When Senators’ Grassley and Kohl released the Physician Payment Sunshine Act of 2009 on January 22, 2009, it represented a significant drift from the bill with the same name that was endorsed by over 25 organizations in 2008 but never introduced as a bill by the Senators.
The rationale for the endorsement was that the deal they cut in 2008 would stand through 2009, well things change.
Now that they have everyone on record endorsing the bill by name, the details can be changed. So what is the difference between PPSA 08 vs. PPSA 09. Last week, we did a side by side comparison of the two bills to ensure accuracy and this is what we came up with:
|
Topic |
2008 |
2009 |
|
Additional Physician Reporting Information |
|
Medicare Billing Number |
|
|
|
Specialty |
|
Items to Report |
|
Prospective ownership (stock options) |
|
|
|
Compensation for serving as faculty or speaker for a continuing medical education program |
|
|
|
Grant |
|
Reporting |
|
Applies reporting to product spend (you have to apply what products the payment was against) |
|
Exception to Report |
$25 exception |
No payment or transfer of value too small |
|
Aggregate Reporting |
$500/year |
$100/year |
|
Unknowingly Failure to Report Penalty per event |
$1,000-$5,000 |
$1,000–$10,000 |
|
Unknowingly Failure to Report Limit |
$50,000 |
$100,000 |
|
Knowing Failure to Report Penalty per event |
$5,000-50,000 |
$10,000-$100,000 |
|
Knowing Failure to Report Limit |
$250,000 |
$1,000,000 |
|
Corrections |
Accepted |
Companies – no changes accepted once submitted Physicians – changes can be requested in writing |
|
States |
No Reports to States |
Reports submitted to states |
|
Preemption |
Preempted state laws |
Partial preemption (No preemption for stricter state laws, if states add direct-to-consumer, or lower limits…) |
Several of these areas are problematic for continuing medical education (CME), they include:
· Compensation for serving as faculty or speaker for a CME program. This would mean that companies would be penalized if a CME provider, i.e., a local hospital failed to report to the manufacturer the amount they spent on a speaker at a local CME event, including the cost of his hotel, travel, meals, and incidentals.
Manufacturers would be hesitant from giving grants to small CME providers because of the potential risk of fines and violations from the Federal government.
In addition, multi supported grants would be difficult to reconcile, largely because if it were reported to each company, the full amount of compensation for serving as faculty, the payment to the physician could be counted as many as 30 times (depending on the number of supporters) rather than the amount they actually received. This could be problematic with the local press, university system rules, and the Internal Revenue Service, who may be perusing the disclosure reports during audits.
Collecting the Medicare Billing Number could also be a problem for CME grants as many physicians, for good reason, are hesitant for giving out this number due to a rise in identity fraud.
· Granted, this is less problematic than the faculty compensation, as many companies are already reporting grants to CME providers. However, there are many little grants outside of CME that would be included in this requirement; many for very worthy local programs, this type of inclusion could cast some type of “conflict” shadow on those grants.
· Applying reporting to product spend is another area of concern as grants and compensation for faculty in CME events is not linked to specific products and given from CME budgets not related to a specific product but rather designated in a therapeutic area.
· The non-preemption clause that was added allows states to add any additional information to the disclosure reports, and include various types of providers.
Overall, this is a significant break from the endorsed draft, and hopefully the policy makers will see through the changes. When the final MedPAC report comes out March, we anticipate additional changes to the final bill.
If this is an area of interest to you, there are several upcoming events around this act including:
Teleconference: National Disclosure Audio Conference Tuesday February 10, 2009
Live Meeting: Summit on Disclosure and Transparency March 5-6, 2009 Washington DC (Disclosure, Thomas Sullivan (I), are on one of the panels)
RX Compliance Report: Revised Sunshine Act deals Pharma sharp blow by eliminating pre-emption of state laws (January 26, 2009) Reprinted with Permission
Physician Payment Sunshine Act: Physician Payment Sunshine Act 2009
Physician Payment Sunshine Act 2008
Chart of Changes from 2008-2009
Senator Grassley: Endorsements of Physician Payment Sunshine Act from 08.
MedPAC: Summary of December 2008 meeting