Healthcare – Page 135 – Legal News Feed

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Navigating Due Diligence in Pharmaceutical CRO Acquisitions: Key Challenges and Opportunities

Pieter Gunst3 years ago03 mins

In the highly competitive pharmaceutical services sector, avid bidding for prominent businesses have observed an exponential acceleration as new players and investors are showing everyday interest. This surge in investors, who previously didn’t focus much on the pharma sector, has necessitated an urgent understanding of central considerations for due diligence. These considerations significantly influence risk…

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CMS Unveils Key Changes to Inpatient and Long-Term Care Payment Systems for FY 2024

Pieter Gunst3 years ago03 mins

The Centers for Medicare & Medicaid Services (CMS), one of the significant bodies within the United States Department of Health and Human Services, unveiled a critical development earlier this month. On August 1, 2023, the CMS formally published its final rule for the federal fiscal year (FY) 2024 inpatient prospective payment system (IPPS) and long-term…

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OIG Establishes Penalties for Information Blocking, Enhancing 21st Century Cures Act Compliance

Pieter Gunst3 years ago02 mins

On July 3, the Department of Health and Human Services’ Office of Inspector General (OIG) established a final rule regarding the statutory civil money penalties for information blocking requirements, as part of the 21st Century Cures Act – a law designed to help accelerate medical product development and bring new innovations and advances to patients…

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ChatGPT and HIPAA Compliance: Navigating Legal Complexities in Healthcare AI

Pieter Gunst3 years ago03 mins

In a world where artificial intelligence (AI) is progressing at an astounding pace, the arrival of ChatGPT in November 2022 has notably aroused interest and popularity within this dynamic sector. According to an analysis by Bricker Graydon LLP, ChatGPT, a natural language processing AI chatbot, is a product of OpenAI — a group known for…

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Texas Medical Association Case Leads to Vacated Provisions in No Surprises Act

Pieter Gunst3 years ago03 mins

In a recent turn of events, Judge Jeremy Kernodle of the U.S. District Court for the Eastern District of Texas has delivered a court’s decision in the Texas Medical Association case. The case challenged certain parts of a federal law known as the No Surprises Act, which primarily geared towards restricting health care providers from…

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Signature Medical Group’s Take on Medical Payment Programs and AI’s Growing Role in Healthcare

Pieter Gunst3 years ago03 mins

Recently, in Episode 154 of “Taking the Pulse”, a health care and life sciences video podcast, hosts Heather and Lauren welcomed Andy Schwartzkopf, the General Counsel and Chief Administration Officer for Signature Medical Group. The Signature Medical Group operates as one of the largest private, multi-specialty medical groups throughout the Midwest. In the episode, Schwartzkopf…

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Ransomware Attack Exposes Fragility of Healthcare Infrastructure in Multiple States

Pieter Gunst3 years ago04 mins

Recent events have once again spotlighted the vulnerability of healthcare infrastructure to cyber threats, with several hospitals and outpatient treatment facilities across three states still grappling with a ransomware attack that took place last week. The attack targeted Prospect Medical Holdings, a Los Angeles-based healthcare organization that oversees 16 hospitals and 165 outpatient facilities scattered…

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Virtual Research Compliance Conference 2023: Bridging Knowledge Gaps and Regulatory Shifts in Healthcare

Pieter Gunst3 years ago02 mins

The healthcare sector upholds stringent regulations when it comes to research compliance. This year, the annual Research Compliance Conference will be held virtually, a significant transformation from the traditional in-person meetings. The virtual engagement is set to occur on November 9, 2023. The conference, which is organized by the Health Care Compliance Association (HCCA), offers…

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Navigating Complexities: 2023 Healthcare Enforcement Compliance Conference Insights

Pieter Gunst3 years ago03 mins

The upcoming 2023 Healthcare Enforcement Compliance Conference, scheduled from November 5th to 7th in Washington, DC, promises to offer invaluable insights for legal professionals and entities operating within the healthcare sphere. Owing to its importance, the conference has attracted the attention of numerous experts and stakeholders in the field, all eager to gain a deeper…

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Uninsured Rates Hit Historic Low Amid Healthcare Reforms and Advancements

Pieter Gunst3 years ago03 mins

In a recent national healthcare update for August 2023, the Department of Health and Human Services (HHS) announced that the rate of uninsured persons in the United States reached its lowest point. Amid the on-going healthcare reforms and changing regulatory landscape, this report indicates a noteworthy convergence of health industry advancements with effective legislation. This…

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Healthcare Private Equity Defies Turbulent Macro Acquisition Environment

Pieter Gunst3 years ago02 mins

The private equity landscape within the healthcare sector continues to remain active and viable, resisting the challenges of a turbulent macro acquisition environment. Even amidst inflation and increasing interest rates, which have impacted the global deal flow since mid-2022, healthcare companies are managing to thrive as an asset class relative to other target industries. The…

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Acorda Therapeutics Secures $16.6M Win in NY Federal Court Over MS Drug Dispute

Pieter Gunst3 years ago02 mins

In accord with a recent ruling, a New York federal judge throws his support to a near $16.6 million arbitrated award issued to Acorda Therapeutics Inc. Acorda Therapeutics, the American biotechnology company based in Ardsley, New York, has been in dispute with Ireland’s global biopharmaceutical company, Alkermes PLC, consequent to a bone of contention revolving…

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California Appeals Court Sides with United Healthcare in Pre-Service Verification Dispute

Pieter Gunst3 years ago03 mins

In a noteworthy development for managed care payors and claims administrators, the California Court of Appeal affirmed a lower court ruling giving the summary judgment in favor of United Healthcare (United). The judgment held that United had not entered into a binding agreement with an out-of-network health care provider at the time of pre-service verification…

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DEA Seeks Public Input on Telemedicine and Remote Prescribing Regulations

Pieter Gunst3 years ago03 mins

The Drug Enforcement Administration (DEA) recently announced plans to host two public listening sessions on September 12 and 13, 2023. The purpose of these sessions is to gather further input on the practice of telemedicine, with an emphasis on the remote prescribing of controlled substances without an in-person evaluation of patients beforehand. The meetings will…

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Telehealth Landscape Shifts: Key Legislative Developments Impacting Providers and Patients

Pieter Gunst3 years ago02 mins

The week of July 25th to 31st, 2023, was marked with significant developments in telehealth. Various states presented legislative and regulatory developments that greatly impact healthcare providers, telemedicine companies, pharmacies, and digital health. These developments have far-reaching effects on entities delivering and facilitating the delivery of virtual care. Such policies and advancements can shape the…

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Divergent Trends in Orange Book and Biologic Patent Litigation Revealed in Updated USPTO Report

Pieter Gunst3 years ago02 mins

The USPTO recently published an updated report on Inter Partes Review (IPR) and Post Grant Review (PGR) proceedings, which spotlighted the Orange Book or biologic patents. These findings incorporate data until March 31, 2023, offering a revealing look into this crucial patent litigation realm. Significant for stakeholders navigating this intricate field are marked variances in…

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Impact of New CMS Final Rules: Legal Implications for Healthcare Professionals and Institutions

Pieter Gunst3 years ago03 mins

The Centers for Medicare & Medicaid Services (CMS) has recently released the Skilled Nursing Facilities (SNF) and Inpatient Prospective Payment System (IPPS) final rules, signaling new alterations to healthcare regulations. This action by CMS is part of a broader initiative to review and modify health care rules to accommodate evolving health scenarios and market needs….

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Departments Unite to Strengthen Mental Health Parity Compliance: Proposed Rules and Congressional Report

Pieter Gunst3 years ago03 mins

On July 25, 2023, the U.S. Department of Health and Human Services (HHS), the Department of Labor, and the Department of the Treasury (collectively referred to as “the Departments”) collectively issued a set of proposed rules regarding the compliance of health plans and issuers with mental health parity requirements. The Departments also published a related…

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Lakewood Resident Admits to Wire Fraud in Large-Scale DME Healthcare Conspiracy

Pieter Gunst3 years ago02 mins

The U.S. Attorney’s Office for New Jersey recently unveiled that Alexander Schleider, a resident of Lakewood, has admitted to wire fraud and conspiracy to commit healthcare fraud. The fraudulent scheme was centered on durable medical equipment (DME). Schleider pleaded guilty to his actions as part of a large-scale kickback plot, which resulted in massive losses…

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Texas Clinical Lab Settles $5.7 Million False Claims Act Judgment, Reinforces Importance of Regulatory Compliance

Pieter Gunst3 years ago03 mins

In a recent development, Texas Clinical Laboratory, BestCare Laboratory Services LLC, and its founder, have agreed to pay $5.7 million to settle a 2018 False Claims Act (FCA) judgement. Arising under the Department of Justice’s ability-to-pay policy, the judgement was imposed based on assertions of fraudulent claims to federal healthcare programs. This resolution seems poised…

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FTC Rises as Key Player in Health Data Privacy Enforcement: Implications for the Corporate Sector

Pieter Gunst3 years ago03 mins

Over the past year, the Federal Trade Commission (FTC)’s actions have indicated its increased role in health privacy enforcement. The FTC has strategically led enforcement actions, policy statements, and regulatory changes aimed at scrutinizing the misuse of consumer health data and related types of information by companies. This has positioned the FTC as one of…

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ChatGPT and Healthcare: Balancing Efficiency Gains with HIPAA Compliance

Pieter Gunst3 years ago03 mins

In the rapidly evolving era of digital health, many medical practitioners and healthcare providers are turning to artificial intelligence tools to streamline their operations and enhance patient care. Among these AI developments, ChatGPT, an advanced conversational AI developed by OpenAI, has been gaining attention for its potential application in the healthcare sector. ChatGPT’s impressive ability…

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Judge Dismisses Johnson & Johnson’s Second Bankruptcy Attempt Amid Talcum Powder Cancer Controversy

Pieter Gunst3 years ago03 mins

In a significant development, a judge has dismissed the second bankruptcy case filed by Johnson & Johnson over its talcum baby powder liabilities. Despite expressing some reservations, U.S. Bankruptcy Judge Michael Kaplan in Trenton, New Jersey, ruled in favor of cancer victims who argued that the new bankruptcy case was devoid of goodwill. Johnson &…

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Employment Law Firm Associates Break New Ground by Forming Union

Pieter Gunst3 years ago03 mins

In a somewhat unexpected twist within the law industry, associates at an employment law firm have decided to form a union. This move signals a growing trend among legal professionals who are seeking more control over their working conditions and pay. While it is quite common for employees in sectors such as education, healthcare, and…

WM Partners Acquires Allergy Research Group, Signaling Enhanced Investment in Healthcare Sector

Pieter Gunst3 years ago3 years ago02 mins

In a recent development in the healthcare and life sciences private equity space, WM Partners has completed the acquisition of Allergy Research Group from Kikkoman Corp. This transaction marks a significant venture for WM Partners into the thriving sector of healthcare. As reported by JD Supra, the details of the transaction have not been fully…