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Patient Protection and Affordable Care Act (PPACA) › PHRMA

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 -
Mintz - Health Care Viewpoints

With Proposal to Cap Drug Price Increases, Massachusetts Once Again Takes Center Stage in the Drug Pricing Debate

Mintz - Health Care Viewpoints on

On March 17, the same day we wrote about proposed legislation in Connecticut to cap drug price increases, Governor Charlie Baker of Massachusetts included a similar proposal in his proposed budget. Similar to the Connecticut...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – January 2019 #4

Mintz - Health Care Viewpoints on

The shutdown is over for now and Congress is hitting the ground running this week. Most priorities have been on standby with the shutdown taking center stage, so this week in a sense represents the first week of the 116th...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – March 2018 #3

Mintz - Health Care Viewpoints on

This is the week. Congress needs to fund the government by Friday to avoid a government shutdown. It’s all but certain that the government will be funded, despite the dysfunction on display in getting through this week. The...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – March 2018 #2

Mintz - Health Care Viewpoints on

This week, Congress returns to Washington with 11 days to finalize a government spending bill. House appropriators will be meeting throughout the week to finalize their respective packages which means we should expect to see...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – January 2018 #3

Mintz - Health Care Viewpoints on

This week, President Trump will go before Congress for his first State of the Union address. Will it be olive branches or brickbats? The next deadline for a government-funding bill is February 8th, a week from Thursday. Will...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: Congress unable to come to agreement on funding the government past Dec. 11 so a short-term funding bill was passed to give more time for negotiations... Tax extenders still being discussed as a vehicle for a...more

K&L Gates LLP

340B Orphan Drug Interpretive Rule Struck Down by D.C. District Court: HHS and HRSA Lose In Second Round of Litigation Over 340B...

K&L Gates LLP on

In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more

BakerHostetler

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

BakerHostetler on

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the...more

Mintz - Health Care Viewpoints

Does Invalidation of 340B Orphan Drug Rule Doom HRSA’s Guidance?

Mintz - Health Care Viewpoints on

Our recent post on HRSA’s Omnibus Proposed Guidance for the 340B Drug Discount Program (Proposed Guidance) noted that since the DC District Court had yet to rule on the validity of HRSA’s “interpretive” 340B orphan drug rule,...more

McDermott Will & Emery

Federal Court Rejects HHS Interpretation of 340B Program’s Orphan Drug Rule

McDermott Will & Emery on

On October 14, 2015, the United States District Court for the District of Columbia (the Court) issued a decision in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human...more

King & Spalding

Victory for Pharmaceutical Manufacturers Challenging HHS’s Interpretive Rule Covering Orphan Drugs Under 340B Program

King & Spalding on

On October 14, 2015, the United States District Court for the District of Columbia struck down an interpretive rule from HHS that limited the prices pharmaceutical manufacturers could charge for orphan drugs sold to certain...more

McDermott Will & Emery

New Challenge to 340B Rule Regarding Orphan Drugs

McDermott Will & Emery on

On October 9, 2014, Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint (the October 9 Complaint) against the U.S. Department of Health and Human Services (HHS), the Health Resources and Services...more

Faegre Drinker Biddle & Reath LLP

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Faegre Drinker Biddle & Reath LLP on

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

Mintz - Health Care Viewpoints

Health Care Update - July 2014 #3

Mintz - Health Care Viewpoints on

In This Issue: - First Guidance following Hobby Lobby released - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives ...more

BakerHostetler

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

BakerHostetler on

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

Foley Hoag LLP

DC District Court Strikes Down 340B Orphan Drug Rule

Foley Hoag LLP on

On May 23, Judge Contreras of the U.S. District Court for the District of Columbia (DC District Court) ruled that the Health Resources and Services Administration (HRSA) did not have the statutory authority to promulgate its...more

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