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False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
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Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
DOJ Addresses AI in Corporate Compliance Programs — The Good Bot Podcast
AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies
Daily Compliance News: March 20, 2025, The Fluid Edition
Innovation in Compliance: Unpacking Healthcare Compliance with Maria Villanueva
False Claims Act Insights - Physician, Refer Thyself: How Stark Law and FCA Intersect
The New York State Department of Health (DOH) published on May 15, 2025, the long-awaited electronic Material Transaction Notice Form (the Form), which replaces its prior email submission process with a portal filing for...more
In a prior blog post, we summarized proposed legislation included in New York Gov. Kathy Hochul's state fiscal year (FY) 2025-2026 budget that would have subjected "material transactions" to additional disclosure and...more
On May 8, the Colorado Court of Appeals concluded that any claim that might be asserted under the Health Care Worker Protection Act (“HCWPA”), C.R.S § 8-2-123, is subject to the notice requirement in the Colorado Governmental...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more
On March 5, 2025, the Colorado state legislature introduced Senate Bill (SB) 25-198, aiming to expand Colorado’s licensed hospital notice requirements for material healthcare transactions and impose notification and...more
We recently discussed increasing state regulation of healthcare mergers and acquisitions in the face of the current Administration’s clear policy of federal deregulation. We noted that 15 states had implemented oversight laws...more
On January 8, 2025, the governor of Massachusetts signed into law H.5159, An Act enhancing the market review process (the “Act”). Among various other healthcare market oversight enhancements, the Act expands the authority of...more
The Massachusetts Senate proposed an amendment on Monday December 2, 2024, that would delay implementation and enforcement of the 2021 Patients First Act addressing health care cost transparency. Section 31 of the amendment...more
On November 15, 2024, the California Board of Pharmacy issued a public notice of its intent to modify Cal. Code Regs. tit. 16 § 1708.2, which governs the discontinuation of pharmacy businesses in California. The regulation...more
The Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”) published its final rules implementing the anti-discrimination provisions under Section 1557 of the Affordable Care Act (“Final Rule”) on May...more
Although they are currently still in the minority, a growing number of states are enacting or proposing legislation that requires applicable parties to provide notice of pending health care transactions....more
The California Legislature recently passed Assembly Bill 3129 (“AB 3129” or the “Bill”), which, if signed by California Governor Gavin Newsom, would increase oversight of healthcare entity transactions involving private...more
On August 31, 2024, the California State Assembly and State Senate passed Assembly Bill 3129 (“AB 3129”). If signed by Governor Newsom, AB 3129 would establish a comprehensive transaction review law that (i) targets private...more
Effective immediately, on August 22, 2024, the Office of Health Care Affordability (OHCA) adopted revisions to the cost and market impact review (CMIR) regulations (Revised Regulations), which govern California’s pre-closing...more
Effective January 1, 2025, if enacted, California Assembly Bill 3129 (Bill) would grant sweeping power to the Attorney General by authorizing the Attorney General to approve, conditionally approve, or disapprove of certain...more
Only two months after California’s cost and market impact review (CMIR) regime began to require notice of certain healthcare-related transactions, the Office of Health Care Affordability (OHCA) has already proposed several...more
On April 26, the US Department of Health and Human Services Office for Civil Rights (OCR) published a Final Rule that adds protections under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule...more
On May 6, 2024, the Department of Health and Human Services (HHS) published its final rule revamping the non-discrimination regulations issued under § 1557 of the Affordable Care Act. The revised rules apply to all...more
The FTC unveiled its long-awaited final rule banning most non-compete agreements during a live broadcast of a Commission meeting on April 23, 2024. The proposed rule, which was first announced in January 2023, underwent an...more
In August 2023, we published a blog post about the California Office of Health Care Access and Information’s (“OHCA”) proposed cost and market impact review (“CMIR”) regulations under the California Health Care Quality and...more
States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care...more
On March 13, 2024, Indiana Governor Eric J. Holcomb signed Senate Enrolled Act No. 9 (“SEA 9”) which will amend the Indiana Code with respect to notice of health care entity mergers and acquisitions....more
On March 13, 2024, Indiana joined the ranks of states exercising greater oversight and regulation of health care transactions. Senate Enrolled Act No. 9 (S.B. 9), which takes effect on July 1, 2024, requires written notice...more
As our December 2023 Insight noted, California’s SB 184 (enacted in June 2022) and accompanying regulations contain pre-transaction notice requirements by “specified health care entities” for certain “material change...more
On February 27, 2024, the Indiana House of Representatives (“House”) voted to pass legislation that would call for increased scrutiny regarding mergers between health care organizations. More specifically, the implementation...more