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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).

CMS’ Proposed New Anti-Fraud Rule for Part D

The Center for Medicare and Medicare Services (CMS) has recently proposed new rules to combat fraud and abuse in the Medicare Advantage and Part D prescription drug program. Part D was created in 2003 as part of the new Medicare coverage for prescription drugs, and now, with 10+ years of data to examine, CMS has apparently seen some practices it wants to put an end to.


In what promises to be a major anti-fraud initiative, CMS said on January 6, 2014 that it will close a loophole that allows doctors not enrolled in Medicare to have drugs covered under Medicare Part D, and will blacklist physicians whose prescribing practices are reckless. The announcement, included as part of a 678-page proposed rule, follows two inspector general reports last year that showed Medicare Part D was paying for drugs written by practitioners who either lacked proper credentials or wrote unusually large amounts of prescriptions for addictive painkillers.


The power to require practitioners to enroll in Medicare, which would take effect next year, was granted to the Centers for Medicare and Medicaid Services in the Affordable Care Act.


“CMS’ fraud and abuse strategy for Part D is data driven,” the agency said in its press release[the link you have], and apparently the data have shown (once again) that where there are loopholes, fraudsters will flourish — taking advantage of the government’s largesse and “pay now and chase later” system of administering health care claims. The data shows in particular that some doctors are over-prescribing opiates and painkillers, and that some doctors show patterns of abusive and fraudulent prescribing practices. By forcing doctors to enroll in Medicare if they want to submit claims to Medicare, CMS will be taking the logical step of making it easier to monitor and crack down on these abusive practices. The goal is not only to save money, but also to “protect Medicare beneficiaries … from the damaging effects associated with prescription drug abuse.”

There are three central points in this lengthy set of new rules:


  1. “CMS is proposing to require that physicians and non-physician practitioners who write prescriptions for coverd Part D drugs must be enrolled in Medicare for their prescriptions to be covered under Part D.”
  2. CMS would be able to revoke a physician’s Medicare enrollment if
    a. He or she has shown a pattern of prescriptions that appear to be abusive and/or represents a threat to patient safety,
    b. His or her DEA certificate of registration is suspended or revoked, or
    c. A licensing body of a state where the physician practices has suspended or revoked the physician’s license to prescribe drugs.
  3. CMS would also be able to obtain data directly from pharmacies, pharmacy benefit managers, and others who contract with Part D sponsors, in order to streamline the efforts of anti-fraud investigative agencies.


CMS will accept comments on the proposed rules until March 7, 2014, at which point it will issue final regulations. While there will always be comments attacking almost any proposed rule, to us these proposed changes are only sensible. Given that CMS must process millions of claims per day – and pays them electronically unless the computer system kicks them out – one would hope that the agency would employ every tool at its disposal to monitor trends, detect abusive patterns, and seek to protect the public from that small percentage of doctors and practitioners who have lost their way and made life more burdensome for their peers and their patients.


So expect the final regulations to keep the three core concepts listed above.