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www.acell.com
ACell, along with other medical device, pharmaceutical, and biologics manufacturers
collaborate with healthcare professionals (“HCPs”) and healthcare organizations and institutions
(“HCOs”) to help ensure that patient’s’ needs are consistently being met and medical science
continues to advance through innovation, training, education, and research.
ACell is required under the Open Payments Program to track and report - on an annual basis
certain payments and transfers of value provided to physicians and teaching hospitals. ACell is
committed to complying with federal and state transparency laws, and to being transparent
regarding our financial relationships with HCPs and relevant HCOs.
The Centers for Medicare and Medicaid Services (“CMS “) have identified categories for
reporting under the Open Payments Program. Examples below are not all-inclusive. For a
complete list of categories, please reference the CMS website at: http://www.cms.gov/
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Name of the manufacturer providing the transfer of value
HCP or teaching institute recipient name and business address
Date of and value of payment or transfer of value
Method of payment or transfer of value i.e., cash, stock, stock options, in-kind items
Payment Categories – CMS has established unique payment categories which will be used
to report value transfers. Examples are:
o Food and Beverage
o Travel and Lodging
o Gifts
o Education
o Honoraria
o Consulting Fees
o Research
o Charitable Contributions
CMS has provided a method for physicians and teaching hospitals to review information
reported by ACell and other manufacturers.
Additional information on this issue can be obtained at:
https://openpaymentsdata.cms.gov/
Providing Business Meals to HCPs:
ACell employees and agents may offer business meals in conjunction with legitimate business
activities, such as providing a meal during a business meeting or during an educational event.
All business meals must: (1) be modest and reasonable in amount, (2) be provided infrequently,
6640 Eli Whitney Drive, Columbia, MD 21046
and (3) not be used to influence or give the perception of influencing clinical or business
decision-making.
ACell has established policies regarding business meal limits and appropriate venues for
employees and agents to utilize when providing HCP meals. Entertainment and recreation are
strictly prohibited.
Common Questions
1. What is a transfer of value?
A "transfer of value" is defined as "a direct or indirect transfer of value, whether in cash,
in kind or otherwise, made, whether for promotional purposes or otherwise, in
connection with the development or sale of medical devices, pharmaceuticals or
biologics".
2. What is a “direct” transfer of value?
A "direct" transfer is one made directly by ACell to the recipient of the benefit.
3. What is an “indirect” transfer of value?
An "indirect" transfer is one "made by a third party on behalf of a company for the
benefit of a recipient where the identity of the company is known to, or can be identified
by, the recipient".
Example: a third party conference organizer requests a Grant from ACell to support an
Educational Conference. The Grant is to cover speaking fees, travel and lodging for
HCPs to speak, AV equipment charges, and room rental fees at the educational
conference. As part of the Grant, the third party organizer requests ACell to provide a
recommended list of speakers on a particular topic. If ACell provides this speaker list and
the organizer uses one of the speakers, the amount of the grant used to pay the HCP
speaking expenses becomes a reportable transfer of value.
4. Can physicians review the specific data that concerns them prior to the data being
reported to CMS for the respective reporting period?
Yes, physicians can review their data prior to it being reported to CMS. In addition to
review, a dispute resolution process has also been established by CMS. If needing
additional information concerning the dispute resolution process it can be found at
www.cms.gov
5. What are the reporting timelines?
Open Payments reporting began in 2014 and occurs annually for transactions in each
calendar year (January 1 through December 31). CMS is responsible for posting reports
under Open Payments by July 1 of the following calendar year.
Example: 2016 data will be posted no later than July 1, 2017.
6. Who can review the data once it posted?
CMPL-016.0 10/2016
Anyone can review the transfer of value data once it is posted on the CMS public
website (https://openpaymentsdata.cms.gov/).
7. If a Physician attends a business meeting and a meal is provided and paid for by ACell, is
this a reportable event?
Yes, this would be considered a reportable event covered under the Food and Beverages
reporting category.
8. If a Physician teaches a course for ACell and is compensated to do so, is this a reportable
event?
Yes, this would be a reportable event covered under the Consulting Fees reporting
category.
9. If a Physician pays for his/her own meal during a business dinner meeting, is this a
reportable event?
No, if a Physician pays for their own meal, there is no transfer of value and therefore a
reportable event has not occurred.
10. What items are generally excluded from reporting?
• Speaking at a continuing education program if certain conditions are met:
o Program meets accreditation/certification requirements;
o The Manufacturer does not select the Physician Speaker and does not
provide a list of individuals to be considered as speakers;
o The Manufacturer does not directly pay the Physician Speaker.
• Educational Items that directly benefit patients or are intended for patient use
• In-kind items for the provision of charity care
• Evaluation Product for which the quantity provided is less than a 90-day supply
for a particular patient
• Discounts and Rebates as applicable under the Anti-Kickback Discount and
Rebate Safe Harbor
CMPL-016.0 10/2016