News & Analysis as of

Final Rules Department of Health and Human Services (HHS) Healthcare Reform

McDermott Will & Emery

Enforcement of Mental Health Parity Regulations Suspended: Takeaways for Plan Sponsors and Health Insurance Issuers

McDermott Will & Emery on

In January 2025, The ERISA Industry Committee (ERIC) filed a complaint against the US Departments of Labor, Health and Human Services, and the Treasury (the departments) seeking to invalidate the 2024 final regulations under...more

Lathrop GPM

Flying Through the Whirlwind: Health Care Industry Continues To Be Buffeted as Administration Rolls Out New Initiatives

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Health care providers and payers have been subject to a flurry of developments at the federal level in recent weeks. Considering that health care represents almost 18% of the U.S. gross domestic product, this was perhaps...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

McDermott+

Breaking Down the New No Surprises Act FAQs Post-TMA III

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On January 14, 2025, the US Departments of Labor, Health and Human Services (HHS), and the Treasury (collectively, the Departments), along with the Office of Personnel Management (OPM), jointly issued Part 69 of a series of...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

McDermott Will & Emery

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

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On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Holland & Knight LLP

Holland & Knight Health Dose: January 29, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott+

Regs on the Menu for Rescission Under Budget Reconciliation

McDermott+ on

Over the next several weeks, both the Trump Administration and the 119th Congress will review the “menu” of Biden-era regulations that they may want to rescind or modify. In one of his first orders, President Trump (like...more

Vorys, Sater, Seymour and Pease LLP

Just Say No!  HIPAA and Requests for Reproductive Health Information

On April 22, 2024, the Office of Civil Rights issued a Final Rule titled HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Privacy Rule). Originally Published by the American Bar Association....more

Ballard Spahr LLP

Practical Pointers for Compliance With New MHPAEA Regulations

Ballard Spahr LLP on

The Departments of the Treasury, Labor, and Health and Human Services have published final regulations under the Mental Health Parity and Addiction Equity Act that prohibit group health plans and health insurers from imposing...more

Epstein Becker & Green

Application of New Mental Health Parity Rules to Provider Network Composition and Reimbursement: Perspective and Analysis

Epstein Becker & Green on

On September 23, 2024, the U.S. Departments of Labor, the Treasury, and Health and Human Services (collectively, the “Departments”) released final rules (the “Final Rules”) that implement requirements under the Mental Health...more

McDermott+

McDermott+ Check-Up: September 27, 2024

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Congress Votes on CR, Health-Related Legislation. After reaching a deal over the weekend, both chambers passed a CR to avoid a government shutdown and fund the federal government through December 20, 2024. This tees up a push...more

McDermott+

McDermott+ Check-Up: September 13, 2024

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House Education & the Workforce Health, Employment, Labor, and Pensions Subcommittee Holds Hearing on ERISA’s 50th Anniversary. Members and witnesses assessed how the Employee Retirement Income Security Act of 1974 (ERISA)...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

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | July 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more

Nelson Mullins Riley & Scarborough LLP

FY 2025 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS)...

On August 1, the Centers for Medicare & Medicaid Services (CMS) issued a final rule to increase Medicare inpatient prospective payment system rates for certain acute care hospitals by a net 2.9% in fiscal year 2025, compared...more

McDermott+

M+ Check-Up: August 2, 2024

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Senate HELP Committee Marks Up Public Health Program Reauthorizations. The bills would reauthorize several programs related to older adults, individuals with developmental disabilities and individuals with traumatic brain...more

Akerman LLP - HR Defense

On the Basis of Sex… Discrimination in Group Health Plans and What Employers Should Know

In just a few days’ time, recently promulgated federal final rules addressing sex-based nondiscrimination in the administration of health care benefits have created a flurry of healthcare industry activity. The angst arises...more

Sheppard Mullin Richter & Hampton LLP

CMS Issues Final Rule on Medicaid and CHIP Managed Care Access, Finance, and Quality

On April 22, 2024, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule (CMS-2439-F), effective July 9, 2024, aimed at advancing healthcare access,...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

Polsinelli

New SAMHSA Rule Expands Access to Medications for the Treatment of Opioid Use Disorder

Polsinelli on

On February 2nd, the U.S. Department of Health and Human Services (HHS) released a final rule expanding patient access to medications for the treatment of opioid use disorder (“OUD”). This new final rule implements changes...more

McDermott+

Healthcare Preview for the Week of: January 29, 2024

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APPROPRIATIONS PROCESS MOVES FORWARD - Over the weekend, negotiators in Congress agreed to certain spending allocations in order to fund various government agencies through most of the year. With both bodies in session...more

Bass, Berry & Sims PLC

HHS Finalizes Rule: “Safeguarding the Rights of Conscience as Protected By Federal Statutes”

Bass, Berry & Sims PLC on

On January 11, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published a Final Rule that seeks to provide clarity regarding OCR’s enforcement authority and processes relating to federal...more

McDermott+

McDermottPlus Check-Up: January 12, 2024

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Congress Works to Meet Imminent Funding Deadlines. Speaker of the House Johnson (R-LA) and Senate Majority Leader Schumer (D-NY) announced an agreement on top-line spending levels to fund the government for the remainder of...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | November 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for November 2023. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new General...more

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