News & Analysis as of

Final Rules Department of Health and Human Services (HHS) Health Care Providers

Fisher Phillips

Minimum Staffing Rules for Long-Term Care Facilities Tossed Out by Federal Courts and Budget Bill: Key Points for Medicare and...

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A federal judge in Iowa recently struck down key parts of a Biden-era final rule that set new minimum staffing standards for long-term care facilities as a condition of participation in Medicare or Medicaid programs. The June...more

Morgan Lewis - ML Benefits

Reproductive Healthcare Privacy Final Rule Vacated by Texas Court

The US District Court for the Northern District of Texas on June 18, 2025 vacated portions of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Rule) related to reproductive healthcare privacy....more

Fisher Phillips

Reproductive Healthcare Privacy Rule Struck Down Nationwide by Texas Judge: What Providers and Employer-Sponsored Health Plans...

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A federal judge in Texas just tossed out Biden-era reproductive healthcare privacy protections, halting a 2024 final rule with nationwide effect. The rule, which largely took effect in December and created new HIPAA privacy...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

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

Foley & Lardner LLP on

The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more

McDermott+

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

McDermott+ on

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

Saul Ewing LLP

Trump on Transparency: Making America Healthy Again Through Executive Order 14221; How Plan Sponsors Can Respond

Saul Ewing LLP on

One mandate under the PPACA required health care providers, non-grandfathered health insurance issuers and self-insured group health plans to provide consumers with access to information about the cost of services before they...more

Winthrop & Weinstine, P.A.

Important Updates on Telehealth Coverage for Medicare Providers

Providers who offer telehealth services to Medicare patients take note: many key telehealth flexibilities that have been in effect since the COVID-19 public health emergency will expire on March 31, 2025. These changes are...more

McCarter & English, LLP

DEA Telemedicine Update

The Drug Enforcement Administration (DEA), in concert with other federal agencies, has taken various steps in the past few months to strengthen a practitioner’s ability to prescribe controlled substances via telemedicine, a...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

Bass, Berry & Sims PLC

The Future of Telemedicine Prescribing Comes Into Focus: New Final and Proposed Rules

On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in...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

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

McCarter & English, LLP

New Jersey Regulatory Update Part I - January 2025

Below is Part I of our New Jersey Regulatory Update focusing on regulations that were finalized in 2024 by various New Jersey agencies that impact healthcare. The final regulations range from additional transparency...more

Baker Donelson

OCR Issues "Dear Colleagues" Letter Regarding AI in Medicine

Baker Donelson on

On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more

Epstein Becker & Green

At Long Last, DEA’s Remote Prescribing Rules 2.0 Are (Really) Here! (Pending Further Consideration by the Incoming Administration...

Epstein Becker & Green on

Remote prescribing via telemedicine continues to be a huge area of interest among prescribers and other health care providers....more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

Goodwin on

On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

McCarter & English, LLP

Nursing Home Update

The federal government has made a variety of changes to federal requirements aimed at improving the quality of care at long-term care facilities across the country. In May 2024, the United States Department of Health and...more

McDermott Will & Emery

CMS Updates Scope of Providers Subject to Provisional Period of Enhanced Oversight

The Centers for Medicare & Medicaid Services’ (CMS) 2025 Home Health Prospective Payment System final rule (Final Rule) expanded the scope of providers subject to a provisional period of enhanced oversight (PPEO) to include...more

Ropes & Gray LLP

Biden Administration Finalizes Its Last Changes To Health Data Interoperability and Information Blocking Regulations

Ropes & Gray LLP on

In December 2024, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (“ASTP/ONC”) within the U.S. Department of Health and Human Services (“HHS”) published two...more

Harris Beach Murtha PLLC

"No Surprises Act" Ruling Favors Regulators, Insurers

Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act (the...more

Holland & Knight LLP

Holland & Knight Health Dose: December 17, 2024

Holland & Knight LLP on

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

Holland & Knight LLP

HHS Finalizes Key Information Blocking Exceptions

Holland & Knight LLP on

The finalization of information blocking exceptions were announced just in the "St. Nick" of time by the U.S. Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy (ASTP), formerly known as...more

ArentFox Schiff

HIPAA Reproductive Privacy Rule Takes Effect Amid Legal and Political Uncertainties

ArentFox Schiff on

As of December 23, health care providers, health plans, and health care clearinghouses (covered entities) and their business associates (collectively, regulated entities) must comply with new reproductive health care privacy...more

Stevens & Lee

Compliance Deadline Imminent: HIPAA Final Rule to Support Reproductive Health Care Privacy

Stevens & Lee on

Around the corner is the Dec. 23 deadline to have your organization bring its HIPAA Notice of Privacy Practices into compliance with the U.S. Department of Health & Human Services’ Office for Civil Rights Final Rule modifying...more

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