According to the Centers for Medicare and Medicaid Services, there has been a final ruling on the National Physician Payment Transparency Program: Open Payments, better known as the Sunshine Act. Under the Open Payments program, data collection of medical device and drug manufacturers who send gifts and payments to physicians and teaching hospitals is now mandatory. This applies to any manufacturer who receives government reimbursement, and collection data will be posted on a public website as of September 30, 2014.
Impact on Clinical Trial Research
Several concerns have been voiced regarding the Sunshine Act as noted by Policy Med. The ruling is so called the Sunshine Act as supporters hope the ruling will shine a light on the connection between pharmaceutical companies and gifts made to those in the medical field. The notion here is that those medical persons and teams who are supporting big pharm research are more likely to use the medical products of said researchers once they receive gifts and payments from the pharmaceutical companies conducting the research. However, many in the medical industry to feel this ruling would be better named the Ruining Research Act. The premise is that there is so much red tape to be added to medical research due to the Sunshine Act that many researchers and training hospitals will be dissuaded from conducting vital research.
A recent study conducted of 103 primary care physicians in the US reported by the ISR states that 74 percent are not in favor of the ruling.
The main issue here is a lack of awareness and transparency of the act. From the study by the ISR:
Over one-third of PCPs are “not at all familiar” with the Sunshine Act and only 10% of principal investigators have a “complete understanding of the act.”
Fortunately of those surveyed by the ISR, “only a handful indicated they would be less likely to participate” in clinical trial research due to the Sunshine Act. Yet it will remain to be seen if this study will have a long term effect on the decline of clinical research trials.
Requirements for Open Payments Reporting
In order to improve the transparency of the Sunshine Act, physicians, hospitals and medical researchers should be fully aware of what is needed in terms of Open Payments reporting. Note that any data that is reported to the website can be reviewed by providers for 45 days before the data will go live. Here are some of the guidelines that are associated with the Sunshine Act:
Any research-related payments or transfers of any value to physicians or teaching hospitals must be reported to the CMS
In a report to the CMS the valued amount, name of the research institution, and the name of the recipient(s) must be included
For physicians solely as the recipient, they must report their name, National Provider Identifier, state professional license number, specialty, and business address
Teaching hospitals as recipients of gifts must include the name of the recipient and business address
For recipients who are neither a physician or teaching hospital, i.e. a clinic, the following information must be reported:
- Research study title
- Total amount of payment along with a detailed list of costs associated with the research via a research protocol and/or written aggrement
- List of all drugs, medical supplies, devices and biologicals that are included in the research study
- Details pertaining to the principal investigator of the physician as the recipient
Tips for Effective Reporting of Open Payments
According to the Huron Consulting Group there are several ways that physicians and training hospitals can remain compliant with the Sunshine Act.
The data will likely be scrutinized by government officials, healthcare organizations, and the public. Inaccurate reporting can lead to ruined customer relations, as well as financial penalties. Consider implementation of an aggregated spending program that will be reviewed at each transition to reduce errors.
Information that is required for data collection will need to be completed in full to prevent errors or common interest concerns.
So to meet the stringent requirements regarding listing the specific medical supplies and devices, all accounts related to the research including accounts payable, travel and entertainment expenditures, and sales force automation should be reviewed thoroughly to prevent errors.
By maintaining adequate record keeping with the Sunshine Act in mind from the onset of a clinical trial or research study, recipients of payment or gifts will be more likely to remain in compliance. The record keeping practice is the base level where hospitals and physicians will be able to protect themselves as the data collected via the Sunshine Act goes public.
To learn more about the requiremebt for Open Payments reporting for clinical trials and medical research studies, join us at CBI's 8th Annual Transparency & Aggregate Spend Forum (August 18-20, 2014 in Washington, DC).