"We know that even small gifts can be associated with physicians' positive attitudes toward sales representatives, and can increase their rate of administering particular drugs or devices. These regulations are a long-overdue step toward greater transparency in healthcare."
Despite the delays, Carome says that once the rule is implemented it should bring greater transparency to the financial relationships between physicians and the drug and medical device industries.
"Such transparency will allow consumer advocates, patients and other stakeholders to better assess the potential influence such relationships have in (a) the development of recommendations by the advisory committees of the FDA, CMS and other regulatory agencies; (b) the development of clinical practice guidelines by professional associations and government agencies; (c) the opinions expressed by medical school faculty and attending physicians during graduate medical education training; and (d) the medical decision making of healthcare providers in the context of clinical care."
Ultimately, Carome says, the worth of the final rule will be determined by how well companies comply with reporting requirements, how vigorously CMS enforces the rule, and how user-friendly and accessible the database will be for the general public.
"Given the delays in implementation, we won't be able to assess the impact of the rule for at least a few years," he says.