Physician Payment Sunshine Act - Comprehensive Compliance Training Course

The Physician Payment Sunshine Act has changed the way gifts and payments made to physicians and teaching hospitals are being tracked and reported. The conduct of clinical trials, too, has been changed as the law requires sponsors and investigators to report payments and gifts.

Penalties for non-compliance with the Act’s requirements are substantial. This package of 3 compliance training webinars discusses the Act’s requirements, State Sunshine Laws, the Final Rule, and Sunshine Act reporting for clinical trials.

How It Works:

Each webinar CD has a series of modules. Our speakers have delivered the modules using PowerPoint slides.

This training is convenient to attend individually or in groups. You don't have to travel from your office. This means you can afford to have your whole team attend. As the webinar recording CDs are licensed to be used multiple times in a location, you can schedule the training as many times for as many groups/batches as you wish. Your team members will learn the material together; everybody will get the same information.

Webinar Topics:

The Sunshine Act Reporting for Clinical Trials
The Sunshine Act Final Rule
Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements?

Who will Benefit?

These webinar recording CDs will be beneficial to the following personnel from medical device, drug, and biologics 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
• Principal and co-Investigators participating in industry-sponsored clinical trials
• Sponsors of clinical trials
• Legal experts involved in assisting physicians and patients alike with medical malpractice
• Medical accounting companies
• Regulatory affairs professionals, research analysts
• Financial analysts and investors, venture capitalists, insurance professionals

Webinars Iincluded in the Package:

Module 1 : The Sunshine Act Reporting for Clinical Trials (Duration: 60 Minutes)

This webinar will discuss the disclosure requirements for clinical investigators under the Sunshine Act. It will discuss the details of the processes; provide templates for reporting formats; and timelines for reporting.

Areas Covered in the Webinar:

• Clinical trial financial reporting requirements
• Kind of payments covered and exempted for reporting to CMS
• Format of reporting to CMS
• Dealing with CMS’s inquiries regarding reported information
• Acceptable and Unacceptable practices
• Comparison of Federal reporting requirements with Industry best practices
• Legal and practical implications of reporting financial information for investigators
• Regulatory solutions for most common anticipated issues with reporting.

About the Instructor:

Dr. Mukesh Kumar, is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products.

Module 2 : The Sunshine Act Final Rule (120 Minutes)

This webinar will discuss in detail the Final Rule for the Physician Payment Sunshine Act, its impact and how to prepare for it. You will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to CMS.

Areas Covered in the Webinar:

• Sunshine Act & the Final Rule
• Terminology used and how it applies to your company
• Considerations to make when putting an SOP in place
• Tracking and reporting requirements
• Customer considerations
• Exceptions that apply to reporting
• Deadlines

About the Instructor:

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.

Module 3 : Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements and Existing State Requirements? (120 Minutes)

This 120-minute webinar will cover the new (Federal) Physician Payment Sunshine Act, the topics raised by the proposed rule and existing State sunshine laws. Attendees will learn about reporting, certification and registration deadlines and what specifically needs to be reported or provided to the relevant authority.

Areas Covered in the Webinar:

• Physician Payment Sunshine Act
• State sunshine laws – for example, Vermont, Massachusetts, Connecticut, Nevada, California, Minnesota, West Virginia, DC, etc.
• The proposed rule for the Physician Payment Sunshine Act
• Terminology used in the new federal law and how it applies to your company
• Exceptions that apply to reporting under the federal and state laws
• Registration requirements
• Deadlines

About the Instructor:

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.

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