News & Analysis as of

Medicaid Regulatory Requirements Prescription Drugs

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 -
Proskauer - Health Care Law Brief

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

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

Jackson Lewis P.C.

Is the One Big Beautiful Bill Act an Employee Benefits Crystal Ball?

Jackson Lewis P.C. on

Takeaways- • Republicans in the U.S. House of Representatives attempt to deliver on President Trump’s campaign promises in the One Big Beautiful Bill Act (BBB or the Act), which passed the House by a razor-thin margin of...more

Maynard Nexsen

The Alabama Community Pharmacy Relief Act: Key Provisions and Legislative Journey

Maynard Nexsen on

Introduction The Alabama Community Pharmacy Relief Act, Senate Bill 252, has successfully passed the Alabama Senate and is now advancing to the House for consideration. This legislation aims to regulate pharmacy benefits...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

Woodruff Sawyer

Reminder: RxDC Reporting Due June 1st

Woodruff Sawyer on

With the 2024 reference year RxDC reporting deadline approaching in June, plan sponsors should re-familiarize themselves with the reporting requirements. The 2024 reference year RxDC Reporting Instructions have been released,...more

Mintz - Health Care Viewpoints

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

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

Davis Wright Tremaine LLP

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

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

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

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

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

Bricker Graydon LLP

CMS finalizes site-neutral payment for clinic visits but declines to finalize clinical families payment limitation

Bricker Graydon LLP on

In its final Calendar Year (CY) 2019 Outpatient Prospective Payment System (OPPS) Rule released November 2, 2018 (the Final Rule), the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to make payments for...more

Robinson+Cole Health Law Diagnosis

Connecticut Enacts Law to Limit Automatic Prescription Refills for Medicaid Beneficiaries

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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