The Sunshine Act–Are You Prepared? The March 31 Reporting Deadline is Roughly 5-Months Away!

By: Mark Gardner, M.B.A., J.D., Attorney and Adjunct Professor at DuVal & Associates
Coming soon.. Please contact customer care for new schedule
Course “The Sunshine Act–Are You Prepared? The March 31 Reporting Deadline is Roughly 5-Months Away!” has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion.

Course Description:

The Sunshine Act is now in effect! Tracking started August 1st. If CMS comes in tomorrow to audit your company will you be found compliant? Did you know CMS uses the word “audit” 20x in the Final Rule of the Sunshine Act? They reserve the right to audit companies for compliance. Fines are $1000-$100,000 per violation. CMS requires you to disclose information about your relationships with physicians and teaching hospitals. Are you ready to make these disclosures to CMS on March 31st? That is roughly 5 months away! How will you report? What will you report? What can you avoid reporting? How will you register? Will you tell doctors and hospitals what you plan to report about them ahead of time? Who is going to attest to the accuracy of the data? Your CEO? Will the government find any skeletons in the closet? Government litigators will no doubt be trolling the CMS database containing all payment information disclosed, which will be made public, for unsavory payments and other information about companies.

This 1-day interactive seminar in San Diego on Nov. 14 will focus solely on the Sunshine Act. The course is taught by Mark Gardner, J.D., M.B.A., a national expert on the Sunshine Act. Mark has helped over 75 companies ranging in size from Fortune 500 to start-ups, drug, biologic, and device, get compliant with the Sunshine Act quickly. Mark worked in the medical device industry in sales and marketing for 10-years before becoming an attorney. He will walk you through countless real-world examples. Come prepared with your questions. You will have ample opportunities to get feedback from this national expert.

The 1st-half of the program will be devoted to the final regulation, in granular detail, and how the new regulation applies to your company. The 2nd-half of the program will focus on strategic matters, like the impact on customers (e.g. how the fraud and abuse laws play a role), and will include an interactive workshop on how to operationally get up to speed quickly. It will also focus on internal policy and procedure development.

Attendees will learn everything they need to know about the Sunshine Act. Topics include: collection of data, registering your company, reporting (and the exceptions), certification/attestation of data, verification of data with customers, correction of data, assumptions document creation, among other things. Importantly, there are many exceptions you need to know about. Not knowing the exceptions, and how they apply, will put you at a competitive disadvantage in the marketplace.

Now is the time to act. Reporting to CMS is roughly 5 months away. Long before March 31, data will need to be vetted and verified with physicians and customers. If you send in the wrong data, CMS will publish it anyway, unless you correct it in time. If a doctor disputes the data, and the matter cannot be resolved, then two sets of data will be reported. Do not let this happen to you. Get ahead of this. Think of your customers and the business impact a dispute would have.

The course is critical for companies of all types (drug, device, biologic) impacted by the Sunshine Act. Not only will the very granular aspects be covered, but also the strategic.

Learning Objectives:

  • Walk in with a basic knowledge and with a firm grasp on the Sunshine Act
  • Find out what is important about the law and what you can discard
  • Determine how the rule applies (or doesn’t) to your company
  • Learn the reporting exceptions
  • Figure out the easiest way to roll-out tracking program at your company
  • How to develop an SOP
  • Learn the terminology
  • Get a grapple on tracking and reporting mechanisms
  • Take on customer issues
  • Learn the corrections process, what the assumptions document entails, how to register, certification/attestation, etc.

If you are looking for answers to these questions, you would certainly benefit by attending this seminar:

  • What are the common mistakes companies are making when they try to get compliant with the Sunshine Act?
  • What do I have to report? What can I avoid reporting? What are the reporting exceptions?
  • How do I report? When do I have to report by? How the does the review process work? What if a doctor disagrees with my information? How do I prepare an assumptions document?
  • Do these rules apply to my company? What about my parent company? What about our distributors?
  • Do all meals and gifts have to be tracked? What if I am working on a joint venture? Who reports then?
  • How does the False Claims Act and Anti-kickback Statute play a role in the Sunshine Act? What state laws do I have to follow now that the Sunshine Act is in effect? Are the laws of Massachusetts, Vermont, Minnesota, West Virginia, D.C., etc., still in play?
  • What sort of policies and procedures do I need in place? How do I design and implement them? What should the policies and procedures cover?
  • How do I train employees and management on the Sunshine Act?
  • What tools should I use to record the data?
  • What are emerging as best practices?
  • What indirect payments must be reported and which ones can I avoid reporting?
  • What are the nuances for drug companies? What about device companies?
  • What is the latest guidance from CMS?
  • How do I register with CMS?
  • …and many many more.

Who will Benefit:

This training program will be beneficial for the following personnel in the medical device and drug companies:

  • Compliance professionals
  • Executive management (remember, the CEO, CFO, or CCO will be required to certify the report made to CMS)
  • Attorneys and in-house counsel
  • Regulatory affairs professionals
  • Finance professionals

Course Outline:

Day One (8:30 AM – 4:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
  1. Introduction to Statistical Hypothesis Testing (2 Hours)
    • Null hypothesis versus the alternative
    • Different errors that can be made in doing statistical tests
    • When do we use the Z-test and when do we use the t-test
    • Testing variances
  2. Working with Confidence (1.5 Hours)
    • Confidence Intervals
    • Tolerance Intervals
    • Sample Size
  3. Overview of Analysis of Variance and Variance Components (3.5 hrs)
    • Fixed versus Random Effects
    • What does a p-value mean and how do I interpret them?
    • Understanding an ANOVA table
    • How do I use ANOVA to calculate variance?
Day Two (8:30 AM – 4:00 PM)
  • Screening experiments
  • Resolution of a design
  • What is an interaction?
  • Building an appropriate model
    • Design Control (2 Hours)
      • Design Verification
      • Design Validation
    • Regression Analysis (2 Hours)
      • Product Stability
    • Analytical Method Validation (1.5 hours)
      • Accuracy and Linearity
      • Precision

Meet Your Instructor

Mark-Gardner_large
Mark Gardner, M.B.A., J.D.,
Attorney and Adjunct Professor at DuVal & Associates

Mark Gardner, M.B.A., J.D., is an attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, dietary supplement, drug, biotech, and food industries. His practice focuses on FDA regulation, health care fraud and compliance, design and implementation of regulatory compliance programs, promotional review, FDA enforcement actions and aggregate spend. Prior to his legal career, he worked in product management and sales for three medical device companies over a 10-year span where he focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications. Gardner is also an adjunct professor at Hamline University School of Law where he teaches food and drug law and serves as a health law regulatory and compliance competition coach. He currently serves as a Co-Chair for LifeScience Alley's Regulatory Special Interest Group. He is the Chairman of the Minnesota State Bar Association Food, Drug and Device Law Section. He serves as a steering committee member of the Minnesota Medical Device Alliance. He is a member of the Medtech Resource Alliance. Gardner speaks and writes on issues that impact FDA regulated products.

Venue

Location 1:
Grand Hyatt San Francisco
345 Stockton Street,
San Francisco, California, USA, 94108

October 17-18, 2013


How to Reach

General Driving Directions:

Driving Directions from Boston Logan International Airport – BOS: 3.2 mile(s) NE
  • Follow signs for Boston/Sumner tunnel.
  • Pay the toll and stay in the right lane in the tunnel.
  • Follow signs for Exit 26/Storrow Drive. After you emerge from the tunnel, take the second left exit to Copley Square/Back Bay.
  • At the first light, turn right onto Beacon St. Follow Beacon St. for 4 blocks and make a left on to Exeter St.
  • After 5 lights, Exeter St. ends at Huntington Ave. Turn right onto Huntington Ave.
  • At the first light, under the sky bridge, make a U-turn to the left. The hotel entrance will be immediately on your right.

Other Transportation:

Bus Station
  • South Station: 1.2 mile(s) E
Subway Station
  • Back Bay Station: 0.2 mile(s) E
Train Station
  • Back Bay / Copley Station: 0.2 mile(s) E
  • North Station: 2 mile(s) NE
Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.
Location 2:
Courtyard Phoenix Camelback
2101 East Camelback Road,
Phoenix, Arizona 85016 USA

December 5-6, 2013
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Testimonials

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- Sr. Mfg Manager, FibroGen Inc.

This seminar is good for statisticians. ComplianceOnline is doing well with organizing seminars and webinars.
- QA Associate, Dr Reddy's Laboratories

I like the concept and use of DOE and specific settings. Good topics covered in this seminar with combined thought process. It was a well organized event by ComplianceOnline.
- Head - Development Quality Assurance, Dr Reddy's Laboratories

The seminar was very good and useful to my area. I like the areas covered on statistical analysis for method validation - Because I am doing lots of validation, method transfer etc. ComplianceOnline is a great tool for quality organizations.
- Associate Director, Pfizer

The training covered a large amount of data but moved at a good pace with lots of examples. The venue was very good and seminar was well organized by ComplianceOnline.
- Novartis

I had registered for a seminar but unfortunately I was not able to attend. The company was very understanding and extremely helpful. I plan on attending a future event soon.
- Director of Regulatory Affairs, Nickell Physician & Pharmacy Services

The program was well organized and coordinated. I like the ICH guidelines, DOE, specifications.
- QA Associate, Dr Reddy's Laboratories

Great examples and stories. Steven kept things interesting and relevant. I like the sessions on Q7 - GMP for API and trending of process parameters / control.
- Project Manager, Bayer HealthCare, LLC

It was good to see common approaches for specification setting. Good practical feedback as to standard practices and regulatory expectations.
- Senior Engineer II, Shire

I like the Stability statistics session. Very knowledgeable presenter who was willing to listen to attendees expertise.
- Senior Stability Scientist, Noven Pharmaceuticals

Good introduction to all areas of ICH and the statistics used with programmatic to implement them at your company. The presenter was very knowledgeable. - Global Head Stability, GlaxoSmithKline Consumer Health R&D

The presentation and flow was well organized and related. I like the Tolerance Intervals since they relate to single point measurements.
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