Are you ready for 2021 Sunshine Act reporting changes?

Posted by on Tuesday, May 4th, 2021 in Compliance, Healthcare Transparency Reporting

The Physician Payment Sunshine Act (the “Sunshine Act”) – a federal law first adopted as part of the Patient Protection and Affordable Care Act of 2010 (“PPACA”) – requires the Centers for Medicare and Medicaid Services (“CMS”) to collect and display information reported by healthcare manufacturers and distributors about the payments and other transfers of value these organizations have made to physicians and teaching hospitals. Currently, CMS fulfills its Sunshine Act obligations to collect and report data to the public through the “Open Payments” program.


As described on the CMS website, Open Payments is designed to promote a, “more transparent and accountable health care system by making the financial relationships between applicable manufacturers and group purchasing organizations (GPOs) and health care providers (physicians and teaching hospitals) available to the public.”  As of 2020, the program has recorded and made available more than $43B in total payments and transfers of value from more than 2500 organizations going to more than 1M healthcare providers.


Changes to Open Payments for 2021

The program has introduced some significant changes for the 2021 reporting year based on a 2018 audit by the Office of the Inspector General (OIG).  As described in its audit report, the OIG recommended that CMS take a number of “practical steps” to, “improve the accuracy, precision, and consistency of the [Open Payments] data to better help consumers use the information.”  A summary of the changes are:

  1. Expand the type of healthcare providers required in the report to now include:
    • Physician assistants
    • Nurse practitioners
    • Clinical nurse specialists
    • Certified registered nurse anesthetists & Anesthesiologist assistants
    • Certified nurse-midwives
  2. Expand the “Nature of Payments” category to include:
    • Debt Forgiveness
    • Long term medical supply or device loan
    • Acquisitions
  3. Consolidated education categories: The accredited/certified and unaccredited/non-certified continuing education program categories are combined into one, “Compensation for serving as faculty or as a speaker for a medical education program.”
  4. Added reporting requirements for the ‘device identifier’ component of the unique device identifier for medical supplies and devices

2021 Open Payments Challenges

The expansion of the covered recipients will add upwards of 500,000 new parties that need to be included in the reporting.  More challenging will be the ability to accurately identify the newly-added covered recipients. Unlike physicians covered in previous years, many nurse practitioners and certified nurse specialists do not have a National Provider Identifier (NPI) number to uniquely identify them.  With more than 400 variations of state license credentials for nursing specialists, there remains some discretion on the part of the reporting entities on which recipients to include in their annual Open Payments reporting.


The new device reporting requirements to tag devices with a “device identifier” code will pose a significant challenge for device manufacturers because of the complexity of these devices.  A single device with multiple components may have a fit into multiple DIs defined by the FDA.  In FAQs issued by CMS regarding the Open Payments device data reporting requirements (updated by CMS as of July 30, 2021), CMS left it to the reporting entity’s discretion to identify the representative DI for the device/product at issue.  

Help Submitting Your Open Payments Data

Sapling Data has experts in data analytics and modeling who can help you extract and transform data from your internal transaction systems for Sunshine Act reporting.  We can cleanse and match payment data with healthcare providers and quickly identify and escalate conflicts or gaps in your data to get the job done with minimal impact to your operation.  Talk to Sapling Data today to learn more about our Healthcare Compliance Monitoring and Transparency Reporting solutions.  


Helpful Links:

PY 2021 Onwards – Submission Data Mapping Document (XLSX)

Covered Recipient Definition Expansion FAQs (PDF)

Program Year 2021 Physician and Non-Physician Practitioner Taxonomy List (XLSX)

Preliminary Medical Device and Medical Supply Reference Data (CSV)

Device Data Reporting FAQs (PDF)