Over the last several months, a handful of federal court decisions—including two rulings this summer on challenges to the admissibility of proposed expert testimony—serve as reminders of the importance of (and parameters around) fair market value (FMV) issues in the context of the Anti-Kickback Statute (AKS) and the False Claims Act (FCA).

First, a quick level-set.  The AKS, codified at 42 U.S.C. § 1320a-7b(b), is a criminal statute that has long formed the basis of FCA litigation—a connection Congress made explicit in 2010 by adding to the AKS language that renders any claim for federal health care program reimbursement resulting from an AKS violation automatically false/fraudulent for purposes of the FCA.  42 U.S.C. § 1320a-7b(g).  Broadly, the AKS prohibits the knowing and willful offer/payment/solicitation/receipt of “remuneration” in return for, or to induce, the referral of federal health care program-reimbursed business.  Remuneration can be anything of value and can be direct or indirect.  In interpreting the “in return for/to induce” element, a number of federal courts across the country have adopted the “One Purpose Test,” in which an AKS violation can be found if even just one purpose (among many) of a payment or other transfer of value to a potential referral source is to induce or reward referrals—even if that clearly was not the primary purpose of the remuneration. Continue Reading Recent Developments on the Fair Market Value Front – Part 1

On December 30, 2014, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a request for public comment in the Federal Register, soliciting suggestions for new safe harbors – or exceptions – to the Anti-Kickback Statute (AKS) and Special Fraud Alerts – statements from OIG that give guidance to providers with respect to fraudulent practices. In the notice, OIG stated that suggestions for new safe harbors should offer “detailed explanation[s] of justifications” and empirical data in support. A number of factors would be considered in reviewing the comments for safe harbors and Special Fraud Alerts, including the proposals’ effect on:

  • Access to health care
  • Quality of health care
  • Patient choice among providers
  • Health care provider competition
  • Cost to Federal health care programs
  • Potential overutilization of services
  • Ability of facilities to service medically underserved areas or populations

OIG will also weigh any financial benefits health care professionals that could be taken into account in decisions whether to order certain services or make referrals to providers. OIG’s yearly solicitation for new safe harbors is more noteworthy this year since it comes after OIG released a proposed rule in October 2014. That rule proposed brand new safe harbors and exceptions to the gainsharing civil monetary penalty, as well as codified certain changes in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 and the Affordable Care Act, including:

  • A correction to the safe harbor for referral serviced based on volume or value of referrals by “either party for the other party”
  • Protection for cost-sharing waivers, including pharmacy waivers of cost-sharing for financially needy Part D beneficiaries and waivers of cost-sharing for emergency ambulance services furnished by state or municipality-owned ambulance services
  • Protection for remuneration between Medicare Advantage organizations and federally qualified health centers
  • Protection for discounts by drug manufacturers under the Medicare Coverage Gap Discount Program
  • Protection for certain free or discounted local transportation services

As industry continues to move towards greater coordination of care and integration and, as Secretary Burwell announced recently, federal health care program payment structures continue to change to base payments on quality rather than quantity, responding to this solicitation provides industry with an opportunity to give information to OIG about how the AKS can present obstacles to these efforts. Requests for new safe harbors should not just dwell on those obstacles, but also propose thoughtful solutions that address OIG’s longstanding concerns with protecting the programs and beneficiaries. Last year’s proposed rules are an indication that OIG has spent time identifying the areas where it can provide safe harbor protection and may show it is more receptive than ever to sound proposals that address new areas.

HHS’s December 30, 2014 notice is available here. Comments to the OIG’s request for new safe harbor and Special Fraud Alert suggestions are due by March 2, 2015.