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Patient Protection and Affordable Care Act (PPACA) Healthcare Biosimilars

The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal... more +
The Patient Protection and Affordable Care Act (PPAC), also known as Obamacare, is a United States federal statute passed in March of 2010. The Act creates a nationwide insurance system and provides federal subsidies to reduce the number of uninsured citizens. less -
Foley & Lardner LLP

ACA Strike-Down: Salvaging the BPCIA via Severability

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Justice Reed O’Connor’s recent decision, Texas et al. v. U.S. et al., No. 4:18-cv-00167-O (E.D. Tex. Dec. 14, 2018), to strike down the entire Patient Protection and Affordable Care Act, 42 U.S.C. § 18001 et seq. (2010) (the...more

Epstein Becker & Green

Is the Affordable Care Act a House of Cards? If Yes, What Does the Recent Texas Court Decision Mean for the US Health Insurance...

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In an unexpectedly broad ruling issued December 14, 2018, the U.S. District Court for the Northern District of Texas declared the Affordable Care Act (“ACA”) as unconstitutional in its entirety. This decision, if ultimately...more

Alston & Bird

A&B Healthcare Week in Review, November 2015

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I. REGULATIONS, NOTICES, & GUIDANCE - On November 21, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Patient Protection and Affordable Care Act; HHS Notice of Benefit and...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Repealing Obamacare becomes problematic in the Senate... More focus on drug prices and reimbursement... FDA asks, should we regulate “natural” and if so, how? ...more

McGuireWoods LLP

Washington Healthcare Update

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Bicameral Bill Introduced to Provide HHS Authority to Reject Proposed Insurance Rates - Before Congress left for its Columbus Day recess, Rep. Jan Schakowsky (D-IL) and Sen. Diane Feinstein (D-CA) introduced the Health...more

McGuireWoods LLP

Washington Healthcare Update

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On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more

Alston & Bird

A&B Healthcare Week In Review, September 2015

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On September 25, 2015, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare Program: Medicare Clinical Diagnostic Laboratory Tests Payment System”. This proposed rule would...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

Manatt, Phelps & Phillips, LLP

Health Update - July 2015

Lessons From the Frontlines: Strategies for Supporting Informed Consumer Decision-Making in the Health Insurance Marketplace - Editor's Note: As marketplaces prepare for the third open enrollment period, consumers are...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House E&C Releases Discussion Draft of 21st Century Cures Legislation Ahead of Legislative Hearing... FDA Finalizes Biosimilar Guidance Documents... CMS Updates Wage Index and Payment Rates for the Medicare Hospice...more

King & Spalding

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

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Biosimilars Are Generally Treated as Single Source Drugs - On March 30, 2015, in the wake of the first biosimilar product licensed by the Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: CMS Releases Three Documents on Biosimilar Reimbursement... SCOTUS: Agencies, Not State Courts, in Charge of Medicaid Rate Setting... HHS OIG and Treasury IG Release Report on ACA’s Advanced Premium Tax Credits....more

Mintz - Health Care Viewpoints

Health Care Update - August 2014 #3

In This Issue: - Stakeholders Urge FDA to Provide Clarity on Biosimilars - Ebola Crisis Continues - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

Knobbe Martens

Biosimilars Webinar - July 23, 2013

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On Tuesday, July 23, Knobbe Martens hosted a live webinar event covering "Preparing for Biosimilars: Key Points for Participating in the U.S. Regulatory Framework." Partners Eli Loots, Carol Pitzel Cruz, and Sheila Swaroop...more

Cozen O'Connor

Health-Care Reform Creates Large-Dollar Biosimilar Drug Market

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Health care reform brought about sweeping changes to our nation's health-care system. Much of the commentary has been focused on the medicaid expansion and the individual coverage mandate, punctuated by the U.S. Supreme Court...more

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