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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Formycon And OneSource Specialty Pharma Partner To Manufacture Biosimilars
Formycon AG has announced a strategic manufacturing partnership with OneSource Specialty Pharma Limited to enhance its biosimilar development capabilities. The collaboration brings together Formycon's biosimilar expertise with OneSource's integrated biologics manufacturing platform in Bangalore, India. With three biosimilars already on the U.S. market and four pipeline candidates in development, this partnership aims to strengthen Formycon's position in the competitive biosimilar landscape.
United States Healthcare
GP
Goodwin Procter LLP
Article
CMS Proposes Mandatory Provider-Based Attestation Framework For Off-Campus Hospital Outpatient Departments
The Centers for Medicare & Medicaid Services has proposed a new framework requiring hospitals to submit mandatory provider-based attestations for off-campus outpatient departments, fundamentally changing how these facilities demonstrate compliance with Medicare requirements. With a January 1, 2028 implementation deadline, hospitals must navigate new National Provider Identifier requirements, centralized electronic submission systems, and detailed documentation processes that will significantly impact reimbu
United States Healthcare
DS
Dinsmore & Shohl
Article
What Is Unbundling? How Splitting One Procedure Into Many Can Inflate Medical Bills
Medical billing unbundling—the practice of separating comprehensive procedures into multiple billing codes—walks a fine line between legitimate coding practices and healthcare fraud. When does this common billing technique cross into illegal territory, and what role do whistleblowers play in exposing systematic abuse that costs government healthcare programs hundreds of millions annually?
United States Healthcare
MS
Miller Shah
Article
Preparing For The Pharma Fraud Enforcement Surge
With Department of Justice False Claims Act settlements reaching a record $6.8 billion in fiscal year 2025, pharmaceutical companies face unprecedented scrutiny over prescription drug claims and compliance programs. Barnes & Thornburg partners analyze the enforcement landscape and outline strategies for mitigating government investigation risks in an era where proactive compliance has become essential to organizational survival.
United States Healthcare
BT
Barnes & Thornburg LLP
Article
Building The Next Generation Of Behavioral Health Platforms
The behavioral health sector faces a critical gap between patient need and treatment access, with only half of the 61.5 million US adults experiencing mental illness receiving care. As regulatory changes reshape reimbursement models and investors increasingly favor specialized, high-quality providers, organizations are pursuing platform-building strategies focused on integrated care delivery, operational excellence, and measurable clinical outcomes to capture growth opportunities across autism services, sub
United States Healthcare
SR
McDermott Will & Schulte
Article
CMS Turns Up The Heat With Sweeping New Enrollment Enforcement Tools In HH PPS Proposed Rule
The Centers for Medicare & Medicaid Services has proposed sweeping changes to Medicare enrollment regulations that would dramatically expand its authority to deny and revoke provider enrollments. These proposals introduce retroactive revocation powers, extended reapplication bars, and new grounds for enforcement actions that could fundamentally reshape program integrity oversight and increase compliance risks for healthcare providers, suppliers, and their investors.
United States Healthcare
SR
McDermott Will & Schulte
Article
Recent FCA Enforcement Illustrates DOJ’s Focus On Wound Care
The U.S. Department of Justice has intensified False Claims Act enforcement in the wound care industry, targeting allegedly medically unnecessary skin substitutes, improper billing practices, and kickback arrangements. With billion-dollar settlements and a record-breaking $6.8 billion in FCA recoveries for fiscal year 2025, federal scrutiny of manufacturers, distributors, and healthcare providers continues to escalate. How are recent Medicare reimbursement changes and regulatory concerns reshaping complianc
United States Government
GP
Goodwin Procter LLP
Article
TEFCA Expansion Signals Heightened Federal Scrutiny Of Health Information Sharing
Federal regulators are dramatically expanding health information exchange through TEFCA while simultaneously ramping up enforcement against information blocking practices. With over 1 billion health records now flowing through the network and a new federal auditor in place, healthcare organizations face heightened scrutiny and potential penalties reaching $1 million per violation. How should providers prepare for this new era of interoperability oversight?
United States Healthcare
BS
Bond, Schoeneck & King PLLC
Article
Health-e Law Episode 27 | Emerging Cybersecurity Threats In Healthcare With Erik Pupo (Podcast)
In this episode of Health-e Law, partner Sara Shanti and Erik Pupo from Guidehouse explore the critical intersection of healthcare data sharing and cybersecurity vulnerabilities. As healthcare systems embrace greater connectivity through initiatives like TEFCA, they face mounting cybersecurity challenges that demand proactive strategies and robust protection measures.
United States Healthcare
SM
Sheppard, Mullin, Richter & Hampton LLP
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