The proposed rule would also require the disclosure of physician's, or immediate family members of a physician, ownership or investment interests in applicable manufacturers and group purchasing organizations.
Drugs and biologicals are defined as those which require prescriptions and which are covered by Medicare, Medicaid or the Children's Health Insurance Program, but not over-the-counter products.
"Collaboration among physicians, teaching hospitals, and industry manufacturers may contribute to the design and delivery of life-saving drugs and devices," the proposed rule begins.
"However, while some collaboration is beneficial to the continued innovation and improvement of our health care system, payments from manufacturers to physicians and teaching hospitals can also introduce conflicts of interests that may influence research education, and clinical decision-making in ways that compromise clinical integrity and patient care, and may lead to increased health care costs."
The Affordable Care Act provides that violators of the reporting requirements will be subject to civil monetary penalties (CMPs), capped at $150,000 annually for failing to report, and $1,000,000 for knowingly failing to report.
The proposed rule goes into detail about how a manufacturing company of a medical product determines whether it will have to report a financial interaction with a particular doctor.
"For example, if once during the calendar year, a sales representative from an applicable manufacturer brings $25 worth of bagels and coffee to a solo physician's office for a morning meeting, regardless of the number of individuals who partake (such as non-covered recipient staff members), the per covered recipient cost is $25. Since this falls above the $10 minimum threshold for reporting a payment or other transfer of value ... this meal must be reported.