T
HE PATIENT PROTECTION and
Affordable Care Act Sec. 6002,
once referred to as "The Sunshine
Act" and now known as "Open
Payments," establishes a disclosure program
on a national scale that promotes transpar-
ency of the financial relationships between
the medical industry ("reporting entities")
and physicians and teaching hospitals.
Reporting entities — comprising applicable
manufacturers of covered drugs, devices,
biological and medical supplies, and
applicable group purchasing organizations
(GPOs) that participate in U.S. federal
healthcare programs — are required to
disclose these financial relationships on a
publicly available website provided through
the Centers for Medicare & Medicaid
Services (CMS). In addition to enabling
informed consumer decisions by the public,
financial tie reporting is designed to dis-
close "the nature and extent of relationships,
prevent inappropriate influences on
research, education, and clinical decision-
making, avoid conflicts of interest that can
compromise clinical integrity and patient
care, and minimize the risk of increased
health care costs."
Open Payments also requires manufac-
turers and applicable GPOs to report
certain ownership or investment interests
held by physicians or their immediate
family members, or other transfers of value
made to physician-owners or investors if
they held ownership or an investment
interest at any point during the reporting
year. Violations by a reporting entity may
carry annual civil penalties of as much as
$150,000 for failure to report and $1 million
for knowingly failing to report. CMS
requires reporting entities to keep all
records related to payments or other
transfers of value for at least five years from
the date that the payment or other transfers
of value are posted.
For purposes of the program, a "physi-
cian" is defined as any professionals who
are legally authorized by the state to
practice medicine, osteopathy, dentistry,
dental surgery, podiatry, optometry or
chiropractic medicine. Physicians are not
required to register with or send any
information to Open Payments. CMS,
however, encourages physicians to report
their financial relationships and review
the reported data about them to ensure
accuracy. In order to review and, if neces-
sary, dispute this data, physicians must
first register in: (i) the CMS Enterprise
Portal and (ii) the Open Payments system.
Though the Sept. 10, 2014, deadline for
registered physicians to dispute and have
data marked incorrect has already passed
and CMS has released data to the public,
physicians can still initiate disputes regard-
ing 2013 data until Dec. 31, 2014. However,
the data will not be marked as disputed in
the public database until 2015. The physi-
cian should consult the CMS website for
further details regarding the types of
payments that are reportable, data collec-
tion periods and dispute process deadlines.
Finally, physicians should be aware that
compliance with Open Payments reporting
requirements does not exempt them from
potential liability associated with payments
or other transfers of value, or ownership
or investment interests under the Federal
Anti-Kickback Statute, False Claims Act
or similar laws.
Thomas A. Mobilia is a Senior Partner
and trial attorney at Martin Clearwater &
Bell LLP who has defended the firm's hospital
clients, medical practices and physicians in
high-exposure cases in state and federal courts
for more than 20 years.
Melanie G. Gelfand is an Associate at
Martin Clearwater & Bell LLP and focuses her
practice on medical malpractice defense. ■
References:
1. Open Payments: Creating Public Transparency
into Physician Financial Relationships, Centers for
Medicare and Medicaid Services (2014), http://www.
cms.gov/Regulations-and-Guidance/Legislation/
National-Physician-Payment-Transparency-Program/
Downloads/Open-Payments-User-Guide-[July-2014].pdf.
2. About Open Payments, cms.gov, (Aug. 25, 2014),
http://www.cms.gov/Regulations-and-Guidance/
Legislation/National-Physician-Payment-Transparency-
Program/About-OPEN-PAYMENTS.html.
3. Participation in Open Payments, cms.gov, (Aug. 25,
2014), http://www.cms.gov/Regulations-and-Guidance/
Legislation/National-Physician-Payment-Transparency-
Program/index.html.
4. Anita Griner, Open Payments: A Matter of
Maintaining Trust, Health Affairs Blog, (Feb. 27,
2014), http://healthaffairs.org/blog/2014/02/27/
open-payments-a-matter-of-maintaining-trust/.
5. Audit and Assess Penalties, cms.gov, (Aug. 25,
2014), http://www.cms.gov/Regulations-and-Guidance/
Legislation/National-Physician-Payment-Transparency-
Program/Audit-and-Assess-Penalties.html.
6. Physicians, cms.gov, (Aug. 25, 2014), http://
www.cms.gov/Regulations-and-Guidance/Legislation/
National-Physician-Payment-Transparency-Program/
Physicians.html.
7. Bruce D. Armon & Karilynn Bayus, Sunshine Act
Implementation Proceeds; CMS Re-Opens the Open
Payments System, Saul Ewing LLP, (August 2014).
8. How Open Payments Works (Aug. 29, 2014),
http://www.cms.gov/Regulations-and-Guidance/
Legislation/National-Physician-Payment-Transparency-
Program/How-OPEN-PAYMENTS-Works.html.
By Thomas A. Mobilia and Melanie G. Gelfand
Open Payments:
Creating Public Transparency in Industry-
Physician Financial Relationships
Thomas A. Mobilia
Melanie G. Gelfand
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Long Island MD NEWS ■ M D N E W S . CO M
