Following yesterday’s teleconference with physicians and teaching hospitals, the Centers for Medicare & Medicaid Services (CMS) held a webinar today regarding the National Physician Payment Transparency Program, also known as Open Payments. The CMS Open Payments system implements the requirements of the Physician Payments Sunshine Act, section 6002 of the Affordable Care Act. The objective of the webinar was to discuss with pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) the collection, tracking and reporting of payments and transfers of value related to research. CMS provided a high-level overview of the reporting requirements related to research and examples for implementing the research reporting template specifications. CMS also notified participants that 25 new frequently asked questions (FAQs), several related to research, were released earlier this week.
Some key areas discussed by CMS related to research included the following:
- Manufacturers and GPOs must report research payments that are provided directly or indirectly, such as through a clinical research organization (CRO). For line 31 of the research reporting template, the manufacturer or GPO will be listed as the entity making the payment for both direct and indirect payments. Further, the manufacturer or GPO reporting the payment does not need to designate whether the payment was provided directly or indirectly.
- If multiple payments are made to a recipient for research under a research agreement, such as a research grant that is paid on a quarterly basis, the payments should be aggregated and reported as one payment using the date of the first payment. However, research-associated payments that are not part of the overall research agreement, such as expenses for travel or meals, may be reported on the general reporting template.
- CMS confirmed that the delayed publication provision will extend to research payments related to new applications of existing products.
- CMS stated that it is up to each manufacturer or GPO to determine the value of product that is provided in connection with research. No guidance will be provided by CMS for this determination.
- Manufacturers and GPOs likely will be able to report more than 5 principal investigators for research payments.
CMS emphasized that it is aware of the reporting challenges for research due to the multitude of ways that research arrangements can be structured and the various expenditure categories that can be associated with the research payments and transfers of value. CMS stated that this was the reason for the creation of the research reporting template separate from the general reporting template. CMS also stated that additional FAQs will continue to be generated.
Additionally, CMS described some resources available to manufacturers and GPOs to assist with tracking and reporting payments under the Sunshine Act. For example, the research reporting specifications are available on the CMS website and questions can be submitted to the CMS Help Desk (firstname.lastname@example.org). CMS has made mobile applications available for physicians and industry to assist with tracking payments and transfers of value. CMS also hopes to release a “user’s guide” by the end of this month.