The lack of transparency has become a serious issue in the medical industry. As a result, the U.S. government established the Sunshine Act to create honesty and accountability in the industry. The Physician Payments Sunshine Act’s ultimate goal is to create transparency in the relationship between medical manufacturers and physicians.
Organizations manufacturing medical devices, supplies, and pharmaceutical products were allegedly getting into underhand dealings with physicians to promote their products. For this reason, the Sunshine Act was put in place to make it a requirement that any financial transactions between manufacturers and physicians be reported publicly. Besides, the manufacturers must report any financial interests that physicians or their family members have in the manufacturing companies.
To Whom Does Sunshine Act Reporting Apply
Generally, the Sunshine Act law applies to manufacturing companies in the medical field. To be specific, these are companies that produce medicine, medical supplies, medical equipment, and all other products used in the medical industry. Companies that deal with the production, propagation and conversion of covered drugs and devices must report any financial relationships with physicians. This applies to all such companies in the U.S.
Secondly, all companies under common ownership with type 1 manufacturing companies must comply with the act. This includes those companies that support the manufacturing companies to produce the products covered by the act. The act clearly defines all products and devices whose manufacturers must comply with the law in section 403.902. In simpler terms, the products in the list are all those that require premarket approval or notification.
Payment Definition as per the Sunshine Act
According to the act, the kind of financial transactions that must be reported include; research payments made to a physician in relation to a research agreement, general payments related to the research, and ownership and investment payments. The act also defines payments as cash and all other forms of rewards such as gifts, food, entertainment, and conference funding.
The Procedure of Complying with the Sunshine Act
For you to make sure that your company is on the right side of the law, the first step is to register with CMS’ Enterprise Identity Management (EIDM) and the open payment systems. Registration is easy, as it can be done online. Additionally, it will only take 30 minutes of your time. If you use a good browser, you can fill in the information and save it to continue later.
Open Payments also has a help desk where you can make calls to enquire about the registration process. Financial transactions above $107.91 per year must be reported. The reporting must be done in detail and must include the following information:
• Recipient’s information or the physician receiving the money.
• Amount of money in question and how the money was transferred.
• Information relating to the product in question for which payment was made.
• Any research-related information where applicable.
• Any ownership information where investment was made.
• Any other details relating to that transaction, including all non-financial payments made to the physician.
After collecting the data above, the company must attest to it, indicating that it is accurate and has no misleading elements. Additionally, some information may be similar for various transactions, which makes the reporting process much easier. The data must be submitted to CMS according to the stipulated deadlines. Typically, CMS publishes this information on its public page by the end of June every year. The page also guides manufacturers on how to make proper reporting.
Misunderstandings About to Sunshine Act
There is a misconception that transactions reported on CMS are illegal. The Sunshine Act does not identify transactions to be legal or illegal. It just makes it a requirement to report for purposes of transparency. Therefore, companies who report on CMS are not necessarily engaging in underhand dealings.
This information is important because most people who do not comprehend it may avoid buying from manufacturers on CMS. Additionally, physicians who have business with manufacturers face challenges when they are misjudged as unethical. Therefore, filing transactions with CMS does not mean that something illegal has taken place.
Secondly, Sunshine Act Reporting does not, in any way, exempt companies or physicians from liability.
The fact that a transaction was transparent does not mean it was legal or illegal. Some transparent transactions are violating the federal Anti-Kickback Statute. Some companies still find themselves on the wrong side of the False Claims Act even after reporting their CMS transactions.
It is also not the goal of raising public awareness about financial relationships to increase trust in physicians. Public disclosure of that information does not affect respondents who know that their physicians have received payments from medical companies. Instead, it only increases the number of people who know that payment information is publicly available if they needed it.
However, as a result of the Sunshine Act, many patients have lost trust in their doctors. The loss of trust affects not only the doctors who have received payments but all doctors in general. The public simply assumes that all doctors cannot be trusted because there is information about some doctors receiving payments from medical supply companies. Therefore, it is highly recommended by physicians that journalists make it clear that the majority of the doctors do not receive any form of payment from manufacturing companies.
Manufacturing companies should make sure that they do not hurt the reputations of physicians they engage within the process of being transparent. This can be done by explaining why various payments were made and how that relationship with the physicians aims to benefit the public. This not only creates a sense of trust in patients, but it also shows the important roles that the manufacturers play in the medical industry.
The government should also be vigilant in clearing any form of misunderstandings that may arise due to compliance with the Sunshine Act Reporting. This would help to make sure that all the parties involved get a fair deal. The medical industry is very sensitive as it deals directly with patients’ welfare, which is why the Sunshine Act is necessary. However, it should be used for all parties’ good and should not hurt the reputation of innocent companies