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Medicaid › Medicare Part D › Pharmaceutical Industry

Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with... more +
Medicaid is a partnership program between states and the federal government to provide healthcare coverage for lower income individuals, people with disabilities, older people, and certain families with children.  less -
Mintz - Health Care Viewpoints

CMS 2026 IRA Price Negotiations Results Likely to Create Upstream and Downstream Effects

Mintz - Health Care Viewpoints on

On August 15, 2024, CMS announced the results of the first round of the negotiated prices between CMS and participating drug manufacturers for the 10 selected drugs under the Inflation Reduction Act’s (IRA) Medicare Drug...more

Epstein Becker & Green

CMS Rules Propose Changes Regarding the Medicare Prescription Drug Inflation Rebate Program, Refundable Drugs, Skin Supplements...

Epstein Becker & Green on

On July 31, the Centers for Medicare and Medicaid Services (“CMS”) published its mammoth proposed rule entitled “Medicare and Medicaid Programs: Calendar Year 2025 Payment Policies under the Physician Fee Schedule and Other...more

ArentFox Schiff

The 2025 Proposed Hospital Outpatient Prospective Payment System and Physician Fee Schedule Rules: What Pharma Stakeholders Need...

ArentFox Schiff on

Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more

Arnall Golden Gregory LLP

OIG Announces New Audit Focus on Diabetes Drugs and Weight Loss

Arnall Golden Gregory LLP on

The U.S. Department of Health and Human Services, Office of Inspector General (“OIG”) announced multiple new OIG Work Plan Items, including two audits, focused on identifying and quantifying improper Medicare and Medicaid...more

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

ArentFox Schiff on

Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

American Conference Institute (ACI)

[Event] 21st Annual Rx Drug Pricing Boot Camp - May 4th - 5th, New York City, NY

American Conference Institute (ACI) on

The American Conference Institute is hosting the 21st Annual Rx Drug Pricing Boot Camp in New York. With both federal and state law makers engaging in greater scrutiny of prescription drug pricing, now is the time when...more

Latham & Watkins LLP

Health Care & Life Sciences: Drug Pricing Digest - October 2022 #2

Latham & Watkins LLP on

2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more

Manatt, Phelps & Phillips, LLP

[Webinar] Implications Across the Health Care System of the New Federal Drug Price Regulation - September 22nd, 1:00 pm - 2:00 pm...

Manatt, Phelps & Phillips, LLP on

The Inflation Reduction Act of 2022 (IRA) includes the most dramatic change to U.S. drug price regulation in history. The new law allows the federal government to “negotiate” the price of many drugs dispensed to Medicare...more

Jackson Walker

Next Steps for Healthcare and the Inflation Reduction Act

Jackson Walker on

On August 16, the President signed the Inflation Reduction Act of 2022 (IRA) into law. While this post focuses on key healthcare provisions in the IRA, the law likewise has significant implications for the energy sector and...more

Goodwin

U.S. Senate Passes Significant Drug Pricing Reform in the Inflation Reduction Act of 2022

Goodwin on

​​​​​​​On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more

Hogan Lovells

Demy-Colton panel explains importance of U.S. market access planning ahead of Phase III trials

Hogan Lovells on

Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S. market, or looking to launch in the...more

Hogan Lovells

U.S. House passes drug pricing legislation

Hogan Lovells on

This morning, the U.S. House passed drug pricing legislation as part of the Build Back Better Act (BBBA) (specifically the Rules Committee version available here and the manager’s amendments available here). In prelude to...more

Hogan Lovells

MDRP and 340B: Updates from last week

Hogan Lovells on

On October 13, 2021, the in-person portion of the annual informaconnect Medicaid Drug Rebate Program (MDRP) Conference concluded in New Brunswick, New Jersey. A day earlier, on October 12, 2021, a joint hearing was held in...more

Foley Hoag LLP - Medicaid and the Law

How does Pfizer’s New Warranty Program for XALKORI get around Medicaid Best Price?

Foley Hoag LLP - Medicaid and the Law on

On October 13th our friends over at STAT broke the news [sorry, Paywall] about a “warranty” pilot program from Pfizer that offers both patients and health plans (including Medicare Part D plans) the opportunity to receive a...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - August 2021

Latham & Watkins LLP on

Drug Pricing Initiatives: US lawmakers continue to debate the drug pricing measure introduced by House Democrats, H.R. 3 (the Elijah E. Cummings Lower Drug Costs Now Act). Among other things, H.R. 3 would empower the...more

Hogan Lovells

Ramping up the drug pricing debate: Dueling bills and paying for health care infrastructure

Hogan Lovells on

The U.S. House of Representatives is considering dueling proposals related to drug pricing under Medicaid and Medicare, including the Republican-led H.R. 19, the “Lower Costs, More Cures Act of 2021” and a reintroduced...more

White & Case LLP

Impact of the CARES Act on the Pharmaceutical and Medical Devices Industries

White & Case LLP on

On March 27, 2020, the President signed the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act. The purpose of the CARES Act is to provide emergency assistance and health care response for individuals, families, and...more

Akin Gump Strauss Hauer & Feld LLP

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

Akin Gump Strauss Hauer & Feld LLP on

[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

Sheppard Mullin Richter & Hampton LLP

Is Prescription Drug Pricing The Cure For Partisanship?

Sheppard Mullin Richter & Hampton LLP on

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

Jones Day

Certain Pharmaceutical Discounts No Longer Safe Under the "Safe Harbors"?

Jones Day on

The proposed rule evidences the HHS' and the Administration's continued interest in reducing federal spending for pharmaceutical products. On February 6, 2019, the Department of Health and Human Services ("HHS") published...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

Sheppard Mullin Richter & Hampton LLP on

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

K&L Gates LLP

HHS Issues Proposed Rule to Remove Safe Harbor for Drug Rebates

K&L Gates LLP on

On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: shutdown risk increases as talks stall; Gottlieb’s Hill testimony postponed; more bills...more

Hogan Lovells

Trump administration proposes ambitious AKS rewrite on drug rebates, but needs answers to big questions

Hogan Lovells on

In a significant step towards implementing its American Patients First blueprint for lowering prescription drug prices and patient out-of-pocket costs, the Trump administration has proposed a series of changes to the...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

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