment activity that totals over $100 to an HCP within a given year
  • High fines from not meeting related HCP spend reporting deadlines

Solution

HICX’s Supplier Compliance solutions help customers overcome these difficulties. Our Physician Payments Sunshine Act solution provides preconfigured templates to identify, collect, and report relevant HCP payments and investment interests.

You can easily use our solution with your existing expense management, event management, and spend tools to pull existing information, or as a standalone solution. Our solution will enable you to:

  • Have access to preconfigured reports and dashboards for management and government submissions
  • Capitalize on preconfigured import/export templates to integrate with your ERPs (e.g., invoice), corporate card provider T&E tools (e.g., Concur), event management tool, or business intelligence platforms
  • Streamline the electronic request, approval, and onboarding of HCPs
  • Assign a unique “golden” record number for each HCP
  • Automatically distribute the unique HCP number to all necessary downstream and upstream systems (e.g., ERP, event management system, spend reporting system)
  • Capture relevant address, bank details, certificates, and Tax IDs
  • Gather upfront agreement to Code of Conduct and disclosures required under the Sunshine provisions
  • Enable HCPs to self-maintain their information, including the import and submission of travel expenses
  • Collect and report on second tier HCP payments made from third parties on your behalf

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