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Data, Databases and Disclosure – What Can Whistleblowers Do with Publicly Available Data

A little known provision, of the Affordable Care Act, Section 6002, requires pharmaceutical companies and device manufacturers to report the payments they have made directly to physicians.  42 U.S.C. § 1320a-7h. The law also requires the Centers for Medicare and Medicaid Services to maintain a database of these payments and to release annual reports detailing this data, which they do annually a year behind the submission date. The Centers for Medicare and Medicaid Services recently released its 2016 data on payments to doctors by pharmaceutical and device manufacturers. The big headline is that industry paid more than $8.2 billion to physicians last year, slightly up from $8.1 billion in 2015.

 

As Biopharmadive reported, giants like Roche and Novartis spent hundreds of millions on physicians, with around half going to research projects and the rest to benefits like travel and consulting fees. Some, like GlaxoSmithKline, claimed they have cut back on payments for speaking engagements, but the data still shows the company paying $901,917 to doctors for such payments.

 

CMS warns that inclusion of particular payments in the database does not indicate “any wrongdoing or illegal conduct.” 78 Fed. Reg. 9457, 9460 (Feb. 8. 2013). There can be many legitimate reasons for a company to pay a doctor, for example for running a research project while being compensated at fair market value. Nevertheless, some of the largest False Claims Act cases in history have been based on companies paying kickbacks to physicians and fraudulently misrepresenting them as legitimate payments. For example, in 2016 Forest Laboratories and Forest Pharmaceuticals paid $38 million to resolve allegations that they had paid doctors kickbacks as part of speaker programs, and earlier this year Shire PLC Subsidiaries paid $350 to settle allegations that it had paid physicians kickbacks for bogus case studies and speaking engagements.

 

CMS data makes it increasingly easy to scrutinize these payment relationships by looking up the physician recipients of pharmaceutical payments in other databases, such as CMS’s Medicare Part D utilization datasets. Such data show what doctors are prescribing (and billing to the government). Some entities have created tools such as Propublica’s Prescriber Checkup, which links data from these and other sources to provide a more fulsome picture of physician and industry activity. Looking up companies of interest in these databases can provide additional evidence to supplement a whistleblower’s personal knowledge.

 

The extent to which such data can support an FCA case alone is more questionable. The FCA has a public disclosure bar that requires courts to dismiss actions based on certain public disclosures unless the whistleblower has information that “is independent of and materially adds to the publicly disclosed allegations or transactions.” 31 U.S.C. § 3730(e)(4). Those public disclosures include federal hearings, congressional, Government Accountability Office or other federal reports, or the news media. Case law has established that allegations released by government agencies through the U.S. Freedom of Information Act fall under the public disclosure bar. Schindler Elevator Corp. v. United States ex rel. Kirk, 563 U.S. 401, 410-11 (2011).

Today’s Arguments Concerning Affordable Care Act

While not technically on whistleblower laws, today’s arguments before the Supreme Court concerning the Affordable Care Act are anything but irrelevant to us.  The structure of the entire health care system is in the balance, with millions of people now eligible for subsidies potentially losing that benefit if the narrow reading of the statute urged by the petitioners is blessed by the majority on the court.  We might have hoped that the ACA debate was settled after the Court’s 2012 ruling upholding the law, but that was perhaps too much to hope for in these times of (“I’m against whatever you’re for”) political division.

 

As the descriptions of the argument have come down, the justices assumed their normal positions, with the four liberal justices arguing that the wording of the statute must be read in context, the three far right justices taking the view that the literal language of the law must be followed even if it eviscerates large portions of the statute, leaving only Justice Kennedy and Chief Justice Roberts to decide the matter.  Roberts asked no questions, and Kennedy seemed troubled by the petitioner’s arguments.

 

Yesterday, Professor Laurence Tribe penned an articulate piece on both the law and the politics of the case.  It’s a good read.

 

It’s hard not to be struck by the amount of energy and turmoil going into the interpretation of four little words in a 1,000 page statute.  If we are going to overturn legislation with this kind of legalistic nit-picking, will there ever be an end to the losers of legislative fights sifting through the volumes to find yet another basis for re-igniting the fight?  Is nothing ever settled?

 

I predict that we’re in for another 5-4 nail-biter over an obscure issue that no one saw coming two years ago.  Rodney King once famously said “Can’t we all just get along?”  It’s tempting to paraphrase him in this context:  “Can’t we all just move forward?”