Unless the United States Supreme Court determines otherwise, the transparency reporting provisions of the Affordable Care Act (section 6002) will soon require drug and medical device manufacturers, among others, to disclose to the Secretary of Health and Human Services any payments or other things of value given to physicians or other recipients covered by the Act. The disclosures would cover consulting fees, compensation for services, honoraria, gifts, entertainment, food, travel, education, research, charitable contributions, grants and other things of value.
The disclosures would also identify the form of the payment such as cash and cash equivalents, in-kind items or services, stock, stock options, any other ownership interest, dividend, profit or return on investment. There are separate disclosure requirements for ownership or investment interests held by a physician in certain manufacturers or group purchasing organizations. While the effective date of the reporting requirement as to physician payments is in March of 2013, the final rules proving additional guidance on the details of the required disclosures are not yet promulgated. Accordingly, entities who may be impacted by the new law should be ready to move quickly to make the disclosures once the rules are finalized.