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Patient Protection and Affordable Care Act (PPACA) › Pharmaceutical Industry › Centers for Medicare & Medicaid Services (CMS)

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 -
Alston & Bird

Health Care Week in Review: Biden Administration Announces $100 Million for ACA Marketplace Navigators and $81.3 Million for...

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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

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+

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

McDermott Will & Emery

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

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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

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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

McDermott+

CMS Issues Two Health Plan Proposed Regs: Different Markets but Similar Policy Goals

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Before the Thanksgiving holiday, the Centers for Medicare & Medicaid Services (CMS) issued two proposed regs that would make changes to certain health insurance plan policies starting in 2025: one impacting Medicare Advantage...more

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

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Here we are in fourth quarter of 2023 already! As companies start wrapping up 2023 and preparing and modeling for 2024, we thought it was a good time to highlight five regulatory developments, changes, or challenges on the...more

McDermott+

McDermottPlus Check-Up: June 16, 2023

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The House and Senate were both in session this week, with healthcare activity continuing at the committee level. The House Energy and Commerce Committee held hearings on the Pandemic and All Hazards Preparedness Act (PAHPA)...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

Alston & Bird

Health Care Week in Review: CMMI Announces Three New Models, President Biden Issues Executive Order

Alston & Bird on

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

Alston & Bird

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

Alston & Bird on

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

Latham & Watkins LLP

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

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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

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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

McGuireWoods Consulting

Washington Healthcare Update - January 2022

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Upcoming Hearings/Markups - January 11 - Senate Health, Education and Labor Committee Hearing: “Addressing New Variants: A Federal Perspective on the COVID-19 Response” 10:00 a.m....more

McGuireWoods Consulting

Washington Healthcare Update - October 2021 #2

McGuireWoods Consulting on

This week in Washington: Reconciliation delayed; short-term debt ceiling fix passed....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

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

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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

ArentFox Schiff

Proposed ‘Kitchen Sink’ Medicaid Rule Could Bring Changes for Pharmaceutical Manufacturers

ArentFox Schiff on

The Centers for Medicare & Medicaid Services (CMS) published a Proposed Rule on June 19, 2020 (the Proposed Rule) which, among other things, suggests updates to Medicaid policies and practices related to drug pricing and...more

King & Spalding

New Risks, New Rewards, New Exposure

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Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Cozen O'Connor

Pharma Price Disclosure Rule Struck Down: Will Hospital Price Transparency Rule Meet The Same Fate?

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On June 16, the D.C. Circuit Court struck down the Centers for Medicare and Medicaid Services’ (“CMS”) rule issued in May 2019 requiring pharmaceutical companies to disclose the wholesale acquisition cost of drugs over $35 in...more

McGuireWoods Consulting

Washington Healthcare Update - January 2020 #4

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This week in Washington: Both the House and Senate are back in session....more

BakerHostetler

Capitol Hill Healthcare Update

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ACA TAXES ON CHOPPING BLOCK IN YEAR-END BUDGET DEAL - Congressional leaders are poised to announce an agreement today that would permanently repeal the Affordable Care Act (ACA) taxes on medical device manufacturers,...more

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