U.S. Physician Payment Sunshine Act
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Agenda
•
Sunshine Act/Open Payments Overview
•
Reporting Requirements
•
Dates and Requirements
•
CMS Data Review Process
•
How Can Physicians Prepare
•
The U.S. Physician Payment Sunshine Act/Open Payments
is a federal
law that
requires all pharmaceutical, biologics and medical device
manufacturers to disclose payments and transfers of value provided to
U.S. physicians and teaching hospitals
•
The Sunshine Act:
–
Makes interactions significantly more visible to the public
–
Covers only U.S. physicians and teaching hospitals
–
Applies to U.S. physicians regardless of the country where a payment or
transfer of value occurs
•
Manufacturers are required to submit Sunshine Act data to the Centers for
Medicare and Medicaid Services (CMS) each year
Sunshine Act/Open Payments Overview
•
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$
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•
Any payments made to another entity “at the
request of” or “on behalf of” a physician or
teaching hospital
•
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A manufacturer is required to report research
payments made to institutions conducting
clinical research on the manufacturer’s
behalf, including the name(s) of the Principal
Investigator(s), even if the manufacturer does
not direct funds to those specific physicians
Reporting Requirements
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:
►
Consulting Payments and Honoraria
►
Research & Clinical-Trial Related
Expenditures
►
Educational Items (
e.g.,
textbooks,
journal article reprints)
►
Educational and Research Grants
►
Royalty Payments and Licensing
Fees
►
Expenses such as Travel, Lodging
and Meals
►
Training & Education Expenses
►
Charitable Donations
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Name of recipient HCP, contact information, specialty
•
HCP’s National Provider Identifier
•
State License Number of HCP
•
Date of the payment or transfer of the item of value
•
Dollar value
•
Product associated with the interaction
•
Description of the type and nature of the payment or item of value
•
Destination (for travel expenses)
•
Payments made or transfers of value provided to physician assistants, nurses,
lab technicians or hospital administrative staff
•
Anatomical models or wall models used to educate patients on a particular
procedure or product
•
Coffee, snacks or other refreshments provided at booths or during large events
at third-party conferences
•
Short-term loan of devices/capital equipment
Important Note: Even if the Sunshine Act excludes these types of payments from its reporting
requirements, manufacturers may still be required to disclose this information for other purposes
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Reporting Requirements (cont’d)
Reporting Requirements (cont’d)
Per CMS, physicians cannot repay a manufacturer for a payment/transfer
of value and have the payment removed from a manufacturer's report.
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U.S. physicians and
teaching hospitals
have 45 days to review
the data that
companies report to
CMS under their
names and to register
inquiries about their
data with CMS
•
Physicians,
teaching hospitals
and companies
have 15 days to
research and
address reported
data inquiries
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Track payments
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Be prepared to
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Dates and Requirements
Dates and Requirements
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Manufacturers
submit 2014
data to CMS
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Review, dispute
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2014 data will
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CMS submits
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Physicians/teaching hospitals can report inquiries to CMS throughout
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•
Only inquires that are reported during the initial 45-day review period
and addressed during the 15-day follow-up period will be included in
the initial public website posting on September 30, 2014
CMS Data Review Process
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July 14 –
September 10, 2014 (Original deadline was August 27, but deadline
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September 11 – 25, 2014
How Can Physicians Prepare?
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•
Reviewing their hospital/medical facility policies
•
Understanding the reason for any payments or transfers
of value
•
Proactively reviewing the data disclosed under their
names
•
Being mindful of responding to media requests
In Closing
We value and look forward to continuing our
essential collaboration with physicians, hospitals
and other health care providers, which allows us to
deliver innovative, less-invasive medical devices
and procedures for the benefit of patients.
We are committed to acting with integrity in all of
our interactions with physicians.
Thank you!
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The U.S. Physician Payment Sunshine Act mandates transparency in reporting payments and transfers of value from pharmaceutical, biologics, and medical device manufacturers to U.S. physicians and teaching hospitals. Reporting requirements include details like recipient information, payment amounts, and product associations. While certain types of payments are excluded from reporting, manufacturers must disclose this information for other purposes. Physicians cannot repay manufacturers to remove payments from reports.
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Presentation Transcript
Physician-Industry Transparency: The U.S. Physician Payment Sunshine Act 1
Agenda Sunshine Act/Open Payments Overview Reporting Requirements Dates and Requirements CMS Data Review Process How Can Physicians Prepare 2
Sunshine Act/Open Payments Overview The U.S. Physician Payment Sunshine Act/Open Payments is a federal law that requires all pharmaceutical, biologics and medical device manufacturers to disclose payments and transfers of value provided to U.S. physicians and teaching hospitals The Sunshine Act: Makes interactions significantly more visible to the public Covers only U.S. physicians and teaching hospitals Applies to U.S. physicians regardless of the country where a payment or transfer of value occurs Manufacturers are required to submit Sunshine Act data to the Centers for Medicare and Medicaid Services (CMS) each year 3
Reporting Requirements All payments or transfers of value over $10 Types of payments or items of value that must be reported include: Any payments made to another entity at the request of or on behalf of a physician or teaching hospital Consulting Payments and Honoraria If, within a calendar year, a manufacturer makes payments to or provides a physician or teaching hospital in excess of $100 in total, then all payments and items of value provided during that calendar year must be reported (even if they are individually less than $10) Research & Clinical-Trial Related Expenditures Educational Items (e.g., textbooks, journal article reprints) Educational and Research Grants Royalty Payments and Licensing Fees A manufacturer is required to report research payments made to institutions conducting clinical research on the manufacturer s behalf, including the name(s) of the Principal Investigator(s), even if the manufacturer does not direct funds to those specific physicians Expenses such as Travel, Lodging and Meals Training & Education Expenses Charitable Donations 4
Reporting Requirements (contd) Name of recipient HCP, contact information, specialty HCP s National Provider Identifier State License Number of HCP Date of the payment or transfer of the item of value Dollar value Product associated with the interaction Description of the type and nature of the payment or item of value Destination (for travel expenses) INCLUDED Payments made or transfers of value provided to physician assistants, nurses, lab technicians or hospital administrative staff Anatomical models or wall models used to educate patients on a particular procedure or product Coffee, snacks or other refreshments provided at booths or during large events at third-party conferences Short-term loan of devices/capital equipment EXCLUDED Important Note: Even if the Sunshine Act excludes these types of payments from its reporting requirements, manufacturers may still be required to disclose this information for other purposes Per CMS, physicians cannot repay a manufacturer for a payment/transfer of value and have the payment removed from a manufacturer's report. 5
Dates and Requirements 2013 2014 2015 JUNE AUG MAR JULY AUG SEP SEP 30 March 31, 2014: Pharmaceutical, biologics and medical device companies provided the Centers for Medicare and Medicaid Services (CMS) with aggregate data regarding interactions with U.S. physicians and teaching hospitals between August 1 and December 31, 2013 Sept. 30, 2014: The statute requires CMS to post data on a public, searchable government- maintained website and continue to post the data annually. CMS must also submit reports to states that include a summary of payments made to covered recipients in each state Aug. 1, 2013: Pharmaceutical, biologics and medical device companies were required to: June 2014: Pharmaceutical, biologics and medical device companies provided CMS with a detailed report regarding interactions with U.S. physicians and teaching hospitals between August 1and December 31, 2013 July 14 Sept. 25, 2014: Review, Dispute & Correction March 31, 2015: Manufacturers submit 2014 data to CMS U.S. physicians and teaching hospitals have 45 days to review the data that companies report to CMS under their names and to register inquiries about their data with CMS April May 2015: Track payments and items of value provided to U.S. physicians and teaching hospitals Review, dispute and correction period for 2014 data June 30, 2015: Be prepared to publically disclose any meal, educational item, consulting payment or other financial interaction between the industry and a physician or teaching hospital 2014 data will be posted on public website Physicians, teaching hospitals and companies have 15 days to research and address reported data inquiries CMS submits report to states **ONGOING** Physicians/teaching hospitals can report inquiries to CMS throughout the year Only inquires that are reported during the initial 45-day review period and addressed during the 15-day follow-up period will be included in the initial public website posting on September 30, 2014 6
CMS Data Review Process CMS informed U.S. physicians and teaching hospitals who registered with the agency that their data was ready, beginning a 45-day review window. July 14 September 10, 2014 (Original deadline was August 27, but deadline was extended to adjust for system downtime) Physicians and teaching hospitals reviewed data for accuracy and completeness, initiated inquiries with CMS by filling out an electronic form to provide transaction details Ended September 11, 2014 The transaction entered into the online form will be flagged as an inquiry, and the system will notify the manufacturer of the details September 11 25, 2014 7
How Can Physicians Prepare? Physicians can prepare by: Reviewing their hospital/medical facility policies Understanding the reason for any payments or transfers of value Proactively reviewing the data disclosed under their names Being mindful of responding to media requests 8
In Closing We value and look forward to continuing our essential collaboration with physicians, hospitals and other health care providers, which allows us to deliver innovative, less-invasive medical devices and procedures for the benefit of patients. We are committed to acting with integrity in all of our interactions with physicians. Thank you! Note: The contents of this presentation are not intended to be legal advice. For information about how the Sunshine Act impacts you specifically, please contact your attorney or your institution s Legal Department. 9
