CMS and the Budetti Blunders

Senators Orrin Hatch and Tom Coburn have raised some concerns about a multimillion dollar anti-fraud command center opened up today.  Complete with a giant screen estimated to have cost hundreds of thousands, the center will house the HHS’ infamous $77 million dollar computer system which, as of last Christmas, had stopped one check for $7,591.  Peter Budetti, the Deputy Administrator of Program Integrity at the CMS(Centers for Medicare & Medicaid Services), a.k.a. the fraud czar, said that the center is expected to pay for itself many times over, repeating an old justification for a contract with Northrop Grumman that was also supposed to result in advances against fraud.  He actually had the “chutzpah” (this is a legal term of art) to say that the CMS could learn something from the private sector.  Perhaps when the private sector does business with itself there may be efficiencies, but, when the private sector does business with the public sector, the government gets robbed like an electronics store during a New York City blackout.  In any event, companies like Northrop Grumman are anything but private; take away the government contracts and their cash flow is about the same as a nine year old’s lemonade stand.  All this goes to show that Budetti may be better served by finding an honest nine year old – hopefully not one of Senator Hatch’s grandkids-for a government contract!

As Groucho Marx said, “Politics is the art of looking for trouble, finding it everywhere, diagnosing it incorrectly, and applying the wrong remedies.”

Blowing the Whistle on Education Fraud

The U.S. government provides $150 billion in loans per year to students participating in higher education programs.  This funding is only available to students attending accredited programs.  Despite the large amount of federal funding at stake, the Department of Education does not itself accredit educational programs.  Rather, the Department of Education relies on accrediting agencies, which are federally-approved private organizations, to assure taxpayers and students that federal financial aid is going to qualified institutions.

Programs seeking accreditation must go through a multi-step process where an accrediting agency evaluates the program to measure its performance against the agency’s own standards and those listed by the Department of Education.  After initial accreditation, programs must follow those standards to maintain accreditation.  False certifications by an educational institution to an accrediting agency, in order to become accredited and receive student funding, or to just maintain accreditation, can lead to Federal False Claims Act liability.  Interestingly, an accrediting agency’s operating funds come from fees paid by the entities they accredit.  This may pose a conflict of interest as accrediting agencies may be incentivized to compromise their standards to accredit as many programs as possible.  If an agency accredits organizations that do not meet certain standards, that agency may also be subject to False Claim Act liability.

Employees of for-profit colleges and online programs should be on alert for potential violations of the False Claims Act.  During the 2009-2010 school-year, for-profit programs received almost $32 billion in grants and loans provided to students under federal student aid programs.  The Government Accountability Office, the investigative arm of the U.S. Congress, has published reports in 2010 and 2011 illustrating various derelictions in the for-profit educational industry.  Investigators found that almost all programs instituted some suspect practices.

A common practice of for-profit schools is to pay recruiters for enrolling students.  The Higher Education Act prohibits schools participating in federal student aid programs from paying commissions, bonuses, or other incentive payments to individuals based on their success in enrolling students or securing financial aid for them.  Several for-profit institutions have also been known to encourage students to falsify their academic credentials to obtain federal funding.  These are just some of the many practices that may violate the Federal False Claims Act.

The federal government does not have the resources to police all college programs profiting from federal financial aid.  Accordingly, whistleblowers play an important role in protecting taxpayer dollars and ensuring that our students receive quality education.

U.S. District Judge Rules that Whistleblower Protections Don’t Extend Overseas

U.S. Disctrict Judge Nancy Atlas ruled last week in Houston that whistleblower protections do not apply overseas.  Khaled Asadi filed suit claiming that General Electric retaliated against him after he voiced concern that the company had violated the Foreign Corrupt Practices Act.

Click here for the full article from the Wall Street Journal Corruption & Currents Blog.  http://blogs.wsj.com/corruption-currents/2012/07/03/judge-says-anti-retaliation-provisions-dont-cover-foreign-whistleblowers/

Guttman and Buschner Represent Key Whistleblower in Justice Dept.’s $1.04 Billion Civil Settlement with GlaxoSmithKline

Reuben Guttman led team on behalf of a former GlaxoSmithKline Therapeutic Sales Manager who alleged misrepresentation in promotion of company’s asthma/COPD drug Advair; firm’s third major whistleblower recovery in 2012, following Abbott Labs’ $1.6 billion settlement and banks’ $25 billion payment over ‘robo-signing’ mortgage fraud. 

BOSTON and WASHINGTON (July 2, 2012) — Reuben Guttman of Guttman, Buschner and Brooks PLLC has represented one of several key whistleblowers behind a $1.04 billion settlement announced today between drug maker GlaxoSmithKline and the U.S. Department of Justice stemming from alleged marketing abuses of various GSK medications. Lois Graydon, is a nursing professional and former GSK Therapeutic Sales Manager.

The U.S. Attorney’s office in Boston led the investigation into promotional tactics behind a total of nine GSK drugs. An accompanying criminal component of the case is expected to substantially increase the sum of the recovery.

Reuben Guttman and Traci Buschner are counsel to Lois Graydon, a registered nurse. She is one of the “relators” who alleged that GSK made false and misleading statements about Advair’s safety and efficacy, thus enabling false or fraudulent claims to Medicare, Medicaid, and other reimbursement programs.

Advair’s share of the recovery – more than $700 million – amounts to over half of the total civil settlement of $1.04 billion.

“The False Claims Act plays an important role in health industry compliance enforcement; health care is an issue that touches everyone and oversight, diligence and transparency are critical,” said Mr. Guttman, one of the country’s leading whistleblower attorneys.

“It is important that the medical community pays attention to this settlement and others and asks critical questions about the scientific support for the use of prescription drugs,” he added.

“In this election year, the safety of pharmaceuticals and their cost to the health care system should be front and center,” Mr. Guttman said.

He added, “Whistleblowers play an important role in compliance enforcement of our laws. We were proud to have represented one of the whistleblowers on this important case under the False Claims Act.”

 

AEI Presents Study on the Effects of Anti-Industry Bias

Last Thursday, June 21, 2012, the American Enterprise Institute held a panel, entitled “Muzzle pharma, harm patients: The dangers of anti-industry bias.”  Sitting on the panel were George Chressanthis, a professor at Temple University, Nitin Jain, a principal at ZS Associates headquarters, Thomas Stossel, a hematologist and oncologist, and J.D. Kleinke, a health care business expert.  The panel presented a new study which aimed at determining the relationship between physicians’ choices of drugs and their access to sales representatives from pharmaceutical companies.  The study looked at between 58,000 to 72,000 cases for three different drugs, Januvia, Vytorin, and Avandia, in an attempt to cover a broad range of cases which would inspire a change in drug choices.  Januvia was their sample for a first-in-class drug, Vytorin, for a negative clinical trial, and Avandia, for an FDA imposed black-box warning.  All the physician and prescription information for the cases were provided by the pharmaceutical companies and no patient outcomes were evaluated.  The study found that, generally, doctors take longer to change to first-in-class drugs but also take longer to switch away from drugs that had a negative clinical trial or for which the FDA had issued a black box warning.  Ultimately, it concluded that access limits are a part of an institutional framework whose anti-industry bias, manifested in access limits, have harmful consequences for patients.  Doctors need to operate from the largest body of information, they argued, and that to restrict them from information in any way adversely affects patient health.

Though the study presented clearly and incontestably that access to representatives caused a change in how physicians made decisions regarding drugs, without a further study of patient outcomes, there’s no basis from which to decide whether or not these changes were productive or effective.  The panel wanted to say that doctors should not rely solely on sales reps for their information but at the same time wanted to say that these same sales reps made a significant impact on physicians’ decision-making procedure.  The intimated bias was that these changes were positive changes, but without more concrete data on the practical results of these prescription changes, it is impossible from this study alone to judge decisively whether access limits have unintended and adverse consequences for patient health.

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