Medicaid and Medicare

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At the end of December, the Second Circuit joined several other circuit courts in holding that a plaintiff adequately pleads an Anti-Kickback Statute (“AKS”) violation when she states with the requisite particularity that at least one purpose of the alleged scheme was to induce fraudulent conduct, the “at-least-one-purpose” rule.

In United States ex rel. Camburn v. Novartis Pharmaceuticals Corp., Relator Steven Camburn alleged that Novartis violated the AKS, and the False Claims Act (“FCA”), in marketing its drug Gilenya, which is prescribed for multiple sclerosis (“MS”).  Since approving Gilenya in 2010, the FDA has imposed a first-dose observation requirement for new patients, who must be monitored by a doctor while attached to an electrocardiogram machine for six hours.Continue Reading Second Circuit Adopts At-Least-One-Purpose Rule For Anti-Kickback Statute Violations

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

EDNY Judge Nina Gershon analyzed several False Claims Act issues in United States ex rel. Omni Healthcare Inc. v. McKesson Corp., ruling on first-to-file, Rule 9(b), and statute of limitations issues.

Relator Omni Healthcare alleged that defendants improperly used “overfill” in vials of injectable drugs. “Overfill” is the amount of a drug in excess of the amount indicated on…
Continue Reading EDNY False Claims Act Overfill Decision Highlights Importance of Timely Naming All Defendants

Since the advent of the Medicaid managed care program there has been a lingering question as to when a Medicaid dollar stopped being a Medicaid dollar.

With fee-for-service providers that were paid directly by the Medicaid program, the answer was always clear-cut – each dollar received from the Medicaid program was a Medicaid dollar and therefore it and the provider…
Continue Reading 2019 Executive Budget Expands OMIG Oversight Authority

As New Yorkers are preparing for Thanksgiving and the official start to the holiday season (although some could argue it started a month ago), required Medicaid providers should also be reviewing their Compliance Programs in preparation to submit their Annual Provider Compliance Program Certification to the New York State Office of the Medicaid Inspector General (“OMIG”).  Required providers must submit…
Continue Reading Medicaid Providers: Don’t Forget to Include Your Annual Compliance Program Certification to Your Holiday “To-Do” List.

As recounted in our recent analysis of the 2018-19 New York State Budget (“Enacted Budget”), the Enacted Budget included new restrictions on fiscal intermediaries participating in the Consumer Directed Personal Assistance Program (“CDPAP”) designed to prevent the dissemination of “false or misleading” advertisements.  Effective April 1, 2018, the newly enacted § 365-f(4-c) of the New York Social Services Law…
Continue Reading Newly Enacted Consumer Directed Personal Assistance Program Advertisement Regulation Challenged in Federal Court

Last week, in LeadingAge New York, Inc. v. Shah, the New York Court of Appeals addressed Department of Health regulations limiting executive compensation and administrative expenditures by healthcare providers receiving state funds. The Court upheld limits related to state funding, but struck down a limit that applied regardless of the source of funding.

In 2012, Governor Cuomo directed agencies…
Continue Reading NY Court of Appeals Strikes Down DOH Limits On Use Of Private Funds For Executive Compensation And Upholds Limits On Use Of Public Funds

Just over one year ago, I wrote about the Department of Health and Human Service’s (“HHS”) $105 million award to support 1,333 federally qualified health centers (“Health Centers”) across the United States improve the quality of comprehensive care provided to patients. It seems like déjà vu, as it was announced last month that HHS set aside $125 million in…
Continue Reading Community Health Centers Receive Quality Improvement Grants

As we previously reported, the 2018-19 New York State Budget passed in March includes significant provisions intended to reduce the number of Licensed Home Care Services Agencies (LHCSAs) around the state. Among these provisions are a two-year moratorium on the establishment of new entities, a limit on the number of LHCSAs with which Managed Long Term Care Plans can…
Continue Reading DOH Issues Request for Information for New LHCSA Need Methodology

This past July 26, 2018 was the 28th anniversary of the Americans with Disabilities Act (“ADA”), landmark civil rights legislation designed to protect the rights of individuals with disabilities. Specifically, the ADA prohibits discrimination on the basis of disability in employment, state and local government, public accommodations, commercial facilities, transportation and telecommunications. It protects anyone with a “disability”, defined…
Continue Reading “Able New York”: The Latest ADA-Related Initiative May Create New Requirements for Long Term Care Providers