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New Regulations Department of Health and Human Services (HHS)

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

Health Care Compliance Association (HCCA)

ORI’s Garrity: Final Rule ‘Walks Delicate Line’

Sheila Garrity, director of the HHS Office of Research Integrity (ORI), recently spoke to RRC about the agency‘s new rule revising research misconduct regulations, which has a compliance date of Jan. 1, 2026 (see related...more

Foley & Lardner LLP

Research Misconduct: ORI Issues Final Rule with Modernized and Streamlined Regulations

Foley & Lardner LLP on

On September 17, 2024, the Office of Research Integrity (ORI) issued a final rule adopting changes to federal regulations governing research misconduct involving federally funded research (Final Rule). The regulations have...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

King & Spalding

The Fifth Circuit Affirms Decision Vacating CMS Regulations Implementing the No Surprises Act IDR Process

King & Spalding on

On August 2,2024, the Fifth Circuit affirmed the vacatur of federal rulemaking related to the No Surprises Act’s (NSA) Independent Dispute Resolution (IDR) process. The Court held that the No Surprises Act does not permit the...more

Ballard Spahr LLP

Courts Invalidate ACA Regulations Following Demise of Chevron Deference

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Following the U.S. Supreme Court’s recent decision to overturn its landmark 1984 Chevron decision, three district courts have struck down provisions in nondiscrimination regulations under the Affordable Care Act that prohibit...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

Foster Swift Collins & Smith

DOT Issues Final Rule: Revised Procedures for Workplace Oral Drug Testing

In June 2024, the U.S. Department of Transportation (DOT) published a final rule with revised procedures for workplace drug and alcohol testing using oral fluid. The revisions detail technical changes in the way oral fluid...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+

McDermottPlus Check-Up: May 3, 2024

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House Energy & Commerce Health Subcommittee Holds Legislative Hearing on Improving Medicaid Access. Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services (CMCS), testified. Members...more

McDermott Will & Emery

2024 Chart of Additional Healthcare Regulations

McDermott Will & Emery on

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

Quarles & Brady LLP

Substance Abuse Disorder Records (42 CFR Part 2) Final Rule Is Here!

Quarles & Brady LLP on

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and Substance Abuse and Mental Health Services Administration (SAMHSA) released its anticipated Final Rule last week. The Final Rule revises...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

McDermott+ on

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

Harris Beach PLLC

New York Wants Comprehensive Cybersecurity Plans for Hospitals by February 2025

Harris Beach PLLC on

New York Gov Kathy Hochul is touting her proposed statewide cybersecurity regulations for hospitals and health systems as “nation-leading,” and, if approved, those entities will have until February 2025 to comply with the new...more

Foster Swift Collins & Smith

USDOT Approves Oral Fluid Drug Testing

On May 2, 2023, the United States Department of Transportation (“DOT”) published a final rule that authorizes employers to use oral fluid drug testing as an alternative methodology to urine drug testing. While the final rule...more

Skadden, Arps, Slate, Meagher & Flom LLP

The Nucleus: Life Sciences Regulation and Enforcement Updates

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more

Jackson Lewis P.C.

U.S. Department of Transportation Allows Oral Fluid Drug Testing

Jackson Lewis P.C. on

The U.S. Department of Transportation (DOT) published new regulations in the Federal Register on May 2, 2023 that will allow covered employers to use oral fluid testing for drugs. While the new rules technically become...more

McDermott Will & Emery

McDermott Health 2023 Annual Report - Digital Health: 2022 Year in Review

McDermott Will & Emery on

Digital health is one of the fast-growing segments of the healthcare market, with patients, clinicians and regulators increasingly aligned behind the opportunities that digitization presents. Over the last three years,...more

Health Care Compliance Association (HCCA)

Compliance Today - December 2022. Intersection of ESG, health equity, and 501(r) compliance

Compliance Today - December 2022 - We are at a critical moment of change when it comes to truly addressing health inequities in this country. With the intersection of environmental, social, and governance (ESG) reporting and...more

ArentFox Schiff

Biden's Executive Order Focusing on Biotechnology Offers Opportunities for AgTech Industry

ArentFox Schiff on

President Biden has revealed the next areas of focus in his effort to protect the United States’ technological leadership and economic competitiveness: biotechnology, biomanufacturing, and the bioeconomy....more

Health Care Compliance Association (HCCA)

[Virtual Event] 2022 Research Conference - October 6th, 8:25 am - 4:30 pm CDT

Stay on top of the latest in research compliance - Do you want to learn: - Current best practices for building and maintaining a  research compliance work plan? - How to better shift your program’s research focus in...more

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