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Regulatory Agencies Healthcare

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

ArentFox Schiff

Associations Can Continue Winning Nationwide Injunctions After Supreme Court Ruling

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The US Supreme Court’s recent decision in CASA v. Trump, 606 US ___ (June 27, 2025), sharply limited the ability of individual plaintiffs to obtain nationwide injunctions....more

Spilman Thomas & Battle, PLLC

Certificate of Need in West Virginia – Where We Stand | Spilman Thomas & Battle

Certificate of Need (CON) emerged as a central issue during West Virginia's recent legislative session, with substantial efforts to eliminate the system ultimately falling short. The CON reform has been a longstanding policy...more

Kerr Russell

What Causes a LARA Investigation?

Kerr Russell on

Question: Over the years, several of my colleagues and I have been the subject of investigations by the Michigan Department of Licensing and Regulatory Affairs. In most of these cases it’s hard to imagine why LARA is...more

Sheppard Mullin Richter & Hampton LLP

Red Tape Rollback: DOJ’s Anticompetitive Regulations Task Force

As we predicted before the inauguration, Trump 2.0 antitrust enforcers have shown continued support for the pro-worker, anti-tech antitrust agenda that has permeated recent antitrust enforcement through the last two...more

Stevens & Lee

Presidential Memorandum Calls for Scrutiny and Fast-Track Repeal of Regulations

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President Trump issued a Memorandum on April 6 directing the heads of all executive departments and agencies to identify on a fast-track basis (60 days) certain categories of “unlawful and potentially unlawful” regulations...more

Benesch

Dialysis & Nephrology Digest - April 2025

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ESRD ETC among value-based care models being ended early by CMS - This decision to end the ESRD ETC payment model and several others on Dec. 31 aligns with CMS’ goal to focus on models that demonstrate potential for...more

King & Spalding

Lawmakers Armed with Loper are Preparing to Take Aim at HHS Policies

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On July 10, 2024, HHS found itself a recipient of one of the dozens of letters sent to various federal agencies by Republican lawmakers. These letters task the federal agencies to themselves identify areas where the agencies...more

Vicente LLP

Colorado's Draft Natural Medicine Rules: Full Breakdown & Commentary

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Nearly fifteen months after Colorado voters approved the Natural Medicine Health Act, the public got its first glimpse of draft rules that will govern the regulated psychedelics program created by the Act. In February’s...more

Mintz - Health Care Viewpoints

California’s Health Care Transactions Review Law: Preparing for What Comes Next

California’s health omnibus trailer bill SB-184 and the final cost and market impact review (CMIR) regulations (CMIR Regulations), which went into effect on December 18, 2023, have ushered in a significant change in...more

Axinn, Veltrop & Harkrider LLP

Ready for the Flood of Litigation Against Federal Agencies?

Yesterday, the Supreme Court heard oral arguments in two related cases that may have a significant impact on litigation against federal agencies – Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce....more

Robinson+Cole Health Law Diagnosis

California Governor Signs Trailer Bill to State Budget Increasing Oversight of Health Care Entities Statewide

On June 30, 2022, Governor Gavin Newsom signed the 2022-2023 California state budget, which included a trailer bill, Senate Bill 184 (the Bill) which makes numerous statutory revisions impacting health programs and consumers....more

Foley & Lardner LLP

COVID-19: Resources for Oncology Providers (Medicaid, Grants, & Stark Law Waivers)

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The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more

Foley & Lardner LLP

COVID-19: Resources for Oncology Providers (Telehealth, Clinical Trials, Reporting Deadlines)

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The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and...more

Seyfarth Shaw LLP

HHS Issues Advisory Opinion on PREP Act: Immunity May Extend Beyond Actual Covered Persons and Approved Countermeasures

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With crisis comes uncertainty, and even the best-intentioned regulations can leave those combating the current COVID-19 public-health emergency out in the cold.  Many have asked whether the recent Declaration under the...more

Seyfarth Shaw LLP

Health CARES - Title III of the CARES Act Impact on Telehealth

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As we previously reported, Congress passed and the President signed the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136) (“CARES Act”) on March 27, 2020. We recently provided guidance on how the CARES Act...more

Seyfarth Shaw LLP

CMS Announces New Priorities for Facility Surveys and Inspections

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In light of findings from the COVID-19 outbreak at a nursing home in Kirkland, Washington, the Centers for Medicare and Medicaid Services (CMS) has announced that it will suspend all routine facility inspections and surveys...more

Morgan Lewis

COVID-19: Healthcare Enforcement & Program Integrity – Compassion or Business as Usual?

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The coronavirus (COVID-19) has created the most dire public health and economic crisis in generations, and the US government is under intense pressure to provide the necessary relief to US citizens, healthcare providers, and...more

BakerHostetler

HELP! FTC Staff Steps Up to the Plate with Guidance for State Officials on Regulating Occupational Boards

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Answering the call from state officials seeking advice regarding antitrust compliance for state boards responsible for regulating occupations, Federal Trade Commission (FTC) Staff have stepped up to answer two questions...more

BakerHostetler

A Deeper Dive: Regulatory Investigations Following a Reported Breach

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In our inaugural Data Security Incident Response Report (the Report), we found that regulators inquired about a company’s breach 31% of the time and multi-state state Attorneys General investigations were launched less than...more

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