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New Regulations Healthcare Department of Health and Human Services (HHS)

Alston & Bird

Health Care Week in Review | Senate Parliamentarian Issues Rulings on Budget Reconciliation Provisions; Supreme Court Upholds the...

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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

McDermott+

Health Plans’ Commitment to Prior Authorization Improvements: What’s New Versus What’s Already Required

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Health plan members of AHIP and the Blue Cross and Blue Shield Association made news earlier this week when they announced a series of steps that a broad swath of health insurers will take to improve the prior authorization...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Alston & Bird

Health Care Week in Review | White House Issues Executive Orders on Biosecurity and Domestic Drug Production; House Committee...

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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

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

Alston & Bird

Health Care Week in Review | Oz Confirmed as CMS Administrator; CMS finalizes CY 2026 MA/Part D Final Rule

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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

McDermott+

Healthcare Preview for the Week of: March 3, 2025

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Attention Turns to Government Funding - Last week, after some drama on the floor, the House passed its version of a budget resolution in a 217 – 215 vote, a week after the Senate passed its “skinny” resolution. For the...more

Health Care Compliance Association (HCCA)

‘Waking Up With Panic Attacks’: NIH 15% Plan Caps Tumultuous Weeks Under New Administration

If NIH succeeds in imposing an across-the-board indirect cost rate of 15%, rough estimates indicate the University of Michigan could lose $119 million a year. Emory University could be down $75 million. For the University of...more

DLA Piper

DEA and HHS Propose Telemedicine Special Registration and Finalize Buprenorphine Telemedicine Prescribing Rules

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On January 17, 2025, the US Drug Enforcement Administration (DEA) and the US Department of Health and Human Services (HHS) published two rules regarding telemedicine prescribing of controlled substances: a proposed rule...more

McDermott Will & Emery

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

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In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

McDermott+

Medicare FFS Regs: Thrills and Chills Under the Trump and Biden Administrations

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Happy Halloween! In the health policy world, there are two things on everyone’s mind this spooky season: the upcoming election and the major calendar year (CY) 2025 Medicare fee-for-service (FFS) final regs that should be...more

McDermott+

CMS Issues Guidance to States on Children’s Access to Medicaid Coverage

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Last week, the Center for Medicaid and CHIP Services within the Centers for Medicare & Medicaid Services (CMS) released what it calls “historic” guidance to states on best practices for adherence to early and periodic...more

Health Care Compliance Association (HCCA)

New ORI Misconduct Rule Offers ‘Thoughtful’ Revisions in Wake of Highly Criticized NPRM

Now that the HHS Office for Research Integrity (ORI) has published its final rule revising 2005 regulations governing misconduct, compliance officials could be engaging in three activities simultaneously: checking to see if...more

McDermott+

Biden Administration Issues Final Reg on Mental Health Parity Requirements

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Biden Administration Issues Final Reg on Mental Health Parity Requirements McDermott+ is pleased to bring you Regs & Eggs, a weekly Regulatory Affairs blog by Jeffrey Davis. Click here to subscribe to future blog posts....more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

McDermott+

McDermottPlus Check-Up: May 24, 2024

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House Energy & Commerce Committee Hearing on FDA. The hearing examined the US Food & Drug Administration’s (FDA’s) regulation of drugs, biologics and devices. House Budget Committee Hearing on Healthcare Monopolies. The...more

McDermott Will & Emery

HHS Final Section 1557 Nondiscrimination Regulations: Gender-Affirming Care and the Role of Carriers Under ASO Arrangements

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) (final regulations) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits...more

McDermott Will & Emery

Ten Takeaways From Long-Awaited Section 1557 Nondiscrimination Protections

On April 26, 2024, the US Department of Health and Human Services (HHS) issued a final rule (press release, fact sheet, FAQs) reinterpreting Section 1557 of the Affordable Care Act (ACA), which prohibits discrimination on the...more

McDermott Will & Emery

2024 Chart of Additional Healthcare Regulations

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During this election year, McDermottPlus is actively monitoring annual regulations that federal agencies are expected to release, as well as “ad hoc” regulations that will be released at the discretion of federal agencies. ...more

McDermott+

McDermottPlus Check-Up: January 26, 2024

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Senate Finance Chair Continues Inquiry into MA Marketing Techniques. Chairman Wyden (D-OR) sent letters to five third-party marketing organizations that participate in the MA enrollment period. The letters seek information on...more

McDermott+

REGS & TURKEY LEGS: The Regs We’re Thankful For

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It’s Thanksgiving week, so instead of eating eggs with your regs, you should sit back, relax and reflect on the regs you are thankful for as you eat your turkey legs (or whatever you enjoy on Thanksgiving). Many of the...more

Proskauer - Health Care Law Brief

HHS Issues HIPAA Guidance on Remote Communication Technologies for Audio-Only Telehealth

The Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”), recently issued new regulatory guidance relating to covered entities’ HIPAA-compliant use of remote communication technologies for...more

Davis Wright Tremaine LLP

Confidentiality of Substance Abuse Treatment Information: HHS Considers Changes to the Part 2 Regulations and Requests Comment

The Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) is considering significant changes to the “Part 2” regulations (the Confidentiality of Alcohol and Drug Abuse...more

Morgan Lewis

HRSA Publishes Orphan Drug Rule for 340B Program

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Rule requires most manufacturers to change government pricing methodologies, calculations, and systems. On July 23, the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human...more

Snell & Wilmer

Final Wellness Rules May Require Review of Existing Wellness Programs

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Final wellness regulations were issued by the Departments of Treasury, Labor, and Health and Human Services (the “Departments”) on June 3, 2013 and apply to employer-sponsored group health plans for plan years beginning on or...more

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