The Centers for Medicare & Medicaid Services (CMS) within the U.S. Department of Health and Human Services have published the final rule for the transparency reports that pharmaceutical and medical device manufacturers must file with the federal government for payments and transfers of value they provide to physicians and teaching hospitals. “Physicians” are defined as doctors of medicine and osteopathy, dentists, podiatrists, optometrists and chiropractors who are legally authorized to practice by the state in which they practice. The requirement was included in the healthcare reform law and the provision is frequently referred to as the “Physician Payments Sunshine Act.”
At the outset, it is important to remember that the law does not prohibit the giving of promotional products to physicians and teaching hospitals. However, the manufacturers of drugs, devices, biological or medical supplies—CMS refers to them as the “applicable manufacturers”—must report the transfers of value. There are two exclusions from the reporting requirements of interest to the promotional products industry—an aggregate $100 of items with values under $10 each and a separate exclusion for educational materials that directly benefit patients or are intended for patient use.
To read a summary and analysis of the CMS’ rules, click here.
The regulations and CMS’s explanatory material cover nearly 300 pages. You can find the Federal Registry Notice here.
For any questions or concerns, e-mail PPAI.