The State of Healthcare Enforcement
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Medicaid Cuts: Potential Challenges and Legal Implications for Long-Term Care Facilities — Assisted Living and the Law Podcast
False Claims Act Insights - How Payment Suspensions Can Impact FCA Litigation
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
UPIC Audits
AGG Talks: Home Health & Hospice Podcast - Episode 8: Hospice Special Focus Program: Pumping the Brakes
Hospice Insights Podcast - Upping the Ante: Will CMS’s Enhanced Oversight Efforts Cause Hospices to Fold?
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
Preparing for CMS Staffing Mandates — Assisted Living and the Law Podcast
Hospice Insights Podcast - Meet the New Laws, Same as the Old Laws: Overpayment Recoupment Update
Podcast — Drug Pricing: Takeaways From the Chicago Medicaid Drug Rebate Program Summit
Podcast — Drug Pricing: How the Demise of Chevron Deference and Other Litigation May Impact the Pharmaceutical Industry
The CMS Interoperability and Prior Authorization Rules
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Findings from Gibbins’ Annual Healthcare Bankruptcy Report
A Fond Farewell: Musings on the End of the Medicare Advantage Hospice Carve-In Demonstration
Video: Braidwood v. Becerra – Challenging the Affordable Care Act’s Preventive Services Coverage Provision – Thought Leaders in Health Law
The ongoing case Jhumra v. Orange County Global Medical Center (OCGMC) stems from an alleged delay in care and serves as a stark reminder of the legal obligations for hospitals and medical staffs under the Emergency Medical...more
On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more
n a July 2, 2025, press release, the U.S. Department of Justice (DOJ) announced a new “DOJ-HHS False Claims Act Working Group” (the Working Group) and identified multiple priority enforcement efforts for the Working Group to...more
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more
On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) took a series of actions to promote enhanced price transparency compliance by hospitals and identify challenges thereto, in order to inform future price...more
On February 25, 2025, President Trump signed an Executive Order directing federal agencies to “rapidly implement and enforce” federal healthcare price transparency regulations....more
On February 25, 2025, President Donald Trump signed an executive order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the “Order”), which...more
The EO announces a policy of the United States to put patients first and ensure they have the necessary information to make well-informed healthcare decisions. The order builds upon Executive Order 13877 (Improving Price and...more
The standard for an “identified overpayment” under Medicare Parts A–D now aligns with section 1128J(d)(4)(A) of the Social Security Act, which incorporates by reference the Federal False Claim Act’s (the “FCA”) “knowledge”...more
The clock is ticking for medical device and pharmaceutical companies to fulfill their obligations under the Physician Payments Sunshine Act (the "Sunshine Act"). With the reporting deadline of March 31 looming and CMS...more
We kick off our annual Year in Preview series with a comprehensive look at health care fraud enforcement in 2025. This post proceeds in three parts. First, we explore what the second Trump administration might bring, looking...more
Compared with other issues, healthcare enforcement during President-elect Donald Trump’s upcoming second term has received little attention. When he takes office again on January 20, should industry actors like pharmaceutical...more
On December 11, 2024, the Texas Health and Human Services Commission filed a complaint in the United States District Court for the Western District of Texas. The complaint seeks to block the enforcement of a May 9, 2014,...more
As summarized in our prior article on this topic, individual coverage health reimbursement arrangements (ICHRAs) are gaining popularity and constituting a larger part of the overall employer-provided health coverage market. ...more
The Centers for Medicare & Medicaid Services (CMS) released highly anticipated updates this month to the Medicare regulations interpreting the federal 60-day overpayment refund requirement (the Overpayment Statute). The...more
The North Carolina Division of Health Service Regulation (“DHSR”) has issued guidance to Adult Care Home (ACH), Family Care Home (FCH), and Skilled Nursing Facility (SNF) providers regarding temporary waivers or modification...more
Learning Objectives: - Discuss the new regulations and subsequent CMS guidance applicable to MAOs regarding coverage criteria and prior authorization - Discuss the broader current landscape between MAOs and providers,...more
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
On July 31, 2024, CMS issued a final rule (the Final Rule) for fiscal year (FY) 2025 updating Medicare payment policies and rates for skilled nursing facilities (SNFs) under the SNF Prospective Payment System (PPS). Under the...more
On June 24, 2024, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services (HHS) issued the 21st...more
Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more
CMS estimates that between 2017 and 2021, Medicare Part A improperly paid $23.9 billion for inpatient hospital stays, with $7.8 billion attributable to short stays that did not qualify for Medicare Part A. On June 13, 2024,...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed tests (LDTs) and "correct...more
Historically, the Centers for Medicare and Medicaid Services (“CMS”) has not aggressively pursued enforcement activity under the Sunshine Act. However, this may change in 2024. Late last year, CMS updated its Open Payments...more