Health Law Scan

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.

Representatives from the defense bar and the healthcare and life sciences industry recently met for the American Health Law Association’s Fraud and Compliance Forum. The conference programming covered an array of topics for practitioners, ranging from the practical risks of and guidance for using artificial intelligence (AI) in clinical operations to discussions of commercial reasonableness and fair market value in compensation.

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.

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community.

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.

Through the issuance of Inauguration Day executive orders, the Trump Administration signaled its apparent intent to tackle drug pricing reforms over the next four years. However, Biden-era policies are likely to limit a comprehensive overhaul of existing reforms in the near term.

Through its passage, the Inflation Reduction Act (IRA) ushered in several reforms directed at rising prescription drug costs, aiming to lower costs for Medicare enrollees and reduce spending by the federal government. Included in these reforms is the establishment of the Medicare Prescription Payment Plan (M3P), a monthly installment plan that allows enrollees to pay back prescription drug costs overtime instead of all at once at the pharmacy. While M3P will reduce monthly out-of-pocket costs for enrollees, it requires plan sponsors to cover all up-front costs until payments are collected. Given the potential for non-payment, Medicare Part D plans would be well advised to prepare and account for potential financial losses.

As noted in our recent LawFlash, the US Department of Justice’s (DOJ’s) COVID-19 Fraud Enforcement Task Force (CFETF) recently released its annual compilation report of its efforts to combat fraud related to pandemic relief programs since 2020. Accompanying the report, Deputy Attorney General Lisa Monaco and the Biden administration announced strong support for creating and securing funding for future data analytics tools like those used by the Pandemic Response Accountability Committee’s (PRAC) Pandemic Analytics Center of Excellence (PACE).

The old adage—March comes in like a lion and goes out like a lamb—didn’t quite hold true for the hospice sector, which experienced a late-month flurry of activity. The government gave the hospice sector a lot to consider, from MedPAC’s suggested freeze on hospice rates to CMS’s 2025 Proposed Hospice Rule (public comments due May 28, 2024) that, if finalized as is, would include a 2.6% payment bump. CMS’s Proposed Hospice Rule lays the groundwork for the long-anticipated Hospice Outcomes and Patient Evaluation (HOPE) quality measures data collection instrument, which will be used to collect data at various points during the hospice stay, not just at admission and discharge.

The US Drug Enforcement Administration (DEA) issued a temporary rule on October 6, 2023 extending COVID-19–era flexibilities through December 31, 2024. With this extension, the DEA will continue to waive provisions under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 that prohibit practitioners from prescribing controlled substances to patients without first conducting an in-person encounter.