This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more
The Situation: As health care providers transition to value-based care models, they have often been forced to rely on safe harbors under the Anti-Kickback Statute, or AKS, that were never designed with value-based payment...more
On November 20, 2020, the Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) issued the final rule “Modernizing and Clarifying the Physician Self-Referral Regulations” (Final Rule)....more
On November 20, 2020 the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of the Inspector General (OIG) issued two final rules to modernize and clarify the Physician...more
This Client Alert serves as the second in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) as part of its...more
Key Points - On October 17, 2019, the OIG proposed rules to add safe harbor protections for coordinated care and associated value-based arrangements. - The OIG proposed several new safe harbors: value-based...more
The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more
As K&L Gates begins its third season of Triage: Rapid Legal Lessons for Busy Health Care Professionals, Hilary Bowman previews several topics that the health care practice group anticipates will have a significant impact on...more
The U.S. Department of Health and Human Services (HHS) has launched its “Regulatory Sprint to Coordinated Care” to accelerate the healthcare system’s transformation to a value-based system rewarding coordinated care. This...more
August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more
Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more
On Monday, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a wide-ranging request for information (RFI) seeking ideas on how it might add or modify safe harbors to the...more
As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more
McCarter & English, LLP’s Health Care Group presents Issue 13 of the Health Law Insights, which discusses the latest legal issues in the health care industry. - Failure to Update Business Associate Agreement Results in...more
Nearly four years after publishing their joint interim final rule with comment period, effective November 2, 2011 (IFC), the OIG and CMS (Agencies) have finalized the waivers of various fraud and abuse laws in the context of...more
On Thursday, October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) jointly issued a rule (the “Final Rule”) to finalize five (5) waivers of certain fraud and abuse...more
Trends & Analysis - Since our last Qui Tam Update, we have identified 39 health-related False Claims Act (“FCA”) qui tam cases that have been unsealed. Of those cases...more
Each year brings significant changes and challenges in the laws governing the health care industry, and 2014 proved to be no exception. What the year may have lacked in the high drama that accompanies comprehensive health...more