News & Analysis as of

Patient Protection and Affordable Care Act (PPACA) › Healthcare › Orphan 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 -
Mintz - ML Strategies

Health Care Update - October 2015

Mintz - ML Strategies on

Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more

BakerHostetler

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

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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

Troutman Pepper

District Court Rules Pharmaceutical Manufacturers Are Not Required to Discount Orphan Drugs - Regardless of the Condition Being...

Troutman Pepper on

HHS’ rule requiring pharmaceutical manufacturers to discount orphan drugs when they were used to treat non-rare diseases was inconsistent with Congress’ intent to exclude all orphan drugs from the 340B discount program for...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

K&L Gates LLP

340B Update: HRSA Proposes Penalties for Drug Manufacturers that Overcharge Covered Entities

K&L Gates LLP on

On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...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

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

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