Manufacturers, Health Insurance, Drug Pricing

Mintz IRA Update — The Consequences and Costs of Redesigning the Part D Program

Mintz - Health Care Viewpoints on 7/16/2024

The passage of the Inflation Reduction Act of 2022 (IRA) marked a significant milestone in Congress’s ongoing efforts to address escalating health care costs. While the IRA aims to rein in government spending on Medicare and...more

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

Arnall Golden Gregory LLP on 7/11/2024

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

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

Epstein Becker & Green on 3/26/2024

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

My Prescription Costs What?

Axinn, Veltrop & Harkrider LLP on 11/10/2023

This WSJ story highlights the challenges faced by patients as they navigate the “convoluted” ways in which drug prices are set between manufacturers and the pharmacy benefit managers (PBMs) who negotiate on behalf of health...more

Medicare Announced First 10 Drugs for Upcoming Price Negotiations

Burr & Forman on 9/5/2023

In 2024, Medicare will, for the first time, have authority under the Inflation Reduction Act passed in 2022 to negotiate drug prices with pharmaceutical manufacturers. On August 29, the Centers for Medicare and Medicaid...more

CMS Reneges on Historic “Grand Bargain” with Manufacturers in Tennessee Wavier Approval

Foley Hoag LLP - Medicaid and the Law on 1/12/2021

Now that we have had the chance to read and meditate on the historic Medicaid waiver approved on Friday January 8th, giving Tennessee permission from the Federal government to fundamentally alter Medicaid’s traditional...more

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

Akin Gump Strauss Hauer & Feld LLP on 10/1/2019

[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

Is Prescription Drug Pricing The Cure For Partisanship?

Sheppard Mullin Richter & Hampton LLP on 7/26/2019

In a rare act of bipartisanship, Senate Finance Committee Chairman Chuck Grassley, R-Iowa, and Ranking Member Ron Wyden, D-Ore., introduced on July 23rd a chairman’s mark, the Prescription Drug Pricing Reduction Act (PDPRA)...more

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

Sheppard Mullin Richter & Hampton LLP on 2/12/2019

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

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

Epstein Becker & Green on 2/6/2019

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

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

Bass, Berry & Sims PLC on 2/5/2019

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

Manufacturers › Health Insurance › Drug Pricing

"My best business intelligence, in one easy email…"