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FCA Claims Based on Average Wholesale Price (AWP) Theory Barred by Public Disclosure Bar

On January 20, 2016, the U.S. District Court for the Eastern District of Missouri dismissed a complaint based on allegations of Average Wholesale Price (AWP) fraud under the False Claims Act (FCA) against CSL Behring, LLC (Behring) and specialty pharmacies Accredo Health, Inc., (Accredo) and Coram LLC (Coram).  See United States ex rel. Lager v. CSL Behring, LLC, et al., No. 4:14-CV-841CEJ, 2016 WL 233245 (E.D. Missouri 2016).  The Court found that relator’s allegations were barred by the public disclosure bar and did not satisfy the “original source” exception.

Relator, a former Behring employee, alleged that the company reported inflated AWPs for prescription drugs, Vivaglobin and Hizentra, causing government health programs to reimburse specialty pharmacies much more than they paid for the drugs ($133 v. $65 and $151 v. $70).    Vivaglobin and Hizentra are classified as “DME infusion drugs” because they are self-administered by patients through a pump, which is considered durable medical equipment (DME). Unlike most drugs which the government reimburses based on a percentage of the average sales price (ASP), DME infusion drugs are reimbursed based on a percentage of the drug’s AWP.  Unlike ASP, AWP is not defined by law or regulation and is not based on actual sales data.  AWP is based on figures the drug manufacturer reports to third-party publishers and is substantially higher than ASP.  In addition to allegations that Behring reported inflated AWPs, relator claimed that Behring used the “spread” between the actual cost and the AWP-based reimbursement rates to induce their customers, including Accredo and Coram, to buy their products.

Citing multiple government sources and media outlets “[that] have long disclosed that AWP does not represent the actual prices of drugs,” as well as “multiple disclosures that manufacturers used the difference between actual costs and AWPs to influence sales,” the court dismissed the complaint under the public disclosure bar, 31 U.S.C. § 3730(e)(4)(A). Id. at *3-*6 (commenting that “[t]his state of affairs has been labeled as a scam and fraud by the press and in multiple civil lawsuits”). The court was unpersuaded by relator’s argument that the public disclosure bar did not apply because the public disclosures did not “contain[] all of the elements of the alleged fraudulent transactions” (emphasis added), including the defendants and drugs at issue.  The court noted that the prior public disclosures “need not contain every fact or legal consequence to trigger the public disclosure bar” (citation omitted) and explained:

In 2007, the court overseeing the multidistrict litigation found that pharmaceutical companies submitted “false, inflated AWPs” that “caused real injuries.” In re Pharm. Indus. Average Wholesale Price Litig., 491 . Supp. 2d at 31.  In 2013 the OIG disclosed the extreme spread between AWP and ASPs for DME infusion drugs, generally, while publications by the third-party publishers and CMS showed the spread for Viaglobin and Hizentra in particular.  These disclosures are sufficient to identify both the defendants and the drugs.

Relator also failed to adequately allege that he was an “original source” pursuant to 31 U.S.C. [...]

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OIG Expands Audit Topics in Work Plan Update

The Department of Health and Human Services Office of Inspector General (OIG) issued an update to its Work Plan on May 28 that included several new Medicare-related topics for OIG audit or inspection.  These additions expand OIG’s work in areas that OIG has previously identified as priorities, such as hospital-based services, lab testing and Part D payments.  These new topics included:

  • Hospital outpatient intensity-modulated radiation therapy claims;
  • Payments for clinical diagnostic laboratory tests, including the top 25 clinical diagnostic laboratory tests by Medicare expenditures in 2014. This report is required by the Protecting Access to Medicare Act; and
  • Compliance with various aspects of the inpatient rehabilitation facility prospective payment system, including the documentation required 42 CFR § 412.622(a)(3) (4) and (5).
  • Examining billing trends within the Part D program, especially those for opioid drugs and pharmacy billing patterns.

OIG also announced several new programmatic studies and reports, including:

  • Examining hospital preparedness for public health emergencies due to high-risk infectious diseases.
  • Identifying best practices and possible challenges in Accountable Care Organizations’ (ACO) use of electronic health records, such as interoperability issues.
  • Whether the durable medical equipment competitive bidding program is affecting beneficiary access to certain items, citing to “anecdotal reports [that] allege that competitive bidding has led to reduced access to DME and, in turn, compromised the quality of care beneficiaries receive” as the reason for adding this review.
  • Creating a portfolio report of the OIG’s Medicare Part D oversight work to summarize OIG audits, evaluations, legal opinions and investigative work, and provide progress information on recommendations to improve oversight of the program by the Centers for Medicare & Medicaid Services, plan sponsors and Medicare Drug Integrity Contractors or MEDICs. This report will likely be similar to the 2012 portfolio report highlighting OIG’s work on personal care services.
  • Examining CMS’s management of the Open Payments program, including CMS’ oversight of manufacturers’ and group purchasing organizations’ compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately and completely displayed in the publicly available database.



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