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Health Insurance Department of Health and Human Services (HHS) Drug Pricing

Alston & Bird

Health Care Week in Review: Agencies issued Requirements Related to the Mental Health Parity and Addiction Equity Act final rules;...

Alston & Bird on

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

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2024

We Americans pay more for prescription medications than just about anywhere else on the globe. And Big Pharma keeps jacking prices higher....more

Epstein Becker & Green

Last Call for Comments on Bipartisan Discussion Draft SUSTAIN Act: Shaping 340B for the Future

Epstein Becker & Green on

Only a few days remain for stakeholders—which includes drug manufacturers, patients, health care providers, pharmacies and others— to take advantage of a rare opportunity to influence the statutory contours of the 340B Drug...more

McDermott+

Regs During an Election Year: What’s on the Menu?

McDermott+ on

Last week, McDermott+Consulting launched an election 2024 resource page, where you can find a 2024 health policy outlook and other insights into the November election. While regulations aren’t necessarily top-of-mind when...more

Burr & Forman

CMS Proposes to Resolve 340B Illegal Rate with $9M Pay-Out for Traditional Medicare; Medicare Advantage to be Negotiated Privately

Burr & Forman on

In July 2023, the Centers for Medicare and Medicaid Services (“CMS”) proposed a final rule to address illegal traditional Medicare rates paid in the 340B Drug Pricing Program from 2018-2022. CMS’ proposal would see CMS pay...more

Akin Gump Strauss Hauer & Feld LLP

What a Difference a Year Makes: IRA’s Drug Pricing Provisions Turn One

This week marks the one-year anniversary since the enactment of the Inflation Reduction Act (IRA), which included sweeping reforms empowering the Secretary of Health and Human Services (HHS) to set prices for certain...more

Mintz - Health Care Viewpoints

Senate HELP Committee Eyes Drug Pricing and PBM Regulation Beyond Federal Programs

On April 25, 2023, the Senate Health, Education, Labor, and Pensions Committee Chairman Bernie Sanders and Ranking Member Bill Cassidy introduced a package of legislation aimed at lowering prescription drug prices. The...more

Robinson+Cole Health Law Diagnosis

340B Update: District Court Rejects 2022 Payment Methodology for 340B Hospitals Following Supreme Court Win

We follow up on our previous blog post concerning the U.S. Supreme Court’s unanimous ruling in favor of 340B hospitals. The Supreme Court previously held that “absent a survey of hospitals’ acquisition costs, HHS may not vary...more

McDermott Will & Emery

Agencies Provide Guidance on Transparency in Coverage Rule Implementation

McDermott Will & Emery on

On April 19, 2022, the US Departments of Labor, Health and Human Services, and the Treasury (collectively, the Departments) released Frequently Asked Questions (FAQs) regarding the implementation of certain reporting...more

Sheppard Mullin Richter & Hampton LLP

Elijah E. Cummings Lower Drug Costs Now Act: The Long and Winding Road to Drug Pricing Reform

As reintroduced in the U.S. House of Representatives by Rep. Frank Pallone, Jr. (D-NJ-6) on April 22, 2021 after originally being introduced on September 19, 2019, H.R. 3, also known as known as the Elijah E. Cummings Lower...more

McGuireWoods Consulting

The Courts and Healthcare Policy - August 2021

The courts continue to play an important role in health policy. 2020 saw several notable lawsuits related to the Affordable Care Act (ACA). Several other Trump administration policies were challenged, including Medicare...more

McDermott Will & Emery

Agencies Issue Final Employer Healthcare Price Transparency Rule

McDermott Will & Emery on

On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more

ArentFox Schiff

HHS Clarifies Position on Copay Accumulators? Or Does It?

ArentFox Schiff on

A HHS Final Rule for Exchange plans states that coupons and copay cards offered directly by drug manufacturers can be counted towards a patient’s annual cost-sharing limit. The Department of Health and Human Services (HHS)...more

Manatt, Phelps & Phillips, LLP

Strategies to Expand Transparency, Enhance Competition and Control Costs

Editor’s Note: In a new toolkit prepared for the Robert Wood Johnson Foundation, summarized below, Manatt Health helps insurance regulators understand the wide range of transparency and competition strategies available to...more

Akin Gump Strauss Hauer & Feld LLP

Battle Lines Drawn with Release of Speaker’s Drug Pricing Plan

[co-authors: Sean Feely, Senior Public Policy Specialist and Julie E. Nolan, Senior Policy Advisor] • On September 19, Speaker Pelosi released a drug pricing plan that includes proposals for Medicare direct price...more

McGuireWoods Consulting

Washington Healthcare Update - September 2019 #1

This week in Washington: Senate to markup the Labor, Health and Human Services, Education and Related Agencies Appropriations Act; House to hold hearings on improving maternal health and the Administration's apparent...more

McGuireWoods Consulting

Washington Healthcare Update April 2019 #4

Congress - Hearings/Markups - House Judiciary Committee: "TBA Markup on CREATES Act, Pay-for-Delay Legislation" - The House Judiciary Committee is planning a markup on the CREATES Act and pay-for-delay legislation....more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Epstein Becker & Green

HHS OIG Proposes Anti-Kickback Safe Harbor Amendments to Regulate and Restrict the Provision of Manufacturer Remuneration to Plan...

On January 31, 2019, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a proposed rule (“Proposed Rule”) that would restrict safe harbor protection under the federal Anti-Kickback...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

Patrick Malone & Associates P.C. | DC Injury...

Will Rx drug costs fall if U.S. puts squeeze on middlemen and curbs rebates?

The Trump Administration has put out its latest prescription to try to slash out-of-control prescription drug prices: Officials want to call medication “rebates” what they say they’ve really become — “kickbacks” — and crack...more

McGuireWoods Consulting

Washington Healthcare Update: January 2019

House - New Leadership Updates - On Jan. 9, eight Democratic members were added to the House Energy and Commerce Committee: Reps. Nanette Diaz Barragan (CA), Robin Kelly (IL), Marc Veasey (TX), Tom O’Halleran (AZ),...more

McGuireWoods Consulting

Washington Healthcare Update

McGuireWoods Consulting on

This Week: The Affordable Care Act was found unconstitutional, but nothing will change as it winds through the courts. As the 115th Congress comes to a close, last-minute bills are introduced, some healthcare legislation...more

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 #4

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Foley & Lardner LLP’s Bipartisan Public Policy Team is pleased to share this week’s “Public Policy Health Care Newsletter” in which we compile the latest health care policy news and legislation. Please note that the next...more

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