District Court in the Seventh Circuit Distinguishes Sanford-Brown, Finds Room for Implied Certification Claims Against Pharmaceutical Manufacturers

Although the Seventh Circuit last year became the first circuit court clearly to reject the “implied certification” doctrine of FCA liability, a district court in that circuit recently sought to cabin the impact of the ruling.  See United States ex rel. Kroening v. Forest Pharm., No. 12-cv-00366 (E.D. Wisc. Jan. 6, 2016).  As reported here, the Supreme Court will review the viability of the implied certification theory later this year.  While the Kroening court ultimately dismissed the relator’s claims under Rule 9(b), the opinion highlights the divergence of the viewpoints around the implied certification theory that the Supreme Court has been asked to help resolve.


HHS Announces that Qualified Health Plans and Other Affordable Care act Programs Are Not “Federal Health Care Programs”

Posted by Kristin Graham Koehler and Monica Groat

The Department of Health and Human Services (“HHS”) recently announced that qualified health plans and other programs established by the Patient Protection and Affordable Care Act (“PPACA”) are not “federal healthcare programs.” This decision may bar the government and relators from alleging violations of the Anti-Kickback Statute (“AKS”) with respect to these plans and programs.

The government has frequently used the AKS as an enforcement tool in conjunction with the False Claims Act (“FCA”), alleging that false claims were submitted to federal healthcare programs, such as Medicare and Medicaid, and relying upon a false certification theory. As previously discussed here and here, the PPACA amended both the AKS and the FCA and expanded the government’s healthcare fraud enforcement authority. Specifically, the Act amended the AKS to clarify that any claims for items or services “resulting from” a violation of the AKS also constitute a “false or fraudulent claim” under the FCA, effectively codifying the false certification theory with respect to the AKS. The PPACA also extended the reach of the FCA to any payments made “by, through, or in connection with” any of the PPACA’s state-based health insurance exchanges, if such payments include any federal funds.

On August 6, 2013, Representative Jim McDermott asked HHS Secretary Kathleen Sebelius whether qualified health plans (the insurance plans available through the PPACA’s health insurance exchanges) are federal healthcare programs. Secretary Sebelius responded that HHS “does not consider” these plans, as well as subsidies paid by the federal government for these plans, the PPACA’s health insurance exchanges, and exchange-related consumer-assistance programs, to be federal healthcare programs.

Strongly objecting to the Secretary’s conclusion, Senator Charles Grassley recently requested additional information regarding this decision. In a letter to the Secretary and Attorney General Eric Holder, Senator Grassley stated that Congress clearly intended “to treat kickbacks under PPACA as False Claims Act violations,” and claimed that this decision would eliminate “a vital tool to investigate and prosecute fraud.” He also asked whether the Department of Justice will decline to intervene in qui tam cases that allege violations of either the FCA or the AKS in connection with PPACA programs.

As Senator Grassley noted, the decision by HHS not to classify qualified health plans and other PPACA programs as federal healthcare programs may limit the ability of both the government and relators to use the AKS in conjunction with the FCA as an enforcement tool with respect to these programs. As discussed here, this decision may also permit pharmaceutical manufacturers to provide copayment assistance to individuals insured by qualified health plans; currently, manufacturers are not permitted to provide this assistance to individuals insured through federal healthcare programs. Finally, Secretary Sebelius’s announcement suggests that the expanded healthcare fraud enforcement authority offered to the government by the PPACA may be somewhat limited by the Administration’s implementation of the Act’s central programs.