In June, the Centers for Medicare and Medicaid Services ("CMS") published its 2021 data from the Open Payments Program. The Open Payments Program makes information available to the public about financial relationships between certain manufacturers and group purchasing organizations ("Reporting Entities") who make payments or transfers, and certain recipients, who are known as Covered Recipients. Covered Recipients are health care providers of various types, including physicians. In 2021, CMS expanded the Open Payments Program by adding five new provider types as Covered Recipients and three additional Nature of Payment categories. Further, device identifiers for medical devices were added, as well as the NPIs of Covered Recipients.

Open Payments consist of payments and other transfers of value, along with ownership and investment interests in the Reporting Entities. The types of payments that are reported are categorized into Nature of Payment Categories, which include: 1) General Payments, which are not associated with a research agreement or research protocol; 2) Research Payments, which are made in connection with a formal research agreement or research protocol; and 3) Physician Ownership Information, which consists of ownership or investment interests held in the Reporting Entities. In 2021, CMS added new Nature of Payment Categories for debt forgiveness, long-term medical supply or device loans, and acquisitions.

C overed Recipients include physicians (excluding medical residents) who are not employees of the Reporting Entities, and teaching hospitals. In 2021, CMS added physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, anesthesiologist assistants, and certified nurse midwives to the list of Covered Recipients.

Open Payments of $10.9 billion were reported during 2021, consisting of 12.10 million records. The largest Nature of Payment Category in terms of dollar value was research payments, which were reported at $7.09 billion. The largest number of payments were in the General Payments category, with 11.42 million payments being reported. Physicians received both the largest number of payments and the greatest monetary value of payments, with 533,056 payments worth $3.37 billion.

The Open Payments Program consists of four phases of activities: 1) Data Collection; 2) Data Submission; 3) Pre-Publication Review, Dispute, and Correction; and 4) Data Publication.

During the Data Collection phase, which covers a calendar year, Reporting Entities collect data about payments they made to physicians and other Covered Recipients and ownership or investment interests held by Covered Recipients.

During the Data Submission phase, which lasts from February 1st through March 31st of each year, Reporting Entities submit data that was collected during the previous calendar year.

During the Pre-publication, Review, Dispute, and Correction of Data phase, physicians and other Covered Recipients have the opportunity to review reported payments and other transfers of value - such as investment interests - that have been attributed to them. From April 1st through May 15th, Covered Recipients have the opportunity to dispute or inquire about data submissions that are believed to be inaccurate or incomplete.

The process of disputing a payment is relatively simple. A dispute may be filed by logging into the Open Payment system via the CMS Enterprise Portal at https://portal.cms.gov/ and select the "Review and Dispute" tab on the menu bar. Search functions can be used to select the appropriate Covered Recipient and the record to be disputed. A "Dispute Record" button opens the "Dispute Record" page and the reason for the dispute can be entered into a text box and submitted directly from the website. In 2021, there were 409 disputed payments, with a monetary value of $13.42 million. So, although Covered Recipients are not required to review the submitted data, it seems like a good practice and CMS encourages the reviews.

When a Covered Recipient initiates a dispute or inquiry, the Reporting Entity has 15 days to respond and ensure that the final report is accurate, by either confirming or correcting the reported data. Accordingly, the period for the reported data to be either confirmed or corrected before publication ends on May 30th. In the interest of accuracy, however, reported data may be corrected or updated after May 30th, and the correction or update will be reflected in subsequent data refreshes or publications.

The Data Publication phase requires that the submitted data be published by June 30th of each year and the data is displayed by CMS at http://openpaymentsdata.cms.gov.

As mentioned above, it is a good practice for physicians to review Open Payment data to make certain that any payments attributed to them are accurate. CMS provides a number of resources for that purpose, including an extensive user guide and a tutorial for the dispute process, which may be accessed at https://www.cms.gov/OpenPayments/Resources/Covered-Recipients.

Additionally, for assistance with Open Payments-related inquiries, CMS provides a help desk that can be reached by telephone at 1-855-326-8366 or by email at openpayments@cms.hhs.gov.

James Henry is a partner with Phelps Dunbar where he specializes in healthcare law.