News & Analysis as of

Final Rules New Regulations Department of Health and Human Services (HHS)

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

McCarter & English, LLP

Federal Telehealth Update

Congress has extended telehealth flexibilities through its recent federal spending bill, H.R. 1968, titled “Full-Year Continuing Appropriations and Extensions Act, 2025” (the Act). Notably for health care providers, among...more

McDermott Will & Emery

CMS Implements First Major Updates to Lab Personnel Requirements in 30+ Years

On December 28, 2024, a long-awaited Centers for Medicare & Medicaid Services (CMS) final rule became effective, significantly updating laboratory personnel requirements under Subpart M of the Clinical Laboratory Improvement...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

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

McDermott+ on

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

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 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

McDermott+ on

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

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+

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

Mintz - Health Care Viewpoints

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

Bradley Arant Boult Cummings LLP

SAMHSA Finalizes Revisions to Part 2 Regulations Governing Confidentiality of Substance Use Disorder Records

On July 15, 2020, the Substance Abuse and Mental Health Services Administration (SAMHSA), a branch of the U.S. Department of Health and Human Services (HHS), published its much-anticipated final rule to revise 42 C.F.R. Part...more

Smith Anderson

DOT Adds Synthetic Opioids to Drug Testing Panel

Smith Anderson on

As of January 1, 2018, employers regulated by the federal Department of Transportation (DOT) must include certain synthetic opioids in their mandated drug testing policies and programs. DOT published a final rule on November...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Department of Transportation Publishes Final Rule on Drug Testing

On November 13, 2017, the U.S. Department of Transportation (DOT) published a final rule making significant changes to 49 Code of Federal Regulations Part 40, which affects employers administering drug tests in the...more

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