Articles and Blogs

The Centers for Medicare & Medicaid Services (“CMS”) continues to scrutinize beneficiary transparency, medical necessity and data‑driven oversight of hospital billing and utilization. This scrutiny means continued compliance risk for hospitals. Two long‑standing compliance tools remain especially relevant for hospital leadership: the Medicare Outpatient Observation Notice (“MOON”) and the Program for Evaluating Payment Patterns... READ MORE

Until this year, the Food and Drug Administration’s (“FDA” or “agency”) Office of Prescription Drug Promotion (“OPDP”) enforcement activity had settled into a relatively predictable pattern. In both 2023 and 2024, OPDP issued five enforcement letters each year, reinforcing a perception that the agency was exercising restraint and directing its limited resources toward more... READ MORE

On November 6, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) issued new General Compliance Program Guidance (“GCPG”) for members of the health care compliance community and other health care stakeholders. Since the release of its first compliance program guidance (“CPG”) for hospitals in 1998, OIG has developed a... READ MORE

The Centers for Medicare & Medicaid Services (“CMS”) has retooled guidance it armed surveyors with regarding how to survey skilled nursing facilities for compliance with the CMS staff vaccine requirements. The revisions address condition-level and actual harm determinations to ensure that deficiency citations recognize good faith efforts by providers. On October 26, 2022, CMS... READ MORE

Reimbursement under the new Patient Driven Payment Model, staff background checks, infection control programs, facility-initiated transfer or discharge of a resident and the use of psychotropic drugs are several new skilled nursing facility (“SNF”) areas of audit and focus of Department of Health and Human Services Office of Inspector General (“OIG”). OIG publishes updates... READ MORE

On May 11, 2021, the Centers for Medicare & Medicaid Services (“CMS”) released over 90 pages of interim final regulations (the “Interim Final Regulations”) to revise the infection control requirements that long-term care facilities (Medicaid nursing facilities and Medicare skilled nursing facilities) and intermediate care facilities for individuals with intellectual disabilities (“ICFs-IID”) must meet to... READ MORE

Most of the new changes to the federal Stark and Anti-Kickback Statutes went into effect on January 19, 2021. Since then hospitals, health systems and medical groups nationwide have focused on updating their physician contracting, compensation and compliance programs to align with the new regulations. This alert focuses on specific changes to the Stark... READ MORE

Mergers and acquisitions in the health care industry present unique challenges that may not be present when undertaking similar transactions in other industries. Because of health care’s highly regulated nature, parties may falter if a health care transaction is not reviewed and negotiated carefully with respect to the distinct concerns that health care presents.... READ MORE

On Wednesday, July 29, 2020, the U.S. Department of Justice Drug Enforcement Administration (“DEA”) proposed a new rule that would require DEA registrants to electronically report “theft or significant loss” of controlled substances within 15 days of discovery of the circumstances requiring the report (“Proposed Rule”). This proposal is notable as currently there is... READ MORE

On May 21, 2020, Hall Render published “Providers Beware: Avoiding the Pitfalls in Regulatory Flexibilities and Relief Funds.” On May 26, 2020, OIG published “OIG Strategic Plan: Oversight of COVID-19 Response and Recovery.” To those who follow health care compliance and enforcement issues closely, the OIG document should come as no surprise. Over the... READ MORE