Sunshine Act--How to Avoid Sunburn this Summer!

  • On: June 17, 2015 at 11:06AM
  • Category: Conferences

DuVal EDU Regulatory Training presents a 90-minute webinar on the Sunshine Act--How to Avoid Sunburn this Summer!

 

 

Later this year medical device, drug and biologics executives will be required to attest to the accuracy of their respective sunshine data before submitting it to CMS. Questions that these executives should be thinking about before attesting to the accuracy and completeness of the data submitted include:

  • Are my data sets correct?

  • Are my data sets in violation of applicable laws or our own internal policies?

  • Are we monitoring compliance and violations?

  • How will our customers react if we submit wrong information?

 

Sunshine violations are the tip of the iceberg. Company executives should also be asking whether the data they submit to CMS exposes them to state violations, the Anti-Kickback Statute and/or the False Claims Act.  If companies have elected to follow PhRMA or AdvaMed will their data submission reflect that choice?

Program Description

This Physician Payment Sunshine Act (“Sunshine Act”) webinar will cover the following:

  • Phase 1 and 2 Open Payments reporting and registration

  • Three levels of sunshine reporting (general payments, research and ownership & investment interests)

  • What to report/what can be skipped

  • Developing a policy

  • Educating on the policy

  • Data collection and reporting

  • Monitoring adherence to policies

  • Mitigating risk

  • Data validation

  • Avoiding reporting disputes

  • Auditing

 

CMS reserves the right to audit companies for compliance and uses the word “audit” twenty times in the Final Rule of the Sunshine Act. Undoubtedly, government litigators will be trolling the CMS database containing all payment information disclosed, which will be made public September 30, 2014, for suspect payments and other information about companies.  Many others will also be interested in this data, including other government agencies (IRS), media, consumer advocacy groups and competitors. Fines are $1000-$100,000 per violation.  Companies must ascertain how and what they will report and when they can lawfully avoid reporting.  

 

Who should attend?

  • Regulatory

  • Legal

  • Compliance

  • Finance

  • Marketing

Helping clients be appropriately aggressive, yet compliant. TM