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LEGISLATIVE ACTIVITY -
On Monday, July 28, the House Committee on Energy and Commerce, Subcommittee on Health will hold a markup to consider two bills: H.R. ____, a bill to require the Secretary of Health and Human...more
The draft guidance also enables some health IT manufacturers to avoid the device tax.
The Food and Drug Administration (FDA) took an unusual step on June 20 by issuing new draft guidance that states its intent to not...more
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 4191 imposes a...more
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
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
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
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
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
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
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