Managing Physician Payment Disclosures: Compliance in the New Era of Transparency
This is the year that drug- and devicemakers will need to begin reporting – for the whole world to see — the types of financial arrangements they have with physicians and teaching hospitals.
Planning for disclosure is one thing. Actually carrying it out will be another altogether. Are you ready for the host of challenges, headaches and questions that are about to land on your desk? If not, read on …
By Sept. 30, 2014, your every payment to physicians and teaching hospitals will be public. The fallout from such publicity may create a host of problems for drug and device makers like yourself — not least, those $1 million potential fines.
Furthermore, you can expect physicians to carefully scrutinize the data and demand corrections when warranted. Some may dispute what exactly must be reported — even whether you need to report at all.
But here’s help setting up a compliant reporting program to withstand such challenges. Managing Physician Payment Disclosures gets you off to a running start, with:
- Key definitions on what information must be reported
- Who qualifies under the law and must report, and who is exempt
- How to build the "assumptions document" that will form the basis for your reporting strategy
- Special considerations for educating physicians and hospitals on implications of the rule
- How to avoid simple mistakes that can result in failure to report
- How to anticipate potential PR and legal problems disclosure may create
- How to address and resolve complaints about data
Plus, Managing Physician Payment Disclosures provides details on the tricky questions likely to arise when implementing the reporting program, including:
- Are non-U.S. payments reportable?
- Must companies report payments occurring before a product is approved?
- Are consulting fees treated differently than gifts?
- Are drug samples considered items of value that must be reported?
- Are product discounts reportable?
- Are payments for treatment of adverse events reportable?
- Does the Sunshine Act preempt all state reporting requirements?
- And many others!
Do you relish facing hordes of angry physicians demanding corrections to their data? How about the prospect of $1 million fines? The answer ought to be clear — especially when this easy-to-read Special Management Report can set you on the right path in an hour or two of reading, max.