Compliance Tip of the Day: Rethinking Corporate AI Governance Through Design Intelligence
Compliance Tip of the Day: COSO Governance Framework: Part 4, Culture
Compliance Tip of the Day: COSO Governance Framework: Part 1, Introduction
Compliance Tip of the Day: Internal Control Deficiencies
FCPA Compliance Report: Stay the Course: Ellen Lafferty on Navigating Anti-Corruption Compliance in 2025
Adventures in Compliance: The Novels – The Hound of the Baskervilles, Introduction and Compliance Lessons Learned
Compliance Tip of the Day: Assessing Internal Controls
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Compliance Tip of the Day: COSO Objective 5 – Monitoring Activities
Compliance Tip of the Day: COSO Objective 4 - Control Information and Communication
Hospice Insights Podcast - Election Inspection: Be Proactive to Avoid Costly Election Statement Denials
Compliance Tip of the Day: COSO Objective 3 – Control Activities
Compliance Tip of the Day – COSO Objective 1 – Control Environment
Compliance Tip of the Day: Code of Conduct as an Internal Control
Rethinking Records Retention
Compliance Tip of the Day: Internal Controls for GTE
FCPA Compliance Report: Revolutionizing Speak Up: Ariel D. Weindling on Enhancing Whistleblower Systems
Compliance Tip of the Day: Implementing Internal Controls
Podcast: Addressing Patient Complaints About Privacy Violations
Compliance Amidst a Global Consensus Breakdown
Drug diversion can pose serious risks to patients, employees, and organizations. Any provider who stores, transports, or dispenses controlled substances should have a robust program designed to deter drug diversion and to...more
On November 22, 2024, the Governor of New York signed into law a closely watched bill that expressly authorizes pharmacy shared services arrangements in the state. These models were not previously addressed in New York’s...more
Mintz’s PBM practice is pleased to present its quarterly publication, PBM Policy and Legislative Update. This edition builds upon prior issues and summarizes activity from July through September that affects the PBM industry....more
On September 26, 2024, the Centers for Medicare & Medicaid Services’ (CMS) Durable Medical Equipment (DME) Medicare Administrative Contractors (DME MACs), Noridian Healthcare Solutions, LLC and CGS Administrators, LLC,...more
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more
The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more
Change Healthcare, an affiliate of Optum and UnitedHealth Group, processes more than 15 billion health care transactions annually and touches one of every three patient records. On February 21, Change disconnected its...more
Drug and device manufacturers doing business in Nevada have upcoming filing deadlines in March, April, and June. By June 1, 2024, compliance officers must sign and submit a certification to the Nevada Board of Pharmacy to...more
In a country that is still struggling with an opioid epidemic, and where there are enough rules and laws regulating the dispensing of medication to fill a tome, it makes sense that medical providers across the nation are...more
On January 30, the U.S. Court of Appeals for the Third Circuit issued a unanimous decision in favor of drug manufacturers, finding that manufacturer restrictions on the use of contract pharmacies under the 340B drug pricing...more
As federal agencies and law enforcement investigate pharmacies around the country for health care fraud and kickback schemes, pharmacies should be proactive in understanding their regulatory environment and the importance of...more
The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more
The Health Resources and Services Administration (HRSA) has issued guidance eliminating a longstanding enforcement position that delayed the ability of hospitals participating in the 340B drug pricing program to use...more
Walmart and Johnson and Johnson, two of America’s corporate titans, each acted in ways that helped to fuel the opioid crisis that federal experts estimate claims 128 Americans’ lives each day, news media investigations show....more
The cold rain in Atlanta threw no cold water on legislative action today as the General Assembly convened for Legislative Day 15. The House and Senate each took up a handful of measures on their respective floors, including...more
Colleges and universities in Connecticut must comply with a new law that requires them to implement a policy regarding the availability and use of opioid antagonists by their students and employees not later than January 1,...more
Next week, I begin a five-part podcast series on emerging issues in healthcare compliance with Jesse Caplan, Managing Director of Corporate Oversight at Affiliated Monitors, Inc. (AMI), the sponsor of the series. Caplan has...more
In October 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) issued an interesting Environmental Scan on International Policies on the Appropriate Use of Biosimilar Drugs (Report). This Report outlines...more
• The Centers for Medicare & Medicaid Services (CMS) has issued the Calendar Year (CY) 2019 Final Rule that updates payment rates and policy changes in the Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory...more
• The Centers for Medicare & Medicaid Services (CMS) has published the Calendar Year (CY) 2019 Final Rule for the Medicare Physician Fee Schedule (PFS), which includes provisions related to Medicare physician payments as well...more
Prescribers in West Virginia are bound by new restrictions set forth in the Opioid Reduction Act, aimed at combating the opioid crisis in West Virginia. The Act was enacted by the state legislature to limit patient access in...more
On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more
For the first time since the enactment of the Medicaid Drug Rebate Program (MDRP), the Centers for Medicare and Medicaid Services (CMS) revised the National Medicaid Drug Rebate Agreement (NDRA) entered into between drug...more
The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more
Four Things Compliance Practitioner Should Know About the Eurasian Economic Union - An effective Compliance risk management at emerging markets for any business significantly depends on timeous observation of changes in...more