Podcast: President Biden's Use of the Defense Production Act - Diagnosing Health Care
Supporting Health Through Supply Chain Management
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Blakes Continuity Podcast: Life Sciences: Liability and Immunity During COVID-19
K&L Gates Triage: Using Drones in Medicine
Scomed Supply v. Hartford Accident & Indemnity Company and Sedgwick Claims Management Services (Bureau of Workers' Compensation Fee Review Hearing Office), No. 79 C.D. 2025 (Pa. Cmwlth. March 16, 2026) - On March 16, 2026,...more
Key Takeaways - Florida’s Agency for Healthcare Administration (AHCA) has implemented a six-month moratorium on the enrollment of new Durable Medical Equipment (DME) providers, effective March 20, 2026....more
Key Takeaways - CMS imposes nationwide DMEPOS enrollment moratorium to combat fraud risk. Effective February 27, 2026, CMS has implemented a six‑month nationwide moratorium on new Medicare enrollment for certain DMEPOS...more
Key Takeaways: Centers for Medicare & Medicaid Services (CMS) deferred $259.5 million in federal Medicaid funds to Minnesota over program integrity concerns....more
The Centers for Medicare and Medicaid Services (CMS) issued a Request for Information (RFI) on February 27, 2026, that signals a potential expansion of federal health care fraud, waste, and abuse enforcement. While the RFI...more
Our Health Care Group examines the Centers for Medicare & Medicaid Services’ (CMS) six-month nationwide moratorium affecting certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) companies and the...more
On February 25, 2026, the Centers for Medicare & Medicaid Services (“CMS”) announced several program integrity actions impacting Medicaid funding and Medicare supplier enrollment, along with a request for stakeholder input...more
The Centers for Medicare & Medicaid Services (CMS) issued a Federal Register notice imposing a six-month nationwide moratorium on new Medicare enrollments for seven types of Durable Medical Equipment, Prosthetics, Orthotics,...more
Key Takeaways - CMS is seeking input by March 30 on a proposed framework to promote U.S.-made PPE and essential medicines in Medicare-participating hospitals....more
The U.S. Environmental Protection Agency (EPA) announced on December 5, 2024, that it published updates to its Recommendations of Specifications, Standards and Ecolabels for Federal Purchasing (Recommendations). EPA notes...more
Summary: On September 24, 2024, the Biden administration issued a final rule designed to address suspicious billing for durable medical equipment that may have cost the Medicare program more than $2 billion....more
On September 13, 2024, the U.S. Environmental Protection Agency (EPA) began a public comment period on a proposed update to its Recommendations of Specifications, Standards, and Ecolabels for Federal Purchasing...more
Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a Draft List of Recognized...more
Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more
On May 14, 2024, the United States Trade Representative (USTR) released its Final Report relating to the four-year review of actions taken in the Section 301 investigation. Within the Report, the USTR confirmed that it...more
As reported in our previous client alert, on May 14, 2024, President Biden announced that he directed his Trade Representative to increase tariffs under Section 301 of the Trade Act of 1974 (Section 301) on a wide range of...more
News Briefs - Biden Places New Tariffs on Chinese Medtech Product Imports - The Biden administration announced its plan to increase tariffs on Chinese-made medical supplies as part of a broader push to tax imports from the...more
On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,”...more
GAO’s recent decision in Marathon Medical Corporation provides a cautionary tale for government contractors seeking to protest the terms by which an agency conducts a procurement. Specifically, Marathon reinforces a...more
On February 5, 2024, Judge Arun Subramanian of the United States District Court for the Southern District of New York largely declined to dismiss a putative class action asserting claims under the Securities Exchange Act of...more
The value of private equity (PE) deals in the healthcare sector has grown from <$2B in 2001 to $151 billion in deals in 2021. Barring government intervention, PE in healthcare is here to stay....more
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more
Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more