News & Analysis as of

Comment Period Proposed Rules Prescription Drugs

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

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The Centers for Medicare & Medicaid Services (CMS) released the calendar year 2026 Physician Fee Schedule (PFS) proposed rule, which was published in the Federal Register on July 16, 2025. The comment period ends on September...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

Goodwin

DEA Proposes Three-Tiered Special Registration System for Prescribing and Dispensing of Controlled Substances

Goodwin on

On January 15, 2025, the Department of Health and Human Services (HHS) and Drug Enforcement Administration (DEA) issued a series of rules relating to the telemedicine prescribing of controlled substances, including a proposed...more

Sheppard Mullin Richter & Hampton LLP

Key Proposals from the CY 2026 Medicare Advantage and Part D Proposed Rule

On November 26, 2024, the Centers for Medicare & Medicaid Services (“CMS”) released the contract year 2026 proposed rule for the Medicare Advantage (“MA”) program, Medicare Prescription Drug Benefit Program (“Part D”),...more

Bass, Berry & Sims PLC

CMS CY 2026 Parts C and D Proposals Focus on Informed Choice

Bass, Berry & Sims PLC on

On December 10, the Centers for Medicare & Medicaid Services (CMS) published a proposed rule, which, if finalized as proposed, has potentially significant implications for Medicare Advantage (MA) plans and Medicare...more

DLA Piper

CMS Releases New Proposed Rule for Medicare Advantage and Part D

DLA Piper on

On December 10, 2024, the Centers for Medicare and Medicaid Services (CMS) released a Proposed Rule for revisions to the regulations governing the Medicare Advantage (MA) program, Medicare Prescription Benefit (Part D),...more

Holland & Knight LLP

CMS Releases CY 2025 OPPS and ASC Proposed 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 Proposed Rule (CMS-1809-P),...more

Epstein Becker & Green

Medicare Advantage, Part D, and More: Proposed Rule Outlines Significant Policy and Technical Changes for CY 2025

Epstein Becker & Green on

On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule titled Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit...more

Venable LLP

CMS Proposes Behavioral Health Program Changes

Venable LLP on

On July 13, 2023, the Centers for Medicare & Medicaid Services (CMS) announced a proposal to significantly expand behavioral health coverage provided under Medicare. The proposal, presented as a part of the calendar year 2024...more

Holland & Knight LLP

CMS Releases CY 2024 OPPS and ASC Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2024 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1786-P),...more

Bricker Graydon LLP

340B Update: Proposed Rule on Drug Acquisition Cost Cuts Suggests Lump Sum Repayment

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The Department of Health and Human Services has published a proposed rule to address short payments on drug acquisition costs for 340B hospitals from 2018 to September 2022. On June 15, 2022, the Supreme Court unanimously...more

McDermott Will & Schulte

CMS Releases Proposed Remedy for 340B-Acquired Drugs Purchased in CYs 2018–2022

On July 7, 2023, the Centers for Medicare and Medicaid Services (CMS) released the proposed rule, Hospital Outpatient Prospective Payment System: Remedy for 340B-Acquired Drugs Purchased for Calendar Years 2018–2022, to...more

Troutman Pepper Locke

FDA Proposes New Rules for Prescription Drug Labeling

Troutman Pepper Locke on

On May 31, the FDA issued a proposed rule to amend prescription drug labeling regulations to require a new type of Medication Guide, specifically a Patient Medication Information guide, for essentially all FDA-approved...more

Foley Hoag LLP

HRSA Proposes to Overhaul 340B Dispute Process

Foley Hoag LLP on

On November 29, 2022, the Health Resources and Services Administration (“HRSA”) published a notice of proposed rulemaking (“Proposed Rule”)[1] to implement an Administrative Dispute Resolution (“ADR”) process for resolving...more

Holland & Knight LLP

CMS Releases CY 2023 Outpatient and ASC Payment System Proposed Rule

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The Centers for Medicare & Medicaid Services (CMS) has released the calendar year (CY) 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (CMS-1772-P),...more

Hogan Lovells

FDA may permit Rx-to-OTC switch using additional conditions beyond traditional labeling

Hogan Lovells on

On June 27, the U.S. Food and Drug Administration (FDA) published the long-awaited proposed rule “Nonprescription Drug Product with an Additional Condition for Nonprescription Use” (ACNU), which would could expand the...more

Quarles & Brady LLP

Hot Off the Press: Mississippi Board of Pharmacy Files Proposed Rule on Shared Pharmacy Services

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On June 10, 2022, the Mississippi Board of Pharmacy filed their much-anticipated proposed rule on pharmacy shared services, starting the clock on the 25-day public comment period. The Board simultaneously filed its...more

McDermott Will & Schulte

Proposed Rule on MA and Part D Would Reinstate Historical Requirements, Make Changes to Prescription Drug Payment Structure

On January 6, 2022, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule regarding Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit...more

Holland & Knight LLP

CMS Releases CY 2022 OPPS and ASC Proposed Rule

Holland & Knight LLP on

The Centers for Medicare & Medicaid Services (CMS) on July 19, 2021, released its calendar year (CY) 2022 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - May 2021 #2

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PhRMA Suit Challenges Co-Pay/Accumulator Portion of December 2020 Medicaid Rule - On May 21, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in the US District Court for the District of...more

ArentFox Schiff

CMS Releases Proposed Changes for Medicare Advantage and Medicare Part D

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) published the Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program,...more

King & Spalding

CMS Issues Medicare Advantage and Part D Proposed Rule for Contract Year 2021 and 2022

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On February 5, 2020, CMS issued a proposed rule advancing multiple updates and changes to Medicare Advantage (MA) and Medicare prescription drug benefit (Part D) programs (Proposed Rule). Unlike in past years, CMS will not...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

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In late December 2019, the Food and Drug Administration (FDA), an agency operating within the Department of Health and Human Services (HHS), issued two documents—a Proposed Rule and a Draft Guidance—intended to establish two...more

Bradley Arant Boult Cummings LLP

HHS Proposes Revisions to Part 2 Regulations Governing Confidentiality of Substance Use Disorder Records - Healthcare Alert

On August 26, 2019, the Substance Abuse and Mental Health Services Administration, part of the U.S. Department of Health and Human Services (HHS), published its much-anticipated notice of proposed rulemaking to revise 42...more

ArentFox Schiff

2020 Proposal for Medicare Part B Drug Reimbursement: Business as Usual

ArentFox Schiff on

On July 29, 2019, the Centers for Medicare & Medicaid Services (CMS) released its annual proposed update to the hospital outpatient prospective payment system (Proposed Rule)....more

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