Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Arnold & Porter Kaye Scholer LLP
The awaited decision of the EU Member States on the new home for the European Medicines Agency (EMA) was published today.
Arnold & Porter Kaye Scholer LLP
The European Commission has finally published the draft amendment to Regulation No 847/2000 regarding the concept of "similar medicinal product" for the purposes of the Orphan Medicinal Products Regulation.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations.
Troutman Sanders LLP
Further briefing and deliberation are expected on a Motion to Intervene filed by several anti-tobacco advocacy and health groups in Nicopure Labs, LLC, v. FDA, No. 17-5196 (D.C. Cir.).
Foley & Lardner
Following on the heels of its plans to review Medicare payments for telehealth services, the federal Office of Inspector General (OIG) at the Department of Health & Human Services (HHS) ...
Troutman Sanders LLP
In the cigar industry's challenge to the FDA's Deeming Regulations, there has been a flurry of activity in anticipation of oral argument on the parties' cross- motions.
Holland & Knight
False Claims Act cases often turn into battles of the experts. But only rarely does that battle turn into a rout.
Foley Hoag LLP
On November 13, 2017, a group of hospital trade associations (the American Hospital Association, the Association of American Medical Colleges, and America's Essential Hospitals) ...
McDermott Will & Emery
On November 7, the FDA published the latest in a series of industry draft guidance documents to help implement menu labeling and nutrient disclosure regulations applicable to chain restaurants...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
On Monday, November 13, our colleagues in the Antitrust Section published an alert on the recent FTC workshop, "Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics."
Sheppard Mullin Richter & Hampton
As federal tax reform efforts proceed rapidly in both chambers of Congress, tax-exempt hospitals and other tax-exempt healthcare organizations are facing major potential changes.
Fenwick & West LLP
Fenwick corporate lawyer Julia Forbess discussed biotech investment and financing trends with the BIO Buzz Center at the 2017 BIO Investor Forum.
Seyfarth Shaw LLP
The Fourth Circuit found that the medical necessity of a given service constitutes a material element of representations regarding submissions for payment, potentially providing payors ...
Ford & Harrison LLP
A cornerstone of Governor-elect Phil Murphy's campaign platform was the decriminalization of marijuana in New Jersey.
Morrison & Foerster LLP
Today's post is the first of two installments on protest grounds related to discussions. This post will focus on the requirement that discussions be meaningful and not misleading, and treat offerors equally.
Reed Smith
The Centers for Medicare & Medicaid Services (CMS) has published its final Medicare physician fee schedule (PFS) rule for CY 2018.
Reed Smith
CMS is redistributing the $1.6 billion in savings from this change by increasing by 3.2% conversion factor for non-drug items and services for 2018.
Seyfarth Shaw LLP
On November 8, 2016, Maine voters approved "Question 1 – An Act to Legalize Marijuana" ("Act"), and joined a handful of other states, including California...
Carlton Fields
The Centers of Medicare and Medicaid Services released a proposed rule that would update the 2018 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System.
BakerHostetler
The year-end schedules of the Senate HELP and Finance committees just became more clogged, as the two panels will lead the review of President Trump's nominee to be Health & Human Services (HHS) secretary.
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Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
EIP allows municipalities like the City to pay providers directly for EIP services and then seek reimbursement from other payors, like third party payors and New York Medicaid.
Foley Hoag LLP
This is the first of a multi-part end-of-year series examining important trends in data privacy and cybersecurity during the coming year.
Lowndes, Drosdick, Doster, Kantor & Reed, P.A.
Notwithstanding what we consider a well-reasoned and proper ruling by an Administrative Law Judge against Governor Scott's emergency rule on generators and fuel, cautious senior living facility...
Troutman Sanders LLP
Recent filings in the cigar industry's challenge to the FDA's Deeming Regulations involve outside support and opposition. The case is Cigar Association of America v. FDA, No. 1:16-cv-01460 (D.D.C.).
Seyfarth Shaw LLP
The Republicans made a last ditch effort to repeal the Affordable Care Act (ACA) the last week of September when they floated the latest iteration of proposed legislation under the Graham-Cassidy bill.
Carlton Fields
On November 2, Humana filed a lawsuit in the United States Court of Federal Claims to recover approximately $600 million allegedly owed by the United States government. See Humana Inc. v. U.S., case number 1:17-cv-01664.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Consumers are increasingly turning to health apps for a variety of medical and wellness-related purposes. This has in turn caused greater amounts of data ...
Thompson Coburn LLP
The fate of crucial federal legislation protecting medical cannabis producers, retailers and consumers from prosecution by the U.S. Department of Justice has recently become uncertain due to...
Day Pitney LLP
The Connecticut General Assembly adjourned in June and now – 123 days later – Governor Dannel Malloy last Tuesday signed into law a two-year state budget.
Stites & Harbison PLLC
Do Kentucky patients have a cause of action against a hospital for the negligent credentialing of a non-employee physician who is given staff privileges by the hospital? In March of 2016, the Court of Appeals answered that question in the affirmative, recognizing a new, stand-alone tort and avenue for recovery against Kentucky hospitals.
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