Physician and Institutional Research Disclosure Reports
AstraZeneca knows that to make a meaningful difference to patient health, it is important to be open about how we conduct our business. We are committed to the highest standards of conduct in all of our operations, including how we partner with physicians and medical institutions.
We partner and collaborate with physicians and institutions in efforts to educate the healthcare community and to conduct scientific and medical research. Patients ultimately benefit when physicians are well informed and knowledgeable about our medicines. AstraZeneca reports information on payments and transfers of value to US-based physicians, medical and research institutions, hospitals, clinics and group practices for all phases of research and development. The types of payments and transfers of value reported include consulting fees, speaker fees, modest meals and travel in association with contracted services or in conjunction with a product or informational discussion, educational items, research and development, royalties, license fees, and ownership or investment interests. We include both direct payments to physicians, as well as payments made to entities related to a physician at the request of, or on behalf of, that physician. In addition, our reports include certain payments to physicians made through third-party entities, such as medical education providers, on behalf of AstraZeneca.
AstraZeneca’s reporting on this site meets the requirements of our April 2010 corporate integrity agreement with the Office of Inspector General of the US Department of Health and Human Services, and incorporates key elements of the Physician Payments Sunshine Act, which went into effect on August 1, 2013. Our disclosure is separated into three reports, located here.
- The first report covers the period of time beginning January 1, 2011, and shows payments and transfers of value to US-based physicians and related entities from that date forward. These include consulting fees, speaker compensation, research payments, meals, travel, educational items, royalties, license fees and ownership or investment interests. Note that for the time period of January 1 through March 31, 2011, only compensation for speaker programs or requisite speaker training is included.
- The second report covers the period of time beginning April 1, 2011, and shows research payments to US-based medical and research institutions, hospitals, clinics and group practices.
- The third report covers the period of time beginning January 1, 2010 through December 31, 2010, and is limited to compensation to US-based physicians and related entities for speaker programs or requisite speaker training.
Only payments and transfers of value made directly or indirectly by AstraZeneca’s US business are included in the reports on this site. In addition, a payment or transfer of value to a physician of less than $10 is not included in the report except where the total amount of all payments and transfers of value to that physician during the reporting period exceeds $100.
These reports will be updated on a quarterly basis, within 90 days following the quarter close. Because of delayed reconciliation for certain indirect payments involving third-party vendors, some payments and transfers of value may not be included until a later reporting cycle. In addition, we have incomplete data concerning a limited number of known payments and transfers of value (less than $200,000 per year) that prevents us from including those transactions in the report. These transactions will be included in a later cycle if additional data become available. Due to the breadth of the data and the complexity of the processes and systems required to collect it, the possibility of other omissions or errors cannot be eliminated. In the event that other discrepancies are identified, the data will be corrected in subsequent reports.
Due to differences in scope and definitions, the data included in these reports may differ from data included in reports submitted by AstraZeneca for compliance with other state and federal transparency reporting laws including the federal Physician Payments Sunshine Act (OPEN PAYMENTS).
For more information, please see our frequently asked questions section.
Frequently asked questions
Why is AstraZeneca reporting this information?
In 2008 AstraZeneca put in place the first components of a major transparency initiative to build on earlier efforts to increase public visibility into how we do business. The initiative focused on increased transparency in seven areas: public policy, compliance, clinical trials, political contributions, medical education grants, contributions to nonprofit organizations and FDA post-marketing study commitments. Later that year we announced our support for the Physician Payments Sunshine Act sponsored by US Senators Charles Grassley and Herbert Kohl.
Beginning in 2010, in anticipation of the Sunshine Act, we began disclosing speaker program fees paid to US-based physicians on our US website. That disclosure was later incorporated into the provisions of the corporate integrity agreement AstraZeneca signed with the US Department of Health and Human Services Office of Inspector General in April 2010. The agreement also expanded our physician payment transparency reporting to mirror that which was expected to be mandated by the Sunshine Act, and now requires that we report all payments and items of value provided directly or indirectly to US-licensed physicians, as well as payments to US-based medical and research institutions, hospitals, clinics and group practices for clinical and pre-clinical research.
What types of payments and transfers of value are being reported?
Direct and indirect payments and transfers of value to US-licensed physicians and US teaching hospitals, including:
- Compensation for speaking, advisory board and consulting services
- Meals and reimbursed expenses for travel and lodging
- Items of value (e.g., textbooks, journal reprints) and
- Investigator fees and study supplies
Certain items such as samples (including vouchers and coupons) and patient educational materials are excluded.
Only payments and transfers of value made directly or indirectly by AstraZeneca’s US business are included in the reports on this site. Payments and transfers of value made by certain non-US AstraZeneca entities may be included in the Sunshine (OPEN PAYMENTS) reports submitted to CMS.
Who is included in these reports?
We are reporting payments and transfers of value to US-based physicians and related entities. This includes both direct payments to physicians as well as payments made to entities related to a physician at the request of, on behalf of, or for the benefit of, that physician. The reporting will also capture certain indirect payments to physicians made through third-party entities, such as clinical research organizations.
We are also reporting payments and transfers of value to US-based medical and research institutions, hospitals, clinics and group practices for all phases of research and development. This includes both direct payments and indirect payments through a contract research organization or academic research organization.
What time period is covered by the reporting?
The Physician Disclosure report published in this site covers payments and transfers of value to US-based physicians starting January 1, 2011. The Institutional Research Payments report covers the period of time starting with the second quarter of 2011. The Speaker report covers payments to US-based physicians from January 1, 2010 through December 31, 2010. The Open Payments report includes data from August 1, 2013 through December 31, 2013 and CMS will release the data publicly by September 30, 2014.
How frequently will payment data be updated?
These reports will be updated on a quarterly basis, within 90 days following the quarter close. Because of delayed reconciliation for certain indirect payments involving third-party vendors, some payments and transfers of value may not be included until a later reporting cycle.
How are physician speakers or consultants identified?
Physicians are selected to consult or speak about AstraZeneca and our medicines based on expertise in a therapeutic area, experience and qualifications. Speakers are required to complete regulatory, compliance and product training, as appropriate.
Does hiring physicians to consult or speak about AstraZeneca products increase the cost of medicines and ultimately healthcare?
No. AstraZeneca believes that patients ultimately benefit and costs are reduced when physicians are well informed and knowledgeable about our medicines and treatment options. Physicians are also indispensible partners in our efforts to bring new medicines to patients. This partnership takes many forms, including clinical trials to investigate the safety and efficacy of potential new medicines and providing us with guidance that allows us to better understand treatment challenges and unmet medical needs.
Does AstraZeneca reimburse for expenses?
Yes. AstraZeneca reimburses physicians for reasonable meal and travel expenses incurred in association with speaker, consulting or research services. These expenses are included in our reports.
How does AstraZeneca ensure the data is accurate?
The information posted is the result of our good faith efforts to capture and present information on payments and items of value accurately. Because of the breadth of the data and the complexity of the processes and systems required to collect it, the possibility of errors and omissions cannot be eliminated. AstraZeneca conducts a comprehensive review of the data included in the reports prior to posting. In the event of identified omissions or discrepancies, the data will be corrected in subsequent reports.
How does AstraZeneca report the value of meals provided to physician offices?
Meals may be provided to healthcare professionals for the purposes of engaging in discussions to share product and disease related information with physicians and their staff. AstraZeneca will submit to CMS the per person value of any meal in which a physician participates. The value of meals provided is determined by dividing the total cost of the meal by the total number of participants of the meal. Participants may include physicians, medical staff, and AstraZeneca representatives.
Are there any tax implications related to these reporting requirements?
Please consult with your tax advisor regarding any questions related to tax implications.
What are the differences between these reports and those required under the Sunshine Act (OPEN PAYMENTS)?
The Sunshine Act reporting requirements are broader than what is included in these reports and include payments and transfers of value provided to US-licensed physicians and teaching hospitals from certain AstraZeneca business entities outside of the US. The OPEN PAYMENTS reports will also be submitted on an annual basis and include detailed information on individual payments and transfers of value.
What can physicians and teaching hospitals do to dispute what was reported to CMS for OPEN PAYMENTS?
Physicans and teaching hospitals can dispute data through the defined CMS review and dispute process on the CMS website. Note that physicians and teaching hospitals must have first successfully registered in both the Enterprise Identity Management System and have requested and received access to the Open Payments system prior to reviewing data and submitting a dispute in the Open Payments system. AstraZeneca will be notified by CMS of the details of their dispute and will be able to review the dispute only after CMS receives the dispute.
What do physicians and teaching hospitals need to do to preview or dispute payments or transfers of value submitted under OPEN PAYMENTS?
Physicians and teaching hospitals must register in CMS’ Enterprise Portal (Enterprise Identification Management system – EIDM) and the Open Payments system in order to view the data that will be made public by September 30, 2014. Registration in EIDM began in June 2014 and is required for access to the OPEN PAYMENTS system (some physicians and teaching hospitals may already have an EIDM account). Registration is a voluntary process, but it is required for physicians and teaching hospitals to review or dispute OPEN PAYMENTS data.
What is the timing to submit disputes for OPEN PAYMENTS?
The Open Payments review, dispute and correction process begins on July 14 and ends on August 27. This 45-day period (July 14 through August 27) is for physicians and teaching hospitals to review and initiate any disputes they may have regarding the data reported about them. Disputes submitted after August 27, 2014 and before January 1, 2015 may not be corrected and re-published until after the next review and dispute window, anticipated in 2015.
Can AstraZeneca change the information reported about physicians or teaching hospitals on the CMS website for OPEN PAYMENTS?
No. Manufacturers cannot change the data unless the CMS defined Dispute and Resolution process is followed and an error was found in the data. AstraZeneca conducts a comprehensive review of the data in the reports to ensure accuracy prior to posting. Physicians can dispute the data reported and AstraZeneca will work to resolve the dispute during the CMS Dispute and Resolution period. Any data that is corrected through the CMS Dispute and Resolution process by or before September 11th will be posted publicly by CMS in late September.
How might I find additional information about OPEN PAYMENTS?
To learn more about the National Physician Payment Transparency Program (OPEN PAYMENTS), please visit the CMS site at:
For guidance on how to complete the registration process, please refer to this step-by-step process:
There is additional information for Physicians and teaching hospitals on how to Review & Dispute OPEN PAYMENTS at:
Physicians and teaching Hospitals can submit questions via email to the CMS Help Desk at email@example.com.
Live CMS Help Desk support is also available by calling 1-855-326-8366, Monday through Friday, from 7:30 a.m. to 6:30 p.m. (CT), excluding Federal holidays. The American Medical Association also has provided information about OPEN PAYMENTS for physicians at the following sites:
What is included in the Nature of Payment categories under Open Payments?
AstraZeneca includes the following in each of the defined categories by CMS in the Open Payments reports:
|CMS “Nature of Payment” Reporting Category||What is included?|
|Consulting fees||Payments to physicians or to entities on the behalf of physicians for consulting services, advisory boards, or training of company employees|
|Compensation for services other than consulting, including serving as faculty or as a speaker at an event other than a continuing education program||Speaking fees paid by the company, medical writing/editorial services provided to support publications, any other fee paid to a physician or teaching hospital as compensation for services provided, exhibit space fees, membership fees, or logistical program fees|
|Honoraria||AstraZeneca does not pay Honoraria, thus this category is not used by AstraZeneca|
|Gifts||Donations, sponsorships, contributions, or in-kind support provided to non 501(c)3 organizations|
|Entertainment||AstraZeneca does not provide Entertainment, thus this category is not used by AstraZeneca|
|Food and beverage||All food and beverage provided to facilitate product discussions, during speaker programs, or while speakers or consultants are providing services. May be provided directly or reimbursed by the company.|
|Travel and lodging||Airfare/train, lodging, or reimbursable mileage provided to speakers or consultants to travel to and from event locations|
|Education||Educational items provided to physicians such as textbook or journal reprints|
|Research||Study fees, study drug, and study supplies provided to research study sites to fund or support clinical or pre-clinical research studies|
|Charitable contributions||Contributions, donations, or sponsorships made directly or indirectly to teaching hospitals that are also 501(c)3 organizations|
|Royalty or license||Payments to physicians or teaching hospitals that are fees or royalties for a licensing agreement|
|Current or prospective ownership or investment interest||AstraZeneca does not make payments in the form of prospective ownership or investment interest, thus this category is not used by AstraZeneca|
|Compensation for serving as faculty or as a speaker for an unaccredited and non-certified continuing education program||Speaking fees for non-accredited independent education programs paid by third parties such as medical education providers where AstraZeneca provided an independent educational grant to the third party to assist with funding for the educational program|
|Grants||Independent grants provided to teaching hospitals for the purposes of funding medical education; scholarships or fellowships, research or investigator awards|
|Space rental or facility fees (teaching hospital only)||Payments to teaching hospitals to rent meeting rooms for educational programs|