Section 6002 of the Affordable Care Act, commonly referred to as the Physicians Payment “Sunshine Act” and now known as the National Physician Payment Transparency Program ‘OPENPAYMENTS’, requires the disclosure of payments or other value provided to physicians and teaching hospitals (‘covered recipients’) by certain manufacturers (‘applicable manufacturers’) of drugs, devices, biological, and medical supplies that are covered by Medicare, Medicaid or the Children’s Health Insurance Program. The Act is designed to increase transparency around the nature and extent of relationships between physicians, teaching hospitals, and industry manufacturers, but it is important to note that the Sunshine Act does not restrict industry-physician collaboration or interactions, or prohibit payments or transfers of value. Rather, it requires the tracking and reporting of certain payments and transfers of value that result from these interactions.
Aesculap Biologics, LLC, as an ‘applicable manufacturer’, along with its subsidiaries, must comply with the requirements of the Act, and as such must report annually on certain payments or other transfers of value made in the course of our professional interactions if the value of these payments or transfers of value exceeds a certain threshold per occurrence or in the aggregate during the reporting period.
The natures of payments or transfers of value that we are required to disclose include:
- Consulting fees
- Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program.
- Food and beverage
- Travel and lodging (including the specified destinations)
- Manufacturer-provided education and educational materials
- Charitable contributions
- Royalties or license fees
- Current or prospective ownership or investment interests
- Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program.
- Compensation for serving as faculty or as a speaker for an accredited or certified continuing education program.
- Space rental or exhibit / facility fees paid to teaching hospitals
- Research and clinical trial expenses
- Product loans exceeding 90 days
- Write-offs of noncollectable receivables
Compliance with the Act necessitates that we collect and record certain information when we make these types of payments or transfers of value, and as such, we ask for the cooperation of our business partners to ensure the accuracy of our records. We must provide to the government (Centers for Medicare and Medicaid Services, or CMS), on an annual basis, a report disclosing all payments or transfers of value in the above-mentioned categories and the corresponding covered recipient, along with the following details about the payment or transfer of value:
- Complete name of recipient
- Specialty of recipient
- Business address of recipient
- State license # of recipient
- National Provider Identifier (NPI) * of recipient
(* The National Provider Identifier is a unique 10-digit identification number issued to health care providers in the United States by CMS. If you do not have an NPI number, or are uncertain of your NPI number, please visit www.cms.gov for more information.)
- Amount of the payment or transfer of value
- Date on which the payment or transfer of value occurred
- Form of the payment or transfer of value (such as cash or cash-equivalent, stock options, etc.)
- Nature or purpose of payment or transfer of value (such as consulting, royalties, etc.)
CMS will publish the data for each reporting year on a public website which, in accordance with the law, must be searchable, understandable, easily-aggregated, and downloadable. Prior to publication on the publicly available website, applicable manufacturers and covered recipients are provided with a 45-day review period followed by a 15-day resolution period during which we may work together to resolve any divergence in the collected data prior to publication. Aesculap Biologics and its employees take all prudent measures to ensure that the information we report is complete, accurate, and fair, and we look forward to working with our business partners to ensure that all data is correct.
Aesculap Biologics recognizes that collaboration, cooperation, and interaction between the medical device industry and health care professionals is critical to advancing new, safe, and effective medical technologies that benefit patients, and we greatly value our ongoing relationship with you. We hope to make this a collaborative effort to the extent possible, and we welcome your input as we work together to comply with this legislation. Please contact Aesculap Biologics with any concerns regarding the Act and its requirements at Aesculap_Compliance@aesculap.com.