Certify webinar 6_21_13_final

Preparing for the 2013 Sunshine Act
Understanding the Sunshine Act & Its Affect On Organizations
Live Webinar Event
Presented by: Certify
June 25th, 2013
www.certify.com | 1.888.925.0510

www.certify.com | @certify
Robert Neveu, President
Certify, LLC
Speaker:

Todays Topic:
The Physician Payments Sunshine Act (Sunshine Act),
which is part of the Patient Protection and Affordable
Care Act (ACA).
Understanding the Sunshine Act & Its
Affects on Organizations

POLL QUESTION

What is the Sunshine Act?

47% of physicians and compliance officers
don’t know about the Sunshine Act
*2012 CBI Audience Poll

Introduced by Senators Charles Grassley of
Iowa and Herb Kohl of Wisconsin to enhance
transparency between drug makers,
physicians and the public in hopes to
provide objective information on the types
of financial relationships that exist between
manufacturers or GPOS and physicians or
hospitals.
The Act requires accurate reporting of all financial transactions between
pharmaceutical manufacturers and healthcare providers to be reported
annually to the Centers for Medicare & Medicaid Services (“CMS”).

The Final Ruling on the Sunshine Act
was issued on February 1, 2013 where the CMS within the Department of
Health and Human Services (HHS) announced the release of the final rule
implementing the Transparency Reports and Reporting of Physician
Ownership or Investment Interests section of the Patient Protection and
Affordable Care Act (“ACA”), commonly referred to as the “Sunshine Act.”

Who does it impact?

Manufacturers and Group
Purchasing Organizations (GPOs)
• Operating in US or conduct activates in US
• Manufacturers producing even one:
• Drug
• Device
• Biologic agent
• Medical supply
Where payment is available under Medicare, Medicaid, or the
Children's Health Insurance Program

Physicians and Teaching Hospitals
Including:
• Physicians that are legally authorized to
practice:
• Medicine
• Osteopathy
• Dentistry
• Dental Surgery
• Podiatry
• Optometry
• Chiropractic Medicine
Not only those enrolled in or billing Medicare
or Medicaid
*A “teaching hospital” is any institution receiving direct or
indirect payments from Medicare for graduate medical
education

What needs to be tracked?

Pharmaceutical and
device manufacturers
must report all gifts
and payments
greater than $10
made to physicians
and hospitals.

When does it begin?

August 1st,2013
BEGIN TRACKING
Manufacturers must begin tracking all spend made
to physicians and teaching hospitals greater than
$10.
Data collection and reporting requirements fall
on manufacturers and GPOs, not on physicians
and teaching hospitals

March 31, 2014
FIRST REPORT DEADLINE
Manufacturers must submit their first report to
the CMS no later than March 31st, 2014.
The report must contain all spend made to
physicians and teaching hospitals from August 1,
2013 through December 31st, 2013.

March 31, 2014 - May 15th, 2014
REVIEW PROCESS
Physicians can voluntarily review and dispute data
before information is made public.
Physicians will have 45 days to review and dispute
any data that appear inaccurate, and manufacturers
and GPOs will then be able to make necessary
corrections.

September 30th, 2014
DATA POSTED TO PUBLIC SITE
All spend over $100 will be made public on
September 30, 2014, published on a public website,
identifying physicians who have received payments.
The data will be released online in an easily
searchable form and will contain contextual
information on the many appropriate reasons for
which physicians and teaching hospitals maintain
relationships with drug and device manufacturers.

Risks of Non-Compliance

Incomplete Submission of Spend
Failure to submit the required information result in
fines of $1,000-$10,000 for each payment not fully
reported for a maximum of $150,000 annually
Knowingly Failure to Submit
Knowingly failure to submit spend and exchanges risk
fines of $10,000-$100,000 for each payment not
reported for a annual maximum of $1,000,000

Impacts on Organizations
• Financial risks for non-compliance (up to
$1,000,000 annually)
• New process for managing and tracking
spend
• Increased cost for resources to maintain
compliance
• Risk of large legitimate payments,
necessary for the development of all drugs
to be misconstrued as improper gifts
64% of
companies
anticipate a
moderate to
significant
change in their
current reporting
process
2012 CBI Audience Poll

CMS estimated that the total cost of
these provisions will be approximately
$269 million in the first year and $180
million annually thereafter.
http://www.policymed.com/2013/02/physician-payment-
sunshine-final-rule-cost-and-impact-of-regulation.html

http://www.policymed.com/2013/02/physician-payment-
sunshine-final-rule-cost-and-impact-of-regulation.html
Break Down of Estimated Cost of Complying with the Sunshine Act
• Large manufacturers are estimated to hire on average 2.5 full time
employees to comply with reporting requirements
• 2 full time bookkeepers/accounting/auditing staff support
• 0.5 full time equivalent compliance officer
• For an average of 5,200 additional hours for the first year
• With an average hourly rate of $35.75, the first year investment to
comply with the new act is roughly estimated at $185,900 per
organization

How to be Compliant

As of 2012, 53% of organizations were not engaged in
any type of transparency reporting
0%
10%
20%
30%
40%
50%
60%
Not engaged in reporting Required Reporting Voluntarily report

How to be Compliant
1. Track and record all spend made to physicians and teaching hospitals over $10
Each itemized expense must include:
• Physician’s name
• Physicians NPI (National Provider Identifier)
• Physicians Primary Specialty Code
• Practice name
• Practice address
• Amount of expense
• Product detail/name
• Nature of benefit
1. Provide detailed spend report to CMS by March 31st, 2014
1. Keep a detailed record (receipt images, expense details) for each itemized expense
The CMS may request verification or further information regarding expenses due to
error, incomplete information or disputes related to physicians. Each expense
reported incomplete may result in fines up to $10,000.

59% of companies are somewhat or
not confident in being complaint with
Sunshine Act in 2013

Summary

Who’s Affected: Medical Device Manufacturers/ Pharmaceutical
Companies and Physicians/Teaching Hospitals
What: Manufacturers to track and report all spend
made to physicians over $10
Compliance Cost: $185,900 for the first year with 25% decrease
in year two
Risks: Fines between $1,000 to 10,000 upward of
$1,000,000 annually
Summary

August 1st,
2013
TRACK
Manufacturers must
begin tracking spend
made to physicians
and teaching
hospitals
March 31st,
2014
May 15th,
2014
September 30th,
2014
REPORT
The first report to be
submitted to the CMS of
data from August 1, 2013
through December
31st, 2013
REVIEW
Physicians will have 45 days to
review and dispute any data
that appear inaccurate, and
manufacturers and GPOs will
then be able to make necessary
corrections. PUBLIC KNOWLEDGE
First public record Sept
30, 2014 published on public
website (identify physicians
who have received payments
or hold ownership.)
Know the Dates

Web-based Travel & Expense
Management software
• 100% fully automated expense
reporting system
• Mobile applications for on-the-go
reporting and management
• Enforce company travel policies
• Integrate with your current accounting
and HR systems
• Integrate with corporate credit cards

Travel & Expense Management Trends for 2013:
How CFO’s are Employing New Technologies to Increase Insight and Drive Growth
Truly Automated Expense Reporting With Certify
ReportExecutiveTM from Certify
1. Schedule company wide or individual
Automatic Expense Report Dates
2. Schedule Reminders
3. ReportExecutiveTM will automatically build
expense reports for end users
4. The user will then be notified by e-mail
and directed to review the expense report
and submit it for approval.

NPI Database Integration
Certify customers utilizing Certify's NPI Integration are able to track T&E expenses and link expenses
with specific Physician and Organization NPI records. Complete integration with the United States NPI
database allows you to generate the required Federal reports instantly.
Certify’s NPI Integration
• Link multiple physicians to a single
expense
• Search for physicians and link them to an
expense
• Instantly create the federal required
report
• Ensure all required fields are attached to
each itemized expense
• Certify’s NPI Database updated monthly

Mobile Access to NPI Database for On-The-Go Functionality
Along with the web-based NPI functionality, Certify has integrated it's mobile application to the US
Federal NPI database, allowing users to track and manage receipts and expenses for Sunshine Act
compliance while on-the-go.

Instant Access to Federally Required Reports for
Sunshine Act Compliance
Certify has developed reporting specific to the Sunshine Act, allowing companies to report all
physician spend by employee, date, category, expense total, NPI, physical name and
address, ensuring compliance with all federal reporting. The NPI Expense Data is dynamic, allowing
the manager to get up-to-the-minute reporting on all Physician Payments.

If you would like to schedule a live
demonstration of Certify, leave a
message in the question box to the
right or visit:
www.Certify.com

Q&A Session

Thank you
for attending todays session.
Sign up for a free 30-day trail of Certify at
https://www.certify.com/FreeTrial.aspx
For more information on Certify:
www.certify.com
1-888-925-0510

Certify webinar 6_21_13_final

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