Penn State May Have Benefitted from a Robust Compliance Program
Curiously not mentioned in any of the stories about Penn State is the existence of a hotline to which eye witnesses of Sandusky’s child rapes could have been anonymously reported, or the existence of an Ethics/Compliance Professional with direct access to and oversight by the board. Well, it turns out they’re not mentioned because they didn’t exist. It appears that even now, Penn State lacks a compliance program, the creation of which Special Investigative Counsel Freeh’s Report recommends. Previously limited to financial fraud and HR issues, a June 21, 2012 posting by Penn State’s internal auditor announces a poster redesign advertising its hotline number, to which any ethical or legal concerns can now be reported. Important will be training throughout the university regarding the law’s protection of whistleblowers, about which, according to Freeh’s Report, top university leaders were unaware.
While it is stunning that, even now, Penn State has not advanced further in setting up these protective measures, it is fair to say that much of higher ed has been slow to adopt compliance best practices common to the healthcare sector and most business entities. Those universities with academic medical centers are among those who caught the wave early, because hospitals had to put compliance programs in place in the late 1980′s at the insistence of the Health and Human Services Office of Inspector General. Experience in the health sector suggests that the kind of exceptionalism and favoritism extended to Paterno and Sandusky might not have happened if a strong compliance program with an ethics officer of stature had been in place. The board would not have learned about crimes on its campus from the newspaper if it received regular updates from a compliance officer about all reports and investigations.
Janitors witnessed Sandusky engaged in sexual behavior or showering with children, but were afraid to make reports lest they’d lose their jobs. An anonymous hotline would have provided a mechanism for this information to have led to a real investigation that would have confirmed the fears that Sandusky was a serial rapist. Again, the ultimate decision-makers would have had an understanding of the full extent of the situation with which they were dealing — surely in the face of full-blown written findings detailing the scope of the horrors occurring on their own campus they would have acted.
Finally, the existence of an autonomous compliance ethics and compliance officer with sufficient stature and experience to conduct a full investigation and force a discussion about the appropriate handling of such catastrophic events could have also changed the outcome. As it was, the oral information reported up the chain became so diluted by the time it reached the University President that a rape was reported to him as “horsing around in the shower.” A complete written report would have avoided any such misunderstandings. More important, the victim would have been identified and hopefully protected — no one involved in handling the matter inquired about or made any efforts to identify any of the victims. Instead, Sandusky was given the heads up that he’d been seen in the shower, putting his child victim at greater risk. To give Special Investigative Counsel Freeh “free rein” after-the-fact is too late; imagine the harm that could have been avoided had such an investigation taken place in response to an early hotline report complaining about Sandusky showering with children. While the success of a robust compliance program for institutional reform is varied, experience in health care suggests that it contributes much to the prevention and discovery of problems.
While universities have certainly taken notice of the disaster that has befallen the children whom Sandusky assaulted and Penn State for its multiple failures, it is less certain that they’ve taken sufficient steps to ensure that similarly horrible events won’t get swept under the rug at their own institutions. Universities are essentially small towns populated by an age cohort with adult problems and responsibility but frequently lacking the maturity to handle either effectively. When you add the numerous high risk activities that are inherent to university life, it is no exaggeration to say that it is by the grace of God that more tragedies don’t occur on campuses. I suspect there’s more than we know, and I fear the lesson of Penn State may be lost.
In short, all university boards should read Special Investigative Counsel Freeh’s Report and take seriously its recommendations for your own institutions. Specifically, corporate compliance should be taken seriously.
If you are interested in learning about the whistleblower programs and the laws protecting whistleblowers, enroll in Seton Hall Law’s 8 week online course entitled The Law Protecting Whistleblowers. Watch Seton Hall’s Online Certificate web page for details to be posted in mid-August.
60 Minutes, Glaxo’s Bad Day & Why Compliance is So Terribly Important
Filed under: Compliance, Pharma, Quality Improvement
In case you missed it: 60 Minutes segment with whistleblower Cheryl Eckerd, a former manager of global quality assurance for GlaxoSmithKline. She describes her experience inspecting Glaxo subsidiary, Cidra, in Puerto Rico. It views like an in-house counsel’s nightmare and a PR professional’s worst day. CBS states:
“But in November, we found out just how much could go wrong at one of the world’s largest drug makers. A subsidiary of GlaxoSmithKline pleaded guilty to [a felony] distributing adulterated drugs.
“There was reason to believe that some of the medications were contaminated with bacteria, others were mislabeled, and some were too strong or not strong enough.”
Ms. Eckerd brought suit under the Federal Whistleblower Act, with the government ultimately recovering $750 million; Ms Eckerd who was “downsized” by Glaxo, received $96 million as her share of the recovery. In addition, when Ms. Eckerd made the information she had gathered about the plant in Puerto Rico available to the FDA, federal agents executed a search warrant and seized drugs worth “hundreds of millions of dollars.”
Las Vegas Infectious Disease Specialists Accused of Fabricating Medicare Services
Photo by a.drian via Flickr
The Las Vegas Sun reports that the Nevada Medical Examiners Board is investigating into the falsification of medical records at HealthSouth Tenaya. Raye Kraft, wife of a patient at this hospital, began to notice “infectious disease specialists Dr. Dhiresh Joshi and his then-employee, Dr. Fadi El Salibi,” writing in Kraft’s husband’s medical charts that they were examining him when they were not. As her suspicion rose, Ms. Kraft took detailed notes of when the specialists charted activity on her husband, compared these notes with her insurance bill and her own notes of the times they actually examined him, and then sent these notes and comparisons along with a complaint to the Nevada Medical Examiners Board.
The Sun reports:
Her claim: that on an ongoing basis, Joshi and El Salibi were writing in the chart that they had examined her husband when they hadn’t, and then billing for it. One supposed exam was nothing more than the doctor’s friendly wave from the door, she said.
Ms. Kraft’s was not the only person suspicious. The article notes that another patient “had complained a year earlier to the medical board of similar experiences.” Additionally, nurses at MountainView Hospital Medical Center also filed complaints “about El Salibi’s fly-by visits.”
In addition, the number of patients Dr. Joshi has claimed to have examined in the course of a day has been deemed further cause for suspicion. According to the Sun, Elizabeth Neubauer, Dr. El Salibi’s former billing manager, “said that Joshi himself routinely billed for 70 patients a day. Other infectious diseases doctors say that’s double the number they could reasonably see in a long day of hospital rounds.”
The Sun also reports:
Indeed, a 2004 Medicare audit showed that in a single day, Joshi billed for an impossibly high number of patients – 104, according to Neubauer’s recollection. Joshi said it was 81 Medicare patients, and 20 of them were seen by medical residents under his supervision.
One might have thought that the audit would have served as a red flag for further examination for fraud and abuse at that time. An “impossibly high number of patients” is, after all, impossible– and therefore seemingly either the result of either inadvertence or knowing falsehood. If a pattern of such “impossible” billing emerges, “inadvertence” begins to seem less likely– especially when coupled with independent allegations of “overbilling.”
The articles reports that “[a]llegations about doctors fraudulently billing Medicare and insurance companies are whispered throughout the Las Vegas medical community . . . .” One might hope that the numerical evidence derived from audits in cases such as this would do more than whisper– and would occasion heightened scrutiny.
Bipartisan Effort to Amend the False Claims Act
photo by oooh.oooh via Flickr
American Health Lawyers Association reports that Senators are seeking to amend the False Claims Act:
Senators Charles Grassley (R-IA), Richard Durbin (D-IL), Patrick Leahy (D-VT), Arlen Specter (R-PA), and Sheldon Whitehouse (D-RI) introduced recently the False Claims Act Clarification Act of 2009 (S. 458), which would amend the False Claims Act (FCA) to strengthen a whistleblower’s ability to bring a qui tam action on behalf of the government, among other things.
This amendment would also clarify some of the ambiguity surrounding the FCA. The AHLA stated:
The bill includes a provision clarifying that the FCA was intended to extend to any false or fraudulent claim for government money or property, whether or not the claim is presented to a government official or employee, whether or not the government has physical custody of the money, and whether or not the defendant specifically intended to defraud the government.
This clarifying amendment may have a significant impact on two areas of health care litigation. First, the amendment would strengthen qui tam actions against pharmaceutical companies where the pharmaceutical companies do not actually present a claim to the government, such as with off-label drug marketing cases. Second, the amendment may strengthen “bootstrapped” qui tam actions, where the qui tam relator brings a FCA action for Anti-Kickback Statute and/or Stark Law violations (physician “self-referral” cases), despite the lack of any specific FCA violation, and because the Anti-Kickback Statute and Stark Law themselves lack a private right of action.
At the very least, the proposed amendment, which would facilitate the use of qui tam actions, is further evidence of the federal government’s increased reliance, and an intention to continue in such reliance, upon qui tam actions as a means of both regulatory and punitive enforcement.
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