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 Centers for Medicare and Medicaid Services (CMS) issued CMS Advisory Opinion No. CMS-AO-2025-1 on February 26, 2025, blessing the relocation of a physician-owned hospital. The hospital planned to relocate eight miles from...more
On Feb. 26, 2025, McGuireWoods successfully assisted a physician-owned hospital in obtaining a favorable advisory opinion from the Centers for Medicare & Medicaid Services (CMS) regarding its proposal to relocate the entire...more
On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...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
In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more
Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more
Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more
On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 23-15, approving a physician practice consultant’s proposal to offer gift cards to its customers when...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain...more
From an agency guidance and regulatory developments perspective, 2022 was fairly quiet until the latter part of the year. Consistent with past practice, the Office of Inspector General for the Department of Health and Human...more
Report on Medicare Compliance 31, no. 35 (September 26, 2022) - The HHS Office of Inspector General (OIG) on Sept. 23 unveiled a new template for requesting advisory opinions. - In a new report, OIG said CMS edits...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
On April 25, 2022, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued a favorable Advisory Opinion regarding a medical device company (Company) in which physicians who order the...more
The Centers for Medicare & Medicaid Services (CMS) recently issued an advisory opinion under the federal physician-self referral law (the “Stark Law”) (Advisory Opinion No. CMS-AO-2021-2) (the “Advisory Opinion”) clarifying...more
HELPFUL HINTS - The Federal No Surprises Act The Federal No Surprises Act (the “Act”) became fully effective on January 1, 2022. The Act protects enrollees in group and individual market plans (including ERISA plans) and...more
On September 29, 2021, OIG issued Advisory Opinion No. 21-13 analyzing a proposal for a clinical study that would involve subsidizing Medicare beneficiaries’ cost-sharing obligations in connection with a clinical study...more
The Centers for Medicare & Medicaid Services (“CMS”) released Advisory Opinion No. CMS-AO-2021-01 in June 2021, which gave the requestor the green light to provide designated health services (“DHS”) through wholly-owned...more
The Centers for Medicare & Medicaid Services (CMS) has issued Advisory Opinion No. CMS-AO-2021-01 on whether a wholly-owned physician practice that provides designated health services (“DHS”) through one or more wholly-owned...more
The Centers for Medicare & Medicaid Services (CMS) recently issued Advisory Opinion No. CMS-AO-2021-01, clarifying that physician groups that furnish designated health services (e.g., laboratory, imaging) through wholly-owned...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
The Centers for Medicare & Medicaid Services (CMS) recently updated its advisory opinion regulations, codified at 42 CFR §§ 411.370 through 411.389, in a final rule issued November 15, 2019. The update liberalizes and...more