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Medicaid › Regulatory Requirements › 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 -
Paul Hastings LLP

CMS Proposes Major ASP Reporting Overhaul — Implications for Fair Market Value and Bona Fide Service Fees

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The Centers for Medicare & Medicaid Services (CMS) recently published its Proposed 2026 Physician Fee Schedule Rule (Proposed Rule), with extensive implications for drug pricing, Average Sales Price (ASP) calculations, and...more

Shipman & Goodwin LLP

340B Drug Pricing Program Is on a Slippery Slope

Shipman & Goodwin LLP on

On July 31, 2025, notice was published in the Federal Register by the Health Resources and Services Administration (“HRSA”) of a “340B Rebate Model Pilot Program” (“340B Pilot Program”). The 340B Pilot Program’s stated...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Proskauer - Health Care Law Brief on

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Alston & Bird

Health Care Week in Review | The House of Representatives Approved a Budget Resolution and President Trump Signed an EO on...

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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

ArentFox Schiff

Massachusetts Enacts Drug Pricing Legislation: Introducing PBM Licensure, Mandatory Cost Reporting, and Consumer Cost-Sharing...

ArentFox Schiff on

On January 8, Massachusetts Governor Maura Healy signed into law “An Act Relative To Pharmaceutical Access, Costs And Transparency.” The Act will have a profound impact on all parties involved in setting and applying drug...more

Ankura

Bona Fide Service Fees, Government Price Reporting, and the Inflation Reduction Act

Ankura on

“Manufacturers are responsible for meeting all four parts of the definition of bona fide service fee before a fee can qualify as a bona fide service fee.” ...more

Maynard Nexsen

2025 Alabama Legislative Update: Regular Session

Maynard Nexsen on

Pharmacy Benefit Managers (PBMs) - This week, there were public hearings held on two pieces of legislation concerning PBMs, but they did not advance as there were no votes on the bills. SB93, sponsored by Senator Andrew...more

Mintz

Mintz IRA Update — Duplicate Discounts Between the 340B Program & Medicare Drug Price Negotiation Program

Mintz on

The 340B Drug Pricing Program (340B Program) is no stranger to controversy. We have previously covered the ongoing contract pharmacy legal battles and the new alternative dispute resolution process. And now, a new 340B hurdle...more

Mintz - Health Care Viewpoints

Massachusetts Aligns with National Trends and Enacts Sweeping Legislation to Regulate Pharmaceutical Benefit Managers

Mintz - Health Care Viewpoints on

On the heels of a nationwide push to regulate pharmacy benefit managers (PBMs), Massachusetts enacted a landmark piece of legislation to increase transparency and oversight within the pharmaceutical supply chain, specifically...more

Ropes & Gray LLP

Adapting to the IRA: Early Lessons Learned on the IRA’s Impact on Deal-Making, Drug Economics, and Business Strategy

Ropes & Gray LLP on

More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more

McDermott+

It’s Raining Regs: CMS Releases Major Laboratory-Developed Test Reg in Midst of Massive Reg Storm

McDermott+ on

Over the last several weeks, the Biden administration has released numerous final regulations in order to “beat the clock” before it ticks down to the Congressional Review Act (CRA) deadline. The CRA authorizes Congress to...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Health Care Compliance Association (HCCA) on

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

McDermott Will & Schulte

Trending in Telehealth: November 8 – 14, 2023

McDermott Will & Schulte on

Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Health Care Compliance Association (HCCA) on

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 18th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 16th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 11th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

Davis Wright Tremaine LLP

[Webinar] 2021 DWT Healthcare Regulatory and Compliance Seminar - A Virtual Series - March 9th, 10:00 am - 12:00 pm PT

Davis Wright Tremaine LLP on

Please join us for our annual healthcare compliance seminar to discuss current developments in healthcare regulation and hospital compliance... Registrants will have the option of selecting the sessions they would like to...more

King & Spalding

FDA Issues Proposed Rule and Draft Guidance on Drug Importation

King & Spalding on

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

Robinson+Cole Health Law Diagnosis

Connecticut Enacts Law to Limit Automatic Prescription Refills for Medicaid Beneficiaries

Robinson+Cole Health Law Diagnosis on

On June 1, 2018, Connecticut Governor Dannel P. Malloy signed into law Public Act 18-77 “An Act Limiting Auto Refills of Prescription Drugs Covered Under the Medicaid Program and Requiring the Commissioner of Social Services...more

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