SUNSHINE ACT:   WHAT COULD FOLLOW

We have asked each of our physicians to review and dispute, if applicable, the data posted under their name on the Open Payments website and ensure consistency with that which was reported internally on the RNUA. Once the data goes public, anyone will be able to view information reported under any physician, including government regulators. It is easy to foresee challenges against physicians now that the Open Payments compensation data will be available. Regulators will now have compensation data to piece together with prescription patterns. Case in point: a Chicago-area psychiatrist has pleaded guilty to receiving illegal kickbacks of almost $600,000 from two pharmaceutical companies in exchange for prescribing their anti-psychotic drug to patients in violation of the anti-kickback statute. According to the plea agreement, Dr. Reinstein prescribed the brand name version of clozapine, Clozaril, for years in exchange for speakers’ fees from the manufacturer, even after the generic version became available. After the manufacturer stopped paying this physician, he met with representatives of IVAX, maker of the generic clozapine, and agreed to switch his patients to the generic if IVAX would pay him for “consulting.” The relationship lasted for years resulting in thousands of false claims being submitted to Medicare and Medicaid.

Under the Anti-kickback Statute, a physician may not prescribe drugs or devices if the physician has been paid in cash or in kind, if one purpose of the payment was to influence referrals of items/services covered by Medicare, Medicaid and other federally funded programs. The Anti-kickback Statute is intended to ensure that a physician’s medical judgment is not compromised by improper financial incentives and is instead based on the best interests of the patient. Now that compensation data is readily available, what should physicians do to avoid scrutiny?

1. Review and dispute, if applicable, payments attributed to you on the Open Payments website. Make sure each payment is accurate and compare it to what has been reported on your RNUA. Going forward, keep careful track of each payment that you receive so that you can better audit payments posted next year. You may want to consider downloading “Open Payments Mobile for Physicians” app to track reportable transfers.
2. Document the business reasons for the agreement: Take a look at your vendor source relationships and ensure that your contract appropriately states the business reason for the deal and that none of the compensation arrangement is tied to referrals. If the only documentation is how much you will be paid, it is difficult to say that the intent was educational, to improve patient care or for other legitimate reasons.
3. Make sure your clinical decisions are justifiable. Dr. Reinstein changed his prescribing patterns based on outside influences. Physicians who have potential financial conflicts of interest, whether as researchers, speakers, consultants, investors, partners, or otherwise, must not compromise their objective clinical judgment or the best interests of patients.