2025 was an important year for Medicare Advantage (MA) plans that pay state-licensed agents and brokers to market their plans and engage in lead generation, subject to complex federal regulations. As we previously discussed on Health Law Scan, improper broker arrangements were identified as a 2025 focus area by the whistleblower bar and the US Department of Justice (DOJ), particularly the US Attorney’s Office for the District of Massachusetts.
Health Law Scan
Legal Insights and Perspectives for the Healthcare Industry
Recent regulatory actions by the Centers for Medicare and Medicaid Services (CMS), the US Drug Enforcement Administration (DEA), and the US Department of Health and Human Services (HHS) highlight heightened federal scrutiny of hospice providers in higher-risk states and continued uncertainty about the future regulation of controlled substance prescribing.
The US Health and Human Services Office of Inspector General (OIG) recently released a report by its Office of Evaluation and Inspections highlighting significant trends and recommendations regarding billing for remote patient monitoring (RPM) in Medicare. The report acknowledges the growing adoption of RPM as a technology-based healthcare service while underscoring the importance of providers and the Medicare program adopting compliance-oriented safeguards when billing and paying for RPM services.
On May 8, 2025, the Boston Bar Association hosted its annual White Collar Crime Conference, a reoccurring theme of which was the recognition of changing times, while also maintaining that the core principles of criminal and civil fraud enforcement remain the same. An anticipated highlight from the conference came from the panel addressing federal and state False Claims Act (FCA) and Anti-Kickback Statute (AKS) enforcement priorities.
Section 1557 of the Affordable Care Act (ACA) prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain healthcare activities. Among other requirements, all healthcare providers that receive, directly or indirectly, federal financial assistance, including but not limited to participation in Medicare or Medicaid must now provide a notice of availability of language assistance services free of charge. The US Department of Health and Human Services’ (HHS) new set of requirements was finalized in April 2024.
The enormous impact of Medicare Star Ratings on payments received by Medicare Advantage plans cannot be overstated. And with billions of dollars in bonus payments at stake, it may come as no surprise that stringent standards set out by the Centers for Medicare and Medicaid Services (CMS) have led to plans to push back against agency interpretations and seek judicial redress. We discuss the issues here.
At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device manufacturer would provide up to $2,000 in subsidies to Medicare beneficiaries for cost sharing obligations as part of the beneficiary’s participation in a clinical trial.
The US Department of Health and Human Services Office of Inspector General (OIG) published favorable Advisory Opinion No. 23-15 on January 3, which concluded that a consultant’s proposal to provide gift cards to existing physician practice customers in exchange for referring other physician practices to the vendor would not implicate the federal Anti-Kickback Statute (AKS).
The US Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer (the requestor) that would provide a free hearing aid to certain qualified patients who received a cochlear implant.
The US Department of Justice (DOJ) announced on June 8, 2023 that Steven King, a compliance executive of pharmacy holding company A1C Holdings LLC, was convicted of defrauding Medicare out of more than $50 million in a scheme involving dispensing medically unnecessary lidocaine and diabetic testing materials.