News & Analysis as of

Medicare Modernization Act

Axinn, Veltrop & Harkrider LLP

Hatch-Waxman Overview

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more

Akin Gump Strauss Hauer & Feld LLP

Anti-Obesity Medications: Noteworthy Developments as Policymakers Weigh Coverage Considerations

Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more

McDermott Will & Emery

The ACA 1557 Final Regulations: Plans and Plan Sponsors as Covered Entities

McDermott Will & Emery on

In a recent On the Subject (available here), we reported on the impact of the final rule (final rule) interpreting Section 1557 of the Affordable Care Act (ACA) on self-funded group health plans that contract with licensed...more

Axinn, Veltrop & Harkrider LLP

Will the PTO's Proposed Expansion of Filing Settlement Agreements Help to Reduce Drug Prices?

In a recent Federal Register notice, the PTO announced a proposed rule requiring that any settlement agreement resolving a PTAB proceeding, even if such agreement occurs prior to a decision to institute an inter partes review...more

Axinn, Veltrop & Harkrider LLP

FDA After Chevron

Under the Supreme Court's Chevron doctrine, courts will defer to a federal agency's interpretation of an ambiguous statute unless that interpretation is unreasonable. Chevron U.S.A. Inc. v. Natural Resources Defense Council,...more

McDermott Will & Emery

The Inflation Reduction Act of 2022: Healthcare Provisions

After almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote...more

ArentFox Schiff

Court Side-Steps Overturning “Chevron” Deference in Recent Health-Care Related Decision

ArentFox Schiff on

The concept of “administrative deference” is a key component to the modern regulatory state. An important aspect of administrative deference is the “Chevron doctrine,” i.e. the concept that the courts should defer to relevant...more

ArentFox Schiff

Contract Year 2023 Part D Proposed Rule Released: Changes To 'Negotiated Price' Would Require Potential DIR Fees at the Point of...

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) published the proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs (the Proposed Rule) on...more

McDermott Will & Emery

Medicare Part D Creditable Coverage Notices due before October 15, 2018

McDermott Will & Emery on

The Medicare Modernization Act of 2003 requires employers who offer prescription drug coverage to provide an annual notice to all Medicare Part D eligible individuals who are participants in, or eligible for, the employer’s...more

King & Spalding

CMS Announces Solicitation for the Rural Community Hospital Demonstration Program

King & Spalding on

CMS announced solicitation for applications for participation in the Rural Community Hospital Demonstration Program (Demonstration). In this request for applications, CMS is seeking information from interested hospitals...more

Robins Kaplan LLP

The FDA Implements the Medicare Modernization Act: A New Role and a New Mission?

Robins Kaplan LLP on

The Food and Drug Administration (FDA) has finally—after thirteen years—issued its final rule to amend its current regulations and implement the Medical Modernization Act governing how the American public get their generic...more

Troutman Pepper

FTC Report Tallies Hatch-Waxman Settlements in First Full Year After Actavis

Troutman Pepper on

On January 13, 2016, the Federal Trade Commission (FTC or the Commission) released an overview of the pharmaceutical patent settlements filed with the Commission in Fiscal Year 2014 (October 1, 2013 – September 30, 2014). The...more

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

Baker Donelson

Highlights of OIG's Proposal to Amend Safe Harbors to the Antikickback Statute and CMP Rules, and to Add New Safe Harbors

Baker Donelson on

On October 3, 2014, the Department of Health and Human Services Office of Inspector General (OIG) issued a proposed rule to establish new safe harbors under the antikickback statute and the civil monetary penalty (CMP) rules,...more

Foley Hoag LLP

Centers for Medicare & Medicaid Services Proposes Changes to Six Protected Class Rule under Medicare Part D

Foley Hoag LLP on

On December 8, 2003, the Medicare Prescription Drug, Improvement, and Modernization Act (the “MMA”) was signed into law by former President George W. Bush1. Prior to the enactment of the MMA, Medicare prescription drug...more

McDonnell Boehnen Hulbert & Berghoff LLP

FTC Releases Another Report on Reverse Payment Settlement Agreements in ANDA Litigation

As it has frequently in the past decade, the Federal Trade Commission on Thursday released a Report on the frequency of reverse payment settlement agreements in ANDA litigation between generic and branded drug makers,...more

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