To: All Washington University Physicians:
Re: Physician Sunshine Act
The Centers for Medicare and Medicaid Services (CMS) recently announced final regulations
implementing the Physician Payment Sunshine Act, legislation included in the Affordable Care Act.
The Sunshine Act requires manufacturers of drugs, devices, biological and medical supplies covered
by Medicare, Medicaid and the State Children’s Health Insurance Program to report to CMS annually
all payments and transfers of value that are made to physicians and teaching hospitals. The
Secretary of Health and Human Services is required to publish the reported data on a public
website. The following summarizes key elements of the law.
Who Reports to CMS?
Manufacturers of “covered” products must report data to CMS. An entity that manufactures covered
products for internal use or for its own patients is not required to report to CMS. Physicians and
teaching hospitals have no reporting obligations.
What is Reported?
All direct and indirect payments or transfers of value provided by a manufacturer to a physician are
reported to CMS, including payments made at the “request of or designated on behalf of” a
physician, regardless of whether the payments were related to a covered product.
The report to CMS includes: the physician’s name; address; specialty; National Provider Identifier;
state professional license number; amount and date of the payment (or transfer of value); nature of
payment (e.g., consulting/speaking fees, royalties, honoraria, gifts, charitable contributions, food,
entertainment, etc.); the name of the covered product, if related to the payment. Also reported is
the form of payment or transfer of value (i.e., cash, cash equivalent, in kind items or services, stock,
stock options, any ownership interest, dividends and return on investments); payments to third
parties; payments to physician owners or investors; research-related payments and, if applicable
whether the payment is eligible for delayed publication.
Research
The reporting obligation applies to a broad range of research activities, including pre-clinical trials,
trials under FDA phases I-IV and investigator-initiated trials. The law allows reporting of all
payments made under a single research agreement or protocol as a single transaction, listing both
the research institution that received the payments and the principal investigator.
Delayed Publication of Certain Research Payments
Payments or transfers of value associated with research may be eligible for delayed publication if
the payment is made in connection with research regarding, or development of, a new drug, device,
biological, or medical supply or a new application of an existing drug, device, biological, or medical
supply. Publication can be delayed until the earlier of FDA approval or clearance of the covered
product, or four years after the payment is made.
Physician Ownership
Manufacturers and group purchasing organizations (GPOs) are required to report direct or indirect
ownership and investments interests held by physicians and their immediate family members.
“Ownership or investment interest” includes stock, stock options (except as paid as compensation
until exercised), partnership and LLC interests, and loans secured with property or revenue.
Reporting is not required for ownership of publicly traded securities, ownership that the reporting
entity is not aware of, and ownership or investment interest held through a retirement plan.
CME Exemption
Payments or transfers of value made as compensation for speaking at continuing medical education
programs are exempt from the reporting obligation provided the following conditions are met:
 The CME event is certified or accredited by one of the following:
o The Accreditation Council for Continuing Medical Education;
o The American Academy of Family Physicians;
o The American Dental Associations’ Continuing Education Recognition Program;
o The American Medical Association;
o The American Osteopathic Association;
 The manufacturer does not pay the speaker directly; and
 The manufacturer does not select the speaker or provide the third party (such as the CME
vendor) with a distinct, identifiable set of individuals to be considered as speakers for the
CME program.
Other Exclusions
Several types of payments made by manufacturers are excluded from the reporting requirement,
including:
 Educational materials and items that directly benefit patients or are intended to be used
with patients;
 Loans for not more than 90 days of a covered device or a device under development or a
limited quantity of medical supplies;
 Product samples and coupons/vouchers intended for patient use without charge;
 Meals, snacks, soft drinks, coffee, or items under $10 made available to all participants of a
large-scale conference;
 Transfers of value of less than $10, unless the aggregate amount exceeds $100/calendar
year;
 Items or services under contractual warranty.
Review and Correction
CMS will provide physicians access to a secure website for review and correction of the payments
and transfers of value attributed to them. The burden is on the manufacturer/GPO to resolve any
disputes and submit revised data to CMS. If a dispute is identified by a physician within 45 days
following the manufacturer’s submission of the data to CMS and resolved within 60 days of the
submission, the revised data will be posted; otherwise, the data submitted by the manufacturer will
be posted with a notation indicating the data is subject to dispute and any revised data, if accepted
by the manufacturer, will be posted as of the next reporting period.
Physicians are encouraged to register with CMS to receive notification that the data is available for
review. Registration will open in 2014.
Implementation Dates
Manufacturers and GPOs are required to commence data collection on August 1, 2013, with reports
due to CMS on March 31, 2014. Reports to CMS are submitted annually.
For questions about the CME requirements contact:
Douglas W. Hanto, M.D., Ph.D.
Associate Dean for Continuing Medical Education
Washington University School of Medicine
314-362-6891
hantod@wusm.wustl.edu
Vicki Tegethoff
Director, Continuing Medical Education
Washington University School of Medicine
314-362-6938
tegethov@wusm.wustl.edu
For questions about other aspects of the Sunshine Act, contact:
Patty Hart
Assistant Vice Chancellor & Associate General Counsel
Office of the Executive Vice Chancellor & General Counsel
Washington University in St. Louis
314-362-6558
patricia_hart@wustl.edu
For more information about WUSM’s clinical conflict of interest policies, go to:
http://fpp.wusm.wustl.edu/fpppolicies/Pages/ConflictofInterestClinical.aspx
http://fpp.wusm.wustl.edu/fpppolicies/Pages/Conflict%20of%20Interest%20%28Clinical%29%20%20PharmaceuticalMedicalDeviceIndustry.aspx
Resources
Physician Payment Sunshine Act of the Affordable Care Act, Final Regulations
http://www.gpo.gov/fdsys/pkg/FR-2013-02-08/pdf/2013-02572.pdf
CMS OpenPayments Program:
http://www.cms.gov/Regulations-and-Guidance/Legislation/National-Physician-PaymentTransparency-Program/index.html
Association of American Medical Colleges/Conflict of Interest
https://www.aamc.org/initiatives/coi