After a year delay, the Centers for Medicare & Medicaid Services (CMS) has issued a final rule aimed at increasing transparency between physicians and drug and device manufacturers. The measure now implements all of the Physician Payment Sunshine Act, a provision of the Affordable Care Act.
Beginning Aug. 1, manufacturers of drugs, devices, biologicals and medical supplies covered by Medicare, Medicaid or the Children’s Health Insurance Program must report to CMS payments or other transfers of value made to physicians and teaching hospitals. Additionally, manufacturers and group purchasing organizations (GPOs) will be required to disclose to CMS physician ownership or investment interests.
Payments or transfers of value that are less than $10 do not have to be reported, unless the annual aggregate of those payments or transfers of value exceeds $100.
General failure to report will result in penalties as much as $150,000, but if there is a known failure to report, penalties could be as high as $1,000,000 annually.
The data will be collected from August through December 2013, and will be available to the public Sept. 30, 2014, on a public website. That means your name, specialty, address and any items provided to you, as well as their value, will be searchable on the website.
The increased transparency is intended to help reduce the potential for conflicts of interest that physicians or teaching hospitals could face as a result of their relationships with manufacturers, according to CMS.
Manufacturers, GPOs, physicians and teaching hospitals also will have an opportunity to review and correct reported information 45 days prior to data publication.
Indiana law does not address industry gifts to physicians, but the AMA has developed an opinion on the issue. Find it here.
Read the final rule at the CMS website.
A manufacturer must disclose these payments or amenities provided to individual physicians or teaching hospitals:
- Charitable contributions on a physician’s behalf
- Direct compensation for serving as faculty or speaker for a medical education program
- Consulting fees
- Ownership or investment interest
- Royalties or license fees
- Speaking fees
- Profit distribution
- Stock or stock option grants
- Any categories the secretary determines appropriate