The DOJ Will Huff & Puff About The Sunshine Act But Not Blowing Any Houses Down
Updated July 1, 2015
July 18, 2014
Earlier this week the AMA announced that physicians have between now and August 27 to review reports about their financial interactions with manufacturers of drugs and medical devices and dispute potentially inaccurate reporting under the Physician Payments Sunshine Act (also known as the Open Payments program).
This program was put in place to prevent manufacturers of drugs and medical devices from outright buying their physician’s business. This could also be known as a kickback and a big ole no-no in the industry-except it’s not.
Johnson & Johnson’s Janssen Pharmaceuticals during illegal off label marketing and illegal kickbacks of Risperdal, which caused 1,207 children to suffered serious problems, 31 children died, 11 of which were off label use and adolescent males reported growing breasts: VP of Marketing at Janssen Pharmaceuticals Alex Gorsky made PresidentDirector of Marketing at Janssen Pharmaceuticals Gary Pruden Executive Director, Global Marketing Leader, Janssen, Pharmaceutical Companies of Johnson & Johnson Bridget RossJohnson & Johnson’s Janssen Pharmaceuticals’ was $2.2 billion by the DOJ for Risperdal’s illegal off label promotion and kickbacks.
And alarmingly last week it was widely reported and largely ignored that San Francisco gynecologist named Dr. Andrew Brill received nearly $213,000 in consulting fees last year from the Johnson & Johnson’s Ethicon’s Gynecare unit (and yes that’s on top of his own salary of $350,000 (based off of national average)). Apparently this information was not only missing from Dr. Brill’s Sunshine Act report the FDA missed it altogether when they asked him to sit on a panel to review (oh wait for it) yep, you guessed it, a possible cancer causing product up for recall made by Johnson & Johnson’s Ethicon’s Gynecare.
Had the Wall St. Journal (WSJ Pharmalot) not inquired into the relationship it’s highly suspect that the evening before the big meeting regarding Johnson & Johnson’s Ethicon’s Gynecare’s products Dr. Andrew Brill would have had a sudden recollection of an extra $213,000 from the company he was reviewing which might be a conflict of interest and recused himself.
Another failed program from The Department of Justice that was meant to deter unethical or illegal behavior not reward it. Hey Mr. DOJ! Why don’t you get Dr. Andrew Brill and Johnson & Johnson to sign Corporate Integrity Agreements? Oh that’s right-JNJ already has multiple corporate integrity agreements! That seems to be working out well for everyone but patients and taxpayers. I have a feeling that when the Sunshine Act information is released to the public it will be about as successful as when CMS (Medicare/Medicaid) released their information earlier this year that revealed they paid one surgeon $21million.
Our government is clearly too worried about driverless cars, nude selfies and diet Pepsi to run a fucking report or background check on someone sitting on their own FDA panel, anyone else worried?
And for the physicians who don’t have enough to do with government mandated “hostage” situation with their EMR data below are the guidelines for obtaining your Sunshine Act information. Warning it does involve a possible retinal scan and Gregorian chant to access.
Physicians already should have registered with the Centers for Medicare & Medicaid Services’ (CMS) Enterprise Portal, the first phase in a three-step process for data review. If you haven’t completed this step, read more about how you can do so now.
Follow this process to complete step 2. Registration is rather cumbersome, so make sure to follow the directions closely and allow enough time to complete it in one session:
1. Log in to the CMS Enterprise Portal.
2. Click the button on the far right that says “Request access now,” then click “Request new system access.
3. Select “Open Payments” from the drop-down menu and input your personal information.
4. Log out of the system and wait two minutes, then log back in.
5. Select “Create my profile.”
6. Select “Start profile” at the bottom of the next screen.
7. Select the profile type “Physician” and then select “Continue.”
8. Enter your personal information, making sure to fill in the required fields that are marked with an asterisk. When you are done, select “Continue.” Do not choose “Cancel” unless you want to start over; canceling will erase all data.
9. Enter your details, making sure to fill in the required fields that are marked with an asterisk.
– When the system asks for your specialty identification code, what it really requires is your provider taxonomy code. The list of these codes is provided in a CMS document, which lists the codes by specialty. Enter the taxonomy code in the Open Payments system.
– Physicians are required to enter at least one license number by selecting “Add license” and entering the state in which the license is held and the license number. When you are finished, select “Continue.”
10. If desired, choose an individual to represent you within the Open Payments system by entering the required information and the access level. You do not need to designate an authorized representative during this initial registration and may choose to do so later.
11. Review the information you’ve entered. Select “Back” to edit any information. If the information is correct, select “Submit.”
The entire registration process will take about 30 minutes to complete and must be finished in a single session, according to CMS. Users cannot save entries or complete their profiles at later times. In addition, the system times out after 15 minutes of inactivity, and it does not have an auto-save feature.
CMS recommends using only Internet Explorer version 8 or later to register for the Open Payments system. CMS also cautions users against using their browser’s navigation buttons, which can delete registration data.
If you experience any difficulties while attempting to use the Open Payments system, you can contact the CMS help desk via email or phone at (855) 326-8366.