Discussions about the impact of major pharmaceutical firms on both the public and private sectors of healthcare are prevalent. Historically, these corporations enticed healthcare experts through pharmaceutical meeting planning, frequently including exotic trips, lavish meals, and significant gifts.
This practice eventually raised concerns about how they influenced doctors’ prescribing habits and the treatments they recommended to their patients.
In 2010, The Physician Payments Sunshine Act (Sunshine Act) was passed as part of the Affordable Care Act (ACA). The act oversees the transparent reporting of endorsements between pharmaceutical companies and physicians. This enables consumers and patients to have access to the right prescribed medication.
The act provides a barrier to protect consumers against biased decision-making and ensures that the relationship between drug manufacturers, producers of medical devices, and biologicals and physicians remain democratized through transparent systems that monitor payments and items of value offered to physicians and teaching hospitals.
What is the Sunshine Act
As already mentioned, the Sunshine Act was introduced back in 2010 by ACA which oversees fair and equal healthcare access to all American citizens. As part of the act, all drug manufacturers are requested to submit an annual report to the Centers for Medicare & Medicaid Services (CMS).
Moreover, the Sunshine Act requires group purchasing organizations (GPOs) to also declare specific ownership interests that are held by their partnering physicians and any immediate family members that might be involved in ownership interest.
Reporting of Transfer of Value
Today, a general rule is that all involved parties such as manufacturers of drugs, biologicals, and other medical devices annually disclose the transfer of value to physicians and educational teaching hospitals.
This means that any transfer of value, which refers to goods and items received, will need to be entered into the Open Payments portal. Transfer of value items can include meals, lodgings, honorarium, gifts, speaker fees, travel allowances, and any specific investor interest individuals might have.
How Does the Sunshine Act Improve Transparency
Manufacturers, such as those mentioned above are required to submit an annual declaration clearly stating payment and transfers of value made to covered recipients.
Seeing as The Centers for Medicare & Medicaid Services (CMS) fulfills this law via the Open Payments Program and platform, it’s now possible for individuals to look up any registered physician in the United States.
Estimates suggest that in 2021, more than 12.1 million records were published and managed to track close to $11 billion in the transfer of value.
While on the surface it might seem like a tedious administrative burden, these efforts are helping to keep the healthcare sector transparent and provide access to ordinary citizens to view and report any possible disputes at any given time.
Pharmaceutical Meeting Planners
Pharmaceutical meetings and networking events are essential collaborations between manufacturers and pharmaceutical healthcare professionals. These events provide industry specialists, experts, and professionals to partner on new developments and sector-specific innovations.
In addition to their other benefits, these events serve as critical tools in pharmaceutical event management, building a climate suited to drawing new business on a large scale. This is an important component of the pharmaceutical industry’s growth strategy.
The variety of commercial options created includes pharmacies, teaching hospitals, private clinics, and cooperation with industry influencers.
Furthermore, as part of the conference strategy, companies often launch new pharmaceutical products or services during the meeting to increase their brand awareness. This is usually where companies promote their business ventures and hope to drive more community-level influence.
With big companies working to foster new lasting relationships in the hopes of securing marketplace influence and growing their dominance against competitors, the value of transfers often goes unnoticed or unreported. This is where the Sunshine Act is vital in ensuring a transparent system between both entities or the involved parties.
Check Out Sunshine Act Overview:
How the Reporting Process Work
As already noted, several expenses are reported and tracked via CMS. Any company that fails to declare its expenses or provides false information will be subject to a fine ranging from $10,000 to $1,000,000. Companies must provide as much information as possible and read the data into the system.
Types of expenses that are required to be submitted under the mandate of the Sunshine Act include:
Declaration of Payments
Typically payments don’t necessarily refer to physical “cash” but instead to payments or transfers of value such as food and drink, any gift, travel, accommodations, contributions to charity, and even entertainment. The Sunshine Act also oversees that all licensed professionals that engage in payment activities in international agreements must declare those payments after the meetings.
Regardless of where these meetings occur, regulations require manufacturers to focus on gathering the in-person data and establish a developing system that helps consumers better understand the reporting criteria for companies.
Data collection
Once a payment has been accepted or approved by the doctor or physician, drug manufacturers will then need to collect all relevant data and verify the accuracy thereof.
Once the data has been analyzed and categorized, only then can it be submitted into the CMS reporting system. Afterward, the data is then cross-checked for accuracy and published on the Open Payments System, which then only allows citizens to review the data table. Gathering the data makes it easy to create reporting systems and focus on delivering transparent services to individuals.
Change of Declarations
Manufacturers must track and report any payment, regardless of size or distribution method, during the meetings. Each year the threshold for declarations changes, which means that all annual payments will need to be reported.
Information Required
Finally, to ensure that all parties remain compliant with federal regulations outlined in the Sunshine Act, manufacturers must collect all the necessary data about payments and transfers of valuable information from all client meetings.
Further information such as personal and business contact details, manufacturing license numbers, and all relevant spending data such as the form of payment, date, and exchange is provided to CMS.
Tips for Pharmaceutical Meeting Planners
Keeping track of all this information is a tiresome procedure that requires a lot of physical working hours to analyze and compile. For pharmaceutical planners that engage with hundreds, if not thousands, of professionals at a networking event, keeping tabs on everyone quickly becomes daunting.
Service and product meetings now have a focused reporting system that ensures regulations are abided by, and data creation is easier for both private and public entities.
Instead, new and innovative technology enables the Sunshine act meeting planner to have more control over specific requirements and the information they have received throughout the event.
Here Are Some Tips for Meeting Planners:
Use Software Programs
Instead of having professionals complete forms the traditional way, consider using software specifically designed for these sorts of meetings and events. The software will enable meeting planners to better control and track the value of transfers.
Establish a List of Existing Physicians
With the aid of technology, meeting planners can establish a database of existing physicians they have worked with and engaged with. This will ensure that in the event of recurring payments, or possible changes, planners can seamlessly access the information they require. Even after meetings have been finalized data can still be updated accordingly.
Update the Database
Having a database of existing physicians and doctors is one thing, but not keeping it up to date can make it harder for companies to declare their information to the CMS system. Be sure to conduct regular updates at intervals, ensuring that all captured information is accurate and can be reviewed in case of a dispute.
Prepare Materials Beforehand
Before any pharmaceutical event, prepare any materials required for any meetings. This gives a person enough time to review the mandated information required by CMS and Open Payments. Additionally, it ensures that companies remain current about any possible declaration changes that might have occurred since the last submission.
Use Apps When Possible
As mentioned, software and technology have enabled meeting planners to have seamless access to information and data whenever required. Moreso, some apps exist purely to make the job of meeting planners a lot easier in capturing important information or transfers of value.
These apps were designed to make the process easier for doctors to accept or decline transfers of value during meetings. Digital signatures are captured and uploaded to an overall transfer of value report, which is then later submitted to the Open Payments System.
FAQs
Who Does the Sunshine Law Apply To?
The Sunshine Law is part of the Affordable Care Act (ACA) and applies to all manufacturers of pharmaceuticals, medical devices, and biologicals that are active participants in the U.S. federal health care system.
Is the Sunshine Act real?
The Sunshine Act was introduced to the Senate in 2007 by Senator Charles Grassley (R-Iowa) and Senator Herb Kohl (D-Wisconsin). In 2010 it was enacted along with the Patient Protection and Affordable Healthcare Act. Then on 30 September 2014, the Open Payment Program portal was launched with the first available data provided by the Centers for Medicare and Medicaid Services.
What Are Sunshine Requirements?
The Sunshine Act requires that all meetings of boards and commissions be made open to the public; a reasonable time notice of meetings must be given; information and minutes of the meetings must be captured.
What is a Sunshine Act meeting?
Any meeting conducted by an agency that is open to public observation, and is mandated to the collegial bodies of upper federal government agencies.
Final Thoughts
The efforts of The Sunshine Act ensure that citizens have the right and access to view any payments received by healthcare professionals such as doctors and physicians by manufacturers of drugs, medical devices, and biologicals.
This enables a transparent system that helps to democratize the federal government healthcare system to ensure fair and equal distribution of prescription medication is provided to civilians.
While the system exists within the realm of the public, pharmaceutical meeting planners are required to keep track of all transfers of value at conference or meetings. This requires them to utilize software-based programming that helps them to capture necessary information that can later be amended and submitted to the Open Payments System.
