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FDA to Cease Active Regulation of MDDS and Other Health IT Devices

The draft guidance also enables some health IT manufacturers to avoid the device tax. The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more

Health Update - Jun 2014

Removing Regulatory Barriers to Accelerate EHR Adoption - Recognizing the potential long-term value of EHRs for improving care and reducing costs, many hospitals considered offering physicians financial support to...more

IRS Ruling Addresses Application of Medical Device Excise Tax in Contract Manufacturing Arrangement

In Private Letter Ruling 201420004 (released May 16, 2014), the Internal Revenue Service (IRS) has ruled on the question of which party in a contract manufacturing arrangement is the "manufacturer" for purposes of the medical...more

White Collar Watch - October 2013

In This Issue: - Small businesses beware: IRS deploys “big data” to scrutinize cash transactions - Google’s scanning of emails may constitute wiretapping: Federal District Court denies Google’s motion to dismiss...more

PA Tax Law News - September 2013: Commonwealth Court Denies Manufacturing Exclusion to Service Provider

On August 6, 2013, in a case with possible implications for other providers of nontaxable services, Pennsylvania’s Commonwealth Court ruled, en banc, that a medical group’s MRI and CT scan equipment does not qualify for the...more

News and Insights from Austin - Q2 2013

Welcome to the summer issue of News and Insights. In this issue, I’m proud to highlight Becca McKnight, who was recently selected by The Food and Drug Law Institute (FDLI) to serve on its Medical Devices Committee. Becca...more

Health Care Reform Update -- June 10th, 2013

In This Issue: Leading the News; Implementation of the Affordable Care Act; Other HHS and Federal Regulatory Initiatives; Other Congressional and State Initiatives; Other Health Care News; and Hearings and Mark-Ups...more

Getting Over the Goal Line: Congress Shows Strong Support for Medical Device Tax Repeal, but Issues Remain

Introduction - The Patient Protection and Affordable Care Act (“ACA”) generates very few areas of agreement. However, in recent months, proposals to repeal one of the most visible and controversial provisions of the...more

Wisconsin Court Confirms Computer-Controlled Medical Devices Are Exempt From Property Tax

In 2008, the Wisconsin Tax Appeals Commission ruled that the following categories of computerized medical equipment are exempt from property tax: - Ultrasound equipment - Magnetic resonance imaging (MRI)...more

Health Care Reform Implementation Update - April 26, 2013

Marilyn Tavenner received bipartisan support from members of the Senate Committee on Finance in her confirmation hearing to lead the Centers for Medicare and Medicaid Services (CMS) though a full Senate vote is being held up,...more

Excise Tax Kicks In Jan. 1 On Certain Medical Devices

Beginning January 1, 2013, manufacturers and importers of certain medical devices will be required by the U.S. Internal Revenue Service (IRS) to pay a new 2.3 percent medical device excise tax on the sales of taxable medical...more

IRS Releases Final Rule on Medical Device Tax

Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more

Medical Devices To Be Taxed: Manufacturers and Importers Be Prepared

Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more

New Rules Will Be “Taxing” On Medical Device Manufacturers

The U.S. Department of the Treasury and the Internal Revenue Service (IRS) recently issued much-anticipated final regulations under Section 4191 of the Internal Revenue Code (Code), which imposes a 2.3% tax on sales of any...more

IRS Issues Device Tax Regulations; Industry Braces for 2013 Implementation

Pending the January 1 effective date, final regulations and interim guidance on the medical device excise tax provide some clarity but leave many questions unanswered. On December 7, the Internal Revenue Service (IRS)...more

Treasury Issues Binding Guidance On Medical Device Excise Tax

The Department of the Treasury and the Internal Revenue Service (IRS) published in the December 7, 2012 Federal Register final regulations and released other interim guidance on the implementation of the new excise tax on...more

IRS Issues Final Regulations for Medical Device Excise Tax Effective January 1, 2013: Industry Continues to Seek Delay or Repeal

The IRS recently published final regulations to implement the 2.3 percent medical device excise tax scheduled to go into effect on January 1, 2013. The final rule makes no major changes from the proposed rule issued earlier...more

Coming in 2013, the Medical Device Excise Tax

Now that the Supreme Court has upheld, at least in part, the Affordable Care Act, one of the additional taxes set to take effect in 2013 is the so-called Medical Device Excise Tax. Beginning in 2013, Section[1] 4191 imposes a...more

U.S. Supreme Court Upholds Patient Protection and Affordable Care Act Under Taxation Clause in Nat'l. Fed'n. of Independent...

In a history-making decision, the Supreme Court today ruled that the Patient Protection and Affordable Care Act (PPACA) is constitutional under the taxation clause of the Constitution. The most controversial provision was the...more

WTO Accession of the Russian Federation - Implications for Pharmaceuticals and Medical Devices

Russia’s accession to the World Trade Organization (WTO) will create opportunities to increase exports of pharmaceutical products and medical devices. On 16 December 2011, WTO Members accepted the terms of the Russian...more

Why Are the Feds Willing to Pay the Cost of Fraud?

Kathleen Sharp tells a good, if scary, story. In “Blood Feud: The Man Who Blew the Whistle on One of the Deadliest Prescription Drugs Ever,” she describes how two Big Pharma companies conspired to develop and market an...more

The Life Sciences Report - Spring 2011

In This Issue: New Pressures on the Pharma and Medical Device Industry Highlight the Importance of Compliance Programs...Page 1-2; Marketing Do’s and Don’ts: What Senior Management of Commercial-Stage Life Sciences...more

IRS Issues Guidance on Calculation of the Annual Fee Imposed on Manufacturers and Importers of Branded Prescription Drugs Under...

On November 29, 2010, the Internal Revenue Service (the "IRS") issued Notice 2010-71, 2010-50 IRB (the "Notice"), which provides guidance on the calculation of the annual fee imposed on certain manufacturers and importers of...more

Reminder: Applications under the $1 Billion Qualifying Therapeutic Discovery Project Program Due July 21, 2010

The IRS recently announced that firms may begin applying for certification for tax credits or grants available under the Qualifying Therapeutic Discovery Project Program. In recent advisories, we reported that the Patient...more

Health Care Reform Advisory: Update on the Billion-Dollar Tax Credit and Grant Opportunity: What Life Sciences Companies Can Do...

In a recent advisory, we reported that the Patient Protection and Affordable Care Act (a.k.a. the health care reform bill) includes $1 billion in tax credits and grants to defray the costs of therapeutic research by small and...more

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