Recent Blog Posts
- Change Is Here – President Trump’s First Day Includes Addressing the Affordable Care Act and Freezing Regulations On his first day in office, President Trump issued an Executive Order entitled “Minimizing the Economic Burden of the Patient Protection and Affordable Care Act Pending Repeal.” The Executive Order is, in effect, a policy statement by the new administration that it intends to repeal the Patient Protection and Affordable Care Act (the “ACA” or the “Act”) as promptly as possible. The Executive Order also directs the Secretary of Health and Human Services and the heads of all other executive... More
- The False Claims Act Under a Trump Administration – What Does Attorney General Nominee Sessions Think? As discussed previously in this blog, efforts to curb fraud, waste and abuse are generally “bi-partisan.” Given the significant monetary recoveries the Government enjoys through enforcement of the federal False Claims Act (“FCA”), we have predicted that efforts in this arena will continue under a Trump administration. However, this is dependent, in part, on the priorities of the new administration and the resources it devotes in this arena. To this end, the testimony of Attorney General nominee Sessions during his... More
- Court Issues Nationwide Injunction Prohibiting Enforcement of Section 1557 Provisions Relating to Gender Identity and Termination of Pregnancy – But Other Provisions Still Can Be Enforced On December 31, 2016, the U.S. District Court for the Northern District of Texas issued a nationwide preliminary injunction that prohibits the U.S. Department of Health and Human Services (HHS) from enforcing certain provisions of its regulations implementing Section 1557 of the Affordable Care Act that prohibit discrimination on the basis of gender identity or termination of pregnancy. This ruling, in Franciscan Alliance v. Burwell (Case No. 7:16-cv-00108-O), a case filed by the Franciscan Alliance (a Catholic hospital system), a... More
- FY 2016 False Claims Act Recoveries: Government Enforcement Remains Lucrative and a Continued Source of Risk for Health Care Entities—But Will This Change in a Trump Administration? The federal government continues to secure significant recoveries through settlements and court awards related to its enforcement of the False Claims Act (FCA), particularly resulting from actions brought by qui tam relators. In fiscal year (FY) 2016, the federal government reported that it recovered $2.5 billion from the health care industry. Of that $2.5 billion, $1.2 billion was recovered from the drug and medical device industry. Another $360 million was recovered from hospitals and outpatient clinics.
Government Intervention Drives Recoveries
- DC Circuit: No False Claims Act Liability for Reasonable, Good Faith Interpretations of Ambiguous Regulations On November 24, 2015, in United States ex rel. Purcell v. MWI Corp., No. 14-5210, slip op. (D.C. Cir. Nov. 24, 2015), the District of Columbia Circuit Court of Appeals ruled that federal False Claims Act (“FCA”) liability cannot attach to a defendant’s objectively reasonable interpretation of an ambiguous regulatory provision. While outside of the health care arena, this decision has implications for all industries exposed to liability under the FCA.
In Purcell, the government alleged that false claims had been submitted as a... More
- The DC Circuit Speaks – Proving Condition of Payment is Key To Implied Certification False Claims Act Cases On July 10, 2015, the U.S. Court of Appeals for the District of Columbia Circuit made clear that in False Claims Act cases brought under an implied certification theory, certifying compliance with the federal statute or regulation at issue must be a condition of payment.
In United States ex rel. Davis v. District of Columbia, No. 14-7060, 2015 WL 4153919 (D.C. Cir. Jul. 10, 2015), a qui tam relator alleged that the District of Columbia had failed to maintain certain records... More
- A “Mixed Bag” from SCOTUS – Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter In a unanimous decision announced May 26, the U.S. Supreme Court, in Kellogg Brown & Root Services, Inc. v. United States ex rel. Carter, 2015 BL 163948, U.S., No. 12-1497, 5/26/15, ruled that the Wartime Suspension of Limitations Act (“WSLA”) applied only to criminal charges and not underlying civil claims in times of war. Thus, the WSLA – which suspends the statute of limitations when the offense is committed against the Government – cannot be used to extend the statute... More
- Extension of Timeline for Publication of the Final Rule – Medicare Programs; Reporting and Returning of Overpayments CMS announced on February 13 (and to be published in a Federal Register notice this week) that despite the general guideline that final rules be issued within 3 years of a proposed or interim final rule, CMS will be taking an additional year to finalize the “Medicare Program; Reporting and Returning of Overpayments” final rule. In February 2012 (see EBG’s February 22, 2012 Client Alert), CMS issued a proposed rule on the requirements under the ACA to report and return... More
- CMS Issues Final Rule Modifying Restrictions on “Direct Solicitation” of Beneficiaries by DMEPOS Suppliers; Changes to Other DMEPOS Supplier Safeguards On March 9, 2012, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule that modifies several of the durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) supplier standards. Most notably, the final rule modifies restrictions on the “direct solicitation” of Medicare beneficiaries by DMEPOS suppliers. CMS stated in the final rule that its reason for making this modification is that the definition of “direct solicitation” was not feasible and has been criticized for being overly broad. DMEPOS... More
- Continuing the Spotlight on Medicare Providers and Suppliers: New OIG Report Details Program Integrity Problems with Newly Enrolled Medical Equipment Suppliers According to a new report released in December 2011 by the Office of Inspector General (“OIG”), more than 25 percent of all durable medical equipment (“DME”) suppliers faced enforcement actions by the Centers for Medicare & Medicaid Services during their first year of participation in the Medicare program. In its report, the OIG reviewed a sample of 229 newly enrolled suppliers and examined multiple data sources in order to assess the extent, if any, that the suppliers in the sample... More