5 Things to Do to Prepare for the Coming Sunshine Act Expansion

Bryan Andrews |

Since the enactment of Open Payments (Sunshine Act), life sciences organizations have faced the daunting task of collecting, verifying, and reporting compliance-related spend. The necessary tracking is time-consuming and can be error-prone, leaving exposure to risk. Penalties for willful or fraudulent reporting to the Centers for Medicare and Medicaid Services (CMS) under the Open Payments program can range from $10,000 to $100,000 per expense report line item.

Life sciences companies are required to report to CMS any direct or indirect payment or other transfers of value (ToV) provided to a covered recipient or any payment provided to a third party on behalf of a covered recipient during a calendar year. ToVs are broadly defined and can include expenses ranging from simple meals to speaker’s fees to stock options. Companies are required to capture the specifics of expenses that are reportable, including who the ToVs were provided to, the type of expense, amount of expense, form and nature of payment, and related drug or device information.

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 manufacturers. 

The expanded scope of the Sunshine Act is a material change to the number and types of 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 ready for the 2021 shift.


Changes to Open Payments for 2021: Data collection and the impact to life sciences companies

Under the CMS Final Rule, the Open Payments program is impacted in the following ways for data collected in 2021 to be reported in 2022:

  • The definition of a “Covered Recipient” is expanded to include five additional provider types:
    1. Physician Assistants (PA)
    2. Nurse Practitioners (NP)
    3. Clinical Nurse Specialists (CNS)
    4. Certified Registered Nurse Anesthetists (CRNA) (CMS includes Anesthesiologist Assistants in the definition of a CRNA) 
    5. Certified Nurse Midwives (CNM)

We will refer to the NP, CNS, CRNA, and CNM providers collectively as Advance Practice Registered Nurses (APRN) for the balance of this article.

This is the first significant expansion to the Open Payments program since reporting started in 2013. Capturing and reporting expense transactions for required HCPs is an already complex process for life sciences organizations, and the addition of APRNs and PAs will only increase this complexity. Internal systems, data management, policies, and training will 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 APRNs and PAs, along with expanded scope of practice and prescribing authority for these professions. Due to these changes, life sciences companies interact with APRNs and PAs in the same manner as physicians. The difference, up until 2021, is that these interactions were not reportable at the federal level.

Including APRNs and PAs will increase the number of possible reportable HCPs by 350k – 400k individuals. 

The number of licensed APRNs and PAs in the U.S. 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.


5 ways to prepare for the expansion of the Sunshine Act

The bottom line is that life sciences organizations will have thousands of additional HCPs to track and will 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 take now to make sure you’ll be ahead of the game:

  1. Leadership: Establish a cross-functional team to implement the new requirements. Include members from Transparency, Commercial Operations, Medical Affairs, Clinical Operations, and Legal. Follow CMS for updates to reporting requirements.
  2. Internal Processes: Review your HCP data collection process from data capture through reporting and auditing. Make sure your systems and processes are prepared for the additional data collection and review.
  3. Data Management: Take time to engage with your Data Management team. What attributes do you currently gather for PAs and APRNs? Consider doing a review and update using a validated HCP database such as MedPro Systems' 25 million record HCP databases, MedProID®, which validates practitioner license information obtained directly from state licensing boards.
  4. 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.
  5. 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


Watch this video to learn how MedPro Concur Connect integrates with SAP Concur solutions to enable pharmaceutical and medical device companies to effortlessly maintain compliance with Open Payments physician spend tracking regulations.

Learn more about how MedPro Concur Connect can help you prepare today.