Since the enactment of Open Payments (Sunshine Act), Life Sciences organizations have faced the daunting task of collecting, verifying, and reporting compliance-related spend and research. The necessary tracking is time-consuming and can be error-prone, leaving exposure to risk.
Penalties for knowing failure to submit timely, accurate, or complete information to the Centers for Medicare & Medicaid Services (CMS) under the Open Payments program can range from $10,000 to $100,000 per transaction. A medical device company recently resolved allegations that it violated the Open Payments program by failing to accurately report payments to a covered recipient with a $1.11M settlement. CMS has signaled that additional enforcement actions are in the pipeline.
To reduce the chance of penalties and fines, organizations have been going to great lengths to track transactions and incorporate controls in their spend management systems. Additionally, due to the public nature of Open Payments data, the amount spent on physicians is often cited in the press and can fuel litigation in the age of the opioid epidemic, so reporting only what is required is a priority for many reporting entities.
The expanded scope of the Sunshine Act is a material change to the number and types of Health Care Practitioners (HCPs) that Life Sciences organizations need to track. In 2019 alone, 615,000 physicians received over $2B in general payments and more than $71.5M in research payments. Now more than ever, organizations need to review and strengthen their HCP processes and make sure the tools they use to track HCP spend are robust, evolving, and incorporate the new requirements.
Changes to Open Payments Requirements
On October 24, 2018, President Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act) that amended the definition of a “Covered Recipient” in Open Payments. On Friday November 1, 2019, CMS issued its final rule implementing this change for data collected in 2021 to be reported in 2022:
- The definition of a “Covered Recipient” is expanded to include five additional provider types:Physician Assistants (PA)
- Nurse Practitioners (NP)
- Clinical Nurse Specialists (CNS)
- Certified Registered Nurse Anesthetists (CRNA) (including Anesthesiologist Assistants)
- Certified Nurse Midwives (CNM)
Note: For simplicity, we will refer to the NP, CNS, CRNA, and CNM providers collectively as Advance Practice Registered Nurses (APRN) for the balance of this article. CMS recently issued guidance classifying PAs and APRNs as Non-Physician Practitioners (NPP).
- Added three new Nature of Payment categories:
- Debt Forgiveness
- Long Term Medical Supply or Device Loan
- Consolidated two Nature of Payment categories (Accredited/Certified and Unaccredited/Non-Certified Continuing Education Programs) into Medical Education Programs
- Added reporting requirements for the Device Identifier (DI) component of the Unique Device Identifier (UDI) for devices and medical supplies.
Impact to Life Sciences – Focus on Non-Physician Practitioners
Capturing and reporting expense transactions for physicians is an already complex process for Life Sciences organizations and the addition of NPPs has only increased this complexity. Internal systems, data management, policies, and training all need to be updated to support the changes to the Open Payments program.
The number of licensed physicians in the United States has been declining and this trend is expected to continue. Conversely, there has been steady growth in the number of licensed NPPs, along with expanded scope of practice and prescribing authority for these professions. Due to these changes, Life Sciences companies frequently interact with NPPs in the same manner as physicians. The difference being that up until 2021 these NPP interactions were not reportable Federally.
Including NPPs increases the number of possible reportable HCPs by 350k – 400k.
The number of licensed NPPs in the US is only part of the challenge. For example, licensing of APRNs varies from state-to-state. Some states use the APRN Consensus Model, which standardizes education, accreditation, certification, and credential identifiers across their member states – but many do not. This inconsistency results in more than 400 variations of state license credentials for APRNs. Another complication is how states identify RN vs. APRN licenses and which version of the nursing license is reporting in the NPI record. Here are a few examples:
- Alabama uses the same number for RN and APRN licenses with a different license type.
- Florida issues RN and APRN licenses using the same number with a different prefix.
- California issues separate RN and APRN licenses by role, plus an Additional Furnishing License to NPs and CNMs (Prescribing Authority).
A recent analysis by MedPro Systems identified wide variations in the license or licenses APRNs reported in their NPI records; some only reported an APRN license, some only reported a RN license, and some reported multiple licenses.
We also anticipate changes to existing state and local reporting requirements due to the principle of preemption, which prohibits any state or local law from requiring a reporting entity to disclose the type of information covered by the Federal Sunshine Act. States will likely either have to remove or change in some meaningful way their reporting requirements for NPPs.
Ensure Your Organization is Ready for Non-Physician Practitioners
The bottom line is that Life Sciences organizations have thousands of additional HCPs to track and need to manage the complexity of identification, licensing, and certification differences by state, in addition to the sheer increase in the volume of transactions to be reviewed. Here are five steps to ensure your organization meets the expanded requirements:
- Leadership: A cross-functional team with members from Transparency, Commercial Operations, Medical Affairs, Clinical Operations, and Legal can confirm compliance with the new requirements. CMS created a new webpage with information regarding the expansion. Follow CMS for additional guidance.
- Processes: Review your HCP data collection process from data capture through reporting and auditing. Make sure your systems and processes (including internal resources and external vendors) are prepared for the additional data collection, review, and remediation.
- Data Management: Take time to engage with your Data Management team. What attributes do you currently gather for NPPs and how are NPPs identified? Consider doing a review and update using a validated HCP database such as our 27 million record HCP database, MedProID®, which validates HCP license information obtained directly from state licensing boards.
- Spend Capture: Review your spend capture process and the critical opportunities for error. Are your users entering HCP names and license numbers by hand? It may be time to consider an integrated solution to minimize accidental data inaccuracies. MedPro Systems’ connector for Concur Expense and Concur Invoice eliminates manual entry of HCP data and quickly captures comprehensive HCP data elements required for Federal Open Payments and State Aggregate Spend reporting. The MedPro Concur Connect suite of solutions also offers a one-step export of HCP data to any Aggregate Spend reporting platform. While other solutions provide HCP data that is beneficial commercially, the MedPro Systems’ connector for Concur Expense and Concur Invoice provides the compliance data necessary for reporting.
- Reporting Tools: Don’t forget the importance of creating accurate and timely reports for CMS. Consider using a reporting process that doesn’t leave your compliance to chance by using a dedicated vendor solution for Aggregate Spend reporting, such as MedPro ComplianceReportingID™, an end-to-end reporting solution to prepare compliant disclosure reports.
How MedPro Concur Connect Can Help
The expansion of the Sunshine Act increases the burden of capturing and reporting accurate HCP data especially as the volume of transactions that needs to be captured increases.
The MedPro Concur Connect suite of solutions currently supports over 400 Life Sciences companies with accurate HCP data in Concur Expense and Concur Invoice, with seamless integration to any Aggregate Spend reporting solution. NPP license capture is fully supported across the MedPro Concur Connect suite, allowing customers to effortlessly adapt to the upcoming expansion reporting requirements.