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.
In the past decade, there has been a significant increase in the utilization of Applied Behavioral Analysis (ABA) therapy, in large part because of expanded coverage under all Medicaid programs since 2022. Both federal and state regulators and enforcement authorities have turned their attention to the coverage and payment of these ABA services and potential fraud and abuse. This blog provides some quick takeaways for stakeholders.
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.
On May 10, 2024, the Centers for Medicare and Medicaid Services (CMS) published its Final Rule to implement minimum staffing standards for long-term care (LTC) facilities in the United States. However, as discussed in our prior blog post, the Final Rule was immediately challenged under the Administrative Procedure Act (APA) in two major lawsuits. These cases have resulted in divergent rulings, injecting more uncertainty across the LTC industry about the future of the application and validity of the Final Rule.
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.
Bipartisan efforts to lower prescription drug costs remains a core focus for the US Congress. Effective October 1, 2024, the Centers for Medicare and Medicaid Services (CMS) has announced the follow-on cohort for its coinsurance savings program under the Medicare Prescription Drug Inflation Rebate Program.
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.