News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) › Medicare Part B › Pharmaceutical Industry

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

Wiley Rein LLP on

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

ArentFox Schiff

Fast 5: Five Quick Regulatory Takeaways for Pharmaceutical Companies

ArentFox Schiff on

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

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

Hogan Lovells

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

Hogan Lovells on

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

King & Spalding

New Risks, New Rewards, New Exposure

King & Spalding on

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

Goodwin

Legal Developments to Keep an Eye Out for in 2020

Goodwin on

Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s...more

BakerHostetler

Capitol Hill Healthcare Update

BakerHostetler on

Below is this week’s “Capitol Hill Healthcare Update,” which is posted on Mondays when Congress is in session. Highlights this week: Trump will discuss healthcare and drug costs in this week’s State of the Union address;...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

K&L Gates LLP

340B Update: CMS Proposes to Reduce 340B Drug Reimbursement; Draft Executive Order Could Mean Further Changes to the 340B Program

K&L Gates LLP on

The Trump administration is considering significant changes relating to the 340B Drug Pricing Program (“340B Program”), which allows certain categories of safety net providers to access discounted pricing on covered...more

Mintz - Health Care Viewpoints

What the Administration Actually Can Do on Drug Pricing

Mintz - Health Care Viewpoints on

The President’s budget makes clear for all to see that the Administration wants to do something related to drug pricing. Unfortunately for the Administration, most of their proposals require Congressional authority that have...more

King & Spalding

CMS Issues Guidance on Reimbursement for Biosimilars under Medicare and Medicaid

King & Spalding on

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

Baker Donelson

CMS Releases CY 2014 Hospital OPPS and ASC Final Rule

Baker Donelson on

CMS has published its Calendar Year (CY) 2014 Final Rule for Medicare policy and payment rates for hospital outpatient prospective payment systems (OPPS) and Ambulatory Surgical Center (ASC) services. This final rule with...more

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