The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule Dec. 13 that will increase public awareness of financial relationships between drug and device manufacturers and certain healthcare providers. This is a provision under the Patient Protection and Affordable Care Act (PPACA).
“Disclosure of these relationships will discourage the inappropriate influence on clinical decision-making that sometimes occurs while still allowing legitimate partnerships,” said Peter Budetti, MD, CMS deputy administrator for program integrity.
The proposed rule would require manufacturers of drugs, devices, biologicals and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program to report to CMS payments or other transfers of value they make to physicians and teaching hospitals. The proposed rule also would require manufacturers and group purchasing organizations (GPOs) to disclose to CMS physician ownership or investment interests.
Drug and biologic manufacturers, medical device or supply manufacturers, and GPOs would be affected by the new reporting requirements. These organizations, as well as the physicians and teaching hospitals, would be allowed an opportunity to review and correct information prior to its publication.
PPACA provides that violators of the reporting requirements will be subject to civil monetary penalties, capped at $150,000 annually for failing to report, and $1 million for knowingly failing to report.
CMS is proposing that data collection will not begin on Jan. 1, 2012 and that manufacturers and GPOs do not need to begin data collection until final regulations are issued. Depending on the timing of the final rule, CMS is proposing that manufacturers and GPOs will be required to submit a partial year on March 31, 2013.
Once the data have been submitted, the agency will aggregate manufacturer submissions at the individual physician and teaching hospital level, provide them with a 45-day period to confidentially review and, if necessary, correct the data and make the data publicly available by Sept. 30, 2013.
CMS will accept comments on the proposed rule until Feb. 17, 2012, and will respond to them in a final rule to be published in 2012.
The proposed rule can be downloaded here.