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Open Payments


Frequently Asked Questions about Cook Medical's approach to Open Payments (U.S. Physician Payments Sunshine Act)

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 U.S. Physician Payments Sunshine Act, now more commonly called Open Payments, required that in mid 2013 we begin tracking our financial interactions with physicians and teaching hospitals. The 2013 financial information was reported on a public, government website by the Centers for Medicare & Medicaid Services (CMS) in September 2014. Financial information will be reported annually

See below for answers to commonly asked questions that physicians have about Cook’s approach to Open Payments. See the box at top right for links to more information about Open Payments.

What is Open Payments and why was it enacted?

Open Payments (commonly 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.

Who is affected by Open Payments?

U.S.-licensed physicians and U.S.-based teaching hospitalsgroup purchasing organizations (GPOs), and manufacturers of drugs, medical devices, biologicals, and medical supplies.

Physicians are defined as U.S. 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.

CMS is scheduled to annually provide at www.cms.gov a list of teaching hospitals that receive federal funds for their graduate medical programs.

What is being reported and when?

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:

  • The physician’s name.
  • The dollar amount of the payment or transfer of value.
  • The nature of the payment (chosen from a pre-determined list of categories—see the next question for more information).
  • A brief contextual description of why the payment was needed.

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.

June 30 annually: CMS is scheduled to publicly post the data from the previous calendar year.

What is a transfer of value?

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.

  • Charitable contributions
  • Consulting fees or (fee-for-service work)
  • Education
  • Entertainment
  • Food and beverage
  • Gifts
  • Grants
  • Honoraria
  • Research activities, including enrolling patients in clinical trials
  • Royalties
  • Speaker fees
  • Travel and lodging

Can I find out what's being reported from Cook Medical under my name?

Yes. You have 2 options.

  1. Physicians and teaching hospitals may request a report directly from Cook Medical at openpayments@cookmedical.com or by calling 1.800.457.4500.
  2. Physicians and teaching hospitals can view the data on the CMS website during the review period. They need to register to access the database.

Will physicians and teaching hospitals need to report transfers of value?

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.

Also, expenses are recorded at the time payment is issued to the physician or teaching hospital, not the time the expense was incurred. For example:

  • A physician pays for travel to teach a product training course for Cook in July of 2014.
  • Cook issues a reimbursement check to the physician in August 2014.
  • August 2014 will be the date that will appear in the CMS database for that transfer of value, not July 2014.

Are any transfers of value exempt from reporting?

Yes. Here is a partial list of exempt payments or transfers of value:

  • Payments or other transfers of value less than $10.18, except when the total annual value of payments or transfers of value provided to a physician is more than $101.75. (Note that these are the value thresholds for 2014. For 2015, transfers of value less than $10.21 are exempt, and the annual limit is $102.07.)
  • Items valued under $10.18 provided at large-scale conferences or events, where it would be difficult to establish the identities of the recipients of the item. (Note that this is the value threshold for 2014. For 2015, transfers of value less than $10.21 are exempt.)
  • Educational materials that directly benefit patients or are intended for patient use. This does not include educational materials provided to physicians for their own education.
  • Discounts and rebates.
  • In-kind items items for the provision of charity care.
  • Product samples, which are defined as demonstration and evaluation products that are intended for patient use.
  • Short-term (less than 90 days) loans of equipment, such as medical mannequins.

Please visit the CMS Open Payments website for more information.

Can I reimburse the company for a transfer of value after the fact?

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.

What if I disagree with a transaction that has been reported to CMS?

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.

Where can I get more information about Open Payments?

The CMS and AMA websites both have more detailed information about Open Payments.

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.