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Collaboration with physicians to develop innovative advancements in medical treatments has been an important part of our history at Cook Medical. For more than 50 years, physicians have worked with us to develop products, conducted clinical trials on our products, and helped us with product training for other healthcare professionals.
Laws have been created in the United States to encourage transparency in the relationships between physicians and industry. The 2010 US Physician Payments Sunshine Act, now more commonly called Open Payments, required that in 2013 we begin tracking our financial interactions with physicians and teaching hospitals. Annually, the financial information is reported on a public, government website by the Centers for Medicare & Medicaid Services (CMS).
See below for answers to commonly asked questions that physicians have about Cook’s approach to Open Payments. See the box on this page for more information about Open Payments.
Open Payments (also known as the Sunshine Act) requires that medical device, pharmaceutical, biological, and medical supply manufacturers report certain transfers of value made to physicians and teaching hospitals.
This legislation was introduced by Senator Grassley (R) and Senator Kohl (D) and became law as part of the 2010 Patient Protection & Affordable Care Act.
One goal of the law is to increase transparency regarding the extent and nature of relationships between physicians, teaching hospitals, and industry manufacturers to help patients make better-informed decisions when choosing healthcare professionals and making treatment choices.
Another goal is to deter the kind of financial relationships that can sometimes lead to increased healthcare costs.
US-licensed physicians and US-based teaching hospitals, group purchasing organizations (GPOs), and manufacturers of drugs, medical devices, biologicals, and medical supplies.
Physicians are defined as US state-licensed doctors of medicine, osteopathy, dentistry, podiatry, optometry, and chiropractic medicine, even if they are not currently practicing. Fellows, but not residents, are included.
Annually by March 31, Cook must submit a detailed report to CMS of payments or transfers of value made the prior calendar year. The financial reports include:
Review and dispute period: After CMS combines all the reported data, registered physicians and teaching hospitals are given 45 days to review the data for accuracy and resolve disputes with the manufacturers. A template dispute form is available to physicians and teaching hospitals registered with CMS to view the data. Manufacturers then have 15 days to correct and resubmit the data.
Each year by June 30: CMS publicly posts the data from the previous calendar year.
Providing anything with discernible economic value, tangible or intangible, directly or indirectly. Below are examples of what is considered a transfer of value under Open Payments. These are called “nature of payment” in the CMS database and are considered a transfer of value.
Yes. You have two options.
No, physicians and teaching hospitals do not need to collect or submit to CMS data about transfers of value they have received. They may want to keep track of payments received from manufacturers so that they can verify that the correct information was reported, however.
Note that some transfers of value to physicians in a group, such as at a group dinner, are averaged across the number of attendees. The reported average dollar amount is not specific to what each person ordered from a menu.
Expenses are recorded at the time payment is issued to the physician or teaching hospital, not the time the expense was incurred.
Yes. Here is a partial list of exempt payments or transfers of value:
Please visit the CMS Open Payments website for more information.
No, CMS has decided that reimbursement is not allowed after a transfer of value has occurred. However, at events that qualify as reportable transfers of value, we are able to offer physicians the option of paying for their own expenses before the expense is incurred. If they register for this option at the time of the event, physicians are sent invoices after the event to pay within 30 days.
Before each annual posting of data, physicians will be given 45 days to review the data and resolve disputes directly with manufacturers. Manufacturers then have 15 days to correct and resubmit the data.
Physicians and teaching hospitals will need to register with CMS to access the database and to dispute data that has been reported. The CMS website provides a dispute template.
In addition, we at Cook Medical have a team who can help with questions from physicians and teaching hospitals. Please feel free to send us an email at OpenPayments@CookMedical.com or call us at 1.800.457.4500 with your specific questions.