News & Analysis as of

Final Rules Prescription Drugs Health Care Providers

McDermott Will & Schulte

Trending in Telehealth: April 2025

Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more

Holland & Knight LLP

CMS Final Rule on CY 2026: Policy and Technical Changes

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The Centers for Medicare & Medicaid Services (CMS) released on April 4, 2025, the final rule for contract year (CY) 2026 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

Foley & Lardner LLP

DEA Buprenorphine Rule Delayed to December 31, 2025

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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

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 & Schulte

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

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

Rivkin Radler LLP

DEA Announces New Telemedicine Rules Expanding Access to Controlled Substances

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On January 16, the U.S. Drug Enforcement Administration (DEA) announced three new telemedicine rules that extend prescribing flexibilities for controlled substances, following the expiration of temporary flexibilities granted...more

Foley Hoag LLP

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications

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On January 6, 2025, FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products.” This...more

Fenwick & West LLP

Understanding the DEA’s New Telemedicine Rules: FAQ for Healthcare Providers and Telehealth Companies

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The U.S. Drug Enforcement Administration (DEA) recently announced new rules that will impact telemedicine practices, especially concerning remote prescribing of controlled substances....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

McCarter & English, LLP

New Jersey Regulatory Update Part II - February 2025

We continue our New Jersey Regulatory Update with this Part II, which focuses on regulations that were finalized in the second half of 2024 and impact healthcare. For example, as a continuation of price transparency efforts,...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Epstein Becker & Green

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

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

Verrill

Prescription for Change: Massachusetts Pharmacies Undergo Regulatory Revamp

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Pharmacies doing business in Massachusetts must act now – The Massachusetts Board of Registration in Pharmacy (the “Board”) has announced a series of new and long-awaited pharmacy licensure regulations that took effect in...more

Dinsmore & Shohl LLP

DEA Expands Telemedicine Flexibilities Through Three New Rules

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The landscape of telemedicine in the United States is undergoing a profound transformation. On January 16, 2025, the Drug Enforcement Administration (DEA) unveiled a series of regulatory changes designed to expand and...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

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

CMS Issues Final 2025 Calendar Year Medicare Physician Fee Schedule Final Rule

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On November 1, 2024, CMS issued a rule finalizing changes to Medicare payments under the Physician Fee Schedule (PFS) and other Medicare Part B policies effective on or after January 1, 2025 (the Final Rule). Section 1848 of...more

Holland & Knight LLP

CMS Releases CY 2025 Medicare Physician Fee Schedule Final Rule

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The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2024, released the calendar year (CY) 2025 Revisions to Payment Policies under the Physician Fee Schedule (MPFS) and Other Revisions to Medicare Part B...more

Holland & Knight LLP

CMS Releases CY 2025 OPPS and ASC Final Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule with comment...more

Alston & Bird

Health Care Week in Review: CMS Releases PFS, OPPS, ESRD, and Home Health Final Rules; Senators Cassidy and Hassan Release a...

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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

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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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

Mintz - Health Care Viewpoints

CMS Publishes Final Rules Implementing Part C and Part D Program Changes

On April 23, 2024, the Centers for Medicare & Medicaid Services (CMS) published final rules setting forth Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024--Remaining...more

McDermott Will & Schulte

New Compliance Obligations for PACE Organizations Coming in 2025

On April 4, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a final rule and press release revising the regulations governing the Medicare Advantage (MA) Program, Medicare Prescription Drug Benefit Program,...more

Holland & Knight LLP

Holland & Knight Health Dose: April 9, 2024

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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

Epstein Becker & Green

SAMHSA Final Rule Regarding OTPs Expands Access, Increases Flexibility for Patients

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more

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