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Comment Period Centers for Medicare & Medicaid Services (CMS) Pharmacies

Husch Blackwell LLP

HHS Unveils 340B Drug Rebate Pilot Program

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On July 31, 2025, the U.S. Department of Health and Human Services (HHS) announced that it will conduct a pilot program testing out a rebate model for 340B drug purchases. Under the program, drug manufacturers will be allowed...more

Goodwin

340B Rebate Pilot Program Proposed by HRSA

Goodwin on

On July 31, 2025, the Health Resources and Services Administration (HRSA), Office of Pharmacy Affairs (OPA) issued a 340B Drug Pricing Program notice (the “Notice”) announcing the launch of a voluntary 340B rebate model pilot...more

Latham & Watkins LLP

Healthcare Life Sciences Drug Pricing Digest - July 2025 #2

Latham & Watkins LLP on

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

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

Latham & Watkins LLP

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

Latham & Watkins LLP on

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

McDermott Will & Schulte

CMS Issues Medicare Advantage and Part D 2021 Proposed Rule

The Centers for Medicare & Medicaid Services (CMS) recently released three items relating to the Medicare Advantage and Part D programs: a proposed rule, Part II of the Advance Notice and Rate Announcement for Calendar Year...more

King & Spalding

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

King & Spalding on

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

HHS Issues Proposed Rule to Update Anti-Kickback Statute Safe Harbors – What Does it Mean for Life Sciences Companies?

King & Spalding on

HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers - In today’s Federal Register, the...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 7: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Part C and Part D Quality Rating System - The November 1, 2018 proposed rule issued by the Centers for Medicare & Medicaid Services (“CMS”) includes enhancements and substantive changes to the Star Rating System in order...more

Holland & Knight LLP

New Proposed Medicare Part B Drug Reimbursement Model Raises Questions

Holland & Knight LLP on

• The Centers for Medicare & Medicaid Services (CMS) has announced a new proposed reimbursement model for certain Medicare Part B drugs and biologicals. • The proposed structure, called the International Pricing Index (IPI)...more

Sheppard Mullin Richter & Hampton LLP

Blog Series Part 5: CMS Proposed Rule on Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug...

Part D Plan Sponsors’ Access to Medicare Parts A and B Claims Data Extracts - As detailed in previous posts in this series, one major objective that the Centers for Medicare and Medicaid Services (“CMS”) addressed in a...more

Mintz - Health Care Viewpoints

In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

Today, January 16, 2018 is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule focuses on many issues. In...more

Mintz - Health Care Viewpoints

CMS Releases the Final Medicare Part D DIR Reporting Requirements for 2016

On Friday, June 23, 2017, CMS released the Final Medicare Part D DIR Reporting Requirements for 2016. Part D sponsors may begin submitting their DIR information on June 30, 2017 and must finish their submissions by the end of...more

BakerHostetler

CMS Doubles Down on Targeting Part D Enrollee Prescription Drug Abuse, But Will Stakeholders Agree?

BakerHostetler on

With the release of its 2017 draft call letter, CMS continues its push to curb opioid dependence, overdose and death among Medicare Part D enrollees. To that end, CMS proposes that Part D plan sponsors edit their benefit...more

McDermott Will & Emery

Medicaid Managed Care Update: A Middle Ground for Network Adequacy Standards

McDermott Will & Emery on

This article is part of a series that takes an in-depth look at several proposals that would affect managed care organizations, health care providers and other industry stakeholders participating in, and contracting with...more

Epstein Becker & Green

CMS Amends Medicare Part D Program Integrity Regulations to Facilitate Beneficiary Access and Expand Coverage for Pharmacist...

On May 1, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule with comment period (“IFC”) that amends Medicare program integrity regulations requiring prescribers to either enroll in...more

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