2024

The SDNY U.S. Attorney’s Office has targeted several labs and their principals for False Claims Act violations arising out of reimbursements for COVID-19 testing services.  In a complaint filed on June 13, the government sued LabQ Clinical Diagnostics, Dart Medical Laboratory, Community Mobile Testing, and their CEO, Moshe Landau.

In response to the COVID pandemic, Congress mandated that private health insurers cover COVID-19 testing and required government health care programs to also cover such testing.  For uninsured persons, Congress appropriated funds for a federal program to reimburse health care providers furnishing COVID-19 testing to uninsured persons (the “Uninsured Program”), administered by an agency within the Department of Health and Human Services.  Before seeking reimbursement, however, COVID-19 testing providers were required to confirm that the patients were uninsured and no one else would pay for the testing. Continue Reading SDNY Sues Labs For Fraudulent COVID-19 Testing Under False Claims Act

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Recently, in United States ex rel. Hart v. McKesson Corp., the Second Circuit clarified the standard for acting “willfully” under the federal anti-kickback statute (AKS).

False Claims Act relator Adam Hart alleged that the defendant violated the AKS by providing business management tools to its customers, without charge, to induce those customers to purchase drugs from them.  The tools helped providers to maximize profits and mitigate the risk that reimbursement rates would fall below the cost of the drugs to them.  One tool, the Margin Analyzer, compared profit margins for drugs considered to be interchangeable, and the second, the Regimen Profiler, provided margin information for an entire course of treatment as opposed to specific drugs.  The unlawful kickback, according to relator, was that the defendant did not offer these tools on a stand-alone basis, but only offered them to providers who agreed to use the defendant as their primary wholesaler of branded and generic drugs.  The defendant allegedly provided the tools as a kickback to induce drug sales. 

The Second Circuit first addressed the proper understanding of “willfulness” under the AKS.  The Court held that, in order to violate the federal AKS, a defendant must act knowing that the conduct is in some way unlawful but does not have to know specifically that the conduct violates the AKS.  The Court stated that this interpretation accords with the general goal of criminal law to punish only those who act with a “vicious will.”  Notably, in 2010, Congress amended the AKS to provide that a violation does not require actual knowledge of the AKS or a specific intent to violate the AKS.  Also, particularly with respect to the analysis of applications of AKS safe harbors to conduct, this interpretation also avoids unfairly sweeping innocent conduct under the reach of the criminal statute.Continue Reading Second Circuit Defines “Willfulness” Standard Under Anti-Kickback Statute

Medical Malpractice Insurance

On January 9, 2024, the federal Centers for Medicare and Medicaid Services (CMS) finally approved New York State’s 1115 waiver amendment to establish the New York Health Equity Reform (NYHER) Program. That application, which is the successor to the state’s Delivery System Reform Incentive Payment (DSRIP) Program that expired in March 2020, was first described in a concept paper issued by the Department of Health (DOH) in August 2021, and was filed with CMS in September 2022. The approved waiver amendment, which expires on March 31, 2027, includes most of the features included in the original application, but not all.

The overall goals of NYHER include:

  • Health-Related Social Needs: Investments in health-related social needs (HRSN) via greater integration between primary care providers and community-based organizations, with a goal of improved quality and outcomes.
  • Health Equity: Improving quality and outcomes of enrollees in geographic areas that have a longstanding history of health disparities and disengagement from the health system, including through an incentive program for safety net providers with exceptional exposure to enrollees with historically worse health outcomes and HRSN challenges.
  • Integrated Care: Focus on integrated primary care, behavioral health, and HRSN with a goal to improve population health and health equity outcomes for high-risk enrollees, including kids/youth, pregnant and postpartum individuals, the chronically homeless, and individuals with substance use disorder (SUD).
  • Workforce: Workforce investments with a goal of equitable and sustainable access to care in Medicaid.
  • Regional Approaches: Developing regionally focused approaches, including new value-based purchasing (VBP) programs, with a goal of statewide accountability for improving health, outcomes, and equity.

These goals are embodied in four new initiatives: (1) HRSN, (2) a Health Equity Regional Organization (HERO), (3) Medicaid Hospital Global Budget Initiative, and (4) Strengthen the Workforce. Each will be examined in turn.Continue Reading CMS Approves a New 1115 Waiver Amendment:  The New York Health Equity Reform (NYHER) Program

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camilo jimenez, Unsplash

As we head into a new calendar year, in the healthcare space it is worth reflecting on the events of the last few years, as a means of predicting what is likely to come.  Last year, the focus in healthcare policy was very much on what will come after COVID; this year, we finally have the opportunity to review what that is.  And we can confidently say that 2024 is likely to see a continuation of many of the trends in healthcare policy that we saw in 2023.Continue Reading Healthcare Policy in 2024: What’s Next?