radar Health Law Scan

Legal Insights and Perspectives for the Healthcare Industry
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 Health and Human Services Office of Inspector General (OIG) released its new General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG is designed to serve as a reference guide for the healthcare compliance community and other healthcare stakeholders.
The HHS Office of Inspector General (OIG) announced on June 15, 2023 that it plans to initiate a new audit of Medicare payments for hospice general inpatient (GIP) services, focused on hospice GIP services furnished to Medicare beneficiaries who were discharged directly to hospice GIP care from an acute hospital stay.
The US Department of Health and Human Services Office of Inspector General (OIG) announced on April 25 that it would be updating its Compliance Program Guidances (CPGs).
The HHS Office of Inspector General (OIG) has, for the last several years, been actively auditing hospices regarding their Medicare regulatory and billing compliance, with a national hospice audit in the works. Recently, OIG has notified certain hospices that it is conducting an audit of hospices’ compliance with CARES Act Provider Relief Fund (PRF) requirements and whether the hospices complied with certain terms and conditions and federal requirements related to the use of those PRF grants that were furnished to Medicare providers as part of the COVID-19 relief efforts in 2020 and 2021.
On October 3, the Office of Inspector General (OIG) of the US Department of Health and Human Services issued a report titled “UPICs Hold Promise to Enhance Program Integrity Across Medicare and Medicaid, But Challenges Remain.” This report detailed OIG’s findings related to the efficacy of the Unified Program Integrity Contractor (UPIC) program.
Perhaps signaling the increasing likelihood of a permanent telehealth solution for the Medicare program, the Office of Inspector General for the US Department of Health and Human Services (OIG) has established a “Featured Topics” resource page on its website dedicated to telehealth and OIG’s work in evaluating telehealth policies. This telehealth resource page serves as a compendium for all the reports OIG has completed or plans to undertake related to telehealth and virtual care technologies, including several audits and evaluations currently on OIG's 2022 work plan. In addition, the resource page provides a helpful overview of the manner in which telehealth fits into the larger Medicare regulatory framework.
Last month, we had an engaging Fast Break session covering the growing importance of risk adjustment in various health insurance programs and novel government theories of liability associated with risk adjustment reporting. Morgan Lewis associates Tesch Leigh West and Michelle M. Arra described the fundamental processes regarding risk adjustment and highlighted recent audit and enforcement trends in this area.