Certify webinar 6_21_13_final

Preparing for the 2013 Sunshine ActUnderstanding the Sunshine Act & Its Affect On Organizations

Live Webinar EventPresented by: CertifyJune 25th, 2013

www.certify.com | 1.888.925.0510

www.certify.com | @certify


Robert Neveu, PresidentCertify, 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



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,2013BEGIN TRACKINGManufacturers 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 DEADLINEManufacturers 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, 2014REVIEW 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, 2014DATA 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 SpendFailure 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


Not engaged in reporting Required Reporting Voluntarily report0%

10%

20%

30%

40%

50%

60%



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

2. Provide detailed spend report to CMS by March 31st, 2014

3. Keep a detailed record (receipt images, expense details) for each itemized expenseThe 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.



POLL QUESTION



POLL QUESTION



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

TRACKManufacturers must begin tracking spend made to physicians

and teaching hospitals

March 31st, 2014

May 15th, 2014

September 30th, 2014

REPORTThe first report to be

submitted to the CMS of data from August 1, 2013 through December 31st,

2013

REVIEWPhysicians 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 KNOWLEDGEFirst public record Sept 30, 2014 published on public

website (identify physicians who have received payments

or hold ownership.)

Know the Dates





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• 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



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Certify webinar 6_21_13_final