PhRMA and AvaMed and several companies including Merck and AstraZeneca line up behind revised Physician Payment Sunshine Act.
In addition to press releases the organizations sent letters to Senator’s Grassley and Kohl announcing their endorsement: PhRMA’s endorsement letter AdvaMed’s endorsement letter. This is following up from Eli Lilly’s endorsement last week.
Senator’s Grassley and Kohl see these endorsements as very positive:
This movement toward transparency is good for the system. It fosters accountability by empowering consumers and other watchdogs,” Grassley said. “The kind of support that continues to grow from industry leaders contributes in an important way to achieving new nationwide requirements. Requiring disclosure of payments to doctors doesn’t mean that anything has to change, and if there’s nothing to hide, there’s no reason to worry. The legislation we’re working to get passed would apply to drug makers and medical device manufacturers of every size. It would make information about payments to doctors, and not just big payments, available to the public in a user-friendly way. It builds on and improves the important state-level
initiatives that revealed important concerns and set the stage for federal reform.”
This is different that the previously introduced Act in that:
· Reporting Starts in 2011 vs. Immediately
· Excludes gifts and consulting of less than $25.00 and requires reporting of aggregate of over $500/year. Previously required reporting of all gifts over $25.00
· Limits fines to $50,000/year for non intentional violations and $250,000/year for intentional violations
· Requires reporting by all companies regardless of revenue, previous bill applied to companies with revenue of $100 million or greater.
· Provides pre-emption of state laws, so that current state laws on disclosure would be invalidated upon enactment of this law.
· Delayed reporting for product development and clinical investigations by two years, this proprietary research.
· Exempts
o Sample
o Educational materials for patients
o Training and other Education
o Transfers not acting in a professional capacity
o Loans for equipment purchases
o Warrantees
o Discounts
o Anything bellow $25.00 indexed to CPI
o In kind items used in charity care
So what does this mean for CME?
Education is included in the first section only to capture education that is not intended for patient benefit. Education intended to benefit patients is excluded.
We understand this may exempt CME – in that that companies only have to report direct payments to physicians/physician practices, as well as payments that are directed by a physician to another entity or on behalf of a physician.
So if a company is directed by Physician A to make a payment to a CME provider, that would be reportable. If a company makes a payment to a CME provider to specifically pay for the attendance of Physician B, that would be reportable. But if a company makes a payment to a CME provider that is for general use by the CME provider and is not tied to a specific physician, that would not be reportable. We are working to gain further understanding of this issue.
This is a much different track than the House version, which would have no limit on fine, includes CME and would eliminate tax exemption for marketing upon the first violation weather intentional or not.
For other articles we have written on this topic:
Physician Payment "Sunshine -Version 3.0"