In February 2008, Old Merck signed what amounted to a felony plea agreement, but called it a "corporate integrity agreement", in which it agreed to -- among other things -- enhance its protections for whistleblower employees, and improve its processes for investigating and reporting potential violations of federal False Claims Act, among other laws. Here is the background on that.
One irony resulting from that woeful chapter is that Merck will now be in a pretty good position to explain to Senator Grassley all the "enhanced procedures" it has in place -- and likely avoid the considerable ire of at least this one Iowa Republican.
Even so, it will be interesting to see whether Merck admits, in its written reply to Senator Grassley, that it undertook these measures only under threat of criminal prosecution, by the United States Attorneys' Health Care Fraud Unit. In any event, here is the latest Senator Grassley letter (H/T Pharmalot):
June 28, 2010
Via Electronic Transmission
Richard T. Clark
Chairman and Chief Executive Officer
Merck & Co., Inc.
One Merck Drive
Whitehouse Station, NJ 08889
Dear Mr. Clark:
I have devoted many years in the United States Senate supporting whistleblower protections, first as the principal sponsor of the 1986 Amendments to the False Claims Act (FCA), then as co-sponsor of the Whistleblower Protection Act of 1989 and cosponsor of the Whistleblower Protection Enhancement Act of 2009. . . .
I sent a [2005] letter requesting information on how Merck & Co., Inc. (Merck) was informing its employees about the FCA, specifically the whistleblower provisions, as part of its internal corporate compliance programs. . . .
. . . .[T]here was no mention or discussion of the FCA or policies regarding whistleblowers in the 144 pages that were provided [by Old Merck] to the Committee. Furthermore, Merck merged with Schering-Plough in March 2009 and Schering-Plough did not have favorable comments regarding the whistleblower provisions of the FCA in its 2004 response. . . .
I continue to believe that any respectable compliance program should include a relevant sample of all federal laws designed to combat fraud and abuse in the Medicare and Medicaid programs. . . .The purpose of this letter is to follow up on whether or not Merck established a compliance program that includes educating its employees on the False Claims Act and whistleblower provisions. Specifically, I would appreciate a response to the questions below. Please repeat the enumerated question and follow with the appropriate answer and supporting documentation:
(1) What changes have taken place at Merck with regard to notifying employees about the FCA? Please provide examples of policies, educational materials, and/or any other documents that Merck distributes to its employees that describe FCA and whistleblower protections.
(2) If a program has been established, what materials are provided to employees to educate them on FCA whistleblower protections, specifically resources on the filing of claims or where employees can seek additional information? Please provide the relevant materials and literature distributed to employees.
(3) Please describe Merck’s process for handling employee complaints or allegations regarding false claims.
(4) If since Merck’s August 2005 response the company has established a compliance program that includes educating its employees on the FCA and whistleblower protections, please describe any quantitative and qualitative differences in the allegations, complaints or reports Merck has received since establishment of that program. How many allegations, complaints and reports has the company received each year?
(5) Of the claims received, how many were resolved in favor of the claimant and how many were resolved in favor of the company?
(6) If Merck’s compliance program does not include notifying its employees of the FCA and whistleblower protections, please explain why it does not include such notification.
(7) What measures does Merck have in place to ensure fair treatment to those filing complaints?
(8) Of employees who have filed complaints, have any complained of unfair treatment and/or retaliation after the filing of the complaint?
(9) What modifications, if any, has Merck made to its compliance program in light of the passage of FERA, which extends whistleblower protections to contractors and agents?
Thank you in advance for your cooperation. I would appreciate a response to the above questions by no later than July 20, 2010. . . .
Sincerely,
United States Senator
Ranking Member,
Committee on Finance
[Emphasis supplied.]
This will be interesting, but pages 2 and 3 of the 2008 Merck plea agreement does provide that contractors and agents are covered: "Covered Persons" includes:
". . . .employees of [Schering-Plough's or] Merck's Corporate Finance Organization who are engaged in, or have responsibilities that directly support, the Covered Functions. . . and. . . . all contractors, subcontractors, agents, and other persons who perform Governent Pricing and Contracting Functions. . . who perform Promotional and Product Services Related Functions on behalf of [Schering-Plough or] Merck. . . .
We'll see -- will Whitehouse Station mention the origin of this "progressive thinking"?
No comments:
Post a Comment