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Hospitals Patient Protection and Affordable Care Act (PPACA) Pharmaceutical Industry

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

Sheppard Mullin Richter & Hampton LLP

Day 2 Notes at the 2020 J.P. Morgan Healthcare Conference

The Big Cost; Cancer is the Answer; and SDOH Evolves - The Big Cost: You’re okay today, and then tomorrow you’re not. Life has changed and there’s a new reality. Whether it’s an acute event – an accident, a heart attack, a...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

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Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

Butler Snow LLP

Pro Te: Solutio Vol. 11 No. 1 – A Reflection on the First Ten Years

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It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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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

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Downs Rachlin Martin PLLC

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017 #3

Act 188 Plans On Hold as New Chemical Bill is Introduced - Nearly three years after the legislature passed a law to regulate children’s products containing chemicals of high concern, a web site intended to inform the...more

Downs Rachlin Martin PLLC

News from the Vermont State House - An analysis from DRM's Government & Public Affairs Team - February 2017

The Agency of Transportation has submitted a proposal to the House Transportation Committee that would allow the agency to seek damages from a utility that fails to move or adjust a utility line that is in a state or local...more

Mintz - Health Care Viewpoints

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

Bass, Berry & Sims PLC

Navigating the ACA in the Trump Era

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On November 8, 2016, the future of the Patient Protection and Affordable Care Act (ACA) became more uncertain. Republicans in Congress have been working to repeal the ACA since it was passed in 2010, and now, with control of...more

McDermott Will & Emery

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

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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

K&L Gates LLP

HRSA Issues 340B Program Omnibus Guidance

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On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more

King & Spalding

Also In The News - Health Headlines - July 2015

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CMS Reopens Attestation Period For First-Time Hospitals Until August – CMS recently announced that eligible hospitals participating in the Medicare Electronic Health Record Incentive Program for the first time in 2015 may...more

Manatt, Phelps & Phillips, LLP

Health Update - June 2015

Examining Fee Splitting Statutes in the Context of Value-Based Healthcare - Editor’s note: One of the goals of the Affordable Care Act (ACA) is to align incentives among provider communities and their patients and...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: House Ways & Means Committee Holds Markup; Makes Significant Legislative Changes to Health Care Bills... Senate Finance Committee Holds Markup on Medicare Appeals Process Bill... CMS Issues Final Rule on...more

McGuireWoods LLP

Washington Healthcare Update

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This Week: President’s FY2016 Budget Request... FDA Commissioner Hamburg to step down... Tennessee Medicaid expansion plan rejected by legislature. 1. Congress House House Ways and Means Committee Hosts Hearing...more

McDermott Will & Emery

New Challenge to 340B Rule Regarding Orphan Drugs

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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

BakerHostetler

It Is Finally Here-the Sun Shines on a New Era

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The Centers for Medicare and Medicaid Services (CMS) publicly launched a database this week detailing the payments doctors and teaching hospitals have received from drug and medical device manufacturers. Under the Physician...more

Polsinelli

You Are Now on the Clock — Sunshine Act Dispute Window Now Open

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Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more

Mintz - Health Care Viewpoints

Health Care Update - June 2014 #2

In This Issue: - Confusion Persists in Anticipation of 340B “Mega-Rule” - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other Congressional and State Initiatives - Other...more

BakerHostetler

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

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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

Mintz - Health Care Viewpoints

Health Update - June 2014

In This Issue: - Judge Rules Against 340B Drug Authority - FDA Approves Skin Infection Drug - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Other...more

McDermott Will & Emery

Federal Court Vacates 340B Rule Regarding Orphan Drugs

On May 23, 2014, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in Pharmaceutical Research and Manufacturers of America v. United States Department of Health and Human Services, et al. At...more

Baker Donelson

CMS Releases CY 2014 Hospital OPPS and ASC Final Rule

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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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