News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) › Pharmaceutical Industry › Prescription Drugs

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 -
Wiley Rein LLP

Recent Developments in Pharmacy-Related Legislation and Regulations

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Over the last two months, there has been a steady influx of regulatory and legislative efforts regarding drug pricing and the pharmacy industry. To streamline your review, we summarize below a few noteworthy developments that...more

McDermott Will & Emery

CMS Advises Preparatory Steps for Anticipated PrEP Coverage Transition to Medicare Part B

McDermott Will & Emery on

On April 15, the Centers for Medicare & Medicaid Services (CMS) released a fact sheet on the potential national coverage determination (NCD) for pre-exposure prophylaxis (PrEP) using antiretroviral drugs to prevent HIV. CMS...more

Cozen O'Connor

Cozen Currents: Populism is Popular

Cozen O'Connor on

The Cozen Lens- • Regardless of which candidate is victorious in November’s presidential election, populism will be sure to shape the next administration’s policies. • In an age of populism, Big Tech has increasingly...more

ArentFox Schiff

Top Legal Considerations for the GCs and CFOs in the Life Sciences Industry in 2024

ArentFox Schiff on

The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more

Ballard Spahr LLP

HHS Announces Temporary Copay Accumulator Non-Enforcement Policy

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The United States Department of Health and Human Services (HHS) has filed court pleadings stating that it does not intend to initiate enforcement actions against plans that maintain copay accumulator programs....more

McDermott+

McDermottPlus Check-Up: May 19, 2023

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The House and Senate were both in session this week, with significant healthcare activity at the committee level. The House Ways & Means Committee met to discuss healthcare price transparency, and the Ways & Means Health...more

McDermott Will & Emery

Welcome (But Last Minute) Relief for Prescription Drug Reporting Originally Due December 27

McDermott Will & Emery on

Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules...more

Alston & Bird

Health Care Week in Review: CMS Issues Prior Authorization Proposed Rule

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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

Patrick Malone & Associates P.C. | DC Injury...

Better Healthcare Newsletter from Patrick Malone - July 2022

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The 21st century American reality is if you get sick, really sick,you're in for a money nightmare on top of the emotional and physical toll of serious disease. Medical costs keep skyrocketing with no sign of easing....more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - July 2022 #2

Latham & Watkins LLP on

Drug Pricing Initiatives: Democrats renewed their efforts to pass drug pricing reform measures in the form of a revised H.R. 5376 (the Build Back Better Act, or BBBA). Democrats intend to adopt the BBBA as part of the budget...more

Foley Hoag LLP - Medicaid and the Law

Enforcing Medicaid’s Guarantee of Access to Prescription Drugs

Foley Hoag LLP - Medicaid and the Law on

Over the years, we’ve written about the difficulties in challenging the entitlement to Medicaid in the federal courts. In light of a series of Supreme Court decisions dating back to 1990, the pathway for an aggrieved Medicaid...more

Brownstein Hyatt Farber Schreck

Summary of Health Care Provisions in Energy & Commerce Reconciliation Bill

Brownstein Hyatt Farber Schreck on

This week, the House Energy and Commerce Committee approved sweeping health care legislation as part of the Democratic Congress’ plan to enact a $3.5 trillion legislative package through budget reconciliation. The committee...more

Sheppard Mullin Richter & Hampton LLP

Federal Government Announces Enforcement Discretion, Deferral For Certain Price Disclosures And Future Rulemakings

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Health plans and issuers racing to implement overlapping price transparency and disclosure requirements in response to the Transparency in Coverage final rule (TiC Final Rule) and the Consolidated Appropriations Act, 2021...more

Wilson Sonsini Goodrich & Rosati

Viatris Receives FDA Approval for First Interchangeable Biosimilar

Wilson Sonsini Goodrich & Rosati on

On July 28, 2021, the U.S. Food and Drug Administration (FDA) announced a landmark approval of Viatris Inc.’s Semglee® as the first interchangeable biosimilar product. Semglee® (insulin glargine-yfgn), indicated to control...more

Foley Hoag LLP - Medicaid and the Law

Summer Reruns: ‘340B Contract Pharmacy Saga’ Back in the Spotlight as OGC Withdraws Advisory Opinion

Foley Hoag LLP - Medicaid and the Law on

Like the Brood X cicadas emerging from their 17-year chthonic slumber, summer 2021 saw the reemergence of something else set to dominate headlines: 340B contract pharmacies.  Given the link between the Medicaid drug rebate...more

Mintz - Health Care Viewpoints

The American Families Plan & A Call for Drug Pricing Legislation

Mintz - Health Care Viewpoints on

On April 28, 2021, President Biden gave his first address to Congress and announced the American Families Plan (AFP or the Act). The AFP follows the 1.9 trillion-dollar stimulus, the American Rescue Plan Act, signed into law...more

McGuireWoods Consulting

Washington Healthcare Update - April 2021 #3

McGuireWoods Consulting on

This week in Washington: Andrea Palm’s nomination for HHS Deputy Secretary Advances out of Senate Finance Committee, Chiquita Brooks-LaSure’s nomination deadlocked....more

K&L Gates LLP

340B Update: Federal Court Halts 340B Administrative Dispute Resolution Rule

K&L Gates LLP on

Safety net providers participating in the 340B Drug Pricing Program (340B Program) continue to grapple with drug manufacturers imposing restrictions on 340B contract pharmacy arrangements. In response to these actions, the...more

Alston & Bird

Alston & Bird Health Care Week in Review - March 2021 #4

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

K&L Gates LLP

HRSA Publishes Long-Awaited (and Long-Overdue) 340B Program Alternative Dispute Resolution Process Final Rule

K&L Gates LLP on

On Thursday, 10 December 2020, the Department of Health and Human Services (HHS), Health Resources and Services Administration (HRSA) issued a pre-publication copy of the long-awaited 340B Drug Pricing Program Alternative...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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Tuesday, 24 November 2020 - U.S. President-elect Joe Biden has pledged to expand the role of the federal government in response to the COVID-19 public health emergency, build on the Affordable Care Act, and continue drug...more

McDermott Will & Emery

Agencies Issue Final Employer Healthcare Price Transparency Rule

McDermott Will & Emery on

On October 29, 2020, the US Departments of Health and Human Services, Labor and Treasury (collectively, the Departments) issued the Transparency in Coverage final rule (the Rule), along with a fact sheet, setting forth...more

Hogan Lovells

[Webinar] Looking ahead to 2021: Impacts of the election for the life sciences and health care industry - November 19th, 12:30 pm...

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Life Sciences and Health Care Horizons virtual event series - The fast pace of innovation in the life sciences and health care industry has reached an all-time high in 2020 as the industry grapples with the new reality of...more

McGuireWoods Consulting

Washington Healthcare Update - July 2020 #3

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This week in Washington: House passes first set of Appropriations bills; President Trump signs Executive Orders on Prescription Drugs after COVID-19 bill stalled....more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

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On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

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