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Here Comes the Sun, Are you Prepared? – Tips for Navigating the New Sunshine Provisions

The Sunshine Act was legislated as part of the Patient Protection and Affordable Care Act (the “ACA”) to reduce the risk of inappropriate financial incentives interfering with medical judgment and patient care by enhancing the transparency of financial relationships between certain health care providers (i.e. physicians and teaching hospitals) and manufacturers of covered drugs and devices.  Because these relationships are being scrutinized now more than ever, those involved in clinical research with manufacturers of drug and device companies   may find the following these general guidelines  helpful in avoiding  risks of non-compliance and legal complications: .

1)      Give all relationships a second glance: Are you comfortable with your relationship to a particular entity being public information – payments will be public information, available on the internet? 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 and 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--leave a paper trail of proof and you will never be 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 are reporting. 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 of the rules, especially hospital rules regulating r 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 our ninth tip suggests, there is more to come on this topic. We will keep you informed with any new information as it develops.

Services may be performed by others.

This article does not constitute legal advice.

Lexington, KYLouisville, KYFrankfort, KY: MML&K Government SolutionsWashington, D.C.