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Alston & Bird

Health Care Week in Review | Senate Finance Committee Releases Budget Reconciliation Text; SCOTUS Upholds TN Ban on...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - May 2025 #2

News Briefs - States, D.C., File Lawsuit to Block Trump's HHS Restructuring - A coalition of 20 attorneys general is suing to block what they say is the Trump administration's "dangerous dismantling" of the federal health...more

McCarter & English, LLP

Texas District Court Vacates FDA’s Final Rule Expanding Oversight to Laboratory Tests in Hospitals

In our May 2024 Healthcare Alert, we discussed a final rule published by the US Food and Drug Administration (FDA) amending its regulations to include in vitro diagnostic products (IVDs), even those manufactured in a...more

Morgan Lewis

Key Messaging from ‘Aging Technology, Emerging Threats: Examining Cybersecurity Vulnerabilities in Legacy Medical Devices’

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On April 1, 2025, the subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce held a hearing on cybersecurity vulnerabilities in legacy medical devices. The hearing was largely a...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - April 2025 #1

News Briefs - Hospital, Device Makers Seeking Exemptions on Tariffs - Medical device makers, hospitals, and other key health industries are pressing to gain exemptions under the Trump administration's new tariff regime with...more

Akin Gump Strauss Hauer & Feld LLP

2025 Perspectives in Private Equity: Health Care & Life Sciences

Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - January 2025 #4

News Briefs - 80 Percent of Health Organizations Hit with Cyberattack - More than 80 percent of healthcare organizations detected a cyberattack on their technology infrastructure within the past year, according to a survey by...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - December 2024 #2

News Briefs - Congress Taking on Healthcare Policies Set to Expire - Congress has begun discussions on important healthcare policies set to expire on December 31....more

Holland & Knight LLP

CMS Releases CY 2025 OPPS and ASC Final Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule with comment...more

Alston & Bird

Health Care Week in Review: CMS Releases Mandatory TEAM Hospital Participants and Issues RFI on Medicare Administrative Contractor...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #4

News Briefs - Statistics Show Upward Trend in Healthcare Data Breaches - Healthcare data breach statistics clearly show there has been an upward trend in data breaches over the past 14 years, with 2021 seeing more data...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2024 #2

News Briefs - State Governments Taking Steps to Make Rules on Healthcare AI - In the absence of federal guardrails on artificial intelligence in healthcare, state governments are figuring out their own rules of the road....more

Alston & Bird

Health Care Week in Review: CMS Released Negotiated Medicare Part D Prices for 10 Drugs and ARPA-H Awarded $150 Million in Funding...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMS Finalizes FY 2025 Payment Rules for Inpatient Hospitals, Inpatient Rehab Facilities, Inpatient...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMS Issues Calendar Year 2025 Proposed Medicare Payment Rules for Physicians and Hospitals

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: HHS Finalizes Provider Disincentives for Information Blocking and House Ways and Means Committee...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Alston & Bird

Health Care Week in Review: CMS Finalizes Medicaid DSH Rule and House Launches Bipartisan AI Task Force

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2023 #3

News Briefs - Senate Committee Advances Bill on 'Ghost Providers,' PBMs - In a unanimous 26-0 vote, the Senate Finance Committee passed a comprehensive draft package that puts pharmacy benefit manager reform and mental health...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - August 2023 #2

News Briefs - Insurers Ignoring Rulings to Pay Surprise Bills, Doctors Say -Insurers are sometimes ignoring rulings to pay providers, or failing to pay them in full, under the arbitration system established by the new federal...more

McGuireWoods LLP

Medical Device Legal News with Sam Bernstein: Episode 11

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A former DePuy Synthes sales representative is arrested for allegedly defrauding a hospital into submitting claims for products not actually used in surgery; A number of additional clinics enter into settlements to resolve...more

Faegre Drinker Biddle & Reath LLP

The Omnibus Appropriations Act Grants FDA Formal Authority to Require Cybersecurity Action by Medical Device Manufacturers

Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more

Bass, Berry & Sims PLC

11th Annual Healthcare Fraud & Abuse Review 2022

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We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more

Alston & Bird

Health Care Week in Review: Congress Passes Omnibus, HHS Releases Hospital Data

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

K&L Gates LLP

Health Care Triage: Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

K&L Gates LLP on

In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more

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