Because these relationships are now being scrutinized more closely than ever, those involved in clinical research with manufacturers of drug and device companies may find the following general guidelines helpful in avoiding risks of non-compliance and other legal complications.
1. Give all relationships a second glance. Are you comfortable with your relationship with a particular entity being made public? Do you want to be associated with that particular vendor? Do they have a reputation that mirrors your practice?
2. Deal with your manufacturers with integrity and above-board behavior. If you are offering services, provide those services and collect for those services. Don’t discount or otherwise expose yourself to anti-kickback law violations.
3. Provide your national provider identifier (NPI) to all entities who will be reporting payments. Don’t be a victim of mistaken identifier or allow payments to another provider to be confused with payments to you. Protect your identifier like you protect your identity.
4. Be your own best resource. Track all payments and gifts from everyone. This is the only way to be certain that you are monitoring yourself and your vendors. Document, document, document. Be sure to leave a paper trail of proof, so that you are never surprised by what is being reported about you.
5. Keep your paperwork in order. Double-check the 1099 forms sent to you by every manufacturer. With your well-documented receipts of gifts and payments, making sure this form reflects accurate information should be easy. The IRS may be double-checking too.
6. Review the reports. With 45 days to review reports and find any mistakes on your payment reporting record, you must be diligent in reviewing information vendors report. You have to be your own advocate.
7. Compliance is key. Tracking and monitoring should be incorporated into your overall compliance plan. This is the best method to ensure that you are taking every precaution to reduce your risk.
8. State laws still rule. Remember that state laws still apply. Keep abreast of all rules, especially hospital rules regulating relationships, and state disclosure requirements.
9. Don’t take off your glasses before the sun sets. Watch for more guidance on the issues of the provision that remain fuzzy. The Sunshine Rule is clouded with many questions, and it is expected that more will come to assist in making these stipulations easier to understand and to navigate.
As the ninth tip suggests, there is more to come on this topic. We will keep you informed with any new information as it develops.
McBrayer, McGinnis, Leslie & Kirkland, PLLC